Objective: Using seven therapeutic subclasses of cardiovascular drugs as a case study, we investigated how different systems of formulary practice have an impact on access to prescription drugs, as well as the likely repercussions of the recently passed Medicare legislation on Medicare beneficiaries. We identified four dimensions of access: availability, coverage, equity, and flexibility. We examined a fifth item, transparency, unrelated to access but relevant to the formulary decision-making process as a whole. Study Design and Methods: Drawing from public data from the US and Dutch drug regulatory agencies, three leading US managed care plans participating in the Medicare Advantage program, Michigan's Medicaid agency, and the Dutch board of insurers, we determined for the period 1991–2004 (1) which cardiovascular drugs were approved for marketing in the United States and the Netherlands and approval dates; (2) formulary status of the approved drugs; and (3) copayments for on-formulary drugs. For each insurer, we determined whether an appeals mechanism is in place for obtaining nonformulary drugs and if so the estimated appeals success rate. Finally, on the basis of publicly available documentation as well as personal communications with officials at the managed care plans, we determined the degree of transparency underlying the formulary decision-making processes. Results: For each dimension identified, we give an ordinal ranking of the selected US and Dutch systems of formulary management. In terms of availability, the number of cardiovascular drugs approved between 1991 and 2004 by the respective drug regulatory agencies was the same (37), while on average the Dutch agency approved this subset of drugs faster than the United States. The Dutch system affords better coverage as 84% versus 68% of approved drugs are on formulary, and there are nominal out-of-pocket costs for beneficiaries across all therapeutic subclasses of cardiovascular drugs. We observed that the Dutch system is more equitable as formulary coverage applies to virtually the entire population, while copayments are practically equal across the population. However, it is less flexible, with little or no choice in drug benefit, and has an underutilized, difficult-to-navigate appeals mechanism for nonformulary drugs. Finally, we observed that both the US and Dutch systems of formulary management lack transparency. Conclusions: The Dutch formulary shows how, from a beneficiary's perspective, a national formulary can succeed in achieving a high degree of (universal) coverage. The United States is unlikely to establish a single formulary for Medicare, yet it is implementing regulations sponsored by the Centers for Medicare and Medicaid Services that are designed to minimize inadequacies in and undue variation between formularies to ensure adequate coverage and a high rate of beneficiary participation.
