Patient groups rebuke CVS on ICER, saying cost-effectiveness reviews discriminate

CVS last month made waves in pharma with a plan to allow clients to exclude drugs based on guidance from drug cost watchdog ICER. Now, patient advocacy groups are hitting back at the decision, urging CVS to reconsider and saying the cost-effectiveness calculations at ICER discriminate against the chronically ill, the elderly and others.

In a letter (PDF) to CVS CEO Larry Merlo, members of the Partnership to Improve Patient Care urged the PBM giant to reconsider its decision to allow reviews by the Institute for Clinical and Economic Review to affect coverage decisions. The patient advocates wrote that they “support access to high-quality, affordable care, but CVS’ reliance on a cost-effectiveness threshold is profoundly misguided.”

In their view, if CVS allows clients to make policy decisions based on the cost-effectiveness reviews, that would ignore “important differences among patients” and instead rely on a “one-size-fits-all" approach. They said cost-effectiveness analyses discriminate “against the chronically ill, the elderly and people with disabilities, using algorithms that calculate their lives as 'worth less' than people who are younger or non-disabled." PIPC counts PhRMA and BIO, two biopharma industry trade groups, among members of its steering committee.

A representative for CVS said because ICER's quality-adjusted life years "standard applies uniformly across all health conditions and plan members, our benefit design will not be discriminatory and, in fact, will improve the chances that patients with disabilities and serious illness will be able to get the treatments they need at a price they and the health system can afford." CVS will meet with patient advocates to discuss their concerns, she added.

ICER VP of communications and outreach David Whitrap said the QALY metric "is recognized as the gold standard for measuring how much a treatment improves patients’ lives, and it effectively rewards innovative medicines that significantly improve the lives of patients most in need."

"Patient populations that start off with a lower quality of life—whether because of a serious chronic illness or disability—actually represent the greatest opportunity for treatments to achieve a significant improvement in QALYs," he added.

RELATED: CVS' move to lean on ICER data could mean dramatic shift in drug pricing leverage

The letter from dozens of patient organizations comes about a month after CVS released a white paper saying it will start allowing clients to exclude from coverage any drug with a quality-adjusted life years (QALY) figure of more than $100,000, as determined by ICER. Health organizations use the metric to determine the cost of medicines in the context of quality and expected remaining years of life. Critics, however, say payers can use the metric to deny access.

CVS said the program will exclude FDA-labeled “breakthrough” drugs, and focus "on expensive, ‘me-too’ medications that are not cost effective, helping put pressure on manufacturers to reduce launch prices to a reasonable level.”

At the time, Bernstein analyst Ronny Gal wrote that CVS’ move gives ICER’s work a “formalized role” in coverage decisions, and that if “others follow, key pricing power will shift from pharma to a pricing arbiter.”

A representative for PhRMA said the group "strongly supports the use of rigorous, objective evidence to guide formulary decision-making," but that it opposes "misuse of subjective, one-size-fits-all cost effectiveness thresholds to deny patient access to life saving treatment options."

ICER and drugmakers have had a contentious past, as the organization has frequently found that pharma’s prices are too high and warrant deep discounts. That’s not always the case, though, as the group recently endorsed Amgen’s price on migraine med Aimovig after other therapies, plus Gilead and Novartis’ pricing on new CAR-T cancer meds despite their high price tags.