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Regulatory Focus™ > News Articles > German Price Watchdog Says ‘No’ to 3 Cancer Drugs

German Price Watchdog Says ‘No’ to 3 Cancer Drugs

Posted 23 January 2015 | By Michael Mezher 

German Price Watchdog Says ‘No’ to 3 Cancer Drugs

The Institute of Quality and Efficiency in Healthcare (IQWiG) gave negative assessments for three recently approved cancer drugs this month.

IQWiG is one of several bodies in Germany charged with conducting health technology assessments (HTAs) for newly approved drugs in Germany. The goal of these assessments is to weigh the benefit of new therapies against the costs to the country’s healthcare system.

According to IQWiG’s assessment, the drugs idelalisib, sipuleucel-T and sucroferric ocyhydroxide did not provide added benefit over the “appropriate comparator therapies” for their given indication.

Reimbursement in Germany

The German government is highly conscious of healthcare spending. In its 2010 Act on the Reform of the Market for Medicinal Products (AMNOG), the German Parliament set forth the requirement for drug makers to submit their newly approved products for a benefit assessment.

The Federal Joint Committee (G-BA), the decision-making body responsible for setting reimbursement amounts in Germany, commissions IQWiG to conduct benefit assessments of drugs after they receive market authorization. G-BA, often through IQWiG, analyzes the dossier to determine if the product provides “additional benefit” over a comparator product.

Based on G-BA’s findings, the Central Federal Association of Health Insurance Funds and the authorization holder will enter into negotiations on the reimbursement price for the product. If a product is not shown to have any additional benefit over a comparator product, the reimbursement price will be set to a reference price group with similar drugs.

Emphasis on Head-to-Head Trials

IQWiG places a heavy emphasis on data gathered from studies that compare a drug to the closest appropriate comparator therapies. IQWiG is also sensitive to the various treatment situations for a given condition.

In the case of idelalisib, a drug used to treat follicular lymphoma or chronic lymphocytic leukemia (CLL), IQWiG states, “the dossier contained no suitable data for any of the therapeutic indications and treatment situations.” G-BA outlines five treatment situations for CLL based on the status of the disease (relapse or remission) and treatment history. IQWiG argues that trials, which combined patients with relapsed and refractory CLL, create “deviations regarding the appropriate comparator therapy.”

IQWiG also points to the use of one-arm studies in the dossier that do not provide an “adequate comparison … with the appropriate comparator therapy.” Specifically, IQWiG takes issue with the design of one of the studies used in idelalisib’s approval, which compared idelalisib plus rituximab to rituximab plus placebo. IQWiG argued that rituximab was an inappropriate comparator, as rituximab monotherapy is not approved to treat either indication.


IQWiG Press Releases – idelalisib, sipuleucel-T, sucroferric oxyhydroxide

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