Market Access

Landscape Analysis

Scope of service:

• Trend analysis: A thorough analysis of the current market situation and trends that may affect the development and commercialisation of the analysed product will be conducted.

• Assessment of competing products: The identification of key products, along with their assessment with regard to potential and market share, will be undertaken.

• Identification of regulatory and reimbursement barriers: A precise analysis of regulatory requirements will be conducted, and benefits for patients and the healthcare system, as well as potential risks that may be encountered during the reimbursement process, will be identified.

• Stakeholder mapping: The identification of key stakeholders, including decision-makers, payers, opinion leaders and patient organisations, will be a crucial aspect of the research.

• Strategic recommendations: A market entry strategy will be formulated, considering the specific characteristics of the product, reimbursement requirements, market realities, and competing products.

Benefits:

• Complete market overview: Comprehensive market knowledge will be provided to enable informed and accurate business decisions to be made.

• Identification of market competition: The identification of key competitive advantages for the product will be undertaken.

• Effective strategy: The assistance provided will encompass the development and implementation of a strategy that is aimed at ensuring success.

Support groups

Scope of service:

• Identification of stakeholders: We will identify key institutions, including decision makers, payers, opinion leaders, patient organisations and other support groups that can influence the reimbursement success of the analysed product.

• Stakeholder analysis: The role of each stakeholder will be analysed, as will the extent of their support for the reimbursement process and their potential assistance in the commercialisation of a particular type of medical technology.

• Mapping: A strategy to build positive relationships and their impact on the progress of the refund process will be developed.

• Engagement strategies: The development of strategies to assist in the establishment of relationships with key support groups/stakeholders will be undertaken.

• Increased efficiency: The subsequent section will propose a series of strategies that will be utilised in order to facilitate the effective realisation of pre-established goals through the medium of individual support groups.

Benefits:

• Complete stakeholder picture: The identification of key institutions and their interrelationships in order to manage them effectively shall be undertaken.

• Enhanced strategic decision-making: An analysis will be provided of the impact of cooperation with individual support groups, and the group that may be key to achieving the objectives will be identified, as well as groups whose support would be beneficial.

• Effective engagement: The development of relationship-building strategies will be undertaken to increase support and engagement among key groups.

Strategic solutions

Scope of service:

• Market analysis: A market analysis will be conducted within the scope agreed upon in advance to facilitate understanding of its dynamics, key trends, and needs.

• Reimbursement strategies: The development of strategies to ensure positive reimbursement decisions shall be undertaken.

• Product evaluation: We will prepare a comprehensive evaluation of the specified product, considering clinical, economic, financial and social aspects.

• Market Access Planning: A detailed plan for applying for a reimbursement will be developed, tailored to the specific nature and requirements of the market.

• Stakeholder management: The establishment of lasting relationships with key stakeholders will support long-term market success.

Benefits:

• Enhanced market awareness: A comprehensive analysis will be provided to enable informed strategic decision-making.

• Greater chances of a positive reimbursement decision: The development of effective reimbursement strategies, tailored to the expectations of the decision-maker and payer, will be undertaken.

• Optimisation of the market access process: Assistance will be provided in the preparation and implementation of a plan to enhance the competitiveness of the product.

• Effective relationship management: The establishment of long-term relationships with key stakeholders will be facilitated in order to support long-term market success.

Submission of refund request/SOLR service

Scope of service:

• Refund Letter Service System (SOLR) Administration: The assistance provided includes the creation of an SOLR account and comprehensive support withfor its use.

• Preparation of application documents: We will provide assistance in the compilation and preparation of all requisite documentation for the purpose of submitting a reimbursement application, in accordance with the formal requirements that are in force.

• Submission of the application: A reimbursement application will be submitted in the SOLR system on behalf of the client, ensuring that all requisite data is accurate and complete.

• Process monitoring: The application assessment process will be monitored on an ongoing basis, with the Client being informed of any progress and any additional requirements. This is of paramount importance due to the exceedingly limited timeframe in which responses to received requests must be prepared and submitted.

• Support at other stages of the process: Where necessary, we will make the requisite additions and provide explanations regarding the comments made by the entities processing the reimbursement application (Ministry of Health, AOTMiT, others).

Benefits:

• Comprehensive support: encompasses every stage of the reimbursement application process, including the compilation of necessary documentation, active monitoring of the status, and the subsequent receipt of the reimbursement decision.

• Compliance: All documentation and applications are meticulously reviewed to ensure adherence to current formal and legal requirements, thereby minimising the risk of delays.

• Constant communication: In order to ensure the highest standards of transparency and security, the client will be kept informed of progress and any additional requirements throughout the process.

Advisory Committees

Scope of service:

• Meeting planning: Assistance will be provided in the planning of Advisory Board meetings, with consideration given to the client's objectives, agenda, and key topics for discussion.

• Selection of experts: The relevant specialists will be invited to cooperate, thereby providing valuable opinions and expert knowledge.

• Logistics: The logistical aspects of the event will be managed by a dedicated team, including the reservation of seats, the organisation of travel, and the arrangement of accommodation for all participants.

• Moderation of meetings: We will ensure that meetings are conducted professionally, guaranteeing smooth discussions and the achievement of the set goals.

• Documentation and reporting: The detailed reports on the course of the meetings will include conclusions and proposals for future proceedings.

Benefits:

• Access to expert knowledge: The experts who are recommended by MAHTA provide valuable guidance and analysis to support decision-making processes.

• Diverse perspectives: The selection of experts will be conducted in a way that ensures a substantive discussion and that the conclusions reached will consider a range of perspectives.

• We take care of the logistics: The logistical aspects of the meeting will be managed by MAHTA, thus allowing our clients to focus on the substantive part of the meeting.

HEOR and Market Access Team support

Scope of service:

• Process Coordination: We provide support to our clients' teams through MAHTA experts, who have extensive experience in coordinating projects and monitoring complex processes. The MAHTA experts have a solid understanding of market realities and the expectations of decision-makers.

• Assessment of available analyses: Furthermore, we will indicate which analyses and studies, as well as their components, offered by other external partners are truly crucial for the success of reimbursement processes.

• Communication with local market access providers: To facilitate cooperation between companies and local partners, MAHTA provides market access services. This measure aims to prevent misunderstandings and accelerate the achievement of objectives.

• Market access activities: We provide a comprehensive market assessment, ranging from analysis of different types of barriers to support in negotiations with payers.

• Stakeholder engagement: We facilitate communication and cooperation with key stakeholders, including decision makers, payers, clinicians, and patient organizations, to ensure a smooth product launch process.

Benefits:

• Optimisation of resources: the main benefit of such a cooperation is the saving of time and budget, ensuring process optimisation.

• Time saving: By outsourcing selected tasks to MAHTA, our Client can focus on other areas of their business.

• Optimisation of offers: A dedicated MAHTA expert will assist in evaluating proposals submitted by external partners for analysis/reporting to ensure they provide real value to our Clients.

• Improving analytical tools: A dedicated MAHTA expert will be able to assess the quality of analysis provided to our Client by various partners and suppliers.

• Comprehensive service: Clients cooperating with MAHTA benefit from the experience of the entire MAHTA Team and receive support in all areas related to HEOR and Market Access.