A draft report by the Institute for Clinical and Economic Review (ICER) stirred up controversy with its determination that despite better outcomes, new drug cocktails for multiple myeloma are less cost effective than the current standard treatment. But the final report has a host of other criticisms as well aimed not only at drugmakers, but the FDA and payers.
The non-profit ICER took a look at drug cocktails that included Bristol-Myers Squibb's ($BMY) Empliciti, Amgen's ($AMGN) Kyprolis and Takeda's Ninlaro, finding they were much less cost-effective than standard treatment with Celgene's ($CELG) Revlimid and dexamethasone. BMS and Amgen have both disputed those finding, criticizing the way ICER came to its conclusions.
But from a patient’s perspective, the ICER evaluators found lots wanting in the way drugs are tested, approved and paid for. From a cost side of things, they point out that it is not just the cost of the specific treatment that patients must evaluate but the cost of all drugs that must be taken with a regimen. ICER suggests that payers and drugmakers need to work together to find ways to discount all of the additional drugs that factor into the total cost of treatment.
The key, the report suggests, is a need for more information. "Given that many important decisions about clinical use, pricing, and coverage must be made near the time of FDA approval," there is just too little insight of all kinds available at the time of a drug’s approval about cost and effectiveness and it is too hard to make comparisons.
The report says that because the industry and FDA are focused on getting effective to market as soon as possible, the process leaves gaps in the information patients and doctors need when making life and death decisions. For example, the process doesn’t give insight into the comparative effectiveness and value of different approaches to sequencing regimens for patients with differing levels of “aggressive” disease.
On top of that, there is no info that evaluates different protocols for maintenance treatment during remission. Given the costs of the drugs, and their side effects, patients need to know which treatment and its attendant costs will give the most benefit at the least cost and with the fewest side effects.
The reports says drugmakers, patients, physicians and federal funders like NIH need to be working together to make this happen. One way to improve the process, the report says, is for patients to be given a voice in the way drug trials are designed, so they can tell drugmakers what the end user of the drugs wants to know.
For payers, the report says that in the case of multiple myeloma, the idea of “fail first” or step therapy just doesn’t apply because most patients will go through most, or all, of the possible treatments to find out what works best for them. There just isn’t enough info on what works best and the trade-offs with each treatment, for those kinds of payment policies to be effective in the face of an aggressive disease.
In fact, the report concludes by saying that in the new world of “accountable care” a focus on trying to cut back the cost of specific drugs is not going to cut it. “The primary mechanisms for cost control should be focused on the entire spectrum of health care services, not solely drug costs for specific classes or certain patient populations.”
- get the final report here
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