OBJECTIVES : Recently in the US, there have been various initiatives to improve price transparency, affordability and access of drugs. The objective was to understand how the pricing and market access landscape will evolve in the US from policy changes.

METHODS : A systematic search was performed to identify key policy changes. A framework was developed to map the implications of policy changes for all relevant stakeholders including patients, payers, providers and manufacturers. In addition, interviews with payers (5 Pharmacy Directors and 5 Medical Directors) were conducted. The likelihood of occurrence of policies and their triggers, catalysts and accelerants were identified. Results were aggregated and analyzed through the “triangulation method”.

RESULTS : Increased manufacturer cost-share of the Medicare doughnut hole, inclusion of drug list-price in direct-to consumer ads, Medicare reform with international price referencing and step-edits, and ICER-based formulary management are some of the key disruptive initiatives for manufacturers. These will drive manufacturers to lower drug prices due to increased negotiating power in Medicare. Initiatives to prohibit PBM gag clauses on the state and national level will decrease costs for patients. Also, increasing premiums and deductibles in both Medicare and commercial plans will lead to increased burden on patients.

CONCLUSIONS : Currently there are many policy changes occurring or likely to occur which will disrupt drug pricing for manufacturers. It will be critical to find a balance between the objectives of ensuring patient access and financial sustainability, while and at the same time allowing manufacturers to earn sufficient returns on their investments so as to promote continued investment in the research and development of new products. This will require consideration of the overall policy package and creating dialogue platforms involving all relevant stakeholders.