Innovation Value Framework - Evidence From EU-4 and UK

Speaker(s)

Xoxi E1, Di Bidino R2, Prada M1, Morris L3, Guillot M4, Vollmer L5, Ariznavarreta A6, Walzer S7
1Intexo SB, Rome, RM, Italy, 2Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, RM, Italy, 3Remap Consulting UK Ltd, Alderley Edge, CHE, UK, 4Nextep and MEDVANCE France, Paris, 75, France, 5MArS - Market Access & Pricing Strategy GmbH and MEDVANCE Germany, Tuebingen, BW, Germany, 6Outcomes10, Castellon, CS, Spain, 7MArS Market Access & Pricing GmbH, State University Baden-Wuerttemberg, University of Applied Sciences Weingarten-Ravensburg, Weil am Rhein, Germany

Presentation Documents

OBJECTIVES: To compare the value framework from HTA bodies in EU-4 and UK in assessing the same drug/therapeutic indication.

METHODS: Drugs with valid Fully Innovativeness status recognised by AIFA in 2019-2020 were identified and national appraisals for each product/therapeutic indication from NICE, HAS, G-BA and AEMPS, were collected. For the analysis were considered the variables: NICE recommendations, HAS Actual benefit (SMR) & Improvement in actual benefit (ASMR), G-BA added benefit and AEMPS Therapeutic Positioning Report (TPR). Considering that for AIFA all the indications in analysis have received the highest level of value recognition, we have identified three groups to analyze the accordance: 1) NICE recommendation yes, HAS ASMR I-III, G-BA considerable and major added benefit, AEMPS TPR reimbursed without restrictions; 2) NICE recommendation yes but with conditions, HAS ASMR IV, G-BA minor added benefit, AEMPS TPR reimbursed with label restriction; 3) NICE recommendation no/ NA, HAS ASMR IV/NA, G-BA no/non-quantifiable or exempted due to insignificance added benefit, AEMPS TPR no-reimbursed. Other variables are to support the interpretation of data analyzed.

RESULTS: A total of 30 therapeutic indications for 24 medicinal products, were analysed. NICE recommended 17 indications. For HAS are 19 the cases with ASMR I-III. For G-BA are 11 assessed as considerable/major the extent of added benefit. AEMPS: 13 with TPR and no label restriction and reimbursed. Compared to AIFA, and referring to the Group 1, NICE recognized 56,7% of cases, HAS 63.3%, GB-A 36.7% and AEMPS 43,3%. Only in 4 cases all other agencies agreed with the AIFA assessment of fully innovativeness. Comparisons were conducted not only versus AIFA decisions but also among the agencies. From the Fleiss' Kappa statistics emerge a slight alignment (kappa= 0.106, p-value= 0.05).

CONCLUSIONS: These results underline the importance of implementing transparency procedures in terms of the value definition criteria used by HTA organisations.

Code

HPR44

Topic

Health Policy & Regulatory

Topic Subcategory

Approval & Labeling, Reimbursement & Access Policy

Disease

STA: Drugs