NorthWest Biotherapeutics Inc (NWBO)

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Also see
http://www.taylorwessing.com/synapse/regulatory_personalised_medicines.html
which includes:

The reimbursement framework in Germany
German flagWhile the legal frameworks covering the authorisation of medicinal products and medical devices are largely harmonised within the EU, decision-making in pricing and reimbursement matters remain within the competence of each Member State. Here, the reimbursement framework in Germany shall be taken as an example to demonstrate dissimilar pathways for medicinal products on the one hand and companion diagnostics on the other.
The German statutory healthcare system provides patients with access to technologically-advanced products and is a focus market for numerous manufacturers. As the social health insurance system covers approximately 90 per cent of the German population, reimbursement of their products via the statutory insurance system is essential to pharmaceutical and medical devices companies. However, Germany remains a complex market for personalised medicine products: while the medicinal product is usually available right after market authorisation (with a benefit assessment procedure running in parallel, see below), it can take several years until the companion diagnostic is accepted for reimbursement within the statutory healthcare system.
Since January 1st 2011, new pricing regulations have been in place for newly authorised medicinal products and their reimbursement by statutory health insurance providers. The G-BA (a public body comprising the head organisations of doctors, hospitals and the statutory health insurance) and the Institute for Quality and Efficiency in Health Care (IQWiG) conduct benefit assessments of newly authorised medicinal products. Their results form the basis of decisions on the prices statutory health insurance funds pay for pharmaceuticals with new active ingredients.
By contrast, the reimbursement of a companion diagnostic depends on whether it is applied in hospital (inpatient) treatment or ambulatory (outpatient) treatment.
On outpatient basis, reimbursement is only available if the companion diagnostic is listed in a specific catalogue of reimbursable services (EBM - einheitlicher Bewertungsmaßstab), which is often not the case. In addition, the use of a companion diagnostic may fall within the (inconsistent) definition of a novel diagnostic or treatment method (neue Untersuchungs- und Behandlungsmethode). In this event, a separate recommendation of the G-BA is needed before the product can be included in the EBM catalogue. However, this procedure can only be initiated by certain members of the G-BA, the head organisations of doctors and the statutory health insurance as well as patient organisations, while manufacturers are denied this right.
In the inpatient care system, diagnostics are mostly covered by DRG (diagnosis related groups) global case-based payments. Compensation of individual treatment or interventions is not obtainable. Depending on the underlying case-based fee, providers may have to operate under considerable cost pressure, e.g. if the companion diagnostic is very cost-intensive. An alternative for reimbursement would be the “NUB” (novel diagnostic or treatment method) track. Yet, the “NUB” definition is different from the one used for ambulatory treatment and applications have to be made to a special institute (InEK - Institut für das Entgeltsystem im Krankenhaus GmbH) by each individual hospital. The final decision on reimbursement is made by local health insurances that might anticipate cost increases for companion diagnostics and often take a restrictive approach as far as the reimbursement of new diagnostic or treatment methods is concerned.
Conclusion
Machine for testingWith personalised medicine playing an important role in determining which therapies are the safest and most effective for a particular patient, investment of lengthy research and development should be acknowledged by a transparent and predictable authorisation and reimbursement system. By addressing the challenges of drug and diagnostic co-development openly, a practicable and standardised co-ordination of the relevant pathways for medicinal products and IVD developers is – both from a medical and legal perspective – to be encouraged.
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