OBJECTIVES: With increasing focus on equitable and faster access to medicines, it is worth considering how initiatives such as the Joint Clinical Assessment will impact daily patient access to therapies. Alignment of the metrics that truly reveal the patient access issue, and the strategies to address it, is critical. Given the specific nature of the challenge, the key issue for patient access is the time and inequities between marketing authorization and reimbursement and fully enabled in-market access.

METHODS: A targeted gray literature search explored variations in time to fully enabled patient access in the market versus national market access and reimbursement, and assessed if value drivers are discussed in relation to patient access. The introduction of novel anticoagulants (NOACs) was evaluated to contextualize the transition from national access to patient access and the implications for health equity and accelerated patient access. Internet searches and industry and payer websites were reviewed to assess the timing of patient access following national reimbursement.

RESULTS: Literature highlights there is misalignment in the definitions of patient access. Most studies define patient access as when a medicine is on the public reimbursement list. While some literature identifies factors affecting uptake of new medicines, we did not find studies that tracked patient access. The introduction of NOACs illustrates the healthcare system implementation challenges that delayed patient access even with national market access and reimbursement in place.

CONCLUSIONS: Stakeholders emphasize the need for strategies and execution for national market and patient access, including early planning for barriers and levers to prioritize and operationalize medicines in complex and stretched healthcare systems. Measuring fully enabled patient access is key to the success of these initiatives, but are we missing the debate on ensuring real-life patient access is discussed and measured?