Institute for Clinical and Economic Review Report Finds Extended-Release Treatments for Opioid Use Disorder Provide Only Marginal Benefits Over Generic Alternatives, at Significantly Higher Prices

— ICER report includes value-based annual price ranges for Probuphine, Vivitrol, and CAM2038 —

BOSTON, October 25, 2018 – The Institute for Clinical and Economic Review (ICER) today released an Evidence Report assessing the comparative clinical effectiveness and value of extended-release medications for the treatment of opioid use disorder. The report focuses on a buprenorphine implant (Probuphine®, Titan), an extended-release naltrexone injection (Vivitrol®, Alkermes), and two extended-release buprenorphine injections: CAM2038 (Braeburn), an investigational agent currently under FDA review, and Sublocade™ (Indivior).

“Opioid use disorder is devastating families and communities in the US,” said David Rind, MD, ICER’s Chief Medical Officer. “Extended-release medications have generated clinical interest because of their potential to improve individuals’ ability to remain in treatment. It is helpful to have multiple formulations available to be able to tailor treatment for each individual’s needs, but the findings of our analysis suggest that these extended-release formulations achieve at most marginal clinical benefits over generic buprenorphine/naloxone, and at far higher costs.”

This Evidence Report will be the subject of an upcoming public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC), in Newton, MA on November 8, 2018. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.

Key Findings

Evidence comparing Probuphine to buprenorphine/naloxone was determined to be inconclusive because the clinical trial population may not be reflective of the more general population being considered for these treatments. The report concludes that Vivitrol produces outcomes equivalent to those associated with buprenorphine/naloxone. Evidence on CAM2038 is still limited and can provide only moderate certainty that the treatment provides better clinical outcomes for patients than buprenorphine/naloxone. Finally, no judgment on the comparative effectiveness of Sublocade to buprenorphine/naloxone could be made because clinical trials have not directly compared the two.

ICER conducted economic analyses on the hēRo3℠ modeling platform to assess the long-term cost-effectiveness of the therapies compared to buprenorphine/naloxone. Even assuming a small clinical benefit with Probuphine, its current price exceeds commonly cited cost-effectiveness thresholds; its list price per implant of $4,950 would need to be discounted by 53%-65% to reach ICER’s value-based price benchmark range. Vivitrol’s value-based price is equivalent to the price for buprenorphine/naloxone since Vivitrol was assessed as producing equivalent outcomes. While there is no announced price yet for CAM2038, ICER calculated the treatment’s value-based benchmark price range to be between $4,100 and $5,300 per year. ICER did not calculate a value-based price for Sublocade because the evidence was viewed as insufficient to compare it to buprenorphine/naloxone.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.