Does a German Launch Make Sense? - Pharmaceutical Executive


Does a German Launch Make Sense?

Pharmaceutical Executive


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AMNOG seems to be focused on forcing companies to negotiate rebates as a means of net price reduction. Currently, mostly for generics, rebates are directly deducted at the pharmacy where the patient gets his or her drugs. The pharmacy claims the rebate back from the manufacturer and only gets the retail price minus the mandated drug company rebate from the sick fund. There is no indication that rebates will be handled differently with AMNOG rebates but nobody seems to really know.

Besides posing limits on pricing for new drugs, AMNOG also introduces many other discounts on existing drugs at manufacturer and wholesaler level. So what about parallel trade? That still exists and will seemingly be in competition with rebated drugs. Pharmacists will likely decide on their choice on the basis of administrative hassle and margin. Kohlpharma, one of the largest German parallel trade wholesalers, just sued the AOK Sachsen-Anhalt as they think it is illegal to favor rebate-contracted pharmaceuticals if there are cheaper parallel trade alternatives.


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Exceptions to the price approval process can be granted for orphan drugs and drugs that are expected to only reach very limited sales revenues. Orphan drugs will automatically be rated as drugs with an additional benefit when they receive marketing authorization, as the G-BA assumes on the basis of the orphan drug status that there are no alternative treatment options. This exception only endures as long as the drug does not exceed a turnover of €50 million ($69.4 million) within 12 months. Low-volume drugs with a projected annual turnover of less than €1 million ($1.4 million) can also qualify for a waiver. After G-BA approval of a waiver, the manufacturer is authorized to set price freely as long as the annual limit is not exceeded.

Reactions to AMNOG

Depending on the perspective, opinions on AMNOG differ markedly. Dr. Rainer Hess, chairman of the G-BA, said it will be a learning process; the head of IQWiG, Jürgen Windeler, declared the reform was long overdue. This is not surprising since it provides IQWiG with a clear role after a long period of ambivalence. Dr. Christoph Mayr, board member of the HIV working committee, notes that new substances will have a hard time receiving a high additional benefit rating; other HIV specialists have stated AMNOG will have blind spots, as studies used by the G-BA to assess additional benefit would not cover all patient groups such as minors or older people.

Meanwhile, the drug industry is struggling to understand AMNOG's impact on the German market. "Even though there are numerous workshops, seminars, etc., about this topic, it seems that nobody really knows what the actual results of AMNOG will be," says Anja Prause, Global Pricing Manager at Bayer Healthcare Pharmaceuticals. On the implications for drug development she thinks it will be made more complicated "as it is unclear if a product can achieve an appropriate price and reimbursement level to recoup development cost in such a strategic market as Germany."

John Lechleiter, CEO of Lilly, argues that it may make more sense to not launch in Germany rather than to accept a "slap in the face rejection over unreasonable demands of evidence at launch that can only practically be gathered during more extensive product use." The recent joint decision by Boehringer Ingelheim and Lilly not to launch the diabetes drug Trajenta in Germany due to their dissatisfaction with the review process underscores that Lechleiter is serious about his concerns.

Dr. Hagen Pfundner of Roche Germany points out the inappropriateness of the monopoly negotiating power of the sick funds. Providing necessary healthcare to a population under adverse economic conditions is no easy task. Governments need to balance the need for public healthcare with their ability to fund this in consideration of many priorities. Unfortunately, many governments choose to use their single-buyer "monopsony" buying power to dictate terms of the purchase. This becomes particularly painful when the rules of the game are unclear and frequently changing. It is also focused primarily on the short-term budget cycle rather than on support for innovativon or health costs overall.


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