MARKET ACCESS CONSIDERATIONS IN PHARMACEUTICAL IN-LICENSING VALUATIONS

Author(s)

Ohanjanyan A, Mukku S, Edathodu A, Samuel J, Leung SK, Digiacomo F, Olid Golzalez A
Access Infinity, London, UK

OBJECTIVES: Valuation of assets in licensing deals is based on the asset’s ‘approvability’, with the estimated value of the asset increasing as the likelihood of regulatory approval grows with each successful clinical development stage. This study aimed to assess the ‘reimbursability’ and price potential in the EU5 of a CNS asset that faces generic competition. METHODS: In-depth interviews with 10 former senior national and regional level payers from EU5 were conducted, along with analysis of historic EU5 at-launch prices of CNS drugs using IMS data. RESULTS: The asset’s successful Phase III trial was 6-weeks long and conducted against placebo as the comparator. Assuming EMA approval, European payers unanimously agreed that this data would not be sufficient for negotiating premium prices in the EU5 markets. Payers requested 6 month-long direct and/or indirect comparative studies against standard of care (SoC) therapies in the EU, all of which are generic. To avoid generic price referencing, superiority in efficacy and/or safety vs SoC would have to be demonstrated. Analogue analysis of CNS drugs launched in genericised EU5 markets showed that comparative studies demonstrating non-inferiority in efficacy and superiority in safety vs generic comparators might lead to 3-4 times price premium over a generic price, while superiority in both efficacy and safety to >5 times price premium. We estimated that with the existing data the asset would be reimbursed at €1-€1.6 per day in EU5 (vs estimated $65 per day in the US). With additional data the asset could be reimbursed at €2.5-€5 per day. CONCLUSIONS:  Estimating the EU5 reimbursement and price potential is a crucial consideration in asset valuation process that can significantly alter the asset’s NPV. Market access analysis should be carried out early in the development process to insure that the clinical development plan addresses the ‘reimbusrability’ issues.  

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Value in Health, Vol. 20, No. 5 (May 2017)

Code

PND42

Topic

Economic Evaluation

Topic Subcategory

Cost/Cost of Illness/Resource Use Studies

Disease

Neurological Disorders

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