BERLIN, Nov 29 (APM) - The volume pricing threshold planned by the German government for 2017 will be so hard for companies to manage that they will eventually ask to have controlled prices from the outset, a lawyer has said.
"In the medium term, the industry will ask lawmakers to introduce a 'fourth hurdle'" to market access, in addition to assessment of the safety, efficacy and quality of a drug, said pharmaceutical law specialist Alexander Ehlers at the meeting of the German society on market access (DFGMA) in Berlin on Friday.
The industry would prefer "a tight timeframe for negotiation of the reimbursed price" before market launch to avoid uncertainties, rather than the threshold idea, he said.
New drugs in Germany are currently launched at a price chosen by the manufacturer, and reimbursed as of their launch. The drugs undergo an added benefit assessment within the first six months and the manufacturer negotiates a reimbursed price on the basis of this rating. This price is usually applied as of the 13th month after market launch.
The drugs care reinforcement bill (AM-VSG), which is under discussion in the German Bundestag (lower house of parliament), includes a new rule: if sales volumes of a new drug go over 250 million euros within the first 12 months after launch, the drug's price will automatically be cut down to the reimbursed price level as of the first day of the following month (APMMA 49974).
In practice, above 250 million euros, the company would make a repayment to the health insurance. The new system would have consequences on provisions and tax-related implications, Ehlers said.
The idea to introduce a threshold emerged solely because of the high prices of the new hepatitis C drugs launched from 2014, "the straw that broke the camel's back", Ehlers said.
Before that, umbrella payer group GKV-Spitzenverband had complained about pricing trends, but politicians considered drugs as "still affordable".
According to Ehlers, the AM-VSG bill would apply from April 1, 2017 if parliamentary discussions go as planned.
The bill is expected to be discussed in plenary session in the Bundestag in mid-February and would go through its final steps in the Bundesrat (higher chamber) on March 10, 2017, he said.
Ehlers also considered that confidentiality on reimbursed prices, which also features in the AM-VSG bill, will not be applied.
"In practice, the reimbursed price will remain public because no real confidentiality will be possible," he said.
The AM-VSG bill as it is says that "all institutions that need [to know] the reimbursed price to fulfil their legal obligations" will be informed. The formulation is "wide" and could even include "European institutions".
Details of this measure would be set in a legal decree written by the health administration, and are currently unknown, Ehlers said.
Ehlers considered that the joint work between German regulatory authorities BfArM and Paul-Ehrlich Institute (PEI), and health technology assessment (HTA) body G-BA will not lead to harmonisation.
The measure was announced as "reducing duplication of work" for pharmas by bundling together the requirements for the added benefit assessment and the approval procedure, he said.
But "in practice, G-BA and the regulatory authorities published a paper on future 'structured cooperation', that rejected harmonisation of the procedures," Ehlers stated.
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