German doctors are urging the new coalition government not to abandon the controversial pharmaceutical benefit analysis system introduced in 2010.
The new administration says it will scrap the system, which was established under the Act on the Reform of the Market for Medicinal Products (AMNOG) to assess newly-licensed drugs and establish whether they provide additional benefits compared to products already on the market.
These assessments then set the basis of product prices agreed in negotiations between manufacturers and the statutory health insurance (SHI) funds and, under AMNOG, if a new product does not show additional benefits, it cannot receive a price higher than those for products already on the market. Before AMNOG, drugmakers were able to set their prices freely in Germany.
As well as newly-licensed medicines, AMNOG also allows for the benefits of products launched pre-2011 to be assessed, provided that such products compete for other medicines for which there is an early benefit assessment or if they are considered to be therapeutically important.
The assessments are carried out by Germany’s drug pricing watchdog, the Federal Joint Committee (G-BA), which consists of doctors, hospitals and health insurers. The G-BA commenced its first assessment for established products in August 2012, when it called on the manufacturers of five gliptin products, used in the treatment of diabetes, to provide it with value dossiers in support of their products. The analysis followed the panel’s decision that the products were in direct competition with Boehringer Ingelheim’s Trajenta (linagliptin), for which the G-BA had issued a negative decision earlier in the year.
Reporting the results of this retroactive benefits assessment, the G-BA found that only two of the gliptin products showed any additional benefits for patients compared with already-available treatments, says Professor Wolf-Dieter Ludwig, chairman of the German Medical Association (Bundesartztekammer)’s Drug Commission. This shows the value of the assessment system, given that gliptins are around ten times as expensive and that prescriptions for them are increasing rapidly, he says.
“The benefit analysts for those medications already on the market is essential for a high-quality and economic medicines provision,” adds Prof Ludwig. He also warns that scrapping the assessment process would create an obstacle to the rational provision of medicines and make it more difficult for doctors and patients to access independent information.
But the G-BA appears to have accepted the removal of its role in assessing established drugs, according local reports, which quote the panel’s chairman, Josef Hecken as describing this process, in the magazine Der Speigel, as “riding a dead horse.”
He also said that a court ruling permitting drugmakers to appeal negative evaluations of their products would mean that the G-BA’s legal department being “tied up for years.”
The Bundesartztekammer’s Drug Commission also points out that 60% of the new drugs analysed so far under the system have been shown to provide no additional therapeutic benefit.