At its July 15th meeting on obeticholic acid, members of the Comparative Effectiveness Public Advisory Council (CEPAC), myself included, were publicly criticized by patient advocates. It was painful to hear our efforts erroneously characterized as misguided, our motivations as corrupt, and our views as distorted. Much of what was said reflected misunderstandings about CEPAC and its parent organization, the Institute for Clinical and Economic Review (ICER).
Today, in a post on its website, ICER fired back, dispelling some of the more widely circulated myths about its work. I recommend you read the whole thing, but if you’re pressed for time, what follows is a summary of just some of its content.
Myth: ICER was founded by, is largely funded by, and does the bidding of health insurers.
Truth: Nope. ICER’s funding is publicly available.
Today, ICER receives 70% of its funding from non-profit philanthropic foundations, the largest source being the Laura and John Arnold Foundation, and no funder influences our research findings or even what drugs we choose to evaluate. Non-profit foundation support is used to support all of ICER’s reports and public meetings. For an annual Policy Summit meeting and evidence policy webinar program, ICER receives funding equivalent to 17% of overall support from pharmaceutical companies and only 9% from health insurers. Support from state contracts contributes the remaining 5% of overall funding.
Myth: ICER ignores patients’ perspective.
Truth: Nope. Not only does the organization invite patients to participate in its deliberative process, patients’ point of view is explicitly part of its publicly available assessment framework.
The ICER framework also includes categories called “additional benefits” and “contextual considerations” that are meant to be able to capture elements of value of importance to patients and their families that might not be included in the “clinical” literature. Issues such as whether patients have had any other reasonable treatment options in the past, sites of care, ease of administration, impact on work and family life – all are given a formal place in the ICER framework and our reports have sections filled with the insights (and data when possible) provided directly by patients and patient groups.
Myth: ICER’s use of quality-adjusted life years (QALYs) devalues the lives of people with serious conditions.
Truth: Nope. This point of view reflects a deep misunderstanding of how QALYs enter into ICER’s methodology, as well as a lack of knowledge of the additional steps ICER takes to safeguard its analysis — as best it can — from known problems with QALYs.
[T]he QALY measures relative improvement from wherever patients start out. If the treatment is one to help patients who have a stroke achieve better functioning, the improvement in quality of life is not discounted in any way just because patients start out with a lower quality of life than someone in perfect health. In fact, starting out with a lower quality of life, whether through a serious illness or disability, offers more “room” for improvement, giving treatments for patients with serious conditions more opportunity to show improvement compared to treatments for patients whose baseline condition is already near perfect health.
Myth: ICER wants to shift money away from caring for patients and toward other uses, like fixing potholes.
Truth: Nope. ICER has no such motivation. It offers public forums to transparently discuss the trade-offs inherent in allocating resources. As such, one cannot ignore that we also use resources to fund highly valued things like education, public safety, national defense, and, yes, fixing potholes.
This is one of the more remarkable and malicious mischaracterizations of our intentions. […] If the shared hope is to be able to provide innovative drugs for all patients with serious illness, and to be able to also afford good education for our children and other services, then we believe that transparent discussions about whether prices for drugs and other health care services are reasonably aligned with the value they bring to patients are an important way to help us get there.
Myth: The only outcome of ICER’s work is to help insurers restrict coverage to the best (if expensive) medications.
Truth: Nope. First of all, insurers will act to restrict coverage of expensive medications (e.g., through tiered formularies, step therapy, prior authorizations, etc.) whether ICER exists or not. But, without ICER and similar organizations, they’re more likely to do so in a manner that only reflects price, and not patient benefits. Second, ICER does not always find that drugs are of low value (at current prices). Some are high value, and ICER says so.
ICER’s purpose is to stimulate a public discussion of these questions, and we do not believe that the right answer is to restrict access to innovative medicines for patients who are likely to benefit. Patients already suffer restrictions to access when drug prices are too high for them to afford, and our goal is to provide a way to get to a “win-win-win” outcome where price is aligned with value, access is broad, clinical use targeted and appropriate, and new investments in future innovation assured.
Much more at the link, including a defense of the charge that ICER’s work will stifle innovation. You should read it all.