Deepak L. Bhatt
CHICAGO — The PCSK9 inhibitor alirocumab was cost effective up to $6,319 per year at a willingness to pay threshold of $100,000, according to an economic analysis of the ODYSSEY OUTCOMES trial presented at the American Heart Association Scientific Sessions.
As Cardiology Today previously reported, reducing LDL to very low levels with alirocumab (Praluent, Sanofi and Regeneron) lowered risk for major adverse CV events and all-cause mortality in patients with ACS on statin therapy. The full results from the ODYSSEY OUTCOMES trial were published on Nov. 7 in The New England Journal of Medicine.
In the ODYSSEY OUTCOMES trial, 18,924 patients with ACS who were on a high-intensity or maximally tolerated dose of atorvastatin or rosuvastatin were assigned alirocumab or placebo every 2 weeks, Deepak L. Bhatt, MD, MPH, professor of medicine at Harvard Medical School, executive director of interventional cardiovascular programs in the Heart and Vascular Center at Brigham and Women’s Hospital and Cardiology Today’s Intervention Chief Medical Editor, said during the presentation.
The primary endpoint was the time to first occurrence of nonfatal MI, CHD death, ischemic stroke or unstable angina that required hospitalization. Secondary endpoints included CV and all-cause death. Follow-up was conducted for a median of 2.8 years.
In the current study, researchers analyzed the diagnosis-related group cost based on Medicare, which was applied to CV death and recurrent nonfatal events including ischemic stroke, MI, unstable angina requiring revascularization and coronary revascularization.
The costs from reimbursement rates that were used in this analysis were the following:
- $18,862 for nonfatal MI without revascularization,
- $12,617 for nonfatal ischemic stroke, and
- $39, 531 for ischemia-driven coronary revascularization or unstable angina.
Other information that was considered included long-term survival probability, health-related quality of life and treatment effect.
The HR in the intention-to-treat population for alirocumab vs. placebo was 0.85, 0.71 for patients with LDL ≥ 100 mg/dL and 0.95 for those with an LDL less than 100 mg/dL.
Compared with the annual event rate per 100 patient-years for patients assigned placebo, those assigned alirocumab had a lower annual event rate per 100 patient-years for CV death (0.89 vs. 1.01), nonfatal MI (3.2 vs. 3.69), nonfatal ischemic stroke (0.44 vs. 0.62), unstable angina (0.14 vs. 0.24) and ischemia-driven coronary revascularization (3.19 vs. 3.7).
The annual price of alirocumab to be cost effective was $100,000 per quality-adjusted life year for the population with a $6,319 base case in the intention-to-treat population. In addition, the annual price for the drug to be cost-effective for a patient with baseline LDL ≥ 100 mg/dL was $13,357 and was $2,083 for those with a baseline LDL less than 100 mg/dL.
The cost effectiveness of alirocumab was less in patients with a baseline LDL less than 100 mg/dL compared with those with an LDL greater than 100 mg/dL in the overall intention-to-treat population regardless of the willingness to pay, according to the researchers.
“Based on both absolute clinical benefit and cost-effectiveness, alirocumab may offer good value in patients with a history of ACS and LDL cholesterol greater than or equal to 100 mg/dL despite maximally tolerated statin therapy,” Bhatt said during the presentation.
Andrew E. Moran
“We need to see how patient perspectives and preferences and patient-level costs factor into this cost effectiveness,” Andrew E. Moran, MD, assistant professor of medicine at Colombia University Medical Center, said during the discussant portion of the presentation. “It could be that the patients taking a medication every other week increases their convenience and they might prefer it to taking a daily pill. On the other hand, taking injections might be something that patients are averse to.”
Results from this study may affect both patients and clinicians, experts said.
“[The ODYSSEY OUTCOMES Economics Study] is going to have a great effect,” Robert Sanchez, PhD, senior director of health economics and outcomes research for Regeneron, told Cardiology Today. “The cost-effective price at the $100,000 willingness to pay threshold is $6,000 per year. However, if you limit it to those who had a baseline LDL-C of greater than 100 [mg/dL], the cost-effective price jumps up to about $13,500 per year,” “That falls well within the current rebate structures that we offer in the United States.”
“When I look at the patients with the LDLs above 100 [mg/dL], these are some of the patients that concern me the most as a cardiologist,” Jay Edelberg, MD, head of CV development for Sanofi, said in an interview. “I’ve had a lot of patients who’ve had events in whom I can’t get their LDL under control, and they have not just another event, but recurrent events. Now we have a treatment that can really get these patients under control.” – by Darlene Dobkowski
Bhatt DL, et al. LBS.01 – Late Breaking Clinical Trial: Answers to Critical Questions in Cardiovascular Prevention. Presented at: American Heart Association Scientific Sessions; Nov. 10-12, 2018; Chicago.
Disclosures: The ODYSSEY OUTCOMES study was funded by Sanofi Aventis and Regeneron. Bhatt reports he has financial ties with numerous drug and device companies, including receiving research funding from Regeneron and Sanofi. Moran reports no relevant financial disclosures. Edelberg is an employee of Sanofi. Sanchez is an employee of Regeneron.