Radar on Drug Benefits

While drugs are increasingly hitting the market that address unmet needs and even offer cures for some rare diseases, private insurers are highly concerned about such therapies’ eye-popping price tags, a recent survey indicated. But one prominent payer executive who spoke during AHIP’s Medicare, Medicaid, Duals & Commercial Markets Forum suggested that insurers are better off working collaboratively with drugmakers to ensure prices are tied to value — rather than engaging in an inter-industry war of words. 

“More and more we’re seeing drugs come through with limited evidence through accelerated approval processes, which generally is a marker for an unmet need, which is a good thing. But the evidence can be thin,” said Michael Sherman, M.D., executive vice president and chief medical officer of Point32Health. During a March 14 panel at the AHIP forum, Sherman pointed to the example of Makena (hydroxyprogesterone caproate), a drug that aims to reduce preterm births but failed to prove clinical effectiveness in trials conducted after it received accelerated approval. With the FDA poised to make a final decision on the drug’s status, Clovis Pharma Group recently announced it would voluntarily pull Makena off the market. 

The FDA is expected to approve several biosimilar medications in the next few years, potentially leading to billions of dollars in savings for payers and patients, according to a recent report from Cardinal Health. However, Bruce Feinberg, D.O., Cardinal Health’s chief medical officer, tells AIS Health that the promise of biosimilars to decrease medication and overall health care costs remains uncertain. He adds that the price differential between biologic drugs and their biosimilars has not reached anywhere near the levels seen between small-molecule medications and their generics. 

Feinberg says that “in most of the biosimilars to date, none of the manufacturers have been quite willing to initiate that race to the bottom on price,” in large part due the high costs of producing biosimilars and funding research and development of them. Whereas the introduction of a generic can reduce prices by 90%, Feinberg says “we’re not seeing those kinds of changes [with biosimilars],” claiming the range is usually from 10% to 30% with an average of 15%.  

The FDA recently approved a new HIV drug for a small patient population desperately in need of treatments. And the twice-yearly medication’s annual price is below the level that respondents to a Zitter Insights poll said they would consider a good value. The medication comes with both potential advantages and disadvantages for patients, providers and payers, say industry experts. 

On Dec. 22, the FDA approved Gilead Sciences, Inc.’s Sunlenca (lenacapavir) for the treatment, in combination with other antiretroviral(s) (ARVs), of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The agency gave the first-in-class capsid inhibitor priority review, fast track and breakthrough therapy designations.