In a letter to the Center for Medicare and Medicaid Services (CMS), Dialysis Patient Citizens (DPC) asked for a “do-over” in the rollout of Korsuva, a drug that treats ESRD-related pruritis. Medicare makes an add-on payment for new drugs that expires after two years, leaving uncertainty about how providers can offer such drugs to patients when that period ends. This uncertainty discouraged nephrologists from prescribing the medication. Empirical research has found a prevalence of moderate to severe pruritis among dialysis patients of 33 percent, but Korsuva has been dispensed to fewer than one percent of patients.
In the letter, several DPC members describe their experiences with severe itching and their frustration about not being offered the drug.
To fix this debacle, DPC is asking the agency to (1) perform an after-action analysis of the circumstances surrounding Korsuva coverage, payment, and clinicians’ reactions, and impact on patients; and report the findings to the Administrator, to Congress, and to the public; (2) undertake a negotiated rulemaking process with stakeholders that ensures that Korsuva is dispensed in the manner that it would be dispensed in the absence of payment bundling; and (3) develop policy going forward that will guarantee the development and uptake of new technologies in a manner congruent with those not subject to Medicare bundling.
