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Regulation on the evaluation of the benefits of medicinal products in accordance with Section 35a (1) of the SGB V for reimbursement agreements pursuant to § 130b SGB V

Original Language Title: Verordnung über die Nutzenbewertung von Arzneimitteln nach § 35a Absatz 1 SGB V für Erstattungsvereinbarungen nach § 130b SGB V

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Regulation on the evaluation of the benefits of medicinal products according to § 35a (1) of the SGB V for reimbursement agreements according to § 130b SGB V (Medicinal Products for Benefit Assessment-AM-NutzenV)

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Date of completion: 28.12.2010

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" Medicinal Products Assessment Decree of 28 December 2010 (BGBl. 2324), as last amended by Article 2 of the Law of 27 March 2014 (BGBl). I p. 261) "

Status: Last amended by Art. 2 G v. 27.3.2014 I 261

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.1.2011 + + +) 

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Input formula

On the basis of § 35a (1) sentences 6 and 7 of the Fifth Book of Social Code-statutory health insurance-which is defined by Article 1 (5) of the Law of 22 December 2010 (BGBl. I p. 2262), the Federal Ministry of Health is responsible for: Unofficial table of contents

§ 1 Scope

The Regulation lays down rules for the evaluation of the benefit of reimbursable medicinal products with new active substances in accordance with § 35a of the Fifth Book of Social Code. In its Rules of Procedure, the Joint Federal Committee shall determine further details for the first time within one month of the entry into force of the Regulation. Unofficial table of contents

§ 2 Definitions

(1) Medicinal products containing new active substances within the meaning of this Regulation are medicinal products which contain active substances whose effects are not generally known in the case of initial authorisation in medical science. A medicinal product containing a new active substance within the meaning of this Regulation shall be considered to be a medicinal product containing a new active substance, as for the first authorised medicinal product containing the active substance of the active substance. (2) A new area of application is an area of application for which a new authorisation is granted in accordance with Section 29 (3) (3) of the Medicines Act, or as a major change of type 2 in accordance with Annex 2 (2) (a) of Commission Regulation (EC) No 1234/2008 of 24 June 2008. November 2008 on the examination of amendments to the authorisations of medicinal products for human and veterinary use 1. 7). (3) The benefit of a medicinal product within the meaning of this Regulation is the therapeutic effect relevant to the patient, in particular with regard to the improvement of the health status, the shortening of the (4) The added value of a medicinal product within the meaning of this Regulation is a benefit within the meaning of paragraph 3, which shall be quantitative and quantitative, and shall be subject to the following conditions: or a higher quality than the benefit of the appropriate comparative therapy (5) Purpose comparative therapy within the meaning of this Regulation is that therapy whose benefit is compared with the benefit of a medicinal product with new active substances for the benefit assessment in accordance with § 35a of the Fifth Book of Social Code. Unofficial table of contents

§ 3 Scope of the benefit assessment according to § 35a SGB V

The benefit assessment according to § 35a (1) of the Fifth Book of the Social Code shall be carried out for reimbursable medicinal products containing new active substances and new combinations of active substances,
1.
to be placed on the market for the first time as from 1 January 2011, provided that, for the first time, a medicinal product containing this active substance is placed on the market,
2.
which have been placed on the market for the first time as from 1 January 2011 and which, after 1 January 2011, have been given a new area of application in accordance with Article 2 (2);
3.
at the earliest one year after the decision on the benefit assessment in accordance with Article 7 (4), at the request of the pharmaceutical entreprentier,
4.
at the earliest one year after the decision on the benefit assessment in accordance with Article 7 (4), if new findings are available on the initiative of the Joint Federal Committee,
5.
for which the Joint Federal Committee has decided on a benefit assessment with a limit of time, when the deadline has expired.
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§ 4 Dossier of the pharmaceutical entrepre

(1) The dossier shall contain information on:
1.
-approved indications,
2.
the medical benefit,
3.
the added medical benefit in relation to the appropriate comparative therapy;
4.
the number of patients and groups of patients for which there is a therapeutically significant added benefit,
5.
the costs of the therapy for statutory health insurance,
6.
the requirement for a quality-assured application.
For medicinal products according to § 35a (1) sentence 10 of the Fifth Book of the Social Code, no information is required on points 2 and 3, unless the conditions of § 35a (1) sentence 11 of the Fifth Book of the Social Code are fulfilled. (2) The dossier should also include the approval number, the date of the authorisation, the authorisation holder, the pharmaceutical central number, the association with the anatomical therapeutic-chemical classification and the name of the medicinal product. The pharmaceutical company shall transmit to the Joint Federal Committee the dossier with the evidence for the benefit assessment in accordance with § 35a (1) sentence 3 of the Fifth Book of Social Code electronically. The Joint Federal Committee shall establish the technical standards to be used in the process and shall specify formats and structure. It should be based on the standards of the Federal Supreme Authority (approval authority) responsible for approval. The dossier is intended to contain in particular a summary of the main statements which are the basis for agreements according to § 130b of the Fifth Book of the Social Code. (3) The dossier shall be transmitted at the latest at the following times:
1.
for medicinal products containing new active substances, which will be placed on the market for the first time from 1 January 2011, at the time of the first placing on the market;
2.
in the case of medicinal products which receive a new area of application in accordance with Article 2 (2) if the medicinal product has been subject to a benefit assessment under this Regulation, within four weeks of the date of authorisation of the new area of application or of the new area of application of the medicinal product information to the marketing authorisation holder of a type 2 change as referred to in Annex 2 (2) (a) of Regulation (EC) No 1234/2008;
3.
(dropped)
4.
for medicinal products for which a benefit assessment has already been adopted and for which the pharmaceutical company has not submitted a new benefit assessment at the earliest one year after the decision or for which the Joint Federal Committee has submitted a request for a benefit assessment , within three months of the request of the Joint Federal Committee,
5.
in the case of medicinal products for which a temporary decision on the benefit assessment is available, on the day of the expiry of the period;
6.
for medicinal products for which a benefit assessment is carried out in accordance with Article 35a, paragraph 1, sentence 11 of the Fifth Book of Social Code, three months after the request of the Joint Federal Committee.
(4) The Joint Federal Committee shall take account of documents submitted in due time. The documents of the authorisation authorities which have not yet been submitted to the pharmaceutical entreprenter at the relevant time for submission have to be taken into account, provided that this does not delay the benefit assessment. (5) The pharmaceutical Business operators may also submit the dossier to the Joint Federal Committee before the dates referred to in paragraph 3. If the pharmaceutical company submits the dossier to the Joint Federal Committee three weeks before the date of the respective date referred to in paragraph 3, the office of the Joint Federal Committee shall carry out a formal preliminary examination of the completeness of the dossier. Dossiers. If the dossier is incomplete, the office of the Joint Federal Committee shall, as a rule, inform the pharmaceutical entreptier within two weeks of the additional information required. The examination of the content of the dossier in accordance with Section 7 (2) shall remain unaffected. (6) For the medicinal product to be evaluated with a new active substance, the pharmaceutical operator shall submit to the dossier the outcome report of the marketing authorisation studies, including the study protocols and the assessment report of the authorisation authority, and any studies which have been submitted to the regulatory authority. In addition, all the results, study reports and study minutes of studies on the medicinal product for which the entreprent was a sponsor, as well as all available information on ongoing or aborted studies with the medicinal product, shall be submitted for: that the entrepre is sponsor or otherwise financially involved, and information about third party studies, as far as these are available. (7) For the appropriate comparative therapy according to § 6, the pharmaceutical entrepre in the dossier, all available results from clinical trials, including: of study protocols which are likely to make findings on the added value of the medicinal product to be assessed. In the absence of clinical trials for direct comparison with the medicinal product to be assessed, or in the absence of sufficient evidence of an added benefit, indirect comparisons can be made in the dossier. (8) The pharmaceutical The costs for the statutory health insurance should be stated at the price of the pharmacy fee and the costs actually incurred by the health insurance companies. The costs shall be disclosed both for the medicinal product to be evaluated and for the appropriate comparative therapy. The direct costs for the statutory health insurance cover a certain period of time. Where medicinal products are used in accordance with specialist or package leaflet, there are regular differences in the use of medical treatment, or in the case of the regulation of other benefits between the medicinal product to be assessed. Medicinal products and appropriate comparative therapy should take account of the cost differences associated with the determination of the costs actually incurred by the health insurance funds. Unofficial table of contents

§ 5 Additional benefits

(1) The additional benefit shall be proven by the pharmaceutical entrepre in the dossier in accordance with § 4. The Joint Federal Committee has no obligation to act. (2) For reimbursable medicinal products with new active substances which are pharmacologically-therapeutically comparable to fixed-value medicinal products, the additional medical benefit is the proof of therapeutic improvement in accordance with § 35 (1b) sentences 1 to 5 of the Fifth Book of the Social Code. The proof of a therapeutic improvement is based on the specialist information and by evaluation of clinical studies according to the international standards of evidence-based medicine. Priority should be given to clinical studies, in particular direct comparative studies with other medicinal products of this fixed group, with patient-relevant endpoints, in particular mortality, morbidity and quality of life. (3) For Medicinal products containing new active substances which do not meet the conditions laid down in paragraph 2 shall be provided with an added benefit for the relevant authorised area of application in comparison with the appropriate comparative therapy referred to in § 6 on the Basis of documents for the benefit of the medicinal product in the approved Application areas. The basis for this is the drug regulatory approval, the officially approved product information as well as announcements of approval authorities and the evaluation of clinical trials in accordance with the international standards of evidence-based medicine. For the first evaluation according to § 35a of the Fifth Book of the Social Code at the time of the market launch, the approval studies should be used for the evaluation of the medicinal product with new active substances. If the approval studies are not sufficient, the Joint Federal Committee may request further evidence. If it is impossible or inappropriate to carry out or request studies of the highest level of evidence, evidence of the best available evidence level must be submitted. (4) In the dossier, please indicate the validity of the evidence with which: Probability and to what extent there is an added value. This information should be given both in terms of the number of patients and the size of the additional benefit. (5) For medicinal products as referred to in paragraph 3, the added value shall be compared with the appropriate comparative therapy. noted as an improvement in the influence of patient-relevant endpoints for the benefit in accordance with § 2 (3). If valid data on patient-relevant endpoints are not yet available at the time of evaluation, the assessment shall be based on the available evidence, taking into account the quality of the study, indicating the probability of the Receipt of an additional benefit and a time limit can be determined until when valid data for patient-relevant endpoints are to be submitted. In the absence of direct comparative studies for the new medicinal product compared with appropriate comparator therapy, or if it does not provide sufficient evidence of an added value, available clinical studies may be appropriate for the appropriate use of the medicinal product. Comparative therapy, which is suitable for an indirect comparison with the medicinal product with new active substances. (6) The validity of the evidence is taken into consideration for the quality of the study, the validity of the endpoints used as well as the evidence level, and it is to be assessed with which Probability and to what extent there is an added value. In the dossier, it is to be stated for all documents submitted, at which evidence level the evidence is provided. The following evidence levels apply:
1.
I a systematic review of studies of the evidence level Ib
2.
I b randomised clinical trials
3.
II a systematic overview work of the Evidenzstufe lIb
4.
II b prospectively comparative cohort studies
5.
III retrospectively comparative studies
6.
IV Case series and other non-comparative studies
7.
V Association observations, pathophysiological considerations, descriptive representations, case-by-case reports, non-studies opinions of recognised experts, consensus conferences and reports of expert committee opinions.
(7) For the medicinal products referred to in paragraph 3, the extent of the added value and the therapeutic value of the added value shall be as follows, taking into account the severity of the disease compared to the benefit of the appropriate comparative therapy as follows: quantify:
1.
A significant additional benefit is provided if a sustained and previously unachieved improvement of the therapeutic benefit in the sense of § 2 (3) is achieved, in particular a cure of the disease, a significant prolongation of survival, long-term freedom from serious symptoms, or the extensive prevention of serious side effects;
2.
A significant additional benefit is available if a significant improvement in the therapy-relevant benefit in the sense of § 2 (3), which has not yet been achieved with regard to the appropriate comparison therapy, is achieved, in particular a reduction in the amount of treatment relevant to the therapy. severe symptoms, a moderate prolongation of the lifespan, a noticeable reduction in the disease for patients, a relevant avoidance of serious side effects or a significant avoidance of other symptoms. Adverse reactions;
3.
a small additional benefit is available if a moderate and not only slight improvement in the therapy-relevant benefit as compared with the appropriate comparison therapy is achieved in the sense of § 2 (3), in particular a Reduction of non-serious symptoms of the disease or a relevant avoidance of side effects;
4.
an additional benefit is available, but is not quantifiable, because the scientific data base does not allow this;
5.
there is no additional benefit;
6.
the benefit of the medicinal product to be assessed shall be less than the benefit of the appropriate comparison therapy; § 7 (2) sentence 6 shall remain unaffected.
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§ 6 Purposeful comparative therapy

(1) The appropriate comparative therapy should be regulated according to standards which result from the international standards of evidence-based medicine. (2) Purposeful comparative therapy must be based on the generally accepted level of treatment. medical findings appropriate therapy in the field of application (§ 12 of the Fifth Book of the Social Code), preferably a therapy for which endpoint studies are available and which has proven itself in practical application, unless Guidelines pursuant to § 92 (1) of the Fifth Book of Social Code or the (2a) If, according to paragraphs 1 and 2, several alternatives are equally appropriate for comparison therapy, the added value can be demonstrated in relation to each of these therapies. Article 35a (1), fourth sentence, of the Fifth Book of the Social Code remains unaffected. (3) For medicinal products of an active substance class, the same appropriate comparative therapy should be used to ensure uniform evaluation. Unofficial table of contents

§ 7 benefit assessment

(1) The Joint Federal Committee shall carry out the benefit assessment. The basis for this is the dossier of the pharmaceutical entrepreate according to § 4. The Joint Federal Committee may commission the Institute for Quality and Efficiency in Health Care or third parties with the benefit assessment. (2) The benefit assessment will examine the validity and completeness of the information in the dossier. In this context, the documents are evaluated with regard to their planning, implementation and evaluation quality with regard to their significance for the probability and extent of the added value and with regard to the information on the therapy costs. The benefit assessment shall also include a summary of the main statements as an evaluation of the information in the dossier in accordance with § 4 (1). The benchmark for the assessment is the generally accepted state of medical knowledge. The basis is the international standards of evidence-based medicine and the health economy. The evaluation shall not be contrary to the findings of the authorisation authority on the quality, efficacy and safety of the medicinal product. In the benefit assessment, a check is made as to whether the medicinal product has an added value compared with the appropriate comparative therapy, which additional benefit for which patient groups is substantiated to the extent to which the present evidence is to be used. (3) The benefit assessment shall be concluded no later than three months after the date of the submission of the evidence in accordance with Section 4 (3). It is to be published on the website of the Joint Federal Committee. (4) The Joint Federal Committee presents the benefit assessment, including the summary of the written and oral hearing. It shall decide upon the holding of the hearings. The decision sets out the main results of the benefit assessment and is part of the guidelines in Section 92 (1), second sentence, point 6 of the Fifth Book of the Social Code. The decision shall be taken within three months of the publication of the benefit assessment. The decision shall be the basis for all medicinal products containing this active substance for agreements pursuant to § 130b of the Fifth Book of the Social Code on reimbursement amounts and for the determination of the suitability, quality and quality of the product. Economic efficiency of the Regulation as well as for recognition as a practical feature or for the assignment of medicinal products without added value to a fixed amount group according to § 35 of the Fifth Book of the Social Code. Unofficial table of contents

§ 8 Consultation

(1) The Joint Federal Committee shall advise the pharmaceutical contractor on the basis of the request made on the basis of the documents submitted in accordance with paragraph 2. The advice shall be provided by the office of the Joint Federal Committee unless it decides otherwise. The consultation can take place prior to the start of the phase three approval studies and with the participation of the Federal Institute for Drugs and Medical Devices or the Paul-Ehrlich-Institut. The pharmaceutical company receives a transcript of the consultation. (2) The pharmaceutical entrepre shall submit to the Joint Federal Committee, with the request of a consultation, the importance of the preparation of a dossier Documents and information available at this time. The information provided in the course of the consultation shall be treated confidentially. The purpose of the consultation is, in particular, the documents and studies to be submitted for the benefit assessment as well as the appropriate comparative therapy. The Joint Federal Committee may conclude agreements with the pharmaceutical company. The Joint Federal Committee shall carry out the consultation within eight weeks of the submission of the documents. (3) The time limit for the submission of a dossier in accordance with § 4 (3) shall apply without prejudice to advice. The right to counsel shall be issued with the date of the submission of the time point in accordance with section 4 (3) or with the submission of the dossier. Unofficial table of contents

§ 9 Disclosure

(1) The dossier shall be published on the website of the Joint Federal Committee at the same time as the benefit assessment in accordance with Article 7 (2), unless operational and business secrets, the protection of intellectual property or the protection of the protection of intellectual property rights are not of personal data. The publication contains the basis on which the evaluation is based. (2) The pharmaceutical entreprenter identifies operational and business secrets in the dossier. This marking must not prevent the obligation to disclose the results of the studies. (3) The Joint Federal Committee may, with the relevant associations of the pharmaceutical industry and with pharmaceutical companies, be able to provide further information. Rule Agreement. Unofficial table of contents

Section 10 Transitional arrangements

(1) For the dossiers to be submitted by 31 July 2011, the Joint Federal Committee shall advise the pharmaceutical contractor on the content and completeness of the dossier by way of derogation from Section 8 (3). The institute can thus instruate the Institute for Quality and Efficiency in Health Care or Third Parties. If the dossier is inadequate in terms of content, the Joint Federal Committee shall, as a rule, inform the pharmaceutical entreplier within three months of the additional information required. (2) The pharmaceutical company shall have the following information. The Joint Federal Committee shall submit the revised dossier within three months of the communication of the Joint Federal Committee referred to in paragraph 1, and Article 4 (4) shall apply accordingly. The date of the re-submission of the dossier shall be decisive for the time limit for the conclusion of the benefit assessment in accordance with Article 7 (3). Unofficial table of contents

Section 11 Entry into force

This Regulation shall enter into force on 1 January 2011.