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Expand Market Share Unleashing Digital Health Potential For All

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“Advancement in digital health is currently restricted mainly to economically and socially privileged populations. Those having access, resources and basic digital skills, are reaping disproportionate benefits from the technology and other associated infrastructure available for this purpose. Unfortunately, underserved population, mostly in rural hinterland and in some urban areas, still do not have much access to this technical advancement in the healthcare space. Ensuring affordable access to “Digital Health” in digital India, would help augment quality healthcare support with equity, to all in the country.” I wrote the above in my article on digital health, published in this blog, way back on March 09, 2015.

About two years down the line from that date, the IQVIA report – ‘The Growing Value of Digital Health’, published on November 07, 2017, also reported: ‘The impact of Digital Health on patient care is accelerating with the increasing adoption of mobile health apps and wearable sensors.’ It highlighted, among others, the following important points:

  • Health-related mobile applications available to consumers nearly doubled from the number available just two years ago, with increasing clinical evidence on app efficacy – supported by 571 published studies in 2017.
  • The use of Digital Health apps with proven reductions in acute care utilization include, diabetes prevention, diabetes management, asthma, cardiac rehabilitation, and pulmonary rehabilitation.
  • ‘Digital health’ signals a high potential in reducing overall health care cost for both patients and the providers – reducing huge burden on the health system, significantly.
  • Efforts by patient care organizations to fit ‘’Digital Health tools into clinical practice have progressed with 540 current clinical trials in the U.S. incorporating these tools, and an estimated 20% of large health systems shifting from pilot ‘Digital Health’ programs to more full-scale rollouts.
  • However, despite progress to date, several barriers still exist to widespread adoption by patient care institutions, and only an intermediate level of adoption has yet occurred.

In this article, I shall explore – how pharma marketers can expand their respective brand market share by unleashing the full potential of digital health, for all, and equitably, while formulating their marketing strategies of the new normal.

Digital health accelerated effective response to COVID-19 challenges:

Never has extensive operational overhaul been more urgent in health care than in the current climate of the COVID-19 pandemic – emphasized the article on ‘Digital health during COVID-19’, published in the February 2021 online issue of The Lancet (Digital Health). The paper underlined – the urgency of the pandemic prompted new models of patient treatment, providing medical professionals tools to respond effectively to the unprecedented crisis, with the advances in digital health.

However, the authors cautioned, ‘to ensure sustained adoption, it is necessary to not assume that digital solutions will naturally assimilate into clinical practice, and instead adopt participatory approaches that regularly involve stakeholders.’ Meanwhile, a confused signal is causing delay in the speedy adoption of digital health.

Is a confused signal delaying speedy adoption of digital health?

As Covid vaccination process gaining steam, the pandemic, apparently, is coming under control in many places of the world, just as it is in India. Alongside, several optimistic health care facilitators, providers and even regulators are probably awaiting the old normal to return – especially, F2F customer services.

Whereas, the above The Lancet (Digital Health) study finds – the clinical demand for digital services are gradually picking up – mostly because of the sudden surge in patient demand during the pandemic. Intriguingly, amid this situation, weak governance of digital technologies and platforms, is increasing health inequities and compromising human rights, which I wrote in my article on digital health, published in this blog, on March 09, 2015.

Weak governance of digital health results, increasing health inequities:

That weak governance of digital technologies and platforms, is increasing health inequities, was reiterated by yet another contemporary article titled – ‘Digital technologies: a new determinant of health,’ published in the November 2021 issue of The Lancet (Digital Health).

The article revealed, ‘The Lancet’ and ‘Financial Times’ Commission on governing health futures 2030’ has made important recommendations for successful integration of digital technologies in health. The bottom line of which is, weak governance of digital technologies is causing health inequities and compromising human rights. The study also emphasized, the future governance of digital technologies in health care ‘must be driven by the public purpose, not private profit’.  

Points to ponder for pharma marketers:

As iterated in the article of the November 2021 issue of The Lancet (Digital Health), the following facts needs to be considered by all, especially I reckon, by astute pharma marketers:

  • The COVID-19 pandemic has caused massive disruptions within health care, both directly as a result of the infectious disease outbreak, and indirectly because of prompt public health measures to mitigate against transmission.
  • This unprecedented disruption has caused rapid dynamic fluctuations in demand, capacity, and even contextual aspects of health care.
  • Therefore, the traditional face-to-face patient–physician care model has had to be re-examined in many countries, including India.
  • To rapidly tide over the crisis, and thereafter to avoid similar possible situations in the future, digital technology and new models of care are being rapidly deployed to meet the challenges of change, triggered by the pandemic.
  • The new models include remote digital health solutions such as telehealth, artificial intelligence – decision support for triaging and clinical care, and home monitoring of several ailments.
  • Operationalizing these new models will be based on the choice of technology support, clinical need, demand from patients, and manpower availability – ranging from pre-hospital to out-of-hospital models, including the hub-and-spoke model.

Conclusion:

It is widely believed today, the pan-industry shift toward digital health of different types is here to stay, in varying degree, though, and accelerate further for several strategic reasons. These include, adding more flexibility in attaining greater efficiency and effectiveness for customer engagement, and patient-perceived brand value delivery to them.

That said, as I wrote before, customer engagement may call for a hybrid business model of virtual and in-person F2F engagements. However, going back to the old normal of in-person F2F engagements for all doctors could probably be a far cry. Similarly, the initial success of e-customer engagement is unlikely to replace in-person and in-clinic F2F engagements of sales reps completely.

From the above perspective, I reckon, pharma marketers may now wish to expand their brand market share, significantly, by unleashing the full potential of digital health for all, and equitably, particularly, in the new normal.

However, in that process, they need to be vigilant for not deviating from the key purpose of digital health for the end users. This must reach across all socioeconomic strata, regardless of patient demographics or their geographical locations. It’s, no doubt, easier said than done, but has to happen – for the sake of health-equity - augmenting healthcare for all in 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.

India To Expand NLEM 2011: A Step In The Right Direction

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Responding to growing discontentment on the flawed National List of Essential Medicines 2011 (NLEM 2011) and equally vociferous demand for its urgent rectification, on May 5, 2015, in a written reply to the Lower House of Indian Parliament (Lok Sabha) the Union Minister for Chemicals and Fertilizers – Mr. Ananth Kumar made the following submission:

“The Ministry of Health and Family Welfare, has constituted a Core Committee of Experts to review and recommend the revision of National List of Essential Medicines (NLEM) 2011 in the context of contemporary knowledge of use of therapeutic products.”

According to earlier media reports, the Government had formed this Core Committee in May 2014 under Dr. V.M Katoch, Secretary, Department of Health Research (DHR) and Director General, Indian Council of Medical Research (ICMR). However to utter dismay of many, even in a full year’s time, the Committee has not been able to come out with any tangible recommendations in this area.

In his reply from the floor of the Parliament, the Union Minister added with a tinge of reassurance:

“The Core committee has already held wide consultations with stakeholders and is likely to come out with its recommendations on the revised NLEM soon… The revised NLEM would form the basis of number of medicines which would come under price control,”

This reply from the Minister was in response to a query from a lawmaker on what steps have been taken by the Government to expand the list of NLEM 2011 and provide them to the poor at affordable prices.

Mr. Ananth Kumar also reiterated, the National Pharmaceutical Pricing Authority (NPPA) has already fixed the ceiling prices in respect of 521 medicines till date, out of 628 NLEM formulations included in the first schedule of DPCO, 2013.

“The revised NLEM would bring more drugs under price control”, the Minister said.

NPPA’s earlier initiative was thwarted:

It is worth noting that in 2014, to include all drugs of mass consumption, in addition to essential and life saving medicines, NPPA initiated an exercise to expand the NLEM 2011.

At that time, quite rightly I reckon, the pharmaceutical industry vehemently protested against this regulatory overreach of NPPA and sought judicial intervention at least in two High Courts of India.

Moreover, as is well known today, NPPA’s attempt to regulate prices of medicines of mass consumption got thwarted, when the Union Government intervened and directed the price regulator to withdraw its related internal guidelines. Coincidentally this lightning action was taken just before Prime Minister Narendra Modi’s schedule visit to the United States in end 2014.

Be that as it may, the industry observers consider the last week’s announcement of the Union Minister, from the floor of the Parliament, to expand the span of NLEM 2011 as a step in the right direction for improving access to affordable essential medicines for all in India.

A brief backdrop for ‘Essential Medicines’:

The World Health Organization (W.H.O) has defined ‘Essential Medicines’ as those that ‘satisfy the priority healthcare needs of the population’. It has been propagating this concept since 1977, when W.H.O published the first Model List of Essential Drugs with 208 medicines. All these medicines together provided safe, effective treatment for the majority of communicable and non-communicable diseases, at that time.

Every two year this list is updated. The current Model List of Essential Medicines, prepared by the W.H.O Expert Committee in April 2013, is its 18th Edition.

According to W.H.O, such ‘Essential Medicines’ are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness. The Organization categorically states:

“Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford.”

Many countries of the world, India included now, have the National List of Essential Medicines (NLEM) and some have provincial or state lists as well, such as, in Tamilnadu Rajasthan and Delhi.

Health being a state subject in India, NLEM usually relates closely to Standard Treatment Guidelines (STGs) for use within the State Government health facilities. Ironically, such measures are currently being taken by just a small number of State Governments in the country.

NLEM – A forward-looking ongoing concept:

According to W.H.O, the concept of ‘Essential Medicines’ is forward-looking and ongoing. This idea prompts the need to regularly update the selection of medicines in the NLEM, reflecting:

  • New therapeutic options
  • Changing therapeutic needs
  • The need to ensure drug quality
  • The need for continued development of better medicines
  • Medicines for emerging diseases
  • Medicines to meet changing resistance patterns

As a part of its ongoing exercise, on May 8, 2015, The World Health Organization (W.H.O) by a ‘News Release’ announced addition of several new treatments for cancer and hepatitis C to its list of ‘Essential Medicines’, which the agency believes should be made available at affordable prices.

All 5 new products for the treatment of Hepatitis C, including sofosbuvir and daclatasvir, were included in the List. These medicines cure more than 90 percent of those infected and cost from US$63,000 to US$94,500 in the United States, depending upon the drug and treatment regimen.

Considering, new breakthroughs made in cancer treatment in the last years, W.H.O also revised the full cancer segment of the Essential Medicines List this year: 52 products were reviewed and 30 treatments confirmed, with 16 new medicines added in the list, including Herceptin of Roche, and Gleevec of Novartis.

“When new effective medicines emerge to safely treat serious and widespread diseases, it is vital to ensure that everyone who needs them can obtain them,” said W.H.O Director-General, Dr Margaret Chan. “Placing them on the WHO Essential Medicines List is a first step in that direction.”

India would also require putting similar effective systems in place for a robust, ongoing and time-bound review process for its NLEM.

Immense health and economic impact of ‘Essential Medicines’:

Globally the health and economic impact of ‘Essential Medicines’ have been proved to be remarkable, especially in the developing countries, as such drugs are one of the most cost-effective elements in healthcare system of any time. That’s why the stakeholders bestow so much of importance on a well thought out and properly crafted list of essential medicines by the astute experts appointed by the Government.

According to W.H.O, while spending on pharmaceuticals represents less than one-fifth of total public and private health spending in most developed countries, it represents 15 to 30 percent of health spending in transitional economies and 25 to 66 percent in developing countries.

In developing countries, such as India, pharmaceuticals are the largest Out of Pocket (OoP) household health expenditure. “And the expense of serious family illness, including drugs, is a major cause of household impoverishment.”

Flawed NLEM could multiply access to medicines problems:

Despite well-documented global evidence regarding high potential of health and economic impact of ‘Essential Drugs’, if the NLEM does not include right kind of drugs and remains flawed, it could have significant adverse impact on the overall access to ‘Essential Medicines’ in India.

In addition, properly structured NLEM could help setting the right course in the procurement and supply of medicines in the public sector – national or state Government schemes that reimburse medicine costs, and also for domestic production of drugs in the country.

A quick overview of NLEM in India:

There was no functional NLEM in India before 2002. According to a paper titled “Decisions on WHO’s essential medicines need more scrutiny”, published in the BMJ on July 31, 2014, in India the first National Essential Medical List (NEML) was prepared in 1996. However, this list was neither implemented for procuring drugs nor were STGs drawn up.

It all started in 2002, when the National Drug Policy of India, announced in that year, was subsequently challenged through a Public Interest Litigation (PIL) in the Karnataka High Court on the ground of being inflationary in nature. The Honorable Court by its order dated November 12, 2002 issued a stay on the implementation of that Policy.

This judgment was challenged by the Government in the Supreme Court, which vacated the stay vide its order dated March 10, 2003 and ordered as follows:

“We suspend the operation of the order to the extent it directs that the Policy dated February 15, 2002 shall not be implemented. However we direct that the petitioner shall consider and formulate appropriate criteria for ensuring essential and lifesaving drugs not to fall out of the price control and further directed to review drugs, which are essential and lifesaving in nature till 2nd May, 2003”.

As a result DPCO 1995 continued to remain operational, pending formulation of a new drug policy, based on NLEM based span of price control, as directed by the Honorable Supreme Court of India. Necessitated by this directive of the Apex Court of the country, the first NLEM of India came into effect in 2002.

In 2011, NLEM 2002 was subsequently reviewed and re-evaluated by a committee of 87 experts from various fields, and was replaced by the NLEM 2011 with 348 drugs.

In the recent years, following a series of protracted judicial and executive activities, the National Pharmaceutical Pricing Policy 2012 (NPPP 2012) came into effect on December 7, 2012. In the new policy the span of price control was changed to all drugs falling under the National List of Essential Medicines 2011 (NLEM 2011) and the price control methodology was modified from the cost-based to market based one. Accordingly the new Drug Price Control Order (DPCO 2013) was notified on May 15, 2013.

However, the matter is still subjudice, as NPPP 2012 would ultimately require passing the acid test of scrutiny by the Supreme Court of India, in the future days.

A recent study emphasizes need for urgent expansion of NLEM:

A March 2015 independent evaluation of DPCO 2013, which controls prices of essential medicines in India as featured in the NLEM 2011, brought to light some interesting facts. The Public Health Foundation of India (PHFI) and the Institute for Studies in Industrial Development released this report titled “Pharmaceutical Policies in India: Balancing Industrial and Public Health Interests” at a conference on pharmaceutical policies in India, held in New Delhi from 3 to 7 March, 2015.

This independent evaluation would most probably be submitted to the Supreme Court where PHFI is one of the petitioners in a case challenging the current NPPP 2012.

The study found that price regulations of NLEM 2011 are limited to just 17 percent of the total pharmaceutical market in India. This leaves 83 percent of the domestic pharma market free from price control, providing only marginal financial relief to patients for all essential medicines, in its true sense, as desired by the Supreme Court of India. Thus, one of the key recommendations of this study is to review the NLEM 2011, urgently.

“Clearly the interests of the pharmaceutical industry have received precedence over the interest of the patient population,” the report highlighted.

Anurag Bhargava, of the Himalayan Institute of Medical Sciences, was quoted in March 2014 BMJ Article titled, “Analysts in India call for urgent expansion of essential medicines list”, saying:

“This is a matter of concern given that the NLEM was not drafted as an instrument for price regulation. It is a representative rather than a comprehensive list of medicines utilized in actual practice. To serve as a reference for rational prescribing, the NLEM includes only a few model dosage forms, strengths, and combinations of drugs.”

NLEM 2011 fails to reflect public health priorities:

The report, with relevant details, brings to the fore that NLEM 2011 has failed to reflect India’s public health priorities. It underscores the following glaring deficiencies in NLEM 2011, which covers just:

  • 1 percent of drugs for anemia
  • 5 percent of respiratory drugs
  • 7 percent of antidepressants
  • 15 percent of drugs for diabetes
  • 18 percent of drugs for tuberculosis
  • 13 percent of anti-malarial drugs
  • 23 percent of cardiac drugs
  • 35 percent of antibiotics

Areas for revision in NLEM 2011:

A critical appraisal of NLEM 2011 was done in the above-mentioned 2014 BMJ paper and also by the NPPA separately.

Taking all these into consideration, some key areas of concerns related to NLEM 2011 floats at the top of mind. A few examples of important issues, which need immediate attention, are as follows (not necessarily in the same order):

  • Other key strengths and dosage forms of the same drugs covered under NLEM 2011
  • Analogues of scheduled formulations not covered
  • Close substitutes in the same therapeutic class not covered
  • Some essential drugs listed in the W.H.O model list and even in Delhi list are missing in the NLEM 2011
  • Several essential HIV and Cancer drugs are not included in NLEM 2011
  • Essential oral anti-diabetic medicines, like glimeperide and glicazide do not find place in NLEM 2011, especially when the list in the DSPRUD for Delhi includes anti-diabetic medicines such as glimepiride, sitagliptin, vildagliptin, saxagliptin
  • Commonly used anti-asthmatic medicines like almeterol and montelukast are missing in NLEM 2011
  • When W.H.O model List (EML) includes capreomycin, cycloserine, ethionamide, kanamycin and para-aminosalicylic acid for treatment of multi-drug resistant tuberculosis, these drugs are missing in NLEM 2011 list
  • Though a large number of Fixed Dose Combinations (FDCs) are prescribed to treat common ailments in India, especially in certain therapeutic groups such as respiratory, cardiovascular, anti-diabetic, dermatology, anti-malarial and anti TB/MDR TB, most of these are missing in NLEM 2011
  • While the W.H.O list mentions 21 vaccines, the NLEM 2011 mentions only nine vaccines
  • A separate list of lifesaving drugs based on existing lifesaving drugs list of government agencies like the CGHS needs to be worked out
  • Pediatric formulations need to be included in NLEM
  • Inclusion of some medical devices which are already covered under the definition of drugs under the Drugs and Cosmetics Act 1940
  • Essential and well-selected lifesaving patented drugs should also feature in the NLEM, just as what W.H.O has done this month by adding to its ‘Essential Medicines List’ all the five patented new curative treatments for hepatitis C, besides 16 new cancer drugs.

Thus, in its present form the NLEM 2011 needs a critical relook and revision, mainly in the light of the missing drugs and keeping in view of the requirements under various National Health Programs as well as the National Formulary of India 2010.

The BMJ paper also highlights, the Indian Academy of Pediatrics has come out with a list of ‘Essential Drugs’ for children in India. Such a list might be consulted for the Pediatric List of Essential Medicine within the NLEM. Provision should be made to review the NLEM at two yearly intervals, as is currently practiced by the W.H.O.

Civil Society steps in:

Accordingly, in August 2014, seven Civil Society Organizations in a letter to Minister Ananth Kumar with a copy to Prime Minister Narendra Modi, among others, wrote as follows:

“Limiting all price regulation only to a list of 348 medicines and specified dosages and strengths in the DPCO 2013 goes against the policy objective of making medicines affordable to the public. The National List of Essential Medicines, a list of 348 rational and cost-effective medicines, is not the basis for production, promotion and prescription in India. In reality the most frequently prescribed and consumed medicines are not listed in the NLEM.”

Healthcare: China on a fast track, India crawls through a slow lane: 

Interestingly, to help improve economic growth and boost domestic consumption, China has recently decided to floor the gas pedal on the fast lane of healthcare reform, while India chose to continue to crawl through its slow lane.

Interestingly, both the countries want to draw similar sets of trend lines for health and economic progress of their respective nations.

This has been vindicated by Reuters report of May 9, 2015, when it highlighted, China would increase its healthcare subsidies by 19 percent this year as part of efforts to deepen social reforms and strengthen safety nets.

The report also indicated, economists view this measure as crucial for China to improve the quality of its healthcare, if it wishes to remake its economy and boost domestic consumption. They say a stronger safety net will encourage Chinese to spend more and save less.

As opposed to the Chinese scenario, in India, the Union Budget 2015-16 came as a real dampener for the healthcare space in the country. This assumes greater significance, as the budget was planned by the reform oriented Modi Government.

Despite the dismal state of current public healthcare services, the annual budgetary allocation for healthcare has been kept at Rs. 33,152 Crore, just a tad more than Rs. 30,645 Crore of 2014-15, with no visible indication for any healthcare reform measure in the country, any time soon.

Conclusion:

‘Essential Medicines’ based drug price control, as was directed by the Honorable Supreme Court of India, is just not far sighted, but a potential game changer in the healthcare space of the country.

While looking at the bigger picture, this policy also promises a significant contribution in the overall economic progress of the nation.

To make this policy effective in the longer term, NLEM should be fair, impartial, far sighted, up to date, robust and beyond obvious any controversy, which includes its authors… just as the spirit behind the good old saying: “Caesar’s wife must be above suspicion.”

Unfortunately, NLEM 2011 is mired with many shortcomings for all the wrong reasons, as discussed above.

The incumbent Government would require striking a just and right balance between public health interest and expectations of the Pharma industry in this critical area. Taking the right policy decision in a transparent an effective manner, balancing the healthcare and economic interest of the country, would be critical.

That said, Pharma industry in India, I reckon, would also not be devastatingly impacted with the possible expansion of NLEM. This is mainly because, currently only 17 percent of the total pharmaceutical market in India comes under price control, based on the span of NLEM 2011 formulations. In any case, the balance 83 percent of the domestic pharma market still falls under the free-pricing zone.

Even when DPCO 1995 came into force, which continued till DPCO 2013 became effective, 20 percent of the total domestic pharmaceutical market was under price control.

Moreover, there was no provision for automatic annual price increases for price-controlled drugs under DPCO 1995. Whereas DPCO 2013 has a provision for annual price increases for all such essential drugs based on WPI. As a result, MRPs of all price controlled essential drugs have gone up effective April 1 of this year and would continue to happen so every year, as long as NPPP 2012 remains in force.

Under this complex mosaic and fast evolving backdrop, the announcement of the Union Minister for Chemicals and Fertilizers – Mr. Ananth Kumar on the floor of the Parliament last week is a laudable one.

To help improve access to affordable essential medicines for all in the country, the Minister has reiterated, “The expanded NLEM would bring more essential drugs under price control.”  This categorical affirmation by the Government in power, though belated, is a step in the right direction…for both better healthcare and also its consequential critical impact on the economic progress of 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.

Herceptin Biosimilar Expands Drug Access to Breast Cancer Patients in India

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Come February 2014, much to the relief of more than 145,000 patients diagnosed with breast cancer in India, Herceptin of Roche, a critical drug for the treatment of the dreaded disease, will face competition, for the first time, from a less expensive biosimilar equivalent. The product named Canmab developed together with Mylan by Biocon has been priced 25 percent less than Herceptin.

Patient access issue for newer cancer therapy:

Herceptin has been a very critical drug, though equally expensive, for breast cancer patients globally.

Mainly because of its unusual high price, the product created an access barrier to majority of patients in India. Arising out of complexity of the problem faced by the cancer patients, hugely compounded by the affordability issue, on January 12, 2013, it was first reported that in a move that is intended to benefit thousands of cancer patients, Indian Government has started the process of issuing Compulsory Licenses (CL) for three commonly used anti-cancer drugs: 

-       Trastuzumab (or Herceptin, used for breast cancer),

-       Ixabepilone (used for chemotherapy)

-       Dasatinib (used to treat leukemia).

For a month’s treatment drugs like, Trastuzumab, Ixabepilone and Dasatinib reportedly cost on an average of US$ 3,000 – 4,500 or Rs 1.64 – 2.45 lakh for each patient in India.

Pricing issue needs a systemic resolution: 

While there is no single or only right way to arrive at the price of a patent protected medicine, how much the pharmaceutical manufacturers will charge for such drugs still remains an important, yet complex and difficult issue to resolve, both locally and globally. Even in the developed nations, where an appropriate healthcare infrastructure is already in place, this issue comes up too often mainly during price negotiation for reimbursed drugs. 

A paper titled, “Pharmaceutical Price Controls in OECD Countries”, published by the U.S. Department of Commerce, after examining the drug price regulatory systems of 11 OECD countries, concluded that all of them enforce some form of price control to limit spending on pharmaceuticals. The report also indicated that the reimbursement prices in these countries are often treated as de facto market price.

Though there is no such system currently prevailing in India, the Government is mulling to put in place a similar mechanism for patented medicines, as captured in the National Pharmaceutical Pricing Policy (NPPP) 2012.

Further, some OECD governments regularly cut prices of even those drugs, which are already in the market. The value of health outcomes and pharmacoeconomics analysis is gaining increasing importance for drug price negotiations/control by the healthcare regulators even in various developed markets of the world to ensure responsible pricing of IPR protected medicines. For various reasons, no such process is followed either for such product pricing in India, as on date.

Roche changed Herceptin strategy for India:

To effectively address the challenge of pricing of patented medicines in India, Roche reportedly entered into a ‘never-before’ technology transfer and manufacturing contract for biologics with a local Indian company – Emcure Pharma for its two widely acclaimed ‘Monoclonal Antibodies’ anti-cancer drugs – Herceptin and MabThera.

Consequently, Roche introduced its ‘made in India’ brand Herclon (Herceptin) with a much-reduced maximum retail price of about Rs. 75,000 for a 440 mg vial and started co-marketing the product with Emcure Pharma in India.

Although Herceptin patent remains valid in the United States (US) until 2018, Roche decided to discontinue its patent rights for Herceptin in India in 2013.

The pharma major reportedly lost this patent earlier in Europe. This vindicates the views of many experts that Herceptin patent was weak, as it would probably not be able to clear the litmus test of a stringent scrutiny under the Patent Acts of India. The report, therefore, argues that core reason for withdrawal of Herceptin patent in India by Roche cannot be attributed, even remotely, to the ‘weak IP ecosystem’ in India.

Biocon Pricing:

According to reports Biocon’s Canmab, the biosimilar version of Herceptin, will be available in 440 mg vial with a maximum retail price of Rs. 57,500 and also in 150 mg vial at Rs. 19,500.

Lower price would lead to greater patient access – Roche argued earlier:

It was reported, when Roche switched over to Herclon with around 30 percent discounted price from very high price Herceptin, access to the drug improved. In fact, that was the logic cited by Roche for the launch of Herclon in India at that time. 

Just to recapitulate, media reports indicated at that time that Roche intends to offer to Indian patients significantly cheaper, local branded version of Herceptin sooner. The same news item also quoted Roche spokesperson from Basel, Switzerland commenting as follows:

“The scope is to enable access for a large majority of patients who currently pay out of pocket as well as to partner with the government to enable increased access to our products for people in need”.

Conclusion:

It is beyond doubt that even with significantly lower price, Canmab would not be able to guarantee 100 percent access to the drug for all breast cancer patients in the country.

However, applying the same logic of Roche, as mentioned above, with further 25 percent price discount for Canmab by Biocon, the access to this drug should expand significantly for over 145,000 diagnosed breast cancer patients in India even, for an argument’s sake, all other factors, including inadequate number diagnostic facilities etc. remain the same. Isn’t that better?

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