OBJECTIVES: To secure reimbursement in Ireland, all new drugs are first evaluated by The National Centre for Pharmacoeconomics (NCPE) for cost and clinical effectiveness and budgetary impact. Based on these evaluations, we investigated the time to reimbursement (TTR) of novel oncology drugs since 2006 that were reimbursed and had a European Society of Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) rating.

METHODS: We developed a database derived from all pharmacoeconomic evaluations conducted by the NCPE from 1st September 2006 until 6th March 2023. A subset of oncology drugs that had been reimbursed and rated by the ESMO-MCBS were extracted, and additional information was added: whether the oncology drug required a companion diagnostic (CDx), originated from the largest twelve pharmaceutical firms (Big 12), or had accelerated access (AA), conditional marketing authorization (CMA), first-in-class (FIC), or orphan status (OS). Analysis was conducted to test the relationship between TTR and the absence and presence of these specific factors employing Spearman’s rank correlation.

RESULTS: Since 2006 there were 189 submissions for oncology drugs to the NCPE (excluding chemotherapeutics). The average TTR for the 61 oncology drugs available for our analysis was 591 days. Factors that were strongly correlated included the presence of a CDx (503 vs 664 days; p = 0.04), CMA (289 vs 596 days; p = 0.02) and ‘Big 12’ (584 vs 316 days; p = 0.03). Other factors such as ESMO-MCBS rating, AA, FIC, and OS did not have a significant correlation with TTR.

CONCLUSIONS: Oncology drugs that require a CDx to guide therapy have a shorter TTR, confirming our previous analysis. CMA also has a positive effect on TTR speed but large pharmaceutical firms do not have an advantage in accelerating the TTR process. This may be because they are bringing more complex medicines to the market, which require longer evaluation time.