OBJECTIVES: In parallel with increasing requests for PROs to be assessed in oncology trials, the European Medicine Agency (EMA) in 2014 published a reflection paper outlining their recommendations. The value PRO claims have to HTA Agencies is less clear. Our objective was to assess whether HTA agencies placed a similar valuation on PROs as the EMA. METHODS: Our focus was HTA agencies in key 3 European countries: Germany, the UK and France Cancer types were selected where they had a high number of HTA assessments: breast cancer (BC), non-small cell lung cancer (NSCLC), pancreatic cancer (PaC); prostate cancer (PC) and leukaemias. Relevant HTA appraisals since January 2013 were identified using Quintiles’ proprietary HTA Accelerator database. The drugs evaluated were compared to their respective European labels. RESULTS: Overall, 85 HTA submissions (AWMSG: 5; NICE: 7; SMC: 23; HAS: 28; G-BA: 11; IQWiG: 11) covering 31 oncology drugs were reviewed. Thirteen (42%) of these drugs had ≥1 PRO claims in their European label; corresponding HTA submissions also included PROs. Manufacturers presented PROs in 67.1% (57/85) of HTA submissions (BC: 72.7%; NSCLC: 100%; PaC: 0%; PC: 77.3%; leukemias: 43.5%). PROs were also presented in the HTA submissions of 8 drugs with no EMA PRO data. In HTA submissions, PROs assessing QoL (51/57, 89.4%) and pain (18/57, 31.6%) were the most common. Statistical significance was observed in 59.6% of the 52 submissions with available results. In the final HTA decision, PROs were mentioned for 43.9% of submissions, not mentioned in 35.1% and were not reviewed by the HTA body in 21.0% of submissions due mainly to methodological issues. CONCLUSIONS: Demonstrating a statistically significant improvement in PROs does not increase the chance of a positive HTA recommendation (65.5% vs 74.1% for submissions without PROs). The value that PRO claims in oncology have to payers needs to be further clarified.