In advance of a meeting to assess the value of multiple myeloma treatments, Amgen is publicly questioning the extent to which the session will fairly evaluate the medicines.
The meeting comes as concerns mount over the cost of these medications. There are now 10 treatments available for multiple myeloma, which causes cancer cells to accumulate in the bone marrow, and three won regulatory approval last fall. But these medicines are also expensive, ranging from $8,000 to $14,000 a month.
So the Institute for Clinical and Economic Review, a nonprofit organization whose members include drug makers and insurers, has scheduled a meeting next month to review their value and determine a benchmark for payers. A draft report is due later this week.
“The costs of managing multiple myeloma are substantial, given the use of multiple therapies, over the course of the disease,” according to a background statement issued by ICER. “The cost of a single course of drug therapy has been estimated to range from $75,000 to $250,000 for patients” who’ve relapsed or did not respond to previous attempts at treatment. ICER noted there are no head-to-head studies.
The event clearly has Amgen worried, because ICER has made waves over the past two years with reports that have repeatedly questioned the economic value of various medicines. In response, payers have used these reports as ammunition in haggling with drug makers.
Notably, ICER criticized pricing for hepatitis C medicines, and, more recently, a new pair of injectable cholesterol medicines. The nonprofit has also reviewed medicines used to treat obesity, diabetes, and heart failure, and more reviews are planned.
But Amgen, which sells the Kyprolis medication, is concerned the review will hinge too heavily on cost effectiveness, and make other comparisons it believes are unwarranted. Kyprolis is not a blockbuster medication. Sales last year were $512 million, but that represented a 55 percent increase in a big, if crowded, market.
In a statement issued last week, Amgen argued that a “thorough and balanced assessment should rely on direct data from rigorous comparative (clinical) trials,” rather than using “opaque methods” to combine “disparate trials” to determine whether the drugs are useful.
“Results produced by independent organizations should be informed by experts, made fully transparent and available, and undergo complete and independent peer review,” the drug maker said.
Some countries measure cost effectiveness by gauging what is known as QALY, or quality-of-life years. This measures both the quantity and quality of life generated by providing a treatment or some other health care intervention. More specifically, a QALY measures life expectancy and the quality of the remaining years of life when using a treatment.
The United States does not officially use QALY, although Amgen developed its own model for assessing value. And the drug maker argued that using its drug as part of a regimen is estimated to be “well below” the benchmarks of $150,000 to $300,000 QALY that is cited as reasonable for treating cancer in the US.
For its part, an ICER spokesman sent us a statement to say that “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.”