Could the Inflation Reduction Act Maximum Fair Price Hurt Patients?

<b>Background:</b> The Inflation Reduction Act's Medicare Drug Price Negotiation Program allows the federal government to negotiate caps for select medications. These price caps may reduce revenue for the pharmacy benefit managers (PBMs) that negotiate the actual price paid for medicines in the U.S. To offset the resulting pressure on their profit margins, it is possible that PBMs would, in turn, increase patients' out-of-pocket costs for medicines with capped prices. The model presented here evaluates how increased out-of-pocket costs for the anticoagulants apixaban (Eliquis) and rivaroxaban (Xarelto) could impact patients financially and clinically. <b>Methods:</b> Copay distributions for all 2023 prescription fills for apixaban and rivaroxaban managed by the 3 largest PBMs, CVS Caremark, Express Scripts International, and Optum Rx, were used to approximate current copay costs. Increased out-of-pocket costs were modeled as a shift of all apixaban and rivaroxaban prescriptions to the highest copay tier. The known linear relationship between copay costs and treatment abandonment was used to calculate the potential resulting increase in treatment abandonment. Known rates of morbidity and mortality due to abandoning anticoagulants were used to estimate resulting increases in morbidity and mortality. <b>Results:</b> If the 3 largest PBMs all shifted costs onto patients by moving all apixaban and rivaroxaban prescriptions to the highest formulary tier, Tier 6, patients' copay amount would increase by <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"><mml:mn>235</mml:mn> <mml:mi>t</mml:mi> <mml:mi>o</mml:mi></mml:math> 482 million for apixaban and <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"><mml:mn>105</mml:mn> <mml:mi>t</mml:mi> <mml:mi>o</mml:mi></mml:math> 206 million for rivaroxaban. Such an increase could lead to 169 000 to 228 000 patients abandoning apixaban and 71 000 to 93 000 abandoning rivaroxaban. The resulting morbidity and mortality could include up to an additional 145 000 major cardiovascular events and up to 97 000 more deaths. <b>Conclusion:</b> The Medicare Price Negotiation Program could impact patients negatively if it causes PBMs to increase patients' out-of-pocket costs for medicines. Policymakers should closely monitor changes in overall affordability, including all patient out-of-pocket expenditures, for medications in the program. Preemptive measures should be considered to ensure that the most vulnerable citizens are not placed in precarious situations, leading to poorer health outcomes.