Economic study of the value of expanding HCV treatment capacity in Germany

Sbarigia, U.; Wirth, Daniel; Nuys, Karen Van; Huber, Caroline; Brookmeyer, Ron; Stahmeyer, Jona T.; Krauth, Christian

doi:10.1136/bmjgast-2016-000130

Cited by 8 publications

(14 citation statements)

References 30 publications

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“…Several studies [40, 41] explore national prioritization strategies aiming at the overall elimination of HCV infections, but these studies lack consideration of screening measures and do not consider target group specific access strategies. Most studies addressing screening for HCV are focusing on specific target groups [42, 43] such as general population (specified as birth cohorts 1945 to 1965 or 1970, PWIDs or health care workers.…”

Section: Discussionmentioning

confidence: 99%

Elimination of hepatitis C virus in Germany: modelling the cost-effectiveness of HCV screening strategies

et al. 2019

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BackgroundChronic hepatitis C is a major public health burden. With new interferon-free direct-acting agents (showing sustained viral response rates of more than 98%), elimination of HCV seems feasible for the first time. However, as HCV infection often remains undiagnosed, screening is crucial for improving health outcomes of HCV-patients. Our aim was to assess the long-term cost-effectiveness of a nationwide screening strategy in Germany.MethodsWe used a Markov cohort model to simulate disease progression and examine long-term population outcomes, HCV associated costs and cost-effectiveness of HCV screening. The model divides the total population into three subpopulations: general population (GEP), people who inject drugs (PWID) and HIV-infected men who have sex with men (MSM), with total infection numbers being highest in GEP, but new infections occurring only in PWIDs and MSM. The model compares four alternative screening strategies (no/basic/advanced/total screening) differing in participation and treatment rates.ResultsTotal number of HCV-infected patients declined from 275,000 in 2015 to between 125,000 (no screening) and 14,000 (total screening) in 2040. Similarly, lost quality adjusted life years (QALYs) were 320,000 QALYs lower, while costs were 2.4 billion EUR higher in total screening compared to no screening. While incremental cost-effectiveness ratio (ICER) increased sharply in GEP and MSM with more comprehensive strategies (30,000 EUR per QALY for total vs. advanced screening), ICER decreased in PWIDs (30 EUR per QALY for total vs. advanced screening).ConclusionsScreening is key to have an efficient decline of the HCV-infected population in Germany. Recommendation for an overall population screening is to screen the total PWID subpopulation, and to apply less comprehensive advanced screening for MSM and GEP.

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Section: Discussionmentioning

confidence: 99%

Elimination of hepatitis C virus in Germany: modelling the cost-effectiveness of HCV screening strategies

et al. 2019

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“…Of the 23 articles that made comparisons of expanded access to earlier fibrosis stages compared to more restrictive treatment access policies, only five models included disease transmission; 41,50,53,55,58 one additional model included a risk of reinfection after successful treatment. 49 While nearly all studies examine the cost-effectiveness of treatment expansion to earlier fibrosis stages for genotype 1, several studies include multiple genotypes and/or focus explicitly on genotypes 2, 3, or 4.…”

Section: Presentation and Discussion Of Published Articlesmentioning

confidence: 99%

Population Health and Cost-Effectiveness Implications of a “Treat All” Recommendation for HCV: A Review of the Model-Based Evidence

Cipriano

Goldhaber-Fiebert

2018

MDM Policy & Practice

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The World Health Organization HCV Guideline Development Group is considering a “treat all” recommendation for persons infected with hepatitis C virus (HCV). We reviewed the model-based evidence of cost-effectiveness and population health impacts comparing expanded treatment policies to more limited treatment access policies, focusing primarily on evaluations of all-oral directly acting antivirals published after 2012. Searching PubMed, we identified 2,917 unique titles. Sequentially reviewing titles and abstracts identified 226 potentially relevant articles for full-text review. Sixty-nine articles met all inclusion criteria—42 cost-effectiveness analyses and 30 models of population-health impacts, with 3 articles presenting both types of analysis. Cost-effectiveness studies for many countries concluded that expanding treatment to people with mild liver fibrosis, who inject drugs (PWID), or who are incarcerated is generally cost-effective compared to more restrictive treatment access policies at country-specific prices. For certain patient subpopulations in some countries—for example, elderly individuals without fibrosis—treatment is only cost-effective at lower prices. A frequent limitation is the omission of benefits and consequences of HCV transmission (i.e., treatment as prevention; risks of reinfection), which may underestimate or overestimate the cost-effectiveness of a “treat all” policy. Epidemiologic modeling studies project that through a combination of prevention, aggressive screening and diagnosis, and prompt treatment for all fibrosis stages, it may be possible to virtually eliminate HCV in many countries. Studies show that if resources are not available to diagnose and treat all HCV-infected individuals, treatment prioritization may be needed, with alternative prioritization strategies resulting in tradeoffs between reducing mortality or reducing incidence. Notably, because most new HCV infections are among PWID in many settings, HCV elimination requires unrestricted treatment access combined with injection transmission disruption strategies. The model-based evidence suggests that a properly constructed strategy that substantially expands HCV treatment could achieve cost-effective improvements in population health in many countries.

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“…It has been suggested that the high SVR12 rates achieved with nucleotide‐based 3‐DAA regimens following a shortened treatment duration of 6 or 8 weeks may be partly ascribed to the more rapid first‐phase decline in HCV ribonucleic acid (RNA) observed when a third DAA was added . In addition to the high levels of therapeutic efficacy achieved with 2‐ or 3‐DAA regimens, the opportunity to provide patients with an effective shorter course of therapy could also have a favorable impact on affordability, adherence, and patient quality of life due to reduced side effects and decreased pill burden …”

Section: Introductionmentioning

confidence: 99%

“…8 In addition to the high levels of therapeutic efficacy achieved with 2-or 3-DAA regimens, the opportunity to provide patients with an effective shorter course of therapy could also have a favorable impact on affordability, adherence, and patient quality of life due to reduced side effects and decreased pill burden. 8,13,14 Simeprevir is a HCV NS3/4A protease inhibitor licensed for the treatment of chronic HCV infection as a component of combination antiviral therapy. The recommended adult dose of simeprevir is 150 mg (100 mg in Japan) once daily (QD) administered with food.…”

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confidence: 99%

Pharmacokinetics, safety, and tolerability of the 2‐ and 3‐direct‐acting antiviral combination of AL‐335, odalasvir, and simeprevir in healthy subjects

Kakuda¹,

McClure²,

Westland³

et al. 2018

Pharmacology Res & Perspec

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This Phase I, open‐label, two‐group, fixed‐sequence study evaluated the pharmacokinetics and safety of AL‐335, odalasvir, and simeprevir in healthy subjects. Group 1 (n = 16) received AL‐335 800 mg once daily (QD) (days 1‐3, 11‐13, and 21‐23), simeprevir 150 mg QD (days 4‐23), and odalasvir 150 mg (day 14) followed by 50 mg QD (days 15‐23). Group 2 (n = 16) received the same AL‐335 regimen as in Group 1 plus odalasvir 150 mg (day 4) followed by 50 mg QD (days 5‐23) and simeprevir 150 mg QD (days 14‐23). Blood samples were collected to determine plasma concentrations of AL‐335 (prodrug) and its metabolites, ALS‐022399 (monophosphate precursor) and ALS‐022227 (parent nucleoside), odalasvir, and simeprevir. Thirty‐two subjects were enrolled. Odalasvir and simeprevir given alone, or in combination, increased AL‐335 area under plasma concentration‐time curve over 24 hours (AUC 0‐24 h) 3‐, 4‐, and 7‐ to 8‐fold, respectively; ALS‐022399 AUC 0‐24 h increased 2‐, 2‐, and 3‐fold, respectively. Simeprevir had no effect on ALS‐022227 AUC 0‐24 h, whereas odalasvir with/without simeprevir increased ALS‐022227 AUC 0‐24 h 1.5‐fold. AL‐335 had no effect on odalasvir or simeprevir pharmacokinetics. Odalasvir and simeprevir AUC 0‐24 h increased 1.5‐ to 2‐fold for both drugs when coadministered irrespective of AL‐335 coadministration. Study medications were well tolerated with no serious adverse events. One subject prematurely discontinued study drugs (unrelated event). This study defined the preliminary pharmacokinetic and safety profiles of the combination of AL‐335, odalasvir, and simeprevir in healthy subjects. These data support the further evaluation of this combination for the treatment of chronic hepatitis C virus infection.

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Economic study of the value of expanding HCV treatment capacity in Germany

Cited by 8 publications

References 30 publications

Elimination of hepatitis C virus in Germany: modelling the cost-effectiveness of HCV screening strategies

Elimination of hepatitis C virus in Germany: modelling the cost-effectiveness of HCV screening strategies

Population Health and Cost-Effectiveness Implications of a “Treat All” Recommendation for HCV: A Review of the Model-Based Evidence

Pharmacokinetics, safety, and tolerability of the 2‐ and 3‐direct‐acting antiviral combination of AL‐335, odalasvir, and simeprevir in healthy subjects

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