- More than 90 organizations, predominantly patient groups, criticized CVS Caremark's decision last month to incorporate value-based drug pricing analyses in some of its coverage choices, urging the company to reconsider in a Sept. 12 letter addressed to CVS CEO Larry Merlo.
- In August, the pharmacy benefit manager (PBM) said it would use the Institute for Clinical and Economic Review's quality-adjusted life years (QALY) metric to exclude certain high-cost drugs from plans. CVS defended the decision Thursday in an emailed statement to BioPharma Dive, saying the company recognizes these concerns while also defending QALY.
- Spearheaded by the Partnership to Improve Patient Care, the letter is the latest example of pushback on efforts to establish quantitative frameworks for valuing medicines. PhRMA and BIO as well as professional organizations and patient groups sit on the partnership's steering committee.
The rhetorical war between PBMs and drugmakers on how to value and pay for medicines has drawn in patient groups, which are concerned that attempts to minimize costs could limit access to new treatments.
In last month's announcement, CVS said it would exclude certain drugs that carry list prices which come in above a threshold of $100,000 per QALY — a measure that attempts to define a drug's value.
Some prominent groups on this open letter include the American Association of People With Disabilities, the National Alliance on Mental Illness and Vietnam Veterans of America.
Their main issues with ICER's framework are not new and mirror some of the criticisms laid out by the drug industry's trade lobby PhRMA. The letter argues QALY ignores individual patient differences, calling it "deeply troubling" from an ethical perspective and knocking it as an "opaque algorithm."
Tony Coelho, president of the Partnership to Improve Patient Care and a former Congressman who led efforts to pass the Americans with Disabilities Act, attacked CVS' decision, characterizing it as an outdated policy that has "no place being referenced as a 'value-based initiative'" in a statement to BioPharma Dive.
ICER defended its methods as it has extensively in the past, arguing its assessments are rooted in conversations with patient and advocacy groups. The group has also taken steps to make its methodology more transparent and accessible.
A CVS Health spokesperson described the QALY-based decision plan as non-discriminatory and said it would help patients get treatments "at a price they and the health care system can afford."
"We like ICER because it's very transparent," CVS Health Chief Medical Officer Troyen Brennan said in a recent interview with STAT News.
"They undertake this activity voluntarily, they're supported largely by philanthropy, and when combined with market pressure, their analysis is every bit as powerful as government regulation might be," Brennan added.
While the debate has intensified, one expert told BioPharma Dive that the actual action being debated may not be so severe.
"CVS has limited this threshold to very few cases so [it] will likely not have a big impact," wrote Walid Gellad, who runs the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, in an email to BioPharma Dive.
Notably, CVS exempted all FDA-designated breakthrough therapies, which are commonly among the highest-priced treatments on the market. CVS did not answer how many drugs it roughly expects this policy to affect.
"My sense is CVS did this, with all the caveats, because it will impact very few drugs," Gellad added.