Avalere examined health technology assessment (HTA) decisions for oncology drugs over the period January 2013-December 2017 from:

• UK’s National Institute for Health and Care Excellence (NICE) – Technology Appraisals
• Canada’s Canadian Agency for Drugs and Technologies in Health (CADTH) and Pan-Canadian Oncology Drug Review (pCODR) – Health Technology Assessments, Common Drug Reviews, and pCODR Recommendation Reports
• Germany’s Institute for Quality and Efficiency in Healthcare/Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) and Federal Joint Commission/Gemeinsame Bundesausschuss (G-BA) – Benefit Resolutions and Drug Assessment Commissions
• France’s National Authority for Health/Haute Autorité de Santé (HAS) – Drug Recommendation Reviews

Avalere found that HTA reports are increasingly including caveats in access such as previous therapy treatment or time limits for reimbursement, all of which Avalere has defined as “recommended with restrictions.” In particular, these restrictions are frequently being tied to overall treatment cost or recommendations to restrict coverage to specific patient subpopulations. The percent of reviewed HTAs that received recommendations with restrictions increased to 62% in 2017 from 44% in 2013 (Figure 2). This rise in recommendations with restrictions parallels the rise in highly targeted, high price therapies.

Key Findings

• NICE and CADTH/pCODR issued the highest percentage of recommendations with restrictions at 71% and 81%, respectively
• Of the 329 oncology HTA reports analyzed from the period 2013-2017, 29% resulted in recommendations without any restrictions
• Our analysis also found that NICE was most likely to not recommend a product for oncology products reviewed by all 4 HTA organizations
• IQWiG/G-BA recommended 55% of reviewed products outright and recommended products with restrictions in 36% of reports
• HAS outright recommended 69% of all products reviewed
• HTA decision criteria reflect differences in cultural values, for example, some countries (e.g., NICE), cost effectiveness is as an explicit element of HTA recommendations, whereas, in other countries (e.g., HAS), HTA recommendations are focused on comparative clinical benefit

Methodology

Avalere examined oncology HTA reports from the 4 HTA bodies published between January 2013 through December 2107. Oncology was defined as products that directly treat cancer or are primarily used in cancer supportive care. Products that treat oncology-related conditions were not assessed. Only draft and final reports were analyzed. For draft reports that were finalized within this time frame, Avalere only examined the most recent report. Conclusions were defined as “Recommended” if explicitly stated or if the product was found to be equivalent to or have improvement/benefit over comparators; “Recommended with Restrictions” if there were limitations placed on access; and “Not Recommended” if explicitly stated or if the product was found to have lesser/insufficient benefit versus comparators. A more detailed discussion of the methodology can be found in the full report.

Funding for this research was provided by The Pharmaceutical Research and Manufacturers of America (PhRMA). Avalere maintained full editorial control.

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