Market access

After years of having just one, limited option available to combat respiratory syncytial virus (RSV) in at-risk populations, the U.S. market this year has suddenly become rich with new products. Yet insurance coverage limitations and supply issues are frustrating efforts to keep elderly adults and very young babies from contracting what can be a life-threatening illness.

This May, the FDA approved both GSK’s Arexvy and Pfizer Inc.’s Abrysvo for people who are 60 and older, and in August, federal regulators approved Abrysvo for use in people who have been pregnant for 32 to 36 weeks, with the goal of protecting their infants after birth. Additionally, in July, the FDA approved Sanofi/AstraZeneca’s Beyfortus (nirsevimab-alip), a monocolonal antibody injection indicated for preventing RSV in newborns and infants born during or entering their first RSV season, and for children up to 24 months old who remain vulnerable to severe disease throughout their second RSV season.

Almost two years after Paxlovid received emergency authorization as a treatment for acute COVID-19 infection, Pfizer Inc. and the U.S. government are now in the throes of transitioning the drug to the commercial market. That means the drugmaker is, in its own words, “working diligently with payers to achieve the best possible formulary placement” for Paxlovid — but also raising some eyebrows with the list price it set for the antiviral therapy.

Pfizer said in a statement that the commercial list price for Paxlovid (nirmatrelvir/ritonavir) in the U.S. will be $1,390 per five-day treatment course. That’s more than twice what the U.S. government paid for the drug, $529 per five-day course, and significantly higher than the price range of $563-$906 that the Institute for Clinical and Economic Review (ICER) suggested would be most cost effective.

A review of market access for diffuse large B-cell lymphoma treatments shows that under the pharmacy benefit, about 43% of the lives under commercial formularies are covered with utilization management restrictions. Around 50% of the lives under Medicare formularies are not covered for at least one of the drugs.

When the Affordable Care Act (ACA) became law on March 23, 2010, it established the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved more than 40 biosimilars, with only a handful of those gaining interchangeable status. That designation, however, may not carry quite the distinction it historically has had if proposed guidance from the agency — which would replace previous guidance — on labeling for interchangeable biosimilars is finalized. Various stakeholders, including manufacturers, pharmacies, patients and providers, stand to be affected, stakeholders say.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.

This summer, Opill (norgestrel) became the first over-the-counter (OTC) daily contraceptive pill approved by the FDA, and it’s slated to hit the U.S. market in early 2024. However, Opill’s OTC designation — which on the surface would seem to increase access to birth control — may have the opposite effect for patients seeking reimbursement from their health plans, experts said during a recent KFF web event.

“Having over-the-counter contraceptives is definitely a positive step,” said Christine Gilroy, M.D., chief medical officer of The Cigna Group’s PBM, Express Scripts. “I am concerned, though, that while it removes the barrier of needing to pay for a physician visit and get a prescription from the physician…in order to be processed against a pharmacy benefit, it does need to be entered into a system that essentially turns it into a prescription.”

A review of market access for multiple myeloma treatments shows that under the pharmacy benefit, about 45% of the lives under commercial formularies are covered with utilization management restrictions. Around 42% of the lives under Medicare formularies are not covered for at least one of the drugs.

Boehringer Ingelheim’s adalimumab-adbm interchangeable biosimilar is now available at an 81% discount to the price of its reference drug, AbbVie Inc.’s Humira (adalimumab), the manufacturer said Oct. 2. In early July, the company launched a branded version of the agent, Cyltezo, at a 5% discount. Both are citrate-free formulations available in various strengths for multiple inflammatory conditions.

Takeda Pharmaceuticals U.S.A., Inc. will voluntarily withdraw Exkivity (mobocertinib) after the Phase III EXCLAIM-2 confirmatory trial did not meet its primary endpoint, the company disclosed Oct. 2. The FDA gave the kinase inhibitor accelerated approval on Sept. 15, 2021, for the treatment of adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The company says it made the decision in consultation with the FDA and is working with the agency on withdrawal timing. It also is working with other regulatory agencies to withdraw the drug globally. In the meantime, Takeda says it is working to make sure that people receiving Exkivity can maintain access to the medication.

A review of market access for spinal muscular atrophy treatments shows that under the pharmacy benefit, about 39% of the lives under commercial formularies are covered with utilization management restrictions. Around 24% of the lives under health exchange formularies are not covered for at least one of the drugs.

Life sciences companies need to be agile in an often-changing market, and forecasting plays a crucial role in being able to do this. The increasing focus on the use of machine learning (ML) and artificial intelligence (AI) can make parts of forecasters’ jobs easier, but there is room for improvement in these and other areas. A recent IQVIA webinar discussed trends in commercial forecasting based on the company’s second annual survey, which was conducted earlier this year.

“This is a very exciting time to be in forecasting,” declared David Wolter, a vice president in IQVIA’s commercial consulting group. And while forecasting is critical to making business decisions, multiple challenges exist within the process.

A review of market access for schizophrenia treatments shows that under the pharmacy benefit, about 27% of the lives under commercial formularies are covered with utilization management restrictions. Around 10% of the lives under Medicare formularies are not covered for at least one of the drugs.