ARE HTAS FOR ONCOLOGY AGENTS TAKING LONGER TO COMPLETE? TRENDS IN TIME TO AN HTA DEICSION IN 6 MAJOR MARKETS

OBJECTIVES: To determine how the time required for health technology assessment (HTA) after regulatory approval has changed. METHODS: Oncology drugs approved 2005-2015 by the EMA, 2013-2015 by Health Canada, and 2009-2015 by TGA were matched on indication with HTAs from G-BA, HAS, NICE, SMC, pCODR, and PBAC. The analysis included 569 HTAs. Resubmissions were excluded. The date of the first reimbursement decision was subtracted from the date of the regulatory approval to determine the time taken to complete HTA and to issue reimbursement decision. Trends over time were analyzed using regression analysis. RESULTS: On average it takes 321 days from regulatory approval to issue a reimbursement decision for oncology drugs. Since 2005, the time from regulatory approval to the first reimbursement decision for has lengthened (increased) by approximately 10 days per year (p¼0.04). Trends over time varied by HTA agency. PBAC’s time to reimbursement has trended upwards (i.e., longer time to issue a decision), while G-BA’s time to decision has been steadily decreasing. HAS and SMC’s time to reimbursement decisions have increased slightly, with a recent dip in 2016. CONCLUSIONS: Delays in patient access to lifesaving oncology therapies appear to be getting longer over the past decade. This increase may be due to changes in HTA processes, the time it takes manufacturers to prepare and submit their dossiers, or the time to finalize intense negotiations between companies and payers. For example, negotiating patient access schemes for higher cost cancer therapies may require more time. The cost-effectiveness agencies (i.e., NICE, SMC, pCODR, PBAC) have demonstrated lengthier trends, while G-BA, an agency that does not consider cost during the evaluation, has not.