by Janelle Dumalaon

BERLIN, Oct 29 (APM) - The German government has said it is open to changing the law to stop new, but potentially inferior, drugs being sold at the same price as the comparator therapies used under the country’s health technology assessment (HTA) system.

The official line delivered in written parliamentary responses came after Germany’s left wing opposition, Die Linke party, suggested pharma companies opting out of HTA may be getting a better price than their product deserved.

Under Germany’s AMNOG laws, companies have the right not to submit a cost-effectiveness dossier. However, this leads to an automatic ‘no added benefit’ rating found for the agent meaning it cannot be priced higher than the comparator therapies.

In many cases, companies have chosen to withdraw the drug from sale rather than sell at comparator therapy price but the Die Linke party said companies choosing to take a lower price because of low HTA ratings could be being overpaid for poor drugs.

According to the written response to a list of questions put forward by Die Linke, the government said it was "monitoring the situation" and would change the law if necessary.

Deputy health minister Annette Widmann-Mauz said: "The federal government does not recognise such a development. The federal government is closely monitoring this question. Should it become convinced legal changes are necessary, it will make an appropriate proposal to the Bundestag (lower house of German parliament)."

Widmann-Mauz did not elaborate on how the government intended to answer the question, or what an appropriate legal change might look like in the response statement sent to APM on Tuesday.

The opposition party also asked the government whether AMNOG's mission of determining the added benefit of newer drugs was "undermined" by pharmas failing to submit dossiers and skipping HTA as result.

Widmann-Mauz said the law has already made provisions for these cases, arguing the no added benefit ruling and subsequent limit on price to that of the comparator therapy protected the payer.

The government finds these cases "permissible", she said.

In its written questions, the opposition party also stated a presumption that pharma companies that did go through HTA were disadvantaged compared with those which did not.

In response to this, the government said 42 out of the 72 drugs for which HTA ratings were assigned based on full submissions were found to have some added benefit which boosted their price. As such, it was advantageous to enter fully into the process, it suggested.

However, Die Linke's questioning appears to raise a secondary consideration for pharma companies choosing comparator therapies from the list provided by Germany’s senior HTA body, the G-BA.

Later and presumed superior, more expensive therapies, will be more difficult to show added benefit against, but offer a higher maximum price if no added benefit is found. And the converse for older cheaper, particularly generic, comparators.

There are an increasing number of cases of pharmas not presenting HTA dossiers for their drugs in Germany (APMMA 38659). Examples include Takeda's Edarbi (azilsartan) for hypertension, Bausch & Lomb's Yellox (bromfenac) in postoperative ocular inflammation, Recordati's Livazo (pitavastatin) in hypercholesterolaemia, Rapidscan Pharma Solutions' Rapiscan (regadenosone) for coronary artery diseases, Alcon Pharma's ophthalmic surgery drug Nevanac (nepafenac) (APMMA 38890), GlaxoSmithKline's epilepsy drug Trobalt (retigabine) (APMMA 38993).

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