Case Studies
Case study 1:
Optimising the positioning strategy of a product in development and delivering implementable Phase III trial design advice to support the strategy
Situation
A company has a product in development for the treatment of Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease whereby the immune system attacks the cells and tissue of the body, which results in inflammation and tissue damage. A treatment had not been developed in this area for a considerable amount of time and the payer perception and market access situation was uncertain.
Problem
The client was unaware of the payer unmet needs in this area and wanted to understand how best to position their product and wanted to develop a clear value story. In doing so the company also wanted to understand what implications the optimal positioning strategy would have on their Phase III trial design.
HERON's Solution
Based on the issues communicated by payers during an advisory board, and preliminary research into the burden of illness and currently available treatment options for SLE, a series of target payer value messages were formulated. To support this value story and the positioning strategy, we developed implementable recommendations on the company's communication strategy as well as on the company's Phase III trial design, including specific patient populations, endpoints and QoL instruments.
Case study 2:
Supporting right first time multi-country reimbursement through deep understanding and Europe wide expertise.
Situation
A company had a policy of increasing revenues through sustained in licensing of compounds. The company had three compounds in different diseases, which required immediate and effective pricing and reimbursement support. This went beyond strategic guidance into the physical delivery of pricing and reimbursement applications and directing and supporting all authority negotiations. The objectives were right first time reimbursement in the appropriate cluster at the target prices in a range of European countries.
Problem
On many occasions the licensing agreements were not uniform across continents and this fragmentation had hindered organisational understanding of individual country pricing and reimbursement requirements. This also placed a huge demand on internal resources to secure pricing and reimbursement approval on a frequent basis in differing countries and had resulted in an organisational state of "freeze" whereby nobody was able or prepared to take responsibility for delivery. Some of the compounds had been licensed for over a year and no reimbursement activity had taken place. It was effectively dead money.
HERON's Solution
Many things were required and all of them priorities. Firstly we had to get to understand what was known and not known. A lot was not known. Secondly identify and compile all the information clinical, regulatory, economic and legal. Thirdly create a company review and sign-off team and put in place, processes to steer through the process effectively and robustly. Fourthly create persuasive, country specific P&R reimbursement application dossiers containing all the necessary information with integrated pricing polices taking a reference price approach. Finally submit the applications with local signatories and handle all questions from the authorities.
The Outcome
Reimbursement in the target clusters for the three products at the target price in the four target European countries within 12 weeks of application. One of the products, a treatment for metastatic breast cancer required pricing and reimbursement approval in Belgium only. This process was successfully complete within 9 months. Belgium is/was recognised as having a lengthy reimbursement appraisal and approvals process.