Moldova revamps funding rules for cancer and rare disease drugs
Moldova will overhaul how state funds cover innovative healthcare treatments, introducing a rigorous assessment framework to evaluate clinical efficacy and cost-effectiveness before paying for expensive medicines from the public budget.
The draft regulation, scheduled for cabinet review on October 21, establishes a unified Health Technology Assessment (HTA) framework. The reform replaces a fragmented mechanism where drug reimbursement, national health programs, and centralized tenders operated under disconnected rules.
Historically, this lack of standardized evaluation hindered evidence-based spending and left patients diagnosed with rare conditions or advanced cancers seeking ad-hoc coverage for vital treatments, including novel therapies for spinal muscular atrophy and cystic fibrosis.
Evidence-based pricing and risk sharing
Under the new system, any medical technology must complete a formal assessment overseen by the Medicines and Medical Devices Agency (AMDM). The review includes clinical scrutiny against existing alternatives, economic assessment relative to national wealth, and overall budgetary impact modeling.
Routine assessments without negotiations must conclude within 120 days, while comprehensive reviews of pharmaceuticals will take up to 180 days. In public health emergencies or critical unmet medical needs, authorities can apply an expedited 30-day fast-track procedure.
The framework establishes an optimal cost-effectiveness threshold of 0.7 times gross domestic product (GDP) per capita for each health unit gained. For rare conditions, orphan drugs, advanced therapy medicinal products, and terminal-stage care, the ceiling extends up to three times GDP per capita.
A pivotal element is the introduction of risk-sharing contracts with pharmaceutical manufacturers. Under these agreements, public health authorities will not pay full upfront costs for treatments with uncertain clinical endpoints, requiring manufacturers to reimburse funds if promised clinical outcomes fail to materialize.
Staged rollout through 2029
Implementation will follow a gradual timetable across the health sector. Pilot evaluations will wrap up by late 2026, making the HTA framework mandatory for all newly proposed medicines starting January 1, 2027.
The mechanism will expand to cover medical devices and specialized hospital technologies on January 1, 2028, becoming the sole gateway for public healthcare financing by January 1, 2029. Products already reimbursed will remain funded under transitional rules until re-evaluated under a schedule due by March 2027.
Operating costs for 2026 will fit inside existing allocations, while rollout in 2027 requires an estimated €1.26 million (approx. 24.6 million MDL), including €42,600 (approx. 832,000 MDL) for dedicated personnel alongside analytical tooling and external clinical expertise. Industry-initiated evaluations will be subject to standardized regulatory fees.
Translation by Iurie Tataru
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