Cost-Effectiveness and Budget Impact of Hepatitis C Virus Treatment With Sofosbuvir and Ledipasvir in the United StatesCost-Effectiveness of HCV Treatment With Sofosbuvir and Ledipasvir

Annals of Internal Medicine

17 March 2015, Vol 162, No. 6>

Original Research | 17 March 2015

Jagpreet Chhatwal, PhD; Fasiha Kanwal, MD, MSHS; Mark S. Roberts, MD, MPP; and Michael A. Dunn, MD

[+-] Article and Author Information

Ann Intern Med. 2015;162(6):397-406. doi:10.7326/M14-1336

Background: Sofosbuvir and ledipasvir, which have recently been approved for treatment of chronic hepatitis C virus (HCV) infection, are more efficacious and safer than the old standard of care (oSOC) but are substantially more expensive. Whether and in which patients their improved efficacy justifies their increased cost is unclear.

Objective: To evaluate the cost-effectiveness and budget impact of sofosbuvir and ledipasvir.

Design: Microsimulation model of the natural history of HCV infection.

Data Sources: Published literature.

Target Population: Treatment-naive and treatment-experienced HCV population defined on the basis of HCV genotype, age, and fibrosis distribution in the United States.

Time Horizon: Lifetime.

Perspective: Third-party payer.

Intervention: Simulation of sofosbuvir–ledipasvir compared with the oSOC (interferon-based therapies).

Outcome Measures: Quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), and 5-year spending on antiviral drugs.

Results of Base-Case Analysis: Sofosbuvir-based therapies added 0.56 QALY relative to the oSOC at an ICER of $55 400 per additional QALY. The ICERs ranged from $9700 to $284 300 per QALY depending on the patient's status with respect to treatment history, HCV genotype, and presence of cirrhosis. At a willingness-to-pay threshold of $100 000 per QALY, sofosbuvir-based therapies were cost-effective in 83% of treatment-naive and 81% of treatment-experienced patients. Compared with the oSOC, treating eligible HCV-infected persons in the United States with the new drugs would cost an additional $65 billion in the next 5 years, whereas the resulting cost offsets would be $16 billion.

Results of Sensitivity Analysis: Results were sensitive to drug price, drug efficacy, and quality of life after successful treatment.

Limitation: Data on real-world effectiveness of new antivirals are lacking.

Conclusion: Treatment of HCV is cost-effective in most patients, but additional resources and value-based patient prioritization are needed to manage patients with HCV.

Primary Funding Source: National Institutes of Health.

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Cost-Effectiveness of Novel Regimens for the Treatment of Hepatitis C VirusCost-Effectiveness of New Regimens for Hepatitis C Virus

Annals of Internal Medicine

17 March 2015, Vol 162, No. 6>

Original Research | 17 March 2015

Mehdi Najafzadeh, PhD; Karin Andersson, MD; William H. Shrank, MD, MSHS; Alexis A. Krumme, MS; Olga S. Matlin, PhD; Troyen Brennan, MD, JD, MPH; Jerry Avorn, MD; and Niteesh K. Choudhry, MD, PhD

[+-] Article and Author Information

Ann Intern Med. 2015;162(6):407-419. doi:10.7326/M14-1152

Background: New regimens for hepatitis C virus (HCV) have shorter treatment durations and increased rates of sustained virologic response compared with existing therapies but are extremely expensive.

Objective: To evaluate the cost-effectiveness of these treatments under different assumptions about their price and efficacy.

Design: Discrete-event simulation.

Data Sources: Published literature.

Target Population: Treatment-naive patients infected with chronic HCV genotype 1, 2, or 3.

Time Horizon: Lifetime.

Perspective: Societal.

Intervention: Usual care (boceprevir–ribavirin–pegylated interferon [PEG]) was compared with sofosbuvir–ribavirin–PEG and 3 PEG-free regimens: sofosbuvir–simeprevir, sofosbuvir–daclatasvir, and sofosbuvir–ledipasvir. For genotypes 2 and 3, usual care (ribavirin–PEG) was compared with sofosbuvir–ribavirin, sofosbuvir–daclatasvir, and sofosbuvir–ledipasvir–ribavirin (genotype 3 only).

Outcome Measures: Discounted costs (in 2014 U.S. dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.

Results of Base-Case Analysis: Assuming sofosbuvir, simeprevir, daclatasvir, and ledipasvir cost $7000, $5500, $5500, and $875 per week, respectively, sofosbuvir–ledipasvir was cost-effective for genotype 1 and cost $12 825 more per QALY than usual care. For genotype 2, sofosbuvir–ribavirin and sofosbuvir–daclatasvir cost $110 000 and $691 000 per QALY, respectively. For genotype 3, sofosbuvir–ledipasvir–ribavirin cost $73 000 per QALY, sofosbuvir–ribavirin was more costly and less effective than usual care, and sofosbuvir–daclatasvir cost more than $396 000 per QALY at assumed prices.

Results of Sensitivity Analysis: Sofosbuvir–ledipasvir was the optimal strategy in most simulations for genotype 1 and would be cost-saving if sofosbuvir cost less than $5500. For genotype 2, sofosbuvir–ribavirin–PEG would be cost-saving if sofosbuvir cost less than $2250 per week. For genotype 3, sofosbuvir–ledipasvir–ribavirin would be cost-saving if sofosbuvir cost less than $1500 per week.

Limitation: Data are lacking on real-world effectiveness of new treatments and some prices.

Conclusion: From a societal perspective, novel treatments for HCV are cost-effective compared with usual care for genotype 1 and probably genotype 3 but not for genotype 2.

Primary Funding Source: CVS Health.

Source

Should we await IFN-free regimens to treat HCV genotype 1 treatment-naive patients? A cost-effectiveness analysis (ANRS 95141)

Journal of Hepatology

Volume 61, Issue 1, Pages 7–14, July 2014

Sylvie Deuffic-Burban, Michaël Schwarzinger, Dorothée Obach, Vincent Mallet, Stanislas Pol, Georges-Philippe Pageaux, Valérie Canva, Pierre Deltenre, Françoise Roudot-Thoraval, Dominique Larrey, Daniel Dhumeaux, Philippe Mathurin, Yazdan Yazdanpanah

Received: August 22, 2013; Received in revised form: February 4, 2014; Accepted: March 6, 2014; Published Online: March 17, 2014

DOI: http://dx.doi.org/10.1016/j.jhep.2014.03.011

Abstract

Background & Aims

In treatment-naive patients mono-infected with genotype 1 chronic HCV, treatments with telaprevir/boceprevir (TVR/BOC)-based triple therapy are standard-of-care. However, more efficacious direct-acting antivirals (IFN-based new DAAs) are available and interferon-free (IFN-free) regimens are imminent (2015).

Methods

A mathematical model estimated quality-adjusted life years, cost and incremental cost-effectiveness ratios of (i) IFN-based new DAAs vs. TVR/BOC-based triple therapy; and (ii) IFN-based new DAAs initiation strategies, given that IFN-free regimens are imminent. The sustained virological response in F3–4/F0–2 was 71/89% with IFN-based new DAAs, 85/95% with IFN-free regimens, vs. 64/80% with TVR/BOC-based triple therapy. Serious adverse events leading to discontinuation were taken as: 0–0.6% with IFN-based new DAAs, 0% with IFN-free regimens, vs. 1–10% with TVR/BOC-based triple therapy. Costs were €60,000 for 12 weeks of IFN-based new DAAs and two times higher for IFN-free regimens.

Results

Treatment with IFN-based new DAAs when fibrosis stage ⩾F2 is cost-effective compared to TVR/BOC-based triple therapy (€37,900/QALY gained), but not at F0–1 (€103,500/QALY gained). Awaiting the IFN-free regimens is more effective, except in F4 patients, but not cost-effective compared to IFN-based new DAAs. If we decrease the cost of IFN-free regimens close to that of IFN-based new DAAs, then awaiting the IFN-free regimen becomes cost-effective.

Conclusions

Treatment with IFN-based new DAAs at stage ⩾F2 is both effective and cost-effective compared to TVR/BOC triple therapy. Awaiting IFN-free regimens and then treating regardless of fibrosis is more efficacious, except in F4 patients; however, the cost-effectiveness of this strategy is highly dependent on its cost.

Keywords: Boceprevir, Chronic hepatitis C, Cost-effectiveness analysis, Direct-acting antivirals, Genotype 1, Interferon-free regimens, Model-based analysis, Telaprevir, Treatment initiation

Source

Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 HCV in interferon ineligible/intolerant individuals

Hepatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

Viral Hepatitis

Liesl M. Hagan^1,*, Mark S. Sulkowski² and Raymond F. Schinazi¹

DOI: 10.1002/hep.27151

Copyright © 2014 American Association for the Study of Liver Diseases

Keywords: Olysio; Sovaldi; direct-acting antiviral agent; interferon-free

Abstract

Background: Treatment guidance for chronic hepatitis C (CHC) released by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) offer two options for interferon-ineligible/intolerant individuals with genotype 1 infection: sofosbuvir/ribavirin (SOF/RBV) for 24 weeks, or sofosbuvir/simeprevir (SOF/SMV) for 12 weeks. A 24-week course of SOF/RBV costs approximately US$169,000, with sustained virologic response (SVR) rates ranging from 52-84%; 12 weeks of SOF/SMV costs approximately $150,000, with SVR between 89% and 100%. Because SOF/SMV is currently used off-label, debate exists among physicians and payers about whether it should be prescribed and covered. This paper presents a cost-effectiveness analysis of these two treatment regimens accounting for costs of drugs, treatment-related medical care, re-treatment for individuals who do not achieve SVR, and natural history of continued HCV infection after failed re-treatment. The model uses a lifetime horizon and a societal perspective. Results: In the base case scenario, SOF/SMV dominated SOF/RBV in a modeled 50-year-old cohort of treatment-naïve and treatment-experienced subjects, excluding those who failed prior therapy with telaprevir or boceprevir. SOF/SMV yielded lower costs and more quality-adjusted life years (QALYs) for the average subject compared to SOF/RBV ($165,336 and 14.69 QALYs vs. $243,586 and 14.45 QALYs, respectively). In base case cost-analysis, the SOF/SMV treatment strategy saved $91,590 per SVR compared to SOF/RBV. Under all one-way sensitivity scenarios, SOF/SMV remained dominant and resulted in cost savings. Conclusions: These results suggest that a 12-week course of SOF/SMV is a more cost-effective treatment for genotype 1 CHC than 24 weeks of SOF/RBV among interferon-ineligible/intolerant individuals, supporting the AASLD/IDSA guidance and offering implications for both clinical and regulatory decision-making as well as pharmaceutical pricing. (Hepatology 2014;)

Source

Should we await IFN-free regimens to treat HCV genotype 1 treatment-naive patients? A cost-effectiveness analysis (ANRS 12188)

Journal of Hepatology

Article in Press

Sylvie Deuffic-Burban, Michaël Schwarzinger, Dorothée Obach, Vincent Mallet, Stanislas Pol, Georges-Philippe Pageaux, Valérie Canva, Pierre Deltenre, Françoise Roudot-Thoraval, Dominique Larrey, Daniel Dhumeaux, Philippe Mathurin, Yazdan Yazdanpanah

Received 22 August 2013; received in revised form 4 February 2014; accepted 6 March 2014. published online 18 March 2014.
Accepted Manuscript
Abstract
Background & Aims

In treatment-naive patients mono-infected with genotype 1 chronic HCV, treatments with telaprevir/boceprevir (TVR/BOC)-based triple therapy are standard-of-care. However, more efficacious direct-acting antivirals (IFN-based new DAAs) are available and interferon-free (IFN-free) regimens are imminent (2015).

Methods

A mathematical model estimated quality-adjusted life years, cost and incremental cost-effectiveness ratios of (i) IFN-based new DAAs vs. TVR/BOC-based triple therapy; and (ii) IFN-based new DAAs initiation strategies, given that IFN-free regimens are imminent. The sustained virological response in F3-4/F0-2 was 71/89% with IFN-based new DAAs, 85/95% with IFN-free regimens, vs. 64/80% with TVR/BOC-based triple therapy. Serious adverse events leading to discontinuation were taken as: 0-0.6% with IFN-based new DAAs, 0% with IFN-free regimens, vs. 1-10% with TVR/BOC-based triple therapy. Costs were €60,000 for 12 weeks of IFN-based new DAAs and two times higher for IFN-free regimens.

Results

Treatment with IFN-based new DAAs when fibrosis stage greater than or equal to F2 is cost-effective compared to TVR/BOC-based triple therapy (€37,900/QALY gained), but not at F0-1 (€103,500/QALY gained). Awaiting the IFN-free regimens is more effective, except in F4 patients, but not cost-effective compared to IFN-based new DAAs. If we decrease the cost of IFN-free regimens close to that of IFN-based new DAAs, then awaiting the IFN-free regimen becomes cost-effective.

Conclusions

Treatment with IFN-based new DAAs at stage greater than or equal to F2 is both effective and cost-effective compared to TVR/BOC triple therapy. Awaiting IFN-free regimens and then treating regardless of fibrosis is more efficacious, except in F4 patients; however, the cost-effectiveness of this strategy is highly dependent on its cost.

Abbreviations: G1, genotype 1, HCV, hepatitis C virus, TVR, telaprevir, BOC, boceprevir, DAA, direct-acting antiviral, IFN, interferon, QALYs, quality-adjusted life years, ICER, incremental cost-effectiveness ratio, GDP, gross domestic product, IL28B, interleukin-28B, DRG, diagnosis-related group, SVR, sustained virological response

Keywords: Boceprevir, Chronic hepatitis C, Cost-effectiveness analysis, Direct-acting antivirals, Genotype 1, Interferon-free regimens, Model-based analysis, Telaprevir, Treatment initiation

No full text is available. To read the body of this article, please view the PDF online.

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Impact of interferon free regimens on clinical and cost outcomes for chronic hepatitis C genotype 1 patients

J Hepatol. 2014 Mar;60(3):530-7. doi: 10.1016/j.jhep.2013.11.009. Epub 2013 Nov 19.

Younossi ZM¹, Singer ME², Mir HM³, Henry L⁴, Hunt S⁴.

Abstract

BACKGROUND & AIMS: Hepatitis C (HCV) is a common cause of chronic liver disease worldwide. Current standard treatment for genotype-1 patients uses a triple combination of pegylated-interferon alpha (IFN), ribavirin (RBV) and a direct-acting antiviral agent (DAA) with 75-80% sustained virologic response (SVR) rates. The aim is to determine cost-effectiveness of staging-guided vs. treat all HCV genotype-1 patients with interferon-based vs. interferon-free regimens.

METHODS: A decision analytic Markov model simulating patients until death compared four strategies for treating HCV genotype-1: Triple therapy (IFN, RBV, DAA) with staging-guidance or treat all, and oral IFN-free regimen with staging-guidance or treat all. Strategies with staging initiated treatment at fibrosis stages F2-F4, with staging repeated every 5years until age 70. The reference case was a treatment-naïve 50-year-old. Analysis was repeated for 50% increase in cost of oral therapy. Effectiveness was measured in quality-adjusted life years (QALYs).

RESULTS: Treatment of all patients with oral IFN-free regimen was the most cost-effective strategy, with an ICER of $15,709/QALY at baseline cost of oral therapy. The ICER remained below $50,000/QALY in sensitivity analyses for baseline and +50% cost of oral therapy scenarios. The treat all strategy was also the most effective strategy; associated with the lowest risk of developing advanced liver disease.

CONCLUSIONS: Treating all HCV patients with oral IFN-free regimen reduced the number of patients developing advanced liver disease and increased life expectancy. Additionally, IFN-free regimen without staging may be the most cost-effective approach for treating HCV genotype-1 patients. The efficacy and safety of these regimens must be confirmed using randomized clinical trials.

Copyright © 2013 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

KEYWORDS: BOC, CHC, CMS, Centers for Medicare and Medicaid Services, Cost-effectiveness analysis, DAA, F0, F1, F2 or F4, GT, HCV, HIV, ICER, IFN, IFN, BV, DAA, Interferon-free oral treatment, Markov model, NADAC, National Average Drug Acquisition Cost, QALYs, RBV, SVR, TVR, Triple therapy, WAC, boceprevir, chronic hepatitis C, direct, acting antiviral agent, genotype, hepatitis C, immunodeficiency virus, incremental cost, effectiveness analysis, mild fibrosis, moderate or advanced fibrosis, pegylated, interferon alpha, quality, adjusted life years (a standard metric that incorporates both length and quality of life), ribavirin, sustained virologic response, telaprevir, wholesale acquisition cost

PMID: 24269472 [PubMed - in process]

Source

Impact of interferon free regimens on clinical and cost outcomes for chronic hepatitis C genotype 1 patients

Journal of Hepatology
Volume 60, Issue 3 , Pages 530-537, March 2014

Zobair M. Younossi, Mendel E. Singer, Heshaam M. Mir, Linda Henry, Sharon Hunt

Received 12 August 2013; received in revised form 21 October 2013; accepted 7 November 2013. published online 20 November 2013.

See Focus, pages 471–472

Abstract

Background & Aims
Hepatitis C (HCV) is a common cause of chronic liver disease worldwide. Current standard treatment for genotype-1 patients uses a triple combination of pegylated-interferon alpha (IFN), ribavirin (RBV) and a direct-acting antiviral agent (DAA) with 75–80% sustained virologic response (SVR) rates. The aim is to determine cost-effectiveness of staging-guided vs. treat all HCV genotype-1 patients with interferon-based vs. interferon-free regimens.

Methods
A decision analytic Markov model simulating patients until death compared four strategies for treating HCV genotype-1: Triple therapy (IFN, RBV, DAA) with staging-guidance or treat all, and oral IFN-free regimen with staging-guidance or treat all. Strategies with staging initiated treatment at fibrosis stages F2-F4, with staging repeated every 5years until age 70. The reference case was a treatment-naïve 50-year-old. Analysis was repeated for 50% increase in cost of oral therapy. Effectiveness was measured in quality-adjusted life years (QALYs).

Results
Treatment of all patients with oral IFN-free regimen was the most cost-effective strategy, with an ICER of $15,709/QALY at baseline cost of oral therapy. The ICER remained below $50,000/QALY in sensitivity analyses for baseline and +50% cost of oral therapy scenarios. The treat all strategy was also the most effective strategy; associated with the lowest risk of developing advanced liver disease.

Conclusions
Treating all HCV patients with oral IFN-free regimen reduced the number of patients developing advanced liver disease and increased life expectancy. Additionally, IFN-free regimen without staging may be the most cost-effective approach for treating HCV genotype-1 patients. The efficacy and safety of these regimens must be confirmed using randomized clinical trials.

Abbreviations: HCV, hepatitis C, IFN, pegylated, interferon alpha, RBV, ribavirin, DAA, direct, acting antiviral agent, SVR, sustained virologic response, IFN, BV, DAA, Triple therapy, ICER, incremental cost, effectiveness analysis, QALYs, quality, adjusted life years (a standard metric that incorporates both length and quality of life), CHC, chronic hepatitis C, HIV, immunodeficiency virus, TVR, telaprevir, BOC, boceprevir, GT, genotype, F2 or F4, moderate or advanced fibrosis, F0, F1, mild fibrosis, WAC, wholesale acquisition cost, NADAC, National Average Drug Acquisition Cost, CMS, Centers for Medicare and Medicaid Services

Keywords: Interferon-free oral treatment, Cost-effectiveness analysis, Markov model, HCV, DAA

Source

Achieving SVR reduces hep C treatment costs

Provided by Clinical Advisor

Jennifer Southall
February 17, 2014

Achieving SVR reduces hep C treatment costs

Patients with hepatitis C virus genotype-1 infection who had no detectable levels of the virus on blood tests, also known as sustained virological response, experienced a 13-fold reduction in treatment costs vs. those who did not achieve a response five years after treatment, according to researchers.

“We have shown important cost reductions arising from sustained virological response [SVR], which previous studies have either assumed or only observed on small numbers of patients,” William L. Irving, of the University of Nottingham in the United Kingdom and colleagues reported in the Journal of Viral Hepatitis.

For the study, researchers assessed health resource usage and costs associated with treatment outcomes in193 patients who received at least two months of treatment with pegylated interferon and ribavirin therapy for HCV genotype-1 infection.

Unit costs were derived from the National Health Service Payment by Results database and the British National Formulary. Average follow-up was 3.5 years for those who achieved SVR and 4.9 years for non-SVR patients.

There were no patients with SVR that experienced progression of liver disease state. Conversely, 7.4% of patients without SVR progressed from chronic hepatitis to cirrhosis, and 4.9% progressed from cirrhosis to decompensated liver disease.

During the five-year post-treatment observation period, researchers observed a 13-fold increase in costs among patients that failed to achieve SVR. This increased to 56-fold among those who were retreated.

“Achievement of a [SVR] has significant effects on health service usage and costs,” the researchers concluded. “This work provides real-life data for future cost-effectiveness analyses related to the treatment of chronic HCV infection.”

References

1. Backx M. J Viral Hepat. 2014; 21, 208–215.

Source

Cost-effectiveness of Sofosbuvir-based triple therapy for untreated patients with genotype 1 chronic hepatitis C

Hepatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

Viral Hepatitis

Salvatore Petta¹, Giuseppe Cabibbo¹,  Marco Enea², Fabio Salvatore Macaluso¹,  Antonella Plaia², Raffaele Bruno³, Antonio Gasbarrini⁴, Antonio Craxì¹, Calogero Cammà¹, on behalf of the WEF study group

DOI: 10.1002/hep.27010

Copyright © 2014 American Association for the Study of Liver Diseases

Publication History
Accepted manuscript online: 13 JAN 2014 01:48PM EST
Manuscript Accepted: 4 DEC 2013
Manuscript Revised: 19 NOV 2013
Manuscript Received: 9 AUG 2013

Abstract

Background and aims: We assess the cost-effectiveness of sofosbuvir (SOF)-based triple therapy(TT) compared with boceprevir(BOC)- and telaprevir(TVR)-based TT in untreated G1CHC patients discriminated according to IL28B genotype, severity of liver fibrosis and genotype1(G1) subtype.

Methods: The available published literature provided the data source. The target population was made up of untreated Caucasian patients, aged 50 years, with G1CHC and these were evaluated over a lifetime horizon by Markov model. The study was carried out from the perspective of the Italian National Health Service. Outcomes included discounted costs(in euro at 2013 value), life-years gained(LYG), quality adjusted life year(QALY), and incremental cost-effectiveness ratio(ICER). Cost of SOF was assumed to be € 3,500 for week, i.e. the price generating a willingness-to-pay threshold of €25,000 per LYG compared with TVR in the entire population of untreated G1 patients. The robustness of the results was evaluated by one-way deterministic and multivariable probabilistic sensitivity analyses.

Results: SOF was cost-effective compared with BOC in all strategies with the exception of cirrhotic and IL28B CC patients. In comparison with TVR-based strategies, SOF was cost-effective in IL28B CT/TT(ICER per LYG €22,229) and G1a(€19,359) patients, not cost-effective in IL28B CC(€45,330), fibrosis F0-F3(€26,444) and in cirrhotic(€34,906) patients, and dominated in G1b patients. The models were sensitive to SOF prices and to likelihood of sustained virological response.

Conclusions: In untreated G1 CHC patients, SOF-based TT may be a cost-effective alternative to first-generation Protease Inhibitors depending on pricing. The cost-effectiveness of SOF improved in IL28B CT/TT and G1a patients. SOF was dominated by TVR in G1b patients even if, in clinical practice, this issue could be counterbalanced by the good tolerability profile of SOF and by the shorter treatment duration. (Hepatology 2014;)

Source

All-oral, interferon-free treatment for chronic hepatitis C: cost-effectiveness analyses

Journal of Viral Hepatitis

Volume 20, Issue 12, pages 847–857, December 2013

Original Article

L. M. Hagan^1,2,3,*,Z. Yang²,M. Ehteshami^1,3,R. F. Schinazi^1,3

Article first published online: 10 JUN 2013

DOI: 10.1111/jvh.12111

Published 2013. This article is a U.S. Government work and is in the public domain in the USA

Keywords: antiviral agents; combination therapy; HCV ; ribavirin; sustained virologic response; triple therapy

Summary

Interferon-based standard of care treatments (SOC) for chronic hepatitis C are unable to provide high cure rates in certain subgroups of the infected population and can cause debilitating side effects. Clinical trials evaluating all-oral, interferon-free treatments have demonstrated high rates of sustained virologic response with no resistance or major adverse events in most populations. As these drug regimens move towards FDA approval, it will be important to assess their cost-effectiveness in addition to their clinical efficacy. A decision-analytic Markov model with a lifetime, societal perspective was used to evaluate the cost-effectiveness of a generalized all-oral drug regimen compared to SOC by modelling the progression of a 50-year-old, HCV-positive cohort through disease natural history and treatment. In base case analysis, all-oral treatment dominated SOC across a range of willingness-to-pay (WTP) thresholds with an incremental cost-effectiveness ratio (ICER) of US$44 514/quality-adjusted life year (QALY). In sensitivity analyses, the model was sensitive to all-oral drug costs as well as rates of SVR and treatment uptake among noncirrhotic subjects, but robust to variations in all other parameters. All-oral treatment was most cost-effective among genotype 1 subjects but remained cost-effective for genotypes 2 and 3 at WTP thresholds ≥$80 000/QALY. Quality-adjusted life years gained per dollar spent were maximized in younger treatment cohorts. Using this model, the degree of cost-effectiveness depended on the WTP threshold and the final cost set for approved drug combinations.

Source