— Expert roundtable suggests that lower prices, needed to align pricing fairly with the added value for patients, could result in broader patient access —

BOSTON, December 20, 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 biologic treatments for asthma associated with type 2 inflammation and/or allergic asthma. The report focuses on dupilumab (Dupixent®, Sanofi/Regeneron), omalizumab (Xolair®, Genentech/Novartis), mepolizumab (Nucala®, GlaxoSmithKline), reslizumab (Cinqair®, Teva), and benralizumab (Fasenra™, AstraZeneca). ICER previously reviewed mepolizumab for its use in severe eosinophilic asthma and dupilumab for its use in atopic dermatitis.

ICER’s report was reviewed at the November 2018 public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), one of ICER’s three independent evidence appraisal committees. During the meeting, the panel found that the evidence demonstrated dupilumab to be clinically superior to the standard of care, but that the evidence was insufficient to distinguish between dupilumab and the other biologics approved for asthma with an eosinophilic phenotype.

During their deliberation, panel members weighed the therapies’ other benefits and contextual considerations. They acknowledged the high burden severe asthma presents to patients, and that dupilumab is intended to care for patients with a condition of high severity and a high lifetime burden of illness. They pointed out that, with a different mechanism of action from the other biologics, dupilumab may allow for the successful treatment of many patients for whom other treatments have failed, which may also lead to increased overall productivity and decreased caregiver burden. Nevertheless, a majority of the panel felt that there is uncertainty about the long-term benefits and risks of dupilumab, citing the lack of long-term trial evidence.

All five biologic treatments would need price discounts of at least 50% to reach commonly cited thresholds for cost-effectiveness, and each of these therapies therefore is deemed to be “low value” based on ICER’s value assessment framework.

“While all five biologics modestly reduce asthma exacerbations and improve daily quality of life, the pricing of this entire therapy class is far out of alignment with the treatments’ incremental benefits,” said David Rind, MD, ICER’s Chief Medical Officer. “These therapies are all similarly priced, and a reduction in price of one or all of these agents would improve value and likely improve patient access.”

Key Policy Recommendations

Following the voting session, a policy roundtable of experts – including clinicians, 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:

  • To provide fair value to patients and the health system, manufacturers should lower the prices of biologic therapies for asthma so that they align with the added value they bring to patients.
  • Plan sponsors should work with payers to develop insurance coverage that makes an explicit commitment to providing streamlined access to all new biologic treatments for asthma if manufacturers price their products in line with independent assessments of added value to patients.
  • Given that manufacturers have not yet priced these biologics at a value-based level, payers are likely to offer preferential formulary status in return for lower prices. For many patients, the evidence is not adequate to determine which drug would be superior as a first option, therefore it is not unreasonable for payers to consider step therapy as a mechanism to achieve lower costs without harming patients.
  • Specialty societies should develop a clear definition of response to biologic therapy, and the FDA should update its guidance for the assessment of outcomes in asthma therapy to standardize the patient populations studied as well as the timing and instruments used to assess outcomes.

ICER’s detailed set of policy recommendations, including considerations for establishing prior authorization criteria, 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.