March 20, 2015

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.

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