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German insurers review Plavix after negative study

Drug AbuseAug 30, 06

German health insurers, under pressure to cut costs amid reforms, are considering whether to restrict prescription guidelines for Sanofi-Aventis’s blood thinner Plavix in a move that could harm the drug’s sales.

A spokeswoman for the Joint Committee (B-GA), the self-regulating body of German health insurers, said on Tuesday it was reviewing a report it had commissioned from an independent research institute which questions the benefits of Plavix for certain patients.

The German Institute for Quality and Efficiency in Healthcare (IQWiG) said clopidogrel, marketed by Sanofi-Aventis and Bristol-Myers Squibb as Plavix or Iscover, offered no benefits over aspirin when used alone as a preventative treatment for conditions resulting from arterial diseases.

However, the drug did offer benefits in the long-term treatment of patients with advanced peripheral arterial disease, said the report, released on Friday.

Sanofi-Aventis, the world’s third biggest drugmaker, criticised the institute’s report. In a statement on its Web site, it said it acknowledged that the drug was advantageous for all patients but that it only showed “additional benefit” for patients with peripheral arterial disease.

Last month, Germany’s health insurers acted on a report by IQWiG, which said there was no justification for the higher prices of innovative forms of insulin over traditional ones, forcing manufacturers to cut costs of the newer drugs.

In the case of clopidogrel, the issue was one of benefit rather than price, the spokeswoman for the B-GA said. She noted that the report’s findings, if adopted by the B-GA, would form the basis of an advisory to prescribing doctors.

Drug industry lobby groups have warned that many more spending limits on drugs could be on their way as Germany’s health insurers are forced to cut costs in the face of a reform that threatens their existence.

Under government proposals for a reform of the 150-billion-euro-a-year ($192 billion) healthcare system, Germany’s current 250 health insurers could be reduced to around 50 as the underperforming insurers are swallowed by rivals.

Plavix was launched in 1998. It is currently marketed in over 80 countries, including the United States, through an alliance with Bristol-Myers Squibb (BMS), Sanofi-Aventis says.

Net sales of Plavix in Europe rose 13 percent to 859 million euros in the first six months of 2006.



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