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When undertaking this assessment it is also important to look beyond reimbursement. Some health technologies might be funded by other budgets than reimbursement. For example Public Health programs often have separate dedicated budget from the Ministry of Health

When performing a landscape assessment (aka, reimbursement assessment), working with "country archetypes" helps rationalizing the search process. Although there will of course be specificities in each market, this allows grouping countries in categories that have similar types of evidence requirements. Based on the type of evidence available (or anticipated) for the product, you can then prioritize some countries.

Review Systems: Analyze Data: Examine current reimbursement rates, processes, and claim outcomes. Identify Gaps: Look for common issues such as denials, delays, or insufficient coverage. Consult Stakeholders: Provider Feedback: Understand challenges faced by healthcare providers. Payer Insights: Get input from payers about policy limitations and areas for improvement. Patient Perspectives: Gather patient feedback on their experience with reimbursement and out-of-pocket costs.

To address gaps in reimbursement systems, engage stakeholders to understand challenges, analyze real-world data to identify issues, use health technology assessments for evidence-based recommendations, and collaborate with regulators for necessary policy changes.

Talking about Medical Device field in Europe, it is important to emphasize that each country has different reimbursement mechanisms. Identifying the reimbursement mechanism first will determine further steps of the reimbursement analysis. Furthermore, policy analysis (i.e., whether there are any barriers for adoption, where exists) and HTA analysis (where this is a stand-alone process) should complement reimbursement analysis to get a full picture.

It is critical to think about your Reimbursement strategy early in the context of your product development strategy. With the development of adaptive trials, you usually only have one (early) opportunity to integrate the evidence elements that will be required by Pricing & Reimbursement, as well as HTA authorities. If you do not consider that priority early enough, you may end-up not being able to obtain acceptable pricing & reimbursement conditions, or even be unable to commercialize your product.

Reimbursement strategy is typically based on good reimbursement analysis (previous step), and may have three pillars, depending on the country: Overcoming the reimbursement barrier (coding/payment), overcoming the barriers towards adoption by care providers (coverage/funding), and overcoming the HTA barrier (if a stand-alone process, not related to reimbursement process). The strategy itself depends on the available evidence, and whether it can meet the evidence requirements (different per country and per process).

Develop Solutions: Create Plans: Design strategies to address identified gaps, such as new reimbursement models or policy changes. Align Objectives: Ensure strategies are aligned with both global and local goals. Prioritize Issues: Impact Analysis: Evaluate which gaps have the most significant effect on access and financial outcomes. Focus Efforts: Address high-priority issues first for maximum impact.

In the same way as general communication, value communication in market needs to be tailored foreach specific audience. Not all stakeholders are interested in the same things. The communication channels and formats also have to be carefully selected for maximum impact.

Value communication is multidimensional and goes beyond creating the specific tool/tactic. For example, if the objective is to create a value proposition deck, there has to be an intentional approach to building out the elements of the core value proposition - starting with a stakeholder mapping exercise to understand all the market access stakeholders involved. Then, once the core value proposition has been developed, an alignment exercise within the team to ensure the core value proposition messages are mapped against the stakeholder mapping output is the first step developing a compelling value story. Tactics without alignment and training are unlikely to actually produce results.

Value Communication: Articulate Benefits: Craft Messaging: Develop clear messages that highlight the benefits of your product or service. Tailor Communication: Adjust messages for different stakeholders (payers, providers, patients). Use Evidence: Present Data: Provide strong clinical and economic evidence to support the value of your offering. Show Impact: Use real-world outcomes and cost-effectiveness analyses to demonstrate value.

Reimbursement monitoring is crucial for preparing manufacturers for future reimbursement reviews, which may occur in a few years, depending on the market. Post-marketing studies to collect RWE can be pivotal in maintaining both reimbursement and pricing levels, and data generated in one country or indication can provide leverage when expanding to other countries or indications.

We also need to anticipate reimbursement reviews and reassessment of the health technologies by the HTA agencies and payers. Therefore it is important to plan post-marketing clinical and health economics studies (ex RWE, HEOR) to defznd the reimbursement

Reimbursement Monitoring: Track Changes: Stay Informed: Monitor updates to reimbursement policies and regulations. Assess Effects: Evaluate how these changes impact your reimbursement strategy. Assess Effectiveness: Measure Performance: Track key metrics such as approval rates and claim processing times. Refine Strategy: Use performance data to make necessary adjustments to your approach.

Several years ago, I worked on building a platform to collect reimbursement status of devices in all markets of the International region at Medtronic. I trust that this should be a first step to have easy access to the existing reimbursement status info. Otherwise, it is complicated to define strategies and tactics if data is split everywhere.

Reimbursement Best Practices: Standardize Processes: Implement Practices: Use proven best practices for documentation and claims processing. Simplify Claims: Streamline the claims process to reduce errors and delays. Share Knowledge: Engage in Networks: Participate in industry forums and professional groups to exchange insights. Train Teams: Provide training on best practices and policy updates to ensure compliance.

Additional Considerations: Leverage Technology: Use Analytics: Apply data analytics to identify trends and predict reimbursement issues. Automate: Implement automation tools to streamline claims and track performance.

When preparing a reimbursement strategy, do not forget to: - Holistically review and understand the evidence situation - Determine the gaps in the available evidence vs the evidence requirements - Consider Coverage with Evidence Development Schemes, which might help generating missing evidence - Remember that the process might take several years, depending on the country and stop-clocks (quality of evidence)