Prescription Drug Affordability Board Activity through March 31, 2025

4 written comments from Community Access National Network, Ensuring Access through Collaborative Health (EACH) Coalition and Patient Inclusion Council (PIC), Let My Doctors Decide Action Network and Dr. Kate Sugarman were published to the website.

Dr. Olson, a physician practicing in Baltimore who supports cost reductions for diabetes medications, provided an oral comment. She frequently prescribes Jardiance and Farxiga, and worries that patients will buy medication from unsafe, foreign sources, or struggle with high co-payments. However, the veterans she treats receive the medication at lower prices and have better outcomes.

Staff Presentation – Cost Review Study Dossier, Sections 1-3 Overview (Farxiga)

Legislation states that the board may

• determine whether the use of a prescription drug will cause affordability changes to the state health system or high out-of-pocket costs to patients.
• determine whether the use of the drug that causes these costs is consistent with FDA approved use or standard medical practice.
• identify the circumstances where the drug may cause an affordability change to the state health system or high out-of-pocket costs to patients.

Six drugs have been selected for the cost review study process and information has been requested for Farxiga, Ozempic and Trulicity. The staff reviewed the information and the board must now make a preliminary determination per the three points above.

The staff has assembled a cost review dossier. The board will be discussing the first three areas today: background information, clinical information and regulatory approval. Each COMAR regulation is a different area, called an “element,” for review.

• Background information - Identifies drug under review
  1. Proprietary and non-proprietary name
  2. NDCS
     • All previously identified
     • Some are no longer active
• Clinical information – diseases & conditions treated
  1. COMAR 14.01.04.05C(1)(g)(i) – FDA indications, doses, and standard medical practice
     • Staff reviewed FDA label and published clinical guidelines
• COMAR 14.01.04.05.C(1)(g)(ii) – Disease burden of condition treated
  1. Impact of the conditions for the drug product
  2. Based on published literature review

• Regulatory approval and market context – history of approval drug use
  1. COMAR 14.01.04.05.C(1)(g)(ix) – analysis of approval process
  2. COMAR 14.01.04.05.C(1)(g)(x) – analysis of shortage status

• COMAR 14.01.04.05.C(1)(g)(xi) – market analysis including lifecycle & patient management, regulatory exclusivities and product hopping

This was followed by a closed session to consider and discuss confidential, trade secret and proprietary information, under GP § 3-305(b)(13) and HG 21-2c-03(e)(1)(iv) (Farxiga, Jardiance); and to consult with counsel and receive legal advice regarding proposed regulations, under GP § 3-305(b)(7).

This is a follow up to the working session in February's meeting. Staff received 135 pages of comments and will cover ones that weren’t covered in February.

A full presentation about comments and response from staff is available here. Comments fell into three categories:

• Definitions, lack of procedures on certain topics, and economic impact statement
• UPL procedures and policy options
• Legal concerns

Staff recommend these revisions:

• For clarity, replace term “methodology” with “framework” throughout.
• Clarify broad scope of designee by removing term “staff” in COMAR 14.01.01.06 hearing provisions.
• As discussed at last meeting, for purpose of clarity, staff recommends amending COMAR 14.01.05.05B(2)(d) (non-UPL) “possible implementation of the policy through legislation, regulation or enforcement.” And for the purpose of clarity and completeness, adding to COMAR 14.01.05.05C(2) (UPL) “strengths and weaknesses of the policy,” “potential impacts of the policy” and “possible implementation of the policy through legislation, regulation or enforcement”

The board approved the proposed amendments to COMAR 14.01.01.01 (Definitions); new COMAR 14.01.01.06 (Hearing Procedures); new COMAR 14.01.05 (Policy Review, Final Action, Upper Payment Limits).

Administrative Update

• Staff will submit regulations will be updated in the register.
• September's meeting has been moved to 9/15/2025. November meeting will be 11/17/2025. The May 19 meeting will be virtual.
• Two positions are open on PDAB's staff: policy analyst and administrative program manager.

New legislation has passed in Maryland: Senate Bill 357 and House Bill 424. The Lowering Prescription Drug Costs for All Marylanders Now Act adds members to the Stakeholder Council and requires the PDAB to confer with the Maryland Medical Assistant Program before setting payment limits. The bill adds representatives from the rare disease community, a patient advocacy organization and oncology.  Under the bill, the board can reconsider payment limits for drugs that become part of a shortage but will not be able to establish a new payment limit for a drug that is currently in shortage.

The bill would also require the board to issue a report one year after setting a payment limit. The report would need to detail the impact of the limit on patient out-of-pocket costs, patient health insurance premiums, reimbursement rates for pharmacies and shortages or supply disruptions.

Senate Bill 406, related to workers compensation, may have implications for the PDAB.