The Institute for Clinical and Economic Review’s draft report on new drug cocktails for ‘multiple myeloma’ being less cost effective than the current standard treatment has drawn criticism from BMS and Amgen, who disagree with the way the ICER has reached its conclusions.
The non-profit ICER inspected drug cocktails that included Bristol-Myers Squibb’s ($BMY) Empliciti, Amgen’s ($AMGN) Kyprolis and Takeda’s Ninlaro to come to the conclusion that they were far less cost effective than standard treatment with Celgene’s ($CELG) Revlimid and Dexamethasone. Keeping the patient’s view point primary, the Clinical and Economic Review body found lots for the asking in the methods of testing, approval and payments of drugs.
The 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 drug makers, but the FDA and payers too.
ICER is of the opinion that from the cost point of view patients not only need to evaluate the cost of specific treatments, but also cost of drugs that must be taken with a regimen. The ICER is of the opinion that the payers and drug makers need to work out ways to discount all of the additional drugs that result in the total cost of treatment reports FiercePharma.
“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 opines the report.
According to the report, gaps remain in information required by patients and doctors when making life and death decisions. This it feels is the case because the industry and the FDA are interested in hitting the market as soon as possible.
Citing an example to elaborate on the above point the report says that the process doesn’t give insight into the comparative effectiveness and the value to different approaches to sequencing regimens for different levels of the ‘aggressive’ disease, for the patients.
Keeping in mind the cost of the drugs and their side effects, the patients need to be made aware of which treatment could cost the least and have the minimum side effects.
This the report feels can only happen when drug makers, patients, physicians and federal funders like NIH work together. The report feels that patients should be given a voice in the way drug trials are designed to improve the process. Their involvement in the process would help drug makers determine the end user’s requirement.
In conclusion the ICER report admits to the fact 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 them. “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.” It adds.