Amgen’s Response to ICER’s Background and Draft Scoping Document: “Treatment Options for Plaque Psoriasis: Effectiveness, Value, and Value-Based Price Benchmarks”
Moderate-to-Severe Psoriasis is a Serious and Disabling Disease
The skin is the largest organ in the body, subject to severe disease like any other organ system. In contrast to mild disease usually associated with the term “psoriasis”, moderate-to-severe psoriasis is a chronic, systemic inflammatory disease associated with widespread and skin involvement, significant comorbidities, and crippling lifelong physical, economic, emotional, and social consequences.1 Effective treatment for patients with this disease is often life-altering2 in ways that clinical trials fail to capture. These effects must be captured in ICER’s assessment of value to avoid the continued trivialization of serious skin diseases.
To understand the profound impact that moderate-to-severe psoriasis has on patients, ICER will need to pay special attention to patient-derived data. The meta-analysis of short-term clinical trials for ascertaining disease outcomes will grossly understate the value of long-term disease control. We strongly recommend that ICER incorporate alternative outcomes estimates into one or more analyses. For example, at least one set of analyses must consider the economic and productivity components of disabling disease, starting with patient experiences like those captured in the National Psoriasis Foundation survey data.3,4
The literature is replete with economic analyses of the impact of severe diseases on educational and career attainment, social interactions and structures, and comorbid conditions such as anxiety and depression (e.g. a “human-capital” approach).5 ICER must use these data in modeling and as “additional considerations” when evaluating the value of treatment for moderate-to-severe psoriasis in order to avoid profound underestimation of the cost of this condition. Lifetime expected utilities should expand beyond the usual clinical-symptom relationship to the value of enabling patients to lead near-normal lives. Economic analyses should reflect the ability of patients with successful treatment outcomes to participate more fully in the national economy. Early patient involvement in a “human-capital” approach will enhance the credibility of such analyses.
Meta-analysis Best Performed by Class
Should ICER choose to perform short-term network meta-analysis, confounders such as dissimilar clinical trial designs for many endpoints and data collection time points will need to be considered and controlled for. To increase the power of the meta-analysis and answer the most relevant questions, we strongly suggest that ICER combine data for each treatment class (e.g. PDE-4, anti‑TNFs, IL-17As, IL 12/23s) rather than perform a drug-by-drug analysis within each class. Within class analyses are extremely limited as no US, no multicenter, and no high quality head‑to-head studies have ever demonstrated the superiority of one agent relative to another within a psoriasis drug class.6
Budget Impact Should be Incremental
Finally, many treatments have been approved for years, but uptake rates remain low: on the order of 20%. ICER must take this low real-world uptake into consideration. We suggest that ICER realistically estimate the change in drug uptake trajectory that might occur with the entry of the new agents. For example, extrapolating uptake to increase from 20% to 24% without new classes, and to increase 20% to 28% with new classes, means that budget impact should be based on the incremental change (4% in this example).
Ongoing Regulatory Assessment
The ongoing regulatory inquiry into the potential risk: benefit profile of antipsoriatic agents raises questions as to the appropriateness of the timing of this review.
- Korman et al. Relationship between psoriasis severity, clinical symptoms, quality of life and work productivity among patients in the USA. Clin Exp Dermatol. 2016;41:514-521.
- Augustin and Radtke. Quality of life in psoriasis patients. Expert Rev Pharmacoecon Outcomes Res. 2014;14:559-568.
- Rapp et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41:401-407.
- Edson-Heredia et al. Disease burden and quality of life in psoriasis patients with and without comorbid psoriatic arthritis: results from National Psoriasis Foundation panel surveys. Cutis. 2015;95:173-178.
- Mustonen et al. Psoriasis causes significant economic burden to patients. Dermatol Ther. 2014;4:115-124.
- Nast et al. Efficacy and safety of systemic long-term treatments for moderate to severe psoriasis: a systematic review and meta-analysis. J Invest Derm. 2015;135: 2641-2648.