Pharma Stakeholder Sentiment: Back to Square One?

Is it fair to push out the core purpose of an important process, or rather a mission, unfairly? Whether we like it or not, it happened that way, over a period of time.

Way back on December 01, 1950, George W. Merck (President and Chairman Merck & Co., Inc.1925-1957), epitomized the core purpose of the drug innovation process. This is something, which apparently was possible only for him to articulate exactly the way he did.

On that day, while addressing the students and the faculty at the Medical College of Virginia, Richmond, George Merck said: “We try to remember that medicine is for the patient. We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.”

To many of us, it may sound more as an altruistic statement, and not really coming from a businessman who wants to excel in the financial performance of the organization. Interestingly, that was not the case, either. Merck removed any possible ambiguity in his statement by stating categorically: “In doing this, it will be as a business­ man associated with that area of the chemical industry which serves chiefly the worlds of medicine and pharmacy.”

In this article, I shall deliberate on whether or not the core purpose of drug innovation, as articulated by George Merck in 1950 has been pushed out of the mind of the stakeholders for good.

Management Guru – Peter Drucker’s similar observation:

It is worthwhile to recapitulate at this stage that around the same time, the Management Guru – Peter Drucker also made a similar observation, which is relevant even today. He said: “Because the purpose of business is to create a customer, the business enterprise has two – and only two basic functions: marketing and innovation. Marketing and innovation produce results; all the rest are costs. Marketing is the distinguishing, unique function of the business.”

Interestingly, when the word ‘customer’ is replaced with ‘patients’, George W. Merck’s iconic statement fits so well even in the realm of business management, including drugs and pharmaceuticals.

Signs of the core purpose of new drug discovery getting pushed out:

The core purpose of new drug innovation in pharma business, as articulated by a top industry pioneer – ‘Medicine is for the patient and not for the profits’, was pushed out eventually, regardless of its reasons. Today’s core purpose of the same process has seemingly become just the opposite of that – ‘Medicine is only for the patient who can afford it – to maximize profit.’

This change in the core purpose was visible in a large number of instances. For example, when the then Bayer CEO Marijn Dekkers reportedly said: ‘Our cancer drug is for rich westerners, not poor Indians.’  However, his exact wordings were “we did not develop this product for the Indian market, let’s be honest. We developed this product for Western patients who can afford this product, quite honestly.” If so,the question that comes up: why then Bayer fought so hard and spent so much of money, efforts and time to keep selling this specific product in India – exclusively?

In any case, this statement from the highest echelon of one of the top global pharma players is a contentious one, especially against George Merck’s articulation, or even Peter Drucker’s for that matter, on the same. By the way, Dekkers made this commentat the Financial Times Global Pharmaceutical & Biotech Conference in December in December 2013.

A wind of change?

The hope for a wind of change flickered when in an interview, Andrew Witty,the erstwhile global CEO of GlaxoSmithKline (GSK), signaled a totally contrasting view of his company. Witty said: “GSK is committed to offering all its new drugs in India at affordable prices.”

Much prior to this, on March 14, 2013 he told a conference on healthcare in London that: “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.” He further expressed: “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.”

Witty era is also over now. He retired from GSK at the age of around 53 on March 31, 2017. Perhaps his refreshing patient-centric thoughts would also not find any takers within the industry. Nonetheless, in March 2018, the same issue resurfaced in an interesting article, followed by a few other related developments.

Call for socializing drug development?

The issue, which is not just limited to high prices for new patented drugs, is much broader. An interesting article titled, “Developing drugs wasn’t always about profit, and it shouldn’t be now”, was published in Quartz- a news website owned by Atlantic Media, brings to the fore the same key point, yet again. It makes some profound observations, such as socializing drug development. The word ‘socializing’ may not be quite acceptable to many, though. Nevertheless, it raises some critical issues worth pondering over, such as:

  • Faith in the power of money pervades our modern medical system. Pharmaceutical companies aren’t evil (usually). They just choose to make the most profitable drugs, not the drugs of greatest value to society.
  • For example, despite antimicrobial resistance being a global threat, pharma companies have largely abandoned new antibiotic development on the eminently sensible principle that they are money-losers. Promising narrow-spectrum antibiotics – agents that precisely target pathogens and spare “good” bacteria - languish in development limbo because there is no hope that they might churn as much profit as several other drugs.

It’s high time, I reckon, to adequately address the dire need for a reliable supply of the medicines that make a vibrant modern society possible. All stakeholders, including the pharma industry, globally, would require putting their heads together in charting out a clear and time bound pathway for its effective resolution, soon. Otherwise, sheer gravity and the complexity of the situation may prompt the policy makers to move towards ‘socializing drug development,’ much to the dismay of many of us.

Hospitals creating nonprofit generic drug company:

On January 18, 2018, The New York Times (NYT), published an article titled “Fed Up With Drug Companies, Hospitals Decide to Start Their Own,” highlighted a novel initiative to address the prevailing situation, in their own way, without depending on others.

It reported, for many years, several hospital administrations have been expressing frustration when essential drugs like heart medicines have become scarce, or when prices have skyrocketed because investors manipulated the market. Now, about 300 of the country’s largest hospital systems are taking an aggressive step to combat the problem. They plan to go into the drug business themselves, in a move that appears to be the first on this scale.

‘The idea is to directly challenge the host of industry players who have capitalized on certain markets, buying up monopolies of old, off-patent drugs and then sharply raising prices, stoking public outrage’, the article elaborates.

‘Price of medications has soared, so have pharma profits’:

‘Big Pharma is jacking up prices for one reason – because it can,’ says a CNN Article, published on April 04, 2018. The article further emphasizes: “As the price of medications has soared, so have pharmaceutical company profits. Total sales revenue for top brand-name drugs jumped by almost $8.5 billion over the last five years. The Government Accountability Office (GAO) reported that 67% of drug manufacturers boosted their annual profit margins between 2006 and 2015 – with profit margins up to 20% for some companies in certain years.”

It further writes, “Not only have pharmaceutical companies reaped outsized profits from these price hikes, so have their CEOs. According to a USA Today analysis, the median compensation package for biotech and pharmaceutical CEOs in the Standard & Poor’s 500 was 71% higher than the median compensation for S&P 500 executives in all industries in 2015.”

Conclusion:

This is happening the world over. But its degree varies. In those countries where there are drug price regulators, only a small percentage of the total pharma market by value comes under price regulation, the rest of the products enjoy virtually free pricing freedom.

Would this ground situation change on its own any time soon? There is no specific answer to this question, yet. Moreover, there doesn’t seem to be none around in the pharma industry today with the stature and articulated vision like George Merck. He started from the very basic. Drawing the ‘square one’, he clearly defined the core purpose of discovery, manufacturing and marketing of medicines. Today’s pharma industry, by and large, seems to be charting in other newly drawn squares. Maximizing profit is now considered a key objective of achieving the core purpose – and not an outcome of achieving the core purpose of pharma business.

However, there are some very early signs of several stakeholders’ sentiment changing in this regard. Are they moving back to the basic – square one?

From the chronicles of the past several years on this issue, pharma industry does not seem to be on the same page with those stakeholders, just yet. If they do, a humongous health worry of a vast majority of the global population could be effectively addressed, as many believe.

The reverberations of this sentiment, though rather faint, can be felt in many countries, including the United States, and not just in the developing world, such as India.

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.

Unsustainable New Cancer Drug Prices: Resolution Remains A Far Cry

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 primarily due to the fact that their prices are disconnected from the actual therapeutic value of products.

Today, a very large number of poor and even the middle-income patients, who spend their entire life-savings for treatment of a disease like cancer, have been virtually priced out of the patented new drugs market.

The plights of such patients are 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.

I discussed about the recent decision of the Government for shelving UHC in my recent Blog Post titled, “Would Affordable ‘Modicare’ Remain Just A Pipe Dream In India?

Irresponsible pricing?

To highlight this point, I shall quote from the research paper titled, “Five Years of Cancer Drug Approvals, Innovation, Efficacy and Costs” published in JAMA Oncology dated April 02, 2015. This report states that just one year’s cost of treatment with a patented new cancer drug now routinely exceeds US$ 100,000. It is much known today that the medical bills for cancer treatment have become the single largest cause of personal bankruptcy, in many countries of the world.

The issue is even more impactful and heart wrenching in India, as with much lower per capita income, compared to the global median, a cancer patient pays around the same price for the same patented drugs in the country. Much talked about Nexavar of Bayer, has been a good example.

The above report underscores, the big global pharma players still vigorously contend to establish that the high cost of drugs is required to support their research and development efforts. However, none would possibly deny the hard data that, when costs and revenues are balanced, the pharmaceutical industry generates high profit margins.

On a lighter vain – the fact that the richest person in India is a pharma player of ‘low price generic medicines’ vindicates this point.

The latest report on pharma R&D costs:

In a ‘Press Release’ of November 18, 2014, Tufts Center for the Study of Drug Development announced, “Cost to develop and win marketing approval for a New Drug is US$2.6 Billion”.

This is around 2.5 times more than its previous estimate published in 2003, which reads as US$802 million.

Although the study is not publicly available, neither has it been peer reviewed, it does reflect that above overall inflation rate, pharma R&D costs are reportedly going up at an annual rate of around 8 percent!

Even if the R&D cost of US$2.6 Billion is accepted as correct to justify high prices of patented drugs, one should note that this figure is applicable only to those types of New Chemical Entities (NCE) that did not receive any outside funding in their developmental process, such as, from the National Institutes of Health (NIH).

It is worth noting, such types of NCEs account for less than one-sixth of the annual new drugs approval in the United States.

Interestingly, Tufts Center receives its funding from the pharmaceutical industry, according to reports.

When is a high cost of medicine defendable?

According to some, high price may be justified, if novel products offer significant benefits to patients giving rise to indirect quantifiable economic value through restoration of health of patients.

This is understandable, as those patented drugs represent significant and well-accepted pharmacological advances over the existing ones, offering novel mechanisms of actions for better treatment value through ‘high-risk-high-cost’ research.

Price is a function of the value that a drug offers:

The price of any drug must be a function of the value that it offers to the patients. Not just the cost of its innovation, irrespective of the fact, whether it is a ‘New-Class (Novel)’ or ‘Next-in Class’ or even a ‘Me-too’ NCE.

The above April 2015 research report published in JAMA Oncology, investigated at length, whether novelty of medications or their relative benefits dictated drug pricing.

In that endeavor, the authors found out that from January 1, 2009, to December 31, 2013, the USFDA approved 51 drugs in oncology for 63 indications. During this period, 9 drugs received more than 1 approved indication.

The study observed:

Of these 51 drugs:

- 21 (41 percent) exert their effect via a novel mechanism of action

- While 30 (59 percent) are next-in-class drugs

Despite this fact, there was no difference in the median price per year of treatment between the 30 next-in-class drugs (US$119, 765) and the 21 novel drugs (US$116, 100).

Global cancer market is soaring high fuelled by astronomical prices:

According to a report that quotes an official of IMS Health, the overall cost for cancer treatments per month in the United States is now US$10,000, up from $5,000 just a year ago. At the same time, according to a 2014 study by the IMS Institute for Healthcare Informatics, global oncology spending has hit US$91 billion in 2013, and despite patent cliff is growing at 5 percent annually.

None likes nightmarish cancer drug-pricing trend:

None likes this worrisome drug-pricing trend, not even in the developed world. God forbid, just one cancer patient in the family can drag even a middle class household to the poverty level, especially in a country like India, where Out of Pocket (OoP) expenses for health hovers around 70 percent and Universal Health Coverage still remains a pipe dream.

Payers, including governments and private insurers, in the top cancer markets such as the United States and Europe, are trying hard to bring the cancer drug prices to a reasonable level through regulatory pressure of various kinds and forms. For example, National Institute for Health and Care Excellence (NICE) in the United Kingdom and the regulators for drug cost-effectiveness in other large European countries, are coming hard on patented new cancer drugs with small improvements in survival time but priced much higher than the existing ones.

Even many private insurers in those countries are now raising questions about the additional value offerings in quantifiable terms, especially for the new cancer drugs and other treatments for life-threatening ailments, such as hepatitis C. To give an example, in late 2014, Express Scripts in America negotiated hard for an exclusive deal with AbbVie to provide its hepatitis C treatment Viekira Pak over Gilead’s exorbitantly priced Sovaldi.

Action by the doctors outside India:

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

Unlike in 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 on their benefits and side effects, but prices as well.

In a recent 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 such drugs. Their solution for this problem includes value-based pricing and NICE like body of the U.K.

This Interesting Video from Mayo Clinic justifies the argument.

Tokenism by the Indian Government:

India sent a signal to global pharma players about its unhappiness of astronomical pricing of patented new cancer drugs in the country on March 9, 2012. On that day, the then Indian Patent Controller General 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.

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

Be that as it may, India did send a very strong signal in this regard, which some construe as mere tokenism. Nonetheless, this action of the Indian Government shook the global pharma world very hard, that it would find difficult to forget in a foreseeable future.

Government’s determination to make it happen is still eluding:

The headline of this article would probably invoke an instant negative response from my friends in the industry, an understandably so, expressing… ‘Hey, are you talking against innovation and suggesting one more regulator for the heavily regulated pharma industry?’ 

I would very humbly say, no…I am suggesting neither of those two, but requesting to give shape to a very important decision already taken by the Government on this issue, in a meaningful way. That decision has been scripted in Para 4.XV of the National Pharmaceutical Pricing Policy 2012 (NPPP 2012) and was notified on December 07, 2012.

On ‘Patented Drugs Pricing’, it categorically states as follows:

“There is a separate committee constituted by the Government Order dated February 01, 2007 for finalizing the pricing of Patented Drugs, and decisions on pricing of patented Drugs would be based on the recommendation of this committee.”

The following long drawn unproductive events would vindicate, beyond even an iota of doubt, that a strong determination to make it happen, by even by the new Government, is still eluding by far.

Is this committee ‘Jinxed’?

To utter dismay of the patients and their well-wishers, the above committee took over six years after it was formed to submit its report.

It recommended ‘Reference Pricing’ for the Patented Drugs in India, after adjusting against India’s Gross National Income and Purchasing Power Parity. The suggested ‘Reference Countries’ were UK, Canada, France, Australia and New Zealand, where there exist a strong public health policy, together with tough bargaining power of the governments for drug price negotiations.

However, our Government found this report useless for various reasons and dissolved the panel. The grapevine in the corridors of power whispers, it could possibly be due to intense pressure from the global pharma players and their powerful lobby groups.

Interestingly, again by the end of 2013, the Department of Pharmaceuticals (DoP) set up a brand new inter-ministerial committee with four representatives each from the Ministry of Commerce and Industry, Ministry of Health and Family Welfare, National Pharmaceutical Pricing Authority (NPPA) and one from the DoP to resolve the same issue of ‘Patented Drugs Pricing’ in India.

Unfortunately, a serious issue of this magnitude has still remained unresolved, even under the new seemingly dynamic Government, till date. There were media reports though, just prior to the Union Budget in January 2015, that ‘the Government may negotiate prices of patented medicines with their manufacturers before allowing pharmaceutical companies to launch them in India.’

The scenario is still far from even sketchy. A lurking fear, therefore, creeps into the minds of many: Is this committee on ‘Patented Drugs Pricing’ jinxed or incompetent or has deliberately been kept non-functional under tremendous external pressure on pricing of patented drugs?

The way forward:

To find an implementable ‘Patented Drug Pricing Model’ soon, the new committee of the Government should consider Pharmacoeconomics Based or Value-Based Pricing (PBP/VBP) Model for the country.

Pharmacoeconomics, as we know, is a scientific model of setting price of a medicine commensurate to the economic value of the drug therapy.  Pharmacoeconomics principles, therefore, intend to maximize the value obtained from expenditures towards medicines through a structured evaluation of products costs and disease outcomes.

Thus, PBP/VBP basically offers the best value for money spent. It ‘is the costs and consequences of one treatment compared with the costs and consequences of alternative treatments’.

To the best of my knowledge, the Public Health Foundation of India, spearheaded by well-reputed internationally acclaimed physician – Dr. Srinath Reddy, has requisite expertise in this area and to build on it further, as required by the committee.

This new model would help establishing in India that the price of any drug is always a key function of the value that it offers and not of the so called ‘high cost of innovation’, irrespective of whether it is a ‘New-Class (Novel)’ or ‘Next-in Class’ or even ‘Me-Too’ NCE.

The concept is gaining ground: 

The concept of ‘Value-Based Pricing’, 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.

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.

Price tags of most of the patented new cancer drugs, do not seem to give any indication that the pharma players believe in this pricing model, even remotely. As JAMA Oncology has established in their recent research study, there is no difference in the median price of per year of treatment between ‘Next-in-Class’ and ‘Novel Drugs’.

Thus far, India has been able to address this issue either through section 3(d) or Compulsory Licensing (CL) provisions of its Patents Act. As the saying goes, ‘proof of the pudding is in the eating’, the net fall-out of these measures has been demonstrably profound. For example, the global pharma giant Gilead has entered into voluntary License (VL) agreements with several local companies to market in India one of the most expensive products of the world – Sovaldi, at a small fraction of its original price of US$1,000/tablet. 

That said, effective long-term resolution of ‘Patented Drugs Pricing’ issue, in my view, is long overdue in India, especially for the treatment of life-threatening diseases, such as cancer. This has been necessitated by the fact that in many cases, therapeutic benefits of most of these drugs are not commensurate to their high costs.

The provision for ‘Patented Drugs Pricing’ has already been made in the NPPP 2012, though not implemented, as yet. While working out an implementable mechanism for the same, the new committee of the present Government may consider ‘Pharmacoeconomics Based or Value-Based Pricing (PBP/VBP) Model’ to effectively resolve this crucial issue. The specialized group that will operate this system could be a part of the National Pharmaceutical Pricing Authority (NPPA) of India.

The struggle for life in the fierce battle against dangerous ailments, without having access to new life-saving drugs, has indeed assumed a mind-boggling dimension in India, especially in the absence of Universal Health Coverage. It would continue to remain so, unless the new Government demonstrates its will to act, putting in place a transparent model of patented drugs pricing, without succumbing to any power play or pressures of any kind from vested interests.

The bottom-line is: It has to happen soon…very soon. For patients’ sake.

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.