More MA Enrollees Are Facing Step Therapy Requirements for Part B Drugs

Over half of Medicare Advantage enrollees were in plans that applied step therapy to the 10 most commonly used rheumatoid arthritis (RA) medications covered by Medicare Part B in 2023, according to a recent Avalere analysis.

Since 2019, CMS has given MA plans the ability to use step therapy protocols — meaning a patient may be required to try a less expensive drug before moving to the more expensive one — for physician-administered and other Part B medications. Avalere analyzed MA plans’ annual medical policy and formulary restrictions for 22 RA drugs from 2018 to 2023 and found that the percentage of MA beneficiaries in plans that use step therapy has increased steadily since 2019. For two of the drugs studied, 78% of enrollees were in MA plans that applied step therapy in 2023.

MA plans also increased their use of step therapy edits referencing biosimilars since the biosimilars of blockbuster drug Humira (adalimumab) entered the U.S. market in 2020. By 2023, about a quarter of MA plans on average applied step therapy protocols to Part B RA biosimilars.

Another study published by AJMC found that step therapy requirements for Part B drugs varied significantly across medications, indications and plan type in large MA plans. Based on data from the Tufts Medical Center Specialty Drug Evidence and Coverage Database through August 2021, the study analyzed 1,789 Part B drug coverage policies of seven of the largest MA plans in terms of covered lives: CVS Corp.’s Aetna, Anthem, Inc. (now Elevance Health, Inc.), Blue Cross Blue Shield of Michigan, Cigna Healthcare, Highmark Health, Humana Inc. and UnitedHealthcare. The database tracks 164 drugs and documents each indication separately for drugs that are approved by the FDA for multiple indications. In total, the database includes 384 drug-indication pairs.

Across all MA plans that offered Part B drug coverage, 45.7% of policies imposed a step therapy protocol and most covered the medication as second-line or third-line therapy. The proportion of policies imposing step therapy varied across MA plans, ranging from 26.1% to 63.7%. Step therapy protocols were most used for drugs treating dermatology conditions (90.2%) and respiratory conditions (88.5%), and they were used the least for oncology drugs (28.6%).

When comparing step therapy protocols in the same insurers’ MA plans and commercial plans, researchers found that their use of step therapy differed for the same drug-indication pairs 46.1% of the time. For half of the pairs, neither the MA nor the commercial coverage policy imposed any step therapy protocol. Compared to MA policies, commercial policies applied step therapy more frequently and included more steps on average.

This infographic was reprinted from AIS Health’s biweekly publication Radar on Drug Benefits.