DO LONGER HTA REVIEW TIMES FOR ONCOLOGY PRODUCTS REFLECT WORSE OUTCOMES? A REVIEW OF 482 HTAS ACROSS 5 MARKETS

OBJECTIVES: To determine how reimbursement decision type affects the time required for health technology assessment (HTA) agencies to issue a decision in oncology. METHODS: Oncology drugs approved between 2005-2015 by the EMA, 2013-2015 by Health Canada, and 2009-2015 by TGA were matched on indication with HTAs from HAS, NICE, SMC, pCODR, and PBAC (n=482). Resubmissions were excluded. The date of the first reimbursement decision was subtracted from the date of the regulatory approval to determine the time to reimbursement decision. Reimbursement decisions were categorized as “recommend,” “recommend with restrictions,” or “do not recommend.” An analysis of variance test was used. RESULTS: On average it took 304, 382, and 353 days to issue “recommend”, “recommend with restrictions,” and “do not recommend” decisions, respectively. Although demonstrating a trend, there was no difference in the time to a decision by the type of decision (p=0.16). All agencies (except SMC) required more time for “recommend with restrictions” decisions than “recommend” decisions. It took longer, on average, for pCODR, HAS, and NICE to issue a “do not recommend” decision than a “recommend” or “recommend with restrictions” decision. CONCLUSIONS: The most positive decision (“recommend”) takes the shortest time for all agencies, except for SMC; “recommend with restrictions” and “do not recommend” decisions require longer time, reflecting challenges in negotiations with manufacturers or the time needed to determine restrictions. For example, negotiating with manufacturers on patient access schemes or allowing the manufacturer to comment, appeal, or counter a preliminary decision could require additional time to reach a conclusion. The time it takes agencies to issue decisions post regulatory approval can lead to delaying patient’s access to oncology treatments.