Regulation On The Benefit Evaluation Of Medicinal Pursuant To Section 35A, Paragraph 1 Sgb V For Refund Agreements According To § 130 B 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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Read the untranslated law here: http://www.gesetze-im-internet.de/am-nutzenv/BJNR232400010.html

Regulation on the benefit evaluation of medicinal pursuant to section 35a, paragraph 1 SGB V for refund agreements according to § 130 b SGB V (drug benefit assessment regulation AM-NutzenV) most NutzenV Ausfertigung date: 28.12.2010 full quotation: "medicinal benefit valuation regulation by December 28, 2010 (BGBl. I p. 2324), most recently by article 2 of the law of March 27, 2014 (BGBl. I p. 261) is changed" stand: last modified by article 2 G v. 27.3.2014 I 261 for more information on the stand number you see in the menu see remarks footnote (+++ text detection from) : 1 January 2011 +++) input formula on the basis of § 35 paragraph 1 set 6 and 7 of the fifth book the social law - statutory health insurance, by article 1, paragraph 5 of the law of December 22, 2010 (BGBl. I S. 2262) is been inserted, decreed the Federal Ministry of health: § 1 scope the regulation details the benefits assessment of reimbursable medicinal products containing new active substances according to section 35a of the fifth book of the social code. The Federal Joint Committee governs more details in its rules of procedure for the first time within one month after entry into force of the regulation.

Article 2 definitions (1) medicinal products containing new active substances within the meaning of this regulation are medicines, containing the active substances, whose effects are not widely known during the first admission in medical science. A medicinal product containing a new active substance in the sense of this Regulation applies as long as a medicinal product containing a new active substance, as there is for the first approved drug containing the active ingredient of exclusivity.
(2) a new field of application is an application area for the after section 29, paragraph 3 number 3 of the German medicines Act a new authorisation is granted or that as a major variation of type 2 to annex 2, paragraph 2 of Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of changes of the approvals of human and veterinary medicinal products (OJ L 334 of December 12, 2008, p. 7) is classified.
(3) the use of a medicinal product within the meaning of this regulation is the patient-relevant therapeutic effect, particularly with regard to improving the State of health, the reduction in the duration of the disease, the extension of survival, the reduction of side effects or enhance the quality of life.
(4) the additional benefits of a medicinal product within the meaning of this regulation is a benefit within the meaning of paragraph 3 which is quantitatively or qualitatively higher than the benefit that the appropriate comparison therapy has.
(5) appropriate comparison therapy within the meaning of this regulation is the therapy, which benefits will be compared with the benefits of a medicinal product containing new active substances for the benefit assessment according to section 35a of the fifth book of the social code.

§ 3 scope of benefit assessment according to section 35a of the SGB V which will benefit assessment according to article 35a, paragraph 1 of the fifth book of the social code carried for reimbursable medicines with new drugs and new combinations of active ingredients, 1 from January 1, 2011, for the first time in the traffic be brought if a medicinal product containing that substance into circulation is brought in for the first time, 2. from 1 January 2011 for the first time on the market have been brought and that after January 1, 2011 a new field of application according to § 2 Paragraph 2, 3 at the earliest one year after the decision on benefit assessment according to § 7 paragraph 4 at the request of the pharmaceutical entrepreneur, 4 at the earliest one year after the decision on the benefit evaluation according to § 7 paragraph 4 If there is new evidence on the initiative of the German Federal Joint Committee, 5 for the the Federal Joint Committee about a benefit assessment with time limit decided has, if the time limit has expired.

§ 4 (1) of the marketing authorisation dossier the dossier contains information about: 1 approved applications, 2. the medical added value in relation to the proper comparison therapy, 4. the number of patients and patient groups for the therapeutically significant added value is the medical benefits, 3., 5. the requirement in relation to the cost of therapy for the statutory health insurance, 6 a quality-secured application.
For medicinal products according to § 35 paragraph 1 set 10 of the fifth book of the social code no numbers 2 and 3 are required, unless the requirements of section 35a paragraph 1 set 11 the fifth book the social law are met.
(2) the dossier should include also the approval number, the date of the authorisation, the marketing authorisation holder, the Pharmazentralnummer, the mapping to the anatomical therapeutic chemical classification and the name of the medicinal. The pharmaceutical entrepreneur transferred electronically according to section 35a, paragraph 1 sentence 3 of the fifth book of the social code the joint Federal Committee the dossier with the evidence for the benefit assessment. The Federal Joint Committee lays down the technical standards to be used, and gives formats and outline. He should follow in the standards of the competent for the approval of the Federal Authority (authority). The dossier should contain in particular a summary of the essential statements that 130 b of the fifth book of the social code is the basis for agreements under section.
(3) the dossier is at the latest to submit at the following times: 1. for medicinal products containing new active substances which, for the first time placed as of January 1, 2011 on the market at the time of the initial marketing;
2. for medicinal products, a new field of application according to § 2 paragraph 2 would get, when for the medicines a benefit assessment under this regulation is made within four weeks after approval of the new application area or the notification of the marketing authorisation on an approval for a change in the type 2 according to Appendix 2, paragraph 2 of Regulation (EC) No 1234 / 2008;
3. (dropped out) 4 for medicines, for which a benefit assessment has been decided already and for the pharmaceutical entrepreneur at the earliest one year after the decision has requested a re-evaluation of the benefit or for which the Federal Joint Committee a renewed benefit assessment causes, three months after the request of the German Federal Joint Committee;
5. for medicinal products for which a temporary decision on benefit assessment is, on the day of the expiry of the period;
6. for medicinal products for a benefit assessment pursuant to section 35a paragraph 1 set 11 of the fifth book of the social code carried out will, three months after the request of the German Federal Joint Committee.
(4) of the Federal Joint Committee has to be considered timely filed documents. Documents of regulatory agencies, which still does not have prevailed the pharmaceutical company to the relevant submission date, are taken into account, provided that this benefit assessment not delayed.
(5) the pharmaceutical entrepreneur may send the dossier to the joint Federal Committee even before the dates referred to in paragraph 3. The pharmaceutical entrepreneur shall submit the dossier three weeks before the respective date pursuant to paragraph 3 in the joint Federal Committee, the Office of the German Federal Joint Committee conducts a formal preliminary examination on the completeness of the dossiers. The dossier is incomplete, the Office of the German Federal Joint Committee tells the pharmaceutical entrepreneur usually within two weeks what additional information is required. The substantive examination of the dossiers pursuant to § 7 paragraph 2 remains unaffected. Paragraph 4 shall apply mutatis mutandis.
(6) for the medicines to be evaluated with new active ingredient, the pharmaceutical entrepreneur in the dossier presents the report of studies including study protocols and the evaluation report of the approval authority, as well as all of the studies that have been submitted to the approval authority. In addition all results, study reports and study protocols of studies on the drug is delivered, for the sponsor was the entrepreneur, as well as all available information about ongoing or aborted studies with the medicinal products for which the contractor is sponsor or is otherwise financially involved, and information about studies of third parties, as far as they are available.
(7) for the appropriate comparison therapy according to § 6 the pharmaceutical entrepreneur in the dossier delivered all available results from clinical studies including study protocols that are suitable to make findings on the added value of the medicinal product to be evaluated. There are no clinical studies for a direct comparison with the medicinal products to be assessed, or they allow no sufficient information about an additional benefit, indirect comparisons can be presented in the dossier.
(8) the pharmaceutical entrepreneur has the statutory health insurance compared to the pharmacy selling price and costs to provide health insurance actually costs. The cost for the medicines to be evaluated, as well as the appropriate comparison therapy to be specified. The direct cost of the statutory health insurance over a certain period are decisive. When the necessary recourse to medical treatment or the regulation of other performances between the medicinal products to be assessed and the appropriate comparison therapy, differences in use of medicines according to the specialist or use information regularly the differences in costs associated for the purpose of establishing are health insurers to take account of costs actually incurred.
§ To prove to additional benefits (1) which is added 5 of the pharmaceutical entrepreneur in the dossier according to § 4. The Federal Joint Committee has no official investigation duty.
(2) for reimbursable medicinal products containing new active substances are pharmacologically therapeutically comparable with fixed medicines of amount of, the medical added value as a therapeutic improvement according to article 35, paragraph 1 is b to prove set 1 to 5 of the fifth book of the social code. The detection of a therapeutic improvement is due to the specialist information and evaluation of clinical trials according to the international standards of evidence-based medicine. Clinical trials are primarily taken into account especially direct comparative studies with other drugs of this fixed amount group with patient-relevant endpoints, especially mortality, morbidity and quality of life.
(3) for medicines containing new active substances which do not fulfil the requirements referred to in paragraph 2, an additional benefit for the respective field of application approved is detected compared to the functional comparison therapy based on specific according to § 6 documents for the benefit of the medicinal product in the approved applications. The drug legal approval, the officially approved product information and notices by regulatory authorities and the assessment of clinical trials according to the international standards of evidence-based medicine are based. For the initial assessment according to section 35a of the fifth book the social law at the time of the launch, the pivotal studies are basically for the assessment of the medicinal product with new active ingredients to be based. The studies are not sufficient, the Federal Joint Committee may require further evidence. If it is impossible or inappropriate, conduct studies of highest level of evidence or request, evidence is the best evidence level available to submit.
(4) in the dossier, it is stating the relevance of the evidence to explain probability and to what extent is an additional benefit. This information should be made based on the number of patients and patients as well as relative to the size of the value added.
(5) for medicinal products pursuant to paragraph 3 the added value compared to the functional comparison therapy is detected as an improvement influencing patient-relevant endpoints for the benefit in accordance with § 2 paragraph 3 may at the time of the assessment valid data to patient-relevant endpoints not yet available, the evaluation is made on the basis of the evidence available, taking into account the quality assurance with the likelihood for the receipt of value added and a period can be determined , until when valid data to patient-relevant endpoints will be presented. There are no direct comparison studies for the new medicines over the proper comparison therapy or they allow no sufficient information about an additional benefit, available clinical studies for functional comparison therapy, suitable for an indirect comparison with the medicinal products containing new active substances can be used.
(6) the validity of the evidence is taking into account the quality of studies to demonstrate the validity of the consulted endpoints as well as the level of evidence and it is assessing probability and to what extent is an additional benefit. For all documents submitted to clarify what level of evidence, the evidence provided is in the dossier. The following evidence levels apply: 1 I a systematic review articles by studies of evidence stage IB 2. I b randomized clinical trials 3. II a systematic review articles of evidence level lIb 4 II (b) prospective comparative cohort studies of 5. III retrospective comparative studies 6 IV case series and studies don't compare other pathophysiologic considerations, descriptive representations, 7 V Association observations, case reports, with studies finished opinions of recognized experts , Consensus conferences and reports by Expertenkommittees.
(7) for medicinal products pursuant to paragraph 3 are as follows to quantify the extent of the value added and the therapeutic importance of added value, taking into account the severity of the disease compared with the benefits of proper comparison therapy: 1 a significant additional benefit exists, if sustainable and so far not reached over the proper comparison therapy great improvement of the therapy relevant benefits within the meaning of article 2, paragraph 3 , in particular a cure of the disease, a significant extension of survival, a long-term freedom from serious symptoms or the widespread avoidance of adverse reactions;
2. a significant additional benefit exists when an improvement so far not reached over the proper comparison therapy of therapy relevant benefits within the meaning of article 2 paragraph 3 is reached, in particular a slowdown more severe symptoms, a moderate extension of service of life, noticeable for patients relief from the disease, a relevant avoidance of adverse reactions or a significant avoidance of other side effects.
3. low added value exists, if a moderate and not only minor improvement so far not reached over the proper comparison therapy of therapy relevant benefits within the meaning of article 2, paragraph 3 is, in particular a reduction in non-fatal symptoms of the disease or a relevant avoidance of side effects;
4. an additional benefit exists, is not quantifiable but, because the scientific data base does not allow this;
5. There is no additional benefit;
6. the use of the medicinal product to be evaluated is lower than the benefits of proper comparison therapy; Article 7, paragraph 2, sentence 6 remains unaffected.

§ Functional therapy comparison (1) which is functional comparison therapy regularly to determine standards, arising from the international standards of evidence-based medicine 6.
(2) the appropriate comparison therapy must be appropriate according to the generally recognised State of medical knowledge treatment in the field of application (article 12 of the fifth book of the social code), preferably a therapy for which endpoint studies are available and proven in practical use, as far as not guidelines according to article 92, paragraph 1, of the fifth book of the social code or the economy bid suggest.
(2a) are equally appropriate pursuant to paragraphs 1 and 2 several alternatives for the comparison therapy, the added value compared to any of these therapies can be demonstrated. section 35a paragraph 1 sentence 4 of the fifth book of the social code shall remain unaffected.
(3) for medicinal products a class the same functional comparison therapy is to be used to ensure a uniform evaluation.

§ 7 benefit assessment (1), which leads the Federal Joint Committee by the benefit assessment. This is the issue of the marketing authorisation pursuant to § 4. The joint Federal Committee can instruct the Institute for quality and efficiency in health care or any third party with the benefit assessment.
(2) the benefit assessment checks the validity and completeness of the information in the dossier. It evaluates the documentation with regard to their planning, implementation and evaluation quality in terms on their meaningfulness for likelihood and severity of the value added and with regard to the information on the cost of therapy. Benefit assessment contains a summary of the essential statements as a review of the information in the dossier to § 4 paragraph 1 scale for the assessment is the generally recognised State of medical knowledge. The international standards of evidence-based medicine and health economics are based. The assessment may disagree with the findings of the regulatory authority, on quality, efficacy and safety of the medicinal product. Assessing the benefits, it is checked whether for the medicinal product added value compared to the functional comparison therapy is, what additional benefit for which patient groups to what extent is proven, how is the present evidence to evaluate and probability each produced the evidence.
(3) the benefit assessment is no later than three months after the time to complete that is determined for the submission of evidence of after section 4, paragraph 3. It is to publish on the Internet page of the German Federal Joint Committee.
(4) of the Federal Joint Committee provides the benefit assessment including the summary of written and oral hearing. He decides after the hearings. The decision contains the main results of the benefit assessment and is part of the guidelines according to article 92, paragraph 1, sentence 2 number 6 of the fifth book of the social code. The decision is to cover three months after publication of the benefit assessment. The decision is basis for agreements for all medicinal products containing that substance pursuant to § 130 b of the fifth book of social code over reimbursement amounts and for the determination of requirements on the appropriateness, quality, and efficiency of regulation, as well as for the recognition as a practice specialty or for the assignment of medicines without additional benefits to a fixed amount set according to § 35 of the fifth book of the social code.

§ 8 advice
(1) of the Federal Joint Committee advises the pharmaceutical business due to its request on the basis of the documents submitted pursuant to paragraph 2. The consultation conducted by the Branch Office of the German Federal Joint Committee unless he decides otherwise. The advice can take place before the start of the phase three studies and with the participation of the Federal Institute for drugs and medicine products or Paul honest institution. The pharmaceutical entrepreneur receives a record of the consultation.
(2) the pharmaceutical entrepreneur submits the joint Federal Committee with the request of a consultancy for the creation of a dossier, he possesses significant documents and information at this time. The information provided within the framework of the consultation are to keep confidential. In particular the documents for the benefit assessment and studies, as well as the appropriate comparison therapy are subject to the advice. The joint Federal Committee can make arrangements accordingly with the pharmaceutical entrepreneur. The Federal Joint Committee carries out consulting within eight weeks after submission of the documents.
(3) the time limit for the submission of a dossier according to § 4 paragraph 3 is without prejudice to the consultation. The Advisory will expire with passing of the time according to § 4 paragraph 3 or with the submission of the dossier.

§ 9 disclosure (1) the dossier is at the same time with the benefit assessment according to § 7 paragraph 2 on the website of the German Federal Joint Committee published, if not operating and business secrets, the protection of intellectual property rights or the protection of personal data suggest. The publication contains the foundations on which the assessment is based.
(2) the pharmaceutical entrepreneur identifies operating and business secrets in the dossier. This marking may not preclude the obligation to disclose the results of the study.
(3) of the Federal Joint Committee may regulate by agreement details with the relevant associations of the pharmaceutical industry and pharmaceutical companies.

Section 10 transitional arrangements (1) dossiers to submitting up to July 31, 2011 the Federal Joint Committee advises the pharmaceutical entrepreneur of section 8(3) of different content and completeness of the dossier. He can instruct that the Institute for quality and efficiency in health care or any third party. The dossier is insufficient in terms of content, the Federal Joint Committee tells the pharmaceutical entrepreneur usually within three months, what additional information is required.
(2) the pharmaceutical entrepreneur has to submit the revised dossier three months after the release of the German Federal Joint Committee referred to in paragraph 1 to the joint Federal Committee; Section 4, paragraph 4 shall apply mutatis mutandis. The date of the renewed submission of the dossier is decisive for the time limit for the completion of the benefits assessment according to § 7 paragraph 3.

Article 11 entry into force this regulation enters into force on January 1, 2011.