CASE STUDY #1
Value message development and GVDs
To develop a set of value messages and a Global Value Dossier (GVD) that sets out the value proposition and payer-relevant evidence to support market access of an ground-breaking new and innovative gene therapy in the treatment of a rare hematologic disorder.
We used a classic comprehensive methodology, combined with digital innovation.
The value messages were developed in collaboration with key internal stakeholders based on evidence from the literature, clinical trials, observational studies, and economic models.
The clarity, influence, and credibility of the VMs were also tested with key payer and clinician stakeholders in real-time using a specialist smartphone platform.
The GVD was developed using the following structure:
• Clinical burden and unmet need
• Clinical value
• Economic value
• Objection handler
The final deliverable was a navigable, interactive slide deck
The classic methodology was refined to reflect that the indication was an orphan disease. Orphan diseases - which we have extensive experience in - have different clinical and economic evidence requirements compared with standard therapeutics, in recognition of the difficulty in generating large amounts of robust trial data.
Depending on the funding structure for orphan drugs, key stakeholders in each of the scope countries may vary.
The key stakeholders and orphan drug HTA and approval processes were mapped for each scope country.
Whilst the largest audience was payers and policy makers, clinicians may also be key influencers, depending on each country-specific orphan drug funding structure.
We matched the content of the value messages and GVD to the data needs and key stakeholder profiles for the current HTA and approval process in each scope country.