Continuous Content Updates: Medicare, Biosimilars, Specialty Market

In March 2021, CMS announced that it would not implement the downside risk component of the Part D Payment Modernization model for CY22. It also would not implement Part D formulary flexibilities that had been proposed with the Part D Payment Modernization model. These flexibilities would have allowed plans to cover fewer drugs in the six protected drug classes.

A study by The AIDS Institute with support from Pharmaceutical Research and Manufacturers of America (PhRMA) found that two-thirds of health plans in 32 states include a copay accumulator.

Additionally, this information was added: Georgia requires plans to count financial assistance toward a patient’s cost-sharing responsibility when a generic equivalent is not available or when a patient has obtained the drug through step therapy, prior authorization, or the health plan’s appeals process.

The following information was either added or updated to reflect changes to the market:

• Examples of biosimilars and their indications
• Reference to the FDA “Purple Book”
• State regulations
• The pricing of biosimilars outside the US with their effect on US access and market share

The following information was either added or updated to reflect changes to the market:

• A detailed description describing how biosimilars are paid for in the US
• An explanation of average sales price (ASP) pricing in addressing formulary strategies
• Information concerning therapeutic switching
• The process by which employers influence pricing of biosimilars
• The benefits of co-pay assistance programs
• Educational needs of providers is listed based on recent survey
• A new section describing the clinician’s need to use clinical guidelines when biosimilars are used with pediatric patients
• A description of substitution laws
• Information describing the responsibility of P&T Committees