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Table 3 Accountability for reasonableness framework requirements

From: The reimbursement for expensive medicines: stakeholder perspectives on the SMA medicine nusinersen and the Dutch Coverage Lock policy

This framework consists of four requirements to come closer to a fair decision-making process about the reimbursement of therapies [23]:

1. Publicity: meaning the reimbursement decisions must be publicly accessible and ensures clarity about reasons behind a reimbursement decision

2. Relevance, also called reasonableness. This condition asks for a reasonable explanation of how the organisation provides “value for money” in meeting the varied health needs of a defined population under reasonable resource constraints. Specifically, an explanation is reasonable if it appeals to reasons and principles that are accepted as relevant

3. There should be a mechanism to challenge and dispute the resolution regarding limit-setting decisions, this includes the opportunity for revising decisions in light of further evidence or arguments

4. There should be a voluntary or public regulation of the process to ensure that conditions 1 to 3 are met