Crystal ball gazing is a perilous activity in this unpredictable world of ours. No-one can say with any degree of certainty what the stock market will do, what will happen to oil prices, and whether the economy will plunge into recession. Similarly, predictions about federal and state prescription drug policies, pharmaceutical prices, and healthcare in general are invariably subject to a large grain of salt.
But, 2019 is around the corner. And, inevitably questions crop up about what analysts and experts think will happen in 2019, to drug prices, and the overall healthcare market. Besides the inevitable hype that surrounds projected transformations in health through, for examples, revolutions in digital health and artificial intelligence, there are the more mundane, yet hugely impactful areas of healthcare. Here, I’ll review three of the most important.
First, reductions in list or Wholesale Acquisition Cost prices of a number of high-profile drugs, coupled with changes in the current rebate system. The examples set by the manufacturers of Repatha (evolocumab), Zepatier (elbasvir and grazoprevir), and Copaxone (glatiramer acetate) will likely pave the way for slashing of list prices of a wave of other products in highly competitive therapeutic classes, perhaps in conjunction with the introduction of the design of more rebate-less formularies by pharmacy benefit managers. In parallel, the Trump Administration will continue to pursue removal of the safe harbor exemption for rebates. This threatens to undermine the entire rebate system. It also raises the profile of a myriad of alternatives to rebates, including upfront discounting and implementation of the above-mentioned formularies that contain far fewer branded products with high rebates. At the same time, I am highly skeptical the Trump Administration will follow through with its controversial plan to lower prices Medicare Part B pays for physician-administered drugs by pegging them to an international price index.
Second, continued ascension of biosimilars. For several years it’s been predicted that biosimilars will emerge as serious challengers in the biologics space. With a few exceptions, such as the filgrastim biosimilar, Zarxio, this hasn’t yet materialized in the U.S. Will 2019 be the year in which biosimilars break through? The two approved infliximab biosimilars are poised to boost their market share, as well as follow-on biologics, such as Basaglar (glargine). Also, certainly compared to the trickle of biosimilars being approved several years ago, there’s been a much steadier stream of approvals in 2017 and 2018 – biosimilars approved through the 351(k) regulatory pathway, and follow-on biologics proceeding through the soon to be abolished 505(b)(2) pathway. Changes in the 340B program’s reimbursement rates for originator biologics versus biosimilars – Average Sales Price (ASP) plus 6% for biosimilars, ASP minus 22.5% for originator biologics – may spark an uptick in physician usage. But, more importantly, familiarity and trust with biosimilars among physicians and patients appear to be growing, albeit slowly. As these barriers to greater uptake gradually fade, the fortunes of biosimilars will improve. Moreover, several major biosimilars loom on the horizon, including approved biosimilar products referencing Humira (Amjevita) and Herceptin (Ogivri) that may not launch yet. Ogivri is slated to launch in 2019 or 2020, while Amjevita will have to wait until 2023. Approval of a Rituxan biosimilar is very likely in 2019. In spite of the approvals, the wrench that may upset more positive movement in certain classes where biosimilars are prevalent is the fact that the U.S. market is plagued by stubborn legal delays, patent disputes, and a number of exclusionary contracts for originator biologics, effectively locking out biosimilars in some instances.
Third, the economy. The economy’s probable downward turn may have a negative impact on list prices of drugs. But, it may also have negatively repercussions for patient access to healthcare as the already growing numbers of uninsured will likely increase, possibly approaching 20% nationwide by 2020. As a result of the recent ruling in Texas striking down the Affordable Care Act, a cloud hanging over the law’s future may further exacerbate issues with insurance access. This amalgam of factors will put further upward pressure on premiums for those who are insured. And, the spill-over effect on community hospitals’ solvency should not be underestimated.