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A ‘Toxin’ Delaying Success of Biosimilar Drugs

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The above comment, although sounds a bit harsh, was made recently by none other than Scott Gottlieb - the Food and Drug Administration Commissioner of the United States. He expressed his anguish while explaining the reasons for a delayed launch of several important biosimilar drugs.

We know, this new genre of drugs has a potential to be a quick game changer, significantly improving access to affordable biologic medicines for many patients. Unfortunately, much desired accelerated progress in this direction, got considerably retarded in the face of a strong headwind, craftily created by the innovator companies, as is widely believed. There are various ways of creating the same. However, the two major ones can be ascribed to:

  • Getting caught in the labyrinth of complex patent challenge.
  • General apprehensions of many doctors on the efficacy and safety of biosimilars as compared to reference drugs.

This is happening in major markets, including India, in varying degree, though.  In this article, I shall deliberate on this issue, starting with the largest pharma market of the world and then focusing on India.

‘Toxin’ that delays biosimilar drug launch:

“Americans could have saved $ 4.5 billion in 2017, if all of the FDA-approved biosimilars were actually available in the United States, instead of getting delayed because of litigations or other agreements.” The Food and Drug Administration Commissioner of the United States – Scott Gottlieb, reportedly, made this comment on July 18, 2018.

Gottlieb referred to some of these as a “toxin” that have prevented other drug makers from launching biosimilar medicines. He accused the manufacturers of pricey biologic medicines of using “unacceptable” anti-competitive tactics to keep competitors off the market. These cost Americans billions of dollars – the report highlighted.

These tactics, as the US FDA commissioner said, are being deliberately used by the innovator pharma and biotech companies and can be corroborated with several examples. One such is the fact that despite the expiration ofthe ‘composition of the matter’ patent for Humira (adalimumab) in December 2016, its ‘non-composition of the matter’ patent would expire not earlier than 2022. The company has therefore made settlement agreements with Amgen and Samsung Bioepis, delaying the launch of adalimumab biosimilars until January 2023.

Protecting own patents Big Pharma challenging rivals’ patents:

Both these are happening for original biologic and biosimilar equivalents, often by the same manufacturers. For example, the Reuters report of October 02, 2016, titled  ‘Big Pharma vs Big Pharma in court battles over biosimilar drugs’ highlighted, although Novartis and Amgen are at each other’s throats in court over the Swiss drug maker’s Enbrel copy, but the two are still cooperating on a drug for migraines.

“One of the biggest surprises has been the number of innovator Biopharma companies, like Amgen, now developing biosimilars to compete with the products of other innovator companies,” the article observes. It also reports that Sanofi, Merck, Eli Lilly, Pfizer, Johnson & Johnson and Biogen are also embroiled in lawsuits over biosimilars.

This trend vindicates that the line dividing makers of brand-name drugs and copycat medicines is blurring as companies known for innovative treatments queue up to peddle copies of rivals’ complex biological medicines, Reuters noted. Consequently, they are now doing both – protecting their high-price products from biosimilars drugs,while simultaneously challenging rivals’ patent claims.

There is another interesting side to it. Notwithstanding, biosimilars are a cost-effective alternative to biologic drugs that could improve patients’ access to expensive biological medicines, prescribers’ perception of biosimilar medicines are still not quite positive, just yet.

Doctors’ attitude on biosimilar prescription:

To illustrate this point, let me quote from recent research findings in this area. One such is the May 2017 study on “Medical specialists’ attitudes to prescribing biosimilars.” The key points are as follows:

  • Between 54 and 74 percent of the specialists are confident in the safety, efficacy, manufacturing and Pharmacovigilance of biosimilars.
  • 71 percent of specialists agreed that they would prescribe biosimilars for all or some conditions meeting relevant clinical criteria.
  • Specialists are less confident about indication extrapolation and switching patients from an existing biologic.
  • The most common situations that they would not prescribe a biosimilar was where there was a lack of clinical data supporting efficacy (32 percent), or evidence of adverse effects.

Overall, medical specialists held positive attitudes towards biosimilars, but were less confident in indication extrapolation and switching patients from the original biologic. Several experts believe that constantly highlighting the fear factors against biosimilar drugs, such as possible risks of interchangeability with reference product, or immunogenicity related serious consequences, though very rare, are fueling the fire of apprehensions on the wide use of biosimilar medicines.

However, several reviews, like the one that I am quoting here finds that ‘switching from the reference product to related biosimilar drug is not inherently dangerous.’I discussed this issue, with details in one of my articles, published in this blog on July 31, 2017.

Any therapeutic difference between the original biologic and biosimilars?

As the US-FDA says: “Patients and their physicians can expect that there will be no clinically meaningful differences between taking a reference product and a biosimilar drug when these products are used as intended. All reference products and biosimilar products meet FDA’s rigorous standards for approval for the indications (medical conditions) described in product labeling.”

The key point to take note of is that the US drug regulator categorically reiterates: “Once a biosimilar has been approved by the FDA, patients and health care providers can be assured of the safety and effectiveness of the biosimilar, just as they would for the reference product.”

The invisible barriers to biosimilar drugs in India:

Although, there are no specific data requirements for interchangeability of biosimilar drugs with the reference product, as mentioned in the latest Indian Guidelines on similar biologic, other visible and visible barriers are restricting the rapid growth of drugs belonging to this genre.

An interesting research study finds, like many other drugs, the cost of biosimilars is a major barrier to the rapid growth of the market in India. The Deloitte Report, titled “Winning with biosimilars: Opportunities in global markets” also articulated: “Approximately 70 percent of the country’s population is considered rural and will focus on the cost of therapy – a 20-30 percent discount on originator biologics may not be sufficient.”

Moreover, many patients who are on original biologic drugs, costing higher than related biosimilars and want to switch over to affordable equivalents, are not able to do so. In many cases, doctors’ do not encourage them to do so, for various reasons, including the general assertion that original biologic drugs are more effective. India being considered as the global capital of diabetes, let me cite an example from this disease area, just to drive home the point.

A recent experience on biosimilar drug interchangeability in India:

Just the last week, I received a call from a friend’s wife living in Delhi who wanted to know whether Lantus 100 IU/ml of Sanofi can be replaced with Glaritus 100 IU/ml of Wockhardt, as the latter costs much less. I advised her to consult their doctor and request accordingly. She said, it has already been done and the doctor says Lantus is a better product.

To get a fact-based idea on what she told me, I referred to two circulars of the National Pharmaceutical Pricing Authority (NPPA) – one for Glaritus and the other one for Lantus and found that both are under drug price control and have respective ceiling prices. As both the circulars are of 2009, these may probably be treated as an indicative price difference. NPPA notified price for a 3 ml cartridge of Glaritus reads as Rs.135. 24. Whereas, the same for Lantus was mentioned as Rs.564.84.

Is an original biologic generally superior to Indian biosimilars?

US-FDA has already reiterated, “Once a biosimilar has been approved by the FDA, patients and health care providers can be assured of the safety and effectiveness of the biosimilar, just as they would for the reference product.”

However, to get India-specific, evidence-based information in this area, I checked, whether Lantus has any clinically proven therapeutic superiority over Glaritus. Interestingly, I came across the results of a 12-week study concluding that biosimilar insulin glargine, Glaritus, is comparable to the reference product, Lantus – providing a safe and effective option for patients with T1DM. Nevertheless, the researchers did say that more studies are required in this area.

The core question that needs to be addressed why is the doctor’s perception so different and the reasons for the same?

Conclusion:

In view of all that has been discussed in this article, I find it challenging to fathom that in the absence of any credible and conclusive specific study, how could a doctor possibly infer that higher priced imported original biologic drugs are generally superior to lower priced biosimilar equivalents? More so, when in India, there are no regulatory issues on interchangeability between original biologic and its biosimilar equivalent.

Or for that matter, a branded generic product is superior to all other equivalent generic drugs without a brand name? This can happen, especially when the vested interests actively work on ensuring that such a perception gains ground, boosting the sales revenue and mostly at the cost of patients’ interest.

As one would witness in many other spheres of life that creating a blatantly self-serving, positive target audience perception, by any means, primarily aimed at destroying the same of others, is assuming increasing importance. Are we seeing the reflection of the same, even in the field of evidence based medical science?

I reckon, it raises a flag for all to ponder, particularly after reading the recent candid comments of the US-FDA commissioner, as quoted above.

Could this be one of those ‘Toxins’, which delays success of biosimilar drugs?

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.

 

With ‘Cutting Corners’ Going North, Pharma Reputation Dives South

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Just a few months ago, on October 24, 2017, ‘New Jersey Law Journal’ came out with an eye-catching headline – “Sanofi Set to Pay $ 61M Settlement in Antitrust Suit Over Vaccine Bundling.” The suit says: “Sanofi-Pasteur allegedly suppressed competition for its pediatric meningococcal vaccine, Menactra, by charging physicians and hospitals up to 35 percent more for its product, unless they agreed to buy Sanofi’s pediatric vaccines exclusively. Sanofi-Pasteur is the vaccines division of French drug manufacturer Sanofi.”

Nevertheless, a statement from the company said: “Despite Sanofi’s strong defenses, Sanofi recognizes that continued litigation is likely to be extraordinarily expensive and time-consuming and thus has agreed to enter into this Settlement Agreement to avoid the further expense, inconvenience, risk and distraction of burdensome and protracted litigation. Sanofi is finally putting to rest this case by obtaining complete dismissal of the action and a release by settlement class members of all released claims.”

When such incidences – of various scales and dimensions, continue being reported by both the global and local media, over a long period of time, one can fathom the potential of their cumulative impact on public and other stakeholders. Severely dented image and reputation of pharma, in general, before the eyes of so many, across the world, is a testimony to this phenomenon. Considering these as ‘cutting corners’ syndromes, I shall discuss in this article, how fast is pharma reputation diving South, with incidences of ‘cutting corners’ keep going North.

‘Cutting Corners’:

The Oxford dictionary defines ‘cutting corners’ as: ‘Doing something perfunctorily so as to save time or money’. Putting it in the context, I reckon, legally or ethically questionable actions with a deliberate intent of making quick profits, if not profiteering, can be termed as ‘cutting corners’ or business malpractices.

‘Cutting Corners’ going North:

This is no way a recent phenomenon. Gradually increasing number of new reports on pharma’s alleged malpractices are not uncommon, either. On the contrary, these keep coming rather too frequently – baffling many industry watchers and its well-wishers, for different reasons.

The details of 20 largest settlements in this area reached between the United States Department of Justice and various pharmaceutical companies from 1991 to 2012, as available from Wikipedia, provide a glimpse to its magnitude and dimension. The settlement amount reportedly includes both the civil (False Claims Act) settlement and criminal fine. Glaxo’s US$ 3 billion settlement is apparently one of the largest civil, False Claims Act settlement on the record, and Pfizer’s US$ 2.3 billion settlement includes a record-breaking US$ 1.3 billion criminal fine. A federal court also recognized all off-label promotion as a violation of the False Claims Act, leading to a US$ 430 million settlement during that period, as this report highlights.

In one of my articles, titled ‘Big Pharma Receives Another Body Blow: Would Indian Slumber End Now?’, published in this blog on May 19, 2014, I quoted a few more examples from 2013 and 2014, as well. A few of these are as follows:

  • In March 2014, the antitrust regulator of Italy reportedly fined two Swiss drug majors, Novartis and Roche 182.5 million euros (U$ 251 million) for allegedly blocking distribution of Roche’s Avastin cancer drug in favor of a more expensive drug Lucentis that the two companies market jointly for an eye disorder.
  • Just before this, in the same month of March 2014, it was reported that a German court had fined 28 million euro (US$ 39 million) to the French pharma major Sanofi and convicted two of its former employees on bribery charges.
  • In May 2013, Sanofi was reportedly fined US$ 52.8 Million by the French competition regulator for trying to limit sales of generic versions of the company’s Plavix. 

Pharma reputation dives South:

That pharma reputation is diving south, is well captured in the ‘Business and Industry Sector Ratings’ by Gallup, dated August 2-7, 2017. According to this public rating, the top 5 and bottom 5 industries came up as follows:

Top 5:

Industry Total Positive % Neutral % Total Negative % *Net positive or negative %
Computer

75

15

8

+67
Restaurant

72

21

7

+65
Farming and agriculture

70

17

12

+58
Grocery

60

23

17

+43
Internet

59

21

18

+41

The bottom 5, including the federal government:

Industry Total Positive % Neutral % Total Negative % *Net positive or negative %
Airline

41

20

35

+6
Oil and gas

38

21

40

-2
Healthcare

38

18

45

-7
Pharmaceutical

33

16

50

-17
Federal Govt.

29

19

52

-23

*Net Positive is % Positive minus % negative (in percentage points)

Image rejuvenation campaign not yielding results:

Arguably, the richest and the most powerful pharma industry lobby group in the largest pharmaceutical market of the world, is incurring a mind-boggling sum of expenditure to mend the severely dented collective reputation and image of its members.

Vindicating this point, a January 18, 2017 media report articulated that a major pharma industry lobby group – PhRMA, is gearing up for a new image building campaign by spending in the “tens of millions” each year to drum up support for the reputationally challenged pharma industry. Such initiatives by PhRMA, as I understand, are not totally new, but rather ongoing. Be that as it may, as the Gallup survey confirms, pharma reputation keeps diving South, unabated.

Mending pharma’s reputation surfaces as one of the top concerns of the pharma industry. It, therefore, demands commensurate priority in working out a meaningful strategic plan, and its effective implementation on the ground, collectively. More so, when the POTUS – Donald Trump, has also emerged as a vocal pharma critic. He has already proclaimed that drug companies “are getting away with murder,” – as the above media report highlights.

Where is this campaign going off the mark?

On this subject, an article of September 5, 2017, published by Ars Technica – a technology news publication aptly epitomized, what is happening today with these campaigns, against what should have happened, instead. The column carries a headline ‘Big Pharma hopes research spending – not reasonable pricing – will improve image’.

The columnist wrote: “To scrub down their filthy reputations, drug makers could try lowering prices, a public mea culpa, or pledging to make pricing and marketing more responsible and transparent. But they seem to have taken a different strategy.” On this score, a relevant example, out of several others, was of Biogen introducing a drug in 2016, for a rare spine disorder and priced it at an eye-popping US$ 750,000 for the first years’ worth of treatment.

In pharma image revamp campaign, the focus on R&D spending or drug innovation, including blatant self-serving demands, such as strictest product patent and data exclusivity provisions, is rather overwhelming. It is understandable that all this fits in well with various pharma lobby group’s mission and mandate, but is unlikely to deliver what consumers would consider good behavior on the part of drug companies.

Is Indian pharma out of this loop?

The answer to this question is an emphatic – ‘No’. Alleged ‘dubious product quality’ related ongoing saga, is known today by all concerned. This had often culminated into US-FDA import bans of many drugs, manufactured by several Indian drug manufacturers – starting from the very top. Nonetheless, that’s not ‘the all’ or ‘end all’ in the ballgame of ‘cutting corners’ in India, as I explained above.

On September 26, 2017, a media report flashed: ‘The Income Tax (IT) investigation wing claims to have unearthed a nexus between a leading pharmaceutical company and doctors, and the evidence showing payments running into Crores to the latter for prescribing the company’s medicines.’

Close on the heels of ‘compromised drug quality standard’, such malpractices come as a double whammy for patients. But, the saga continues. In my article, titled ‘Healthcare in India And Hierarchy of Needs’, published in this blog on November 06, 2017, I mentioned about the October 31, 2017 public notice of the State Attorney General (AG) of Connecticut. The notice cited several instances of alleged drug price fixing in the United States. Interestingly, this lawsuit includes name of several large Indian companies, such as Dr. Reddy’s Laboratories, Emcure, Glenmark, Sun Pharma, and Zydus Pharma. The expanded complaint also names two individual defendants, one among them is the promoter, the chief executive officer and managing director of a large Indian pharma manufacturer.

Further, as I wrote before, the Maharashtra government’s recent announcement on enactment of a new law called the “Cut practices in Medical Services Act, 2017”, casts a darker shadow, not just on the doctors’ reputation, but also over the health care industry, in general, including pharma.

Today’s patients are more informed:

In today’s world, wider access to the Internet for a large number of global population has a profound implication in every sphere of life. News, discussions, opinions, comments and a plethora of other information on various industries, including pharma, are available from different credible websites, just as anything else.

Additionally, the social media, collectively, have made exchanges and interpretations of such information within various groups and communities, as fast as these could be. Just as many other different things, wrongdoings or malpractices, if any, of various industries, also get quickly captured and shared by the Netizen with ease and élan. These include incidences of ‘cutting corners’ by constituents of the pharma industry too.

Conclusion:

The Public Relationship campaigns of pharma lobby groups, with a hope to bridging the industry’s ‘trust deficit’, have been reported from the United States and other countries. However, any such campaign for the pharma industry in India hasn’t arrested my attention, as yet.

It’s beyond any reasonable doubt or debate that the pharma industry, in general, has saved and is still instrumental in saving more lives, in every nook and corner of the world. Ironically, the same industry, for its own deeds prompted mostly by the self-serving needs, has been suffering a massive collateral damage.

The industry’s long unblemished image and reputation have been severely tarnished,   requiring rejuvenation with an inclusive approach. This may call for a mindset, at least, nearer to the same of George W. Merck – the legendary President and Chairman Merck & Co., Inc. He articulated a vision – “Medicine Is For The Patient, Not For The Profits”, and practiced it religiously. In today’s context, this may sound rather utopian in letters, but surely not in its spirit… be that as it may….

Pharma lobby groups hope to reverse the current trend by focusing only on R&D spending, drug innovation and strictest patent protection and data exclusivity ecosystem is apparently a non-starter. That ongoing multi-million-dollar pharma image revamp campaigns haven’t yet captured any tangible positive outcomes – not even in the United States, is possibly a testimony to this fact.

The status quo is expected to continue. More so, when ‘reasonable pricing’ of drugs is one of the top most demands of patients, patient groups and even many governments – and that’s exactly where the buck stops in pharma business.

In my view, pharma reputation restoration process isn’t merely a one-sided communication issue, as it appears today. A strategic blue print of this critical industry need, deserves to be drawn on a much broader canvass with a patient-serving mindset, instead of just a self-serving one. Otherwise, with incidences of ‘cutting corners’ going North, pharma reputation will keep diving South… till it finds its very bottom.

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.

 

The Stakeholder-Mix Has Changed, But Pharma Marketing Has Not

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“We try never to forget that medicine is for the people. It is not for profit. Profits follow, and if we have remembered that, they never fail to appear.”

In 1952, George Wilhelm Herman Emanuel Merck, the then President of Merck & Co of the United States said this. He was then aptly quoted on the front cover of the ‘Time Magazine’, epitomizing his clear vision for the company: “Medicine is for people, not for the profits”.

The globally acclaimed Management Guru – Peter F. Drucker had also clearly articulated in his management classics that, “Profit is not the purpose of business and the concept of profit maximization is not only meaningless, but dangerous.” He further said, “There is only one valid purpose of a business, and that is to create a customer” 

As this is an ongoing process, in the pharma perspective, it may be construed as ensuring access to new drugs for an increasing number of patients.

It really worked: 

In those days, driven by such visionary leadership, the pharma used to be one of the most respected industries and Merck topped the list of the most admired corporations in America. It is clear that pharma leadership at that time wanted to make ‘inclusive growth’, both in the letter and spirit, as an integral part of the organizational progress, moving with time.

Thus, it worked. The sales and marketing growth of the global drug industry at that time was not lackluster, either, in any way. The R&D pipeline of the drug companies used to be also rich, with regular flow of breakthrough new products too. 

Straying away from ‘inclusive’ to ‘self-serving’ strategies:

Much water has flown down the bridges, since then, so is the change in the public and other stakeholders’ perception about the pharma industry, in general. 

Sharply in contrast with George W. Merck’s (Merck & Co) vision in 1952 that “Medicine is for people, not for the profits”, in December 2013 the global CEO of Bayer reportedly proclaimed in public that: “Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India but for Western Patients that can afford it.” 

It appears that the focus of the pharma industry on ‘inclusive growth’ seems to have strayed away to ‘self-serving growth’, with the passage of time. As a result, a large majority of the new stakeholders started harboring a strong negative feeling about the same industry that continues its active engagement with the very same business of developing new drugs that save many precious lives. 

Granted that the business environment has changed since then, with increasing complexities. Nonetheless, there does not seem to be any justifiable reason for straying away from ‘inclusive growth’ strategies.                                         

As are regularly being reported, both in the global and local media, mindless arrogance on fixing exorbitant high new drug prices severely limiting their access, unabated malpractices in drug marketing and escaping with hefty fines, releasing only favorable clinical trial data, just to mention a few, are giving the industry image a strong tail spin.

Stakeholders changed, but pharma marketing did not:

Keeping the same strategic direction and pace, overall pharma brand marketing strategy also continued to be increasingly ‘self-serving’, and tradition bound. Success, and more success in building relationship with the doctors, whatever may be the means, is still considered as the magic wand for business excellence, with any pharma brand. Thus, since over decades, building and strengthening the relationship with doctors, continue to remain the primary fulcrum for conceptualizing pharma marketing strategies. 

It does not seem to have not dawned yet for the pharma marketers, that over a period of time, the market is undergoing a metamorphosis, with several key changes, and some of these would be quite disruptive in the traditional pharma marketing ball game. Consequently, the above key the fulcrum of pharma marketing is also gradually shifting, slowly but surely.

In this article, I shall deliberate only on this area.

A new marketing paradigm:

The key customer in the pharma business is no longer just the doctors. That was the bygone paradigm. The pharma stakeholders’ mix is no longer the same as what it used to be. 

The evolving new paradigm constitutes multitude of important stakeholders, requiring a comprehensive multi-stakeholder approach in modern day’s pharma marketing game plan.

Patients, governments, policy influencers, health insurance providers, hospital administrators, social media, and many others, have now started playing and increasing role in determining the consumption pattern of pharma brands, and their acceptability. More importantly, these not so influential stakeholders of the past, are gradually becoming instrumental in building overall pharma business environment too. This necessitates customized engagement strategy for each of these stakeholders, with high precision and relevance.

Changing mindset is critical: 

An effective response to this challenge of change, calls for a radical change in the marketing mindset of the top pharma marketers. The most basic of which, is a strong will to move away from the age old ‘one size fits all’ and ‘self-serving’ initiatives with some tweaking here or there, to a radically different ‘inclusive marketing’ approach.  In this game, both the types and the individual customer concerned, would occupy the center stage for any meaningful interactions on the brands and associated diseases, besides many other areas of relevance.

Multi-stakeholder – Multi-channel approach:

For a multi-stakeholder customized engagement, innovative use of multiple channels would play a crucial role, more than ever before.

Availability of state of the art digital tools, would facilitate crafting of comprehensive marketing strategies, accordingly. For example, for the doctors, some companies are moving towards e-detailing.

As I discussed in my article in this Blog titled, “e-detailing: The Future of Pharmaceutical Sales?” on September 13 2013, this modern way of interaction with the doctors is fast evolving. E-detailing is highly customized, very interactive, more effective, quite flexible, and at the same time cost-efficient too. Live analytics that e-detailing would provide instantly, could be of immense use while strategizing the game plans of pharmaceutical marketing.

A feel of the changing wind direction:

A relatively new book titled, “Good Pharma: How Marketing Creates Value in Pharma”, published in March 2014, and written by Marcel Corstjens, and Edouard Demeire, well captures some of the key changes in the pharma industry with a number interesting examples. 

The above book seems to somewhat respond to Ben Goldacre’s bestselling book ‘‘Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients’, which I discussed in this blog on October 15, 2012.  It made some important observations in many areas of pharma business. I am quoting below just a few of those incoming changes to give a feel on the urgent need of recasting the marketing models of the pharma industry:

On emerging markets’ like India:

“Emerging markets should not be seen as low-hanging fruits. Their prevalence of diseases may not be the same, the stakeholders may be very different. In addition, the healthcare infrastructure is often not very sophisticated, and these markets can be rather volatile and difficult to predict. It’s not a sure bet; you have to invest. … Companies need to commit seriously to building a heavily localized approach that is substantiated by a global reputation.” This is perhaps not happening in India, to a large extent, as I reckon.

On personalized Health Care (PHC): 

The new drugs brought to market by the pharma companies are not just expensive, but often work only for small segments of the patient population. In India this situation mostly leads to very high out of pocket expenditure, which often is wasted for the drug not working on the patient. Thus, the regulators and payers in the developing countries are setting the threshold for higher reimbursement. The authors observed that PHC is now being put forward as the industry’s best bet for satisfying stricter effectiveness criteria, not only by developing new drugs, but also by investing in the magical trio of the future: “drug-biomarker-diagnostic. In that case, pharma marketing would need to undergo a significant change, starting from now.

On ‘Category captains’:

The book also says, “The most financially successful companies in the past 20 years has been Novo-Nordisk. They have specialized in diabetes, they’re extremely good at that. Roche specializes in oncology. The larger the company, the more ‘captive’ areas they can have. The success of Novo-Nordisk, a relatively small company, proves firms of all sizes have a chance to compete, as long as they stick closely to their strengths. When this happens in a much larger scale, pharma marketing would also be quite different and more focused.

Many pharma companies are still avoiding to change, successfully. For example, as announced on May 31, 2016, Intercept Pharma of the United States announced its new liver disease drug with a hefty price tag of US$ 70,000 a year. According to the report, the company said, prices are justified by a drug’s level of innovation and cost savings for the healthcare system. This justification has now become very typical in the pharmaceutical world, which has been facing barrage of criticisms, including from Capitol Hill, about too-high drug prices.

However, as we move on, the writing on the wall seems to be very clear on the sustainability of health care business, the world over.

Conclusion:

Finally, the question arises, would the traditional approach still be good enough to achieve the desired sales and marketing objectives, any longer?

No, probably not, I reckon. With changed mindsets, ‘getting under the skin’ of each stakeholder, separately, would assume key importance. It would play a key role, while devising each component of any cutting-edge pharma sales and marketing strategy, tactic, and task.

The shift from the old paradigm, signals towards a total recast of pharma marketing to make it more ‘inclusive’, and not just ‘self-serving’. Newly crafted commensurate grand marketing plans and their effective implementation should satisfy the needs and wants of all stakeholders, simultaneously. Singular focus on building, or further strengthen the relationship with prescribing doctors, won’t be adequate enough, anymore.

Thus, the name of the new pharma ballgame would again be ‘inclusive marketing for inclusive growth’.

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.