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Refunds unsuccessful in improving cost-effectiveness of PCSK9 inhibitors
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Outcomes-based pricing for PCSK9 inhibitors marginally improved the cost effectiveness of the therapy for patients with atherosclerotic CVD, according to a study published in the Annals of Internal Medicine.
“Although outcomes-based pricing may have a role in other settings, our analysis of its application to PCSK9 inhibitors — effective preventive medications with a high price tag — shows the potential limitation of this approach for high-cost preventive therapies,” Dhruv S. Kazi, MD, MSc, MS, associate professor of medicine at University of California, San Francisco School of Medicine, and colleagues wrote.
Therapy for atherosclerotic CVD
Researchers estimated the cost-effectiveness of PCSK9 inhibitors of 8.9 million patients aged 40 years to 84 years using the Cardiovascular Disease Policy Model. Patients in this study had atherosclerotic CVD and LDL of at least 70 mg/DL with statin therapy. The researchers compared baseline statin therapy with the addition of ezetimibe vs. baseline statin therapy with the addition of a PCSK9 inhibitor.
The primary outcome was incremental cost-effectiveness ratio, which investigators calculated with incremental health care costs from 2017 per quality-adjusted life-year gained, and a willingness-to-pay threshold of $100,000 per quality-adjusted life-year.
Data from the FOURIER trial of evolocumab (Repatha, Amgen) was used as a model for the effectiveness of PCSK9 inhibitors. As Cardiology Today previously reported, patients who reduced their LDL levels below 0.2 mmol/L with evolocumab had a reduced risk for recurrent CV events.
Compared with patients taking ezetimibe with statin therapy, those taking a PCSK9 inhibitor with a statin and did not receive a refund had an incremental cost-effectiveness ratio of $324,000 per quality-adjusted life-year. Incremental cost-effectiveness ratios were greater than $100,000 per quality-adjusted life-year after a manufacturer refunded either drug costs for 1 year, drug costs with inpatient costs for stroke or MI or all drug costs accrued before the event.
Drug cost refunds
After a manufacturer refunded drug costs with inpatient costs for stroke or MI, patients taking a PCSK9 inhibitor with statin therapy had a 3.1% improvement of their incremental cost-effectiveness ratio.
Results were similar when drug prices were based either on the Federal Supply Schedule or generic pricing.
“Broad use of PCSK9 inhibitors among the 8.9 million U.S. adults with ASCVD who met trial criteria would substantially increase drug expenditures nationally,” Kazi and colleagues wrote. “Outcomes-based pricing would not reduce this effect. Although we did not examine other eligible populations, the similarity in event rates and the cost-effectiveness of PCSK9 inhibitors in patients intolerant of statins or with heterozygous familial hypercholesterolemia suggests that results would probably be similar.”
“Paying for evolocumab only when it works also poses a conceptual problem because [it] is a preventive drug,” Sham Mailankody, MBBS, medical oncologist and hematologist at Memorial Sloan Kettering Cancer Center in New York, and Peter B. Bach, MD, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, wrote in a related editorial. “One may accept the tenuous premise that, if a patient had a heart attack, evolocumab did not work and thus the patient should not pay for it. However, it does not mean that, if a patient did not have a heart attack, the agent did work and thus the patient should pay for it. As such, the inverse has been mistaken for the contrapositive. Preventive interventions are ever thus: They benet only a few who receive them, and we nearly never know who those persons are.” – by Darlene Dobkowski
Disclosures: Kazi reports no relevant financial disclosures. Mailankody reports he received grants from Juno Therapeutics and Takeda Oncology and personal fees from Seminars in Oncology. Bach reports he received personal fees from Novartis plus numerous insurance companies, financial companies and professional societies, and grants from the Kaiser Foundation Health Plan, Laura and John Arnold Foundation and the NIH. Please see the study for all other authors’ relevant financial disclosures.
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