The FDA approvals of three new drugs that treat multiple myeloma—as well as at least one experimental drug currently in development—have raised questions about the costly new entrants and how they will compete in the market.
The Institute for Clinical and Economic Review, a Boston-based nonprofit that evaluates whether new drugs are worth their price tags, said January 5 that it plans to systematically assess the effectiveness and cost-effectiveness of a number of treatments for multiple myeloma.
The FDA approved three new treatments for relapsing forms of the rare blood cancer during a three-week span in November. All three drugs tout the ability to extend life five to eight months longer than the current standard of care, such as Celgene’s Revlimid or Takeda’s Velcade.
The agency on November 16 approved Johnson & Johnson’s Darzalex—the first monoclonal antibody approved to treat the disease. The FDA approved the drug in patients who have taken at least three other treatments. The drug was priced at $23,400 per month for patients during the first two months of treatment. The cost of treatment after that is $11,212 per month for the next four months and $6,337 for each month thereafter.
Four days later, the FDA approved Takeda’s once-weekly pill Ninlaro for use in patients who have already tried at least one treatment. Ninlaro is the heir-apparent to Takeda’s flagship oncology drug Velcade; it is also the first oral proteasome inhibitor for the disease. Takeda priced it at $8,670 per month, or $2,890 per capsule, according to multiple news outlets.
The regulator then gave the nod to Bristol-Myers Squibb’s and AbbVie’s Empliciti on November 30 for use in patients who have received one to three prior therapies. The drug is used in combination with Celgene’s Revlimid and the corticosteroid dexamethasone. Empliciti is priced at roughly $10,000 per month, according to The Wall Street Journal.
There is at least one other treatment in the pipeline to watch. Celgene and Bluebird Bio plan to begin testing an engineered T-cell therapy in multiple myeloma patients this year. In smaller, early-stage trials, T cell, or CAR-T, therapies have shown high remission rates in certain forms of cancer.
Leerink Partners analyst Seamus Fernandez wrote in a December analyst note—regarding new data released at the American Society of Hematology meeting—that Darzalex has the most “disruptive” potential of the new approvals.
“The most impressive is certainly Darzalex, and the combined presentations of monotherapy and Phase-II trials at ASH suggest that this drug will ultimately be added to many combinations and lines of treatment,” he wrote, adding, “By comparison, Ninlaro and Empliciti offered more incremental activity in their trials…and are likely to find niches in the treatment sequence.”
ICER’s assessments provide information about whether the price of a drug is higher than the value it can provide to patients and the healthcare system. The nonprofit is expected to release a draft of the multiple myeloma drug report in early February.
ICER receives most of its funding from nonprofit foundations, drugmakers and health insurers. ICER does not use manufacturer or health insurer money to fund drug reviews, however.