Doctors in Germany often prescribe medications without any proof of additional benefit, a recent study indicates, revealing that the reasons behind this are unscientific. EurActiv Germany reports.
Not all new medications released on the German market actually mean real progress in therapy for patients.
This conclusion is among the findings of a report on Germany’s Pharmaceutical Law Restructuring Act (AMNOG) conducted by the public health insurance company DAK-Gesundheit.
Wolfgang Greiner from the University of Bielefeld investigated the impact of AMNOG, which took effect in 2011. Under the law, new pharmaceuticals must be evaluated on their usefulness.
Since 2011, medicines are analysed directly after their approval by the joint federal committee of insurance funds, doctors and clinics regarding their added value.
The manufacturer is required to provide a dossier on the subject, while the committee can make use of scientific expertise for the appraisal. If an added value – compared to a conventional form of therapy – is not proven, a fixed price is determined. If added value is discovered, the insurance funds and manufacturers negotiate a price.
AMNOG also introduced the use of European medication prices as a criterium in the price negotiation procedure in Germany. A framework agreement defines a selection of countries, whose prices are to be used as a comparison for German prices.
But four years after the reform of the pharmaceutical market, the study reveals certain inconsistencies.
The most important goal of reforms was that medicines without added benefit should be prescribed considerably less often.
But a surprising result, the DAK’s AMNOG report revealed, is that medications are often prescribed even when they are not proven to result in therapeutic progress.
As a result, drugs without additional benefit reached remarkable prescription rates and increases within the first year after the test results were published.
Fampyra, a medication used to treat multiple sclerosis, is described as an example in the study. Sales from this drug increased ten-fold in the two years after testing, although no additional value had been found.
“Based on the critical scientific evaluation of the medicines, one would expect a different prescription behaviour from doctors,” said Herbert Rebscher, head of DAK-Gesundheit. “But it is up for speculation, why doctors often do not orient themselves according to the scientific assessment. A lack of information probably plays a significant role here.”
Overall a good report
But Rebscher gave the law an overall good testimony. “Overall, the AMNOG proves to be successful and useful from a social policy perspective because the scientific assessment of new medications separates the wheat from the chaff. In this way we can spend payments from our insurance holders on real added value and not on pseudo-innovations,” he explained.
“The AMNOG has contributed to a fundamental change of view in German health care because it allows for a good evidential basis to have a direct influence on the amount refunded,” Greiner continued. “But the system should continue its methodical development and involve cost-benefit-analyses in the future as well. Various assessment procedures have already shown approaches for this.”
Indicating the diabetes medication Vildagliptin as an example, the AMNOG report shows how quickly and to which alternative therapies the patients’ were transitioned.
Two-thirds of DAK-insured patients who took Vildagliptin until market withdrawal, were directly shifted to other therapies by their doctor within the following quarter. Almost 12% were moved to the therapies determined as comparable by the German federal joint committee (G-BA). 44% received the similar product Gliptine and a small percentage were moved to a new drug class.
The conclusion: a drug that has been withdrawn from the market can, to a large extent, be quickly and easily replaced by other medications.
Obstacle to innovation?
Concerns that AMNOG is an obstacle to innovation did not prove true. The pharmaceutical industry can put new medications on the market for one year at freely determined prices and without application testing.
“But we must prevent the financing capability of the solidarity-based system from being jeoparidised by completely inflated entry-level prices,” Rebscher emphasised. “We are calling for the negotiated price to be retrospectively applied to the first year of market entry.”
“If a new medication reduces hospital stays or makes lengthy aftercare unnecessary, this should also be considered, according to previous experiences from the assessment procedure, when establishing a refundable amount,” Greiner said.
Still, Greiner said the potential cost of side-effects or complications that are related to using the new medications must be calculated into this sum.
Germany is not alone in its efforts to improve conditions for the pharmaceutical industry within its borders. In April, the European Parliament voted in favour of the second Innovative Medicines Initiative (IMI2), a multi-billion Euro research programme run jointly by the European Commission and the pharmaceutical industry.
The Innovative Medicines Initiative (IMI) is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI is a joint undertaking between the EU and the pharmaceutical industry association EFPIA.
- EurActiv Germany: Studie: Medikamente ohne Zusatznutzen werden zu oft verordnet