Payers’ requirements for the use of Camyzos in patients with obstructive hypertrophic cardiomyopathy are generally consistent with the registration study, but they also imposed restrictions beyond the FDA indication or ICER recommendation.
Health plans vary in the use of step therapy, approval duration and reauthorization criteria for the heart drug Camzyos (mavacamten), finds a review by researchers at Tufts Center for the Evaluation of Value and Risk in Health (CEVR).
Developed by Bristol Myers Squibb, Camzyos was approved in April 2022 to treat adults with obstructive hypertrophic cardiomyopathy (HCM), a condition that causes thickening of the heart muscle. There is no cure for hypertrophic cardiomyopathy but medications such as beta blockers and calcium channel blockers can reduce risk of complications.
Camzyos addresses the excessive contraction of the heart that leads to severe disease where the blood flow is obstructed. At the time of launch, the wholesale acquisition cost was about $89,500 a year. The approval of Camzyos was based on data from the phase 3 EXPLORER-HCM trial, which enrolled 251 patients. Results from the trial showed that Camzyos improved symptoms, functional status, and quality of life, as well as the ability to relieve left ventricular obstruction.
Researchers at Tufts CEVR, led by Molly T. Beinfeld, wanted to look at U.S. payer coverage of Camzyos one year after its approval and what sources they were using to make their decisions. They looked at clinical requirements and step-therapy protocols, and reauthorization requirements.
The data used come from the Tufts-CEVR Specialty Drug Evidence and Coverage (SPEC) Database, which contains detailed information on how 18 large U.S. commercial health plans cover specialty drugs and products. As of April 2023, coverage policies for Camzyos were available for 13 commercial health plans.
Tufts researchers found that clinical restrictions imposed by plans — such as left ventricular wall thickness and left ventricular ejection fraction assessment — aligned with the eligibility requirements in the EXPLORER-HCM trial.
But they also found that 12 of the 13 plans imposed some restrictions beyond the FDA indication. For example, some plans required positive genetic tests for familial HCM, which the researchers said create unnecessary barriers and costs. “Although the diagnosis of HCM is subtle and sometimes requires confirmation through genetic testing, candidacy for mavacamten is not likely to be related to confirmation of an inherited cardiomyopathy,” they wrote.
In terms of step therapy, two plans had no requirements for Camzyos. Nine required an inadequate response, intolerance, or contraindication to beta blockers and/or calcium channel blockers. Two plans also required patients step through disopyramide, which Tufts said creates barriers to access because there is a lack of evidence comparing Camzyos with disopyramide.
Plans limited initial use but that varied from 3 months to 12 months and reauthorization was required by all but one plan; 11 payers required some demonstration of clinical benefit.
Tufts researchers also found that payers were generally consistent with recommendations made by the Institute for Clinical and Economic Review (ICER), with the exception of the two plans that required patients to step through disopyramide before accessing Camzyos