Independent CEPAC votes on value and subsequent policy roundtable discussion suggest that drug prices after rebates align well with added value for patients and therefore insurers should consider limiting or abolishing step therapy coverage policies

Boston, Mass., December 2, 2016– The Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report and Meeting Summary  on the comparative clinical effectiveness and value of targeted immunomodulators for treatment of moderate to severe plaque psoriasis.

“The evidence shows that targeted immunomodulators for patients with moderate to severe plaque psoriasis provide considerable improvement in quality of life and ability for people to function at work, in school, and in social activities,” noted Steven D. Pearson, MD, MSc, ICER’s President. “In addition, the net prices for these drugs after rebates are well aligned with the added value patients experience. As a consequence, it appears reasonable that insurers should provide more flexibility in coverage for these drugs, while at the same time it remains equally important that drug manufacturers avoid future price increases that would push more financial burden onto patients and health system budgets.”

The report reviews the evidence on the comparative clinical effectiveness of eight targeted immunomodulators and includes economic analyses to determine the value of the drugs in the short- and long-term. Economic analyses in this report rely on pricing information from SSR Health LLC, which uses publicly disclosed data on net dollar sales and volume information to estimate average prices after typical discounts and rebates.The report incorporates a summary of evidence votes taken during a public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC), as well as key policy implications stemming from discussion with a panel of patients, clinical experts, a major insurer, and a state Medicaid program. The report is accompanied by a Report-at-a-Glance document, which summarizes key points of the evidence review and economic model, value-based price benchmarks for each drug, voting results, and policy implications.Highlights of the meeting, as summarized in the Final Evidence Report, include:

Comparative Clinical Effectiveness and Value

The Council voted that the evidence was not adequate to distinguish among the different IL-17A drugs, but several head-to-head studies have demonstrated that IL-17A agents, along with the IL-12/23 inhibitor ustekinumab, provide increased net health benefit over etanercept. A majority of the Council also voted that all FDA-approved drugs under review represent an intermediate or high long-term value for money. This assessment of value accounts for numerous factors, including net health benefit, cost, benefits or disadvantages of the treatment, and other contextual considerations.

The Council’s votes highlight that the drugs provide significant clinical benefit for patients with moderate-to-severe plaque psoriasis, and that the prices of the drugs are well-aligned with the benefits they provide.

A more detailed review of the votes can be found in the full report.

Policy Implications

During the meeting, the Council discussed policy implications of their evidence votes with a panel of subject-matter experts, including patient, physician, and payer representatives.  Several key policy themes emerged from this discussion, with much of the conversation centering on issues of coverage and access for patients.  Among the key implications are the following:

  • Clinical societies and patient advocacy groups should work to update outdated treatment guidelines for patients with moderate-to-severe chronic plaque psoriasis to provide better precision on the therapies that are appropriate for specific patient subpopulations. In addition, updated guidelines should be produced in a form that is easy to understand and easy to use for patients, clinicians, and payers.
  • Purchasers and insurers should consider limiting or abolishing step therapy in coverage for targeted immunomodulators for moderate-to-severe plaque psoriasis, given that these treatments have good value relative to non-targeted treatments. If step therapy is used, allow new members who have recently switched insurers to bypass step therapy if they are already on an effective treatment, and remove requirements for patients to have higher out-of-pocket expenses for “later step” treatments.
  • Purchasers and insurers should base co-payment and/or co-insurance for therapies on net prices that account for discounts and rebates instead of list price.
  • Researchers and manufacturers should conduct research that directly compares real-world treatment options and sequential treatment effectiveness for both naïve and treatment-experienced patients. These groups should also work to generate additional information on the treatment durability of IL-17A agents.

A more detailed discussion of the recommendations can be found in the full report. The final report and the Report-at-a-Glance can be found on the ICER website.

  • Open Input Period: June 16, 2017-July 6, 2017
  • Draft Scoping Document Posted: July 10, 2017 
    • Public Comment: July 10-July 31, 2017 
  • Revised Scoping Document Posted: August 7, 2017
  • Draft Evidence Report Posted: November 14, 2017 
    • Public Comment: November 14, 2017-December 13, 2017 
  • Evidence Report Posted: January 11, 2018
  • Public Meeting: January 25, 2018
  • Final Report Posted: February 7, 2018

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.