Tasks & Targets of Market Access
Until recently, 3 hurdles in the "developed" markets had to be managed in the approval process for new pharmaceutical preparations / products:
- The demonstration of the therapeutic efficacy (through various clinical studies of phases I to IIIa, also corresponding with the patient size of the target indications: normal cases, expedite procedures, orphan drug procedures, etc.)
- The demonstration of toxicological harmlessness (by means of the data evaluation of preclinical studies and toxicological profiles, as well as the detection of undesirable drug effects / "side effects" in the clinical trials of phases I - III a)
- The proof of pharmaceutical quality (via GMP, GLP, etc.)
The ICHs (International Conferences of Harmonization) have harmonized the approval procedures for the above-mentioned 3 key criteria for the USA / Canada, Europe and Japan. This also benefits the internationally active pharmaceutical and healthcare groups.
Firstly, in the Anglo-Saxon region (Australia, Canada, and in some regions of the USA, UK [NICE]), further procedures were developed to examine the economic benefits (perspective: payers) of innovation vs. “tradition”, e.g. in comparison to existing procedures. These assessment methods, known as Health Technology Assessments (HTAs), represent established standards in these countries.
Germany prioritized – in comparison to the “Anglo-Saxons” – other directions with the AMNOG ("German Rehabilitation Law = Arzneimittelneuordnungsgesetz”). We will discuss this in the section below.
In a "holistic" market access process, the challenge is not only represented by the three abovementioned approval hurdles, but further and especially in the collection, documentation and evaluation of evidence-based data on the cost-benefit efficiency of innovations [e.g. comparative clinical studies of phases IIIb / IV and their evaluations as well as "piggyback” questions], carrying out meta-analyses to studies as well as intelligent modeling (e.g. Markov simulations, etc.)
It has not been enough for a long time and especially currently and in the future to deal with the market entry rather late and in the narrower pre-registration phase (with market entry and, parallel to this, with measures for securing the market). A much earlier start of market access procedures - approximately 3 years before the planned launch - is mandatory now.
Due to the 4th hurdle "benefit assessment", it is particularly necessary in Germany to put the added value of a new active substance to test as early as possible in the process of developing new drugs.
The „medical add-on-benefit” is the keyword of "innovation compared to tradition". The patient groups that benefit from the innovation are the "key determinants" of the utility definition: showing the net use of a (new) drug.
Thus, only if it is possible to set success criteria based on validated data and outcomes at an early stage for satisfying reimbursement with pricing as high as possible. Accordingly, the high investment costs of the development phases of innovation will come to an adequate RoI. This has to become "habitual" for "affiliates", but also for the HQs of the provider groups.
Due to the special or specific emphasis on the (additional) benefit and the added value of a new pharmaceutical product or a medical technology innovation, Market Access does not only extend to the phases of research and development (i.e. prelaunch). Market Access also has to be included in the phases after market launch – it is crucial for the value presentation and acceptance of an innovative product or innovative intervention / measure.
In companies - on the provider's side - market access is required and prioritized for the complex and challenging process and has to integrate: upper / executive management, service providers and specialists in medical and marketing affairs, market analysis and then coordinating, stimulating and controlling: the specialists of Market Access Units and -Teams.