Effect estimates [95% CI] BOC+PegIFN/RBV vs. PegIFN/RBV

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Prudence Wilkerson
6 years ago
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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 5a from March 0 In its session on 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 December 0 (Federal Gazette, 0, page 786), as follows: I. Appendix XII shall be amended in alphabetical order to include the active ingredient boceprevir: Therapeutic indication: Victrelis is indicated for the of chronic hepatitis C (CHC) genotype infection, in combination with alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous.. Additional benefit of the pharmaceutical over appropriate comparator a) In combination with as compared to in previously untreated patients with chronic hepatitis C viral (chcv) genotype infection Appropriate comparator: plus ribavirin Extent and probability of additional benefit over plus ribavirin: Indication of an additional benefit of boceprevir; extent not quantifiable Study results according to endpoints : Effect estimates [95% CI] BOC+PegIFN/RBV vs. PegIFN/RBV Incident rate BOC+PegIFN/RBV vs. PegIFN/RBV/ absolute risk reduction (ARR) p-value SVR RR.68 [.44;.96] 6.% vs. 7.7% ARR = 5.6% p < 0.00 Health-related quality of life No applicable data available Overall mortality RR 0.5 [0.0;.0] < % vs. % p = 0.95 Anaemia RR.68 [.9;.0] 49% vs. 9% ARR = 0% p < 0.00 Psychiatric incidents RR 0.94 [0.8;.06] 55% vs. 59% p = 0. Infection RR.0 [0.87;.6] 5% vs. 50% p = 0.94 AE RR.0 [0.99;.0] 99% vs. 98% p = 0. SAE RR.4 [0.86;.08] % vs. 9% p = 0. Termination due to AE RR 0.78 [0.54;.] % vs. 6% p = 0.0 Data from the benefit assessment conducted by the Institute for Quality and Efficiency in Health Care (IQWiG), page (Sprint-) Figures given only in cases with significant differences; negative ARR figures are in favor of appropriate comparator (PegIFN/RBV)

2 b) In combination with as compared to in previously treated patients with chcv genotype infection Appropriate comparator: plus ribavirin Extent and probability of additional benefit over plus ribavirin: Indication of an additional benefit of boceprevir; extent not quantifiable Study results according to endpoints : Effect estimates [95% CI] BOC+PegIFN/RBV vs. PegIFN/RBV Incident rate BOC+PegIFN/RBV vs. PegIFN/RBV absolute risk reduction (ARR) SVR RR.76 [.78; 4.9] 58.6% vs..% ARR = 7.% p < 0.00 Health-related quality of life No applicable data available Overall mortality Incalculable 0.6% vs. 0% p = Anaemia RR.0 [.5;.47] 4% vs. 0% ARR = % p < 0.00 Psychiatric incidents RR.09 [0.8;.46] % vs. 44% p = 0.6 Infection RR 0.89 [0.69;.4] 50% vs. 56% p = 0.40 AE RR.0 [0.98;.08] 99% vs. 96% p = 0.4 SAE RR.98 [0.68; 5.7] 0% vs. 5% p = 0. Termination due to AE RR. [0.74;.88] 8% vs. % p = 0.5 Data from the benefit assessment conducted by the Institute for Quality and Efficiency in Health Care (IQWiG), page (Respond-) Figures given only in cases with significant differences; negative ARR figures are in favor of appropriate comparator (PegIFN/RBV). Number of patients and criteria for defining patients eligible for a) In combination with as compared to in previously untreated patients with chronic hepatitis C viral (chcv) genotype infection Number: approx.,000 (diagnosed, previously untreated patients with chronic hepatitis C virus infection) b) In combination with as compared to in previously treated patients with chcv genotype infection Number: approx. 4,000 (diagnosed, previously treated patients with chronic hepatitis C virus infection). Requirements for quality-assured administration The specifications outlined in the product information are to be followed. 4. Costs of ("Lauer-Taxe", effective 5 February 0) a) In combination with as compared to in previously untreated patients with chronic hepatitis C viral (chcv) genotype infection Duration of : Chart: previously untreated patients (without ) with chronic hepatitis C virus (chcv) infection who respond early to p-value without (Early responders ) untreated (Low initial viral load ; ) Mode of Number of s weekly 4 weeks ribavirin +, then 4 weeks boceprevir + ribavirin weekly 4 weeks ribavirin + 8 weeks 4 weeks Duration per (days) Duration of per patient per year HCV-RNA test: week 8, 4: undetectable Genotype patients with low initial viral load (LVL) ( IU/ml) who test HCV-RNA negative by week 4 and remain negative until week 4 An overall duration of 4 weeks can lead to increased risk of relapse. For these patients, tolerance of the combination and additional prognostic factors like degree of fibrosis should be taken into consideration. 68 4

3 Chart: previously untreated patients without with chronic hepatitis C virus (chcv) infection who do not respond early to ; previously untreated patients with without with untreated Mode of weekly 4 weeks ribavirin, then weeks boceprevir, then weeks ribavirin Number of s weeks weekly 4 weeks ribavirin +, then 44 weeks boceprevir + ribavirin, weeks weekly weeks ribavirin + Termination rules in accordance with Victrelis product information were not represented. weeks Duration per (days) 4 08 Duration of per patient per year 4 08 Consumption: Chart: previously untreated patients (without ) with chronic hepatitis C virus (chcv) infection who respond early to Strength without (Early responders) 400mg ( [4 00mg]) 80 micrograms Number/amount per pack ; tablets pre-filled (80 μg Average annual consumption,06 tablets 980 tablets 8 pre-filled untreated (Low initial viral load) + 80 micrograms pre-filled (80 μg 840 tablets 4 pre-filled Body weight < 75 kg Tablets or pre-filled Largest pack

4 Chart: previously untreated patients (without ) with chronic hepatitis C virus (chcv) infection who do not respond early previously untreated patients with Strength without with untreated Body weight < 75 kg Tablets or pre-filled Largest pack + 400mg ( [4 00mg]) 80 micrograms,400mg ( [4 00mg]) 80 micrograms 80 micrograms Number/amount per pack ; tablets pre-filled (80 μg tablets pre-filled (80 μg pre-filled (80 μg Average annual consumption,688 tablets,680 tablets pre-filled,696 tablets,680 tablets pre-filled,680 tablets pre-filled

5 Costs: Cost of pharmaceutical: Chart: previously untreated patients with chronic hepatitis C virus (chcv) infection who respond/do not respond early to with/without (Early responders and non-early responders) with untreated (Low and not low initial viral load) (Victrelis 00mg) ( tablets) (Copegus 00mg) () (Pegasys 80μg) ( pre-filled ) (Pegasys 80μg) (4 pre-filled ) (Copegus 00mg) () (Pegasys 80μg) ( pre-filled ) Cost (pharmacy retail price) Cost after legally mandated rebates,979.07,465.0 section 0a, paragraph a: 5.00, section 0a, paragraph a: 80.7,6.8,80. section 0a, paragraph a: 59.8, section 0a, paragraph a: 79.76, section 0a, paragraph a: 80.7,6.8,80. section 0a, paragraph a: 59.8 Costs for additional, necessary statutory health insurance (SHI) benefits: Chart: previously untreated patients with chronic hepatitis C virus (chcv) infection who respond/do not respond early to without (Early responders and l with untreated (Low and not low initial viral load) Description of additional SHI expense item Test for HCV- RNA levels Number of additional necessary SHI expense items per episode, cycle, etc. in week 8 Number of additional, necessary SHI expense items Cost per unit none none Annual costs: Chart: previously untreated patients (without ) with chronic hepatitis C virus (chcv) infection who respond early to Annual costs per patient without (Early responders) untreated (Low initial viral load),44.6 (Duration of 8 weeks) 9,7.46 (Duration of 4 weeks)

6 Chart: previously untreated patients without with chronic hepatitis C virus (chcv) infection who do not respond early to ; previously untreated patients with Annual costs per patient without with untreated (not low initial viral load) 44,00.58 (Duration of weeks) 54,6.4 (Duration of weeks) 9,496.9 (Duration of weeks) b) In combination with as compared to in previously treated patients with chcv genotype infection Duration of : treated, without treated, with ; treated treated Mode of weekly 4 weeks ribavirin +, then weeks boceprevir + ribavirin, then weeks ribavirin + Number of s weeks weekly 4 weeks ribavirin +, then 44 weeks boceprevir + ribavirin weeks weekly weeks ribavirin + weeks 4 weekly 7 weeks ribavirin + 7 weeks Termination rules in accordance with Victrelis product information were not represented. Patients who did not respond to previous with interferon and ribavirin and/or have relapsed Duration per (days) Treatment days per patient per year (in one 7 weeks) Therapy for previously treated patients with the combination of Rebetol and PegIntron : duration of weeks according to product information 4 Therapy for previously treated patients with the combination of Copegus and Pegasys : duration of 7 weeks according to product information

7 Consumption: Strength (mg) treated, without 400mg ( [4 00mg]) 80 micrograms Number/amount per pack ; tablets pre-filled (80 μg Average annual consumption 688 tablets,680 tablets pre-filled treated, with ;,400mg ( [4 00mg]) 80 micrograms tablets pre-filled (80 μg,696 tablets,680 tablets pre-filled treated + 00 micrograms pre-filled (00 μg,680 tablets pre-filled treated + 80 micrograms pre-filled (80 μg,50 tablets 7 pre-filled (in one 7 weeks) Body weight < 75 kg Tablets or pre-filled Largest pack Costs: Cost of pharmaceutical: Cost (pharmacy retail price ) Cost after legally mandated rebates treated with/without ; treated Largest pack (Victrelis 00mg) (Copegus 00mg) (Pegasys 80μg) (Copegus 00mg) (Pegasys 80μg) (Rebetol 00mg) (PegIntron 00μg),979.07,465.0 section 0a, paragraph a: 5.00, section 0a, paragraph a: 80.7,6.8,80. section 0a, paragraph a: 59.8, section 0a, paragraph a: 80.7,6.8,80. section 0a, paragraph a: 59.8, section 0a, paragraph a: 9.74,.56,809. section 0a, paragraph a: 500.9

8 Costs for additional, necessary statutory health insurance (SHI) benefits: treated, without treated, with ; treated Description of additional SHI expense item Test for HCV- RNA levels Number of additional, necessary SHI expense items per episode, cycle, etc. in week 8 Number of additional, necessary SHI expense items Cost per unit none none Annual costs: Annual costs per patient treated, without treated, with ; treated treated 44,00.58 (Duration of weeks) 54,6.4 (Duration of weeks) 0,75.78 (Duration of weeks) 9,45.8 (Duration of 7 weeks) II. This resolution takes effect on the day of its publication in the internet on the website of the Federal Joint Committee on March 0. The justification for this resolution will be published on the website of the Federal Joint Committee at Berlin, March 0 The Federal Joint Committee in accordance with SGB V, section 9 The Chair Hess

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