–Value-based price benchmarks for new IL-23 agents range from $25,000-$42,000 per year, which would require a discount of 37%-57% from the list price of guselkumab, the only drug in this group currently priced in the market —

BOSTON – June 12, 2018 – The Institute for Clinical and Economic Review (ICER) today released a condition update report assessing the comparative clinical effectiveness and value of targeted immunomodulators for the treatment of moderate-to-severe plaque psoriasis.

ICER previously reviewed treatments for plaque psoriasis in 2016. In addition to incorporating new clinical data and updated costs for previously reviewed therapies, this condition update includes analyses of the recently approved medications guselkumab (Tremfya®, Johnson & Johnson), tildrakizumab (Ilumya, Sun Pharma/Merck), and certolizumab pegol (Cimzia®, UCB), as well as risankizumab (AbbVie), which was recently filed for review by the FDA.

“Our 2016 review found that all targeted therapies for plaque psoriasis are more effective than non-targeted agents, and that many are priced in alignment with the added benefit they provide patients. As a result, we urged insurers to consider limiting or altogether abandoning step therapy requirements for these agents,” noted Dan Ollendorf, PhD, Chief Scientific Officer at ICER. “In this update, which also looks at several additional new therapies, we find again that the evidence demonstrates relatively minor differences in overall effectiveness across all targeted agents. However, following two years of price increases since our original report, all older therapies have become significantly less cost-effective. Unfortunately, the newest approved therapies have been launched at prices that have tracked this upward trend and are therefore similarly overpriced in relation to their clinical value to patients.”

This Evidence Report will be the subject of an upcoming public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) in Burlington, VT on July 12, 2018. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy. The Council will also review ICER’s upcoming report on treatment for endometriosis during this meeting.

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.

Key Findings

In assessing clinical evidence on the four newly-reviewed therapies, ICER found high certainty of a substantial net health benefit in comparison to placebo. In direct or indirect comparisons among active agents, ICER concluded the following:

  • There is insufficient evidence to distinguish the net health benefit between guselkumab and risankizumab
  • The net health benefit of tildrakizumab is only “comparable or inferior” to that of guselkumab and risankizumab
  • Two head-to-head trials have demonstrated that the net health benefit of guselkumab is “incrementally” better than that of adalimumab
  • The net health benefit of certolizumab pegol is “comparable or better” to that of etanercept, but “comparable or inferior” to that of adalimumab

Findings on the clinical effectiveness of drugs included in ICER’s 2016 review remains largely unchanged, except in comparisons of secukinumab to adalimumab and ustekinumab. In both instances, the evidence rating of secukinumab improved due to the emergence of new data.

ICER’s economic analyses found that, while some therapies fall within the commonly accepted range for cost-effectiveness of $50,000 to $150,000 per quality-adjusted life year (QALY), adalimumab, etanercept, certolizumab pegol, guselkumab, and ustekinumab exceeded the $150,000 per QALY threshold. Adalimumab, etanercept, and ustekinumab were found to meet this threshold in ICER’s previous review. While other therapies included in ICER’s 2016 review remained within the range for cost-effectiveness, many edged closer to the upper threshold. Neither tildrakizumab nor risankizumab was included in ICER’s model, as prices are not yet available for these agents.

In calculating value-based price benchmarks for the newest agents, ICER concluded that to align with the benefit provided to patients the price of certolizumab pegol would need to be discounted by 43%-63%, and the price of guselkumab would need to be discounted by 37%-57%.

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.