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Paying For The Best Health Outcomes At The Lowest Possible Cost

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“Bayer CEO Dr. Marijn Dekkers is happy to have fair Outcomes-Based Pricing”, reported ‘PharmaTimes’ on December 3, 2014.

Dr. Dekkers was quoted saying, “It is okay to be tested on that in the process of price-setting, that is fine, we should only be paid for the value we bring”. However, at the same time he also reminded, “When we have a new drug that is significantly better than the previous drug but the previous drug just went generic, we are compared to the 20% price, not the 100% price”.

I reckon, the above statement of the Bayer CEO sounds quite amazing, if not bizarre, especially considering the legality in the prevailing global pharma patent regime.  Thus, any discontentment in this area, howsoever intense these are, would unlikely to be able to attract any unbiased favorable ear, across the world.

Another aspect of the aggressive patented drug pricing trend, I deliberated in one of my earlier blog posts titled, “An Aggressive New Drug Pricing Trend: What It Means To India?” of October 27, 2014.

What is it really?

As many would know, another common terminology of Outcome-Based Pricing (OBP) is Value-Based-Pricing (VBP). This approach for pricing is basically intended to offering the best value for the money spent in healthcare. It is ‘the costs and consequences of one treatment compared with the costs and consequences of alternative treatments’. For pharmaceutical players, VBP/OBP would mean not charging more than the actual real value of the product offerings.

As we shall find below, this concept is gaining ground now in the developed markets of the world, prompting the pharmaceutical companies generate requisite ‘health outcomes’ data using similar or equivalent products. Cost of incremental value that a product will deliver is of key significance. Some independent organizations such as, the ‘National Institute for Health and Clinical Excellence (NICE)’in the United Kingdom (UK) has taken a leading role in this area.

An evolving scenario:

It would be worthwhile to note that over a period of time, while pricing new pharma products, manufacturers have been traditionally considering the costs of all inputs of various kinds incurred to bring these drugs into the market and thereafter adding hefty mark-ups on those medicines in a non-transparent manner to arrive at the market price.

This absolutely opaque process of patented drugs pricing is increasingly making the stakeholders, such as patients’ groups, payors, including the governments and insurers much concerned about the differential value offerings of these high priced new drugs over the existing ones for commensurate improvement in the actual health outcomes for the patients.

The relevance:

In the past decade, there has been a clear trend in the price negotiation of new and complex pharma based on health outcomes models as the pharma players are coming under increasing pressure from the payors/patients to improve the treatment cost-effectiveness.

In an article published in the Harvard Business Review of October 2013, Michael Porter and Thomas Lee had cautioned, “ In healthcare, the days of business as usual are over…it is time for a fundamentally new strategy. At its core is maximizing value for patients: that is, achieving the best outcomes at the lowest cost.”

They elucidated the relevance of value based pricing, supporting very strongly the idea of paying for “value” in healthcare.

Thus, if this trend were not checked, the healthcare spending would keep going up, as it is happening today globally, impacting access of these drugs to patients significantly due to spiraling cost pressure.

 A recent vindication:

‘Gallup’ in an articles titled, “Cost Still a Barrier Between Americans and Medical Care” published in December 5, 2014, has reported that in U.S., 33% of Americans have put off medical treatment because of cost. Interestingly, more of them put off treatment for serious conditions than non-serious and more with private insurance had put off treatment in 2014 than 2013.

Thus, to address this issue, as we shall see below, various governments either have or in the process of developing regulatory policies to rationalize new drug prices based on the Outcome/Value-Based Pricing (OBP/VBP) Models of different kinds.

In this backdrop, Bayer CEO’s acceptance of OBP/VBP is indeed a welcoming development. This process is undoubtedly one of the most reasonable ways to arrive at a patented drug price.

For a large majority of stakeholders, treatment outcomes and differential value offerings of new medicines are the most critical factors to monitor the value pathway of patients’ medical care, irrespective of types of illnesses.

The move has already commenced: 

Deloitte Center for Health Solutions in a study on Value-Based Pricing for

Pharmaceuticals, has highlighted that unlike the United States, many countries, where the government plays a decisive role in pricing and price negotiations of pharmaceuticals, have focused on reducing costs through value-based pricing agreements.

The article gives examples of Denmark, where Bayer entered into a “no cure, no pay” initiative on Levitra (vardenafil) for erectile dysfunction in 2005.  Patients not satisfied with the treatment were eligible for a refund. Similarly, in 2007, after the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom (UK) initially concluded that Velcade (bortezomib) was too expensive as compared to its estimated benefits to the population, Johnson & Johnson offered to forgo charges for patients who did not have an adequate medication response.

Further, according to the Burrill Report of October 2013, as part of an effort to regain market share for its statin Zocor, which had been losing ground to then Warner Lambert’s Lipitor, Merck had reportedly offered an out of box proposition to consumers and insurers in 1998. Merck’s “Get to Goal” guarantee offered refunds to any takers who failed to reach target cholesterol levels set by their doctors within six months of using Zocor and adjusting their diet.

Could serve the purpose of global pharma too:

The above Burrill Report also states, “The performance-based pricing also serves a simpler purpose for drug makers. It allows them to provide discounts that may be necessary to establish acceptable value in one market without affecting the price for a drug in other markets around the world as a number of payers peg the price they will pay for a drug to what price a specific country may negotiate with the drug maker.”

Following this trend it appears that like Dr. Dekkers, other head honchos of global pharma majors would ultimately be left with no option but to willy-nilly toe this line in most of the countries across the world for their patented products.

This would be necessitated due to increasing product-pricing pressure based on quantification of differential benefits of the new medicines over already existing ones, as would be reflected in the analysis of intensive cost-effectiveness data.

Defining a measure of cost-effectiveness:

One of the several other methods to measure the cost-effectiveness of a new drug, as reported in a case study published by ‘2020 Public Services Trust at the RSA’, is as under:

“The efficiency of new products can be captured through incremental cost-effectiveness ratios (ICER). These are usually based on quality-adjusted life-years (QALY), which are a measure of how many extra months or years of reasonable quality life a patient might gain as a result of treatment, based on average life expectancy. Life expectancy is usually extrapolated from the results of clinical trials whilst the quality adjustment is based on patients’ experiential response to the level of pain, mobility and general mood which are usually expressed as a weighted utility value of between 0 and 1. The final calculation of the ratio is based on the difference in the cost to QALY ratio between the new drug and the standard available treatment. However, to make sense of the ICERs it has been necessary to establish thresholds beyond which drugs are no longer deemed cost-effective.”

As the above case study highlights, “NICE had established a notional upper limit of £20-30,000 per QALY above which a drug will generally not be recommended, although in exceptional circumstances this can be increased as was the case for beta-interferon, where it was raised to £36,000.”

The Indian perspective:

In developing countries such as India, expenditure towards medicines is considered as an investment made by patients to improve their health and productivity at work. Maximizing benefits from such spending will require avoidance of those medicines, which will not be effective together with the use of lowest cost option with comparable value and ‘health outcomes’.

For this reason, as stated above, many countries have started engaging the regulatory authorities to come out with head to head clinical comparison of similar or equivalent drugs keeping ultimate ‘health outcomes’ of patients in mind.

A day may come in India too, when the regulatory authorities will concentrate on ‘outcomes/value-based’ pricing models, both for patented and high price branded generics, where low priced equivalents are available.

However, at this stage it appears, this would take some more time. Till then for ‘health outcomes’ based medical prescriptions, working out ‘Standard Treatment Guidelines (STG)’, especially for those diseases, which are most prevalent in India, should assume high importance.

Standard Treatment Guidelines (STG):

STG is usually defined as systematically developed statements designed to assist practitioners and patients in making decisions about appropriate cost-effective treatment in specific disease areas.

For each disease area, the treatment should include “the name, dosage form, strength, average dose (pediatric and adult), number of doses per day, and number of days of treatment.” STG also includes specific referral criteria from a lower to a higher level of the diagnostic and treatment requirements.

In India, the medical experts have already developed STGs for some disease areas. However, formulation of STGs covering all major disease areas and, more importantly, their effective implementation would ensure cost-effective healthcare benefits to a vast majority of population.

The Ministry of health of the respective states of India should encourage the medical professionals/institutions to lay more emphasis on ‘health-outcomes/value based’ prescription of medicines, ensuring more cost effective treatment for their patients.

Conclusion:

The medical practitioners in their part should ideally volunteer to avoid prescribing expensive drugs offering no significant improvement in ‘health outcomes’, against the cheaper equivalents. The Government should initially encourage it through ‘self-regulation’ and if it does not work, stringent regulatory measures must be strictly enforced, within a reasonable time frame.

Be that as it may, it clearly emerges today that in the healthcare arena, effective implementation of ‘Outcomes/Value-Based-Pricing-Models’ would ensure paying for the best health outcomes at the lowest possible cost, especially for those who deserve it the most, not just in India, but across the world too.

By: Tapan J. Ray

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

 

The ‘TINA Factor’: A Hotspot for Patented Drugs

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An article published in a global business magazine on December 5, 2013 mentioned that Marijn Dekkers, the CEO of Bayer AG reportedly has said at the Financial Times Global Pharmaceutical & Biotech Conference held this month that:

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

The head honcho deserves kudos for revealing his mind upfront, while inviting two quick questions, as follows:

  • If that is so, why did Bayer launch Nexavar in India?
  • Did Bayer have any other alternative or choice for not doing so, other than negotiating for a ‘Voluntary License’?

As Bayer already had decided against any ‘Voluntary License’ for Nexavar in India, the simple answer to both the questions is : There Is No Alternative (TINA). And…that’s my ‘TINA Factor’, now a hotspot for patented drugs in India.

I shall dwell on it below, just in a short while.

Bellicose stance for high drug prices and more stringent patent regime:

Everybody acknowledges, beyond even an iota of doubt, that the contribution of the global pharmaceutical industry in the ongoing fight of mankind against diseases of all kinds, is commendable and exemplary.

However, over a period of time, as the low hanging fruits of pharma R&D are in the process of getting all plucked, raw commerce mainly driven by likes of “The Wall Street” quarterly expectations, have started overriding public health considerations involving a large section of the society, across the world, including India.

In this evolving scenario, healthcare has to be extended to almost everybody in the society by the respective Governments in power with strong support from the pharma industry. Instead, to utter dismay of many, the later seems to have opted for a bellicose stance.  Their lobby groups appear to be power playing with all might in the corridors of power, to make the product patent regime of faster growing emerging markets more and more stringent, restricting smooth entry of affordable generic or biosimilar drugs increasingly difficult.

Underlying reasons for Big Pharma’s near obsession to have in place an ever stringent patent regime, defying all public health interest particularly of the developing countries, I reckon, are mainly three-fold:

  • Grant of product patent for any innovation irrespective of triviality
  • To have absolute pricing freedom for patented drugs for unlimited profits
  • To enjoy and extend product monopoly status as long as possible

Probably, to camouflage these intents, the reasons for high prices of patented drugs are attributed to the over-used buzz-words – fostering and re-investing in innovation, which is more often underscored as frightfully expensive.

Fair enough, in that case, let the high cost of R&D be appropriately quantified involving independent  experts and made known to public. It will then not be like a jig saw puzzle for people to understand the real intent or the truth behind high drug prices. Thereafter, practical solutions need be fleshed-out putting the bright brains and minds together to make new medicines affordable to patients, across the world.

Most probably, that is not to happen, unless a legally binding system of disclosure of expenses is made mandatory for R&D, just as the ‘Physician Payment Sunshine Act’ of the United States demands public disclosure of gifts and payments made to doctors by the pharma players and allied businesses.

On the contrary, incessant efforts by vested interests still continue to keep the patented drug prices beyond the reach of common man. The following are just some very recent examples:

Another ‘defiant move’ in drug pricing:

In another recent development, US-FDA on December 6, 2013 approved Sovaldi (sofosbuvir) of Gilead Sciences Inc. This new drug is reported to be a cure for chronic infection with hepatitis C virus, without co-administration of interferon.

According to the report of July 2013 of the World Health Organization (WHO), about 150 million people are chronically infected with hepatitis C virus, and more than 350, 000 people die every year from hepatitis C- related liver diseases, across the world.

Most interestingly, Gilead Sciences have reportedly decided to keep the price of Sovaldi at a staggering US$ 1,000 (Rs. 62,000) -a-day for one tablet to be continued for 12 weeks. Thus the cost of a three month course of treatment with Sovaldi would be a mind boggling sum of US$ 84,000 (Rs.L 5.21), just for one patient.

It is worth noting that the above price/table of Sovaldi, as decided by Gilead Sciences, has started culminating into a storm of protest, almost immediately, even in the United States (US). The biggest drug benefits manager in that country – Express Scripts Holding Co. in a decisive move to drive down spending on the medicines, reportedly plans to start a price war when Sovaldi comes to market next year or early in 2015 wearing a price tag of US$ 1,000 a pill.

Further, on this seemingly defiant pricing strategy, that too for a life saving drug affecting patients belonging to all strata of the society, ‘Doctors Without Borders’ have reportedly commented: “Using patents to block affordable versions of sofosbuvir and pricing this drug out of reach of the most vulnerable groups who need it most is simply putting profits before people’s lives.”

Brewing a fresh initiative for more stringent high drug price regime:

To foist stricter pharmaceutical patent regime, making access to affordable drugs for the world’s poor increasingly challenging, an initiative is reportedly brewing afresh led by the United States (US).

Ministers of Trade from 12 countries initiated a discussion on December 6, 2013 at Singapore to meet the US deadline of forging a deal on the proposed ‘Trans-Pacific-Partnership (TPP)’ before the end of 2013.

These twelve countries – Australia Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, USA and Vietnam, contributing 40 percent of the world economy, are expected to hammer out the TPP deal first, though other countries may hitch on thereafter.

However, after 4 days of intense negotiation, the US-led TPP talks ended on December 10, 2013, without beating into shape any deal. These countries would reportedly meet again on January 2014, in contrast to earlier plan.

The global human right groups like ‘Medicins Sans Frontieres (MSF)’ and ‘Doctors Without Borders’ have reportedly commented, “The ‘Data Protection’ period will prevent drug regulatory agencies in TPP signatory countries from referencing data needed to approve lower-cost generic versions of a protected drug, delaying competition that would lead to cheaper prices”.

In a poll commissioned by ‘Avaaz’ – a global advocacy group, reportedly 62 percent of Americans, 63 percent of Australians, 70 percent of New Zealanders, and of 75 percent Chileans opposed limiting access to generic medicines through the patent proposal in TPP.

Quite expectedly, the powerful US pharma lobby group ‘Pharmaceutical Research and Manufacturers of America (PhRMA)’ said, “It was necessary for companies to recover investments and conduct further research into new cures”.

Breath of fresh air:

The good news is that some prudent developments are also seen around in the midst of a monopolistic drug pricing scenario, offering a breath of fresh air. Some countries around the world, including an important payor in the Unites States, National Institute for Health and Care Excellence (NICE) of UK which assesses the value of drugs for NHS use, and even ‘National Development and Reform Commission (NDRC)’ of China, have now started taking note and proactive measures in different ways on monopolistic high drug prices.

A recent report highlighted that ‘National Development and Reform Commission (NDRC)’ of China would examine and regulate the price-related monopolistic practices of six industries operating in the country, including pharmaceuticals and would crack down wherever they find excessively high prices. 

Can India insulate itself from pricing onslaught?

Despite growing global pressure against ‘putting profits before people’s lives’, one may arguably expect more such initiatives spearheaded by Big Pharma to make the patent regime, of especially the emerging markets, more stringent in the years ahead.

That said, ‘The TINA Factor’, which I shall now dwell upon, would probably help reinforcing the protective shield of Indian patent regime against foreseeable assaults with strategies quite similar to as cited above, denying access to new life saving drugs to most of the general population of the country.

‘The TINA Factor’ and three ‘Alternatives’ available to MNCs:

Since enactment of patient-friendly patent laws by the Parliament of India effective January 1, 2005, many global pharma companies and their lobby groups have been continuously expressing immense displeasure and strong anger in many ways for obvious reasons, just as the CEO of Bayer AG did recently.

There are, of course, a few exceptions, such as Sir Andrew Witty, the global CEO of GlaxoSmithKline (GSK), who has been publicly expressing balanced views on this subject in several occasions, so far.

Being driven by anger and possibly desperation any MNC may wish to choose one of the following three ‘Alternatives’ available to them:

Alternative 1: Do not apply for the product patent in India at all.

‘The TINA Factor’: In that case the product will be made available in a platter for the generic players to copy.

Alternative 2: Obtaining the relevant patent from the Indian Patent Office (IPO), do not launch the patented product in India.

‘The TINA Factor’: After three years from the date of grant of patent, as per the statute, the said product could become a candidate for CL on the ground that the patented invention has not been worked in India.

Alternative 3: Launch the product only at the international price.

‘The TINA Factor’: If any patented new product is not available to patients at a ‘reasonably affordable price’ or ‘reasonable requirements’ of patients with respect to the patented invention are not satisfied, again according to statutes, interested parties are free to apply for CL to the IPO, following the steps as specified in the Act. Moreover, the Government itself may issue CL in national emergencies or ‘extreme urgency’ for non-commercial use.

Considering the ‘TINA Factor’, it appears, if the new products do not conform to the ‘Indian Patents Act’ and are NOT launched with ‘reasonably affordable prices’ or ‘reasonable requirements’ of patients are NOT met with these new drugs, the possibility of their legal generic entry at much lower prices is rather high in India. CL granted by the IPO for Bayer’s Nexavar to NATCO vindicates this point.

Summing-up effects of the ‘TINA Factor’:

Many would now reckon that the ‘TINA Factor’, being a hotspot for patented drugs in India, has the potential for getting adopted by many other countries in not too distant future. Two of its palpable effects, as felt in the country so far, may be summed-up as follows:

  • It leaves no option to any MNC, other than launching their new products in India, especially after obtaining  relevant patents from the IPO.
  • It also squashes apprehensions of many that discontented Big Pharma would be able stop launching patented new products in India, depriving a large number of patients of the country.

Conclusion:

‘The TINA Factor’, thus created by the lawmakers, is expected to remain undiluted, unless commensurate changes are made in the Indian Patents Act.

Not withstanding the reported anger expressed by the CEO of Bayer AG or recently reported ‘absurd pricing’ of Sovaldi, or even for that matter, fresh attempts that are now being made to cobble together a TPP deal, patented new products would continue to be launched in India, as they will receive marketing approval from the Drug Controller General of India (DCGI).

Any possibility of dilution of the ‘TINA Factor’ seems remote now, though powerful overseas pharma lobby groups are investing heavily for a change to take place in various ways.

It also does not seem likely, at least in the near to mid-term, that India would be a party to its ‘Patents Act’ diluting any ‘Free Trade Agreement’ or remain unmoved with high drug prices like, US$ 1000/tablet for life saving drugs like sofosbuvir, more so, if those are considered essential medicines in the country.

Come 2014, it appears improbable that any new Union Government would be able to garner enough numbers in the Parliament to amend Indian Patents Act, buckling under pressure of powerful lobby groups, directly or indirectly, and daring to ignore public sentiment on this sensitive issue. 

Considering all these, the point to ponder now:

While abhorring pro-patients ‘Patents Act’ of India, can the Big Pharma come out with any viable alternative today for NOT launching their life saving patented new drugs in the country with the ‘TINA Factor’ prevailing?

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.