Evidence Gap Analysis and Planning
Reimbursement and health technology assessment (HTA) agencies need the right clinical and economic evidence in order to back a new product.
Manufacturers must understand and meet those evidence requirements to ensure their product reaches patients.
A given evidence package rarely satisfies all payers’ demands. Identifying and addressing gaps in that evidence is an important part of maximising market access. And, that is one way in which RJW&partners can help.
Evidence gap analysis for a biologic treatment in severe atopic dermatitis
Our mid-sized pharma client had a new product in Phase 3 trials for severe atopic dermatitis. Demonstrating the product’s benefits versus lower-cost topical and oral treatments, and the severe burden of disease, was critical in order to justify the target price.
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WHERE WE FIT IN
HOW WE STAND OUT
Early planning is always a good idea. So, at RJW&partners, our team will build evidence development programmes early in phase 2, helping ensure phase 3 trials and other evidence collection meets HTA agencies’ needs.
When pivotal studies are in place, we help plan and assemble additional clinical and economic evidence to support a product’s effectiveness.
Testing payer reactions to certain data can help determine whether a particular study is necessary to support access at a given price, for instance, or what evidence will support sales volume assumptions.
We are flexible and pragmatic. We adapt our methods and approach to your situation and needs, drawing on primary and secondary research, and our own clinical development and pricing and market access expertise.
Our goal is to provide you with clear, detailed, actionable analysis on how to maximise your product's price and market access.
Building Evidence Gap Analysis into Development
Assessment of evidence gaps and support needs for a cystic fibrosis treatment
A medium-sized biotech company was developing a new product for cystic fibrosis indicated for the treatment of multiple disease genotypes, with varying levels of severity.
Our client wanted to conduct an evidence gap analysis and develop a support plan that captured the local needs and learnings from market access experience with their other cystic fibrosis products.