We can help you understand how to develop effective and appropriate dossiers for exchange of pre- and post-approval information with payers. Learn more about the recent guidance.
Your messages need to be flexible, tailored to each of your audiences, and clearly articulated. Let us help develop your global value dossiers (GVDs) and other high-impact communication tools to ensure your research findings and value messages can be adopted by the relevant audiences.
To help communicate your product’s value, we can provide a wide range of deliverables including GVDs, market access toolkits, slide sets, objection handlers, and onsite or virtual training and workshops.
Global Value Dossiers
GVDs present evidence-based messages that demonstrate what your new product brings to the market and how it will be positioned relative to other products. Information is presented so that all users are able to access the sections they need and affiliates can apply the value story to their local markets. Key sections in a GVD include:
- Value story
- Disease burden
- Unmet needs
- Value of the product (clinical, humanistic, economic)
- Market access strategy
- Objection handling
Pre-Approval Dossiers and Post-Approval AMCP Dossiers
A pre-approval dossier, whether for an unapproved product or unapproved use of an approved product, allows you to communicate key product information—including clinical evidence—to US payors well in advance of approval. Let our team of experts help you prepare dossiers to make the most of your pre-approval product communication opportunities. Following approval, we can also work with your team to develop a rigorous AMCP dossier to help you communicate key clinical and economic evidence in support of your product to US payors in response to unsolicited requests for information from the payor. Key sections in these dossiers include:
- Executive Summary (Post-approval AMCP dossier) or Overview (Pre-approval dossier)
- Product Information and Disease Description
- Clinical Evidence
- Economic Information/Evidence
To help you communicate with audiences who may not require the level of detail contained in the GVD, we can develop slide sets to present your information in a clear and concise format. Typical audiences for these slide sets include stakeholders in non-HTA markets and regional and local payers.
Objection handlers are for reactive use when your teams are challenged by payers and need to respond quickly, but accurately, with a globally-approved answer. They can be developed in collaboration with your affiliates and incorporate payer research to ensure both the questions and answers are relevant and impactful.
Training & Workshops
As you approach product launch, you will need to communicate all aspects of a product’s value to your affiliate teams. We can support you with this by presenting a range of value demonstration materials, including mock-payer training at roll-out meetings, either face-to-face or via WebEx. For face-to-face meetings, we can conduct interactive workshops to maximize engagement between attendees and ensure active learning.
Your Value Story: Key Questions to Answer
To fully understand your product’s value story, you need to take into account many different factors and perspectives. Below are some of the key questions that you need asked and that we can help answer.
|Key Factors||Key Questions About Your Product|
|Patient Perspective||Can I afford it? Is it easy for me to adopt it?|
|Payer Perspective||What outcomes matter and differentiate it? Can the system afford it?|
|Provider Perspective||What is the best possible treatment?|
|Clinical Trial Results||How will the product influence the clinical pathway? Are there data that can be leveraged at launch to influence reimbursement and market access?|
|Economics||What are the implications versus the standard of care? How do outcomes and costs impact pricing potential? How can affirmative data (e.g., FDAMA Section 114) be generated?|
|Pricing & Reimbursement Landscape||How rigorously do payers manage the disease? How have payers handled reimbursement of alternative treatments?|
|HEOR Strategy||What additional studies will be needed to improve coverage and pricing potential?|
|Literature Review||What lessons from existing studies can be applied to support its value proposition?|