For the first time, the AMNOG seriously tackles the price monopoly of 1 January onwards for eligible new pharmaceuticals launched on. Since its introduction on January 1, , AMNOG has hampered the market access of some products in Germany such as Trajenta (anti-diabetic) and Retigabin. AMNOG is here to stay. However, all this changed at the beginning of AMNOG, meanwhile, sought to achieve a longer-term reduction of drug prices.
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All English translations are courtesy translations only. Only the German versions are binding. Here you will find:. It completely revises pricing regulations for newly authorized pharmaceuticals and their reimbursement by statutory health insurance providers.
Sincetheir findings form the basis of decisions on the prices statutory health insurance providers pay for new pharmaceuticals with new active ingredients. For the first time, pharmaceutical companies are obliged to submit a dossier on product benefit when a new product is launched on the German market or authorized for new indications.
Within three months of market authorization of a new pharmaceutical, the G-BA assesses recognition of any additional benefit claimed over the appropriate comparator.
For this purpose, the company submits a dossier to the G-BA based on the authorization documents and all studies carried out on this pharmaceutical.
Implementation of AMNOG: An industry perspective
The dossier must prove an additional benefit of the pharmaceutical over the appropriate comparator specified by the G-BA. The result of the benefit assessment is published on 2101 internet, and pharmaceutical companies, federations, and experts are given the opportunity to submit written and verbal statements on the result. After another three months, the G-BA anog a resolution based on the benefit assessment smnog the hearings.
In particular it contains statements on the extent of additional benefit, patient groups eligible for treatment, requirements for quality-assured administration, and the cost of treatment with the pharmaceutical.
This resolution is published without delay, and includes the G-BA’s decision on the pricing procedure for the new medicine. Within six months, if additional benefit is proved, the Central Federal Association of Health Insurance Funds and the pharmaceutical company negotiate the reimbursement price paid by the statutory health insurance funds.
This takes the form of a rebate on the retail price originally set by the company. If no agreement is reached, an arbitration board determines the reimbursement price using European pricing levels as its standard.
If the G-BA decides that the new pharmaceutical does not have any additional benefit over the appropriate comparator preferably a therapy for which endpoint studies are available and which has proved beneficial in practical useit will be included in the reference price system within six months of market launch. If a pharmaceutical without additional benefit cannot be allocated to among reference price group, a reimbursement price will also be agreed on.
The annual qmnog costs must not exceed those of the appropriate comparator.
– AMNOG since
It supplements the various AMNOG stipulations and its accompanying legal regulations, and summarizes them into a uniform set of rules. A new fifth chapter was added to the rules of procedure. In four sections, it defines in detail the steps of the benefit assessment.
It includes three appendices: The AMNOG provides for the benefit assessment of reimbursable pharmaceuticals with new active ingredients based on proof provided by the pharmaceutical company. This also applies to newly authorized indications of these pharmaceuticals.
Each step of the benefit assessment is described in the chapter 5 of the G-BA rules 0211 procedure in detail.
Appendix II is of particular importance to pharmaceutical companies. It describes clearly the standards for proof of additional benefit, for determining the appropriate comparator, and for the dossier submitted by the pharmaceutical company.
Pharmaceutical companies may submit the dossier to the G-BA in advance for the purpose of a check for formal completeness without regard todata contents. Where necessary, the G-BA will then give comments in writing to the company which additional documents or information is required.
201 pharmaceutical company must send these documents, including all clinical trials it has commissioned or carried out, to the G-BA in electronic form no later than the day the pharmaceutical is first brought into circulation. For electronic transmission, the dossier must be sent to the Federal Joint Committee as a CD or DVD, and include a cover letter signed by an authorized person including authorization, if applicable.
Please use two envelopes and note the following on the inside envelope containing the cover letter and CD or DVD: Please use the following address on the outside envelope: New address from amnof January on: The staff office is closed from 24 December to 1 January Documents will be accepted on 27, 28 and 31 December from 8: Please send any general questions regarding benefit assessments to the following email address.
You will receive a prompt reply:.
AMNOG – evaluation of new pharmaceutical
A consultation before the start of phase 3 authorization studies must involve the Federal Institute for Drugs and Medical Devices or the Paul Ehrlich Institute. Further information on the involvement of the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute in the consultation is summarized in a guideline Leitfaden.
Please include the required documents on CD or DVD, along with a cover letter signed by an authorized person including authorization, if applicable and addressed to the Federal Joint Committee:.
Pharmaceutical companies can send any questions they may have regarding the G-BA consultation procedure to the following email address:. Visit our official German website. Here you will find: You will receive a prompt reply: Please include the required documents on CD or DVD, along with a cover letter signed by an authorized person including authorization, if applicable and addressed to the Federal Joint Committee: Pharmaceutical companies can send any questions they may have regarding the G-BA consultation procedure to the following email address: Consultation fees in accordance with SGB V, section 35a back to top Questions and answers on the procedure Questions on the scope of application Questions on the special case of orphan drugs Questions on appropriate comparators Questions on compiling dossiers Questions on documents in module 5 of the dossier Questions on submitting dossiers Questions on hearing procedures Questions on the handling of confidential documents Questions on the revisability of G-BA decisions Questions on price negotiations with statutory health insurance providers back to top.