Medicare Proposes Legislative Changes to Protected Drug Classes, Including Antineoplastics

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The Centers for Medicaid & Medicare Services (CMS) is implementing changes to protected classes of pharmaceuticals starting in 2020.

Since Medicare Part D was created, Medicare recipients have been given appropriate access to 6 specific classes of drugs (referred to as the protected classes). This has allowed patients to access “all or substantially all” medications within these 6 categories regardless of price so that they can maintain specific drug regimens prescribed by their physicians. This access has also helped to ensure that patients are adherent to the medicines they need to manage their chronic conditions.

Current Medicare Part D policy requires sponsors to include on their formularies all drugs in the 6 protected classes: (1) antidepressants; (2) antipsychotics; (3) anticonvulsants; (4) immunosuppressants for the treatment of transplant rejection; (5) antiretrovirals; and (6) antineoplastics, except in limited circumstances.

According to a recent CMS ruling, prior authorization and step therapy requirements are only permitted on new patient starts for 5 of the 6 classes (antiretrovirals are excluded). Although these requirements have been a part of existing Part D policy since 2006, this measure was finally approved in May 2019. Broader use of prior authorization and step therapy for drugs in these classes, which would affect current patients, was proposed but not approved.

Additional measures that were proposed but not finalized include excluding a drug in one of the protected classes from a formulary if the price exceeds a specific threshold over a set period, and excluding a drug in one of these classes from a formulary if the drug is a new formulation of an existing single-source product (without regard to whether the original formulation stayed on the market).

Many patient advocate groups have voiced opposition to these proposals, citing concerns that they would weaken the ability of Medicare recipients to access the critical medicines on which they rely.

“These [proposed] changes would have hindered patients’ access to medications, including those designed to target specific conditions that do not have a therapeutic equivalent. Timely access to the most clinically appropriate therapies is essential to achieving the best possible outcomes for cancer patients. Delays in obtaining the most clinically appropriate care results in poorer physical and psychosocial health outcomes, as well as increased out-of-pocket spending,” said Kim Czubaruk, Senior Director, Policy and Advocacy, Cancer Policy Institute, Cancer Support Community, Washington, DC.

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Last modified: April 27, 2020