Example Market Access:
Until recently, there were 3 hurdles in the approval process for new pharmaceutical preparations/products in the "developed" markets:
- Proof of therapeutic effectiveness (through the various clinical studies in phases I to IIIa, in the order of magnitude depending on the target indications: Normal Cases, Expedite Procedures, Orphan Drug Procedures, etc.)
- Proof of toxicological safety (through the data evaluation of preclinical studies and toxicological profiles, as well as the recording of undesirable drug effects/"side effects" in the ongoing or completed clinical studies of phases I - III a for approval)
- Proof of pharmaceutical quality (via GMP, GLP, etc.)
The ICHs (International Conferences of Harmonization) have harmonized the approval procedures for the USA/Canada, Europe and Japan with regard to the 3 key criteria mentioned above. This is also to the advantage of the international pharmaceutical and healthcare groups in particular.
Initially in Anglo-Saxon countries (Australia, Canada, and in some regions of the USA, UK [NICE]), further procedures were then developed in order to compare the economic benefits of innovations vs. the costs to be borne by the healthcare systems (payers) in comparison to already to present or prove the existing procedures. These assessment procedures, known as Health Technology Assessments (HTAs), are now standard in these countries.
With the AMNOG (Arzneimittelneuordnungsgesetz), Germany "additionally" took a different path than "the Anglo-Saxons" in a number of aspects.
Key statement:
In a "holistic" market access process, the challenge lies not only in the 3 aforementioned legal hurdles, but above all in the collection, documentation and evaluation of evidence-based data on the cost-benefit efficiency of innovations with explanation of the (additional) benefit [i.e. also comparative clinical studies of phases IIIb / IV and their evaluations together with "piggy back questions], carrying out meta-analyses on studies and intelligent modeling (e.g. Markov simulations etc.)
The life science and health sector is constantly faced with the challenge of more than meeting disproportionately high health policy, economic and technological requirements.
The purpose of many companies in the health and medical technology sector is to develop and manufacture services in the service of health and products made from the most modern materials and in compliance with the strictest quality aspects.
Real innovation combined with high quality of services and products and cost-effectiveness of the application is the top priority.
In order to be successful in the future as well, companies in this industry must constantly change dynamically and adapt to the current circumstances.
Companies in the life sciences sector need networked and holistic solutions.
When it comes to personal well-being, the effect of medication or complex medical technology, doctors, pharmacists, clinics, pharmaceutical companies or device manufacturers face special challenges in customer service.
Because in the heavily regulated life sciences sector with its numerous regulations, reliable information is required on all channels at all times of the day and night.
Customers expect personalized support with a high level of competence and trustworthiness, quick help and an overview at all times, even in critical situations, the protection of confidential data and compliance regulations.