PHP181 - HEALTH TECHNOLOGY ASSESSMENT OF ONCOLOGY THERAPIES IN SPAIN AND ITALY: KEY METRICS AND CONSIDERATIONS

Abstract

Since 2015, national and regional health technology assessment (HTA) agencies in Italy and Spain have reviewed an increasing number of oncology therapies. This research examined the key metrics and considerations that paved the road to HTA success or failure in Spain and Italy, and compared the two decentralized markets. HTA reviews for non-orphan oncology drugs reviewed between January 2015 and December 2017 were identified in the Global Market Access Solution (GMAS) tool and corresponding HTA agency databases. 111 reviews published by national and regional Spanish and Italian HTA agencies were analyzed. Overall survival (OS), progression-free survival (PFS), safety, health-related quality-of-life, trial design and evidence quality were examined, as well as the HTA rating (recommended, restricted or rejected) for each drug. Spanish and Italian payers rarely rejected oncology therapies, instead preferring to restrict what patient populations were eligible to receive the therapy. 46% of restrictions related to an eligible patients’ ECOG score. Overall survival was the gold standard for measuring efficacy, but Spanish and Italian payers were willing to accept progression free survival, particularly in the event of immature OS data. Italian agencies place more emphasis on evidence quality, as demonstrated through a GRADE rating, than Spanish agencies, while Spanish agencies considered HRQoL more often than Italian payers. Concerns about clinical trial design were a common cause of restriction in Italy and Spain. In Italy, improper comparator was the most-cited concern, while Spanish payers most notably commented on a lack of blinding. The key metrics for oncology HTA decisions in Spain and Italy were similar in both countries, with a similar emphasis on efficacy. The decentralized nature of both healthcare systems means that there are multiple stakeholders across both countries, with varying methodologies. Spain recommended oncology drugs without restriction at a much higher rate than Italy.