MedicalResearch.com Interview with:
Inmaculada Hernandez, PharmD, PhD
Assistant Professor of Pharmacy and Therapeutics
University of Pittsburgh School of Pharmacy
Pittsburgh, PA 1526
MedicalResearch.com: What is the background for this study?
Response: A few months ago, the results of the FOURIER trial were published. This trial was the first one to evaluate the efficacy of PCSK9 inhibitors in the prevention of cardiovascular events, since the approval of these agents was based on trials that evaluated their efficacy in reducing levels of LDL-C. The results of the FOURIER trial did not meet the expectations generated by prior studies that had simulated how much the risk of cardiovascular events should decrease based on the observed reduction in LDL-C levels. A few hours after the publication of the results of the FOURIER trial, Amgen (evolocumab´s manufacturer) announced that it would be willing to engage in contracts where the cost of evolocumab would be refunded for those patients who suffer a heart attack or a stroke while using the drug.
MedicalResearch.com: What are the main findings?
Response: In my research letter published in JAMA Internal Medicine, I simulate how much these refunds would reduce the price of evolocumab. I found that these refunds would barely reduce the price of evolocumab by 2%, and that PCSK9 inhibitors would still not be cost-effective. Moreover, I found that, based on the price after the application of these refunds, it would take over $1.5M to prevent one heart attack and almost $5M to prevent a stroke.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: The outcomes-based refunds suggested by Amgen would translate into a bare 2-3% reduction in the price of evolocumab. This discount is negligible compared to the current refunds that Amgen is offering payers for evolocumab (around 30-35%). Amgen´s announcement to engage in outcomes-based refunds can be considered a marketing strategy that would not translate into any significant price reduction and is far from making PCSK9 inhibitor therapy cost-effective.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Future research should evaluate outcomes-based contracts that are applied in lieu of the current industry discounts, and where manufacturers and payers bear a higher amount of financial risk.
MedicalResearch.com: Is there anything else you would like to add?
Response: Outcomes-based and value-based contracts have the opportunity to increase the efficiency of pharmaceutical spending (i.e. make sure that health care dollars are spent on drugs that are of value to those patients that take them), and to bring transparency to the negotiation of manufacturer-payer rebates. However, in negotiating these contracts, insurers will have to make sure that manufacturers bear a considerable financial risk, one that makes worth the administrative burden of the implementation of these contracts. Moreover, these types of contracts should not only reflect outcomes (i.e. the incidence of events that are related to lack of effectiveness or safety of the drug), but also the cost-effectiveness of the therapy under negotiation.
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