— Policy recommendations repeat call for insurers to minimize step therapy requirements on these treatments that are priced in alignment with clinical benefits, but cautions manufacturers against the ongoing price increases that are beginning to threaten the cost-effectiveness of entire therapy class —
Boston – August 3, 2018 – The Institute for Clinical and Economic Review (ICER) today released a Final Condition Update report and Report-at-a-Glance on targeted immunomodulators for the treatment of moderate-to-severe plaque psoriasis. ICER first reviewed treatments for plaque psoriasis in 2016. This update incorporates new clinical data and cost information for previously reviewed therapies, and includes analyses of more recently approved medications guselkumab (Tremfya®, Johnson & Johnson), tildrakizumab (Ilumya™, Sun Pharma/Merck), and certolizumab pegol (Cimzia®, UCB), as well as risankizumab (AbbVie), which is currently being reviewed by the FDA.
ICER’s condition update report was reviewed at a July 2018 public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC), one of ICER’s three independent evidence appraisal committees. During the meeting, the New England CEPAC voted that, compared to TNFα inhibitors, both guselkumab and risankizumab offer a superior net health benefit based on currently available evidence. The Council further voted that evidence was not adequate to show a net health benefit of tildrakizumab compared to TNFα inhibitors, or of the TNFα inhibitor certolizumab pegol over the other subcutaneously-administered TNFα inhibitors (adalimumab and etanercept).
“Similar to the findings of our 2016 report, we again found that many targeted therapies offer benefit over non-targeted therapies, and we are able to further clarify which agents may be most effective,” noted Dan Ollendorf, PhD, ICER’s Chief Scientific Officer. “While many of these therapies currently represent reasonable value, patients continue to face insurance barriers that interfere with their access to these potentially life changing therapies, and recent price increases for many agents may further limit access. Insurers should work to expand access to therapies that are priced in accordance with their clinical benefits, and manufacturers must be transparent about the rationale behind any future price increases.”
In addition to clinical benefits, Council members noted that these new therapies appear to reduce complexity of care, reduce caregiver or family burden, improve ability to return to work or other activities, and use a novel mechanism of action, meaning that the newer treatments may be effective in patients for whom other therapies have failed.
A majority of the Council judged that guselkumab offers an intermediate long-term value for money compared with non-targeted therapy. Certolizumab pegol was found to offer a low long-term value for money, based on its high price and lack of evidence suggesting that it is superior to other therapies in its class; however, Council members noted that it is an important option for women who are pregnant or breastfeeding given evidence regarding its safe use for those individuals.
Recommendations from ICER’s 2016 report were updated based on a moderated discussion of the New England CEPAC, informed by input from a clinical expert and a patient advocate representative. ICER’s updated policy recommendations include the following:
- Insurers should consider limiting or abolishing step therapy approaches to coverage. Despite reasonable cost-effectiveness for many of the agents, step therapy continues to be the dominant approach among most insurers, and patients and clinicians reiterate that it delays improvements to patients’ quality of life. ICER points to Express Scripts as a potential best practice in coverage, noting that leaders say they have sought to renegotiate contracts with the manufacturers of all targeted immunomodulators with a psoriasis indication, the goals being to eliminate all step therapy for treatment of a psoriasis diagnosis and establish a formulary with an equal co-payment structure for all drugs for treating psoriasis.
- If step therapy must be used, ICER’s report includes policy examples that may ease patient burden, such as allowing individuals switching to a new insurer to bypass step therapy if they are already using an effective treatment and removing requirements for higher out-of-pocket costs for “later step” treatments.
- Manufacturers should foster transparency in the rationale for price increases, including new clinical evidence, improvements in therapy delivery or tolerability, or other considerations.
Additional policy implications, as well as more detailed discussion of the implications, are available in ICER’s Final Report.
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.