Tag Archives: Cost

Moving Beyond The Pill: No Longer An Option

Posted on by
Reply

Many of us would prefer to live, as long as possible, in the comfort zones of old paradigms, hoping to succeed in the same way as we had succeeded in the past. But the wheel of time keeps moving, triggering a significant shift in various paradigms. This includes even the health care space. Most of these changes, as they tend to attain a critical mass, capture the imagination of some in the pharma industry – escaping the attention of many.

One such area of a shifting paradigm is increasing patient preference to get actively engaged in their health care. More specifically, such preferences span across the entire chain of any disease management process – from diagnosis to treatment, often including continuous monitoring, whenever required.

Thus, the creation of well-differentiated value-added patient engagement services, based on credible research data of statistical significance, craftily bundled around the pill, will assume paramount importance. More importantly, such value offerings should lead to demonstrable improvement in treatment outcomes.

This, I reckon, would be the new recipe for pharma marketing excellence in the coming years. In this article, I shall focus on this fast-evolving landscape.

Dawns a new realization:

Early realization of this change is working as an impetus for some global pharma majors to redraw their strategic business models, making appropriate course corrections, which are mostly fundamental in nature.

The article titled ‘How Pharma Can Offer More than Pills’, published in the Harvard Business Review (HBR) on July 23, 2015 identifies the following two realizations as the impetus behind moving beyond the pill initiatives:

  • Medicines alone are often not enough for patients to achieve optimal clinical outcomes.
  • As pharmaceutical pipelines dry up, beyond-the-pill businesses can be valuable new sources of revenues.

Joseph Jimenez, the global CEO of Novartis, appears to be one of the first and foremost to recognize this requirement when he said in 2014 that: “Creating value by embedding products into a holistic offering with the aim to improve patient outcomes and provide tangible competitive advantages.” Jimenez said at that time, “Beyond-the-pill is a logical and inevitable path forward for all.”

As this new realization gets effectively translated into cutting-edge business strategies, “Medicines could accordingly reach market with a label that includes an ‘around the pill’ solution such as a wearable or another tracking device”, as the above HBR article foresees.

Shifting success requirements:

Going forward, delivering only the value of a pill won’t be quite enough to make the sales revenue and profit trend moving north, registering a steep gradient.

As more patients want to experience differential values in the entire disease treatment process through greater participation and engagement, business success requirements of pharma players call for a major shift, accordingly. This would involve moving away from the traditional model – from increasing sales through a growing number of treatments, to boosting revenue through patient-centric well-differentiated value offerings. I repeat, the entire process should ultimately lead to quantifiable improvement in treatment outcomes.

Direct ‘patient engagement’ is easier said than done:

Direct patient engagement is easier said than done. It is not just something that is ready to happen at any given point of time. Pharma companies will require to first equip much greater number of patients, through various means, to become actively engaged in health care, as they step into this direction.

It is envisaged that most of these direct patient engagement endeavors of pharma will be on various digital platforms. The process would require accurately identifying the target groups, what exactly they consider of immense value for such engagement –  and finally effectively delivering those value offerings in innovative and customized ways to them, for improved treatment outcomes.

‘Patient engagement’ should be measurable:

The level of such engagement needs to be continuously measured through ‘patient activation’ tools to establish cost-efficient improved outcomes. Researchers have established that patients with a lower ‘activation score’ ultimately incur higher costs.

An interesting article on ‘patient activation’ describes this terminology as ‘the skills and confidence that equip patients to become actively engaged in their health care.’ It says that health care delivery systems are now turning to ‘patient activation’ as yet another tool to help them and their patients improve outcomes and influence costs. To establish this point, the paper examined the relationship between ‘patient activation levels’ and billed care costs.

In this analysis of 33,163 patients, the researchers found that patients with the ‘lowest activation levels’ had predicted average costs that were 8 percent higher in the base year and 21 percent higher in the first half of the next year than the costs for patients with the highest activation levels. Both are significant differences.

Following an analogous approach, Novartis has been able to demonstrate better disease outcomes with its cardiovascular drug Entresto, as reported in the Financial Times dated April 14, 2017. Ably supported by remote monitoring and coaching programs for patients with advanced heart failure, Novartis has reportedly been able to establish that its customized disease treatment solution brings down hospitalization and cardiovascular death rate by around 20 percent.

Greater pharma accountability needed for treatment cost versus outcomes:

The authors of this paper, further established ‘patient activation’ as a significant predictor of cost even after adjustment for a commonly used “risk score” specifically designed to predict future costs. This trend, when reaches the decisive moment, is likely to assign greater accountability for costs and outcomes, even to the pharma players.

While moving into this direction:

Accurately knowing patients’ ability and willingness to manage their health will be a critical piece of information for the drug companies. This would prompt the pharma marketers to be highly proficient in generating a huge pool of credible data on target patient groups in various relevant areas, including expectations, aspirations, preferences and treatment related behavior. Thereafter, strategic game plan for business excellence should be based on in-depth analysis of this huge database, created on an ongoing basis.

If any skill gap exists in generating and analyzing the data meaningfully, pharma companies may wish to collaborate with external expertise in this area. A few excellent examples in this area have already started being reported, such as

Astra Zeneca’s partnering with Vida Health to offer free health coaching services to heart attack sufferers, or Sanofi partnering with Verily (previously known as Google Life Sciences) to develop new services for patients to manage diabetes better.

With similar initiatives, pharma players can effectively demonstrate to their stakeholders, details of better health outcomes that their patient-centric disease treatment solutions are offering – eventually taking their brands to a new trajectory of more inclusive success.

Conclusion:

Those days are not too far when many patients, especially with chronic diseases, such as hypertension, arthritis or diabetes, would prefer to buy a comprehensive disease management solution to lead a better quality of life, instead of just buying a pill – and quite often for lifelong.

In a new paradigm, with changing ‘value expectations’ of many patients in the entire treatment process, ‘value creation’ and ‘value delivery’ mechanisms of drug companies are likely to change accordingly. One of the key barriers to this shift is mostly the traditional business culture of most pharma players. Another significant one is its slow pace of moving into the digitized world, as compared to other science and technology driven industries.

Moving ‘beyond the pill’ would necessitate a basic shift in the mindset – from selling a pill to selling better health outcomes. In this endeavor, pharma CEOs require leading from the front. Instilling courage within the organization to ensure this fundamental strategic shift in the company’s business model taking place on the ground, is their prime responsibility. Thus, stepping into this new paradigm with requisite wherewithal, sooner, would no longer be just for business excellence, but for its long-term survival too.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

High Innovation-Cost Makes Cancer Drugs Dear: A Fragile Argument?

Posted on by
Reply

Cancer is a major cause of high morbidity and mortality in India, just many other countries, according to a report of the World Health Organization (W.H.O). While deaths from cancer worldwide are projected to continue to rise to over 1.31 million in 2030, the Indian Council of Medical Research (ICMR) estimates that India is likely to have over 1.73 million new cases of cancer and over 8,80,000 deaths due to the disease by 2020 with cancers of breast, lung and cervix topping the list.

 Cancer treatment is beyond the reach of many:

Despite cancer being one of the top five leading causes of death in the country, with a major impact on society, its treatment is still beyond the reach of many. There are, of course, a number of critical issues that need to be addressed in containing the havoc that this dreaded disease causes in many families –  spanning across its entire chain, from preventive measures to early diagnosis and right up to its effective treatment. However, in this article, I shall focus only on the concern related to affordable treatment with appropriate cancer with medicines.

To illustrate this point, I shall quote first from the address of the Chief Minister of Maharashtra during inauguration of Aditya Birla Memorial Hospital Cancer Care Center on November 26, 2016. He said: “Cancer is the dreadful disease of all the time and for Maharashtra it is a big challenge as we are infamously at number two position in cancer cases in the country as after Uttar Pradesh, most cases are found here.” Incidentally, UP is one of the poorest state of India.

Underscoring that the biggest challenge before the technology is to bring down the cost of the cancer treatment and make it affordable and accessible for all, the Chief Minister (CM) further observed, “although, technological innovation has increased in last one decade, the accessibility and affordability still remain a challenge and I think, we need to work on this aspect.”

A new cancer drug launch vindicates the CM’s point:

The Maharashtra CM’s above statement is vindicated by a national media report of September 13, 2017. It said, Merck & Co of the United States have launched its blockbuster cancer drug ‘Keytruda’ (pembrolizumab) in India, around a year after its marketing approval in the country. Keytruda is expected to be 30 percent cheaper, compared to its global prices, costing Rs 3,75,000 – 4,50,000 to patients for each 21-day dose in India.

The point to take note of, despite being 30 percent cheaper, how many Indian patients will be able to afford this drug for every 3 weeks therapy? Doesn’t it, therefore, endorse the CM’s above submission? Well, some may argue that this exorbitant drug price is directly linked to high costs for its innovation and clinical development. Let me examine this myth now under the backdrop of credible research studies.

Cancer drugs are least affordable in India – An international study:

On June 6, 2016, by a Press Release, American Society of Clinical Oncology (ASCO) revealed the results of one of the largest analyses of differences in cancer drug prices between countries worldwide. The researchers calculated monthly drug doses for 15 generic and eight patented cancer drugs used to treat a wide range of cancer types and stages. Retail drug prices in Australia, China, India, South Africa, United Kingdom, Israel, and the United States were obtained predominantly from government websites. The study shows that cancer drug prices are the highest in the United States, and the lowest in India and South Africa.

However, adjusting the prices against ‘GDPcapPPP’ – a measure of national wealth that takes into consideration the cost of living, cancer drugs appeared to be least affordable in India and China. The researchers obtained the ‘GDPcapPPP’ data for each country from the International Monetary Fund and used it to estimate the affordability of drugs.

Why are cancer drug prices so high and not affordable to many?

The most common argument of the research based pharma companies is that the cost of research and development to bring an innovative new drug goes in billions of dollars.

The same question was raised in a series of interviews at the J.P. Morgan Healthcare Conference, published by the CNBC with a title “CEOs: What’s missing in the drug pricing debate” on January 11, 2016, where three Global CEOs expressed that the public is getting overly simple arguments in the debate about drug pricing. All three of them reportedly cited three different reasons altogether, as follows:

  • Eli Lilly CEO said, “Some of the noise you hear about drug pricing neglects the fact that we often must pay deep discounts in a market-based environment where we’re competing in many cases against other alternative therapies, including those low-cost generics.”
  • Pfizer CEO took a different approach by saying, “if you look at the market, about a decade ago, 54 percent of the pharmaceutical market was genericized; today 90 percent is genericized.”
  • However, as reported by CNBC, Novartis CEO Joseph Jimenez, focusing on innovation and in context on cancer drugs, argued “innovation has to continue to be rewarded or we’re just not going to be able to see the kind of breakthroughs that we have seen in cancer research, specifically regarding the uses and benefits of the cancer-fighting drug Gleevec. We continued to show that the drug was valuable in other indications in cancer and so we needed to be reared for that innovation and we’re pricing according to that.”

Is drug innovation as expensive and time intensive as claimed to be?

An article titled, “The high cost of drugs is the price we pay for innovation”, published by the World Economic Forum (WEF) on March 28, 2017 reported, “15 spenders in the pharmaceutical industry are investing about US$3 billion in R&D, on average, for each successful new medicine.”

The November 18, 2014 report on the ‘Cost of Developing a New Drug,’ prepared by the Tufts Center for the Study of Drug Development also announced: “The estimated average pre-tax industry cost per new prescription drug approval (inclusive of failures and capital costs) is: US$ 2,558 million.”

Not everybody agrees:

Interestingly, Professor of Medicine of Harvard University – Jerry Avorn questioned the very basis of this study in the article published in the New England Journal of Medicine (NEJM) on May 14, 2015. It’s not just NEJM even the erstwhile Global CEO of GSK – Sir Andrew Witty had questioned such high numbers attributed to R&D cost, around 5 years ago, in 2013. At that time Reuters reported his comments on the subject, as follows:

“The pharmaceutical industry should be able to charge less for new drugs in future by passing on efficiencies in research and development to its customers. It’s not unrealistic to expect that new innovation ought to be priced at or below, in some cases, the prices that have pre-existed them. We haven’t seen that in recent eras of the (pharmaceutical) industry, but it is completely normal in other industries.” Quoting the study of Deloitte and Thomson Reuters on R&D productivity among the world’s 12 top drugmakers that said the average cost of developing a new medicine, including failures, was then US$ 1.1 billion, Witty remarked, “US$ 1 billion price-tag was one of the great myths of the industry.”

A decade after Sir Andrew’s comment, his view was virtually corroborated by yet another research study, published this month. The study reemphasized: “The Tufts analysis lacks transparency and is difficult to judge on its merits. It cannot be properly analyzed without knowing the specific drug products investigated, yet this has been deemed proprietary information and is governed by confidentiality agreements.” I shall discuss this report briefly, in just a bit.

The latest study busts the myth:

The latest study on the subject, titled “Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval”, has been published in the ‘JAMA Internal Medicine’ on September 11, 2017. It busts the myth that ‘high innovation-cost makes cancer drugs dear,’ providing a transparent estimate of R&D spending on cancer drugs. Interestingly, the analysis included the cost of failures, as well, while working out the total R&D costs of a company.

The report started by saying: “A common justification for high cancer drug prices is the sizable research and development (R&D) outlay necessary to bring a drug to the US market. A recent estimate of R&D spending is US$ 2.7 billion (2017 US dollars). However, this analysis lacks transparency and independent replication.”

The study concludes: “Prior estimates for the cost to develop one new drug span from US$ 320.0 million to US$ 2.7 billion. We analyzed R&D spending for pharmaceutical companies that successfully pursued their first drug approval and estimate that it costs US$ 648.0 million to bring a drug to market. In a short period, development cost is more than recouped, and some companies boast more than a 10-fold higher revenue than R&D spending—a sum not seen in other sectors of the economy. Future work regarding the cost of cancer drugs may be facilitated by more, not less, transparency in the biopharmaceutical industry.” The researchers also established that ‘the median time to develop a drug was 7.3 years (range, 5.8-15.2 years).’

“Policymakers can safely take steps to rein in drug prices without fear of jeopardizing innovation”:

NPR – a multimedia news organization and radio program producer reported: In an invited commentary that accompanies the JAMA Internal Medicine analysis, Merrill Goozner, editor emeritus of the magazine Modern Healthcare, noted that “the industry consistently generates the highest profit margins among all U.S. industries.” Goozner argues that the enormous value of patent protection for drugs far outweighs the inherent riskiness of pharmaceutical research and development, and agrees with the study authors when he writes: “Policymakers can safely take steps to rein in drug prices without fear of jeopardizing innovation,” NPR wrote.

Conclusion:

So, the moot question that surfaces: Is Pharma innovation as expensive and time consuming as claimed to be? If not, it further strengthens the credibility barrier to Big Pharma’s relentless pro-innovation messaging. Is the core intent, then, stretching the product monopoly status as long as possible – with jaw dropping pricing, unrelated to cost of innovation?

Further, incidents such as, shielding patent of a best-selling drug from low priced generic competition, by transferring its patents on to a native American tribe, probably, unveil the core intent of unabated pro-innovation messaging of major global pharma companies. In this particular case, being one among those companies which are seeking to market cheaper generic versions of this blockbuster eye drug, Mylan reportedly has decided to vigorously oppose such delaying tactic of Allergan before the Patent Trial and Appeal Board.

As a cumulative impact of similar developments, lawmakers in the United States are reportedly framing new laws to address the issue of high drug prices. For example, “California’s Senate Bill 17 would require health insurers to disclose the costs of certain drugs and force pharmaceutical manufacturers to detail price hikes to an agency for posting on a government website. The proposal would also make drugmakers liable to pay a civil penalty if they don’t follow its provisions.”

The myth of ‘high innovation-cost makes cancer drugs dear’ will go bust with such revelations, regardless of the blitzkrieg of self-serving pro-innovation fragile messaging.  Alongside, shouldn’t the Indian Policy makers take appropriate measures to rein in cancer drug prices, being free from any apprehension of jeopardizing innovation?

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Dawns A New Era: Regenerative Medicine For Degenerative Disease

Posted on by
Reply

Could breakthrough innovation in ‘Regenerative Medicine’ significantly reduce the need of expensive lifelong medications, or even make the use of some important medical devices less relevant, or even help avoiding expensive and risky surgical interventions? The common answer to these critical questions is now getting clearer, in tandem with the rapid progress of the science of ‘Regenerative Medicine.’

On June 13, 2017, Nature Biomedical Engineering published an interesting an article titled, “3D-printed vascular networks direct therapeutic angiogenesis in ischemia.” In simple words, these 3D-Printed patches are going to usher in a highly innovative way to treat ischemic diseases, in the future. As the researchers highlighted, arterial bypass grafts are currently considered as the gold standard for the treatment of end-stage ischemic disease, though many patients are unable to tolerate the cardiovascular stress of arterial surgery. The researchers found that implantation of 3D-printed grafts containing endothelial-cell-lined lumens, induces spontaneous and geometrically guided generation of collateral circulation in ischemic settings.

In rodent models of hind limb ischemia and myocardial infarction, these scientists successfully demonstrated that the vascular patches rescue perfusion of distal tissues, preventing capillary loss, muscle atrophy and loss of function.

In this article, I shall deliberate on the importance of this discovery, and its overall future implications on a broader perspective.

Regenerative medicine:

Here comes the basic question – What is ‘Regenerative Medicine’?

It is defined as a highly innovative branch of medicine that develops implementable methods to regrow, repair or replace damaged or diseased cells, organs or tissues. According to RegerativeMedicine.net following are illustrations of some conditions or diseases that regenerative medicine has the potential to cure, and what their current state of treatment looks like in in the American perspective:

  • Heart valves- 250,000 patients receive heart valves, at a cost of US$27 billion annually
  • Heart disease and Stroke- 950,00 people die of heart disease or stroke, at a cost of US$ 351 billion annually
  • Diabetes- 17 million patients have diabetes, at a cost of US$ 132 billion annually

I discussed in this blog, the subject of ‘3D Printing in health care’ on January 11, 2016. Hence, won’t dwell on that subject here

Ischemia, and the relevance of the above discovery:

Ischemia, as many would know, is a condition that restricts adequate flow of blood in some parts of our body, which over a period, may narrow, harden or even block the important blood vessels, much often resulting in stroke, heart attack or other related life-threatening vascular disorders.

Currently, ischemic heart conditions are usually treated either with blood thinning drugs, or blood vessel relaxants. In more serious stages of this condition, doctors prefer angioplasty or other surgical interventions, such as coronary artery bypass.

In this broad perspective, the relevance of the above discovery in addressing various debilitating or life- threatening ischemic conditions, is profound. Its novelty lies in the ability of the scientists making a 3D-printed patch that can be infused with cells to help grow healthy new blood vessels.

An emerging medical space:

The science of ‘Regenerative Medicine’ is increasingly being considered as an emerging medical space aimed at the treatment of those diseases that are usually classified as degenerative, incurable and irreversible. As it appears today, this science has the potential to unfold a new paradigm in this space, where patients can expect cure for many serious ailments, such as, spinal injuries, heart disease, Parkinson’s, Alzheimer’s disease and even diabetes, besides many others.

One more recent pursuit in this much uncharted frontier was reported in the British news daily – ‘The Telegraph’ on February 21, 2017, revealing the outcome of a path-breaking medical study for freezing the progression of a crippling ailment called Multiple Sclerosis (MS). This research followed a unique Stem Cell (SC) transplantation process, and is regarded as the largest long-term follow-up of SC transplantation treatment study of MS in regenerative medicine.

This study, spearheaded by Imperial College London, established that 46 per cent of patients who underwent the treatment did not suffer a worsening of their condition for five years. The process works by destroying the immune cells responsible for attacking the nervous system. This is indeed a very significant development in the space of medical research.

The treatment, called autologous hematopoietic stem cell transplantation (AHSCT), was given to patients with advanced forms of MS who had failed to respond to other medications. However, the researchers noted that the nature of the treatment, which involves aggressive chemotherapy, carried “significant risks”.

As many would know, MS is caused by the immune system malfunctioning and mistakenly attacking nerve cells in the brain and spinal cord, leading to problems with movement, vision, balance and speech. It’s a lifelong condition and often causes serious disability, with no cure still in sight. The disease is most commonly diagnosed in people in their 20s and 30s, although it can develop at any age.

A potential game changer:

According to California Institute for Regenerative Medicine (CIRM), this procedure has a game changing potential for successful use:

  • To replace neurons damaged by spinal cord injury, stroke, Alzheimer’s disease, Parkinson’s disease or other neurological problems
  • To produce insulin that could treat people with diabetes, and heart muscle cells that could repair damage after a heart attack, or
  • To replace virtually any tissue or organ that is injured or diseased

Research on “Regenerative Medicine’ signals a new hope:

Following are examples of just a few more promising developments, indicating that research in ‘Regenerative Medicine’ is taking rapid strides, signaling a new hope:

- A cure for Type 1 diabetes:

According to an international report on October 9, 2014, for the first time after 23 years of research, Harvard University has been able to manufacture millions of beta cells required for transplantation. It could mean a cure for diabetes, and the end of daily insulin injections for patients living with Type 1 diabetes. Although, just around 10 per cent of all diabetes is Type 1, it is the most common type of childhood diabetes.

The report indicated, the stem cell-derived beta cells are presently undergoing trials in animal models, including non-human primates, where they are still producing insulin after several months.

Another report of April 2014 indicates that for the first time, scientists have successfully replaced the damaged DNA of a type 1 diabetes sufferer with the healthy genetic material of an infant donor. When these cells are injected back into the diabetic patient, it is expected that they will begin to produce insulin on their own.

- Restoring vision in macular degeneration:

Yet another study published in ‘The Lancet’ in October 2014 stated that scientists in the United States have announced that single transplant of stem cells has helped restore the sight of patients suffering from incurable forms of blindness due to Age-related Macular Degeneration (AMD). Currently no effective treatments exist for this eye disorder, which can cause complete blindness due to the loss of light-receiving photoreceptor cells in the retina.

To recreate a type of cell in the retina that supports those photoreceptors, the new treatment uses stem cells derived from embryos that are only a few days old and have the ability to develop into any kind of tissue in the body. However, the transplants have proved controversial because they use stem cells derived from spare human embryos left over from IVF treatment.

- A cure for heart failure:

One more international report of May 01, 2014 states, by injecting human stem cells into the organs of macaque monkeys, scientists have been able to regenerate their damaged hearts by up to 40 per cent in just a few weeks. Thus, it appears now that a cure for heart failure could be just a few years away and would mean that even people who are “bed-bound” with heart failure could be “up and about” again within a few weeks.

As on date, the heart muscle cannot be repaired, making people with severe heart failure necessarily wait for a heart transplant, provided the patients are willing, and can afford so.

Conclusion:

There is a host of diseases, including several chronic ailments, such as diabetes, heart conditions, rheumatoid arthritis, or some types of cancer, which can’t be reversed, however, could be managed with a lifelong treatment. For most of these diseases, ‘Regenerative Medicine’ has the potential to be a game changer by transforming many lives.

Moreover, ‘Regenerative Medicine’ is expected not just to bring down the cost of health care and the disease burden significantly, but would also help increasing the economic productivity of a nation considerably.

Currently, medical research of the highest order in this area, has mostly been conducted by various academia of global repute, along with a few in the industry. It should soon involve, besides patients, several industries, including pharmaceuticals and biotech sectors, in a big way.

Nevertheless, this emerging trend sends a clear signal that to treat various chronic, incurable, irreversible and seriously debilitating degenerative diseases ‘Regenerative Medicine’ is now poised to take a giant leap in the health care space.  In that process, it would possibly help healing various ailments in a more meaningful, providing a cure for many chronic diseases that was a badly missing piece in the medical science, so far.

Thus, ‘Regenerative Medicines’ to treat many ‘Degenerative Diseases’ signal a great potential to give an altogether new shape and dimension to the future of global health care. It is also expected to ensure lesser lifelong usage of expensive drugs, setting a new normal to bring back the patients’ lives back to the pre-disease state.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

 

Is The Global Generic Drug Market Slowing Down?

Posted on by
Reply

Driven by a strong environmental headwind, both within and outside the country, several pharma companies in India have recently started raising a red flag on their future earning guidance for the stock market, though citing quite different reasons altogether. Quoting the following two recent examples, I shall illustrate this point:

“For decades, the generic drug business has followed a simple model for growth: wait for a chemical medicine to go off patent, then copy it. But 2018 promises to be one of the industry’s last big bumper crops, with $27.8 billion worth of therapies losing protection. The following year’s haul drops by almost two thirds, and the year after it shrinks even further” – reported the May 27, 2017 article in Bloomberg titled, ‘Pharma Heir Seeks a New Holy Grail as Generic Drugs Run Dry,” quoting the promoter of Glenmark.

Another May 27, 2017 article by Reuters also quoted similar business sentiment, though for a much different reason, of the world’s fifth-largest generic drug maker – Sun Pharma, following similar concerns of Dr. Reddy’s Laboratories Ltd and Lupin Ltd. Here, the promoter of Sun Pharma said, “We may even have a single digit decline in consolidated revenue for full-year 2018 versus full-year 2017.”

These red flags, though signal different reasons, prompt some fundamental questions: Is the global generic drug market, especially the US, slowing down? If so, what then is the real reason of the anticipated business slow-down of large Indian pharma players? Is it due to lesser number of patented products going off-patent in the future years, or is it due to pricing pressure in various countries, including the US, or a combination of several other factors alongside? In this article, I shall deliberate on this emerging concern.

Global generic drug market – the past trend:

Several favorable environmental factors have been fueling the growth of generic drug prescriptions across the world, and the trend continues going north. Currently, the growth of generic drug prescriptions is outpacing the same for the patented ones. According to the April 2017 research study titled “Generic Drugs Market: Global Industry Trends, Manufacturing Process, Share, Size, Growth, Opportunity and Forecast 2017-2022”, published by IMARC, the global generic drug market was valued at around US$ 228.8 Billion in 2016, growing at a CAGR of around 9 percent during 2010-2016.

This trend has been well captured in numbers, from various different angles, in the September 2016 report of Evaluate Pharma, as follows:

Global trend of prescription generic drug sales (2008-2015) 

Year 2008 2009 2010 2011 2012 2013 2014 2015
Global Rx Drug Sales (2008-15) (US$ Billion) 650 663 687 729 717 724 749 742
Growth per Year (%) +2.0 +3.5 +6.1 (1.6) +0.9 +3.5 (1.0)
Rx Generics Drug Sales (US $Billion) 53 53 59 65 66 69 74 73
Generics as % of Total Rx Drugs 8.2 8.0 8.6 9.0 9.2 9.5 9.9 9.9
% Market at risk to patent expiry or available for new generic drugs entry 3.0 4.0 4.0 5.0 7.0 4.0 5.0 6.0

(Table 1: Adapted from the report ‘World Preview 2016, Outlook to 2022’ of EvaluatePharma, September 2016)

The Table 1 shows, while the overall global sales growth of prescription drugs faltered during 2012-15 period, mainly due to after effects of patent expiry of several blockbuster drugs, the general trend of generic drug sales continued to ascend. As we shall see below, the projected trend in the succeeding years is not much different, either.

Global generic drug market – present, and projected future trend:

The global generic drug market is currently growing at a faster pace than the patented drugs, and this overall trend is likely to remain so in future too, as we shall find below.

Globally, North America, and particularly the US, is the largest market for generic drugs. According to the QuintilesIMS 2016 report, generic drugs saved patients and the US health care system US$227 billion in 2015. Although around 89 percent of the total prescriptions in the US are for generic drugs, these constitute just 27 percent of total spending for medicines. In other words, the share of patented drugs, though, just around 11 percent of total prescriptions, contribute 73 percent of the total prescription drug costs.

Backed by the support of Governments for similar reasons, Europe is, and will continue to register impressive growth in this area. Similarly, in Latin America, Brazil is the largest market for generic drugs, contributing 23 percent and 25 percent of the country’s pharma sector by value and by volume, respectively, in 2015.

Major growth drivers to remain the same:

The following major factors would continue to drive the growth of the global generic drug market:

  • Patent expiration of innovative drugs
  • Increasing aging population
  • Healthcare cost containment pressure, including out of pocket drug expenditure
  • Government initiatives for the use of low cost generic drugs to treat chronic diseases
  • Despite high price competition more leading companies are taking interest in generic drugs especially in emerging markets

India – a major global player for generic drugs:

India and China dominated the generic drug market in the Asia pacific region. India is the largest exporter of the generic drug formulations. A large number of drug manufacturing plants belonging to several Indian players have obtained regulatory approval from the overseas regulators, such as, US-FDA, MHRA-UK, TGA-Australia and MCC-South Africa. Consequently, around 50 percent of the total annual turnover of many large domestic Indian drug manufacturers comes from exports.  The top global players in the generic drug market include Teva Pharmaceuticals, Novartis AG, Mylan, Abbott, Actavis Pharma and India’s own Sun Pharma.

No significant change in the future market trend is envisaged:

When I compare the same factors that fueled the growth of global prescription generic drug market in the past years (2008-2015) with the following year (2016), and the research-based projections from 2017-2022, no significant change in the market trend is visible.

Global trend of prescription generic drug sales (2015 – 2022)

Year 2015 2016 2017 2018 2019 2020 2021 2022
Global Rx Drug Sales (2015-22) (US$ Billion) 742 778 822 873 931 996 1060 1121
Growth per Year (%) (-1.0) +4.8 +5.7 +6.2 +6.6 +7.0 +6.5 +5.7
Rx Generics Drug Sales (US $Billion) 73 80 86 92 97 103 109 115
Generics as % of Total Rx Drugs 9.9 10.3 10.5 10.5 10.4 10.4 10.3 10.3
% Market at risk to patent expiry or available for new generic drugs entry 6.0 6.0 4.0 4.0 4.0 2.0 2.0 5.0

(Table 2: Adapted from the report ‘World Preview 2016, Outlook to 2022’ of EvaluatePharma, September 2016)

The Table 2 shows, the overall global sales growth trend of prescription drugs appears a shade better in 2008-15 period, even with the after effects of patent expiry (Table 1), as compared to 2016-22. The scope for entry of new generic drugs goes below 4 percent of the total prescription drug market only in two years – 2020 and 2021. Thus, any serious concern only on this count for a long-term growth impediment of the global generic drug market, post 2018, doesn’t seem to be based on a solid ground, and is a contentious one. Moreover, the sales trend of prescription generic drugs as a percentage of the total value of all prescription drugs, hovers around 10 percent in this statistical projection, which is again a shade better than around 9 percent of the past comparable years.

What triggered the major pricing pressure?

With its over 40 percent of the total pharmaceutical produce, predominantly generic drug formulations, being exported around the world, India has become one of the fastest growing global manufacturing hubs for medicinal products. According to Pharmaceutical Export Promotion Council of India (Pharmexcil), United States (US) is the largest market for the India’s pharma exports, followed by the United Kingdom (UK), South Africa, Russia, Nigeria, Brazil and Germany.

Since long, the largest pharma market in the world – the US, has been the Eldorado of pharma business across the globe, mostly driven by the unfettered freedom of continuously charging a hefty price premium in the country. Thus far, it has been an incredible dream run, all the way, even for many large, medium and small generic drug exporters from India.

However, ongoing activities of many large drug companies, dominated by allegedly blatant self-serving interests, have now given rise to a strong general demand on the Governments in different countries, including the US, to initiate robust remedial measures, soon. The telltale signs of which indicate that this no holds barred pricing freedom may not be available to pharma, even in the US, any longer.

Self-inflicted injury?

The situation where several major Indian generic companies are in today, appears akin to an avoidable self-inflicted injury, basically falling in the following two important areas. Nonetheless, even after the healing process gets over, the scar mark would remain for some more time, till the business becomes as usual. Hopefully, it will happen sooner than expected, provided truly ‘out of box’ corrective measures are taken, and followed up with a military precision.

Huge price hikes:

According to the Reuters report of September 11, 2016, US Department of Justice sent summons to the US arm of Sun Pharma – Taro Pharmaceutical Industries Inc. and its two senior executives seeking information on generic drug prices. In 2010, Sun Pharma acquired a controlling stake in Taro Pharmaceutical Industries.

On September 14, 2016, quoting a September 8, 2016 research done by the brokerage firm IIFL, ‘The Economic Times’ also reported that several large Indian generic drug manufacturers, such as, Sun Pharma, Dr. Reddy’s, Lupin, Aurobindo and Glenmark have hiked the prices of some of their drugs between 150 percent and 800 percent in the US. These apparently avoidable incidents fuel more apprehensions in the prevailing scenario. As I wrote in this Blog on September 12, 2016, the subject of price increases even for generic drugs reverberated during the last Presidential campaign in the US, as well.

Serious compromise with product quality standards:

Apprehensions on dubious quality standards of many drugs manufactured in India have now assumed a gigantic dimension with import bans of many India made generic drugs by foreign drug regulators, such as US-FDA, EMA and MHRA. Today, even smaller countries are questioning the Indian drug quality to protect their patients’ health interest. This critical issue has started gaining momentum since 2013, after Ranbaxy pleaded guilty and paid a hefty fine of US$ 500 million for falsifying clinical data and distributing allegedly ‘adulterated medicines’ in the United States.

Thereafter, it’s a history. The names of who’s who of Indian drug manufacturers started appearing in the US-FDA and other overseas drug regulators’ import ban list, not just for failing to conform to their quality standards, but also for willful non-compliance with major cGMP requirements, besides widely reported incidents of data fudging and falsification of other drug quality related documents.

Global murmurs on generic drug quality among doctors:

There are reported murmurs both among the US and the Indian doctors on the generic drug quality standards, but for different drug types and categories.

According to the Reuters article published on March 18, 2014, titled “Unease grows among US doctors over Indian drug quality”, many US doctors expressed serious concerns about the quality of generic drugs supplied by Indian manufacturers. This followed the ‘import bans’ by the USFDA and a flurry of huge Indian drug recalls there. Such concerns are so serious, as India supplies about 40 percent of generic and over-the-counter drugs used in the United States, making it the second-biggest generic drug supplier after Canada.

While the doctors in the US raise overall quality concerns on the products manufactured by the large Indian branded generic companies, Indian doctors are quite at ease with the branded generics. They generally raise quality concerns only on generic drugs without any brand names.

Thus, a lurking fear keeps lingering, as many feel that Indian drug manufacturing quality related issues may not necessarily be confined only to exports in the developed world, such as, the United States, European Union or Canada. There is no reason to vouch for either, that such gross violations are not taking place with the medicines consumed by patients in India, or in the poorer nations of Africa and other similar markets.

In conclusion:

Sun Pharma has publicly expressed its concern that pricing pressure in the US may adversely impact its business in 2018. There doesn’t seem to be any major surprise on this statement, as many believe it was likely to happen, though for a different reason, since when the global media reported in September 2015: “FDA revokes approval for Sun Pharma’s seizure drug over compliance issues.”

As investors are raising concerns, the following comment by the Co-Chairman and Chief Executive of Dr. Reddy’s Laboratories, reported by ‘Financial Express’ on August 24, 2015, well captures the vulnerability of Indian generic drug business in this area: “The U.S. market is so big that there is no equivalent alternative. We just have to get stronger in the U.S., resolve our issues, build a pipeline and be more innovative to drive growth.”

Inadequate remedial measures could unleash this pressure to reach a dangerous threshold, impacting sustainable performance of the concerned companies. On the other hand, adequate remedial action, both strategic and operational, could lead to significant cost escalation, with no space available for its neutralization through price increases, gradually squeezing the margin. It will be a tight rope walk for many in the coming years.

As research reports indicate, the global generic drug market is not and will not be slowing down in the long term, not even in India. There may be some temporary ups and downs in the market due to pricing pressure, and the number of novel products going off-patent in some years. Nevertheless, the traditional business models being followed by some large companies may retard their respective business growth, considerably.

The pricing pressure is a real one. However, from the Indian perspective, I reckon, it’s primarily a self-inflicted injury, just as the other major one – the drug import bans on the ground of serious compromise with product quality standards. Many Indian generic drug players don’t believe so, and probably would never will, publicly.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Making New Cancer Drugs Cost-effective

Posted on by
Reply

The prices of new cancer drugs are increasingly becoming unsustainable across the world, and more so in India. A sizable number of poor and even middle-income patients, who spend their entire life’s savings for the treatment of this dreaded disease, is pushed towards extreme economic hardship. Their plight in India would continue to remain so, till Universal Health Care (UHC) comes into force, as enunciated in the National Health Policy 2017.

Thus, the delivery of affordable and equitable cancer care poses one of India’s greatest public health challenges. Public expenditure on cancer in India remains below US$ 10 per person, as compared with more than US$ 100 per person in high-income countries. The May 2014 paper, published in ‘The Lancet Oncology’, analyzed this concern in detail.

In this article, after giving a brief backdrop, I shall explore a possible alternative to make cancer treatment with new drugs affordable to many by scaling up this strategic option.

Cancer – the second leading cause of death:

According to the World Health Organization (W.H.O), cancer is the second leading cause of death globally and accounted for 8.8 million deaths in 2015. This works out to nearly 1 in 6 of all global deaths, with US$ 1.16 trillion being the estimated total annual economic cost of cancer in 2010. Lung, prostate, colorectal, stomach and liver cancer are the most common types of cancer in men, while breast, colorectal, lung, cervix and stomach cancer are the most common among women. To reduce significant disability, suffering and deaths caused by cancer worldwide, effective and affordable programs in early diagnosis, screening, treatment, and palliative care are needed. Treatment options may include surgery, medicines and/or radiotherapy – the report reiterates. In many instances, anti-cancer drugs are the mainstay treatment.

For the country, Indian Council of Medical Research (ICMR) reported over 736, 000 people succumbing to the disease in 2016. This figure is expected to shoot up to 880,000 by 2020. ICMR estimated the total number of new cancer cases at around 1.45 million in 2016, and the same is likely to reach 1.73 million by 2020. The situation in this area, therefore, rather grim across the world, including India.

Cancer treatment cost in India is one of the highest in the world:

Anticancer drugs are generally expensive. As stated in a related article, published in the Nature Reviews Clinical Oncology on March 14, 2017, in the United States, a novel anticancer drug routinely costs more than US$ 100,000 per year of treatment. When adjusted for per capita spending power, these lifesaving medicines become most unaffordable in economically developing nations, such as India and China. Not only are their launch prices high and fast rising, but these also often escalate during the respective patent exclusivity period.

That in terms of the ability to pay for drugs, cancer drugs are most affordable in Australia and least affordable in India and China, was established in one of the largest research study presented at the 2016 Annual Meeting of the American Society of Clinical Oncology. Moreover, even in those cases where cancer could be detected early, about half the patients in India are compelled to skip the treatment for high drug cost, highlights another article.

Interestingly, the concerned drug manufacturers seldom, if at all, justify such astronomical drug prices and subsequent price increases well supported by some rational factors, such as, the extent of benefit patients are likely to derive, the novelty of the agents, or detailed spending on research and development, the above paper states.

The increasing trend of price escalation of cancer drugs harms many patients, often directly, through increased out-of-pocket expenses, which reduce levels of patient compliance, or drive thousands of cancer patients skipping the drug treatment, altogether. Consequently, it also harms the society by imposing cumulative price burdens on many patients that are unsustainable.

Despite high cost, annual global spending on anticancer drugs has already exceeded US$100 billion, and is predicted to reach US$150 billion by 2020. In India too, oncology is a leading therapeutic segment, which reached a turnover of Rs. 2,000 Crore (around US$ 320 million) in 2013 and is expected to grow to Rs. 3,831 crore (around US$ 615 million) by the end of 2017, according to a report of Frost and Sullivan.

The reason for high drug price:

The real reason for the high cost of cancer drugs, just as many other life-saving medicines, is quite challenging to fathom. Many attribute its reason to unsustainable R&D models of the global pharma companies, in general.

For example, “the spiraling cost of new drugs mandates a fundamentally different approach to keep lifesaving therapies affordable for cancer patients” – argued an article titled, “How Much Longer Will We Put Up With US$ 100,000 Cancer Drugs?”, published by Elsevier Inc. In the same context, another article titled “Making Cancer Treatment More Affordable”, published in the ‘Rare Disease Report’ on Feb 09, 2017, reiterated that the current R&D model needs to change, as the cost of many such treatments is higher than the cost of an average person’s house in the United States.

Nonetheless, the drug manufacturers answer this difficult question with ease and promptness, citing that the cost of innovation to bring these drugs through a complex research and development (R&D) process to the market, isn’t just very high, but is also increasing at a rapid pace.

Pharma R&D cost:

An analysis by the Tufts Center for the Study of Drug Development, published in the Journal of Health Economics in March, 2016 pegged the average cost to develop and gain marketing approval for a new drug at US$ 2.558 billion. It also said that the total cost of innovation of a new drug and bringing it to market, has increased more than double from US$ 1.22 billion in 2003 to US$ 2.6 billion in 2014. Although these numbers are being vehemently challenged in several credible journals and by the international media, many global pharma majors justify the high new drug prices

by highlighting that developing a new molecule takes an enormous amount of time of 12 to 14 years, lots of financial resources and huge efforts.

On the other hand, an article titled, “Does it really cost US$ 2.6 billion to develop a new drug?”, published in The Washington Post on November 18, 2014 observed that: ‘The never-ending debate about what drugs should cost is in part driven by the fact that no one seems to know what it actually costs to develop one.”

But, why is the decline in the R&D productivity trend?

According to a 2014 review article titled, “Recent Advances in Drug Repositioning for the Discovery of New Anticancer Drugs”, published in the International Journal of Biological Sciences, while the total R&D expenditure for drug discovery worldwide increased 10 times since 1975 (US$ 4 billion) to 2009 (US$ 40 billion), the number of NMEs approved has remained largely flat (26 new drugs approved in 1976 and 27 new drugs approved in 2013). The average time required for drug discovery to market launch has also increased over time in the US and in the EU countries from 9.7 years during 1990s, to 13.9 years from 2000 onwards.

Be that as it may, the bottom-line is regardless of tremendous advancement in biological science, technology and analytics, especially in the new millennium, coupled with increasing investments in pharma R&D, the total number of NMEs that has reached the market hasn’t shown commensurate increase.

One of my articles published in this blog titled, “How Expensive Is Drug Innovation?” found an echo of the same in a globally reputed journal. This study, published by the BMJ on May 2016, titled “Propaganda or the cost of innovation? Challenging the high price of new drugs”, expressed deep concern on the rising prices of new medicines. It reiterated that this trend is set to overwhelm health systems around the world.

Need for an alternative R&D strategy:

The hurdles in discovering and developing new drugs call for alternative approaches, particularly for life threatening diseases, such as cancer. I reckon, it’s about time to scale-up a viable alternative strategy to bring down the R&D cost of new drugs, improve the success rate of clinical development, reduce a decade long ‘mind to market’ timeframe for an innovative drug or a treatment, and of course, the mind blogging cost of the entire process, as asserted in the above report from the Tufts Center.

One such alternative strategy could well be: ‘Drug Repurposing’

Drug Repurposing:

As defined by the National Center for Advancing Translational Sciences, ‘drug repurposing’ “generally refers to studying drugs that are already approved to treat one disease or condition to see if they are safe and effective for treating other diseases”.

As many molecules, with well-documented records on their pharmacology and toxicity profile, have been already formulated and undergone large clinical trials on humans, repurposing those drugs building upon the available documents and experiences for fresh clinical trials in different disease conditions, would hasten the regulatory review process for marketing approval, and at a much lesser cost.

I shall quote here just two such examples of ‘drug repurposing’ from well-known molecules, as follows:

  • Sildenafil (Viagra): The blockbuster drug that was launched by Pfizer in 1998 for the treatment of erectile dysfunctions was originally developed for the treatment of coronary artery disease by the same company in 1980s.
  • Thalidomide: Originally designed and developed by a German pharmaceutical company called Grünenthal in Stolberg as a treatment for morning sickness in 1957, but was withdrawn in 1961 from the market because it caused birth defects. The same molecule was reintroduced in 1998 as a ‘repurposed drug’ to effectively treat patients with erythema nodosum leprosum (ENL) – a complication of leprosy, and multiple myeloma – a type of cancer.

I had given many more examples of ‘drug repurposing’ in one of my earlier articles published in this blog.

Repurposing drugs for cancer:

The above-mentioned review article of International Journal of Biological Sciences 2014 clearly noted: “Drug repositioning has attracted particular attention from the communities engaged in anticancer drug discovery due to the combination of great demand for new anticancer drugs and the availability of a wide variety of cell and target-based screening assays. With the successful clinical introduction of a number of non-cancer drugs for cancer treatment, ‘drug repurposing’ now became a powerful alternative strategy to discover and develop novel anticancer drug candidates from the existing drug space.”

The following are some recent successful examples of ‘drug repurposing’ for anticancer drug discovery from non-cancer drugs, which are mostly under Phase I to II clinical trials:

Drug Original treatment Clinical status for cancer treatment
Itraconazole Fungal infections Phase I and II
Nelfinavir HIV infections Phase I and II
Digoxin Cardiac diseases Phase I and II
Nitroxoline Urinary Tract Infections Preclinical
Riluzole Amyotropic lateral sclerosis Phase I and II
Disulfram Chronic alcoholism Phase I and II

‘Drug repurposing’ market:

A January 2016 report by BCC Research estimates that the global market for drug repurposing will grow from nearly US$ 24.4 billion in 2015 to nearly US$ 31.3 billion by 2020, with a compound annual growth rate (CAGR) of 5.1 percent for the period of 2015-2020.

Expressing concern just not enough:

There are enough examples available across the world regarding stakeholders’ expression of great concern on this issue, with the buzz of such protests getting progressively shriller.

However, in India, high prices of cancer drugs do not seem to be a great issue with the medical profession, just yet, notwithstanding some sporadic steps taken by the National Pharmaceutical Pricing Authority (NPPA) to allay the economic burden of cancer patients to some extent. Encouragingly, the top cancer specialists of the American Society of Clinical Oncology are reportedly working out a framework for rating and selecting cancer drugs not only for their benefits and side effects, but prices as well.

In a 2015 paper, a group of cancer specialists from Mayo Clinic also articulated, that the oft-repeated arguments of price controls stifle innovation are not good enough to justify unusually high prices of cancer drugs. Their solution for this problem includes value-based pricing and NICE like body of the United Kingdom. An interesting video clip from Mayo Clinic justifies the argument.

All this can at best be epitomized as so far so good, and may help increase the public awareness level on this subject. However, the moot point remains: Has anything significantly changed on the ground, on a permanent basis, by mere expression of such concerns?

Conclusion:

This discussion may provoke many to go back to the square number one, making the ongoing raging debate on Innovation, Intellectual Property Rights (IPR) and Public Health Interest to gather more steam, but the core concern continues to remain unresolved.

I hasten to add that all such concerns, including strong protests, may no doubt create some temporary pressure on drug manufacturers, but they are experienced enough to navigate through such issues, as they have been doing, so far. However, for making new cancer drugs cost-effective for a vast population of patients, coming out of the current strategic mold of pharma research and development would be necessary. Grant of Compulsory License (CL), or the expectation of the local drug manufacturers for a Voluntary License (VL) of new cancer drugs, can’t be a routine process either, as it appears unrealistic to me, for various reasons.

I have discussed in this article just one alternative R&D strategy in this area, and that is Drug Repurposing (DR). There could be several others. DR is reportedly gaining increasing focus, as it represents a smart way to exploit new molecular targets of a known non-oncological drug for a new therapeutic applications in oncology. Be that as it may, pharma companies and the academia must agree to sail on the same boat together having a common goal to make new cancer drugs cost-effective for majority of cancer patients struggling hard, for life.

I would conclude this article quoting the President and Chief Science Officer of Illinois-based Cures Within Reach who said: “What I like about drug repurposing is that it can solve two issues: improved health-care impact and reduced health-care cost – That’s a big driver for us.”

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

How Cost-Effective Are New Cancer Drugs?

Posted on by
Reply

The main reason why cancer is so serious a disease, is the ability of the malignant cells to spread in the body, both locally by moving into nearby normal tissue, and regionally to nearby lymph nodes, tissues, or organs, affecting even the distant parts of the body. When this happens, doctors term it as metastatic or stage IV (four) cancer.

Although most patients with metastatic tumors would eventually die of cancer, the treatment with various types of anticancer drugs, could help prolong life, in varying degree. No wonder, many new anticancer drugs now obtain regulatory approval based on their effectiveness on metastatic cancer patients. Consequently, it has now become almost a routine to administer newer anticancer drugs to patients with early stage of disease, after they have undergone surgery or radiotherapy.

But, these lifesaving drugs are expensive – very expensive! For example, a newer anticancer treatment is often priced at US$ 100,000 or more per patient, which, obviously, a large majority of the population can’t just afford.

Are these new drugs cost-effective?

To put in simple words, cost effectiveness of a drug is generally ‘expressed in terms of a ratio where the denominator is a gain in health from a measure (years of life, premature births averted, sight-years gained) and the numerator is the cost associated with the health gain.’

From this perspective, a January 2015 research study titled, “Pricing In The Market For Anticancer Drugs”, published by the National Bureau Of Economic Research of the United States observed that anticancer drugs like bevacizumab (US$ 50,000 per treatment episode) and ipilimumab (US$120,000 per episode) have fueled the perception that the launch prices of anticancer drugs are fast increasing over time.

To evaluate the pricing trend of these drugs, the researchers used an original dataset of 58 anticancer drugs, approved between 1995 and 2013, and found that launch-prices, adjusted for inflation and drugs’ survival benefits, increased by 10 percent, or about US$ 8,500, per year. This study was restricted to drugs administered with the primary intent of extending survival time for cancer patients and drugs for which survival benefits have been estimated in trials or modeling studies. The researchers did not consider drugs administered to treat pain or drugs that are administered to alleviate the side effects of cancer treatments.

The paper concluded, as compared to the older ones, newer anticancer treatments, generally, are less cost-effective. Despite this fact, the prices of these drugs are rising faster than their overall effectiveness.

How much do these drugs cost to prolong a year of life for cancer patients?

Another paper, titled “Cancer Drugs Aren’t As Cost-Effective As They Used To Be”, published in the Forbes magazine on September 30, 2015, expressed serious concern on the declining cost-effectiveness of new anticancer drugs. The author termed this trend as unacceptable, and more disturbing when providing just a year of life to cancer patients costs around US$ 350,000 to even US$ 800,000. High prices should reflect large benefits, and we need to demand value out of medical interventions – he recommended.

Do the claims of efficacy also reflect the real-world effectiveness?

Providing an answer to this question, a very recent article titled, “Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines”, published in the well reputed medical journal ‘JAMA Oncology’ on December 29, 2016, concluded as follows:

“Although innovation in the oncology drug market has contributed to improvements in therapy, the magnitude and dimension of clinical benefits vary widely, and there may be reasons to doubt that claims of efficacy reflect real-world effectiveness exactly.”

As stated above, this conclusion was drawn by the researchers after a detail study on the overall survival, quality of life, and safety benefits of recently licensed cancer medicines, as there was a dearth of evidence on the impact of newly licensed cancer medicines.

The authors analyzed in detail health technology assessment reports of 62 cancer drugs approved in the United States and Europe between 2003 and 2013, and found that these were associated with increased overall survival by an average of 3.43 months between 2003 and 2013. Following is a summary of the detail findings:

  • 43 percent increased overall survival by 3 months or longer
  • 11 percent by less than 3 months
  • 30 percent was not associated with any increase in overall survival, which means almost one third of these drugs lacked evidence to suggest their increased survival rate when compared to alternative treatments
  • Most new cancer drugs, though improved quality of life, were associated with reduced patient safety

The researchers expect this study to support clinical practice, and promote value-based decision-making in the cancer drug treatment, besides assessing their cost-effectiveness.

Some overseas Cancer Institutes protested:

In 2012, doctors at the Memorial Sloan-Kettering Cancer Center reportedly announced through ‘The New York Times’ that their hospital would not be using Zaltrap, a newly patented colorectal cancer drug at that time, from Sanofi. This action of the Sloan-Kettering doctors compelled Sanofi to cut the price of Zaltrap by half.

Unlike India, where prices of even cancer drugs do not seem to be a great issue with the medical profession, just yet, the top cancer specialists of the American Society of Clinical Oncology are reportedly working out a framework for rating and selecting cancer drugs not only for their benefits and side effects, but prices as well.

In a 2015 paper, a group of cancer specialists from Mayo Clinic also articulated, that the oft-repeated arguments of price controls stifle innovation are not good enough to justify unusually high prices of these drugs. Their solution for this problem includes value-based pricing and NICE like body of the United Kingdom.

This Interesting Video from Mayo Clinic justifies the argument.

Was it a tongue-in-cheek action from India?

On March 9, 2012, India did send a signal to global pharma players on its apparent unhappiness of astronomical pricing of patented new cancer drugs in the country. The then Indian Patent Controller General, on that day, issued the first ever Compulsory License (CL) to a domestic drug manufacturer Natco, allowing it to sell a generic equivalent of a kidney cancer treatment drug from Bayer – Nexavar, at a small fraction of the originator’s price.

However, nothing has changed significantly since then on the ground for cancer drugs in the country. Hence, many construe the above action of the Government no more than mere tokenism.

In this context, it won’t be out of place recapitulating an article, published in a global business magazine on December 5, 2013 that quoted Marijn Dekkers, the then CEO of Bayer AG as follows:

“Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India, but for Western Patients that can afford it.”

Whether, CL is the right approach to resolve allegedly ‘profiteering mindset’ at the cost of human lives, is a different subject of discussion.

VBP concept is gaining ground: 

The concept of ‘Value-Based Pricing (VBP)’, has started gaining ground in the developed markets of the world, prompting the pharmaceutical companies generate requisite ‘health outcome’ data using similar or equivalent products.

Cost of incremental value that a product delivers over the existing ones, is of key significance, and should always be the order of the day. Some independent organizations such as, the National Institute for Health and Clinical Excellence (NICE) in the UK have taken a leading role in this area.

Intriguingly, in India, public health related issues, however pressing these are, still do not seem to arrest much attention of the government to provide significant relief to a large majority of population in the country.

Conclusion:

Warren Buffet – the financial investor of global repute once said, “Price is what you pay. Value is what you get.” Unfortunately, this dictum is not applicable to the consumers of high priced life-saving drugs, such as, for cancer.

Prices of new drugs for the treatment of life-threatening ailments, such as cancer, are increasingly becoming unsustainable, across the world, and more in India. As articulated by the American Society of Clinical Oncology in 2014, this is mainly because their prices are disconnected from the actual therapeutic value of products.

Currently, a sizable number of poor and even middle-income patients, who spend their entire life’s saving for treatment of a disease like cancer, have been virtually priced out of the patented new cancer drugs market.

The plight of such patients is worse in India, and would continue to be so, especially when no trace of Universal Health Care/Coverage (UHC) is currently visible anywhere near the healthcare horizon of the country.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

India Needs More Integrated, High Quality E-Commerce Initiatives In Healthcare

Posted on by
Reply

In the digital space of India, many startups have been actively engaged in giving shape to a good number interesting and path breaking ideas, especially since the last ten years. One such area is ‘electronic commerce’ or ‘e-commerce’.

In the e-commerce business, particularly the following business model is gaining greater ground and popularity:

Here, an e-commerce company plans to generate large revenue streams on hundreds and thousands of items without producing and warehousing any of these, or carrying any inventory, handling, packaging and shipping. It just collects, aggregates and provides detailed and reliable information on goods and/or services from several competing sources or aggregators, at its website for the consumers.

The firm’s strength primarily lies in its ability to draw visitors to its website, and creating a user-friendly digital platform for easy matching of prices and specifications, payment and delivery, as preferred by the buyers.

Growing e-commerce in India:

Today, e-commerce players in the country are not just a small few in number. The list even includes many of those who have already attained a reasonable size and scale of operation, or at least a critical mass. Among many others, some examples, such as, ‘Flipkart’, ‘Bigbasket’, ‘HomeShop18’, ‘Trukky’ and ‘Ola’ may suffice in this context.

Currently, these companies try to satisfy various needs of the consumers related to, such as, lifestyle, daily households, logistics, and other chores, at any time of the users’ convenience and choice, with requisite speed, variety and reliability.

Healthcare initiatives need to catch up:

Despite the overall encouraging scenario, every day in India a large number of the population, even those who can afford to pay, at least a modest amount, still struggle while going through the unstructured and cumbersome process of access to better and comprehensive health care services. The situation continued to linger, despite the ongoing game-changing digital leaps being taken by many startups in various other fields within the cyberspace of India.

Nevertheless, the good news is, it has now started happening in the healthcare space, as well, though most projects are still in a nascent stage. The not so good news is, many of these world class services, though available, are still not known to many.

The medical treatment process is complicated:

The medical treatment process is just not complicated; it is non-transparent too. There is hardly any scope for doing an easy-to-do personal research by common people to ascertain even a ballpark number on the treatment cost, with requisite details of the various processes, that a patient may need to undergo. 

Thus, in pursuit of quality health care at optimal cost in today’s complex scenario in India, one will require to get engaged in time-intensive and complicated research, first to find out, and then to effectively manage the multiple variables for access to comprehensive and meaningful information to facilitate patients’ decision making on the same. For most people, it’s still a challenge to easily collect all these details on a user-friendly platform of any credible and transparent online website.

The usual treatment process:

The usual process that any patient would need to follow during any serious illness is cumbersome, scattered and non-transparent. This is, of course, a natural outcome of the generally deplorable conditions and, in many cases, even absence of quality public health infrastructure in India, forget for the time being about the Universal Health Care (UHC). 

During such illness, one will first need, at least, a General Practitioner (GP), if required a secondary and a tertiary doctor, alongside well-equipped diagnostic laboratories. Then follows the medical prescriptions, or advice for any invasive procedure, buying the right medicines, as required for the treatment of the disease condition, and thereafter comes the desired relief, hopefully. 

Each of these steps being different silos, there were not many easy options available to most patients, in this tortuous quest for good health, but to go for expensive private health care. Currently, this entire process is over-dependent on word-of-mouth information, and various advice from vested interests.

Never before opportunity:

There seems to be an immense opportunity waiting in the wings for any e-commerce business in India, providing a comprehensive and well-integrated information network for the patients directly, enabling them to take well-informed decisions for reliable, cost-effective and high quality health care services.

This has been facilitated by increasing mobile phone usage in India. According to India Telecom Stat of January 2016, the number of mobile phone users in the country has now crossed one billion. Experts believe that a large section of these subscribers will soon be the users of smartphones.

Rapid growth of internet connectivity with the affordable smartphones, fueled by the world’s cheapest call tariffs, commensurate availability of various attractive packages for data usage, would empower the users avail integrated, comprehensive and high quality e-commerce services in the healthcare sector too, sooner than later.

Would it reduce health care cost?

A transparent system of integrated health care services could bring health care cost significantly.

For example, one can find out from such websites, not just a large number of doctors from any given specialty, including dentistry. Alongside will be available many other important information, such as, their location, availability time and fees charged.

This would help patients comparing the doctors from the same specialty, especially from the quality feedbacks published on the website. This would facilitate patients taking a well informed decision for disease treatment according to their individual needs and affordability. The same process could be followed for selecting diagnostic laboratories, or even to buy medicines.

Such open and transparent websites, after gaining desired confidence and credibility of the users, would also help generate enough competition between healthcare service providers, making the private health care costs more reasonable, as compared to the existing practices.

These e-commerce companies would arrange immediate appointments according to the convenience and needs of the patients, and also help in delivering the prescribed medicines at their door steps. 

Some initiatives around the world:

Many startups are now setting shops in this area, around the world. Just to give a flavor, I would cite a few examples, as follows, among many others:

Name Country Services
Doctoralia http://www.doctoralia.com Spain A global online platform that allows users to search, read ratings, and book appointments with healthcare professionals 
iMediaSante http://www.imediasante.com/ France Provides patients to make medical appointments from a mobile for free. 
DocASAP http://www.docasap.com United States An online platform enabling patients to book appointments with the doctors and dentists of their choice.
Zocdoc https://www.zocdoc.com/ United States Solves patient problems with instant online appointment booking, provides verified reviews and tailored reminders.
Lybrate.com https://www.lybrate.com/ India Provides access to a verified online doctor database of over 90,000 medical experts, including in Ayurveda and Homeopathy, for appointments and to ask any question.
Practo http://www.practo.com/ India An online platform for patients to find and book appointments with doctors. Doctors use Practo Ray software to manage their practice.  

An Indian example:

In this sphere, one of the most encouraging Indian examples would be the Bangalore based Practo Technologies Private Ltd. This startup debuted in 2008, and in a comparative yardstick, has been the country’s most successful business in this area, so far. Its key stated goal has been bringing order to India’s rather chaotic health care system.

Currently, Practo connects 60 million users, 200,000 doctors and 10,000 hospitals. According to a May 27, 2016 report of Bloomberg Technology, Practo website is used to book over 40 million appointments, every year.

This e-commerce company also offers online consultations, and home deliveries of medicine. Its software and mobile applications link people and doctors, as well as hospital systems, so that they can effectively manage the visits and billing, while helping patients find physicians and access their digital medical records.

At present, Practo offers services in 35 cities, and plans to extend that to 100 by the end of this year. The company reportedly is now expanding in Indonesia, the Philippines and Singapore, with a future expansion plan in Latin America, starting with Brazil in March 2016.

How would India shape up?

Although, these are still the early days, according to Grand View Research Inc., based in San Francisco in the United States, the global healthcare information technology market is right on track to reach US$ 104.5 billion by 2020. Increasing demand, especially from the middle income population for enhanced healthcare facilities, and introduction of technologically advanced systems, are expected to boost the growth of this industry.

Increasing rural penetration of e-commerce on integrated health care, would be a major growth booster for this industry in India.

Besides its distant competitor Lybrate, Practo does not have any tough competition in India, at present. However, the scenario may not remain the same, even in the near future. 

Keeping an eye on this fast growing market, two former top executives from India’s e-commerce leader – Flipkart are launching their own health-tech startup creating a new rival for Practo, according to the above Bloomberg report. Thus, it is a much encouraging fast ‘happening’ situation in the interesting digital space of the country. 

Conclusion:

Evolution of Indian e-commerce in health care is an encouraging development to follow. It would offer well-integrated, comprehensive and cost-effective health care services to many patients. Gradually penetration of this digital platform, even in the hinterlands of India, would help minimize quality health care related hassle of many patients, along with a significant reduction of out-of-pocket health expenditure cost.

Interestingly, there is no dearth of doomsayers against such novel initiatives, either. A few of them even say, it doesn’t make sense for the doctors to list themselves in the e-commerce directory for the patients to find them, as the patients desperately need them for any medical treatment, in any case. Others counter argue by saying that acquiring patients online should be a preferable way for doctors to maximize their income, among others, especially by eliminating the referral fees, which many specialists in India require paying for the source of referral.

However, I reckon, a larger number of credible and transparent e-commerce websites for integrated healthcare services, all in one website, would enhance competition, bring more innovation, and in that process delight many patients in India. Never before it was so promising, as the country is making a great progress in the smartphones’ usage, along with Internet access, in the country. The unique facility of free search for medical care services would also help patients immensely in choosing quality, and cost effective medical treatment interventions that would suit their pocket. 

To achieve this goal, the highly competitive digital process of integration and aggregation of requisite pre-verified latest information on different health care service providers and aggregators, in the most innovative and user-friendly way, would play a crucial role. In tandem, delivering the prescribed medicines at the patients’ door steps in strict compliance with the regulatory requirements, would really be a treat to follow in the rapidly evolving digital startup space of India.

The name of the game is ‘Idea’. The idea of offering innovative, well-integrated, comprehensive, user-friendly, and differential value delivery digital platforms for healthcare e-commerce. It shouldn’t just overwhelmingly be what the sellers want to force-feed, but where the majority of patients on their own volition can identify the differential values, and pay for these, willingly.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Leveraging 3D Printing In Pharma, For Cost Containment And Patient-Centricity

Posted on by
Reply

Today, although a number of new and state of the art drugs is regularly being developed, and brought to the market at a reasonably rapid pace, their access to the majority of the global population has still remained a huge challenge. One of the key access barriers continue to remain exorbitant prices of these drugs.   

Keeping commensurate pace with gradual improvement in the pinpointed diagnosis of various diseases with modern diagnostics, processes, devices and techniques, fueled by increasing health awareness within a sizeable section of the population, more patients are now aspiring for access to a better quality of life, and greater productivity at work. This is happening all over the world, though with varying degree and magnitude. 

Consequently, there has been a sharp increase in the demand for healthcare, which has caused a huge bottleneck in the overall healthcare delivery process, for various reasons. The huge gap between the availability of high-tech drugs/healthcare services, and their access to the general population, mostly due to affordability reasons, is going north at a rapid pace. 

Two-pronged cost containment pressure:

This unfettered ascending trend is creating primarily the following two types of cost containment pressure: 

  • Being driven purely by the economical reasons, the Governments and other payers have started taking stringent cost-containment measures, bringing huge pricing pressure, especially on the drugs and medical device manufacturers.
  • In countries, such as, India, where the ‘Out of Pocket’ expenditure on healthcare in general, and the medicines in particular, is hovering around 70 percent, the patients, several Governments have started announcing drug price control policy to protect the health interest of patients. 

However, currently, only some piecemeal measures are being initiated, including in India, where a holistic approach for all, such as, Universal Health Care (UHC) and several other similar options, are long overdue.

Three different remedial measures:

In my view, consideration of either of these three following approaches, or an innovative blend of these, would enable the Governments to address this pressing issue, remove the existing bottle neck, and thereby bridge the healthcare access gap, holistically:

A. Fast implementation of Universal Health Care (UHC).

B. Closer look at the entire Pharmaceutical Value Chain with a resolve to work out innovative, game-changing solutions to reduce cost of each of its critical components, significantly.

C. Effectively addressing the emerging need of Patient-Centricity.

A. Fast implementation of Universal Health Care (UHC):  

I have already discussed UHC in one of my articles titled, “Universal Health Coverage: The Only Alternative To Drug Price Control in India?”, published in this Blog on November 9, 2015.

B. Cost containment with 3D printing:

A report of IMS Health, published on November 18, 2015, forecasts the increase of  total global spend for pharmaceuticals by US$ 349 billion on a constant-dollar basis, compared with US$182 billion during the past five years. It also indicated, more than half of the world’s population will live in countries where the use of medicine will exceed one dose per person per day by 2020, up from 31 percent in 2005, as the “medicine use gap” between the developed and the emerging markets narrows. 

This steep ascending trend would eventually affect the pharma ‘Value Chain’ in a significant way, throwing open several path-breaking high-technology based options, with impressive favorable impact on the general costs of medicines. 3D-printing technology is expected to play a significant role in this initiative.

Before proceeding further, let me zero-in on a few critical components, as follows, of the pharma ‘Value Chain’, as I see visualize these: 

  • Drug innovation (R&D)
  • Manufacturing
  • Marketing
  • Supply Chain

According to my understanding, at least in 3 of the above 4 ‘Value Chain’ components, there is an immense potential of leveraging 3D printing technology effectively, and in a big way.

In my article of January 11, 2016, published in this Blog, titled “3D Printing: An Emerging Game Changer in Pharma  Business”, I have already discussed the game changing impact of 3D Printing technology on the drug discovery process, drug manufacturing strategy, and supply Chain effectiveness in the pharma business. 

Hence, I prefer not to dwell on those areas, yet again, here. Instead, I shall briefly deliberate on the application of 3D Printing technology to effectively address the emerging need of ‘Patient-Centricity’ with an interesting and a very recent example. 

C. Improving ‘Patient-Centricity’ with 3D printing: 

At this stage, there is a need to understand what exactly is the ‘’Patient-Centricity’. It seems to be a popular buzzword now with the health care related companies, primarily to give an impression that they are really focusing on ‘Patient-Centricity’.

However, there does not seem to exist any universally accepted definition of this terminology, just yet. Nevertheless, one appropriate definition could well be: “A focused and transparent approach to providing maximum possible benefits to a patient from a drug, device, technology, or health care services.” 

I briefly focused on a part of this basic issue in my article titled, “‘Disease Oriented Treatment’ to ‘Patient Oriented Treatment’- An evolving trend’, published in this Blog on January 7, 2013.

As I said before, in this article, to explain ‘Patient-Centric’ approaches with 3D printing, I would quote from a very recent, and a path-breaking work in this area.

On May 25, 2016, ‘The Straits Times’ reported, the researchers at the National University of Singapore have found a way to use 3D printers to create low-cost tablets. With the help of this technology a tablet can be so personalized to respond to individual patient’s needs that the drug can be customized to take on different release profiles, such as, constant release, pulsed release, increasing or decreasing release, and any arbitrary interval as required by the patient. However, the most striking is, different drugs with different release profiles can also be combined in a single pill.

Once administered, the tablet dissolves layer by layer over a period of time, releasing the drug at a controlled rate. The duration can be altered by changing the chemical composition of the liquid.

It is worth noting here that the conventional tablets are only capable of a constant rate of release, requiring the patient to manually control the dosage and release rate, by taking doses according to a prescribed schedule, given by the doctor. In this scenario, if a patient requires different drugs with different dosages and intervals, it can become inconvenient to keep track and potentially dangerous, especially when the patient misses a dose, the report highlighted. 

The commercially available printer used in the project costs just S$2,000.

The Assistant Professor Soh Siow Ling, who leads the project, reportedly, expects that the low cost will allow it to be used in hospitals and neighborhood clinics. He further explained, “Every single person is different, based on many factors such as genetics, age, body mass and so on. Different people also have different activity levels and consumption habits, which affect their needs. It is, (therefore), not desirable to use the same drug to treat different illnesses which have similar apparent symptoms.”

The report indicated that in October, 2015, these findings were published in an issue of Advanced Materials, which is a peer-reviewed materials science journal.

A patent for the tablets was filed last year, and they are currently in talks with multinational corporations, and medical professionals to identify potential applications, the article highlighted. 

Changing role of doctors:

From the above developments, it appears that unleashing the full potential of 3D printing technology in the pharma industry, would also enable the medical profession to move further towards ‘Patient-Centricity’, in its true sense.

This technology would empower them offering to each patient, the right drug or drug combinations, with most suitable drug delivery system, and exactly the way individual patients would prefer, with a very high degree of precision.

Thus, from overall disease treatment perspective, especially with medicines, this approach offers a great potential to be significantly more effective, and convenient to individual patients, as compared to the conventional approaches. 

I reckon, over a period of time, professional competitiveness would drive the doctors further honing their effectiveness in the disease treatment process, and that too with a high degree of precision. In that situation, many doctors may decide to setup on-demand 3D drug-printing facilities even at their clinics.

The gradual embodiment of this brilliant technology by the doctors, is expected to throw open new vistas of opportunity, also to personalize the shapes, colors and flavors of any medicine, according to individual patient’s choice. This, in turn, would improve patient compliance, ensure a predictable relief from the disease, and demonstrate ‘Patient-Centricity’ of a high order by the medical profession, in general. 

Conclusion:

For the first time ever, with Aprecia Pharmaceuticals in the United States getting approval of the US-FDA on August 3, 2015 for the market launch of a 3D printed prescription drug for oral use by the epilepsy patients, dawns a new paradigm in the global pharma business horizon.

Effective application of this ‘disruptive innovation’ could well be a game changer not just in the ‘value chain’ of conventional pharma business models, across the world, but also for taking a giant leap towards ‘Patient-Centricity’. The doctors are also expected to be very much an integral part of this process. 

Besides all the above benefits, 3D printing can also encourage low-volume production, whenever required, and a wide variety of Active Pharmaceutical Ingredients, to meet any immediate demand, mostly for use in research and developmental work. 

Thus, noting the ongoing significant progress in this area, I reckon, leveraging 3D printing technology in pharma, not just to address the cost containment pressure, effectively, but also to ensure a tangible and visible move towards ‘Patient-Centricity’, in true sense. All-round success in the innovative application of this cutting-edge technology in the global pharma industry, would eventually separate men from boys in pursuit of business excellence. 

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.