Global Insight Perspective | |
Significance | The German Health Ministry has rejected a G-BA recommendation to end reimbursement for Sanofi-Aventis' cardiovascular drug, Plavix, as a preventive monotherapy. |
Implications | The Ministry decision was based on the potential for confusion among physicians who may be uncertain which patients can be prescribed Plavix under the G-BA's "unclear" guidelines. The G-BA has said the problem lies in how the Ministry wants the guidelines to be written, and is expected to rewrite its guidelines on Plavix accordingly. |
Outlook | Sanofi-Aventis has had a temporary reprieve, in that Plavix will continue to be reimbursed in all indications until the Ministry accepts a reworked G-BA recommendation. However, the case highlights issues within the current structure of drug-reimbursement evaluations that will lead to more delays and confusion over reimbursement, unless the G-BA is more transparent in its decision-making process. |
The Federal Joint Committee on Healthcare (G-BA) has been left to defend its recent decision to end reimbursement for Sanofi-Aventis' (France) blood-thinner, Plavix (clopidogrel bisulfate), as a preventive monotherapy for heart disease, after the German Health Ministry intervened to reject its recommendation. The G-BA's decision in January followed an evaluation by the Institute for Quality and Efficiency in Healthcare (IQWiG), which last August found that Plavix did not demonstrate any significant advantage over regular aspirin when used as a monotherapy in cardiovascular disease (see Germany: 22 January 2007: G-BA Announces End to Reimbursement for Sanofi-Aventis' Plavix as Monotherapy).
While the Health Ministry historically tends to agree with the G-BA's reimbursement recommendations—indeed, this is only the second time that they have differed—the Ministry's department of insurance and reimbursement is reported to have expressed concern over discrepancies between the findings of IQWiG's initial evaluation and the terms of the G-BA's final reimbursement decision. More specifically, the Ministry has said that the G-BA's recommendation did not reflect IQWiG's evaluation, which dealt with Plavix as a monotherapy only in cases where aspirin had been contraindicated. This could, according to the Ministry, result in confusion over exactly which patient group should or should not be prescribed Plavix. Additionally, according to Scrip, the G-BA has come under fire from the Ministry for issuing its recommendation on Plavix reimbursement, while other assessments of the drug were still being carried out. The potential loopholes in the G-BA's decision could, the Ministry believes, leave the G-BA open to legal action in the event of any serious adverse events linked to incorrect prescribing of the drug.
Faced with heavy criticism, the G-BA has insisted that its methodology in arriving at its final recommendation for Plavix is not at fault, and has not been questioned by the Ministry. Instead, a spokesman has said that the Ministry's reversal of its recommendation has arisen from a difference in understanding between the Ministry and the G-BA of how the latter's recommendations should be presented, with the Ministry now expecting to see a list of treatment groups in the regulation itself as opposed to in a separate appendix, as was previously the G-BA's customary practice.
Outlook and Implications
For now, Germany's public health insurance funds will have no alternative but to continue reimbursing Plavix for all patient groups until the G-BA issues a new set of guidelines that are approved by the Health Ministry. This is good news for Sanofi-Aventis, which has borne the brunt of several unfavourable regulatory decision in Germany of late, leading it to rethink its corporate strategy in the country (see Germany: 29 January 2007: Sanofi-Aventis Calls Time on Research Investment Programme in Germany and France: 3 November 2006: Sanofi-Aventis Follows Up French Job Cuts with 320 More in Germany). However, the reprieve is likely to be temporary in nature, as the Health Ministry's hesitation over stopping Plavix's reimbursement is based on technicalities in the way the G-BA's report was put together, rather than any defence of the benefits of the drug itself.
While not explicitly condemning the methodology of the G-BA or IQWiG, the Health Ministry's concern at the potential for incorrect prescribing brought on by the hasty adoption of the G-BA's recommendation does seem to hint at problems within the current structure of drug reimbursement evaluations. Pharmaceutical companies have already accused IQWiG of having poorly defined, narrow criteria on which it bases its drug appraisals (see Germany: 19 March 2007: Playing NICE: What Will IQWiG's Role Mean for Future Growth in the German Pharma Market?), and the latest development in the Plavix case suggests that the G-BA, too, will be seen by the industry as jumping the gun in recommending reimbursement cuts without waiting for all available evidence.