As drug prices continue to rise, patients with disabilities, chronic conditions or diseases and mental illnesses suffer the most, as drugs treating their conditions already tend to be much more expensive and much less likely to be covered by insurance companies. Despite a recent spate of hearings on Capitol Hill to explore ways to lower drug prices, Big Pharma blitzed Washington with $52 million in lobbying just in the first quarter of 2019.

Now Sen. John Cornyn (R-Texas), a co-author of the Affordable Prescriptions for Patients Act, which would classify a variety of Big Pharma pricing practices as anticompetitive, said there will be “changes” to his bill.

One nonprofit watchdog group, the Institute for Clinical and Economic Research (ICER), conducts cost-effectiveness analyses of new drugs to pressure drug companies to lower their prices. As the argument goes, if the cost-effectiveness ratio of a drug is too high, insurers won’t cover it, and patients won’t be able to afford it out-of-pocket, so it’s a loss for the pharmaceutical companies.

ICER has successfully pressured drug companies to lower their prices on some drugs — even though from a patient perspective, they’re still astronomically high. (Swiss drug company Novartis, for example, lowered its gene therapy drug for a deadly, rare disease from $5 million to $2.1 million after discussions with ICER).

ICER just released two reports on a new drug for multiple sclerosis and the much-anticipated, recently-FDA-approved “miracle” drug esketamine for depression, concluding their cost-effectiveness ratios are much too high, which could influence insurers’ decisions to cover the drugs in a healthcare environment where those who suffer from chronic conditions and mental illnesses already struggle to convince insurers to cover treatment, like psychotherapy.

But the Partnership to Improve Patient Care (PIPC) says ICER does more harm than good by putting a “price tag” on patients’ life expectancy and quality of life.

ICER uses the QALY method (quality-adjusted-life-year) to determine the cost-effectiveness ratio of a drug. The U.K.’s National Health Service (NHS) first used the QALY method in the 1960s to ration health care treatments. Since then, the U.K. abolished the QALY method because it prevented British citizens from accessing cancer therapies.

Here’s how it works: if a person suffering from depression or multiple sclerosis has a QALY value of 0.5, that means they have 50 percent of the value of one year of life of a healthy person. The underlying principle is to mathematically quantify the quality of life for people with certain health conditions.

“There are several problems with the QALY,” said PIPC Disability Advocate Ari Ne’eman in a call with reporters Friday. “Often members of the general pubic are surveyed via telephone and asked whether they’d trade ten years of life in a wheelchair or five years of life being able to walk. If the answer is yes, you’d calculate the life in the wheelchair has a rate of 0.5 and worth approximately 50 percent of life not in a wheelchair.”

Besides the inherent subjectivity of the QALY method, PIPC also argues it’s inherently discriminatory against those with certain health conditions.

“There are real concerns when we talk about use of QALY to make reimbursements [to patients with certain health conditions],” Ne’eman said. “First, in general, this is really not consistent with what people with disabilities and chronic illnesses aspire to in their own health state. When you talk to people, they express an interest in living longer and quality of life improvements. QALY tends to undervalue life extension for people with certain conditions and undervalue life quality for people with other conditions.”

QALY also doesn’t account for small changes in a person’s health unless it affects a person’s overall life expectancy or “quality of life value” compared to fully healthy persons. Ne’eman argues this dismisses drugs that may not cure a patient but still substantially improve quality of life from the patient’s perspective.

In other words, QALY fails to account for the “full nuance of people’s health states.”

“Many people with chronic illness in particular find significant improvements in quality of life even as the result of incremental improvements in their health state,” Ne’eman said. “When we talk about QALY, which usually is only able to acknowledge health distinctions in very broad terms, that doesn’t necessarily account for the dramatic differences in quality of life that even a very modest incremental reduction in depression symptoms can provide. Instead of treatment metrics, which are specific to conditions or diagnoses, QALY is undervaluing the value of treatments that people with disabilities have either come to depend on or have derived significant benefit from.”

ICER’s report on esketamine for depression in particular, Ne’eman said, is problematic because it concludes the drug is far too expensive for its effectiveness because while it significantly reduces or eliminates symptoms of depression, it doesn’t improve life expectancy or result in significant enough “productivity gains” (i.e., the drug doesn’t help those suffering from depression to be as productive members of society as completely healthy people).

Andrew Sperling, director of legislative and policy advocacy at PIPC, said ICER’s study on esketamine for depression isn’t even very scientific — the nonprofit didn’t even conduct a randomized control study.

“[The problem is] they looked at existing ketamine, which has different properties from esketamine,” Sperling said in a call with reporters Friday. “When ketamine is done off label, it’s done for many different things, like fibromyalgia and chronic fatigue, but the challenge is the dosing and the frequency and it’s somewhat of a Wild West scenario. This ICER report is very troubling in that it [really doesn’t set forth] the way in which patients should get it in the most safe and effective way.”

Besides the ethical problems the QALY method raises, which researchers explored in a 2018 study, advocates at the PIPC worry ICER will make it more difficult for patients to get the treatments they need as the nonprofit grows its influence.

“Given that drug companies are relying on this sort of report [from ICER], this is of grave concern,” Ne’eman said.

Even though ICER’s mission is to pressure drug companies to lower prices for drugs, PIPC Executive Director Sara van Geertruyden pointed out that ICER’s methods aren’t very ethical and reduce human beings to pawns in a profit game between Big Pharma and insurers.

“Private insurance coverage decisions are very much of a black box,” she said. “It’s not like they come out and say this is why we put this particular product on a lower tier or decided not to cover it. A lot of them have been subjected to utilization management. The real issue we have been trying to tackle is that it is not appropriate for patients with disabilities to be caught in the middle. Where the patient and the disability community are aligned is, their access should not be restricted as part of this path forward. We shouldn’t be saying, we’re not going to pay for x, y, z in an effort to reduce prices.”

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