by Hélène Mauduit
BERLIN, Mar 10 (APM) - Germany's lower chamber of Parliament, the Bundestag, has passed the drugs care reinforcement drug bill (AM-VSG), including numerous changes in health technology assessment (HTA) procedure and pricing policy.
The upper house, the Bundesrat, will pass the bill at one of its next meetings, probably on Friday March 31, and the new law is expected to come into force in April, said health minister Hermann Groehe in a Thursday statement.
Speaking on Wednesday, Groehe described the final version of the bill, which modifies the 2011 AMNOG law, as "a total work of art", providing a balance between support to the quality of care, innovation and financial viability.
The bill was drafted on the basis of the April 2016 report of the "pharma dialogues", a set of meetings held over 18 months between the government, pharma lobbies, research institutes and pharma industry trade union IG BCE.
The objective was to find measures reinforcing Germany's attractiveness to the pharma industry, improving access to innovation and keeping the drug spend sustainable.
The government sent the bill to parliament in October 2016, including two key measures, a 250 million-euro volume pricing threshold to limit high drug prices, and confidentiality on reimbursed prices, requested by the pharma industry.
The two political groups of the ruling coalition in the Bundestag, conservatives CDU/CSU and social democrats SPD, had numerous discussions in the last four months without being able to reach an agreement on these key measures.
They finally decided to remove them in order to get the bill passed before the end of the legislature on June 30 (APMMA 52120), and agreed on other amendments.
The bill will help provide "innovative drugs at sustainable prices to patients" and offer "a reliable environment for pharma companies", said CDU rapporteur Michael Hennrich in Thursday's final discussion.
Hennrich said that the Parliament, which did not participate in the pharma dialogues, had added its own vision. "I am not sad that price confidentiality is not coming… In times of transparency, the voters would not have appreciated it," he said.
The suppression of the volume pricing threshold sends out "a clear signal to the pharma industry", he added.
In health technology assessment, the AM-VSG introduces the possibility of a single procedure for successive indications of the same drug, and facilitates assessment of paediatric drugs (APMMA 52160).
In pricing, drugs with a "no added benefit" rating will get more flexible pricing and an option to renegotiate (APMMA 52162). This will benefit drugs indicated in chronic diseases, such as epilepsy, which have so far fared badly in assessments, said Hennrich and the SPD's Martina Stamm-Fibich.
Cytostatic drug tenders initiated by health insurers will be prohibited (APMMA 52171), and an obligation for pharmas to inform hospitals about drug shortages is introduced (APMMA 52174).
Pharma lobby BPI, representing small and medium size companies, expressed dissatisfaction in a Thursday statement that the bill remains "far behind the objectives of the pharma dialogues". "The law is inconsistent and arbitrary and is no 'total work of art' à la van Groehe".
BPI disapproves of the continuation of the drug price freeze until 2020, but welcomes pricing and HTA measures in favour of antibiotics and paediatric drugs.
Pharma lobby BAH is satisfied that its recommendation on the pricing of dosages of drugs specially adapted for children has been included in the bill.
Paediatric formulations of known drugs will find "economically acceptable conditions" on the German market, it said in a Thursday statement.
Generic lobby ProGenerika disapproved in a Thursday statement of the increased pressure on generic drug prices, which it said would lead to more uncertainties in the drugs supply.
It mentioned the introduction of discount agreements on cytostatic drugs, pushing already low-level prices down further, and the continuation of the price freeze, prompting companies to further streamline their product portfolios.
ProGenerika also regretted that politicians had not taken the opportunity to include an obligation for payers to conclude multiple-bidder discount contracts.
The government and MPs missed an opportunity to provide decisive support for biosimilars by not including quotas or objectives in prescriptions in the bill as had been mentioned in the Pharma dialogue report, said biosimilar lobby Pro Biosimilars in a Thursday statement.
Considerable savings could be achieved if biosimilars were more widely prescribed, it said.
hm/clg
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
