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.
In the U.S., this problem is solved by increasing co-payments and access hurdles for the insured and accepting that a large part of the population is not insured, so in effect has no access at all. In the rest of the civilized world with population health insurance and regulated pricing, the situation is better, but nevertheless society increasingly faces problems to decide where its money is best spent. Given slow or no economic growth, total expenditures are more or less fixed if the deficit is not allowed to grow, so increases in the total healthcare budget will displace other societal expenditures. If the total healthcare budget is not allowed to grow, drug expenditures will displace other necessary health expenditures.
Industry continues to make huge profits from TIM sales. Despite all protestations regarding the high cost of drug development, profits of Big Pharma are up, not down, and your stock broker will advise you to buy their shares. Rheumatologists, professional societies and patients have hugely benefited from the spinoff of the high prices of TIMs: large amounts of money flow to grants and investigator-initiated research, industry roundtables, consultancy fees and support for patient organizations. I’m afraid this has made us look away from the simple, inconvenient truth: prices for these drugs are way too high.
Rather than criticizing research that confirms this, we as rheumatology professionals have a responsibility to help bring the prices down. If they remain at this level, society is better off spending its money elsewhere, to the detriment of our patients.
Maarten Boers, MSc, MD, PhD
Professor of Clinical Epidemiology
Department of Epidemiology and Biostatistics
VU University Medical Center
Amsterdam, The Netherlands
The ACR Replies
We sincerely appreciate the thoughtful comments from Dr. Boers regarding the ACR’s response to ICER’s report on rheumatoid arthritis drugs. We agree that drug prices are too high, and as outlined in our newly revised position statement on Comparative Effectiveness Research, the ACR lauds research efforts to understand which drugs provide the greatest benefit at the lowest cost to patients. Dr. Boers is correct when he states that the potential for misuse of ICER’s report by insurance companies is a “huge concern”: Both government and third-party payers in the U.S. have a long history of enacting policies that delay and impede patient access to medically necessary treatments while patients’ out-of-pocket expenses continue to rise. We also agree with Dr. Boers that, as rheumatology professionals, we have a responsibility to help bring prices down. The ACR has numerous initiatives in this regard, including our Patient Access to Treatment Act (PATA) that has recently been reintroduced in Congress. That said, our proximate concern remains the welfare of our patients, which is threatened by uneven access to life-changing medications. So while the ACR continues its long-term efforts on multiple fronts to reduce drug costs and improve access to care, we remain vigilant for dangers that interfere with our ability to provide optimal care for our patients.