The costs and benefits of an early access scheme for oncology medicines in Ireland

BACKGROUND: Access to new oncology medicines is subject to delays in many countries due to lengthy appraisal processes. This study examines the cost to the Irish healthcare system of implementing a cost-sharing agreement to expedite access to oncology medicines. METHODS: The hypothetical cost of implementing an early access scheme in Ireland was estimated for oncology medicines commencing appraisal in 2022. The scheme would have required the manufacturer to cover the cost for the first 180-day period and provide a further rebate if costs per patient over the whole duration of access exceeded those that would have arisen from the finally agreed price. Costs of the new medicine and savings arising from any therapies displaced were estimated on a daily basis using data published in the technical summaries of the National Centre for Pharmacoeconomics, Ireland (NCPE) assessment for each medicine. RESULTS: The scheme would have reduced the time patients waited to access oncology medicines by more than two years on average. Assuming new medicines attract a discount of 30% at reimbursement and that medicines with an existing agreement are subject to a 30% discount, and that a further discount of 10% would be negotiated at reimbursement for the new indication, the costs to the government over the duration of the scheme would have been €64·0 m. Earlier access would have generated an additional 1,590 quality-adjusted life years (QALY) over the lifetime of patients accessing the scheme, after discounting. Costs were sensitive to assumptions on discounts negotiated at reimbursement. Costs fell substantially if patients with private insurance were assumed to access care through that insurance. CONCLUSION: Protracted assessment times lead to substantial health losses to patients with cancer in Ireland. A cost-sharing scheme would accelerate access to new treatments by more than two years with costs of €64 m or less in the majority of scenarios considered.