Patient Characteristics Vary Throughout Class D Protected Drug Classes


Medicare Part D policies currently require sponsors to close with the exception of limited "all or most of all" drugs in six "protected" classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretroviral and antineoplastic.1 Overall, in 2016, 18 million Part D registrants used at least one drug in one of the six protected classes, and the total expenditure for protected class medicines was 19 percent of the total Section D expenditure. In the rules proposed by CY 2020 Medicare Part D, the Medicare & Medicaid Service Center (CMS) proposes to provide D tools to sponsor more tools such as prior authorization and therapeutic steps to manage the formulary in a protected class.2

The impact of this proposed change in patients tends to depend on the type of patient prescribed the drug in this class. Manatt Health found a large difference in the characteristics of patients among protected classes in the analysis of drug incidence data in Section D 2016. It shows that the proposed changes can have very different effects on patients depending on the protected class including their treatment therapy.

The number of applicants who may be affected by change varies greatly from class to class.

  • Antidepressants have the highest number of registrants. More than 12.36 million Part D registrants used drugs in this class in 2016 compared to only 180,000 registrants for immunosuppressants, the class with the smallest number of registrants.

There are also significant differences in the age of the patient.

  • Patients taking antiretroviral drugs tended to be younger than patients using antineoplastic, with an average age of 57 years compared with 73 years, respectively.

Some classes have a much more significant user base among Part D applicants who fulfill dual requirements (who qualify for Medicare and Medicaid).

  • Multiple eligibility, measured by at least one month of multiple eligibility status in 2016, represents a greater proportion of those taking antiretroviral (68 percent) and antipsychotic drugs (60 percent) compared to four other protected classes, ranging from anticonvulsants (42 percent )) and antidepressants (36 percent) become immunosuppressants (30 percent) and antineoplastic (26 percent).

Similar variations can be seen in the use of protected class medicines among Part D applicants who qualify for Medicare due to disability.

  • More than two-thirds of applicants taking antiretroviral drugs currently qualify for Medicare through disability. In contrast, more than half of the registrants qualify for Medicare through traditional age criteria (Old Age and Victim Guarantees) for all other protected class D drug classes.

For five of the six protected classes, 25 percent of Part D registrants who use protected class medicines contribute 80 percent or more of the total expenditure in each protected class.

  • In particular, 25 percent of registrants using antineoplastic accounted for 99 percent of expenses in antineoplastic; 25 percent of registrants using antipsychotics accounted for 93 percent of the expenditure of Part D in the protected class. In contrast, 25 percent of applicants using ARVs accounted for 41 percent of expenditure in the protected class.

Patients using protected class medicines are listed in stand-alone Part D Plans (PDP) and Medicare Advantage D Section Plans (MA-PDP) in the same proportion as the general Medicare population, regardless of the protected class. In 2016, around 60 percent of Part D registrants were in PDP and 40 percent in MA-PDP.3

1CMS. Manual Benefits of Medicare Prescription Drugs Chapter 6, Section 30.2.5. Obtained on January 16, 2019, from

2The Fed. Reg. 83 (231). 62152. [November 30, 2018]. Obtained on January 16, 2019, from

3Kaiser Family Foundation (KFF). (2016). Medicare Part D in 2016 and Trends Over Time. Obtained on January 16, 2019, from


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