Pharmaceutical Market Reorganization Act

from Wikipedia, the free encyclopedia
Basic data
Title: Law to reorganize the pharmaceutical market in the statutory health insurance
Short title: Pharmaceutical Market Reorganization Act
Abbreviation: AMNOG
Type: Federal law
Scope: Federal Republic of Germany
Legal matter: Social law
Issued on: December 22, 2010
( BGBl. 2010 I p. 2262 )
Entry into force on: mostly January 1, 2011
Weblink: Text of the AMNOG
Please note the note on the applicable legal version.

With the law for the reorganization of the pharmaceutical market in the statutory health insurance (Arzneimittelmarktneuordnungsgesetz - AMNOG), the increasing pharmaceutical expenditure of the statutory health insurance should be contained in Germany . The price of new drugs should be based on their additional benefit compared to therapies already on the market.

The law was passed by the German Bundestag on November 11, 2010 and its major parts came into force on January 1, 2011. Above all, it changed the fifth book of the Social Security Code , as well as other laws such as the Medicines Act .

background

In order to contain the rising drug costs, which burdened the system of statutory health insurance, experts had initially proposed so-called negative lists (non-reimbursement of prescription-free, inappropriate or controversial drugs) or positive lists (reimbursement only for drugs classified as appropriate and cost-efficient). However, these models could not be implemented politically, partly because of strong resistance from the pharmaceutical industry.

At the end of 2009, the Christian-liberal federal government agreed in its coalition agreement to reorganize the pharmaceutical market. It should be made more competitive, medium-sized and patient-friendly. The immediate cause was the pharmaceutical expenditure of the statutory health insurance, which in 2009 had increased by around 1.5 billion euros compared to the previous year, thus continuing the trend of previous years.

Above all, spending on new drugs rose sharply because manufacturers were able to set the prices themselves - regardless of the additional benefit for the patient. With his draft law, Federal Health Minister Philipp Rösler (FDP) closed this regulatory gap for new drugs in the summer of 2010.

Innovations

With the AMNOG, the federal government took three types of measures to achieve the goals set out in the coalition agreement: structural changes, dismantling of overregulation and short-term savings.

Structural innovations

Early benefit assessment of pharmaceuticals (§ 35a SGB V ): The Drug , the pharmaceutical quality, safety and efficacy of a drug in the foreground; the gain in benefits for patients compared to drugs that have already been introduced is not examined. Since 2011, manufacturers have had to submit dossiers with evidence of these so-called additional benefits for all drugs with new active ingredients at the time of market launch. They submit these dossiers to the Federal Joint Committee (G-BA), the highest self-governing body of the German health system. The G-BA then regularly commissions the Institute for Quality and Efficiency in Health Care (IQWiG) with a dossier assessment, which must be available after three months at the latest. The dossier evaluation is followed by a commenting procedure at the G-BA. On this basis, the G-BA decides no later than three months after the dossier assessment whether the drug has an additional benefit compared to an appropriate comparative therapy specified by the G-BA and - if so - what extent it has.

If no additional benefit can be proven, an amount will be set for the reimbursement by the statutory health insurance in the outpatient area, which is based on the price of pharmacologically-therapeutically comparable drugs or other comparative therapies. If the G ‑ BA determines an additional benefit, the National Association of Statutory Health Insurance Funds and the manufacturer negotiate a price based on the assessment of the additional benefit. If they cannot agree, an arbitration board is called. The reimbursement amount negotiated or determined in this way will take effect no later than one year after the new drug has been launched on the market, including for those with private health insurance and self-payers.

If an arbitration award is not accepted, both the manufacturer and the National Association of Statutory Health Insurance Funds can request a cost-benefit assessment (KNB) by IQWiG. The form of presentation of the results of a KNB published by IQWiG is the efficiency frontier . Such a KNB would not have a suspensive effect, ie the arbitration award would initially come into force.

Both the manufacturer and the National Association of Statutory Health Insurance Funds have legal recourse against an arbitral award. The State Social Court of Berlin-Brandenburg is responsible in the first instance. The action has no suspensive effect. However, an application can be made to establish suspensive effect in proceedings for interim legal protection.

For drugs for the treatment of rare diseases ( orphan drugs ), the procedure is simplified insofar as they must already have an additional benefit due to the approval. In this case, IQWIG is not commissioned to evaluate; the G-BA decides solely on the extent of the additional benefit. Only when they have achieved sales of over 50 million euros with the statutory health insurance within twelve months do they have to go through a “standard” benefit assessment, in which it can also be determined that there is little or no additional benefit. This fictitious additional benefit by law has recently come under increasing criticism.

Originally, benefit assessments were also to be carried out for drugs that had been on the market for some time (so-called inventory market call). However, this rule was lifted in early 2014 ( see below ).

deregulation

The so-called bonus-malus regulation was lifted to relieve the doctors. The regulation for prescribing special drugs (second opinion) has been abolished. The legislature also tried to reduce bureaucratic hurdles for insured persons and service providers with a simplification of the profitability audits, a clearer regulation of therapy and prescription exclusions as well as a more competition and patient-friendly design of discount contracts for pharmaceuticals that are free of patent and with the same active ingredients.

Savings

Together with a regulation in the law amending health insurance law and other regulations (GKV-AmendmentG) that came into force on July 30, 2010, the AMNOG provided for annual savings for the GKV of 2.2 billion euros. The legislator hoped to save around two billion euros per year from the introduction of the early benefit assessment alone. In fact, the savings are lower (443 million euros in 2014).

The statutory manufacturer discount that pharmaceutical companies and pharmacies must grant the statutory health insurers has been increased from six percent to 16 percent for the years 2010 to 2013. At the beginning of 2014 it was fixed at seven percent up to and including 2017. Instead of a drug for which their health insurance company has negotiated a discount, patients can choose another product with an identical active ingredient, but then have to pay the additional costs.

Further changes

  • With the AMNOG, the Independent Patient Advice Germany (UPD) was permanently established as a statutory health insurance benefit (Section 65b SGB V).
  • The G-BA can only restrict or exclude the prescription of a drug if it has been proven to be inexpedient (previously: if it is inexpedient) or another, more economical treatment option with comparable benefits is available (Section 92 SGB V).
  • Manufacturers are obliged to publish the results of clinical trials of their drugs within one year of the end of the study (Section 42b of the German Medicines Act).
  • The validity of the antitrust law for the GKV has been expanded so that the antitrust authorities of the federal and state governments can monitor compliance with the regulations and take action against behavior contrary to antitrust law. Since 2011 civil courts have been responsible for antitrust disputes between statutory health insurance and service providers instead of social courts.

implementation

At the same time as the AMNOG, the Medicines Benefit Assessment Ordinance (AM-BenefitV) of the BMG came into force on January 1, 2011 , in which the details of the benefit assessment are regulated. Also in January 2011, the G-BA adjusted its rules of procedure. In September 2011, IQWiG published its "Methods 4.0", in which it describes its evidence-based approach to dossier assessment and specifies the six categories provided for in the AM-BenefitV (additional benefit significant, considerable, minor, non-quantifiable, not proven; benefit less than for comparative therapy).

The first dossier assessment was published in October 2011; The assessment of individual outcomes and the derivation of the overall conclusion on the added benefit were explained in the appendix. In July 2013, IQWiG published the first dossier assessments as part of the existing market review, also introduced with the AMNOG, which was finally stopped again in spring 2014 (see next section ).

By the end of 2014, over 100 valuation procedures had taken place, 52 of which had been completed with reimbursement price procedures. In nine of these cases the price was set by the arbitration board. Nine pharmaceutical companies withdrew 19 products (in two cases only temporarily) from the German pharmaceutical market due to the early benefit assessment. In these cases, patient care was not endangered due to the availability of alternative products. However, the price level for new drugs has not yet been reduced to the extent aimed at by the legislature.

Later changes

In June 2013, the Bundestag passed the Third Act amending pharmaceutical and other regulations. If several comparative therapies are equally useful from a medical or evidence point of view, the manufacturer can since then choose against which of these comparative therapies he can demonstrate an additional benefit of his active ingredient. Previously, the G-BA had to choose the most economical appropriate comparative therapy in such cases.

In February 2014, the Bundestag passed the 14th law amending the fifth book of the social security code. This extended the price moratorium, raised the manufacturer discount (except for generics) and deleted the existing market calls for benefit assessment (Section 35a, Paragraph 6, SGB V). A benefit assessment commissioned by IQWiG at the end of 2013 for drugs already on the market before 2011 on the basis of manufacturer dossiers was then discontinued.

literature

  • Franz Knieps, Hartmut Reiners: Health reforms in Germany. History - intentions - controversies . Huber, 2015, ISBN 978-3-456-85433-5
  • Uwe K. Preusker (Hrsg.): Lexicon of the German health system . 4th edition, medhochzwei, 2013, ISBN 978-3-86216-114-0

See also

Health reform in Germany

Individual evidence

  1. ^ The law for the reorganization of the pharmaceutical market (AMNOG). In: www.bmg.bund.de. Retrieved December 16, 2015 .
  2. Press release: Federal government decides to reorganize the pharmaceutical market. In: www.bmg.bund.de. Retrieved December 16, 2015 .
  3. GKV-SPITZENVERBAND: Better testing of orphan drugs. In: Deutsche Apothekenzeitung. October 22, 2015, accessed December 9, 2016 .
  4. ^ The law for the reorganization of the pharmaceutical market (AMNOG). In: www.bmg.bund.de. Retrieved December 16, 2015 .
  5. AOK Federal Association - Press - Press release - Drug Ordinance Report 2015: Drug expenditure at record level (23.09.15). (No longer available online.) In: www.aok-bv.de. Archived from the original on December 22, 2015 ; accessed on December 16, 2015 . Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / www.aok-bv.de
  6. Ticagrelor: Considerable added benefit for certain patients. In: www.iqwig.de. Retrieved December 18, 2015 .
  7. Rainer Hess: The AMNOG in retrospect: Cost brake with collateral effect. In: Interdisciplinary Platform for Benefit Assessment, Issue 1, July 2015: Four Years AMNOG - Discourse and Impulse, ISSN 2364-916X, pp. 8-13.
  8. ^ Bundestag passes third amendment to the AMG. In: www.bmg.bund.de. Retrieved December 16, 2015 .
  9. BM Gröhe: "We ensure an affordable supply of pharmaceuticals at a high level". In: www.bmg.bund.de. Retrieved December 16, 2015 .

Web links