Amgen takes issue with yet-to-be published multiple-myeloma drug report

Amgen has taken issue with a pending comparative-effectiveness assessment of multiple myeloma drugs, including one that it markets.

The drugmaker issued a statement criticizing technology assessments that use dollars per quality-adjusted life-years relative to cost-effectiveness data.

“Amgen believes that thorough and balanced assessments should rely on direct data from rigorous comparative trials when available rather than using opaque methods to combine multiple, disparate trials to arrive at different estimates of efficacy, or make assumptions to create unrealistic “worst-case” scenarios,” Amgen said in a March 31 statement. In the statement, the drugmaker suggested using an economic model it developed.

See also: New multiple myeloma drugs prompt cost-effectiveness report

The Institute for Clinical and Economic Review, a Boston-based nonprofit that evaluates the price tags and health outcomes claims of new drugs, is expected to release a draft report this week examining the health and economic outcomes of eight drugs used to treat multiple myeloma. “Comparing the results across different drugs is difficult when there are no head-to-head studies, but we feel confident that patients, clinicians, and policymakers can benefit from an independent, objective analysis of the existing data,” a spokesman for ICER said in an email.

Amgen markets Kyprolis, which is used to treat patients with relapsed or refractory multiple myeloma. The drug is not one of Amgen's top-selling products — it generated $512 million in sales in 2015 — but Kyprolis sales are growing at a time when the company's year-over-year revenue was flat. Kyprolis revenue, on the other hand, rose 55% from 2014 to 2015.

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The market for multiple myeloma treatment is becoming much more competitive. In November, the FDA approved three new therapies that treat the rare blood cancer: Johnson & Johnson's Darzalex, Takeda's Ninlaro, and Bristol-Myers Squibb's and AbbVie's Empliciti. All three drugs cost at least $8,500 per month of treatment, with Darzalex priced at $23,400 per month during the first two months of treatment.

Bristol-Myers Squibb launched a new campaign about using immuno-oncology therapies to treat multiple myeloma. It markets Empliciti, which was approved in November, with AbbVie. 

ICER has said its report will examine Takeda's Velcade, Celgene's Revlimid and Pomalyst, Kyprolis, Darzalex, Empliciti, Ninlaro, and Novartis' Farydak. It is expected to be released on Thursday. An unnamed source said that it is unusual for a company like Amgen to release a statement before a draft report is published.

ICER, which received a $5 million grant last year to fund more evaluations of new drugs, has plans to expand the number of drugs and medical devices it reviews. “There's a real hunger for this,” Steven Pearson, ICER's president and founder, told MM&M earlier this year.

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The organization recently reviewed Entresto, Novartis' new heart-failure drug. It found that the drug provides greater net health benefits than the standard of care but also raised concerns about its price, recommending that Novartis discount Entresto by 9%.