Health Care Consultancy is specialised in out-patient and in-hospital market access projects for (orphan) medicinal products, vaccines, cell therapies, immunotherapies, medical devices and medical technologies.
We are equipped to provide the full coordination of market access projects for multiple European countries. Furthermore, we work together with a selected team of European partners that apply the same thorough and dedicated methods as we do. Among the European partners are Belgium, Germany, Italy, France, Spain, the United Kingdom/Scotland, Portugal, Scandinavia, Austria and Switzerland.
(see section: European Group)
Our team creates complete market access dossiers containing sections on therapeutic, economic and budget impacts. We do not aim to write encyclopedia but focus on competent and result driven data processing that is understandable for the assessing committee members. Similarly, we provide tailor-made documents for regional or local access procedures, such as negotiations between hospitals and health insurance companies. Reviewing dossier services are provided as well.
We provide full coordination and execution of market access procedures and ensure that dossier elements and market access activities reflect a consistent approach. Based on our helicopter view, we guarantee that all involved partners are aligned. For efficiency reasons, we prefer to work closely together with the client team members and perform the coordination and execution by our senior consultant and one assisting staff member to maintain continuity and progress.
As a result of our creativity in seeking solutions within the formal access procedures, we continue to be successful in getting the product available to the patient. Consistently, against all expectations, we managed to find innovative solutions for complex cases; where others deemed market access impossible, we succeeded.
A specialized expert team is equipped to perform a European SCAN to identify key issues in the market access of new products or therapies throughout Europe. We analyze facts with three levels: medical, disease and reimbursement, in order to find the optimal strategy and legal facts and stakeholder analysis are part of this analysis. Though some issues may be facilitated on a corporate level, other issues need a local approach, therefore, strategies and road maps are generated.
Beyond dossier writing and management of market access procedures, we have access to providers for legal support, support on key opinion leader management, pharmacovigilance, monitoring and registries, hospital financing structures, health insurers management and home care facilities, and, if necessary, also expert procedures for creating appraisals, consensus reports and guidelines (see also www.global-expertsfoundation.com).
We have developed a helicopter view approach through our contacts with numerous health care stakeholders, and, therefore, we are skilled to coordinate market access projects that include professional societies and patient organizations. Our personalized approach and professional attitude results in effective and tailor-made stakeholder management. In numerous projects, stakeholders fully accepted our role and cooperated to achieve the project’s common goal: patient access to effective therapies.
Our expertise has been extended by a European SCAN in which we matched the market access strategies and outcomes in three countries for a new product in breast cancer development. We compared the international market access assessments and learned that, though the clinical data set was similar, the health authorities had different considerations and decided differently on market access in each country.
Grade system applied on orphan medicinal products:
We experienced the application of the GRADE system in the market access assessment procedure of an orphan medicinal product. Whether the outcome proves to be satisfactory or not, we questioned its application (explain).