AFLIBERCEPT IN NEOVASCULAR (WET) AGE-RELATED MACULAR DEGENERATION- AN ANALYSIS OF THE PAYER DECISION LANDSCAPE
Author(s)
Brown A*1;Ferreira A2;Lamle S2, Milnes F2 1Abacus International, Manchester, United Kingdom, 2Novartis Pharma AG, Basel, Switzerland
OBJECTIVES: To investigate and analyse decisions of Health Technology Assessment or national drug reimbursement agencies for aflibercept in neovascular (wet) aged-related macular degeneration, including decision outcomes, the rationale for these, the data package and any payer critique of the manufacturer approach. METHODS: A search of decision-making agency websites in key European markets, Canada and Australia was conducted to identify relevant decisions. Data were extracted and used to conduct a qualitative analysis of decisions. RESULTS: Five decisions were identified; from NICE (England & Wales), SMC (Scotland), HAS (France), G-BA (Germany) and PBAC (Australia). In all instances, the clinical and economic arguments, where applicable, were based on demonstration of non-inferiority of aflibercept to an existing therapy, ranibizumab. These arguments were supported by two key trials of aflibercept vs. ranibizumab: VIEW 1 and 2, and also indirect comparisons and network meta-analyses. In all decisions, aflibercept was either recommended for the full licensed indication or recommended with restrictions. All agencies commented that the key trials were well conducted and unbiased; however, they also state that the dosing schedule for ranibizumab did not reflect the license or clinical practice in respective markets, and it was unclear if there would be any difference in the frequency of injections between therapies in the clinical setting. Furthermore, for the economic models for NICE, SMC and PBAC, the respective agencies thought the frequency of injections and number of clinician visits for ranibizumab were overestimated. All agencies concluded that aflibercept demonstrated no additional clinical benefit over ranibizumab. For example, HAS in France granted an ASMR level V: no improvement in clinical benefit, while NICE recommended that aflibercept be used in accordance with their recommendations for ranibizumab. CONCLUSIONS: While aflibercept is an effective alternative therapy to ranibizumab, payers have concluded that it offers no demonstrable added clinical benefit compared with ranibizumab.
Conference/Value in Health Info
2013-11, ISPOR Europe 2013, The Convention Centre Dublin
Value in Health, Vol. 16, No. 7 (November 2013)
Code
PSS53
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Sensory System Disorders