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Pricing and Reimbursement of Nanomedicine

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Pricing and Reimbursement of Nanomedicine

 

An important aspect for a realistic estimation of a return of investment for a new nanomedical product is the eligibility for reimbursement by health insurances. This decision is taken at the national level based on criteria such as efficacy or innovation potential:

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As pricing and reimbursement of Medicinal Products (pharmaceuticals) are subject to the individual responsibility of each member state, various systems exist at present within the European Union.

The entry portal for application for reimbursement of medicinal products are, as a rule, ministries which ask expert teams to categorize the product according to the criteria as mentioned above.

Pricing and reimbursement processes are conducted by one or two different authorities. In general, a Europe-wide price comparison of pharmaceuticals precedes the national price setting procedure. The comparison involves economic viewpoints such as pharmacological tests, the assessment of a therapeutic benefit and a health technology assessment.

Pricing is effected, in most instances, on the basis of the manufacturer’s price. In some countries, the wholesale price basis applies. If a pharmaceutical is publicly financed, a governmental authority defines the price on the basis of statutory pricing, supported by a relevant body, e. g.: a pricing committee. This procedure is often amended by individual price negociations.

In some of the EU member states, product pricing is determined by negotiation between the individual hospital and the medical device company. In most Member states a system of Diagnosis Related Groups (DRG) is used to set a price for a particular medical procedure, including any medical device that will be used in this procedure.

Health Technology Assessment (HTA) is used to decide which product will be formally approved for use in a procedure ensuring that only those medical devices are reimbursed which are clinically and economically effective. HTA is a comprehensive process to evaluate the social, economic, organizational and ethical issues of a health technology. It becomes increasingly important for reimbursement decisions.

An assorted list of international HTA Agencies can be downloaded here.

 

 

Ecosystem of Nanomedicine:

EU Regulatory Process  >> International Regulatory Processes >> Clinical trials >>  Pricing and Reimbursement


Contact:

Should you have any question or require further information related to the ecosystem of Nanomedicine, please contact:

Dr. Klaus-Michael Weltring
Gesellschaft für Bioanalytik Münster e. V.
Tel. +49 (0)251 38450333
weltring@bioanalytik-muenster.de

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