Boston, Mass. And San Francisco, Calif., March 14, 2016 – The Institute for Clinical and Economic Review (ICER) has released two final reports titled Mepolizumab (Nucala®, GlaxoSmithKline plc.) for the Treatment of Severe Asthma with Eosinophilia: Effectiveness, Value, and Value-Based Price Benchmarks and Insulin Degludec (Tresiba®, Novo Nordisk A/S) for the Treatment of Diabetes: Effectiveness, Value, and Value-Based Price Benchmarks. The reports evaluate the comparative clinical effectiveness and value of two new drugs, mepolizumab for treatment of severe asthma with eosinophilia, and insulin degludec for treatment of types 1 and 2 diabetes mellitus. The reports also include value-based price benchmarks for both drugs based on their long-term cost-effectiveness for patients and potential short-term budget impact on the overall health care system. The final reports incorporate a summary of the February 12, 2016 public meeting of the California Technology Assessment Forum (CTAF), during which an independent panel of experts in evidence review voted on key questions raised in the reports, and a policy roundtable discussed how best to apply the evidence to clinical practice and insurance coverage.
During the meeting, the CTAF Panel voted with near unanimity that current evidence is not sufficient to demonstrate a net health benefit associated with use of insulin degludec as compared to insulin glargine U100 (Lantus®, Sanofi-Aventis) for patients with type 1 diabetes and patients with type 2 diabetes using either a basal-only insulin regimen or a basal-bolus regimen. As a result of the Panel’s votes that evidence was insufficient to show a net health benefit, votes on value were not taken during the meeting. ICER’s analyses concluded that the value-based price benchmark for insulin degludec is $7,006 to $7,154 per year. This represents an 8-10% discount from a weighted average cost per year, which is well within the range of typical discounts negotiated by payers.
Following the Panel’s votes, a policy roundtable discussed the implications of the findings for policy and practice. Recommendations, which are detailed in the full report, provide guidance for stakeholders confronted with decisions about the use of insulin degludec. The recommendations include implementation of utilization management to regulate uptake of insulin degludec, development of policies to support improved access to basic diabetes testing and treatment supplies, consideration of relaxed HbA1c targets for patients with frequent hypoglycemia, and further research into the short- and long-term effects of hypoglycemia, including its effect on quality of life.
The CTAF Panel voted that for patients with severe eosinophilic asthma, the evidence is adequate to show that adding mepolizumab to standard care provides greater net health benefits than standard care alone. In considering the value of the drug, however, the Panel found that the addition of mepolizumab to standard care represents a low to intermediate care value and a low provisional health system value due to the drug’s high cost in relation to the clinical benefit it provides. ICER’s analyses found the value-based price benchmark for mepolizumab to be $7,787 to $12,116 per year, which represents a 63-76% discount from the full list price of $32,500 per year.
Recommendations for payers, patients, physicians, and manufacturers suggest use of prior authorization and clinical criteria to support access for patients most in need of this drug, optimization of therapy used in addition to mepolizumab, and additional research into the long-term effects of the drug.
A full summary of the policy recommendations is available in each of the final reports. The report on insulin degludec is available here, and the report on mepolizumab is available here. ICER has also produced a “Report At-a-Glance” to further distill the findings of the full report on mepolizumab. A similar summary will be available for the report on insulin degludec in the coming weeks.
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.