HTA

Feasibility study

Scope of service:

• Requirements assessment: Any potential barriers to market entry, as well as the relevant legal requirements, will be examined.

• Analysis of clinical guidelines and potential comparators: The clinical guidelines will be analysed to determine the place of the assessed technology in the therapeutic process. Potential comparators will also be indicated.

• Cost analysis: Based on the available data, we will conduct a cost analysis to estimate the expenses or savings associated with reimbursing the new technology.

• Opportunity and risk analysis: The identification and analysis of potential opportunities and risks associated with the implementation of the project will be conducted. In the subsequent phase, we will propose strategies to ensure the optimal usage of opportunities while mitigating potential risks.

• Strategic recommendations: The development of detailed recommendations for further steps and strategies for implementation will be undertaken.

Benefits:

• Understanding the potential of a particular market: A detailed market analysis will be provided to assist in the objective assessment of the potential and likelihood of reimbursement success for the technology under evaluation.

• Documentation and comprehensive strategy: The analysis will provide all the information necessary for the rational planning of activities in the reimbursement process, including cost data and an analysis of opportunities and risks, as well as strategic recommendations.

Scoping Analysis

Scope of service:

• Description of the health problem: A comprehensive description of the health problem will be presented, encompassing its epidemiology, pathophysiology, and the impact on the quality of life of patients.

• Review of current standards of care: The analysis of current clinical guidelines and clinical practice in the country and worldwide will facilitate the identification of treatment standards for a given condition.

• Evaluation of available treatment options: A review of the current treatment methods in use will be conducted, with due consideration given to their availability and market share.

• Analysis of regulatory and reimbursement status: An examination will be undertaken of the present legal and reimbursement status of the under consideration therapies in Poland and a number of selected countries of those therapies under consideration.

• Identification of comparators: The identification of relevant comparators for the intervention under assessment will serve as a reference point in the HTA report.

Benefits:

• Comprehensive understanding of the clinical context: A comprehensive overview of the health issue and its respective treatment methods will be presented.

• Support for the health technology assessment process: The preparation of a solid foundation for further analysis, clinical and economic evaluation, and assessment of the impact on the healthcare system will be undertaken.

Clinical Appraisal

Scope of service:

• Document that meets formal requirements: The preparation of a Clinical Appraisal document is to be undertaken, the objective of which is to meet all formal requirements and provide a comprehensive description of the health effects of the medical technology under analysis.

• Systematic literature review: A Systematic Literature Review will be conducted to identify all scientific publications that meet the PICOS criteria, including primary research and secondary studies.

• Extraction and analysis of results: A comprehensive extraction of results from all included studies will be performed, and the analysis of the results will be conducted using methods appropriate for the selected material.

• Meta-analyses: If necessary, we will conduct meta-analyses of the results of identified studies. If required, network meta-analyses and MAIC analyses can be prepared. We use advanced statistical techniques to combine the results of different studies to obtain more precise and reliable estimates of clinical effectiveness.

• Comprehensive assessment of the impact of new technology: The documentation provided includes a comprehensive assessment of the clinical benefits associated with the introduction of new medical technology into the reimbursement system.

Benefits:

• Support for policy makers and clinicians: Our analyses provide reliable and credible data that supports informed decision-making by policymakers, clinicians, and other stakeholders in the healthcare sector.

• Comprehensiveness: The scope of our work extends beyond conventional presentations of clinical data; it encompasses comprehensive analyses that provide a thorough evaluation of the benefits and risks associated with the use of new technologies.

• Building knowledge of new technologies: We facilitate the establishment of trust in new technologies by providing reliable evidence of their effectiveness and safety.

• Regulatory compliance: It is assured that all assessments comply with the relevant standards and regulatory requirements.

Global cost-effectiveness model

Scope of service:

• Innovative and accurate de novo models: A variety of models are created, including Markov models, partitioned survival models and simulation models. Statistical analyses are prepared on the basis of individual patient data in R. The analytical skills of the team are constantly being refined in order to ensure that the solutions offered are as accurate as possible and tailored to the specific health problem.

• Scenario analysis: The optimal model parameterization is performed, and various solutions and scenarios are tested to maximize health benefits (QALY) and the ICER and the cost-effectiveness ratio (ICER).

• Threshold analysis: The cost-effectiveness of medical technologies is determined in relation to the statutory threshold for the cost of obtaining an additional quality-adjusted life year (QALY).

• Cross-validation: The model structure is constructed in a series of stages, and a comprehensive set of validation activities is performed to ensure the adequacy, correctness, and accuracy of the model.

• Technical report: A concise report is provided, delineating the assumptions, methodology, parameterisation, and results of the model.

• Cost-effectiveness analysis report: The preparation of a document that fulfils all formal requirements will be undertaken.

Benefits:

• Budget and time savings: The global corporate model will be prepared in a reliable and transparent manner, thus eliminating the need for further optimisation of results and the implementation of onerous adaptations.

• Ease of use and customisation: The models are flexible, making them easy to use and quick to adapt to different markets.

• Optimisation of results: The model structure is built in multiple stages, with various solutions being tested to maximise health benefits (QALY) and optimise the cost-effectiveness ratio (ICER)

• High reliability: In order to verify analytical and cost solutions, leading experts in the field of healthcare are consulted.

Budget impact model (BIM)

Scope of service:

• User-friendly model: The model provided is characterised by its pragmatism, accuracy, and intuitiveness in terms of both use and adaptation.

• Scenario assessment: A detailed analysis of various scenarios for introducing the new technology will be presented, with the aim of understanding their potential impact on the budget and determining the consequences of the most likely options.

• Comprehensive cost analysis: A precise estimate of the costs associated with the implementation of new medical technologies will be provided, taking into account both direct and indirect costs.

• User guide: A User Guide will be developed to facilitate understanding of the tool's functionality and adaptation. The training session will encompass an explanation of the model's functionality.

• Budget Impact Analysis Report: The preparation of a document that meets all formal requirements will be undertaken.

Benefits:

• Decision support: Our analyses provide reliable results that support informed business decisions.

• Easy to use and customise: The models are intuitive, making them easy to use and adapt.

• Customisation: The models are flexible and can be adapted to the specific needs of different countries and healthcare systems.

Adapting models to local markets

Scope of service:

• Assessment of existing models: A "gap analysis" will be conducted to assess the level of suitability of existing analytical materials for the requirements of a given market.

• Adaptation of models to different markets: Existing cost-effectiveness and budget impact models will be adapted to align with the specifications of the client's designated markets. We will undertake the supplementation of any missing analyses and perform local parameterization (costs, population characteristics, break-even point, etc.).

• Local validation: To ensure the accuracy and reliability of the results, additional model validation will be conducted to eliminate potential inaccuracies.

Benefits:

• Compliance with local requirements: The delivery of customized models that comply with local standards and align with market realities will be carried out.

• Improved quality and reliability: The implementation of additional validation and auditing procedures will facilitate the optimisation of existing analytical materials.

Concept of the cost-effectiveness model structure and analysis of its feasibility

Scope of service:

• Initial model design: Initial versions of economic models will be developed, tailored to specific customer needs, with key parameters and variables considered.

• Feasibility study: A detailed feasibility assessment of the model will be conducted, with a view to identifying potential challenges and opportunities for implementation.

• Scenario analysis: The development and evaluation of a range of model building scenarios will be undertaken to ascertain their potential impact on results, and the most effective approach will be selected.

• Expert consultation: In order to adapt the models to actual clinical practice and clinical guidelines, consultations will be held with clinical experts.

Benefits:

• Better project planning and management: In the context of project management, establishing a robust foundation is imperative for the formulation of pragmatic work schedules and the identification of potential project risks.

• Optimization of work effort and model results: Further work will focus on refining the appropriate model, identifying potential opportunities, and clearly articulating objectives.

• Time savings: Effective work on the correct model is dependent on adequate planning and preparation of the process.

Support for post-submission processes of the reimbursement portfolio

Scope of service:

• Process monitoring: The progress of reimbursement applications and HTA reports is monitored, with regular updates on their status being provided.

• Regulatory communication support: In order to facilitate the smooth progression of the application, we offer strategic assistance in the communication with the regulatory authorities and the preparation of responses to their queries. This is undertaken with the aim of ensuring that the application complies with the requisite requirements and of minimising the risk of delays. Responses are prepared to address both substantive questions and criticism from the Agency regarding HTA reports and comments on the Verification Analysis/Critical Appraisal.

• Application updates and amendments: If required, reimbursement applications are modified to reflect new data and changing regulatory requirements. We proactively recommend modifications to the reimbursement strategy depending on changing circumstances.

• Decision-maker negotiations: MAHTA provides assistance to its clients in preparation for the negotiation process by sharing insider knowledge and preparing analytical materials (such as an objection handler and a negotiation calculator).

Benefits:

• Increased chances of success: Our support services increase the likelihood of a successful reimbursement process, thereby minimising the risk of rejection.

• Time efficiency: The assistance provided by MAHTA is designed to accelerate reimbursement processes, thereby eliminating delays and ensuring rapid market introduction of technologies.

• Substantive support: Consulting services provided by the company facilitate improved understanding of regulatory requirements and enable effective management of these requirements.

• Behind-the-scenes knowledge: Our expertise in current trends and market realities enables us to provide informed guidance, facilitating optimal decision-making.

Audit and Optimization of Reimbursement Portfolio

Scope of service:

• Audit and gap analysis: A detailed analysis of the existing cost-effectiveness model, technical report, statistical report, relevant literature, and individual patient data from clinical trials will be performed, with the aim of identifying suboptimal solutions and areas for improvement.

• Simulations and scenarios: A range of scenarios will be modelled in order to evaluate the impact of a variety of concepts and analytical solutions on the results of the model.

• Model parameterization: In order to enhance the precision and dependability of the estimates, a range of values and solutions for the model parameters of primary significance will be examined.

• Validation: A thorough validation of the models will be conducted to ensure that they are computationally and conceptually correct and comply with current standards and guidelines.

• Optimization of analyses and narratives: The model and associated reports are updated, whilst ensuring that the narrative focuses on the therapeutic benefits and full therapeutic value of the client's product.

Benefits:

• Optimization of results: Reflection of the full value of medical technology in the model, expressed through QALY and ICUR results.

• Maximization of reimbursement success: Optimization and reliability of the threshold price estimate for medical technology will increase the success of the negotiation process.

• Reduction of critical comments from the HTA Agency: As a result of our work, the reimbursement portfolio is complete and compliant with HTA guidelines.

Training courses

Scope of service:

• Training programs: MAHTA provides training programmes in the field of HTA and market regulations, which are comprehensive in nature and tailored to the needs of various target groups, including those with different levels of expertise.

• Educational materials: The materials provided are of a high quality and include presentations, spreadsheets and case study examples.

• HTA experts: Training courses are led by experienced specialists who share their knowledge and experience in the field of medical technology assessment.

• Tailored to specific needs: Training programs are flexible and can be tailored to specific customer requirements.

Benefits:

• Increased competence: Our training courses help participants gain the knowledge and skills necessary to understand issues in the field of health technology assessment.

• Decision support: Trained participants are better prepared to make informed strategic decisions about new medical technologies.

• Increased efficiency: Thanks to our training, organizations can make better use of their resources and increase the efficiency of HTA processes.

• Acquisition of practical skills: The skills acquired during the training allow participants to independently carry out selected analyses in the field of health technology assessment.