Ready. Set. Access.

Market Access Strategic Execution Consultant

Chronic low back pain: employers with onsite or near-site clinics can become a gold mine for market access​

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Opioids are currently considered the most effective pharmacologic options for the treatment of chronic low back pain. Although effective, opioids can be just as dangerous because of the risk of opioid addiction, which can be devastating for individuals and their families.

At least 3 innovating manufacturers are heeding this call and are soon to launch treatments for chronic low back pain without the risking addiction (lucky for patients and providers because they will have options–though this competition will pose an up-hill access and commercialization battle for the manufacturers). A top barrier for the manufacturers will be optimum formulary placement. The first entrant might enjoy the perks of being first-to-market as did Gilead in 2014 with hepatitis C , but not for long. Entrance of the other competitors for chronic low back pain will be justification for payers to demand rebates and rebate walls.

Of course, standing your ground with the right value story will certainly help you gain traction–but  have you considered all potential audiences for your value story (for example, employers with onsite or near-site clinics)?

According to PwC’s most recent Medical Cost Trend report, employers are fed up with the high health care costs and are taking matters into their own hands as they are now taking bold new steps in their efforts to contain costs. For example, they themselves are negotiating contract prices, setting up their own provider networks, and in some cases, building parallel health systems to take care of their employees at more manageable costs.

The most recent survey report from Mercer and the National Association of Worksite Health Centers suggests that general medical clinics are offered by 33% of organizations with 5,000 or more employees (up from 24% in 2012 and just 17% in 2007), and another 11% of employers of this size are considering adding a clinic by the end of this year. Based on consumer experiences with these clinics and the imminent entrance of Haven (comprised of JPMorgan Chase, Amazon and Berkshire Hathaway), it seems logical that such onsite workplace clinics will continue to become more prevalent.

Employers that are self-insured and those with onsite or near-site clinics can be potential gold mines for market access–especially for the small and mid-size biopharmaceutical companies. I believe that buy-in of such employers through effective business-to-business interactions is a great way to increase access to therapies for chronic low back pain.

It’s time to make big strides and turn heads. Ready. Set. Access.

Innovation and outcomes data can ward off the biosimilar threat

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Biologics, for the longest time, had been enjoying freedom from generic erosion. Now, biosimilars are an impending threat to these biologics.

FDA approval of a biosimilar is only the first hit. Upon FDA approval, payers are already using publicly available data and approved labeling to see how they can leverage biosimilars in their contracting strategies.

Even so, the LAUNCH of the biosimilars is what really puts a dent in the revenue. Biosimilar launch is an important milestone, considering only 7 of the 20 currently FDA approved biosimilars have launched into the market (see Figure 1 below for my summary of approved and marketed biosimilars in the US). Threat of patent litigation is the biggest hurdle to overcome for biosimilars before they can launch into the market.

Figure 1

Despite biosimilar launch, the reference product might be able to retain a reasonable market share—UNLESS, the biosimilar is designated as interchangeable by the FDA. The FDA recently issued the final guidance on interchangeability designation last month. I believe that biosimilars deemed as interchangeable by the FDA can cause a lethal blow to the reference product (in terms of market access and subsequent market share), because that’s when a biosimilar can truly behave like a generic drug and cause that “generic erosion” that we all know about.

So, what are the options for manufacturers of the reference products? 

A) Take cover, you’re in for a hit
B) Start a campaign to downplay the importance of biosimilars
C) Innovate to bring a meaningful change to the market

When in doubt, go with ‘C.’ The adage didn’t always serve me well in pharmacy school, but that IS the correct answer here (former commissioner of the FDA, Scott Gottlieb, would agree with me).

The biosimilar threat is real. However, having a good pulse on the market will enable a sound strategy to retain—and perhaps even grow—the market share of the reference product.

According to an insightful analysis by Rand, Amgen has been able to successfully put up a fight against not just 1, not 2, not 3, but 4 biosimilars in the market through innovation. 

Genentech’s Herceptin (trastuzumab) is up for a similar fight against an army of 5 biosimilars (already approved, though yet to launch). Innovation seems to be the name of the game for Genentech as well: interestingly, in February 2019, FDA approved Genentech’s Herceptin HYLECTA, a subcutaneous version of the intravenous Herceptin. If Genentech can successfully serve this innovation up to payers and organized customers, such as IDNs, with the proper outcomes data, I think Genentech will be just fine.

Innovation is certainly a steep climb, and Amgen and Genentech are clearly taking the high road to accept this challenge.

This just goes to show that there is ALWAYS room for improvement. Furthermore, those who are agents of change that continue to improve, take the cake. In the famous words of Steve Jobs, “Innovation distinguishes between a leader and a follower.” 

It’s time to make big strides and turn heads. Ready. Set. Access.

Effective market access teams can help save billions in revenue leakage

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Adam Fein of Drug Channels has slapped a whopping $153 billion label on the gross-to-net bubble problem—this was how much biopharmaceutical companies were losing in 2017 alone due rebates and other reductions. When biopharmaceutical companies are unable to make the case to differentiate their products, they end up having to provide massive rebates to payers (40%, 50%, 60%, and sometimes even more) in order to secure a favorable formulary placement.

Effective market access teams can justify the uniqueness of their products despite other players in the same therapeutic area. From my experience, there is a hook for EVERY product IF the right questions are asked. For example, “patients with which comorbidities can benefit most from my product,” or “which drug-drug-interactions does my product avoid, in contrast to the competitors,” or “patients with which genetic profile can benefit from my product?”

Market access may be complicated, but it’s possible as it is noble. Patients are looking to this team to ensure that they can gain access to the treatment they need. Furthermore, it’s the market access team that’s charged with helping to solve the $153 billion problem.

It’s time to make big strides and turn heads. Ready. Set. Access.

Krishna Patel, PharmD
Market Access Strategy and Execution Consultant
info@sojusllc.com
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