ICER Publishes Final Evidence Report and Policy Recommendations on Treatments for Obesity Management

— Independent appraisal committee voted that evidence is adequate to demonstrate that semaglutide provides a net health benefit compared to lifestyle modification alone; however, at current pricing, semaglutide represents “low” long-term value for money —

— Semaglutide would only achieve common thresholds for cost-effectiveness if priced between $7,500 – $9,800 per year after rebates —

— Payers establishing step therapy with less expensive or off-label medications should allow individuals to choose from multiple options and permit combination therapy —

BOSTON, October 20, 2022 – The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of subcutaneous semaglutide (Wegovy, Novo Nordisk), liraglutide (Saxenda, Novo Nordisk), phentermine/topiramate (Qsymia, Vivus Pharmaceuticals), and bupropion/naltrexone (Contrave, Currax Pharma) for the treatment of obesity.

ICER’s report on these therapies was reviewed at the September 2022 public meeting of the of the New England CEPAC (New England CEPAC), one of ICER’s three independent evidence appraisal committees.

Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, ICER’s Chief Medical Officer. “As such, obesity, and its resulting physical health, mental health, and social burdens is not a choice or failing, but a medical condition. The development of safe and effective medications for the treatment of obesity has long been a goal of medical research that now appears to be coming to fruition. With a condition affecting more than 40% of adults in the US, the focus should be on assuring that these medications are priced in alignment with their benefits so that they are accessible and affordable across US society.”

Voting on Clinical Effectiveness and Contextual Considerations

For adults without pre-existing diabetes and either a BMI ≥30 kg/m2 or ≥27 kg/m2 with at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes, or dyslipidemia):

All panelists (15-0) found that the evidence is adequate to demonstrate a net health benefit of semaglutide added to lifestyle modification compared to lifestyle modification alone.

All panelists (15-0) found that the evidence is adequate to demonstrate a net health benefit of liraglutide added to lifestyle modification compared to lifestyle modification alone.

A majority of panelists (14-1) found that the evidence is adequate to demonstrate a net health benefit of phentermine/topiramate added to lifestyle modification compared to lifestyle modification alone.

A majority of panelists (10-5) found that the evidence is adequate to demonstrate a net health benefit of bupropion/naltrexone added to lifestyle modification compared to lifestyle modification alone.

By votes ranging from 10-5 to 15-0, a majority of panelists found that the evidence is adequate to demonstrate a net health benefit of semaglutide compared to liraglutide, phentermine/topiramate, or buprioprion/naltrexone.

During their deliberations, panel members also weighed the therapy’s other potential benefits, disadvantages, and contextual considerations. Voting highlighted the following as particularly important for payers and other policymakers to note:

Magnitude of the lifetime impact on individual patients with obesity;

Patients’ ability to achieve major life goals related to education, work, or family life;

Society’s goal of reducing health inequities.

Voting on Long-Term Value for Money

Phentermine/topiramate and bupropion/naltrexone both meet commonly accepted cost-effectiveness thresholds when compared to lifestyle modification alone; both of these combination therapies are cost-saving when prescribed generically.  When used for weight loss among patients with obesity (and not treatment of diabetes), semaglutide does not meet typical cost-effectiveness thresholds at its current estimated net price, but it is more effective, less burdensome, and more cost effective than liraglutide.

At an annual net price of $13,618, semaglutide exceeds typical cost-effectiveness thresholds. ICER’s health-benefit price benchmark range for semaglutide is between $7,500 – $9,800 per year.

After reviewing the clinical evidence and considering the treatments’ other potential benefits, disadvantages, and contextual considerations noted above, the New England CEPAC evaluated the long-term value of semaglutide at its current pricing:

A majority (11-4) of panelists found that semaglutide added to lifestyle modification represents “low” long-term value for money.  

A majority (12-3) of panelists found that semaglutide added to lifestyle modification represents “low” long-term value for money when compared to phentermine/topiramate.  

Access and Affordability Alert

At semaglutide’s current net price, approximately 0.1% of the 142 million adult patients across the US with overweight or obesity eligible for treatment with semaglutide could be treated within five years without crossing the ICER potential budget impact threshold of $777 million per year.

ICER is issuing an access and affordability alert for semaglutide in the management of overweight and obesity.  The purpose of an ICER access and affordability alert is to signal to stakeholders and policy makers that the amount of added health care costs associated with a new service may be difficult for the health system to absorb over the short term without displacing other needed services, creating pressure on payers to sharply restrict access, or causing rapid growth in health care insurance costs that would threaten sustainable access to high-value care for all patients.

Key Policy Recommendations:

ICER’s independent assessment of value informs the critical decisions that stakeholders across the US health system need to make around pricing and coverage. Following the voting session, a policy roundtable of experts — including clinical experts, patient advocates, and representatives from US payers — convened to discuss the pricing implications and recommendations to ensure fair access.  Key recommendations stemming from the roundtable discussion include:

Payers may consider step therapy, particularly given that the more expensive options are not priced at a cost-effective level, and failure to reach clinical goals with a first-step option should not lead to irremediable harm.  However, payers should only use step therapy when they have designed it to provide adequate flexibility to meet the needs of diverse individuals and when implementation can meet high standards of transparency and efficiency.   

Manufacturers should set prices that will foster affordability and good access for all patients by aligning prices with the patient-centered therapeutic value of their treatments.  Medication pricing at launch should also be moderated until additional evidence is generated to demonstrate long-term safety and reductions in adverse cardiovascular outcomes.

Patient organizations have a vital role to play in promoting the dissemination of objective information about new therapies for obesity to individuals and clinicians in order to support shared decision-making.  In addition, patient groups have a powerful voice and should apply it to create significant pressure for fair pricing and appropriate payer coverage across all sectors of the health system.

ICER’s detailed set of policy recommendations, including comprehensive considerations for establishing evidence-based prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.

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.