from 29 March 2012 Effect estimates [95% CI] Telaprevir + PegIFN/RBV vs. PegIFN/RBV

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 5a from 9 March 0 In its session on 9 March 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 5 March 0 (Federal Gazette, AT 6 April 0 B6), as follows: I. Appendix XII shall be amended in alphabetical order to include the active ingredient telaprevir: Therapeutic indication: Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the of genotype chronic hepatitis C in adult patients with compensated liver disease (including ): who are -naïve; who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.. Additional benefit of the pharmaceutical over appropriate comparator a) In combination with peginterferon as compared to peginterferon in -naïve patients with genotype chronic hepatitis C virus (chcv) infection Appropriate comparator: peginterferon (PegIFN) plus ribavirin (RBV) Extent and probability of additional benefit over peginterferon plus ribavirin: indication of an additional benefit of telaprevir, extent not quantifiable. Study results for -naïve patients according to endpoints : Effect estimates [95% CI] + PegIFN/RBV vs. PegIFN/RBV Incident rate + PegIFN/RBV vs. PegIFN/RBV, absolute risk reduction ARR Sustained virological RR.7 75% vs. 44% ARR = % response (SVR) p-value EQ-5D (EuroQol) MD [0.00; 0.06] 0.9 vs p = Overall mortality n/a < % vs. % n/a Anaemia RR.65 [.;.06] 4% vs. 5% ARR -6% p < 0.00 Rash RR.8 [.;.46] 6% vs. % ARR -% p < 0.00 Psychiatric incidents RR.06 [0.94;.0] 5% vs. 5% p = 0.4 Infection RR 0.79 [0.66; 0.94] % vs. 9% ARR 8% p = 0.00 AE n/a 99% vs. 98% n/a SAE RR.4 [0.86;.08] 0% vs. 7% p = 0.95 Termination due to AE RR.8 [0.85;.] 0% vs. 7% p = 0.4 Data from the benefit assessment conducted by the Institute for Quality and Efficiency in Health Care (IQWiG) for -naïve patients without Figures shown for significant differences only, minus sign: increased risk of unfavourable outcome Data from the ADVANCE study 4 Mean difference; higher value corresponds to higher quality of life assessment

2 b) In combination with peginterferon as compared to peginterferon in previously treated patients with genotype chcv infection Appropriate comparator: peginterferon plus ribavirin Extent and probability of additional benefit over peginterferon plus ribavirin: indication of an additional benefit of telaprevir, extent not quantifiable. Study results for previously treated patients according to endpoints : Effect estimates [95% CI] + PegIFN/RBV vs. PegIFN/RBV Incident rate + PegIFN/RBV vs. PegIFN/RBV, absolute risk reduction (ARR) p-value SVR RR.86 [.6; 5.7] 64% vs. 7% ARR 47% p < 0.00 EQ-5D No applicable data available Overall mortality n/a < 0% vs. % n/a Anaemia RR.96 [.;.95] 4% vs. 7% ARR 7% p < 0.00 Rash RR.78 [.6;.4] 57% vs. % ARR 5% p < 0.00 Psychiatric incidents RR 0.89 [0.7;.0] 46% vs. 5% p = 0. Infection RR.05 [0.79;.8] 7% vs. 6% p = 0.88 AE RR.0 [0.98;.07] 98% vs. 96% p = 0.4 SAE RR.4 [.06; 5.5] % vs. 5% ARR 7% p = 0.07 Termination due to AE RR. [0.7; 6.4] 6% vs. % p = 0.7 Data from the benefit assessment conducted by the Institute for Quality and Efficiency in Health Care (IQWiG) for previously treated patients Figures shown for significant differences only, minus sign: increased risk of unfavourable outcome. patients and criteria for defining patients eligible for a) In combination with peginterferon as compared to peginterferon in -naïve patients with genotype chcv infection Number: approx.,000 (diagnosed, -naïve patients with chronic hepatitis C infection) b) In combination with peginterferon as compared to peginterferon in previously treated patients with chronic hepatitis C virus (chcv) infection Number: approx. 4,000 (diagnosed, previously treated patients with chronic hepatitis C infection). Requirements for quality-assured administration The specifications outlined in the product information are to be followed. 4. Costs of a) In combination with peginterferon as compared to peginterferon in -naïve patients with genotype chronic hepatitis C virus (chcv) infection Duration of : Duration of : -naïve patients (without ) with chcv infection who respond early to Treatmentnaïve patients (without ) who respond early to + ribavirin + peginterferon Mode of daily daily weekly weeks telaprevir, weeks ribavirin s per patient 4 weeks (days)

3 Mode of s per patient (days) (low initial viral load, ) plus peginterferon daily weekly 4 weeks ribavirin 4 weeks HCV-RNA test: week 8, 4: undetectable Genotype patients with low initial viral load (LVL) ( 800,000 IU/ml) who test HCV-RNA negative by week 4 and remain negative until week 4 An overall duration of 4 weeks can, however, correspond to a higher relapse rate than an overall duration of 4 weeks Duration of : -naïve patients with chronic hepatitis C virus (chcv) infection who do not respond early to ; -naïve patients with Treatmentnaïve patients without who do not respond early to, naïve patients with + ribavirin + peginterferon Mode of daily daily weekly weeks telaprevir, weeks ribavirin s per patient weeks (days) + patients who do peginterferon, not respond early to, -naïve patients with high initial viral load, -naïve patients with daily weekly weeks ribavirin weeks Termination rules in accordance with Incivo product information were not represented. HCV-RNA test: week 8, 4: undetectable Genotype patients with high initial viral load (> 800,000 IU/ml) Consumption: Consumption: -naïve patients (without ) with chronic hepatitis C virus (chcv) infection who respond early to patients without who respond early to patients without who respond early to (Low initial viral load ) Strength (mg),50 mg ( 75 mg),000 mg 00 mg 00 mg 80 µg,000 mg 00 mg 00 mg 80 µg Number/amount per pack pre-filled (80 µg each) pre-filled (80 µg each) Average annual consumption 0 tablets 4 pre-filled 0 tablets 4 pre-filled Tablets or pre-filled HCV-RNA test: week 8, 4: undetectable Genotype patients with low initial viral load (LVL) ( 800,000 IU/ml)

4 Consumption: -naïve patients with chronic hepatitis C virus (chcv) infection who do not respond early to ; -naïve patients with ; -naïve patients with high initial viral load patients who do not respond early to, naïve patients with (High initial viral load ) Strength (mg),50 mg ( 75 mg),000 mg ( 00 mg + 00 mg 80 µg,000 mg ( 00 mg + 00 mg 80 µg Number/amount per pack pre-filled (80 µg each) pre-filled (80 µg each) Average annual consumption,680 tablets pre-filled,680 tablets pre-filled Tablets or pre-filled HCV-RNA test: week 8, 4: undetectable Genotype patients with high initial viral load (> 800,000 IU/ml) Costs: Cost of pharmaceutical: Cost of pharmaceutical: -naïve patients with chronic hepatitis C virus (chcv) infection patie nt group patients, with/without (Incivo 75 mg ()) (Copegus 00 mg) ()) alpha-a (Pegasys 80 µg ( prefilled )) Cost (pharmacy retail price) Cost after legally mandated rebates,6.60 0,67.4 [.05 ;,587. ],00.7, [.05 ; 80.7 ],80. [.05 ; 59.8 ] Rebate in accordance with SGB V, section 0 Rebate in accordance with SGB V, section 0a "Lauer-Taxe", effective March 0 Costs for additional, necessary statutory health insurance (SHI) benefits: none Annual costs: Annual costs: -naïve patients with chronic hepatitis C virus (chcv) infection who respond early to Patient group Annual costs patients without who respond early to 4,60.8 patients without who respond early to (Low initial viral load ) 9,7.46 HCV-RNA test: week 8, 4: undetectable Genotype patients with low initial viral load (LVL) ( 800,000 IU/ml)

5 Annual costs: -naïve patients with chronic hepatitis C virus (chcv) infection who do not respond early to ; -naïve patients with Patient group Annual costs patients with chcv infection who do not respond early to ; -naïve patients with patients with chcv infection who do not respond early to ; -naïve patients with ; -naïve patients with high initial viral load 5, ,496.9 Genotype patients with high initial viral load (> 800,000 IU/ml) b) In combination with peginterferon as compared to peginterferon in previously treated patients with chronic hepatitis C virus (chcv) infection Duration of : Duration of : previously treated patients with chronic hepatitis C virus (chcv) infection Relapse patients without who respond early to Relapse patients who do not respond early to, nonresponders, previously treated patients with Mode of daily daily weekly weeks telaprevir, weeks ribavirin daily daily weekly weeks telaprevir, 6 weeks ribavirin s per patient 4 weeks weeks (days) Previously treated patients with chcv infection daily weekly weeks ribavirin weeks Previously treated patients with chcv infection 4 daily weekly 7 weeks ribavirin 7 weeks Patients who relapsed following previous with interferon and ribavirin HCV-RNA test: week 8, 4: undetectable Combination of Rebetol and PegIntron : duration weeks according to product information 4 Combination of Copegus and Pegasys : duration 7 weeks according to product information

6 Consumption: Consumption: previously treated patients with chronic hepatitis C virus (chcv) infection Relapse patients without who respond early to Strength (mg) Number/amount per pack,50 mg ( 75 mg),000 mg ( 00 mg + 00 mg) 80 µg pre-filled (80 µg each) Average annual consumption 0 tablets 4 pre-filled Relapse patients who do not respond early to, non-responders, previously treated patients with,50 mg ( 75 mg),000 mg ( 00 mg + 00 mg),680 tablets 80 µg pre-filled (80 µg each) pre-filled,000 mg ( 00 mg + 00 mg) 00 µg pre-filled (00 µg each),680 tablets pre-filled,000 mg ( 00 mg + 00 mg),50 tablets 4 80 µg pre-filled (80 µg each) 7 pre-filled (in a 7 weeks) Tablets or pre-filled HCV-RNA test: week 8, 4: undetectable Combination of Rebetol and PegIntron : duration weeks according to product information 4 Combination of Copegus and Pegasys : duration 7 weeks according to product information

7 Costs: Cost of pharmaceutical: Cost of pharmaceutical: previously treated patients with chronic hepatitis C virus (chcv) infection Population Previously treated (Incivo 75 mg ()) Cost (pharmacy retail price) Cost after legally mandated rebates,6.60 0,67.4 [.05 ;,587. ] (Copegus 00 mg) ()) alpha-a (Pegasys 80 µg ( prefilled )) (Rebetol 00 mg) ()) alpha-b (PegIntron 00 µg ( prefilled )),00.7,6.8,05.68, [.05 ; 80.7 ],80. [.05 ; 59.8 ] [.05 ; 9.74 ],809. [.05 ; ] Rebate in accordance with SGB V, section 0 Rebate in accordance with SGB V, section 0a "Lauer-Taxe", effective March 0 Costs for additional, necessary statutory health insurance (SHI) benefits: none Annual costs: Annual costs: -naïve patients with chronic hepatitis C virus (chcv) infection who respond early to Patient group Annual costs Relapse patients without who respond early to Relapse patients who do not respond early to, non-responders, previously treated patients with 4,60.8 (Duration of 4 weeks) 5,78.64 (Duration of weeks) 0,75.78 (Duration of weeks) 9,45.8 (Duration of 7 weeks) HCV-RNA test: week 8, 4: undetectable Combination of Rebetol and PegIntron : duration weeks according to product information Combination of Copegus and Pegasys : duration 7 weeks according to product information II. This resolution takes effect on the day of its publication in the internet on the website of the Federal Joint Committee on 9 March 0. The justification for this resolution will be published on the website of the Federal Joint Committee at Berlin, 9 March 0 The Federal Joint Committee in accordance with SGB V, section 9 The Chair Hess