by Hélène Mauduit

BERLIN, Apr 26 (APM) - Germany's pharma industry and doctors have asked the government to urgently clarify pricing on new drugs by introducing a new measure into a bill being discussed in Parliament.

The federal association of statutory physicians KBV suggests introducing a new article on drug pricing into the blood and tissue samples bill, it said in a Wednesday press release.

The provision should say that a reimbursed price, negotiated by a pharma company and umbrella payer group GKV-Spitzenverband (GKV-SV) or decided by an arbitration body, is automatically considered "economically efficient" in all indications of the drug, the KBV said.

Under German law, physicians must only prescribe economically efficient drugs. They face sanctions if they cannot justify a prescription.

The bill, which aims to transpose two European directives into German law, is planned to be passed by summer, before the legislature ends and a new Bundestag is elected on September 24.

The association of research-based pharmaceutical companies vfa and the association representing small and middle-sized pharma companies BPI suggested similar changes in position papers on the bill sent to the Parliament before a hearing on Wednesday.

The KBV explained that the change was necessary to protect prescribers from any potential consequences of the March ruling of the Berlin-Brandenburg social court on GlaxoSmithKline's diabetes drug Eperzan (albiglutide) (APMMA 52297).

The ruling called into question the legal basis of pricing for drugs which get a 'mixed' rating in added benefit assessment. Mixed rating happens when the higher health technology assessement (HTA) body G-BA splits up an indication by subgroups and each subgroup is rated separately. On this basis, a reimbursed price is calculated as a weighted average of theoretical prices per subgroup, a so-called 'mixed price' ("Mischpreis").

The bill offers a final opportunity to introduce such a measure before the end of the legislature, said KBV chair Stephan Hofmeister.

In March, BPI said that the single price for 'mixed' benefit drugs should be maintained (APMMA 52314) and vfa warned that many drugs could be withdrawn from the German market if the court decision was confirmed in later instances, saying that 40% of prescriptions could be potentially fall within the scope of the ruling (APMMA 52505).

Pharma association BAH also supported the initiative. "There is no valid reason to deviate from the 'mixed pricing' currently practiced. The reimbursed prices should continue to be valid for all patients covered by the market approval," it said in a press statement on Wednesday.

A mixed price already represents a "compromise" agree by both parties, the manufacturer and the GKV-SV, and "it takes into account that the drug showed 'staggered' added benefits", it said.

Major health insurer AOK disagreed with the industry's and doctors' views, saying that no reimbursed price is automatically considered as cost-effective by health insurers.

Reimbursed prices are calculated "on the basis of a previously determined additional benefit in specific indications", but "this has nothing to do with economic efficiency," said the chairman of AOK federal association Martin Litsch in a Wednesday statement.

There is no reason to "release doctors from their responsibility to only prescribe economically efficient drugs" as laid down in the German Social Code.

"If doctors have the choice between several drugs with the same benefit and the same medical need, then they should continue to choose the most cost-effective medicine among them."

Listch accused vfa of "scaremongering" by saying drug withdrawals could potentially be massive. Figures referring to 40% of prescriptions are "exaggerated", he said.

/hm/clg