Spotlight on Market Access

Amgen Inc. has tapped Optum Health Solution’s new biosimilars-focused private-label subsidiary Nuvaila to be the sole distributor of its Wezlana (ustekinumab-auub), the first available biosimilar of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine (formerly Janssen Biotech, Inc.). While such deals may be beneficial to manufacturers that can strike them, they are essentially locking out competitors that can’t from the biosimilar market, asserts an industry expert.

Stelara is approved for the treatment of adults and pediatric patients at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adults and pediatric patients at least 6 years old with active psoriatic arthritis, adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis.

The FDA’s accelerated approval pathway has become an increasingly popular way for drugmakers to get novel medications to market. However, the strength of clinical evidence from studies supporting these accelerated approvals is not always high.

Through the accelerated approval pathway, the FDA allows new drugs to come to market that treat serious conditions, based on pivotal trials that use surrogate endpoints or intermediate clinical endpoints that are “reasonably likely” to predict the clinical benefit. Between 2015 and 2022, 159 drug-indication pairs received accelerated approval. Three pairs were excluded due to absence of the product label or FDA review documents in the Drugs@FDA database. Among the remaining 156 approved drug-indication pairs, 77% were supported with evidence from single-arm pre-approval pivotal studies — trials that had no comparators — and 22% from Phase I trials, according to a recent study published by the BMC Medicine journal. The median number of participants in those trials was 92.

While many retail pharmacies are backing off from their provider group subsidiaries, private-equity groups continue to invest in the space, activity that is likely to continue under the new administration. Roll-up mergers have been of great interest to drug wholesalers, which have become almost as vertically integrated as the major PBM/insurer entities. As pressure grows on the buy-and-bill system, this integration will be a big story over the next couple of years, asserted longtime industry expert Adam J. Fein, Ph.D., president of Drug Channels Institute, an HMP Global Company, during a Dec. 13 webinar.

Taking a broad look at the drug channel, Fein observed that private-equity groups have become a “big part of health care markets.” Retail pharmacies had been acquiring primary care organizations that were started by venture capital and private-equity companies but “have now realized that’s not such a great business.” He pointed to Walgreens Boots Alliance, which has considered selling VillageMD and, more recently, is reportedly in talks to sell itself to private-equity group Sycamore Partners, according to The Wall Street Journal.

The beginning of the new year should see the start of the next wave of highly anticipated biosimilars: those of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine (formerly Janssen Biotech, Inc.). While payers are saying they plan to have some of the biosimilars on formulary, many also say they will keep the reference drug on a preferred tier, according to Zitter Insights.

Stelara is approved for the treatment of adults and pediatric patients at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adults and pediatric patients at least 6 years old with active psoriatic arthritis, adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis.

While many upcoming health care policies remain unclear, potential changes brought about by the Trump administration will be a net negative credit-wise for the industry, according to an S&P Global Ratings analyst. 

In a Dec. 2 article, analyst Arthur Wong named the top five developments S&P Global is watching: the Affordable Care Act, Medicare drug pricing negotiations in the Inflation Reduction Act (IRA), the Federal Trade Commission’s (FTC) tone on mergers and acquisitions (M&A) and tariffs, and HHS priorities. “We do not envision any rating changes due to the change in administration until it becomes clear what policies will be implemented and their time frame,” Wong wrote. “However, we see more downside than upside risk to ratings over the near term.”