Xarelto® (rivaroxaban) is a direct oral anticoagulant (DOAC), specifically, a selective inhibitor of factor Xa, that helps prevent blood clots. A recent sequence of events led to an interesting scenario regarding the coverage of Xarelto for a specific population.
2023 Beers Criteria
Xarelto was mentioned in the 2019 Beers Criteria to “use with caution for treatment of VTE or atrial fibrillation in adults ≥75 years.” In 2023, the recommendation in the Beers Criteria update was modified to “avoid for long-term treatment of atrial fibrillation or VTE in favor of safer anticoagulant alternatives.” This change applies to all people ages 65 and older. Based on data from observational studies and meta-analyses, Xarelto was found to have a higher risk of major and gastrointestinal bleeding in older adults compared to other DOACs, Eliquis® (apixaban) in particular. However, the 2023 Beers Criteria update also notes that Xarelto may be appropriate in certain situations, such as when once daily dosing is preferred to ensure medication adherence. Additionally, DOACs were found to have a lower risk for intracranial hemorrhage than warfarin. Eliquis does not appear on the Beers List, but for Pradaxa® (dabigatran), it is recommended to “use caution [when selected] over other DOACs (e.g., apixaban) for long-term treatment of nonvalvular atrial fibrillation or VTE.” The updated Beers Criteria does not eliminate the use of Xarelto in patients older than 65 years but adds a point to consider for patients, providers, and caregivers.
Medicare Pricing Negotiations
In August 2022, the Inflation Reduction Act was signed into law providing the opportunity for Medicare to negotiate prices of high expenditure medications that do not have generic or biosimilar competition. Xarelto is one of the ten drugs selected for negotiation, applicable for 2026. The Medicare Drug Price Negotiation Program shared information that 1.34 million Medicare Part D enrollees used Xarelto from June 2022 to May 2023, resulting in $6.03 billion of gross covered prescription drug costs. Eliquis is also included on the Medicare negotiation list, while Pradaxa is not. This list of drugs was announced by the Centers for Medicare and Medicaid Services (CMS) on August 29, 2023, months after the 2023 Beers Criteria update was released on May 4, 2023.
Impact
The 2023 Beers Criteria includes an update indicating cautionary use of Xarelto in adults older than 65 but does not always necessitate therapy discontinuation. CMS selected Xarelto, months after the Beers update, as one of the 10 drugs subject to negotiation. Did CMS consider the impact of selecting a drug for negotiation that recently experienced a cautionary use consideration in the primary population that is covered by Medicare? Including Xarelto on the Medicare Drug Price Negotiation list for 2026 guarantees that Medicare Part D programs will cover this medication, along with the other drugs on the list at the negotiated prices. This is a potential concern as Medicare beneficiaries, or their providers, may turn to Xarelto as their preferred DOAC if this negotiated price is lower than the cost of other DOACs. Could there be short-term financial savings but long-term increased costs due to adverse effects from the use of Xarelto in the Medicare population? Healthcare providers should continue to evaluate situations that are medically appropriate for the use of Xarelto on a case-by-case basis, while considering the Beers Criteria recommendations to provide individualized and holistic patient care.
Posted: October 2023