ongoing Insulin degludec/liraglutid 1 daily ongoing x daily

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 15 October 2015 In its session on 15 October 2015, 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 6 August 2015 (Federal Gazette, AT 12 October 2015 B2) as follows: I. Appendix XII shall be amended in alphabetical order to include the active ingredient insulin degludec/liraglutide: Therapeutic indication: Xultophy is indicated for the of adults with type-2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control (see sections 4.4 and 5.1 for data available on various combinations). This resolution refers only to the therapeutic indication of 18 September 2014: Xultophy is indicated for the of adults with type-2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a basal insulin do not provide adequate glycaemic control. The new therapeutic indication of Xultophy from 25 June 2015, corresponding to the greater change of type 2 in accordance with EC regulation 1234/2008, appendix 2, number 2, letter e of the commission of 24 November 2008 for the investigation of changes in the market authorization of human and veterinary medicines Xultophy is indicated for the of adults with type-2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control (see sections 4.4 and 5.1 for data available on various combinations). shall be addressed in a separate resolution. 1. Additional benefit of the pharmaceutical over appropriate comparator a) e in combination with oral anti-diabetic medications for the of diabetes mellitus type 2, when an oral anti-diabetic combination therapy does not provide adequate glycaemic control: Appropriate comparator: plus human insulin (Please note: if metformin is unsuitable according to the product information, or metformin in combination with insulin is not sufficiently effective, human insulin is to be used as a option) Extent and probability of additional benefit over metformin plus human insulin: An additional benefit has not been proved. b) e in combination with oral anti-diabetic medications for the of diabetes mellitus type 2, when this oral anti-diabetic in combination with basal insulin does not provide adequate glycaemic control: b1) In the combination with metformin Appropriate comparator: Human insulin plus metformin if applicable Extent and probability of additional benefit over human insulin and metformin 1 : An additional benefit has not been proved. 1 The comparative assessment is conducted on the basis of a direct comparison of insulin degludec/liraglutide in combination with metformin to the combination of a long-acting insulin analogue (insulin glargine) with metformin.

2 b2) In combination with oral anti-diabetic medications (except metformin): Appropriate comparator: Human insulin plus metformin if applicable Extent and probability of additional benefit over human insulin plus metformin: An additional benefit has not been proved. 2. Number of patients and criteria for defining patients eligible for a) e in combination with oral anti-diabetic medications for the of diabetes mellitus type 2, when an oral anti-diabetic combination therapy does not provide adequate glycaemic control: approx. 582,000 to 733,000 patients b) e in combination with oral anti-diabetic medications for the of diabetes mellitus type 2, when this oral anti-diabetic in combination with basal insulin does not provide adequate glycaemic control: approx. 170,000 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 Xultophy (active ingredient: insulin degludec/liraglutide) at the following public link (last accessed: 2 September 2015): _Product_Information/human/002647/WC pdf The use of GLP1 receptor antagonists (including liraglutide) is associated with a risk of developing acute pancreatitis. Patients must be informed of the characteristic symptoms of acute pancreatitis. According to an EMA statement on pancreatic cancer in the context of a GLP1-based therapy (including liraglutide), although clinical data do not indicate an increased risk of these substances, an evaluation of the risk cannot be made at this time due to the short duration of the study and the low number of cases. 4. Costs of a) e in combination with oral anti-diabetic medications for the of diabetes mellitus type 2, when an oral anti-diabetic combination therapy does not provide adequate glycaemic control: : Mode of Number of s per Number of days pe patient per year an oral anti-diabetic combination therapy does not provide adequate glycaemic control 2 ) 1 daily according to product information or is not sufficiently effective) Therapy only with human insulin if metformin is not suitable according to the product information or not sufficiently effective in combination with human insulin 2 The combination of insulin degludec/liraglutide with metformin is shown as an example of the combination with an oral anti-diabetic medication.

3 Consumption: Strength Dose/day Quantity per pack 3 consumption Average annual an oral anti-diabetic combination therapy does not provide adequate glycaemic control 2 ) 100 IU 4 /ml 3.6 mg/ml IU mg 15,000 IU 13, ,250 IU 1,000 mg 6 1,000 3,000 mg 180 tablets tablets according to product information or is not sufficiently effective in combination with human insulin) 100 IU/ml IU 5 3,000 IU 13, ,000 mg 6 1,000 3,000 mg 180 tablets 365 Therapy only with human insulin if metformin is not suitable according to the product information not sufficiently effective 100 IU/ml IU 5 3,000 IU 13, Costs: Cost of pharmaceutical: Cost (pharmacy an oral anti-diabetic combination therapy does not provide adequate glycaemic control 2 ) [ ; ] according to product information or is not sufficiently effective in combination with human insulin) Human insulin 9 (NPH insulin) Therapy only with human insulin if metformin is not suitable according to the product information not sufficiently effective in combination with human insulin Lauer-Taxe, effective: 1 September Largest pack 4 1 unit (U) insulin degludec equals 1 IU human insulin. 5 Average insulin need: IU/kg BW/day; reference body weight: 76.3 kg BW ("microcensus 2013"). The maximum daily dosage is 50 dosage steps (50 units insulin degludec and 1.8 mg liraglutide). 6 Calculation is based on a strength of 1,000 mg. Dosage according to product information 1,000 3,000 mg. 7 Rebate in accordance with SGB V, section Rebate in accordance with SGB V, section 130a 9 Reference price

4 Costs for additional, necessary SHI benefits 10 : Designation Appropriate comparator metformin + Single-use human insulin; therapy only with human needles insulin if metformin is unsuitable according to product information or is not sufficiently effective) Cost/pack 11 Number/day Consumption /year Cost/year Annual costs: Annual costs per patient an oral anti-diabetic combination therapy does not provide adequate glycaemic control 2 ) e+ metformin 2, , according to product information or is not sufficiently effective in combination with human insulin) + metformin according to product information or is not sufficiently effective in combination with human insulin) Therapy only with human insulin if metformin is not suitable according to the product information or not sufficiently effective in combination with human insulin (combination insulin) Costs for additional, necessary SHI benefits (single-use needles): b) e in combination with oral anti-diabetic medications for the of diabetes mellitus type 2, when this oral anti-diabetic in combination with basal insulin does not provide adequate glycaemic control b1) In combination with metformin : Mode of Number of s per Number of days pe patient per year these oral anti-diabetic medications in combination with basal insulin do not provide adequate glycaemic control 12 ) 1 daily 10 Additional necessary SHI expense items apply only for the administration of human insulin twice a day over the pharmaceutical evaluated. 11 Number of single-use needles/pack = 100; least expensive pack according to "Lauer-Taxe"; effective: 1 September Combination of insulin degludec/liraglutide with metformin.

5 Intensified conventional insulin therapy Human insulin (bolus insulin 13 ) Mode of Number of s per Number of days pe patient per year 3 daily 14 Consumption: Strength Dose/day Quantity per pack 3 consumption Average annual these oral anti-diabetic medications in combination with basal insulin do not provide adequate glycaemic control 12 ) 100 IU 4 /ml 3.6 mg/ml IU mg 15,000 IU 13, ,250 IU 1,000 mg 6 1,000 3,000 mg 180 tablets IU/ml IU 5 3,000 IU 13, ,000 mg 6 1,000 3,000 mg 180 tablets 365 Intensified conventional insulin therapy Human insulin (bolus insulin 13 ) Costs: Cost of pharmaceutical: Pharmaceutical evaluated 100 IU/ml IU 5 3,000 IU 13, IU/ml 100 IU/ml IU IU 15 Cost (pharmacy 3,000 IU 3,000 IU 5, ,709.7 IU 5, ,709.7 IU [ ; ] Human insulin 9 (NPH insulin) combination insulin Rapid-acting human insulin. With main meals % of the daily insulin requirements are normally covered by basal insulin; average insulin requirement: IU/kg BW/day; reference body weight: 76.3 kg BW ("microcensus 2013").

6 Intensified conventional insulin therapy Human insulin 9 (NPH insulin) Cost (pharmacy Human insulin (bolus insulin) Lauer-Taxe, effective: 1 September 2015 Costs for additional, necessary statutory health insurance (SHI) benefits: Appropriate comparator Human insulin + metformin if applicable Annual costs: Designation Single-use needles Cost/pack 16 Number/day Consumption/ year Cost/year , Annual costs per patient these oral anti-diabetic medications in combination with basal insulin do not provide adequate glycaemic control 12 ) e + metformin 2, , metformin (combination insulin) Intensified conventional insulin therapy Costs for additional, necessary SHI benefits (single-use needles) b2) In combination with oral anti-diabetic medications (except metformin) 17 Treatment duration: Mode of Number of s per Number of days per patient per these oral anti-diabetic medications in combination with basal insulin do not provide adequate glycaemic control 17 ) 1 daily Glibenclamide or glimepiride 1 x daily combination insulin Number of single-use needles/pack = 100; least expensive pack according to "Lauer-Taxe"; effective: 1 September 2015 The combination of insulin degludec/liraglutide with a sulfonylurea (glibenclamide or glimepiride) is shown as an example of the combination of with other oral anti-diabetic medications.

7 Intensified conventional insulin therapy Mode of Number of s per Number of treatmen days per patient per year Human insulin (bolus insulin 18 ) 3 daily 19 Consumption: Strength Dose/day Quantity per pack 3 consumption Average annual these oral anti-diabetic medications in combination with basal insulin do not provide adequate glycaemic control 17 ) Glibenclamide 20 or glimepiride 100 IU 4 /ml 3.6 mg/ml 3.5 mg 1 6 mg IU mg mg 1 6 mg 15,000 IU 13, ,250 IU 180 tablets 180 tablets tablets 100 IU/ml IU 5 3,000 IU 13, ,000 mg 6 1,000 3,000 mg 180 tablets 365 Intensified conventional insulin therapy Human insulin (bolus insulin 13 ) 100 IU/ml IU 5 3,000 IU 13, IU/ml 100 IU/ml IU IU 21 3,000 IU 3,000 IU 5, ,709.7 IU 5, ,709.7 IU Costs: Cost of pharmaceutical: Cost (pharmacy Pharmaceutical evaluated [ ; ] Glibenclamide or [ ; ] glimepiride [ ; ] Human insulin 9 (NPH insulin) Rapid-acting human insulin. With main meals. Calculation is based on a strength of 3.5 mg. Dosage according to product information mg 40 60% of the daily insulin requirements are normally covered by basal insulin; average insulin requirement: IU/kg BW/day; reference body weight: 76.3 kg BW ("microcensus 2013").

8 Cost (pharmacy combination insulin 9 Intensified conventional insulin therapy Human insulin 9 (NPH insulin) Human insulin (bolus insulin) Lauer-Taxe, effective: 1 September 2015 Costs for additional, necessary statutory health insurance (SHI) benefits: Appropriate comparator human insulin + metformin if applicable Designation Single-use needles Cost/pack 22 Number/day Consumption /year Cost/year , Annual costs: Annual costs per patient these oral anti-diabetic medications in combination with basal insulin do not provide adequate glycaemic control 17 ) e + 2, , glibenclamide or insulin degludec/liraglutid + glimepiride 2, , metformin (combination insulin) Intensified conventional insulin therapy 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 15 October The justification for this resolution will be published on the websites of the Federal Joint Committee at Berlin, 15 October 2015 The Federal Joint Committee in accordance with SGB V, section 91 The Chair Prof. Hecken 22 Number of single-use needles/pack = 100; least expensive pack according to "Lauer-Taxe"; effective: 1 September 2015