from 5 September 2013

Transcription

1 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 from 5 September 2013 In its session on 5 September 2013, the Federal Joint Committee resolved to amend the Pharmaceutical Directive (AM- RL), version published 18 December 2008/22 January 2009 (Federal Gazette, number 49 a of 31 March 2009), last amended on 15 August 2013 (Federal Gazette, AT 28 August 2013 B3), as follows: I. Appendix XII shall be amended in alphabetical order to include the active ingredient lixisenatide: Therapeutic indication: Lyxumia is used for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. 1. Additional benefit of the pharmaceutical over appropriate comparator a) Add-on combination therapy in combination with metformin, when metformin, together with diet and exercise, do not provide adequate glycaemic control: Appropriate comparator: sulfonylurea (glibenclamide or ) + metformin Extent and probability of additional benefit over sulfonylurea (glibenclamide or ) + metformin: An additional benefit has not been proved. b) Add-on dual combination with an oral anti-diabetic medication (except metformin), when it, together with diet and exercise, does not provide adequate glycaemic control: Appropriate comparator: metformin + sulfonylurea (glibenclamide or ) (Please note: if metformin is inappropriate when used according to product information, human insulin is to be used as a treatment option) Extent and probability of additional benefit over metformin + sulfonylurea (glibenclamide or ): An additional benefit has not been proved. c) Add-on triple combination with an oral anti-diabetic medication when it, together with diet and exercise, does not provide adequate glycaemic control: Appropriate comparator: metformin + human insulin (Note: if applicable therapy only with human insulin if metformin is ineffective) Extent and probability of additional benefit over metformin + human insulin: An additional benefit is not considered proved. d) Add-on combination with a basal insulin (with or without metformin when basal insulin (with or without metformin), together with diet and exercise, does not provide adequate glycaemic control: Appropriate comparator: metformin + human insulin (Note: if applicable therapy only with human insulin if metformin is not tolerated or ineffective when used according to product information) Extent and probability of additional benefit over metformin + human insulin: An additional benefit has not been proved.

2 2. Number of patients and criteria for defining patients eligible for treatment a) Add-on combination therapy with metformin when metformin, together with diet and exercise, does not provide adequate glycaemic control: Number: approx. 634,600 patients b) Add-on dual combination with an oral anti-diabetic medication (except metformin), when it, together with diet and exercise, does not provide adequate glycaemic control: Number: approx. 35,900 patients c) Add-on triple combination with an oral anti-diabetic medication when it, together with diet and exercise, does not provide adequate glycaemic control: Number: approx. 62,400 patients d) Add-on combination with a basal insulin (with or without metformin) when basal insulin (with or without metformin), together with diet and exercise, does not provide adequate glycaemic control: Number: approx. 170,100 patients 3. Requirements for quality-assured administration The specifications outlined in the product information are to be followed. The European Medicines Agency (EMA), the European regulatory authority, provides the contents of the product information for Lyxumia (active ingredient: lixisenatide) at the following public link (last accessed: 1 July 2013): _Product_Information/human/002445/WC pdf So far no studies are available on the combination therapy of lixisenatide with dipeptidyl peptidase-4 (DPP4) inhibitors. The use of GLP1 receptor antagonists (including lixisenatide) is associated with a risk of developing acute pancreatitis. Patients should be informed of the characteristic symptoms of acute pancreatitis. According to a current EMA statement on pancreatic cancer in the context of a GLP1-based therapy (including lixisenatide), although clinical data do not indicate an increased risk of these substances, a final evaluation of the risk cannot be made due to the short duration of the study and the low number of cases. 4. Costs of treatment a) Add-on combination therapy in combination with metformin, when metformin, together with diet and exercise, do not provide adequate glycaemic control: Duration of treatment: Number of treatments per Mode of treatment Pharmaceutical evaluated in combination with metformin Duration per treatment (days) Treatment days per Appropriate comparator (glibenclamide or + metformin) Glibenclamide or Consumption: Strength Number/amount per pack (tablets) 1, 2 Average annual consumption (tablets) 2 Pharmaceutical evaluated in combination with metformin 20 µg 6 pre-mixed pens 3 27 pre-mixed pens Largest pack. Tablets, if not indicated otherwise. Each pre-mixed pen contains 3 ml solution; according to product information this corresponds to 14 individual doses (each 20 µg/0.2 ml) per pre-mixed pen.

3 Number/amount per pack Average annual consumption Strength (tablets) 1, 2 (tablets) 2 1,000 mg 1,095 Appropriate comparator (glibenclamide or + metformin) Glibenclamide 4 or 5 Costs: Cost of pharmaceutical: 3.5 mg 1 mg 6 mg 1,000 mg Cost (pharmacy retail price) 6 Pharmaceutical evaluated in combination with metformin ,095 1,095 Cost after legally mandated rebates [ ; ] Appropriate comparator (glibenclamide or + metformin) Glibenclamide 9 or [ ; ] [ ; ] "Lauer-Taxe", effective 1 August 2013 Costs for additional, necessary statutory health insurance (SHI) benefits: none Annual treatment costs: Pharmaceutical evaluated in combination with metformin Annual treatment costs per patient + metformin 1, , Appropriate comparator (glibenclamide or + metformin) Glibenclamide + metformin or + metformin b) Add-on dual combination with an oral anti-diabetic medication (except metformin), when it, together with diet and exercise, does not provide adequate glycaemic control: Duration of treatment: Number of treatments per Duration per Treatment days per Mode of treatment treatment (days) Pharmaceutical evaluated in combination with another oral anti-diabetic medication (except metformin) 10 Glibenclamide or A strength of 3.5 mg was assumed for the calculation; doses according to product information: mg. A strength of 1,000 mg was assumed for the calculation; doses according to product information: 1 3 g. Largest pack. Rebate in accordance with SGB V, section 130. Rebate in accordance with SGB V, section 130a. Reference price Sulfonylurea (glibenclamide, ) are named as examples of further anti-diabetic medications.

4 Number of treatments per Mode of treatment Appropriate comparator (glibenclamide or + metformin) Duration per treatment (days) Treatment days per Glibenclamide or Consumption: Strength Number/amount per pack (tablets) 1, 2 Average annual consumption (tablets) 2 Pharmaceutical evaluated in combination with another oral anti-diabetic medication (except metformin) µg 6 pre-mixed pens 3 27 pre-mixed pens Glibenclamide 4 or 3.5 mg 1 mg 6 mg ,095 Appropriate comparator glibenclamide or + metformin Glibenclamide 4 or 3.5 mg 1 mg 6 mg , ,000 mg 1,095 Costs: Cost of pharmaceutical: Cost after legally mandated Cost (pharmacy retail price) 1 rebates Pharmaceutical evaluated in combination with another oral anti-diabetic medication (except metformin) [ ; ] Glibenclamide 9 or [ ; ] [ ; ] Appropriate comparator (glibenclamide or + metformin) Glibenclamide 9 or [ ; ] [ ; ] "Lauer-Taxe", effective 1 August 2013 Costs for additional, necessary statutory health insurance (SHI) benefits: none Annual treatment costs: Pharmaceutical evaluated Annual treatment costs per patient + glibenclamide or 1, , or 1, , Appropriate comparator (glibenclamide or + metformin) Glibenclamide + metformin or + metformin

5 c) Add-on triple combination with an oral anti-diabetic medication, when it, together with diet and exercise, does not provide adequate glycaemic control: Duration of treatment: Mode of treatment Number of treatments per Duration per treatment (days) Pharmaceutical evaluated in triple combination with an oral anti-diabetic medication 11 Treatment days per Glibenclamide or Appropriate comparator (metformin + human insulin, or only human insulin, if applicable) (NPH insulin) Conventional insulin therapy (combination insulin) Consumption: Number/amount per Strength pack (tablets) 1, 2 Average annual consumption (tablets) 2 Pharmaceutical evaluated in triple combination with an oral anti-diabetic medication µg 6 pre-mixed pens 3 27 pre-mixed pens 5 1,000 mg 1,095 Glibenclamide 4 or 3.5 mg 1 mg 6 mg ,095 13,797 27,594 IU Appropriate comparator (metformin + human insulin, or only human insulin, if applicable) 100 IU/ml 3,000 IU (NPH insulin) ,000 mg 1095 Conventional insulin therapy Combination insulin IU/ml 3,000 IU 13,797 27,594 IU Costs: Cost of pharmaceutical: Cost (pharmacy retail price) 6 Cost after legally mandated rebates Pharmaceutical evaluated in triple combination with an oral anti-diabetic medication [ ; ] Glibenclamide 9 or [ ; ] [ ; ] sulfonylurea (glibenclamide, ) are named as examples of further anti-diabetic medications in lixisenatide add-on triple combination therapy. Average insulin need: IU/kg kg/day; reference body weight: 75.6 kg KG (microcensus 2009).

6 Cost after legally mandated Cost (pharmacy retail price) 6 rebates Appropriate comparator (metformin + human insulin, or only human insulin, if applicable) 9 (NPH insulin) [ ; ] Conventional insulin therapy Combination insulin [ ; ] "Lauer-Taxe", effective 1 August 2013 Costs for additional, necessary statutory health insurance (SHI) benefits: Description of therapy Combination therapy with human insulin (or therapy only with human insulin, if applicable) Annual treatment costs: Additional necessary SHI expense items Description Cost/pack 13 Number/day Consumption/year Cost/year Blood sugar strips , Lancets , Annual treatment costs per patient Pharmaceutical evaluated in triple combination with an oral anti-diabetic medication 11 + metformin + glibenclamide or 1, , or 1, , Appropriate comparator (human insulin + metformin, or only human insulin if applicable) human insulin (NPH insulin) + metformin Conventional insulin therapy (combination insulin) Costs for additional, necessary statutory health insurance (SHI) benefits (blood sugar test strips) Costs for additional, necessary statutory health insurance (SHI) benefits d) Add-on combination with a basal insulin (with or without metformin when basal insulin (with or without metformin), together with diet and exercise, does not provide adequate glycaemic control: Duration of treatment: Treatment days per Number of treatments per Duration per Mode of treatment treatment (days) Pharmaceutical evaluated in combination with basal insulin and metaformin, if applicable (NPH insulin), if applicable Appropriate comparator (human insulin + metformin; only human insulin, if applicable) (NPH insulin) 13 Number of test strips/pack = 50; Number of lancets = 200/pack, least expensive pack according to "Lauer-Taxe"; effective: 15 August 2013.

7 Conventional insulin therapy (combination insulin) Mode of treatment Number of treatments per Duration per treatment (days) Treatment days per Consumption: Strength Number/amount per pack (tablets) 1, 2 Pharmaceutical evaluated in combination with basal insulin and metaformin, if applicable Average annual consumption (tablets) 2 20 µg 6 pre-mixed pens 27 pre-mixed pens 100 IU/ml 3,000 IU 13,797 IU 27,594 IU (NPH insulin) 12, if applicable 5 1,000 mg 1,095 Appropriate comparator (human insulin + metformin; only human insulin, if applicable) 100 IU/ml 3,000 IU 13,797 27,594 IU (NPH insulin) ,000 mg 1,095 Conventional insulin therapy Combination insulin IU/ml 3,000 IU 13,797 27,594 IU Costs: Cost of pharmaceutical: Cost after legally mandated Cost (pharmacy retail price) 1 rebates Pharmaceutical evaluated in combination with basal insulin and metaformin, if applicable [ ; ] (NPH insulin) 9 [ ; ], if applicable Appropriate comparator human insulin + metformin; only human insulin, if applicable (NPH insulin) 9 [ ; ], if applicable Conventional insulin therapy Combination insulin [ ; ] "Lauer-Taxe", effective 1 August 2013 Costs for additional, necessary statutory health insurance (SHI) benefits: none Annual treatment costs: Annual treatment costs per patient Pharmaceutical evaluated in combination with basal insulin + metformin, if applicable + human insulin (NPH insulin) 1, , human insulin, if applicable (NPH insulin) + metformin 1, , Appropriate comparator (human insulin + metformin, or only human insulin if applicable) human insulin (NPH insulin) + metformin Conventional insulin therapy (combination insulin)

8 II. This resolution takes effect on the day of its publication in the internet on the website of the Federal Joint Committee on 5 September The justification for this resolution will be published on the website of the Federal Joint Committee at Berlin, 5 September 2013 The Federal Joint Committee in accordance with SGB V, section 91 The Chair Hecken

9 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 From 23 January 2014 In its session on 23 January 2014, 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 14 January 2014 (Federal Gazette, AT B4) as follows: I. In appendix XII, the information on the benefit assessment of the active ingredient lixisenatide shall be amended in point 4. Costs of treatment as follows: 1. In subsection a the information none under the header Costs for additional, necessary SHI benefits shall be replaced by the following chart: Additional necessary SHI benefits Designation of therapy Designation Cost/pack 9a Number/day Consumption/ye Cost/year Pharmaceutical evaluated (lixisenatide) in combination with metformin Single-use needles Footnote 9a shall be added after footnote 9 as follows: 9a Number of single-use needles/pack = 100; least expensive pack according to "Lauer-Taxe"; effective: 15 August In subsection a, under the header annual treatment costs the following line shall be added to the chart after the line + metformin 1, , : Costs for additional, necessary SHI benefits: Single-use needles In subsection b the information none under the header Costs for additional, necessary SHI benefits shall be replaced by the following chart: Additional necessary SHI benefits Designation of therapy Designation Cost/pack 9a Number/day Consumption/ye Cost/year Pharmaceutical evaluated (lixisenatide) in combination with another oral anti-diabetic medication (except metformin) Single-use needles Footnote 9a shall be added after footnote 9 as follows: 9a Number of single-use needles/pack = 100; least expensive pack according to "Lauer-Taxe"; effective: 15 August In subsection b under the header Annual treatment costs, the following line shall be added to the information in the chart after the line + glibenclamide or 1, , or 1, ,424.68

10 : Costs for additional, necessary SHI benefits: Single-use needles The chart in subsection c under the header Costs for additional, necessary SHI benefits shall be replaced by the following chart: Designation of therapy Pharmaceutical evaluated Single-use (lixisenatide) in triple combination needles with an oral anti-diabetic Combination therapy with human insulin (or therapy only with human insulin) 8. Footnote 13 shall read as follows: Additional necessary SHI benefits Designation Cost/pack 13 Number/day Consumption/year Cost/year Blood sugar test strips a a 1 3 1, Lancets a 1 3 1, Single-use needles a Number of test strips/pack = 50 (2 x 25); number of blood lancets/pack = 200; number of single-use needles/pack = Footnote 13a shall be added after footnote 13 as follows: 13a Least expensive pack according to 'Lauer-Taxe' effective: 15 August The chart in subsection c under the header Annual treatment costs shall be replaced by the following chart: Designation of therapy Annual treatment costs per patient Pharmaceutical evaluated in triple combination with an oral anti-diabetic medication 11 + metformin + glibenclamide or 1, , or 1, , Costs for additional, necessary SHI benefits Single-use needles Appropriate comparator (human insulin + metformin; only human insulin, if applicable) (NPH insulin) + metformin : Conventional insulin therapy (combination insulin) Costs for additional, necessary (SHI) benefits Blood sugar test strips Lancets Single-use needles In subsection d the information none under the header Costs for additional, necessary SHI benefits shall be replaced by the following chart: Additional necessary SHI benefits Designation of therapy Designation Cost/pack 9a Number/day Consumption/ye Cost/year Pharmaceutical evaluated (lixisenatide) in combination with basal insulin and metformin, if Single-use needles Footnote 9a shall read as follows: 9a Number of single-use needles/pack = 100; least expensive pack according to "Lauer-Taxe"; effective: 15 August In subsection d under the header Annual treatment costs, the following line shall be added to the information in the chart after the lines + human insulin (NPH insulin) 1, , or lixisenatide + human insulin (NPH insulin) + metformin 1, ,122.04

11 : Costs for additional, necessary SHI benefits: Single-use needles II. This resolution takes effect on the day of its publication in the internet on the website of the Federal Joint Committee on 23 January The justification for this resolution will be published on the website of the Federal Joint Committee at Berlin, 23 January 2014 The Federal Joint Committee in accordance with SGB V, section 91 The Chair Hecken