by Hélène Mauduit
BERLIN, Mar 30 (APM) - German umbrella payer group GKV-Spitzenverband (GKV-SV) is pushing for drugs to be priced by indication instead of a single price per drug, a conference heard.
A price per indication as proposed under GKV-SV's pricing model (NOE - Nuztenorientierte Erstattungsbetrag APMMA 44836) would resolve issues around the economic efficiency of prices, said GKV-SV's head of medicines at GKV-SV Antje Haas at the Forum-Institut für Management's Health technology assessment and reimbursement 2017 conference in Berlin.
The validity of single prices for drugs which get a mixed rating in added benefit assessment, called "mixed" prices, has been called into question by a preliminary ruling from the Berlin-Brandenburg social court (APMMA 52297).
The ruling was given on GlaxoSmithKline's diabetes drug Eperzan (albiglutide) only, but the question has been raised repeatedly for drugs with a mixed rating in added benefit assessment since pricing procedures under the AMNOG law began in 2011.
Setting a price for each indication or subgroup of patients - which would take into account the price of the comparative therapy for this indication or subgroup in Germany, annual costs of comparable drugs and the prices in other European countries - would eliminate all legal uncertainties, Haas said at the conference on Monday.
A price per indication would also solve issues regarding drugs which have lost patent protection in some but not all indications, Haas said, mentioning Pfizer's Lyrica (pregabalin) and Novartis's Glivec (imatinib).
Lyrica lost patent protection in 2015 in epilepsy and general anxiety disorder, but it is still protected in neuropathic pain until July. Since health insurers do not receive information on the indication in the prescription, they cannot be sure whether a patient is eligible for a generic or the original.
The situation is similar for Novartis's Glivec, which lost patent protection in 2016 in chronic myeloid leukaemia (CML) and other types of leukaemia, but is still protected in gastrointestinal stromal tumours (GIST).
Pfizer and Novartis have sued health insurers which wanted to sign discount agreements with generic manufacturers.
Later at the conference, conservative party CDU drug expert Michael Hennrich said he supported the concept of a price per indication. But he added that coding for indications, which would be necessary to implement differentiated prices, would be "highly problematic".
Talking about the drugs bill (AM-VSG) which has just been passed in the Bundestag, Haas raised questions about the new framework for pricing negotiations for drugs with no added benefit (APMMA 52160).
Under the new framework, drugs with a "no added benefit" rating will get more flexible pricing in "particular cases". In pricing negotiations between the GKV-SV and the manufacturer, the comparator chosen as the reference price will not automatically be the cheapest drug, as is currently the case.
"The bill leaves a lot of questions open," said Haas. "What are the particular cases? How high can the price go now? We will have intensive discussions with manufacturers in the next price negotiations. I am curious to see what results we will get."
The new system could be applied retroactively to drugs which already have reimbursed prices. The manufacturer will have three months after the AM-VSG bill is promulgated to request new price negotiations with GKV-SV.
This potentially concerns around 60 drugs which received a 'no added benefit' rating. Fifteen of them are no longer marketed in Germany.
The higher health technology assessment (HTA) body G-BA has the opportunity to "input" into the new framework in its ratings, said Thomas Mueller, head of pharmaceuticals at G-BA, at the conference on Tuesday.
"The HTA procedure is suitable to indicate in what situations this new rule can be used," he said.
The G-BA may indicate that a drug must "remain a therapy option" even if no added benefit is proven, he said.
/hm/clg
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