Pharma lobby group calls for AMNOG changes as 13 drugs withdrawn from Germany

BERLIN, Feb 19 (APM) - German pharma lobby group VfA has called for AMNOG to become more “supply friendly”, revealing 13 drugs have been withdrawn from the German market since the law’s introduction four years ago.
Janssen’s combination therapy Vokanamet (canagliflozin+metformin) in diabetes became the latest drug to be opted out of price negotiations - according to a February 11 statement - with the payer after a no-added benefit ruling (APMHE 41396), meaning the drug will no longer be available in Germany. (APMHE 41530)
On its website, umbrella payer group GKV-Spitzenverband displays pharmas which have used the opt-out procedure for price negotiations - currently six as it has not been updated to include the latest opt-out. But VfA told APM on Wednesday that a further six drugs had been withdrawn from the market because of AMNOG. These include Novartis’ Galvus (vildagliptin) (APMHE 38784) and Sanofi’s Lyxumia (lixisenatide) in diabetes (APMHE 38816).
Both pharmas pulled their drugs after pricing negotiations with the payer group failed.

Focus on controlling costs

VfA director Birgit Fischer said in a Tuesday statement that access to new and innovative medicines is not a guiding force in German health policy, adding that a “one-sided orientation towards controlling costs” dominated.
While acknowledging that a “record” 40 new drugs were introduced to Germany in 2014, Fischer maintains that AMNOG is derailing research-based pharma’s chances of earning back the €5.7 billion invested in developing new drugs last year.
“Refinancing the high cost of drug research in Germany is no longer guaranteed when prices for new medicines over here dip below the European average,” said Fischer, adding that strengthening market and competition mechanisms, and fostering a “fair culture of negotiation” could provide a solution.
According to the organisation, 82% of drugs that underwent added benefit assessment fell below the European median price, with 38% are among the lowest price in Europe.
Independent experts told APM on Monday that Germany’s focus on maintaining the financial sustainability of drugs supply could threaten the supply of innovative drugs.
(APMHE 41487).

Payer group hits back at criticism

German statutory health insurers disagree, with umbrella payer organisation GKV Spitzenverband hailing AMNOG’s principles and implementation as “good and right”. That drugs with “major added benefit” enjoy high reimbursement prices and those with “minor added benefit” get lower prices is fair, said the payer in a Tuesday statement.
“Being ‘new’ is no longer the most critical attribute in a drug’s evaluation, instead it proven added benefit for patients is the most important criteria,” said the GKV in the statement.
In its AMNOG review published on Tuesday, major German statutory health insurer DAK gave the law a mainly positive assessment but said it needed to be rectified that doctors are prescribing drugs with a “no added benefit” rating “strikingly” often. (APMHE 41517).
In 2014, AMNOG talks between pharmas and the GKV produced 59 reimbursement prices during negotiations, with a further nine agreed in mediation. Seven drugs have been opted out of price negotiations by pharmas and are not available in Germany, while a further six were withdrawn from the market.
:: Janssen-Cilag, Invokana (canagliflozin) - opt-out
:: Janssen-Cilag, Kombipräparat Vokanamet (canagliflozin+metformin) - opt-out
:: GlaxoSmithKline, Trobalt (retigabin) - opt-out
:: Aegerion Pharmaceuticals, Lojuxta (lomitapid) - opt-out
:: Boehringer Ingelheim, Trajenta (linagliptin) - opt-out
:: Novartis, Rasilamlo (aliskiren/amlodipin) - opt-out
:: Pfizer, Xiapex (collagenase clostridium histolyticum) - opt-out
:: Almirall Hermal, Constella (linaclotid)
:: Novartis, Galvus / Jaira / Xiliarx (vildagliptin)
:: Novartis, Eucreas / Icandra / Zomarist (vildagliptin+metformin)
:: Sanofi-Aventis, Lyxumia (lixisenatide)
:: Eisai GmbH, Fycompa (perampanel)
:: Bausch & Lomb/Dr. Mann Pharma, Yellox (bromfenac)



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