Pharmaceutical directive (am-rl)

Resolution
by the Federal Joint Committee
on an amendment to the Pharmaceutical Directive (AM-RL):
Appendix XII - Resolutions on the benefit assessment of pharmaceuticals
with new active ingredients, in accordance with the German Social Code,
Book Five (SGB V), section 35a
Linagliptin
from 29 March 2012
In its session on 29 March 2012, the Federal Joint Committee resolved to amend the Pharmaceutical Directive (AM-RL), version published 18 December 2008/22 January 2009 (Federal Gazette, number 49a of 31 March 2009), last amended on 15 March 2012 (Federal Gazette, AT 16 April 2012, B6), as follows: Appendix XII shall be amended in alphabetical order to include the active ingredient linagliptin: Linagliptin
Trajenta® is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults: – in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. – in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. – in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. 1. Additional benefit of the pharmaceutical over appropriate comparative treatment Appropriate comparator: sulfonylurea (glibenclamide, glimepiride) Extent and probability of additional benefit over sulfonylurea (glibenclamide, glimepiride): As the necessary proof documents for the benefit assessment were not submitted in their entirety, an additional benefit over the appropriate comparator is considered not proved (SGB V, section 35a, paragraph 1, sentence 5). b) Dual combination therapy linagliptin + metformin Appropriate comparator: sulfonylurea (glibenclamide, glimepiride) + metformin Extent and probability of additional benefit over sulfonylurea (glibenclamide, glimepiride) + metformin: As the necessary proof documents for the benefit assessment were not submitted in their entirety, an additional benefit over the appropriate comparator is considered not proved (SGB V, section 35a, paragraph 1, sentence 5). c) Triple combination therapy linagliptin + sulfonylurea + metformin Appropriate comparator: metformin + human insulin Extent and probability of additional benefit over metformin + human insulin: As the necessary proof documents for the benefit assessment were not submitted in their entirety, an additional benefit over the appropriate comparator is considered not proved (SGB V, section 35a, paragraph 1, sentence 5). 2. Number of patients and criteria for defining patients eligible for treatment b) Patients with dual combination therapy linagliptin + metformin c) Patients with triple combination therapy linagliptin + sulfonylurea + metformin 3. Requirements for quality-assured administration The specifications outlined in the product information are to be followed. 2 A strength of 3.5 mg was assumed for the calculation; doses according to product information: 1.75 – 10.5 mg 3 Rebate in accordance with SGB V, section 130: 4 Rebate in accordance with SGB V, section 130a: "Lauer-Taxe", effective 1 March 2012 Costs for additional, necessary statutory health insurance (SHI) benefits: none b) Dual combination therapy linagliptin + metformin 2 A strength of 3.5 mg was assumed for the calculation; doses according to product information: 1.75 – 10.5 mg 3 A strength of 1,000 mg was assumed for the calculation; doses according to product information: 1 – 3 g 3 Rebate in accordance with SGB V, section 130: 4 Rebate in accordance with SGB V, section 130a: "Lauer-Taxe", effective 1 March 2012 Costs for additional, necessary statutory health insurance (SHI) benefits: none c) Triple combination therapy linagliptin + sulfonylurea + metformin 2 A strength of 3.5 mg was assumed for the calculation; doses according to product information: 1.75 – 10.5 mg 3 A strength of 1,000 mg was assumed for the calculation; doses according to product information: 1 – 3 g 4 Average insulin need: 0.5 – 1 IU/kg kg/day; reference body weight: 70 kg 3 Rebate in accordance with SGB V, section 130: 4 Rebate in accordance with SGB V, section 130a: "Lauer-Taxe", effective 1 March 2012 Costs for additional, necessary statutory health insurance (SHI) benefits: none Linagliptin + metformin + glibenclamide/ This resolution takes effect on the day of its publication in the internet on the website of the Federal Joint Committee on 30 March 2012. The justification for this resolution will be published on the website of the Federal Joint Committe

Source: http://www.english.g-ba.de/downloads/91-1028-20/Linagliptin_ENG.pdf