ICER Report on Immunomodulator Drugs for Plaque Psoriasis Finds Average Discounted Prices Well-Aligned with Added Clinical Benefits for Patients

Report will be subject to public deliberation at New England Comparative Effectiveness Public Advisory Council meeting on November 18^th

Boston, Mass., November 4, 2016 – The Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of eight targeted immunomodulatory drugs for the treatment of plaque psoriasis.  This Evidence Report will be the subject of the upcoming public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) on November 18, 2016.  The report shows that there is limited evidence for distinguishing the relative effectiveness of many of these drugs, but all offer added benefits for patients for whom topical and non-targeted systemic therapies have proven unsuccessful.  ICER’s report was able to access and use information on the average prices of these drugs net of negotiated rebates in the US market. Assuming these discounted prices, the Evidence Report estimates that the additional overall costs for treatment with immunomodulatory drugs are reasonably aligned with the added benefits they provide to patients.

“Few head-to-head trials have been done to compare newer, targeted immunomodulators for plaque psoriasis, and even the trials that have been done often fail to capture all the outcomes that really matter to patients,” noted Steven D. Pearson, MD, MSc, President of ICER.  “That being said, our analyses suggest that current market competition has led to discounts for these drugs that makes their net price low enough to be in reasonable proportion to the improvement these drugs bring to patients’ lives. This is promising because when prices for drugs do meet standards for reasonable long-term cost-effectiveness, we can expect better access to these treatments, better health outcomes, and overall costs that translate into more affordable care for patients now and in the future. We look forward to the public meeting at which these findings will be debated with further input from patient groups, clinical experts, manufacturers, insurers, and others.”

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report reflects changes made based on comments received from patient groups, clinicians, the manufacturers of the drugs, and other stakeholders.

The ICER report reviewed the following agents:

Anti-TNF

• Adalimumab (Humira®, AbbVie, Inc.)
• Etanercept (Enbrel®, Amgen, Inc.)
• Infliximab (Remicade®, Janssen Biotech, Inc.)

IL-17A

• Secukinumab (Cosentyx®, Novartis Pharmaceuticals)
• Ixekizumab (Taltz®, Eli Lilly and Co.)
• Brodalumab (investigational, Valeant Pharmaceuticals International, Inc.)

IL-12/23

• Ustekinumab (Stelara®, Janssen Biotech, Inc.)

Phosphodiesterase (PDE)-4

• Apremilast (Otezla®, Celgene Corporation)

Key Findings of the Evidence Report

Findings from placebo-controlled trials indicated a substantial net health benefit of all therapies as compared to placebo. Between-agent comparisons were completed using a combination of direct and indirect evidence, including head-to-head trials and a network meta-analysis.  Overall, the ICER review concluded that newer agents targeted against the inflammatory factor IL-17a produced better outcomes than the older, anti-TNF drugs.  Further, the economic analyses performed by ICER looking at the long-term value for money resulted in incremental cost-effectiveness ratios across all of the agents well-aligned with commonly-accepted thresholds for cost-effectiveness (range: $89,610 – $129,904/quality-adjusted life year).  And finally, the potential budget impact of two agents – ixekizumab (approved in March 2016) and brodalumab (not yet approved) – was calculated and neither agent is expected to pose a challenge to health system budgets.

To better reflect real-world practice, ICER applied an average discount to the wholesale acquisition cost (WAC) for each drug class to arrive at an estimated net price for use in the cost-effectiveness analyses. The drug discounts were determined from information on net pricing provided by SSR Health. The full report includes more information on the cost-effectiveness ratios, including calculations that use WAC, as well as more detail on the methods and results of the entire comparative clinical effectiveness and comparative value analyses.

ICER is committed to a transparent public engagement process to ensure that all stakeholders have the opportunity to provide input to the reports and public meetings. As noted above, after ICER’s Draft Evidence Report was released on September 29th, interested stakeholders had a four-week period to provide comments. ICER staff considered these comments and made revisions to the report as needed. The Evidence Report, as well as the accompanying voting questions, public comments, and ICER’s written response to comments, are available on the ICER website.

The Evidence Report will be the subject of the November 18^th public meeting of the New England Comparative Effectiveness Public Advisory Council  during which the independent Council will vote on key questions raised in the report, and a policy roundtable of experts will discuss recommendations to apply the evidence to policy and practice. During the meeting, a limited amount of time will be available for pre-registered stakeholders to provide a brief oral comment on the report. Requests to make an oral comment were accepted during the public comment period on the Draft Evidence Report.

Registration for the in-person meeting is open here. Registration for a live webcast of the meeting is open here.

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