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German Bundestag passes bill on HTA on key antibiotics, ATMPs and management of drug shortages

BERLIN, 14 Feb (APM) - The German Bundestag has passed a bill on management of drug shortages, health technology assessment (HTA) on key antibiotics and advanced therapy medicinal products (ATMPs) triggering pricing consequences.
The law on "fair competition between statutory payers" (GKV-FKG) is expected to come into force at the end of March or the beginning of April once it is published in the Federal Law Gazette.
The bill was voted on Thursday by both political groups of the ruling coalition, conservative party CDU/CSU and social democrats SPD as well as the Green and liberal FDP.
The initial goal of the bill was to reshape the financing system of the 105 statutory payers based on morbidity-oriented risk compensation (Morbi-RSA) mechanism and to make it fairer. Various drug measures were added afterwards as the bill was an opportunity to quickly implement measures in German law.

Better managing shortages

The law includes several measures aiming at better managing shortages (APMHE 65189).
A new advisory board dedicated to shortages on critical drugs will be created at drugs' regulator BfArM, giving a permanent framework to the current quarterly "jour fixe" meetings. It will include representatives of medical associations, pharmacists, wholesalers, pharma companies, hospitals, statutory payers and patients.
This advisory board will advise BfArM to set up and publish a list of "supply-relevant and critical" drugs.
Pharma companies and wholesalers will have an obligation to report imminent  shortages of these drugs in the out-patient sector to BfArM - as is already existing for hospital pharmacies.
Drugs' regulators BfArM and Paul Ehrlich Institute (PEI) are authorised to set stricter storage requirements of critical drugs for companies and wholesalers (over the current obligation of two week storage).
In case of short supply, the obligation to label drugs in German will be lifted to allow selling of imported packages from a non-German speaking country.
Moreover, in case of short supply of a drug, patients will no longer have to pay more when they are given an alternative medicine or brand which is usually not covered by their payer. This is an exception introduced to discount agreements.

Drug HTA for all ATMPs

All EU-authorised ATMPs will be assessed as drugs in health technology assessment (HTA) procedures in Germany in the future (APMHE 65391).
Their use will no longer be subject to the requirements for the evaluation of examination and treatment methods.
ATMPs which are approved at national level in Germany by drugs' regulator Paul Ehrlich Institute (PEI) according to section 4b of the German Medicinal Products Act, are expressly excluded from the scope of the scheme.
So far, HTA body G-BA was reviewing whether an ATMP was assessed as a drug or a treatment method. If the ATMP is classified as a treatment method, it undergoes the procedure only for the reimbursement as a new treatment option in hospitals ('NUB') - not the AMNOG procedure on HTA and pricing.

Reserve antibiotics gets orphan-like status

Reserve antibiotics active against multi-resistant bacteria will get an orphan-like status in HTA procedure in Germany as an incentive for their development and marketing (APMHE 65312).
It means that they are automatically assumed to have added benefit and G-BA has only to assess to what extent they are beneficial - mirroring regulation on HTA on orphan drugs.
Within nine months of the law being enacted - until beginning of 2021- the Robert Koch Institute, in agreement with BfArM, will determine criteria for the classification of active substances as reserve antibiotics in accordance with the current state of medical science.

High-risk pool

The law will introduce a "high-risk pool" in the Morbi-RSA mechanism to minimise the immediate cost of high-cost therapies, including ATMPs, for payers (APMHE 65000).
For a treatment, including drugs, in the "high-risk pool", health insurance companies would receive 80% of an expenditure exceeding €100,000 a year for each treated insuree.
The current system is designed for chronic treatments administered and paid over years. This financing tool does not suit one-time therapies such as ATMPs, which tend to have a high initial cost but can mean other costs are avoided in the following years.

Clarification on post-launch data collection from day one of launch

The law adds a clarification in the newly introduced post-launch data collection for drugs with "limited scientific evidence" (orphan drugs, drugs conditionally approved or approved under exceptional circumstances) decided by G-BA (APMHE 63300).
It says that G-BA can order post-launch data collection for the purpose of added benefit assessment as soon as the first day of marketing in Germany.
The law also adds that medical societies, the Drug Commission of the German medical profession (AkdÄ) and the pharmaceutical company concerned, are consulted by G-BA when considering such a data collection.
It also adds that introducing a legal action against a decision does not have a suspensive effect.
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