Number of treatments per patient. Designation of therapy Strength Dose/day Number/amount per pack 1

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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 16 October 2014 In its session on 16 October 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 21 August 2014 (Federal Gazette, AT B1), as follows: Appendix XII shall be amended in alphabetical order to include the active ingredient insulin degludec: Therapeutic indication: (Tresiba ) is indicated for the treatment of diabetes mellitus in adults. 1. Additional benefit of the pharmaceutical over appropriate comparator I. a) Monotherapy for the treatment of diabetes mellitus type 2 in adults: Appropriate comparator: Extent and probability of additional benefit over human insulin: An additional benefit has not been proved. b) Combination therapy with one or more oral anti-diabetic medications for the treatment of diabetes mellitus type 2 in adults: Appropriate comparator: plus human insulin (Please note: if metformin is unsuitable according to product information, human insulin is to be used as a treatment option) Extent and probability of additional benefit over metformin plus human insulin: An additional benefit has not been proved. c) Combination therapy with bolus insulin (with one or more oral anti-diabetic medications) for the treatment of diabetes mellitus type 2 in adults: Appropriate comparator: plus metformin if applicable (Please note: an additional administration of metformin is not normally indicated in combination with bolus insulin [without oral anti-diabetic medication] as part of ICT) Extent and probability of additional benefit over human insulin (plus metformin, if applicable): An additional benefit has not been proved. d) Treatment of diabetes mellitus type 1 in adults: Appropriate comparator: Extent and probability of additional benefit over human insulin: An additional benefit has not been proved. 2. s and criteria for defining s eligible for treatment a) Monotherapy for the treatment of diabetes mellitus type 2 in adults: s: approx. 44,600 s

2 b) Combination therapy with one or more oral anti-diabetic medications for the treatment of diabetes mellitus type 2 in adults: s: approx. 263,700 s c) Combination therapy with bolus insulin (with one or more oral anti-diabetic medications) for the treatment of diabetes mellitus type 2 in adults: s: approx. 625,900 s d) Treatment of diabetes mellitus type 1 in adults: s: approx. 161,750 s 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 product information for Tresiba (active ingredient: insulin degludec) at the following public link (last accessed: 1 July 2014): _Product_Information/human/002498/WC pdf 4. Costs of treatment a) Monotherapy for the treatment of diabetes mellitus type 2 in adults: Duration of treatment: Mode of treatment treatment days per per year (NPH insulin) Consumption: Strength Dose/day Number/amount per pack 1 Average annual consumption IU 3 /ml IU 3,000 IU 13,797 27,594 IU 100 IU/ml IU 3,000 IU 13,797 27,594 IU (NPH insulin) 2 Costs: Cost of pharmaceutical: (NPH insulin) Lauer-Taxe, effective: 1 October Largest pack. Average insulin need: IU/kg BW/day; reference body weight: 75.6 kg BW ("microcensus 2009"). 1 unit (U) insulin degludec equals 1 IU human insulin. Rebate in accordance with SGB V, section 130. Rebate in accordance with SGB V, section 130a. Reference price.

3 Costs for additional, necessary SHI benefits 7 : Additional necessary SHI benefits Cost/pack 8 Consumption/ Number/day year Cost/year Appropriate comparator (NPH insulin) Single-use needles Annual treatment costs: Annual treatment costs per 1, , (NPH insulin) Costs for additional, necessary SHI benefits 7 (single-use needles) b) Combination therapy with one or more oral anti-diabetic medications for the treatment of diabetes mellitus type 2: Mode of treatment treatment days per per year Pharmaceutical evaluated (insulin degludec in combination with an oral anti-diabetic medication [metformin]) 9 Pharmaceutical evaluated (insulin degludec in combination with more than one oral anti-diabetic medication [metformin + a sulfonylurea (glibenclamide or glimepiride)]) 10 Glibenclamide or glimepiride Appropriate comparator (metformin + human insulin, or only human insulin, if applicable) (NPH insulin) Or therapy only with human insulin if metformin is unsuitable according to product information Conventional insulin therapy (combination insulin) Additional necessary SHI expense items are incurred only if human insulin is administered twice daily, instead of insulin degludec once daily. single-use needles/pack = 100; least expensive pack according to "Lauer-Taxe"; effective: 1 October is named as an example of an additional anti-diabetic medication. The combination with metformin and a sulfonylurea (glibenclamide or glimepiride) is named as an example of the combination with other anti-diabetic medication.

4 Consumption: of therapy Strength Dose/day Number/amount per pack 1 Average annual consumption Pharmaceutical evaluated (insulin degludec in combination with an oral anti-diabetic medication [metformin]) IU 3 /ml IU 3,000 IU 13,797 27,594 IU 1,000 mg 11 1,000 3,000 mg 180 tablets 365 1,095 tablets Pharmaceutical evaluated (insulin degludec in combination with more than one oral anti-diabetic medication [metformin + a sulfonylurea glibenclamide or glimepiride]) IU 3 /ml IU 3,000 IU 13,797 27,594 IU 1,000 mg 11 1,000 3,000 mg 180 tablets 365 1,095 tablets Glibenclamide or glimepiride 3.5 mg mg 180 tablets ,095 tablets 1 6 mg 1 6 mg 180 tablets 365 tablets 27,594 IU Appropriate comparator (metformin + human insulin, or only human insulin, if applicable) 100 IU/ml IU 3,000 IU 13,797 (NPH insulin) 2 1,000 mg 11 1,000 3,000 mg 180 tablets tablets Or therapy only with human insulin if metformin is unsuitable according to product information Conventional insulin therapy (combination insulin) IU/ml IU 3,000 IU 13,797 27,594 IU Costs: Cost of pharmaceutical: Pharmaceutical evaluated (insulin degludec in combination with an oral anti-diabetic medication [metformin]) Pharmaceutical evaluated (insulin degludec in combination with more than one oral anti-diabetic medication [metformin + a sulfonylurea glibenclamide or glimepiride]) Glibenclamide or [ ; ] glimepiride [ ; ] Appropriate comparator (metformin + human insulin, or only human insulin, if applicable) (NPH insulin) Or therapy only with human insulin if metformin is unsuitable according to product information Conventional insulin therapy (combination insulin) Lauer-Taxe, effective: 1 October Calculation is based on a strength of 1000 mg. Dosage according to product information mg. Calculation is based on a strength of 3.5 mg; dosage according to product information mg; at a daily dosage of more than 2 tablets it is recommended to divide the total amount into one morning and one evening dosage at a ratio of 2:1.

5 Costs for additional, necessary SHI benefits 13 : Additional necessary SHI benefits Cost/pack 8 Consumption/ Number/day year Cost/year Appropriate comparator (NPH insulin) Single-use needles Annual treatment costs: Annual treatment costs per Pharmaceutical evaluated in combination with one or more oral anti-diabetic medications (insulin degludec + metformin 9 or insulin degludec + metformin + a sulfonylurea 10 ) + metformin 1, , metformin + glibenclamide or insulin degludec + metformin + glimepiride 1, , , , Appropriate comparator (metformin + human insulin; therapy only with human insulin if metformin is unsuitable according to product information) (NPH insulin) + metformin Therapy only with human insulin if metformin is unsuitable according to product information Conventional insulin therapy (combination insulin) Additional, necessary SHI benefits 13 (single-use needles) c) Combination therapy with bolus insulin (with one or more oral anti-diabetic medications) for the treatment of diabetes mellitus type 2 Mode of treatment treatmen days per per year Pharmaceutical evaluated in combination with with bolus insulin (with or without an oral anti-diabetic medication [metformin]) 9 (bolus insulin) 14 3 x daily 15 Pharmaceutical evaluated in combination with bolus insulin (with more than one oral anti-diabetic medication [metformin + a sulfonylurea glibenclamide or glimepiride]) 10 (bolus insulin) 14 3 x daily 15 Glibenclamide or glimepiride Appropriate comparator (human insulin + metformin if applicable human insulin + metformin option) 16 (NPH insulin) (bolus insulin) 14 3 x daily Additional necessary SHI expense items are incurred only if human insulin is administered twice daily, instead of insulin degludec once daily. Rapid-acting human insulin. With main meals. An additional administration of metformin is not normally indicated in combination with bolus insulin [without oral anti-diabetic medication] as part of ICT).

6 Mode of treatment Appropriate comparator (human insulin + metformin if applicable human insulin option) 16 (NPH insulin) (bolus insulin) 14 Consumption: treatment days per per year 3 x daily 15 Strength Dose/day Number/amount per Average annual consumption Pharmaceutical evaluated (insulin degludec in combination with with bolus insulin with or without an oral antidiabetic medication [metformin]) IU 3 /ml IU 17 1,000 mg 11 1,000 3,000 mg 180 tablets 365 1,095 tablets Pharmaceutical evaluated (insulin degludec in combination with bolus insulin with or without more than one oral anti-diabetic medication [metformin + a sulfonylurea glibenclamide or glimepiride]) IU 3 /ml IU 17 1,000 mg 11 1,000 3,000 mg 180 tablets 365 1,095 tablets Glibenclamide 3.5 mg mg 180 tablets ,095 tablets or glimepiride 1 6 mg 1 6 mg 180 tablets 365 tablets Appropriate comparator (human insulin + metformin if applicable human insulin + metformin option) 16 (NPH insulin) mg 11 1,000 3,000 mg 180 tablets tablets Appropriate comparator (human insulin + metformin if applicable human insulin option) 16 (NPH insulin) 2 Costs: Cost of pharmaceutical: Pharmaceutical evaluated (insulin degludec in combination with with bolus insulin with or without oral anti-diabetic medication [metformin]) (bolus insulin) % of the daily insulin requirements are normally covered by basal insulin; average insulin requirement: IU/kg BW/day; reference body weight: 75.6 kg BW ("microcensus 2009").

7 Pharmaceutical evaluated (insulin degludec in combination with bolus insulin with more than one oral anti-diabetic medication [metformin and a sulfonylurea glibenclamide or glimepiride]) (bolus insulin) Glibenclamide 6 or glimepiride [ ; ] [ ; ] Appropriate comparator (human insulin plus metformin if applicable human insulin + metformin option) 16 (NPH insulin) (bolus insulin) , if applicable Appropriate comparator (human insulin plus metformin if applicable human insulin option) 16 (NPH insulin) (bolus insulin) Lauer-Taxe, effective: 1 October 2014 Costs for additional, necessary SHI benefits: 18 Appropriate comparator (NPH insulin) Additional necessary SHI benefits Cost/pack 8 Consumption/ Number/day year Cost/year Single-use needles Annual treatment costs: Annual treatment costs per Pharmaceutical evaluated in combination with bolus insulin with or without one or more than one oral anti-diabetic medications (insulin degludec + bolus insulin or insulin degludec + bolus insulin + metformin 9 or insulin degludec + metformin + a sulfonylurea 10 ) + bolus insulin , bolus insulin 14 + metformin , bolus insulin 14 + metformin , glibenclamide or insulin degludec + bolus insulin 14 + metformin , glimepiride Appropriate comparator (human insulin + metformin if applicable human insulin + metformin option) 16 (NPH insulin + bolus insulin 14 ) + metformin Appropriate comparator (human insulin + metformin if applicable human insulin option) 16 (NPH insulin + bolus insulin 14 ) Additional, necessary SHI benefits 18 (single-use needles) Additional necessary SHI expense items are incurred only if human insulin is administered twice daily, instead of insulin degludec once daily.

8 d) Treatment of diabetes mellitus type 1 in adults: 14, 19 (bolus insulin) Mode of treatment 3 x daily treatment days per per year (NPH insulin) (bolus insulin) 14 3 x daily 15 Consumption: Strength Dose/day Number/amount per Average annual consumption IU 3 /ml IU 17 (NPH insulin) 2 Costs: Cost of pharmaceutical: (bolus insulin) 6, (NPH insulin) (bolus insulin) 6, Lauer-Taxe, effective: 1 October 2014 Costs for additional, necessary SHI benefits 20 : Appropriate comparator (NPH insulin) Additional necessary SHI benefits Cost/pack 8 Consumption/ Number/day year Cost/year Single-use needles According to the product information, insulin degludec must be combined with a rapid-acting insulin for the treatment of diabetes mellitus type 1 (Tresiba product information; effective: May 2014). 20 Additional necessary SHI expense items are incurred only if human insulin is administered twice daily, instead of insulin degludec once daily.

9 Annual treatment costs: Annual treatment costs per + bolus insulin , (NPH insulin) + bolus insulin Additional, necessary SHI benefits 20 (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 16 October The justification for this resolution will be published on the websites of the Federal Joint Committee at Berlin, 16 October 2014 The Federal Joint Committee in accordance with SGB V, section 91 The Chair Hecken