ICER Provides Policy Recommendations for Extended-Release Treatments for Opioid Use Disorder

— CAM2038 could reach fair value-based price if launched with annual price less than $5,300 —

BOSTON, December 3, 2018 – The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report and Report-at-a-Glance 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: Sublocade™ (Indivior) and CAM2038 (Braeburn), an investigational agent with an expected FDA approval decision later this month.

ICER’s report was reviewed at the November 2018 public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC), one of ICER’s three independent evidence appraisal committees. During the meeting, a majority of the panel found that the evidence is not adequate to demonstrate that any of these extended-release treatments provides superior net health benefit over buprenorphine/naloxone, nor is the evidence adequate to distinguish between the four extended-release treatments.

However, access to multiple treatment options for patients with opioid use disorder is a clinical and policy priority.  During their deliberation, panel members weighed the therapies’ other benefits and contextual considerations. The panel expressed concern that opioid use disorder can be particularly severe and can represent a high lifetime burden of illness. The panel underscored how the reduced complexity of Vivitrol, Sublocade, and CAM2038 may allow the successful treatment of many patients for whom other available treatments have failed, significantly improving patient outcomes. The panel also noted that less frequent dosing schedules and doctors’ visits could lead to improved patient privacy and reduced stigma.

Nevertheless, Probuphine, Vivitrol, and Sublocade are all far more expensive than buprenorphine/naloxone, and at their current prices each exceeds commonly cited cost-effectiveness thresholds. While there is no announced price yet for CAM2038, ICER calculated that a value-based price benchmark for the therapy would fall between $4,100 and $5,300 per year.

“Opioid use disorder is devastating American families and communities,” said David Rind, MD, ICER’s Chief Medical Officer. “While extended-release treatments could make it easier for some individuals to avoid relapsing back to uncontrolled opioid use, the available options are priced far beyond their incremental benefits. We are hopeful that the injectable CAM2038, slated for FDA approval in just a few weeks, is launched with a price that meets commonly cited cost-effectiveness thresholds, so that clinicians will have the flexibility to tailor the treatment of opioid use disorder to the needs of patients with the knowledge that those patients will have access to needed treatment.”

Key Policy Recommendations

Following the voting session, a policy roundtable of experts – including a clinician, patient advocates, and manufacturer and payer representatives – convened to discuss the implications of the evidence for policy and practice. Key recommendations stemming from the roundtable discussion include:

  • All stakeholders should strive to decrease the stigma around OUD and enhance awareness that it is a chronic disease that requires long-term treatment.
  • Manufacturers should align the price of these extended-release medications with their added benefits to patients, and once that is done, payers should make these treatments easier for patients to access.
  • Regulators and government policymakers should consider eliminating restrictions on prescribing extended-release treatments, and avoid legislative action favoring one OUD treatment over the others.

ICER’s detailed set of policy recommendations is available in the Final Evidence Report.

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.