The American Society of Nephrology (ASN) submitted comments to Medicare on its Medicare Advantage and Part D Drug Pricing Proposed Rule on January 25.  ASN objected to segments of the proposed rule that remove protections from the “six protected classes of drugs” in Medicare Part D. Specifically, ASN objected to proposals to:

• Implement broader use of prior authorization and step therapy for protected class drugs, including to determine use for protected class indications; and
• Exclude a protected class drug from a formulary if the price of the drug increased beyond a certain threshold over a specified look-back period.
   

The six protected classes include antidepressants, immunosuppressants, antipsychotics, antiretrovirals, anticonvulsants, and antineoplastics. When Congress designed the Medicare Part D program, it ensured that the full range of these drugs would be guaranteed for all patients. The reason for these protections is the complex range of conditions these drugs are designed to treat – and the equally variable reactions of patients to these drugs – requiring flexibility for the patient and their physician to provide the appropriate drug or combination of drugs.

The society expressed concern that the proposed changes to Medicare Part D protected classes would make it more difficult for some transplant recipients to access the vital range of drugs used to prevent organ rejection. Clearly, transplant recipients need immunosuppressive medications to support long-term graft survival. 

ASN conveyed to Medicare that immunosuppression medications are not interchangeable and limiting options for immunosuppression will likely negatively impact patient outcomes, since not all patients tolerate immunosuppressive drugs, even if listed within the same class, in the same way. Their therapeutic benefits and adverse effects can vary significantly from patient to patient. Physicians often must adjust therapeutic regimens to address their patient-to patient variability. For some patients, especially children who are unable to take tablets or capsules, liquid formulations of immunosuppressive drugs must be prescribed. Limiting immunosuppressive options can also negatively impact transplant recipients doing well on a particular immunosuppressive regime. Altering their drugs as a result of the proposed rule could result in reduced efficacy or intolerable side effects and result in allograft rejection.

While strongly opposing Medicare’s proposal to remove protections from these six classes of drugs, ASN expressed its appreciation of Medicare’s efforts to lower the out-of-pocket costs of prescription drugs for Medicare beneficiaries in other parts of the proposed rule. The society specifically supported proposed provisions that prohibit “gag clauses” in pharmacy contracts by restricting Part D sponsors from prohibiting or penalizing a pharmacy from disclosing a lower cash price to an enrollee.

ASN will continue to follow this issue and will update KNO readers as developments occur.