Drugs without added value are still prescribed.
18.02.2015 14:08
The AMNOG report by the DAK-Gesundheit health insurance company reveals weaknesses in the AMNOG system. According to the report, only half of the pharmaceutical active ingredients examined offer any added benefit. At the same time, the report also notes that drugs without added benefit are experiencing considerable increases in prescriptions.
Not all new medications that come onto the market represent a genuine advancement in therapy for patients, the authors of the AMNOG report conclude. The analysis considered 58 active ingredients in 64 procedures up to 2013. Professor Wolfgang Greiner from Bielefeld University investigated the effects of the drug reform (AMNOG) for DAK-Gesundheit.
According to the law, new drugs must undergo scientific evaluation to assess their benefits. "Overall, the AMNOG (Act on the Reform of the Market for Medicinal Products) is proving to be a successful and sensible social policy measure because the scientific evaluation of new drugs separates the wheat from the chaff. This allows us to spend our insured members' contributions on genuine added value and not on pseudo-innovations," emphasizes Professor Herbert Rebscher, CEO of DAK-Gesundheit.
„However, the report also reveals weaknesses that must be addressed collaboratively within this learning system,“ said Rebscher. Professor Wolfgang Greiner, a member of the German Council of Experts on Healthcare Assessment, summarized: „The AMNOG (Act on the Reform of the Market for Medicinal Products) has contributed to a fundamental rethinking of the German healthcare system, as it ensures that sound evidence-based practice directly influences reimbursement levels. However, the system should continue to develop methodologically and incorporate cost-benefit analyses in the future. Various assessment methods have already demonstrated promising approaches for this.“.
Four years after the reorganization of the pharmaceutical market, several inconsistencies have emerged. The reform's primary goal was to significantly reduce prescriptions for drugs without added benefit. However, a surprising finding of the DAK-AMNOG report is that even drugs not certified as offering therapeutic progress are still frequently prescribed. For example, active ingredients without added benefit achieved remarkable prescription figures and increases within the first year after the publication of the review results. One example is "Fampyra," a drug for multiple sclerosis. Sales of this drug increased tenfold in the two years following the review, despite the fact that no added benefit was found.
„A critical scientific evaluation of the medications would lead to a different prescribing behavior among doctors,“ says Rebscher. „The reasons why doctors often do not follow the scientific evaluation are purely speculative: Perhaps a lack of information plays a role.“
The report states that the problem of the rapid and routine availability of evidence-based results in everyday practice is also evident in the benefit assessment process and should be addressed in connection with the establishment of the Institute for Quality Assurance and Transparency in Healthcare (IQTIG). Some manufacturers are boycotting the AMNOG (Act on the Reform of the Market for Medicinal Products) by failing to submit benefit dossiers. This effectively deprives them of their new resources for benefit assessment. Manufacturers resort to this approach particularly when it becomes clear to them that no additional benefit can be achieved.
The AMNOG report by DAK-Gesundheit also revealed that, in practice, active ingredients without a submitted dossier account for only a very small share of sales of all benefit-assessed active ingredients. Their proportion of the total number of procedures is also small: From 2011 to 2013, only seven manufacturers failed to submit a dossier for an active ingredient covered by the benefit assessment. The analysis of the therapeutic benefit forms the basis for the subsequent pricing. The pharmaceutical industry and health insurers demonstrate a remarkable success rate and willingness to compromise in price negotiations.
„It’s encouraging that the negotiating parties reach an agreement in three out of four price negotiations,“ Rebscher summarizes. The remaining quarter, where no agreement has been reached, will be negotiated further by the arbitration board. If price negotiations fail there as well, pharmaceutical manufacturers can withdraw the drug from the market (opt-out). However, of the 13 drugs negotiated there so far, only six are available in Germany. Seven manufacturers opted for the drug's opt-out option in response to the arbitration proceedings. When AMNOG was introduced, the pharmaceutical industry feared that widespread market withdrawals would lead to supply shortages. Even though some drugs have disappeared from the market, this has not yet resulted in supply bottlenecks.
Using the example of the diabetes drug vildagliptin, the AMNOG report demonstrates how quickly and to which alternative therapies patients were switched. Two-thirds of DAK-insured patients who received vildagliptin before its market withdrawal were switched by their doctors directly to other therapies within the following quarter. Nearly twelve percent were switched to comparator therapies (glibencalmid or glimepiride) previously defined by the Federal Joint Committee (G-BA). Forty-four percent received similar gliptins, and a small percentage were switched to a new class of drug. The conclusion: A drug withdrawn from the market can, to date, be largely replaced quickly and easily by other medications. Fears that AMNOG would stifle innovation have also proven unfounded. The pharmaceutical industry can launch new drugs at unrestricted prices for one year without a benefit assessment.
„However, it is essential to prevent the financial viability of the social security system from being jeopardized by excessively high initial prices,“ emphasizes Rebscher. „We advocate that the negotiated price should apply retroactively to the first year after market entry.“ Professor Wolfgang Greiner adds: „Based on previous experience with the evaluation process, if a new drug reduces hospital stays or eliminates the need for lengthy follow-up treatments, this should also be taken into account when determining the reimbursement amount.“
However, the costs of side effects or complications associated with the use of new drugs would have to be factored in, Greiner points out. Drugs that were on the market before the AMNOG (Act on the Reform of the Market for Medicinal Products) came into effect are not subject to a benefit assessment (existing market). The benefit of these drugs has not been evaluated. "It is regrettable that such a systematic evaluation and the resulting information are not being collected," comments Professor Greiner. Consequently, questionable drugs remain on the market. Even when their patents expire, they remain available as generics.
The AMNOG report by DAK-Gesundheit also shows, however, that at least from a financial perspective, the end of the existing market valuation is compensated for. The now continued direct price regulation through a moratorium and a collective discount is roughly equivalent to the anticipated price effect from renegotiating existing market prices. However, the problematic lack of information regarding quality for patients remains. If one were to consider the benefit discounts negotiated to date, the potential savings in the existing market and the effects of the now extended instruments would roughly balance each other out.