PNS143 PRIORITIZATION OF DRUGS FOR REIMBURSEMENT IN THE MALTESE HEALTH SYSTEM.

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Governments often experience difficulties in striking an optimal balance between ensuring access to promising drugs while sustaining the healthcare system. We investigated, how Malta, the smallest EU country, prioritizes drugs for inclusion in the basic benefit package. Our descriptive analysis of the Maltese reimbursement system was based on policy documents and semi-structured interviews guided by the Hutton Framework. We interviewed 33 key stakeholders including policymakers, committee members, clinicians, pharmacists, hospital managers and representatives of patients, pharmaceutical industry, and procurement department. In Malta, drugs for reimbursement pass through the Health Technology Assessment (HTA) unit for drawing up an assessment report of the drug, two committees advising the Minister for Health, and a procurement unit (CPSU). The first committee, the Government Formulary List Advisory Committee (GFLAC) prioritizes the drug based on health benefits and estimated costs compared to other drugs within a clinical pathway. GFLAC advises the second committee, the Advisory Committee on Health Care Benefits (ACHCB). The ACHCB further prioritizes the drug based on affordability (i.e., budget impact), sustainability and capacity of the system. Between 2014 and 2017, the committees recommended 34% of the 190 new drugs and rejected 45%. For 21% of the drugs, the decision is pending. Drugs recommended by the ACHCB are subsequently endorsed by the minister. As final decision-maker, the minister can also prioritize clinical pathways at assessment. For example, since 2017 specific annual budgets have been allocated to oncology and diabetes. For other recommended drugs (without clinical pathways), CPSU additionally prioritizes which medicines to procure first since procurement of approved drugs often exceeds CPSU’s available budget. Decision-making at multiple levels complicates the prioritization of drugs in Malta. Pending decisions further impact the prioritization process. The main criteria for prioritisation at each level seems, however, to be budget impact and allocation of sufficient funding.