As always CMR Institute remains vigilant to the changes in this complex marketplace and are quick to make the appropriate updates to our content.  Hover over the boxes below, to learn more about each content update.

Medicare Part D

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.

Copay Acumulators

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 Entry of Biosimilars into the US Market

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

Protecting Market Access as Biosimilars Emerge

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

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