LETTERS TO THE EDITOR

Keep watching this watchdog

Posted

To the editor:

Food and Drug Administration regulators have approved more than 600 new medicines since the turn of the century. And more treatments are on the way. Scientists are currently developing more than 7,000 experimental drugs.

Unfortunately, one self-styled health care “watchdog” could significantly slow this research. The non-profit Institute for Clinical and Economic Review routinely analyzes the cost-effectiveness of new drugs. But the institute uses a flawed methodology that often finds cutting-edge, lifesaving medicines aren’t worth the price.

The institute wants the FDA to rely on those cost-benefit analyses when deciding whether to approve experimental drugs. And now, agency officials say they’re “receptive” to reviewing the institute’s data.

Any collaboration between our nation’s premier health safety regulator and the institute — an organization which seeks to put a price on human lives — would prove problematic for patients.

The health care watchdog claims to have patients’ best interests at heart, but its methodology suggests otherwise. The institute relies on an outdated, discriminatory benchmark known as “QALY” — or quality-adjusted life year.

This metric evaluates treatments’ cost-efficiency. If a medicine delivers one QALY, that means it offers one additional year of perfect health. The institute recommends that drugs not cost more than $175,000 for each QALY they deliver. And if a medicine fails to meet this criterion, the institute advises that insurers or government agencies not cover the treatment.

Already, governments in foreign countries flat-out deny certain treatments to patients based on QALY assessments. Consider the United Kingdom. Around one-in-six British cancer patients can’t access the drugs that their doctors recommend — all because British health regulators say the medicines aren’t sufficiently cost-effective. British regulators also recently blocked sales of a new cystic fibrosis treatment.

QALY assessments are bad enough for regular patients, but they’re even worse for Americans suffering from rare diseases. Here’s why. It takes $2.6 billion and up to 15 years to create a single new drug. Drug manufacturers normally recoup those costs by selling enormous quantities of medicines to large groups of people at relatively low prices. For example, about 35 million Americans take statins to treat high cholesterol. In many cases, each pill costs mere pennies.

But when medications are only purchased by a small handful of rare disease patients, companies have to charge higher prices to recoup their costs. Consequently, rare diseases drugs are often quite expensive — and thus score badly on value assessments. The clinical and economic review institute evaluated five rare disease drugs between December 2014 and 2018, and judged four of them “low value.”

The institute insists it wants to help patients and the FDA make more-informed decisions. The group has proposed hosting debriefing sessions with patient groups at the end of each cost-effectiveness review. Then, the institute and patients would co-write a letter to the FDA with tips for gathering more effective data in future clinical trials.

But the institute has spent years devaluing the lives of people with chronic illnesses and disabilities. Patients would be wise to think twice before trusting the organization to have their best interests at heart.

Kenneth Thorpe

The author is a professor of health policy at Emory University, and chair of the Partnership to Fight Chronic Disease.

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Kenneth Thorpe,

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