The Centers for Medicare and Medicaid Services (CMS) named the 15 drug makers that will take part in the Medicare Drug Price Negotiation Program, which allows the agency to negotiate the prices of certain high expenditure, single-source drugs without generic or biosimilar competition.

The drugs in the program include those used for diabetes, lung cancer, breast cancer, and a number of other chronic conditions.

Some of the next steps in the negotiation program process include the following:

• Invite each participating drug company with a selected drug to engage in a meeting on its data submission.
  
  

• Host patient-focused roundtable events (one dedicated to each selected drug) that will be open to patients, patient advocacy organizations, and caregivers. These events are intended to collect patient-focused input on topics such as patient experience, therapeutic alternative(s) to the selected drugs, the extent to which the selected drugs address unmet medical needs, and the impact of selected drugs on specific populations.
  
  

• Host town hall meetings for all selected drugs, focused on the clinical considerations related to the selected drugs.
  
  

• Send an initial offer for each selected drug for which the drug company is participating in the Negotiation Program with CMS’s proposal for the maximum fair price and concise justification no later than June 1. The drug company will have 30 days to respond to the initial offer by accepting the offer or providing a counteroffer, if desired. In developing an initial offer, CMS will consider evidence related to the selected drugs and their therapeutic alternatives as well as other factors, such as research and development costs and unit costs of production and distribution of the selected drug. CMS will invite the drug company to a negotiation meeting to take place during the 30-day period after CMS sends the initial offer and before the response from the drug company is due to begin negotiation discussions.
  
  

• If agreement on a maximum fair price is not reached through the initial offer or counteroffer, CMS will invite each participating drug company for up to two additional negotiation meetings before the negotiation period ends on Nov. 1.

Comments or questions? Contact Patrick Connole at pconnole@parkplacelive.com.