d) Patients with moderately to severely active Crohn s disease who have had an inadequate response with, lost

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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 8 January 2015 In its session on 8 January 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 18 December 2014 (Federal Gazette, AT 28 January 2015 B2), as follows: I. Appendix XII shall be amended in alphabetical order to include the active ingredient vedolizumab: Therapeutic indication: Ulcerative colitis (Entyvio ) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF α) antagonist. Crohn s disease (Entyvio ) is indicated for the treatment of adult patients with moderately to severely active Crohn s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF α) antagonist. 1. Additional benefit of the pharmaceutical over appropriate comparator. : A TNF alpha antagonist (adalimumab or infliximab) : A TNF alpha antagonist (adalimumab or infliximab under consideration of prior therapies) (Please note: If treatment with a TNF alpha antagonist (adalimumab or infliximab) fails, a dosage adjustment or switch to the other TNF alpha antagonist is possible.

2 c) Patients with moderately to severely active Crohn s disease who have had an inadequate response with, lost. : A TNF alpha antagonist (adalimumab or infliximab) : A TNF alpha antagonist (adalimumab or infliximab under consideration of prior therapies) (Please note: If treatment with a TNF alpha antagonist (adalimumab or infliximab) fails, a dosage adjustment or switch to the other TNF alpha antagonist is possible. 2. of patients criteria for defining patients eligible for treatment : approx. 5,100 patients c) Patients with moderately to severely active Crohn s disease who have had an inadequate response with, lost : approx. 11,000 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 product information for Entyvio (active ingredient: vedolizumab) at the following public link (last accessed: 18 November 2014): WC pdf Treatment with Entyvio must be initiated monitored by a specialist physician experienced in the diagnosis treatment of ulcerative colitis or Crohn s disease. Patients should be given the package leaflet patient alert card. 4. of treatment

3 Duration of treatment: Mode of treatment every 8 weeks, or every 4 weeks 1, Every 8 weeks, 5 mg/kg 378 mg 2 [4 x 100 mg] Every 2 weeks, once per week 3, of treatments Duration per treatment (days) Treatment days Consumption: /amount per mg : Cost of pharmaceutical: (Entyvio ) (Remicade ) (Humira ) (pharmacy retail price) 4, (1 unit of ) 3, (4 units of 100 mg) 5, (6 units of ) Cost after legally mated rebates 4, [ ; ] 3, [ ; ] 4, [ ; ] "Lauer-Taxe", effective: 1 January 2015 for additional, necessary statutory health insurance (SHI) benefits: not applicable Annual treatment costs: Annual treatment costs 1 26, , , , , Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to Entyvio 300mg every four weeks (Entyvio product information: effective: May 2014). Based on a body weight of 75.6 kg (microcensus 2009 body dimensions in the population). Patients who experience insufficient response may benefit from an increase in dosing frequency to Humira every week (Humira product information: effective: September 2014). Rebate in accordance with SGB V, section 130. Rebate in accordance with SGB V, section 130a.

4 Other SHI expense items: Surcharge for the production of a parenteral solution 6 Cost per patient per cycle 1 max max max max c) Patients with moderately to severely active Crohn s disease who have had an inadequate response with, lost Duration of treatment: Mode of treatment of treatments Duration per treatment (days) Treatment days every 8 weeks, every 4 weeks 1, Every 8 weeks, 5 mg/kg mg 2 [4 x 100 mg] Every 2 weeks, once per week 8, Consumption: /amount per The "Hilfstaxe" (a pricing contract for substances formulations made with substances) has not been used in its entirety to calculate the costs because it (1) is negotiated flexibly, (2) is not representative for the provision of care due to the large number of invoicing modes for cytostatics, largely non-public contracts, which are not bound by the "Hilfstaxe", (3) may not include all relevant substances at any one time, for these reasons is unsuitable for a stardized cost overview. In contrast, the publicly accessible pharmacy retail price shown in the listing services in accordance with SGB V, section 131, paragraph 4 is a suitable basis for a stardized calculation. According to the "Hilfstaxe" (effective: 4th supplementary agreement on the pricing contract for substances formulations made with substances, from 14 August 2014), surcharges of maximum 81 apply per application-ready preparation to parenteral solutions. This amount can be lowered in contracts. These additional extra costs are not added to the pharmacy retail price; they follow the calculation regulations set forth in the "Hilfstaxe". The costs shown are based on the pharmacy retail price the maximum surcharge for production, thus only approximate the actual treatment costs. 7 Although there are no comparative data, the limited data available for patients who initially responded to 5 mg/kg but whose response then weakened, suggest that an increased dosage can restore response (Remicade product information: effective: July 2014). 8 Patienten who experience insufficient response may benefit from a reduction in the dosing interval to Humira every week (Humira product information: effective: September 2014).

5 /amount per 100 mg 4 6, : Cost of pharmaceutical: (Entyvio ) (Remicade ) (Humira ) "Lauer-Taxe", effective: 1 January 2015 (pharmacy retail price) 4, (1 unit of ) 3, (4 units of 100 mg) 5, (6 units of ) Cost after legally mated rebates 4, [ ; ] 3, [ ; ] 4, [ ; ] for additional, necessary statutory health insurance (SHI) benefits: not applicable Annual treatment costs: Annual treatment costs 1 26, , , , , Other SHI expense items: Surcharge for the production of a parenteral solution 6 Cost per patient per cycle 1 max max max max II. This resolution takes effect on the day of its publication in the internet on the website of the Federal Joint Committee on 8 January The justification for this resolution will be published on the websites of the Federal Joint Committee at Berlin, 8 January 2015 The Federal Joint Committee in accordance with SGB V, section 91 The Chair Hecken