Fireside Chat:
SPTR and PDABs Best Practices
Chris Weiser, Tiffany Frankson
PDABs and SPTR Best Practices
Chris Weiser, Senior Counsel, U.S. Market Access Legal, at Sanofi and Tiffany Frankson, Assistant General Counsel, Pricing and Access at Pfizer, had a fireside chat at the Medicaid Drug Rebate Program (MDRP) Summit in September 2023 in Chicago, IL.
Weiser is Senior Counsel in Sanofi’s U.S. Market Access group, primarily working across government price reporting, state drug price transparency, and other issues relating to market access. Frankson is principal member of the Pricing and Access team at Pfizer, with a focus on providing critical legal support for U.S. and global drug guidance.
The discussion outlined best practices for pharma manufacturers when complying with state price transparency reporting, which is a complex and ever-changing domain. Both Weiser and Frankson spoke about the change of focus of state requirements, from quantity of reporting to the accuracy of reporting data. As a result, individual states have placed a greater emphasis on enforcement to improve compliance among manufacturers (e.g., Oregon). They agreed that having appropriate internal controls and resources are important and beneficial for overall compliance. Benefits spoken about include enabling identification of manufacturing issues in a more manageable way, facilitating better decisions and reducing the risk of penalties.
State price transparency has several components, all of which were dissected throughout the fireside chat. Implementation of this legislation thrives when “all colleagues are engaged internally.” Frankson emphasised the importance of partnering with relevant internal stakeholders to form a multifunctional team across divisions (e.g., government pricing, legal, commercial, and finance teams). Both agreed that having a single organization and cross functional governance team approach optimizes reporting decisions at small and large companies.
The first step is “evaluating staffing needs.” They proposed a strategy to request extra resources from stakeholders: “What would the potential penalties be if reporting isn’t done properly, if the correct staff aren’t available?” In this instance external staff can be an effective short-term asset, providing support with drafting policies, opining on adequacy of same, and other roles.
Additionally, state price transparency is also reliant on written policies and procedures, and Weiser said that “internal controls are only as good as [what] you have written down.” Good documentation of all processes is best practice to improve articulation and communication to new and existing staff.
States often make changes to regulations, and therefore, it is imperative that manufacturers have a process for updating their policies. Key areas that should have written policies were highlighted: lack of or gaps in guidance from states, conflicting guidance, timing submissions, acquisitions, and handling statements from agency personnel.
The speakers recommended that process refinement, which is crucial for manufacturers, be applied in this area as well. The first step is to identify decision makers within the company that are responsible for decisions regarding State price transparency and communicating with regulatory bodies.
Prescription Drug Affordability Boards (PDABs)
PDABs, prescription drug affordability boards, have been introduced by a half dozen states in the U.S. with the goal of lowering prescription drug spending and improving affordability for patients. All have different requirements and penalties, with Frankson and Weiser describing this as “fair game.” They provided a deep dive into the PDAB process of each state. One example was Washington, which has authority to collect sensitive proprietary data from manufacturers, contrasting with other states where reporting to PDAB is voluntary. Additionally, this is the only state where there is a penalty enforced for failing to report to PDAB: a $100,000 fine per violation. The Affordability Review Board process for Washington consists of identification, selection, and determination. Frankson urged manufacturers to consider implementing PDABs into government processes and outlining strategies to deal with instances in which a drug product is eligible for review by the board.
The speakers provided the audience with tools for manufacturers to thrive despite ever-changing legislation. With the changing landscape, Weiser and Frankson shared that it is important that manufacturing companies are well equipped to adapt to these changes and are committed to making prescription drugs more affordable across the industry.
