Radar on Drug Benefits

Three FDA-approved multiple sclerosis treatments and one MS drug that the FDA is currently reviewing are not cost effective, according to an analysis from the Institute for Clinical and Economic Review (ICER). Jon Campbell, Ph.D., ICER’s senior vice president for health economics and one of the report’s authors, also tells AIS Health that there was “insufficient evidence” to differentiate the clinical effectiveness of any of those four drugs, which are known as monoclonal antibodies.  

The findings were part of a larger ICER draft evidence report published on Oct. 17 that examined the clinical effectiveness and cost effectiveness of oral and monoclonal antibody disease modifying therapies (DMTs) for relapsing-remitting MS. About 85% of the 1 million Americans with MS have the relapsing-remitting form.  

The median launch price of oncology drugs increased by over 8,000% between 2008 and 2021, according to a new report compiled by the office of Rep. Katie Porter (D-Calif.), from $2,115 to $180,087. The report, which draws mainly on data from the FDA's Center for Drug Evaluation and Research (CDER), calls for reforms to the FDA approval process and Medicare’s market access rules in order to curb or unwind launch price growth, which have made oncology drugs unaffordable for many critically ill patients. 

The report calls for reforms to launch price regulations, some of which could be implemented under existing FDA authority. It also examines how launch pricing dynamics may change as the federal government prepares to implement Medicare drug price negotiation — part of this year’s blockbuster Inflation Reduction Act — which will begin in 2026. The report observes that “some health policy experts project that recently enacted reforms could even apply upward pressure on launch prices,” as pharmaceutical manufacturers seek to recoup revenue that Medicare price negotiation may tamp down.

Although Centene Corp.’s decision to contract with Cigna Corp. rather than CVS Health Corp. for PBM services loomed large during major health insurers’ third-quarter earnings conference calls, it wasn’t the only PBM-related discussion worth noting. 

For example, during Elevance Health, Inc.’s earnings call on Oct. 19, executives offered some insights about how the firm’s in-house PBM IngenioRx is carving out a niche in the marketplace. 

“We are, as you know, trying to be a different PBM,” Peter Haytaian, Elevance’s president of Diversified Business and IngenioRx, said in response to an analyst’s question about the PBM’s progress selling its services to self-insured employers that already contract with Elevance.  

Centene Corp. recently announced that it will shift the bulk of its pharmacy benefits business to Cigna Corp.’s Express Scripts PBM; while discussing Cigna’s latest quarterly results, the carrier’s executives told Wall Street analysts that the deal will likely be a drag on profitability in 2023. Health care insiders tell AIS Health, a division of MMIT, that regulatory compliance, temporarily elevated staffing needs, tech-related capital costs and manufacturer contracting transitions are the likeliest sources of overhead that the deal will generate. 

Cigna executives told investors during a Nov. 3 conference call that the Centene deal, which analysts generally praised, would have some start-up costs. Centene Chief Financial Officer Drew Asher said during an Oct. 25 conference call with investors that “we have about $40 billion plus or minus of gross [drug] spend, and almost all of that is [currently] with Caremark,” CVS Health Corp.’s PBM. Cigna CEO David Cordani said that the deal will cover “approximately 20 million Centene members.”