Cost Review Study Process

1. Drugs reported by the public as having potential affordability issues. At this stage, drugs are identified as eligible for cost review. During an initial PDAB meeting, the board reviews drugs reported by the public as having potential affordability issues. At this time, the Board has opportunity to add prescription drug products for inclusion on the list of eligible drugs for cost review.
2. Drugs considered for cost review. At this stage, the Board will identify prescription drug products to consider for cost review. This is a subset from eligibility list. These drug products are referred to the Prescription Drug Affordability Stakeholder Council for input.
3. Prescription Drug Affordability Stakeholder Council (PDASC) reviews drugs considered for cost review. The PDASC will review and discuss the referred prescription drug products at an open meeting.
4. Additional Discovery. The public has the opportunity for comment and the PDASC conducts listening sessions.

Following the review of the PDASC, the board selects prescription drug product(s) for cost review. This may be an even smaller subset of drugs from the previous step.

• At this stage, all drugs selected will undergo a Cost Review Study and posted on the website. With this posting, the public has 60 days to provide written comments.
• The Board may also request information from Manufacturers; Carriers, HMOs and MCOs; Pharmacy Benefits Managers; and Wholesale Distributors.
• All of the data collected will be analyzed towards making a determination.

Board staff may assemble a dossier of data and analyses for consideration in cost review study as outlined in COMAR 14.01.04.05.
 

1. The Board makes a preliminary determination. The Board may preliminarily determine whether the prescription drug has led or will lead to affordability challenges to the State health care system or High out of pocket costs for patients. Following this determination, the drug follows one of two paths:
   1. If the drug does not create an affordability challenge: the Board takes no further action.
   2. If the drug does creates an affordability affordability challenge: the Board conducts a Policy Review.
2. The Board conducts a Policy Review. If there are affordability challenges, the Board takes measures to alleviate these issues. The Board seeks to answer questions such as:
   1. What are the existing policies and drivers of the affordability challenge?
   2. What is the issue that we want these policies to solve?
   3. What policies can we recommend to make the prescription drug more affordable?
3. The Board presents the final results. The final results may include one or both of the following options:
   1. Upper Payment Limit (UPL) Policy. An Upper Payment Limit is a state-mandated cap on the total amount that any person or organization can pay for a specific high-cost medication. It creates a single maximum price for a drug within the state to ensure patients and healthcare providers are not overcharged.
   2. Non-Upper Payment Limit Policy. The affordability challenge may be addressed by other policy that does not include limits on the maximum cost of the drug.
4. The Board adopts the final results. The final determination is presented in a Final Cost Review Study Report and is adopted by the Board. Any policy recommendations, either UPL or Non-UPL is then adopted by the Board.