BERLIN, May 12 (APM) - Germany's drugs care reinforcement law (AM-VSG), which includes changes to health technology assessment (HTA) procedures and pricing policy, has come into effect.
The AM-VSG was published in the Federal Law Gazette on Friday and came into effect on Saturday.
The law, which updates the HTA and pricing procedure introduced by the AMNOG law in 2011, was passed by the lower chamber, the Bundestag, in March (APMMA 52179) and formally adopted by the upper chamber Bundesrat at the end of March.
In HTA, the AM-VSG introduces the possibility of a single procedure for successive indications of the same drug, and facilitates assessment of paediatric drugs and new antibiotics (APMMA 52160).
This changes, like others concerning the HTA procedure, will come into force after the highest HTA body, G-BA, has updated its procedural rules.
In pricing, drugs with a "no added benefit" rating will get more flexible pricing. In negotiations following G-BA's assessment, the comparator chosen as the reference price will no longer automatically be the cheapest drug, as is currently the case (APMMA 52162).
This new rule may be applied retroactively to reimbursed prices negotiated before May 13. Companies or umbrella payer group GKV-Spitzenverband (GKV-SV) have until August 13 to request new price negotiations.
The GKV-SV will also update its rules on pricing negotiations, including new options for negotiations on a reimbursed price such as volume pricing agreements.
The current price moratorium for drugs launched before 2011 - and therefore not submitted to the AMNOG drug pricing procedure - is maintained unchanged until June 30, 2018. This moratorium keeps prices for these drugs at the same level as on August 1, 2009.
From July 1, 2018 until the end of 2022, price adjustments based on the inflation rate will be introduced (APMMA 48704).
New rules for generics tendering procedures will come into force on March 1, 2018. Health insurers will have to leave a minimum of six months between the agreement and first deliveries at the agreed price (APMMA 52160).
The aim is to give more time to generic manufacturers - especially small and medium-sized companies - to adapt to the new pricing conditions.
The law also forbids tenders for vaccines by individual insurers, to ease market conditions and supply.
It prohibits drugs tenders on cytostatic drugs, which had been initiated by health insurers (APMMA 52171). All previously signed contracts will be terminated on August 31.
The law also introduces an obligation for manufacturers to inform hospitals about drug shortages (APMMA 52174).
It provides for a new doctor information system (AIS) which will allow physicians to access the G-BA's rulings on added benefit assessment of a new drug using their practice software.
The ministry of health said it plans to publish the regulation on the AIS before the end of 2017.
Members of the G-BA - impartial members, umbrella payer group GKV-Spitzenverband (GKV-SV) and representatives of doctors and hospitals -, pharma associations and the 16 regions will be consulted on the system's development (APMMA 52375).
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