Boston, Mass. And San Francisco, Calif., December 21, 2015 – The Institute for Clinical and Economic Review (ICER) has released two new reports titled Mepolizumab for the Treatment of Severe Asthma with Eosinophilia: Effectiveness, Value, and Value-Based Price Benchmarks and Insulin Degludec for the Treatment of Diabetes: Effectiveness, Value, and Value-Based Price Benchmarks. The reports offer a comprehensive review of currently available evidence on two new drugs that have triggered significant interest as potential advances in the care of patients with asthma and diabetes. Both reports will be subject to a public meeting of the California Technology Assessment Forum on February 12, 2016.
The ICER reports provide analyses of the clinical effectiveness, long-term cost-effectiveness, and potential budget impact of mepolizumab (Nucala®, GlaxoSmithKline) and insulin degludec (Tresiba®, Novo Nordisk). In addition, the results of these analyses are used to calculate a value-based price benchmark for each intervention. These price benchmarks reflect estimates of how much better the interventions are at improving patient outcomes, tempered by thresholds at which additional new costs would contribute to growth in health care costs exceeding growth in the overall national economy.
ICER concludes that the annual price of mepolizumab would need to be discounted 63-76% to be better aligned with value to patients and the health system while insulin degludec would need to be discounted less than 10% (well within the range of most negotiated discounts) to do so.
"Understanding the value of new drugs is critical," Steven D. Pearson, MD, MSc, the Founder and President of ICER noted. "By bringing our scientific approach to evaluating the effectiveness and value of new drugs, we are aiming to help the health care community determine what should be used, which patients benefit most, and at what price innovative treatments represent a reasonable value."
Mepolizumab (Nucala®, GlaxoSmithKline) is a once-monthly injectable to treat severe eosinophilic asthma that received FDA approval in November and is now available for administration in a doctor's office, with a price tag of $32,500 a year. Approximately 22 million US residents currently have asthma and approximately 5-10% of them have severe forms of the disease. Those with severe asthma are responsible for half of the estimated $50 billion that is spent on direct medical care for asthma each year.
ICER's analysis concludes that there is moderate certainty that adding mepolizumab to the current standard of care (steroids and other controller medications) provides a comparable or better net health benefit compared to standard care alone in patients with severe eosinophilic asthma. It achieves this benefit by significantly reducing the number of exacerbations of asthma symptoms and by reducing the need for oral steroids, which can be very toxic if taken at high doses for long periods of time. However, there is uncertainty about whether these benefits will persist over the long term because of the short duration of clinical trials for mepolizumab. The results of ICER's cost-effectiveness analysis show the price range based on widely-accepted cost-effectiveness thresholds ($7,787 to $12,116/year) is much lower than the actual list price for mepolizumab ($32,500/year). The draft ICER value-based price benchmark for mepolizumab, with all the assumptions detailed in the report, is $7,787 to $12,116 per year, which represents a 63-76% discount from the full list price ($32,500 per year).
Insulin degludec (Tresiba®, Novo Nordisk) is a long-acting insulin that patients with diabetes inject once per day. The drug was approved by the FDA in September and will be available in the U.S. in early 2016. Dosing is based on insulin needs and body weight; based on the profile of patients in the insulin degludec clinical trials, the list price per insulin unit is expected to translate to an annual cost of approximately $7,800/year. Approximately 6 million Americans with type 1 and 2 diabetes use insulin therapy as part of their treatment plan to control their blood glucose level.
ICER's analyses concluded that the evidence for the net health benefit of insulin degludec provides moderate certainty of equivalent glycemic control with a reduction in nocturnal hypoglycemia in comparison to other long-acting insulins like insulin glargine (Lantus®, Sanofi-Aventis US LLC) and insulin detemir (Levemir®, Novo Nordisk A/S). The draft ICER value-based price benchmark for insulin degludec is $7,006 to $7,154 per year. This represents an 8-10% discount from the average cost per year, which is well within the range of typical discounts available to payers.
The draft reports, as well as accompanying draft voting questions, will be open to public comment until January 12, 2016. Comments should be emailed to [email protected]. ICER will review all comments received and incorporate changes to the reports as necessary. Revised draft reports and voting questions will be posted on or about January 25, 2016. Guidelines for submitting public comments, including formatting specifications, are posted on the CTAF website.
The revised draft reports will be the subject of deliberation and vote at the next meeting of the California Technology Assessment Forum (CTAF) on February 12, 2016, in Oakland, California. During this meeting, the CTAF Panel will publicly deliberate on the evidence presented in the reports, vote on the effectiveness and value, and discuss the findings with a policy roundtable of experts to determine strategies to implement evidence-based recommendations that support effective coverage and use of these treatments. The meeting will be free and open to the public.
There will also a limited number of slots available for anyone wishing to make an oral comment on the reports during the in-person meeting. Requests to make an oral comment should be submitted to [email protected] by Thursday, February 5, 2016.
Date: February 12, 2016,
Location: Oakland, CA
Click here for meeting details.
Additional explanatory material is available on the ICER website:
ICER Rating System Overview [including Evidence-Based Medicine (EBM) matrix]
Frequently Asked Questions regarding the drug assessment program
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.