Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Das IQWiG als neuer Eckpfeiler bei der Entscheidungsfindung des Portfolios der Generikaunternehmen

Carola Seidel (Abschlußjahr: 2008)

Language: Deutsch

The growing demand for long-term changes in the German health system to improve the quality and efficiency within the domain of statutory health insurance funds (SHI funds) results in a new law - the SHI Modernisation Act, legally effective from January 1st, 2004. One of the outcomes is the establishment of the Institute for Quality and Efficiency in Health Care (in Germany called IQWiG) undertaking commissions from the Federal Joint Committee and the Federal Ministry of Health on the evaluation of benefits of medicinal products. Since April 1st, 2007 this has been legally expanded to the evaluation of cost-benefit ratios of medicinal products.

The findings of the IQWiG are published in final scientific reports, which are forwarded to the Federal Joint Committee and the Federal Ministry of Health. Based on these reports the Federal Joint Committee is authorised to limit or exclude the reimbursement by the SHI funds in annex 10 of the prescribing guideline provided that the Federal Ministry of Health agrees. Legal basis for the prescribing guideline is given in Book V of the Social Code.

The prescribing guideline states that these limitations or exclusions are justified, if according to the generally accepted current state of medical knowledge the therapeutic benefit, the necessity or efficiency are not proven as well as if a further available treatment, having the same therapeutic benefit, is more efficient. Due to the fact that 90% of the German population are insured by SHI funds, reimbursement limits or exclusions significantly affect the sales volume of the corresponding medicinal product, as a large proportion of sales market will become inaccessible.

This Masterthesis is meant to demonstrate that the IQWiG builds a new cornerstone in the decision process of the portfolio of generic companies.

Generic companies have to regularly decide whether to develop generic medicinal products by themselves or whether to in-licence such products in order to generate their portfolio. With regard to own developments it is of vital importance to start intime insuring product launch being directly on patent expiry. Thus, decision process for own developments should occur eight to ten years before patent expiry; whereas to in-licence a medicinal product can be handled relatively in short-term.

Based upon the aforesaid, during the development period generic companies bear the risk to develop a generic medicinal product whose reimbursement can be limited or excluded by the Federal Joint Committee based on the benefit respectively in near future cost-benefit evaluation of the IQWiG. It was demonstrated by case examples that the Federal Joint Committee makes use of this privilege and that his decisions rest on the scientific reports of the IQWiG. In this connection it gets clear that the new definition of the patient-related benefit of the IQWiG is of crucial importance for the assessment of medicinal products in the domain of the SHI funds.

All commissions, pre-reports and final reports are published on the Internet page of the IQWiG. This demonstrates that generic companies are able to pursue the process of all commissions very early on and should incorporate the findings and recommendations to their decision process of product portfolio.

Pages: 53