Drug Benefit Assessment Ordinance

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Basic data
Title: Ordinance on the benefit assessment of pharmaceuticals according to Section 35a (1) SGB V for reimbursement agreements according to Section 130b SGB V
Short title: Drug Benefit Assessment Ordinance
Abbreviation: AM-BenefitV
Type: Federal Ordinance
Scope: Federal Republic of Germany
Issued on the basis of: Section 35a Paragraph 1 Clause 6 and 7 SGB ​​V
Legal matter: Pharmaceutical law
References : 860-5-41
Issued on: December 28, 2010
( BGBl. I p. 2324 )
Entry into force on: January 1, 2011
Last change by: Art. 13 G of 9 August 2019
( Federal Law Gazette I p. 1202, 1217 )
Effective date of the
last change: 		August 16, 2019
(Art. 21 G of August 9, 2019)
GESTA : M014
Please note the note on the applicable legal version.

basis

The German drug benefit assessment regulation (also called "early benefit assessment") is a from the Federal Ministry of Health issued decree of the Federal coincide with the Pharmaceutical Market Restructuring Act came (AMNOG) came into force. It regulates the details of the benefit assessment of reimbursable drugs with new active ingredients according to Section 35a of Book Five of the Social Code .

On the basis of the ordinance, the Federal Joint Committee (G-BA) decides on the additional medical benefit of a new drug in relation to the appropriate comparative therapy. Before doing this, the Institute for Quality and Efficiency in Health Care (IQWiG) - on behalf of the G-BA - evaluates the available data and issues an initial assessment / recommendation. If there is an additional benefit, the drug manufacturer can negotiate a price for the drug with the umbrella association of statutory health insurance funds (GKV-Spitzenverband) . If the manufacturer cannot prove that his drug has an additional benefit, the G-BA assigns the drug to a fixed price group .

criticism

Claim by the manufacturer

In 2012, the Swiss pharmaceutical company Novartis filed a lawsuit with the State Social Court of Berlin Brandenburg (LSG). In order to stop the deadline set by the end of 2012 for submitting the dossier for two of his preparations, an urgent application was also submitted. The entire process of drug pricing in Germany is now endangered by the procedure, said Josef Hecken , impartial chairman of the G-BA, to SPIEGEL ONLINE. "The evaluation of further funds is delayed as the manufacturers wait for the court's decision." The court rejected the urgent application: lawsuit against the request to submit a dossier in the benefit assessment procedure has no suspensive effect.

The impartial chairman of the G-BA, Josef Hecken, rejected calls from five medical societies for changes in the early benefit assessment of drugs as unfounded.

Criticism from the payers

One of the criticisms made by the cost bearers of the current design of the procedure is that the manufacturers can determine the price of the drugs themselves until the arbitration board has decided, which has led to considerable increases in costs. One of the demands of the cost bearers is therefore that the manufacturers have to reimburse costs after the decision of the arbitration board.

Cost-benefit assessment

In October 2013, IQWiG completed its first cost-benefit assessment (KNB) on antidepressants . However, the results of this KNB are not directly relevant to the decision. Because the legal situation has changed since the order was placed: Originally, the results were supposed to form the basis for the decision to set a “maximum amount” for pharmaceuticals. This was the task of the National Association of Statutory Health Insurance Funds. Since the Act on the Reform of the Market for Medicinal Products (AMNOG) came into force in 2011, a KNB is primarily intended for the case that price negotiations fail after the regular early benefit assessment and the arbitral award is also challenged. Then manufacturers or the National Association of Statutory Health Insurance Funds can apply for a KNB.

Existing market

There have been numerous benefit assessments since the introduction of the AMNOG. So far, however, only those drugs that received marketing authorization after January 1, 2011 have been tested. In some cases, a negative evaluation resulted in the manufacturer not introducing the drug despite approval.

In April 2013, the G-BA set binding criteria for calling up additional drugs in the so-called existing market - drugs already on the market before January 1, 2011 - and at the same time identified the first preparations that should be subjected to a benefit assessment one after the other.

With the entry into force of the Fourteenth Act to Amend the Fifth Book of the Social Security Code on April 1, 2014, Section 35a (6) of the Social Code Book V was repealed. This abolished the option provided in the AMNOG to initiate benefit assessments on the basis of manufacturer dossiers for drugs that have already been approved and are on the market (existing market). The dossier evaluations that the G-BA commissioned IQWiG in November 2013 were not completed. The G-BA finally stopped the benefit assessment of the existing market.

Individual evidence

  1. ↑ Lawsuit against benefit assessment: pharmaceutical industry dismantles the cost damper for pills , SPON from February 22, 2013.
  2. ↑ LSG confirms the legal opinion of the G-BA , PM of the Federal Joint Committee of March 1, 2013.
  3. ↑ struggle pill prices , SPON from March 1, 2013.
  4. ↑ Early benefit assessment: “The arguments of professional societies are not convincing” (PDF; 58.7 kB) PM of the G-BA dated May 24, 2013.
  5. ↑ Richard, Sabine, "Adjusting the course," Health and Society (5) 2016, 4-6.
  6. ↑ First cost-benefit assessment completed IQWiG press release of October 30, 2013.
  7. ↑ G-BA lays down criteria for calling the existing market and determines the first active ingredient groups for the benefit assessment , PM of the Federal Joint Committee of April 18, 2013.
  8. ↑ 14th law amending SGB V comes into force on April 1, 2014 , BMG press release of April 1, 2014.
  9. ↑ After legal reform: G-BA finally discontinues the benefit assessment procedure of the existing market , G-BA press release from April 17, 2014, accessed on April 18, 2014

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