BERLIN, Nov 14 (APM) - Novartis' Gilenya is being parallel traded out of Europe’s richest country after Germany's health technology assessment (HTA) pushed down the price of the innovative multiple sclerosis agent, according to a report.
In its report, IMS Health cited the factors leading to the drug being cheaper in Germany than the “economically weakest” EU countries, and used it as an example of how the country remains the biggest parallel import market but is starting to grow in terms of exports. (APMMA 40422)
Gilenya was introduced into Germany at 1,850 euros for 28 x 0.5 mg capsules, putting it among the more expensive EU countries, IMS noted in the German-language report.
Later its reimbursement price fell some 550 euros to 1,300.32 for the same four-week supply, IMS continued.
Between these two prices Gilenya went through Germany’s two-stage HTA processes gaining a ‘considerable added benefit’ rating from the superior G-BA assessing body. (APMMA 30967).
After this Novartis and German payer representative GKV-Spitzenverband entered pricing negotiations which include a host of countries used as pricing references.
IMS said at 1,300 euros the final price paid by German health insurers is lower than in all 15 EU reference countries, including Bulgaria at 1,548.62 euros and Romania at 1,610 euros - two of Europe's “economically weakest” countries.
As a consequence of Gilenya's “low” reimbursement price, stock intended for the German market is being bought up by parallel exporters from pharmacies and sold abroad in Denmark, Austria and Sweden where it could fetch prices between 1,680 and 1,750 euros, according to the case study.
IMS estimates that more than 10% of the German Gilenya is being exported and uses Facebook reports of delivery problems and patients struggling to get their treatment to illustrate the effect on supply this is having.
In one message taken from a German-language Facebook group on December 17, 2013, a commenter says they are unable to buy Gilenya at the pharmacy for the first time ever and was told it was in short supply.
The report looked into the effect of Germany’s AMNOG laws on pricing of drug and parallel trade and IMS Health senior manager Frank Weissenfeldt told APM the phenomenon was only likely to increase under current laws.
Although not cited by IMS, rather than endure low prices, many pharmas have decided to withdraw their drugs from Germany, following a poor added benefit rating, which would mean the drug would not fetch more than competitors already on the market.
However, Novartis' Gilenya gained a solid scientific assessment and is still cheap enough to parallel export.
Examples of drugs withdrawn from Germany include: Novartis' diabetes drugs Galvus (vildagliptin) and Eucreas (vildagliptin+metformin) (APMMA 38784) as well as Sanofi's Lyxumia (lixisenatide) also for diabetes.
Eisai's anti-epileptic Fycompa (perampanel) disappeared from the market after negative HTA rulings (APMMA 35481).
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