“Now, one-fourth of the Indian pharma market to be under price control.” This possibility was reported by some national dailies, on July 03, 2018. The new methodology of drug price control could be anything – ranging from earlier ‘cost-based’ model to the current ‘market-based’ one – to even the new pharmaceutical index, as proposed by the Government ‘think tank’ – Niti Aayog. This gives an indication of acceptance by the policy makers that none of the price control mechanisms have worked as intended, till the last 48 years. Otherwise, why are such changes taking place?

On the other hand, the drug pricing models of the pharma industry, are also not working. Drug pricing related issues, directly or indirectly, continue driving pharma reputation down south. Strong negative vibes on the industry continues, despite a vigorous and expensive advocacy of the industry trade associations, primarily positioning the need to encourage ‘drug innovation’ right at the front. No perceptible impact of this pharma strategy on the policy makers is still visible, besides a few spoon-fed media editorials – as many believe. The saga continues. The pricing focus keeps remaining solely on a company’s financial interest. How far the price of a drug can be stretched to benefit the company, is the point to ponder. Why aren’t the basis and rationale of drug pricing made transparent, voluntarily? In this article, I shall discuss on this contentious issue.

Current pricing approach becoming counterproductive: 

The good news is, of late, some global drug majors apparently have been compelled to realize that this approach is gradually becoming more and more counterproductive, inviting more drastic measures from many Governments. Even recently in the United states, ‘Trump wants U.S. Health Secretary to get tough on drug prices, opioids.’ This situation demands, more than ever before, that a measurable quantum of all-round health benefits accrued by patients with the medicine, have to be factored into the drug pricing model, now.

Can pharma too, look for an ‘Out of the box’ solution?

I found two excellent examples of ‘looking outside the box’ in an article featured in the Pharmaceutical Executive, on March 06, 2018. Both the illustrations from non-pharma companies focus on product output to the consumer rather than inputs on the same by the companies, such as the cost of a drug innovation to an innovative company. Many find difficult to accept – why for extending life of cancer patients by just three to six months, an innovative oncology drug would cost thousands of rupees more to the sufferers, or their family?

Couple of interesting ideas:

The two interesting ideas are as follows:

- Erstwhile Monsanto, the article says, ‘had historically been able to maintain its market position and technological edge in developing superior genetically modified seeds through patents and contracts with farmers. In order to fully capture the value of its genetically modified seeds, however, Monsanto went a step further and shifted to a royalty type price model, charging a fee after the crops were harvested based on the yield. This end-use fee shifted Monsanto’s price model from seed-based to yield-based pricing, i.e., from input- to output based.”

-  The second one comes from a time “when Michelin developed a new tire that lasted 25 percent longer than existing tires, the company found it difficult for customers to accept a premium” – the paper highlights. “Rather than giving away the innovation, Michelin changed its pricing model. Truck fleets, a key customer segment, track cost per mile for each truck as their revenue model is also based on charging its customers per mile. Michelin decided to adapt its pricing model and to offer the new tires on a price per mile rather than per tire basis. The company then offered a contract to replace the tires after they wore down. Under this new pricing model, customers perceived a parity price as they were not asked to pay more, while longer lasting tire from Michelin was able to capture a premium for its innovation” – the article emphasized.

Two patient-oriented pharma pricing models:

Looking somewhat ‘outside the box’ and trying to factor in patients’ overall interest, some global majors are contemplating the following two broad approaches:

• Value based pricing (VBP)
• Outcomes based pricing (OBP)

The Drug Pricing Lab (DPL) based at Memorial Sloan Kettering Cancer Center defines these two models as follows:

Value-based pricing: When the price of a drug is based on its measured benefits, for instance, in clinical trials leading to its approval.  Methods used to determine value-based prices are transparent, reproducible and data driven.

Outcomes-based pricing: Refers to arrangements between manufacturers and payers, in which the manufacturer is obligated to issue a refund or rebate to the payer that is linked to how well the therapy performs in a real-world population. This refund or rebate is off of a list price that the manufacturer sets.

These concepts are neither very new or untried. Nevertheless, these are being used very selectively by some global pharma majors, from time to time. There doesn’t seem to be any consistent approach with these two models, thus far. For example, in 2005, with its erectile dysfunction drug Levitra (vardenafil), Bayer entered into a “no cure, no pay” initiative in Denmark, where patients dissatisfied with the treatment get a refund. Moreover, there are several instances of interchangeable use of these two definitions, in various literature. But, I shall stick only to the above definition, in this deliberation.

Are there any takers for VBP?

A few other pharma majors, such as Eli Lilly, have accepted the need in finding a right balance between investment on innovation and providing affordable medicines, as the key to bettering the health of the world with value-based pricing. It will call for requisite engagement between the drug manufacturers and health planners, covering the following two points, especially in the Indian context:

• Critical scientific evidence about new drugs would create a pathway to set accurate rates for better availability to patients who need treatment.
• Making drug price regulators and health policy planners better anticipate the holistic impact of the drug on patients, leading to generation of more accurate efficacy and pricing/health economics data.

The major issue with VBP:

The critical point to note, that for a meaningful discussion on VBP, the pharma players will require to share their pricing data with the competent authorities. In this regard, the article, titled “Pricing Turning Point: The Case for Innovating Pharma’s Model,” published by Pharmaceutical Executive on March 06, 2018, flags an important reality.

It says,a drug pricing model consists of two parts – How to charge (the details of the rationale)? And how much to charge (the level)? The article reinforces that the pricing decisions in the pharma industry generally focus on ‘how much to charge’, for the last 100 years. This process is now being stretched to a mind boggling level that raises many eyebrows in ‘disbelief’. I, therefore, reckon, it would be a real challenge for the drug maker to make the basis or rationale of a pricing decision transparent to all. In that case, the moot question is, how would the value-based pricing work?

Are there any takers for OBP?

According to reports,  the erstwhile CEO of Novartis – Joe Jimenez, and his Amgen counterpart at that time – Robert Bradway, among others, publicly spoke about pegging drug costs to their outcomes. Intending to be a part of the drug pricing solution, Novartis inked performance-based contracts with Cigna and Aetna on its new heart failure medication Entresto, so did Amgen on its anti-lipid drug – Repatha. Novartis also fleshed out the details of outcomes-based pricing model in a comprehensive report, describing its benefits to address the affordability challenge. However, such initiatives have not gained momentum, just yet.

OBP may not be the right option, and why:

Thereafter,the Drug Pricing Lab (DPL), based at Memorial Sloan Kettering Cancer Center,analyzed that the methods manufacturers use to generate list prices are typically opaque, inconsistent, and driven more by market factors than clinical data. These methods are often referred to by manufacturers as “pricing to what the market will bear”.

‘The Drug Pricing Lab’ illustrated the basic difference to patients between the ‘value-based’ and ‘out-come’ based pricing models by looking into Amgen’s outcome-based refund contract with Harvard Pilgrim for Repatha (Evolocumab). Amgen had agreed to refund Harvard Pilgrim the cost of medication for patients who have a heart attack or stroke, an estimated 3.5 percent of individuals on the drug. This equates to a reduction in annual list price from US$ 14,100 to US$ 13,620. In contrast, the ‘Institute for Clinical and Economic Review’finds that a value-based price for Repatha would be US$ 2,200 to US$ 5,000 per year, one third to one fifth the expected price resulting from the outcomes-based contract.

VBP comes out as a better option:

Based on the available data, it appears that VBP is a better option that focuses on tangible value delivery of a drug to individual patients. This is quantified with the help of available statistical tools, in a transparent manner. Application of Health economics is also being tried in this area.

Thus, the core concept behind VBP is that any drug price should be a function of the differential value that it delivers over the conventional ones, generally used for treating the same disease. Unfortunately, arriving at a consensus on the ‘value assessment’ metrics for a drug, often throws a tough challenge, especially to the manufacturers.

Conclusion:

Recently, with exorbitantly high-priced new drugs coming into the market, the issue of drug pricing mechanism has become a major concern for all stakeholders. Pharma companies can’t wish it away, any longer, even with the high decibel advocacy of ‘protecting and encouraging innovation’ of new drugs. The consequent potential risks are becoming too costly.

This situation prompts the pharma players to reengage with the consumers, providing quantifiable details about the differential value that a drug offers to patients and its relationship to the price that the company charges.  This is easier said than done. It’s time for drug companies to establish a solid link between these two. As I said before, many stakeholders are refusing to accept, just to extend life for a few months, why should an innovative anti-cancer drug cost thousand or even lakhs of rupees more than a conventional one – pushing families into dire financial distress?

Pharma players can’t afford to remain a part of this critical problem, any longer. They should take responsibility to become a part of the solution. With VBP or with any other credible alternatives, making drug pricing transparent – voluntarily, may work better for them than facing mandatory price control. It’s a different ball game altogether, requiring a new mindset, and… the name of the game is: ‘out of the box’ Ideas.

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.