I read with interest the articles in the June issue of The Rheumatologist pertaining to high drug costs. Simon Helfgott rheuminated on it, and Susan Bernstein, a medical journalist, wrote a two-page article titled “Concerns About Cost.” Both articles were thoughtful summaries of a complex issue, putting large question marks over both initial prices and subsequent steep price increases of biologics and other targeted therapies.
Therefore, it comes as a big disappointment that the publication of ICER’s report on the cost effectiveness of this class of drugs is met with such disapproval (“RA Treatment: ICER releases final report on targeted immune modulators”). The report unequivocally confirms that biologics are not cost effective at the current price levels, despite their (also unequivocally) beneficial treatment effects. This is not a surprise, but a confirmation of earlier research: only industry-sponsored studies have suggested otherwise. What could be better than to use this report as a weapon, a call for action to get industry to moderate their prices?
Instead, rheumatologists, the ACR and patient advocacy organizations appear to have chosen to attack the report itself for “flawed methodology.” An interesting tactic against a highly respected institute that employs state-of-the-art methodology. The most curious comment in the article: “The ICER report is basically flawed in that the methodology and analysis do not cohere with the ACR and EULAR guidelines on treatment with targeted immune modulators [TIMs].” The physician quoted appears to suggest the methodology and analysis involved in writing guidelines is of higher quality than a formal meta-analysis and cost-effectiveness analysis. Curious indeed, given current guidelines are still largely based on expert opinion given lack of evidence, such as provided by the ICER report, and the fact that these guidelines offer little in terms of cost-effectiveness considerations.
One of the people interviewed for the article acknowledged the flaws, specifically questioning the representativeness of the patients in the studies compared with the true RA population. It is true that patients in the large registration studies are atypical (i.e., they have a much more active, severe and often therapy-resistant disease than patients seen in common practice). Unfortunately, this makes the real cost effectiveness of TIMs even worse: less severe patients are more amenable to cheaper (non-TIM) therapy and start off in a better condition. This means there is less room to improve, fewer QALYs to gain, so the cost per QALY goes up.
The concern appears to be that the ICER report will be used by insurance companies to limit access to these therapies, potentially leading to suboptimal treatment. This is indeed a huge concern, not only for RA patients, but all patients with a disease for which treatment costs have ballooned out of any reasonable proportion: cancer, hepatitis C and even gout.