Tegafur / Gimeracil / Oteracil (1) – Teysuno®

• In accordance with Section 4(3)(1) of the Medicinal Products Benefit Assessment Regulation (AM-NutzenV) in conjunction with Chapter 5, Section 8(1) of the Rules of Procedure (VerfO) of the G-BA, submitted the dossier on the active substance combination tegafur/gimeracil/oteracil to the G-BA on 28 June 2012.
• The submitted dossier did not contain Module 4.
• The pharmaceutical manufacturer therefore did not provide any information on the medical benefit and the additional medical benefit compared with the appropriate comparator therapy.
• The G-BA notes that the pharmaceutical manufacturer has not submitted all the evidence required under Section 35a(1) in conjunction with Chapter 5, Section 9 of the VerfO for the benefit assessment of the medicinal product.
• Pursuant to Section 35a(1), fifth sentence, of SGB V, this means that the additional benefit of Tegafur/Gimeracil/Oteracil in relation to the appropriate comparator therapy is deemed not proven.
• The benefit assessment was published on 1 October 2012 on the G-BA’s website (www.g-ba.de) , thereby initiating the written commenting procedure.
• The G-BA reached its resolution on the basis of the benefit assessment and the comments submitted during the written and oral consultation procedures.
• Appropriate comparator therapy
  • The appropriate comparator therapy is the dual combination of cisplatin with 5-fluorouracil or capecitabine.
  • For the indicated therapeutic indication, medicinal products containing the following active ingredients (INN) are authorised: 5-fluorouracil, capecitabine, calcium folinate, doxorubicin, epirubicin, mitomycin, carmustine, docetaxel, trastuzumab
  • Non-pharmacological treatment is not an option.
  • No relevant resolutions have been made.
  • In accordance with the current state of medical knowledge, combination chemotherapy containing a fluoropyrimidine and a platinum-based active ingredient (INN) is considered an appropriate comparator therapy.
  • 5-fluorouracil and capecitabine have marketing authorisation as fluoropyrimidines for this indication. Both are regarded as therapeutically comparable.
  • Cisplatin and oxaliplatin are considered as platinum-based agents. Both are regarded as therapeutically comparable, although there are differences in their toxicity profiles which are taken into account in the treatment decision.
  • As the medicinal product under assessment has a marketing authorisation for use in combination with cisplatin, it can be assumed that cisplatin represents the more suitable treatment option for patients who are eligible for treatment with the medicinal product under assessment.
  • The evidence regarding antineoplastic palliative therapy for advanced gastric cancer supports both the dual combination of 5-fluorouracil (or capecitabine) with cisplatin (or oxaliplatin) and the triple combination, in which docetaxel or an anthracycline – in particular epirubicin – is added.
  • With regard to anti-HER2-targeted therapy – trastuzumab in combination with 5-FU/capecitabine and cisplatin – it is to be assumed that patients meeting the relevant criteria will, in accordance with guidelines, generally be treated with anti-HER2-targeted therapy and are therefore not eligible for treatment with the medicinal product under assessment.
  • The combinations of 5-fluorouracil and cisplatin, and capecitabine and cisplatin, represent therapeutic alternatives. In view of the respective costs of these treatments, it is not appropriate to specify one of the two treatment options.
  • The findings set out in Annex XII do not restrict the scope of treatment required to fulfil the medical mandate.

Adult patients with locally advanced or metastatic adenocarcinoma of the stomach or the gastro-oesophageal junction who are suitable for treatment with cisplatin in combination with 5-fluorouracil or capecitabine

• The pharmaceutical manufacturer has not, despite being requested to do so, submitted the necessary evidence to the G-BA in full for the benefit assessment pursuant to Section 35a of the German Social Code, Book V (SGB V).
• The legal consequence stipulated in Section 35a(1), fifth sentence, of SGB V is that any additional benefit is deemed not proven.
• Number of patients or definition of the patient groups eligible for treatment
  • Number: approx. 10,500 to 12,000 patients
  • The figures given for the number of patients refer to the target population within the statutory health insurance scheme (GKV). The G-BA bases its resolution on the patient numbers specified in the benefit assessment.
• Requirements for a quality-assured application
  • The guidelines set out in the summary of product characteristics (SmPC) for Teysuno® (active ingredients: tegafur/gimeracil/oteracil) must be observed.
  • Due to the specific characteristics of the disease and the medicinal product, prescribing this medicinal product requires appropriate specialist qualifications: a specialist in internal medicine, haematology and oncology; a specialist in internal medicine and gastroenterology; or a doctor participating in the oncology scheme. Alternatively, the prescription may be issued following a resolution by an interdisciplinary tumour board.
• Treatment costs
  • The treatment costs are based on the information provided in the summary of product characteristics (SmPC) and the Lauer Tariff (as at 15 November 2012). The resolution is based on the treatment costs set out in the benefit assessment.

Courtesy translation only, please refer to the German original.