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 5a from 5 December 0 In its session on 5 December 0, the Federal Joint Committee resolved to amend the Pharmaceutical Directive (AM-RL), version published 8 December 008/ January 009 (Federal Gazette, number 49a of March 009), last amended on 0 October 0 (Federal Gazette, page 404), as follows: I. Appendix XII shall be amended to include the following in alphabetical order: Therapeutic indication: Brilique, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non ST elevation myocardial infarction [NSTEMI] or ST elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).. Additional benefit of the pharmaceutical over appropriate comparator a) Unstable angina pectoris (UA)/non ST elevation myocardial infarction (NSTEMI): Appropriate comparator: clopidogrel Extent and probability of additional benefit over clopidogrel : proof of a significant additional benefit Study results according to endpoints : Mortality Effect estimates [95% CI] ticagrelor vs. clopidogrel Incident rate ticagrelor vs. clopidogrel/absolute risk reduction (ARR) Overall mortality HR 0.7 [0.60; 0.89].8% vs. 5.% ARR =.5% Cardiovascular mortality HR 0.70 [0.56; 0.87].% vs. 4.6% ARR =.5% p-value p = 0.00 p = 0.00
Morbidity Effect estimates [95% CI] ticagrelor vs. clopidogrel Incident rate ticagrelor vs. clopidogrel/absolute risk reduction (ARR) Myocardial infarction HR 0.78 [0.65; 0.94] 4.8% vs. 6.% ARR =.% p-value p = 0.008 Stroke HR.00 [0.70;.44].% vs..4% p = 0.994 Health-related quality of life Side effects No applicable data available. Severe bleeding incidents HR.07 [0.95;.0] % vs..% p = 0.74 Life-threatening or fatal bleeding incidents Dyspnea RR 0.55 [0.49; 0.6] Bradycardia RR 0.79 [0.65; 0.97] AE RR 0.95 [0.9; 0.97] SAE RR.0 [0.9;.09] Termination due to AE RR 0.7 [0.60; 0.8] HR.09 [0.9;.9] 6.6% vs. 6. % p = 0.89 4.0% vs. 7.7% ARR = 6.% 4.4% vs..5% ARR = 0.9% 7. % vs. 68.6% ARR =.7% p < 0.00 p = 0.0 p < 0.00 9.7% vs. 9.8% p = 0.88 8.% vs. 5.7% ARR =.5% p < 0.00 Data from the benefit assessment conducted by the Institute for Quality and Efficiency in Health Care (IQWiG), page 5; myocardial infarction endpoint data from written hearing procedure Figures given only in cases with significant differences; negative ARR figures are in favour of clopidogrel Incident rate clopidogrel vs. ticagrelor, see notes in the IQWiG benefit assessment, page 6 b) ST elevation myocardial infarction (STEMI), treated with pharmaceuticals: Appropriate comparator: clopidogrel Extent and probability of additional benefit over clopidogrel : no additional benefit proved c) ST elevation myocardial infarction (STEMI), percutaneous coronary intervention: Appropriate comparator: prasugrel Extent and probability of additional benefit over prasugrel : no additional benefit proved Exceptions Patients 75 years old for whom treatment with prasugrel has been determined unsuitable following an individual benefitrisk assessment: a non-quantifiable additional benefit based on hints Patients with transient ischaemic attack or ischaemic stroke in medical history: a non-quantifiable additional benefit based on hints d) ST elevation myocardial infarction (STEMI) aortocoronary bypass operation: Appropriate comparator: mono with ASA Extent and probability of additional benefit over mono with ASA: no additional benefit proved. Number of patients and criteria for defining patients eligible for treatment a) Patients with unstable angina pectoris (UA)/patients with non ST elevation myocardial infarction (NSTEMI) Number: 8,000 to,000 b) Patients with ST elevation myocardial infarction (STEMI), treated with pharmaceuticals: Number: 7,000 to,000 b) Patients with ST elevation myocardial infarction (STEMI), and percutaneous coronary intervention: Number: 45,000 to 55,000 Number of patients 75 years old for whom treatment with prasugrel has been determined unsuitable following an individual benefit-risk assessment: 0 5% of patients with STEMI and percutaneous coronary intervention b) Patients with ST elevation myocardial infarction (STEMI), and aortocoronary bypass operation: Number: 5,000 to 6,000. Requirements for quality-assured administration The specifications outlined in the product information are to be followed.
4. s of treatment "Lauer-Taxe", effective December 0 a) Unstable angina pectoris (UA)/non ST elevation myocardial infarction (NSTEMI): of : per treatment (days), daily, daily, daily, daily of treatment up to months Consumption: Strength (mg) Number of tablets per pack Average annual consumption (number of tablets) 00 mg 75 mg 00 mg 00 00 00 00 s: of pharmaceuticals: (pharmacy retail price ) after legally mandated rebates (Brilique) 69.46 47.57 paragraph :.05 Rebate in accordance with SGB V, section 0a, paragraph a: 9.84 (6%) 8.4 5.0 paragraph :.05 Rebate in accordance with SGB V, section 0a, paragraph :. (6%) ASA.8.07 paragraph : 0.7 (5%) paragraph b: 0.4 (0%) Lowest-cost generic s for additional, necessary statutory health insurance (SHI) benefits: 70 patient after the first month; then as medically recommended 09 9 b) ST elevation myocardial infarction (STEMI), treated with pharmaceuticals: of :, daily, daily, daily, daily per treatment (days) 8 8 of treatment up to months, with clopidogrel up to 8 days based on the regulation in Appendix III, number a AM-RL
Consumption: Strength (mg) Number of tablets per pack Average annual consumption (number of tablets) 00 mg 75 mg 00 mg ; for clopidogrel: smallest pack s: of pharmaceuticals: 00 00 8 00 (pharmacy retail price ) after legally mandated rebates (Brilique) 69.46 47.57 paragraph :.05 Rebate in accordance with SGB V, section 0a, paragraph a: 9.84 (6%) 6..89 paragraph :.05 Rebate in accordance with SGB V, section 0a, paragraph : 0.9 (6%) ASA.8.07 paragraph : 0.7 (5%) paragraph b: 0.4 (0%) ; for clopidogrel: smallest pack Lowest-cost generic s for additional, necessary statutory health insurance (SHI) benefits: 70 8 patient after the first month; then as medically recommended 09 5 c) ST elevation myocardial infarction (STEMI), percutaneous coronary intervention: of : Prasugrel of treatment up to months, daily, daily, daily, daily per treatment (days) Consumption: Strength (mg) Number of tablets per pack Average annual consumption (number of tablets) Prasugrel 00 mg 0 mg 5 mg 00 mg Maintenance dosage 0 mg Reduced maintenance dosage 5 mg 00 00 98 98 00 70
s: of pharmaceuticals: (pharmacy retail price ) after legally mandated rebates (Brilique) 69.46 47.57 paragraph :.05 Rebate in accordance with SGB V, section 0a, paragraph a: 9.84 (6%) Prasugrel (Efient) 86.5 49.86 paragraph :.05 Rebate in accordance with SGB V, section 0a, paragraph a: 4.4 (6%) ASA.8.07 paragraph : 0.7 (5%) paragraph b: 0.4 (0%) Price applies to 0 mg and 5 mg strengths s for additional, necessary statutory health insurance (SHI) benefits: patient after the first month; then as medically recommended 09 Prasugrel 94 d) ST elevation myocardial infarction (STEMI) aortocoronary bypass operation: of :, daily, daily per treatment (days) Mono with ASA, daily of treatment up to months Consumption: Strength (mg) Number of tablets per pack Average annual consumption (number of tablets) 00 mg 00 00 Mono with ASA 00 mg 00 s: of pharmaceuticals: (pharmacy retail price ) after legally mandated rebates (Brilique) 69.46 47.57 paragraph :.05 Rebate in accordance with SGB V, section 0a, paragraph a: 9.84 (6%) ASA.8.07 paragraph : 0.7 (5%) paragraph b: 0.4 (0%) 70
s for additional, necessary statutory health insurance (SHI) benefits: patient after the first month; then as medically recommended 09 Mono with ASA II. This amendment takes effect on the day after its publication in the Federal Gazette. The justification for this resolution will be published on the website of the Federal Joint Committee at www.g-ba.de. Berlin, 5 December 0 The Federal Joint Committee, in accordance with SGB V, section 9 The Chair Hess