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Impending new guidelines on prescribing biologics advise German doctors to consider the economic case for prescribing a biosimilar instead of the reference product. The guidelines are a first step towards increasing usage of biosimilars in a bid to save costs.

The guidelines were mandated by the Act for Greater Security in the Pharmaceutical Supply System (GSAV), which was enacted in August 2019. This is a wide-ranging piece of legislation, and one of its most important provisions was to drive down medicine costs by increasing biosimilar uptake. 

The guidelines are the first step in this process, the next is to allow pharmacists to switch patients on to biosimilars, unless doctors categorically state this should not be an option, in 2022. (Also see "Germany Could Introduce Biosimilar Substitution By Pharmacists In Three Years" - Pink Sheet, 20 Feb, 2019.)

Six of the ten drugs with the highest sales per patient are biologics, according to the G-BA, the highest decision-making body within the self-governing statutory health insurance system. There are nearly 300 biologics on the German market, 16 of which now compete with biosimilars. Biosimilars are around 37% less expensive than that of the originator, says the G-BA.

According to the guidelines, at the beginning of treatment for the first prescription, doctors should select a less expensive product, which the G-BA says is usually the biosimilar.

If patients are already being treated with a particular biologic, doctors should check to see whether they can be switched to a less expensive biosimilar. A switch should not be made if there are any medical reasons why it would be inappropriate, for example, if the patient may experience side-effects.

The guidelines also emphasize the importance of rebate contracts and say that physicians do not need to evaluate a drug’s costs when a patient’s insurer has such a contract in place. 

These guidelines on prescribing biosimilars are the first to be issued at a national level by the G-BA. Meanwhile, the Association of Statutory Health Insurance and Physicians (Kassenärztliche Vereinigungen, the GKV) has already recommended the use of biosimilars as the preferred option in all approved indications, according to Eda Zhuleku, a life science specialist at the law firm Allen & Overy LLP. 

The guidelines are likely to have some effect on increasing usage of biosimilars, but the biggest impact of GSAV will be felt when biosimilar substitution is introduced in 2022, said Zhuleku in an interview with the Pink Sheet.

In preparation for the new rules, Zhuleku expects that both originator and biosimilar companies will increasingly negotiate rebate contracts with insurers for their products if possible. In addition, originator firms will ramp up efforts to promote their drugs to physicians on the basis of safety. Rebate contracts will prove the most effective way of ensuring the product is prescribed, she said.

The new guidelines will be instituted by amending the Arzneimittel-Richtlinie, the directive on prescription medicinal products in statutory health care. They will come into force when they have been formally approved by the health ministry and published in the Federal Gazette.

The GSAV also introduced new requirements on data collection for companies marketing orphan drugs and conditionally approved medicines.  (Also see "Zolgensma First To Be Subject To New German Data Collection Rules" - Pink Sheet, 18 Aug, 2020.)


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