- A new report from the Institute for Clinical and Economic Review (ICER) found most currently available targeted immune therapies for rheumatoid arthritis to be priced above its thresholds for cost-effectiveness, despite substantial evidence proving the drugs' clinical benefit.
- AbbVie's market-leading Humira (adalimumab), for example, would require a discount of between 55% and 69% from its current wholesale acquisition cost (WAC) to meet ICER's value range of $100,000 to $150,000 per quality-adjusted life year, according to the final report's findings, which were published last week.
- Sufficient evidence exists to suggest with moderate certainty that two drugs, Roche's Actemra (tocilizumab) and Sanofi/Regeneron's experimental Kevzara (sarilumab), present an improved net health benefit over Humira monotherapy, ICER said.
Many of the world's top drugs are targeted immune modulators (TIMs) indicated for treatment of rheumatoid arthritis.
This broad class of newer drugs substantially improved upon older disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate, helping many patients better control disease symptoms and extending survival. Even so, the broad market opportunity — rheumatoid arthritis is estimated to affect between 1.3 and 1.8 million Americans — continues to draw drugmaker interest, with potential new entrants from the Sanofi/Regeneron team (sarilumab) and Eli Lilly (baricitinib) currently undergoing regulatory review.
In its report, ICER considered 11 TIMs, including those two experimental agents.
"Our analyses indicate that all the TIMs of interest in this evaluation substantially improved health outcomes compared to conventional DMARDs alone," ICER concluded in its report.
"However, their additional cost led to cost-effectiveness estimates that were well above commonly cited thresholds for cost effectiveness, and the discounts required to achieve these thresholds are greater than estimated current discounts from WAC."
In its conclusion, ICER suggested policy makers "may need to consider regulatory intervention" in order to ensure drug prices for TIMs don't continue to increase as they have in recent years.
Drugmakers from across the industry have sparred with ICER over its evaluations, frequently accusing the organization of failing to incorporate patient perspectives and attacking its use of benchmarks like quality-adjusted life years (QALY).
Amgen, for example, has criticized ICER's methodology, arguing its model "relies too heavily" on short-term trial data, thereby overestimating the effect of conventional DMARD therapy.
"The ICER rheumatoid arthritis report fails to fully capture the value of targeted immune modulators by using an outdated, one-size-fits-all economic model," the company said in an emailed statement.
ICER has responded forcefully in the past, publishing a point-by-point rebuttal of often-used criticisms last August. Additionally, the group recently revised its value-assessment framework, drawing on feedback and comments from payers, patient groups and the industry. This most recent report largely relied on the older framework while reviews that begin in 2017 will use the newer one.
Previous reports from ICER on treatments for hepatitis C, high cholesterol and multiple myeloma have found many top-selling brands to be overpriced compared to cost-effectiveness benchmarks.
Analyses such as these provide evidence-based fodder that payers and other stakeholders have seized upon to push back against the industry on pricing. Given the well-entrenched position of many TIMs in the market, the direct impact of ICER's report in the existing rheumatoid arthritis market may be more limited.
But its conclusions regarding Actemra and sarilumab could impact payer consideration of those drugs, or guide the pricing calculus of the Sanofi/Regeneron team and Eli Lilly for their respective experimental drugs, if approved by the FDA.