Challenge

A privately held specialty pharmaceutical company focused in the field of psychiatry was conducting a Phase III clinical evaluation of its new formulation (one-per-day) of a commonly prescribed anxiolytic. While the company had plans to market the drug in the US itself, it had plans to secure one or more marketing partnerships for commercialization in Europe where the product would enjoy a 10-year exclusivity period. The pricing and reimbursement landscape in Europe is both heterogeneous and different from the US (as, indeed, are psychiatric practice and prescribing guidelines). In turn, this meant that the validity of the market opportunity in Europe could not be taken for granted. Alacrita was asked to undertake focused payer research to provide business plan validation and to quantify commercial value/serve as negotiating leverage.

Solution

lacrita first reviewed documentation describing the drug, the target product profile, market survey information and points of clinical differentiation. We held a kick-off telephone with the client to ask questions and brainstorm how best to communicate these messages to payers. We then conducted desk research in the target markets (Germany, France, UK) to document:

  • Current recommended standard of care for General Anxiety Disorder (GAD)
  • Overview of European market access landscape and data requirements
  • Pricing and reimbursement systems and framework
  • Pricing of comparator products and any published health technology assessments (HTA)

We then formulated a pre-read document describing the new drug and its proposed ‘clinical value elements’ and ‘payer-value elements’ for review by payers prior to telephone interviews with them. We recruited ‘real payers’ currently involved (or involved within the past 18 months) in Health Technology Assessments, reimbursement and pricing decisions, at national or regional level. The objective of the interviews was to test potential payer value elements for the drug and their impact on likely pricing and reimbursement and formulary position for the product. We probed who payers are likely to view as the eligible patients, and possible reimbursement/market access restrictions. We also tested the evidence required to support the company’s targeted price range and preferred formulary position. One key area we probed payers on was the impact of the US Phase III trial being placebo controlled (European payers have a very strong preference for the comparator to be the standard of care, in this case the immediate release formulation of the same drug), and the extent to which the PK data (current and in process) would suffice to support a pricing decision above the level of the lowest-price generic product.

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