To evaluate the impact of HTA on the development and market access of new pharmaceutical products in Australia, Canada, England, France, Germany, Italy, Spain and the USA. METHODS:

An annual benchmarking study was developed in collaboration with 9 multinational pharmaceutical companies to establish appropriate developmental performance metrics to identify if scientific advice was received, when it was received, from whom and the outcome and specific HTA requirements included into the development process. In addition data were also collected across 8 jurisdictions (Australia, Canada, England, France, Germany, Italy, Spain and the USA) to identify what evidence was submitted, the time it took and what additional evidence was requested. Data on 19 projects that entered phase III and 30 products achieving first world approval from 2009-2012 were analysed.  RESULTS:

For the phase III projects, 63% received HTA scientific advice, of which 61% occurred during phase II, with company-sponsored advisory boards the being most frequent provider. The main HTA-related requirements included in development were patient-reported outcomes (84%), HTA-acceptable endpoints (74%), and cost-effectiveness analysis (74%). For licensed products, the median time from regulatory submission to reimbursement decision varied from 639 days (Australia) to 846 days (Italy). Additional comparators for local HTA submission were requested by all jurisdictions except USA. England and France showed the highest percentage of products being reimbursed as per the regulatory label (50% and 55% respectively). CONCLUSIONS:

Companies are actively taking scientific advice and incorporating HTA requirements into their development process, although they are still challenged by divergence in HTA process and decision making across jurisdictions. Benchmarking HTA processes at the product level supports companies in driving excellence in risk management and strategic planning