Does Regulatory and Reimbursement Parallel Processing Provide Swifter Funded Access to Medicines for Patients? Evaluation of Cancer Medicines Using the Australian Parallel Process.

Objectives: To assess the impact of a parallel regulatory and reimbursement process on (1) direction of funding decisions, (2) time lag until funding recommendation, and (3) type of evidence submitted, for cancer medicines.

Methods: Public regulatory and reimbursement decision documents were reviewed for cancer medicines considered by the Pharmaceutical Benefits Advisory Committee since the introduction of parallel processing. Medicine-indication pairs were identified from these documents and data extracted on the type and quality of evidence submitted, funding decisions, and timelines, by type of review process. Associations were explored using univariate and multivariable logistic regression analysis.

Results: A total of 182 cases were selected from the 1590 screened. Compared with sequential evaluation, a higher proportion of parallel review submissions presented a cost-effectiveness/cost-utility analysis (67.0% vs 79.7% P < .01) and used the same pivotal evidence as used for market authorization (77.5% vs 90.0%, P = .08). There was no difference in the quality of supporting evidence and other decision-relevant predictors used for either process. Submissions undergoing parallel review were not more likely to receive a negative public funding decision (adjusted odds ratio 0.46; 95% CI 0.14-1.39; P = .17). Under parallel processing, the lag between drug registration and Pharmaceutical Benefits Advisory Committee funding recommendation was drastically reduced (67 weeks) when compared with the sequential process.

Conclusions: The type of evidence supplied to regulators and health technology assessment bodies and the funding decisions that ensue have not been affected by the introduction of parallel processing in Australia. The parallel process has, however, drastically reduced the time taken to the initial funding decision.