Resolution by the Federal Joint Committee on an amendment to the Pharmaceutical Directive (AM-RL): Appendix XII Resolutions on the benefit assessment pharmaceuticals with new active ingredients, in accordance with the German Social Code, Book Five (SGB V), section 35a From 19 February 2015 In its session on 19 February 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 31 March 2009), last amended on 19 February 2015 (Federal Gazette, AT 11 March 2015 B5) as follows: I. Appendix XII shall be amended in alphabetical order to include the active ingredient daclatasvir: Therapeutic indication: (Daklinza ) is indicated in combination with other pharmaceuticals for the chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4, and 5.1 the product information). For HCV genotype specific activity, see sections 4.4 and 5.1 the product information. 1. Additional benefit the pharmaceutical over appropriate comparator a) Treatment-naïve (without cirrhosis), genotype 1: in combination with sosbuvir Appropriate comparator: Dual (combination peginterferon alfa and ) or triple (combination a protease inhibitor (boceprevir or telaprevir), peginterferon alfa and ) Extent and probability benefit over peginterferon alfa + protease inhibitor (boceprevir or telaprevir) Hint minor benefit. b) Treatment-naïve (with compensated cirrhosis), genotype 1: in combination with sosbuvir (if applicable ) Appropriate comparator: Dual (combination peginterferon alfa and ) Extent and probability benefit over peginterferon alfa : An benefit has not been proved. c) Treatment-experienced, genotype 1: in combination with sosbuvir (if applicable ) Appropriate comparator: Dual (combination peginterferon alfa and ) or triple (combination a protease inhibitor (boceprevir or telaprevir), peginterferon alfa and ) Extent and probability benefit over peginterferon alfa and over peginterferon alfa + + protease inhibitor (boceprevir or telaprevir): An benefit has not been proved. d) Treatment-naïve (with compensated cirrhosis) and, genotype 3: in combination with sosbuvir Appropriate comparator: Dual (combination peginterferon alfa and )
Extent and probability benefit over peginterferon alfa : An benefit has not been proved. e) Treatment-naïve and ; genotype 4: in combination with sosbuvir (if applicable ) Appropriate comparator: Dual (combination peginterferon alfa and ) Extent and probability benefit over peginterferon alfa : An benefit has not been proved. f) Treatment-naïve, genotype 4: in combination with peginterferon alfa Appropriate comparator: Dual (combination peginterferon alfa and ) Extent and probability benefit over peginterferon alfa : Hint considerable benefit. g) Treatment-experienced, genotype 4: in combination with peginterferon alfa Appropriate comparator: Dual (combination peginterferon alfa and ) Extent and probability benefit over peginterferon alfa : An benefit has not been proved. Study results according to endpoints: a) Treatment-naïve (without cirrhosis), genotype 1: in combination with sosbuvir Treatment results in adult with HCV infection (genotype 1, -naïve, without cirrhosis) (study AI444040) [Daklinza product information (table 5), effective: August 2014] Treatment-naïve Treatment results daclatasvir SVR 12 a 12 weeks duration 41/41 (100%) a Patients with missing data at week 12 after end were assessed as responders if their next available ihr HCV RNA count was < LLOQ. For one -naïve patient data for both week 12 and week after end were missing. Summary adverse events, study AI444040 [assessment report on Daklinza (procedure EMA/H/C/003768/0000), (table page 75), effective: June 2014] /sosbuvir (without ) 12 weeks (N = 41) Patients with events Endpoint n (%) Death 0 SAE (any grade) 1 (2.4) Treatment-related SAE 0 Withdrawal due to AE 0 AE overall (any grade) 38 (92.7) AE (severity 3/4) 1 (2.4) Treatment-related AE (any grade) 22 (53.7) Treatment-related AE (severity 3/4) 0
Endpoint Treatment-related adverse events (any grade; 5% der overall population study N = 211) /sosbuvir (without ) 12 weeks (N = 41) Patients with events n (%) Fatigue 13 (31.7) Headache 6 (14.6) Nausea 7 (17.1) Anaemia 0 Insomnia 2 (4.9) Pruritus 0 f) Treatment-naïve, genotype 4: in combination with peginterferon alfa Addendum (A15-02) IQWiG dossier assessment on daclatasvir (A14-31) table 2: Sensitivity analyses for endpoint SVR in study AI444042 in consideration findings on SVR 12 Morbidity SVR Endpoint category Endpoint Type analysis Analysis N DCV + PEG + RBV Patients with events n (%) N PLC + PEG + RBV Patients with events n (%) DCV + PEG + RBV vs. PLC + PEG + RBV RR [95% CI]; p-value a Absolute risk reduction (ARR%) d Sensitivity analyses Replacement strategy 2 b 83 (77.1) 42 (56.3) 1.37 [0.99; 1.91] p = 0.061 Replacement strategy 3 c 83 (88.0) 42 (66.7) 1.32 [1.02; 1.71] p = 0.036 ARR = 21.3% Without replacement missing values Reference value 74 64 (86.5) 32 18 (56.3) 1.54 [1.12; 2.11] p = 0.08 ARR = 30.2% a b c d If not otherwise indicated: IQWiG calculation, asymptotic. Variances were adjusted using the data set resizing approach a (approach W3 in [Higgins JP et al.; 2008]). Patient numbers were not rounded when correcting variances; exact percentages were maintained. In the PLC + PEG + RBV arm, missing values were replaced by the risk observed in the control arm (56.3%). In the DCV + PEG + RBV arm, missing values were assumed to be nonresponders. Missing values in both arms were assumed to be responders. Own calculation. IQWiG dossier assessment on daclatasvir (A14-31) table 20: results (AI444042) RCT, direct comparison: DCV + PEG + RBV vs. PLC + PEG + RBV (-naïve with CHC genotype 4) DCV + PEG + RBV vs. DCV + PEG + RBV PLC + PEG + RBV PLC + PEG + RBV Endpoint category Endpoint Evaluation N Patients with events n (%) N Patients with events n (%) Mortality All-cause mortality 82 0 (0) 42 0 (0) Health-related quality life No data available RR [95% CI]; p-value a
DCV + PEG + RBV PLC + PEG + RBV DCV + PEG + RBV vs. PLC + PEG + RBV Endpoint category Endpoint Evaluation N Patients with events n (%) N Patients with events n (%) RR [95% CI]; p-value a Side effects b AE During phase 82 80 (97.6) 42 40 (95.2) During the first phase 82 80 (97.6) 42 40 (95.2) SAE During phase 82 8 (9.8) 42 2 (4.8) During the first phase 82 8 (9.8) 42 2 (4.8) 2.05 [0.46; 9.22] p = 0.402 Termination due to adverse events During phase 82 4 (4.9) 42 3 (7.1) During the first phase a b 82 4 (4.9) 42 2 (4.8) 1.02 [0.20; 5.37] p > 0.999 If not otherwise indicated, own calculation: unconditional exact test (CSZ method according to [Martin Andres AM et al., 1994]). If not otherwise indicated, number with event during the phase. Due to the large difference in observation duration between the two arms, only qualitative statements are possible (see table 19, IQWiG dossier assessment on daclatasvir (A14-31)). DCV: daclatasvir; HCV: hepatitis C virus; CI: confidence interval; LLOQ: lower limit quantification; N: number evaluated ; n: number with events; PEG: peginterferon alfa; PLC: placebo; RBV: ; RNA: ribonucleide acid; RCT: randomized controlled trial; RR: relative risk; SAE: serious adverse event; SVR 12: sustained virological response 12 weeks after end ; SVR : sustained virological response after end ; AE: adverse event 2. and criteria for defining eligible for a) Treatment-naïve (without cirrhosis), genotype 1: in combination with sosbuvir Number: approx. 14,700 b) Treatment-naïve (with compensated cirrhosis), genotype 1: in combination with sosbuvir (if applicable ) Number: approx. 600 c) Treatment-experienced, genotype 1: in combination with sosbuvir (if applicable ) Number: approx. 43,500 d) Treatment-naïve (with compensated cirrhosis) and, genotype 3: in combination with sosbuvir Number: approx. 8,700 e) Treatment-naïve and ; genotype 4: in combination with sosbuvir (if applicable ) and f) Treatment-naïve, genotype 4: in combination with peginterferon alfa and g) Treatment-experienced, genotype 4: daclatasvir in combination with peginterferon alfa Number: approx 3,000
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 the product information for Daklinza (active ingredient: daclatasvir) at the following public link (last accessed: 20 January 2015): http://www.ema.europa.eu/docs/en_gb/document_library/epar_-_product_information/human/003768/ WC5001728.pdf Treatment with daclatasvir must be initiated and monitored by physicians experienced in the with chronic hepatitis C viral infection. 4. Costs a) Genotype 1 Treatment-naïve (without cirrhosis), genotype 1: in combination with sosbuvir Treatment-naïve (with compensated cirrhosis), genotype 1: in combination with sosbuvir (if applicable ) Treatment-experienced, genotype 1 in combination with sosbuvir (if applicable )] Treatment duration: Table: Treatment-naïve (with/without cirrhosis) and (with/without cirrhosis), genotype 1 1 (without cirrhosis) Treatment-naïve 2 and (with cirrhosis) (if applicable + ) 3 Appropriate comparator triple Treatment-naïve without Boceprevir cirrhosis (early responders) 4 Mode 12 weeks daclatasvir () daclatasvir (if applicable ) 3 x daily 4 weeks + peginterferon, then boceprevir s 1 cycle 12 weeks 1 cycle 1 cycle 28 weeks Duration per () 196 28 Duration () 196 28 1 2 3 4 For whose also included an NS3/4A protease inhibitor, an extension to should be considered (Daklinza product information, effective: August 2014). For -naïve with cirrhosis and positive prognosis factors, such as IL28B-CC genotype and/or low initial viral load, a reduction to 12 weeks can be considered. (Daklinza product information, effective: August 2014). For with highly advanced liver disease or other negative prognosis factors, such as previous, the administration can be considered. Patients in whom HCV RNA is no longer detectable in weeks 8 and (Victrelis product information, effective: March 2014).
Mode s Duration per Duration without cirrhosis Boceprevir 3 x daily 1 cycle weeks 2 2 4 weeks, then 32 weeks boceprevir, then 12 weeks Treatment-experienced with cirrhosis/non-responders Boceprevir 3 x daily 1 cycle weeks 308 308 4 weeks, then 44 weeks boceprevir relapse 5 without cirrhosis who respond early to 6 Telaprevir 3 x daily 1 cycle weeks 12 weeks telaprevir, then 12 weeks Treatment-naïve (without cirrhosis) and experienced Telaprevir 3 x daily 1 cycle weeks 12 weeks telaprevir, then 36 weeks 5 Patients who relapsed following previous with interferon and. 6 Patients in whom HCV RNA is no longer detectable in weeks 4 and 12 (Incivo product information, effective: December 2013).
Mode s Duration per Duration Appropriate comparator dual Treatment-naïve without cirrhosis (low initial viral load 7, 8 ) 1 cycle Treatment-naïve (with/without cirrhosis) and experienced 9 weeks 1 cycle weeks Treatment-experienced 10 72 weeks 1 cycle 72 weeks 504 72 504 72 (in one cycle 72 weeks) Consumption: Table: Treatment-naïve (with/without cirrhosis) and (with/without cirrhosis), genotype 1 Dosage per day, strength (mg) Number/ amount per pack Average annual consumption 1 (without cirrhosis) 60 mg 400 mg tab. tab. Treatment-naïve 2 and (with cirrhosis) (if applicable + ) 3 60 mg 400 mg ( tab.) tab. tab. (0 tab.) Appropriate comparator triple Treatment-naïve without cirrhosis (early responders) 4 Boceprevir 2,400 mg (3 x [4 x 200 mg]) tab. 2,016 tab. tab. 980 tab. 12 (4) pre-filled 28 prefilled 7 Genotype 1 with low initial viral load (LVL) (< 800,000 IU/ml) who test HCV RNA negative by week 4 and remain negative until week. 8 An overall duration can lead to increased risk relapse. For these, tolerance the combination and prognostic factors like degree fibrosis should be taken into consideration. 9 Therapy for with the combination Rebetol /generic and Pegintron : duration weeks according to product information. Therapy for previously treated/genotype 1 with the combination Copegus and Pegasys : duration 72 weeks according to product information. Body weight < 75 kg. 10 11
Dosage per day, strength (mg) Number/ amount per pack Average annual consumption without cirrhosis Boceprevir 2,400 mg (3 x [4 x 200 mg]) tab. tab. 2,688 tab. 1,680 tab. pre-filled Treatment-experienced with cirrhosis/non-responders Boceprevir 2,400 mg (3 x [4 x 200 mg]) tab. 3,696 tab. tab. 1,680 tab. pre-filled relapse 5 without cirrhosis who respond early to 6 Telaprevir 2,250 mg (3 x [2 x 375 mg]) tab. tab. 504 tab. 0 tab. pre-filled Treatment-naïve (without cirrhosis) and experienced Telaprevir 2,250 mg (3 x [2 x 375 mg]) tab. tab. 504 tab. 1,680 tab. pre-filled Appropriate comparator dual Treatment-naïve without cirrhosis (low initial viral load) 7, 8 tab. 0 tab. pre-filled Treatment-naïve (with/without cirrhosis) tab. 1,680 tab. pre-filled Treatment-experienced 9 100 µg 14 tab. 1,680 tab. pre-filled Treatment-experienced 10 tab. 2,520 tab. 72 pre-filled
Costs: Cost pharmaceutical: Cost (pharmacy retail price) Cost after legally mandated rebates 13,325.25 12,565.75 (Daklinza ) [ 1.77 12 ; 757.73 13 ] Sosbuvir 19,999.46 18,858.79 (Sovaldi ) [ 1.77 12 ; 1,138.90 13 ] Boceprevir 3,146.09 14 3,144.32 (Victrelis ) [ 1.77 12 ] Telaprevir 9,359.53 14 9,357.76 (Incivo 375 mg) [ 1.77 12 ] 1,004.21 822.27 (Copegus 200 mg) [ 1.77 12 ; 180.17 13 ] 764.05 726.54 (generic 200 mg) [ 1.77 12 ; 35.74 13 ] Peginterferon 3,362.30 (12 count) 3,052.37 (Pegasys ) [ 1.77 12 ; 308.16 13 ] 1,147.34 (4 count) 1,042.85 [ 1.77 12 ; 102.72 13 ] Peginterferon 3,051.66 2,878.88 (PegIntron 100 µg) [ 1.77 12 ; 171.01 13 ] Lauer-Taxe, effective: 15 January 2015 Costs for, statutory health insurance (SHI) benefits: Table: Treatment-naïve (with/without cirrhosis) and (with/without cirrhosis), genotype 1 Patients with HCV infection genotype 1 (if applicable + ) (12, ) SHI benefits per cycle e.c. and year Cost per unit Appropriate comparator triple Treatment-naïve without cirrhosis (early responders) 4 Boceprevir + +peginterferon (28 weeks) 3 x in weeks 8, 12, 3 89.50 without cirrhosis Boceprevir + +peginterferon ( weeks) 3 x in weeks 8, 12, 3 89.50 Treatment-experienced with cirrhosis/non-responders Boceprevir + +peginterferon ( weeks) 3 x in weeks 8, 12, 3 89.50 12 13 14 Rebate in accordance with SGB V, section 130. Rebate in accordance with SGB V, section 130a. Retail price in accordance with German Medicines Act, section 78, paragraph 3a in connection with SGB V, section 130b.
SHI benefits per cycle e.c. and year Cost per unit relapse 5 without cirrhosis who respond early to 6 Telaprevir () 2 x in weeks 4, 12 2 89.50 Treatment-naïve (without cirrhosis) and experienced Telaprevir ( weeks) 4 x in weeks 4, 12,, 36 4 89.50 Appropriate comparator dual Treatment-naïve without cirrhosis (low initial viral load 7, 8 ) () 2 x in weeks 4, 2 89.50 Treatment-naïve (with/without cirrhosis), 9 ( weeks) 1 x in weeks 4, 12 1 89.50 Treatment-experienced 10 (72 weeks) 1 x in week 12 1 89.50 Annual costs: Table: Treatment-naïve (with/without cirrhosis) and (with/without cirrhosis), genotype 1 Annual costs (12 weeks) experienced 1 (without cirrhosis) 37,697.25 Sosbuvir 56,576.37 (if applicable ) () Treatment-naïve 2 and experienced (with cirrhosis) 75,394.50 Sosbuvir 113,152.74 (if applicable ) 3 ( 4,111.35) Appropriate comparator triple Boceprevir (28 weeks) Treatment-naïve without cirrhosis (early Boceprevir 18,865.92 responders) 4 4,933.62 Peginterferon 7,147.59 Additional SHI benefit 268.50
Boceprevir ( weeks) experienced without cirrhosis Boceprevir ( weeks) Treatment-experienced with cirrhosis/nonresponders Telaprevir () Annual costs Boceprevir 25,154.56 8,222.70 Peginterferon 12,209. Additional SHI benefit 268.50 Boceprevir 34,587.52 8,222.70 Peginterferon 12,209. Additional SHI benefit 268.50 relapse 5 without Telaprevir 28,073.28 cirrhosis who respond early to 6 4,111.35 Peginterferon 6,104.74 Additional SHI benefit 179.00 Telaprevir ( weeks) Treatment-naïve (without cirrhosis) and experienced Telaprevir 28,073.28 8,222.70 Peginterferon 12,209. Additional SHI benefit 358.00 Appropriate comparator dual + peginterferon () Treatment-naïve (without cirrhosis) (low initial viral 4,111.35 load) 7, 8 Peginterferon 6,104.74 ( weeks) Additional SHI benefit 179.00 Treatment-naïve (with/without cirrhosis) 8,222.70 Peginterferon 12,209. Additional SHI benefit 89.50 Treatment-experienced 9 7,265.40 (72 weeks) Peginterferon 11,515.52 Additional SHI benefit 89.50 Treatment-experienced 10 12,334.05 Peginterferon 18,314.22 Additional SHI benefit 89.50
b) Genotype 3 [Treatment-naïve (with compensated cirrhosis) and, genotype 3: in combination with sosbuvir ] Duration : Table: Treatment-naïve (with compensated cirrhosis) and, genotype 3 Treatment-naïve (with cirrhosis) and experienced (with/without cirrhosis) Mode daclatasvir s 1 cycle Duration per Duration Appropriate comparator dual Treatment-naïve (with cirrhosis) 1 cycle Treatmentexperienced (with/without cirrhosis) weeks 1 cycle weeks Consumption: Table: Treatment-naïve (with compensated cirrhosis) and, genotype 3 Treatment-naïve (with cirrhosis) and experienced (with/without cirrhosis) Dosage per day, strength (mg) 60 mg 400 mg Number/ amount per pack tab. Average annual consumption tab. tab. 0 tab. Appropriate comparator dual Treatment-naïve (with cirrhosis) 800 mg 1 x [2 x 200 mg]) tab. 672 tab. pre-filled Treatmentexperienced (with/without cirrhosis) 800 mg 1 x [2 x 200 mg]) tab. 1,344 tab. pre-filled
Costs Cost pharmaceutical: (Daklinza ) Sosbuvir (Sovaldi ) (Copegus 200 mg) Peginterferon (Pegasys ) Cost (pharmacy retail price) Cost after legally mandated rebates 13,325.25 12,565.75 [ 1.77 12 ; 757.73 13 ] 19,999.46 18,858.79 [ 1.77 12 ; 1,138.90 13 ] 1,004.21 822.27 [ 1.77 12 ; 180.17 13 ] 3,362.30 3,052.37 [ 1.77 12 ; 308.16 13 ] Lauer-Taxe, effective: 15 January 2015 Costs for, statutory health insurance (SHI) benefits: Table: Treatment-naïve (with compensated cirrhosis) and, genotype 3 SHI benefits per cycle e.c. and year Cost per unit Treatment-naïve (with cirrhosis) and experienced (with/without cirrhosis) () Appropriate comparator dual Treatmentnaïve (with cirrhosis) +peginterferon () 1 x in week 4 1 89.50 Treatment-experienced (with/without cirrhosis) +peginterferon ( weeks) 1 x in week 12 1 89.50 Annual costs: Table: Treatment-naïve (with compensated cirrhosis) and, genotype 3 Annual costs () Treatment-naïve (with cirrhosis) and (with/without cirrhosis) 75,394.50 Sosbuvir 113,152.74 4,111.35 Appropriate comparator dual () Treatment-naïve (with cirrhosis) 3,289.08 Peginterferon 6,104.74 Additional SHI benefit 89.50
( weeks) Annual costs Treatment-experienced (with/without cirrhosis) 6,578.16 Peginterferon 12,209. Additional SHI benefit 89.50 c) Genotype 4 [Treatment-naïve and, genotype 4: in combination with sosbuvir (if applicable ) Treatment-naïve, genotype 4: in combination with peginterferon alfa Treatment-experienced, genotype 4: in combination with peginterferon alfa ] Treatment duration: Table: Treatment-naïve and, genotype 4 Mode s Duration per Duration 1 (without cirrhosis) 12 weeks daclatasvir 1 cycle 12 weeks Treatment-naïve 2 and (with cirrhosis) (if applicable + ) 3 () daclatasvir (if applicable ) 1 cycle () () 15 1 cycle daclatasvir 15 If the patient achieves undetectable HCV RNA titer in both weeks 4 and 12, all 3 components the regime should be administered for a total weeks.
Mode s Duration per Duration 1 experienced 16 cycle weeks daclatasvir, then Appropriate comparator Treatment-naïve (early 17, 18 responders) 1 cycle Treatment-naïve (incl. early responders 17, 18 ) and weeks 1 cycle weeks Consumption: Table: Treatment-naïve and, genotype 4 Dosage per day, strength (mg) Number/ amount per pack Average annual consumption 1 (without cirrhosis) 60 mg 400 mg tab. tab. Treatment-naïve 2 and (with cirrhosis) (if applicable + ) 3 60 mg 400 mg ( tab.) tab. tab. (0 tab.) 15 60 mg tab. tab. 0 tab. pre-filled 16 If the patient achieve undetectable HCV RNA titer, but not in both week 4 and week 12, Daklinza should be discontinued after, but with peginterferon alfa and should be continued for a total weeks. 17 Patients who test HCV RNA negative by week 4 and remain HCV RNA negative until week. 18 An overall duration can be associated with a higher relapse rate than an overall duration weeks. For these, tolerance the combination and prognostic factors like degree fibrosis should be taken into consideration.
Dosage per day, strength (mg) Number/ amount per pack Average annual consumption 16 60 mg tab. tab. 1,680 tab. pre-filled Appropriate comparator Treatment-naïve (early 17, 18 responders) tab. 0 tab. pre-filled Treatment-naïve (incl. early responders 17, 18 ) and tab. 1,680 tab. pre-filled Costs Cost pharmaceutical: (Daklinza ) Sosbuvir (Sovaldi ) (Copegus 200 mg) Peginterferon (Pegasys ) Cost (pharmacy retail price) Cost after legally mandated rebates 13,325.25 12,565.75 [ 1.77 12 ; 757.73 13 ] 19,999.46 18,858.79 [ 1.77 12 ; 1,138.90 13 ] 1,004.21 822.27 [ 1.77 12 ; 180.17 13 ] 3,362.30 3,052.37 [ 1.77 12 ; 308.16 13 ] Lauer-Taxe, effective: 15 January 2015 Costs for, statutory health insurance (SHI) benefits: Table: Treatment-naïve and, genotype 4 SHI benefits per cycle e.c. and year Cost per unit 15 (with/without cirrhosis) 15 (if applicable + ) 3 (12 and ) () 2 x in weeks 4, 12 2 89.50 16 ([]/ weeks) 3 x in weeks 4, 12, 3 89.50
SHI benefits per cycle e.c. and year Cost per unit Appropriate comparator Treatment-naïve (early 17, 18 responders) +peginterferon () 2 x in weeks 4, 2 89.50 Treatment-naïve (incl. early responders 17, 18 ), +peginterferon ( weeks) 1 x in weeks 4, 12 1 89.50 Annual costs: Table: Treatment-naïve and, genotype 4 Annual costs (12 weeks) experienced 37,697.25 1 (without cirrhosis) Sosbuvir 56,576.37 (if applicable ) () Treatment-naïve 2 and experienced 75,394.50 (with cirrhosis) Sosbuvir 113,152.74 (if applicable ) 3 ( 4,111.35) () 75,394.50 15 4,111.35 Peginterferon 6,104.74 Additional SHI benefit 179.00 ([]/ weeks) 75,394.50 16 8,222.70 Appropriate comparator () Peginterferon 12,209. Additional SHI benefit 268.50 Treatment-naïve (early responders) 17, 18 4,111.35 Peginterferon 6,104.74 Additional SHI benefit 179.00 ( weeks) Treatment-naïve (incl. early responders 17, 18 ) and experienced 8,222.70 Peginterferon 12,209. Additional SHI benefit 89.50
This resolution takes effect on the day its publication in the internet on the website the Federal Joint Committee on 19 February 2015. The justification for this resolution will be published on the websites the Federal Joint Committee at www.g-ba.de. II. Berlin, 19 February 2015 The Federal Joint Committee in accordance with SGB V, section 91 The Chair Pr. Hecken