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German agency refuses to rule on drug’s benefits until Pfizer discloses all trial results

BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b2521 (Published 22 June 2009) Cite this as: BMJ 2009;338:b2521
  1. Ned Stafford
  1. 1Hamburg

    An independent scientific institute that conducts healthcare research and evaluations mainly on behalf of Germany’s public health insurance regulator has accused the drug giant Pfizer of “concealing” research data on its depression treatment reboxetine.

    The Institute for Quality and Efficiency in Health Care, which is based in Cologne and known in Germany as IQWiG, contends that Pfizer has refused to provide a complete list of all published and unpublished trials of reboxetine, which was approved in 1997 in Germany and marketed by Pfizer as Edronax.

    If the institute says it is unable to assess the benefit of the drug because of lack of data, it is likely that health insurance companies in Germany may refuse to reimburse its cost.

    “Deception through concealment is no trivial offence,” said the institute’s director, Peter Sawicki. “By concealing study data, the manufacturer is depriving patients and doctors of the opportunity to make an informed decision on different therapy options.”

    He added that he would like to see legislation in Europe that would force drug companies to release all clinical trial results in a timely manner. “In the United States this obligation has been clearly implemented in law since 2008,” Dr Sawicki said. “We need a comparable definite and transparent implementation in Europe as soon as possible.”

    Since October 2007 IQWiG has been conducting a “benefit assessment” of reboxetine and two other depression treatments for the Federal Joint Committee (G-BA). This committee, made up of doctors and representatives of public health insurance associations, determines which medical treatments are beneficial enough to be covered by public health insurers.

    The three drugs under review are currently on the list of covered drugs. A ruling by the G-BA that a drug is beneficial—and therefore has to be paid for by public health insurers—is extremely important for drug companies, as more than 90% of Germans are covered by public insurers.

    In a preliminary report issued on 10 June IQWiG ruled that reboxetine had “no proof of benefit.” It said that reboxetine “was tested in at least 16 trials on approximately 4600 patients with depression.” But it added: “However, the institute only had access to data on approximately 1600 of these patients. If the unpublished data are not included, there is a high risk of incorrectly estimating the benefit and harm of this agent.”

    Martin Fensch, head of communications for Pfizer Deutschland in Berlin, told the BMJ that reboxetine is a safe, effective, and well tolerated drug. “It has been approved in a number of European countries and continues to be scientifically monitored by the appropriate regulatory authorities on a constant basis,” he said.

    He said that IQWiG is not a “regulatory authority” but a “private institute,” formed to conduct cost-benefit analyses of drugs, and he added: “There is no obligation to provide IQWiG with information. However, Pfizer is confident that we have submitted all data relevant to conducting an accurate cost-benefit assessment.”

    He said that Pfizer would continue to work with the institute “to determine what additional data may be required to obtain a complete assessment of the costs and benefits of [reboxetine].”

    If Pfizer plans to release additional data, it will have to do so soon. Beate Wieseler, deputy head of drug assessment at IQWiG, said that the deadline for written public comment on the preliminary report was 9 July.

    “Within the hearing process,” she said, “Pfizer could submit additional data as part of their comments on the preliminary report. These documents would be handled according to our defined procedures, which include full publication of all documents submitted.”

    The final report on reboxetine will be published by the end of the year and delivered to G-BA, Dr Wieseler said. She said that the report will not make a specific recommendation on whether public health insurers should cover the cost of the drug. “The decision whether a drug should be covered by the [public health insurers] is made by G-BA,” she said.

    The two other depression treatment drugs being reviewed by IQWiG are mirtazapine and bupropion XL. The institute said that GlaxoSmithKline, manufacturer of bupropion XL, had provided complete clinical study reports. It said that there was “proof of benefit” of bupropion XL. It had access to only 27 of at least 31 trials of mirtazapine, which is made by Essex Pharma, and said that the “results must be viewed with caution.”

    Notes

    Cite this as: BMJ 2009;338:b2521

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