Launch excellence and thorough planning is critical to success in access. As part of that, HTA submissions are an integral part of many reimbursement procedures across many key healthcare markets. Good execution requires excellent organization, strategic insight, good analytic capabilities, and attention to detail, as well as advanced clinical communication skills.
Our diverse team of experts makes us ideally placed to seamlessly weave together the clinical and economic stories within your HTA submission to communicate a compelling and clear strategic narrative. We are confident in advising clients on how to manage different strategic HTA challenges related to their clinical and economic evidence package. We also provide advisory services based on analyses of previous HTA submissions as well as specialist advice through clinical and economic advisory boards. Amaris teams are fully integrated and set up to deliver all parts of your HTA submission, including the systematic reviews, indirect treatment comparison (including individual patient data analyses), economic models, and the submission documents. Our complete HTA solution provides efficiency and consistency in delivery, resulting in a strong and compelling HTA story.
HTA submissions are an integral part of many reimbursement procedures across most important healthcare markets. With an increasingly complex landscape of medical technologies and therapeutic indications, having a well thought-out HTA dossier is critical to reimbursement success. Good execution requires excellent organization, strategic insight, good analytic capabilities, and attention to detail, as well as advanced clinical communication skills. Our diverse team of experts makes us ideally placed to seamlessly weave together the clinical and economic stories within your HTA submission to communicate a compelling and clear strategic narrative. We are confident in advising clients on how to manage different strategic HTA challenges related to their clinical and economic evidence package. We also provide advisory services based on analyses of previous HTA submissions as well as specialist advice through clinical and economic advisory boards. Amaris works internally as a single team to deliver all parts of your HTA submission, including the systematic reviews, indirect treatment comparison (including individual patient data analyses), economic models and submission documents. Our complete HTA solution provides efficiency and consistency in delivery, resulting in a strong and compelling HTA story.
Our services in HTA services include:
- Reimbursement dossier writing
- Reimbursement submission strategy
- Advisory boards organization
- Clinical and disease burden evidence adaptations
- Economic model adaptations
We have experience in the following therapeutic areas:
Our HTA team has conducted submissions in various disease areas including oncology, autoimmune diseases, infectious diseases, mood disorders, metabolic, and cardiovascular and respiratory diseases, as well as orphan diseases. We have worked on nearly 100 submissions to key health technology assessment agencies, including NICE, CADTH, HAS, INESS, GBA and ICER.
Focus on one type of project: The Amaris HEMA team has extensive experience in supporting pharmaceutical and medical device companies with their reimbursement submissions worldwide. Key markets within which we offer reimbursement submission services include the United Kingdom, France, Spain, Germany, Canada, and the United States. At Amaris we understand the importance of being a flexible partner, especially when it comes to dynamic projects such as submissions where strategy can change often as product evidence evolves over time. This is why we always tailor our services based on individual client needs and manage project team resources accordingly.
Here is how we would typically conduct an HTA submission project:
Step 1. Project initiation:
Conduct overall project risk assessment. Assign teams for different workstreams as the project requires while ensuring a common link for efficient knowledge exchange. Define roles and responsibilities between Amaris and client team members. Align on timelines and rounds of reviews within and between workstreams, especially if evidence behind the asset is expected to evolve during the project delivery.
Step 2. Preparation of submission:
After an initial review of the clinical and economic evidence packages against the decision problem which the company needs to answer or propose, Amaris typically conducts an overall assessment to discuss risks and mitigation strategies. Any need for project plan amendments are discussed and implemented. Once preliminary submission strategy has been agreed on, the teams proceed with preparation of any submission analyses and documentation. A typical workflow would include:
- Evidence adaptation: Economic and clinical evidence collection is typically needed to ensure that the submission is sufficiently tailored for the geographical context in which it is done. This is typically conducted in either a targeted or a systematic way. Where evidence is lacking, primary data collection can also be initiated. Economic model adaptations are planned and executed as required by the specific context of the submission. For more information on our economic modelling capabilities, please see our services in health economics.
- Writing of the submission document: An initial outline of the submission document is developed, outlining the key arguments and messages we want to communicate, together with the most important data in support of those. Once there is a general agreement on the submission document outline, the team proceeds with the drafting of the full sections of the submission document. After a number of multidisciplinary reviews this is finalized. The submission is developed by a team composed of technical experts as well as medical writers to ensure a well-balanced and impactful document. Several quality check steps are followed by the Amaris team to ensure document consistency and quality, beyond use of language. Cross-references, links, and references are checked for errors and duplications before finalization and submission of the final documents.
Step 3. Post-submission support:
After final submission to the evaluators, Amaris remains available to manage any clarification questions or requests for further analyses. These are treated with priority once received by the team and managed clearly and concisely.
We believe that the following elements are our key success factors when performing HTA submissions:
- Multidisciplinary project teams working together to ensure a well-written and scientifically robust submission document
- High flexibility to ensures a fast turnover of document drafts and data analyses
- Processes and procedures in place to ensure the highest quality of deliverables across our offices
- Thought leadership: Our team of experts has extensive experience in navigating the evidence complexity which often is associated with submission, especially if used to support a product value proposition
- Access to local knowledge and experience: a key differentiator to drive strategy during HTA evaluation
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