Value Evidence Identification
GalbraithWight are experts in identifying the clinical, HEOR and RWE evidence required by Payers to ensure you can deliver on the Value Strategy for your brand, and achieve successful pricing, reimbursement and funding. Value Evidence Identification includes formal process such as Early Scientific Advice, and in-depth Payer research to identify key Value Drivers and emerging Standard of Care. This provides vital insights on patient population, place in treatment algorithm, comparators, end points, PROs and trial design.
Early Scientific Advice – Formal or Surrogate
Clinical trials are by far the most expensive part of development, costing many $millions. To make this massive investment as productive as possible, it is vital to engage with Payers to understand their evidence requirements in terms of patient population, endpoints, comparators and PROs, in the same way companies already engage with the Regulatory Agencies.
We conduct rigorous Early Scientific Advice, both through the formal processes offered by HTA Agencies such as NICE, HAS, G-BA and CADTH, and through direct Payer engagement in countries with no formal process, such as the USA.
Where formal Payer engagement is not desired by our Client, or a faster, low-cost option is sought, we conduct ‘surrogate’ Early Scientific Advice with recent senior level ex-Payers, conducted to the same rigorous standards.
The end deliverable is a clear set of recommendations for the clinical and HEOR evidence development plan to ensure the right evidence is developed in time for Market Access requirements.
Disease Area & Payer Landscape Insights Research
Payer research is a vital too in gaining real insights into value drivers in each disease area, both for today, and in predicting how the environment may evolve for a future launch where Standard of Care may change as new options become available.
We have conducted Payer research for over 20 years and have a very experienced team; many of whom have been senior market research leads in big Pharma prior to joining GalbraithWight, and all of whom work to the high standards demanded both for Market Research ethics and Pharmacovigilance standards required for market research projects.
We have a well-developed process which ensures the quality of our work, and a network of local partners around the world who conduct all interviews in local language to ensure no nuances are lost in translation. Our research reports carry not only key insights, but a clear analysis of the implications of those insights for our Clients brands, and a set of robust recommendations based on this analysis, to make the outputs truly actionable.
Evidence Gap Analysis & Mitigation Plan
There is no such thing as the perfect evidence set. One of the key services we provide is a comprehensive Gap Analysis, based on the desired Value Strategy for the brand. This involves a critical evaluation of the evidence development plan in the context of the aspirational Value Story at the time of launch. Through this process we identify the key evidence gaps, and the implications of these gaps.
We then develop the evidence Mitigation Plan, to address each of the key gaps identified, in a set of recommendations to augment the clinical and HEOR evidence development plans, so these gaps are managed. Examples include ‘bridging strategies’ to explain the statistical relationships between early outcomes to the more mature outcomes sought by Payers. The end deliverable is a comprehensive Gap Analysis and Mitigation Plan with a clear set of recommendations for action.
HEOR External Expert Working Groups
To ensure all the deliverables from your Market Access plan are as robust as possible and able to withstand critical review by HTA agencies, we subject the work conducted on the Value Story, economic models, systematic literature reviews and indirect treatment comparisons to critical evaluation and validation by an external group of experts as an ongoing part of the plan.
These external experts have many years’ experience in HTA decision making, and critical evidence review. Many are ex-Payers from the major HTA agencies or medicines policy leads from US insurers, or members of key academic units involved in health technology assessment. The end deliverable is a Market Access plan which is even more robust as a result of this additional critical evaluation and improvement.
What Our Clients Say
Why Partner with GalbraithWight
The global Strategic Market Access Consultancy with 20 years thought leadership partnering Pharma and Biotech Clients.
Experts in value strategy based on in-depth customer insights, creating value through clinical and HEOR evidence, achieving successful pricing, reimbursement and funding approval, brand launch and commercialisation, from discovery to loss of exclusivity.
Unparalleled expertise in building market access and commercial capabilities from foundation to expert level for global, regional and country teams, training thousands of managers from over 70 countries across five continents.
Highly expert team with extensive senior level strategic and operational international experience in major Pharma companies, who know and understand how to embed & operationalise our solutions in complex organisations and cross-functional teams, delivered on the ground throughout North and South America, Europe, Asia, Middle East and Africa.