OBJECTIVES: Patient access scheme (PASc) is an alternative market access agreement between healthcare payers and manufacturers, to enable provisional or conditional coverage of health technologies especially for innovative and high cost medicines. This study aims to assess the review process of PASc proposal submitted to the Ministry of Health (MOH) Malaysia.

METHODS: A PASc proposal for drug used in the treatment of chronic iron overload due to blood transfusions by thalassaemia patients was received from a pharmaceutical company in 2017. This proposal was submitted with the intention to displace the existing drug available in MOH formulary used for the similar indication. Evaluation of PASc was done by the Medicine Evaluation Team. In the review process, a few aspects were considered: types of scheme used, cost of treatment of the proposed drug, inventory and logistic issue, price referencing, number of population requires the proposed drug, appraisal of assumptions made, reviewing of published literatures and local/ international guidelines on the clinical use of the proposed drug. In addition, a budget impact analysis was performed from the perspective of MOH.

RESULTS: Throughout the review process, we acknowledged that the company offered a complex financial-based scheme with free supply of drugs (bonus). All the aspects were analysed accordingly, however, a few issues were identified from the proposal. These include the shortage of free drug supply based on our revised assumptions made by adapting to the real scenario in MOH setting, the process of drug supply is not feasible and the cost-saving from the scheme is not in line with the additional budget incurred to MOH.

CONCLUSIONS: PASc is an overwhelming global agenda but the limitation of guidelines in directing its review process creates a hurdle. The review process developed in this study could serve as a guide to facilitate the evaluation of PASc proposal.