HTA, Pricing and Reimbursement
Based on years of experience developing over 250 HTA/AMCP dossiers on behalf of our clients, Mapi understands that each phase in the adaptation process poses unique challenges. We often find that the literature review is not complete or not compliant with the specifications from local Health Technology Assessment (HTA) authorities; that there are no local weights for the utilities available and local resource data is scarce. The core model needs more than just quick changes to the inputs, as it needs contextualized local inputs. Common issues include price (window) ambiguity and delayed local Key Opinion Leader (KOL) involvement, impact championing, and adoption.
Starting early and working with the right experts makes all the difference in optimizing your product launch from an access perspective. Our experts work with you to critically review and synthesize your clinical, health related quality of life, and economic evidence, and we generate real-life data to ensure that your economic model and submission dossier will resonate with your key stakeholders.
Preparing Your Local Submission: The Mapi Way
Mapi is the right strategic partner for your next pharmacoeconomic dossier/submission. The HTA landscape is always evolving, and Mapi has the experience and expertise needed to generate and collect the right data for a successful local submission.
It’s About Time
There are many variables impacting the development of a local submission, and one of the biggest is the underestimation of time needed. Timelines are a vital part of each phase, and each phase has its own unique time requirement.
At Mapi, we understand how important time management is with your adaptation, and we work to actively shorten your timeline by becoming involved much earlier in the process than other partners, anticipating challenges, and engaging key opinion leaders early and often.
Local Submission Preparation
Our first step is to ensure that our teams are aligned on the strategy and positioning of your product. Our depth of industry experience makes this easy for both parties. We then critically review all data in-house, including systematic literature reviews and network meta-analysis, to ensure these are fit for purpose.
Mapi experts thoroughly investigate the core model, including model specifications, to understand its implications for patients, interventions, comparators, and studies. Next, we engage stakeholders by testing and refining your value messages for KOLs, as well as entering into early discussions with authorities.
Review of Materials
As we enter the Review of Materials phase, Mapi experts perform a full preparedness test for all of the materials, assumptions, and inputs. We conduct systematic literature search for inputs needed. KOLs are closely involved in validating model structure, relevant subgroups, comparators, and assumptions from the beginning onwards.
Local Model Adaptation
We also confirm any structural changes to models, checking items like: the need for additional comparator/subgroup(s), additional cost categories (i.e. direct and indirect costs), and alternate presentation of results including uncertainty analyses.
Mapi then prepares an overview of your project’s data requirements. We prioritize data collection based on transferability:
- High transferability: treatment effect
- Medium transferability: patient characteristics, baseline risk, and health utilities
- Low transferability: population characteristics, resource use, and unit costs
Next, a gap analysis is performed, and we collaborate with you on the methods necessary to fill data gaps. These methods can include targeted analysis, KOL interviews, registry accesses, and chart reviews.
At the data collection phase, we prioritize involving KOLs in validating all inputs.
HTA Dossier Development
If price is not available at the beginning of the dossier development phase, Mapi works with you to discuss and agree on a range of prices that are likely. We also discuss the value statements that correspond to all possible outcomes of the model and ensure that these are aligned with the Global Value Dossier. Finally, results tables are prepared for easy updating. Once price is available, Mapi updates the results tables and the final conclusion/value statements.
To ensure no unnecessary delays in dossier development, Mapi undertakes preparatory tasks, in parallel where possible. Mapi also provides extensive aftercare, and all questions raised by reviewers will be swiftly handled. Based on years of experience, however, we’ve found that not many questions on the methods applied will be raised while working with Mapi.