Grunenthal CEO Claims German Reimbursement Hurdle Is Fair, As Pain Drug Palexia Rolls Out Across Europe

German reimbursement authority’s strong emphasis on drugs’ added benefit is logical, opines Grunenthal CEO Harald Stock. And all health care systems will eventually move the same way.

It’s not often that pharma CEOs have anything positive to say about Europe’s increasingly tough reimbursement hurdles. But as private Grunenthal GMBH rolls out its new pain drug Palexia (tapentadol) across the region, CEO Harald Stock argues that European health technology assessment (HTA) agencies’ focus on added benefit versus existing treatments is reasonable. “It’s logical that if we can’t differentiate our drugs, then they will be compared to other existing treatments, and this may affect price,” he said. “But given Palexia’s profile, we shouldn’t be overly concerned about that.”

His comments came as the first drugs start to emerge from a controversial new reimbursement system in place in Germany since January 2011, known as AMNOG, whereby the added benefit of newly launched treatments is assessed over existing standards of care. Drugs that don’t differentiate themselves will be subject to reference pricing.

The first drug to test the new system, AstraZeneca PLC’s clot-buster Brilique (ticagrelor), emerged relatively unscathed Dec. 15, scoring “significant” added benefit over existing therapies in its most important indication. But others are faring less well: InterMune Inc.’s Esbriet (pirfenidone) didn’t impress German HTA body IQWiG, which issues recommendations to the reimbursement authority, the G-BA. It concluded that the drug, despite being approved as an orphan product, showed no additional benefit on mortality or quality of life for patients with idiopathic pulmonary fibrosis. Several firms have withdrawn their drugs from the German market in anticipation of an unfavorable outcome.

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