Treating patients with hepatitis C virus (HCV) infection using recently approved direct-acting agents can be cost effective, but will also have substantial effects on healthcare costs, researchers show.
Recently approved drugs cure more than 90% of patients with hepatitis C and could make the liver disease rare in the United States.
However, MedPage Today wrote that the cost of the new agents has been an issue since Gilead Sciences, the maker of sofosbuvir (Sovaldi), priced the drug at $1000 a pill, or $84,000 for a 12-week course of treatment.
Sofosbuvir was the first of the direct-acting agents indicated for use in some patients without interferon, which unpleasant and dangerous side effects.
Other agents have since been approved, including simeprevir (Olysio), which was priced at $66,360 for 12 weeks of therapy, and the single-pill combination of sofosbuvir and ledipasvir (Harvoni), priced at $94,500 for 12 weeks.
Two articles published this week in the Annals of Internal Medicine analyzed the cost effectiveness of these drugs and modeled the potential effects on healthcare spending in the US.
Mehdi Najafzadeh et al. evaluated the cost effectiveness of the common treatments (boceprevir, ribavirin, and interferon) with that of interferon-containing and interferon-free regimens, using different assumptions about their price and efficacy. They used discrete-event simulation to analyze data from publications.
They found that the combination of sofosbuvir and ledipasvir was the optimal strategy for patients with HCV genotype 1 infection, and was cost saving when sofosbuvir cost less than $5500/week. For patients with HCV genotype 2 infections, the combination of sofosbuvir, ribavirin, and interferon was cost saving when sofosbuvir cost less than $2250/week. For patients with HCV genotype 3 infections, the combination of sofosbuvir, ledipasvir, and ribavirin was cost saving when sofosbuvir cost less than $1500/week.
The authors conclude that the demand for the agents is likely to be high and that, combined with their “very high prices, could substantially increase short-term overall drug spending for many public and private payers.” The study was funded by CVS Health.
Senior author Niteesh Choudhry explained to Reuters that the analysis considered benefits over the course of a person’s life, after the cost of treatment was paid up front.
Reuters wrote that the study showed that the drugs cost $12,825 for every healthy year of life patients gained over older treatments—this is below the usual cutoff of $50,000 per healthy year of life gained for cost effectiveness.
In a second article, Jagpreet Chhatwal et al. evaluated the cost effectiveness of sofosbuvir and ledipasvir using a simulation model to estimate the costs of giving the drugs to all eligible Americans, compared to interferon-based regimens.
They found that the new drugs, at 2014 prices, would cost an extra $65 billion in the next 5 years. However, Reuters wrote that based on reduced 2015 prices, the costs would total an additional $20 billion over the next 5 years.
Treating the patients with the new drugs would also prevent about $16 billion in healthcare spending on treatment of cirrhosis, liver transplantation, and patient death. The study was funded by the National Institutes of Health.
Chhatwal et al. concluded that treatment of HCV infection is cost effective for most patients, but additional resources and value-based patient prioritization are needed.
“One of the arguments has been that these expensive drugs will ultimately save us money,” Chhatwal told HealthDay. “But our data show that’s clearly not the case.”
He stressed, however, that none of this means that patients should not be getting the new drugs. “We know these drugs are good, and patients need treatment,” Chhatwal told HealthDay. “High costs shouldn’t be an obstacle.”
Eugene Schiff (University of Miami Miller School of Medicine) told HealthDay that it is important to consider the effects of the drugs for patients. “Even in relatively milder cases, people have fatigue…you get rid of the virus, and they feel better, they function better, their quality of life improves.”
Schiff said that new hepatitis C drugs from other companies are in the pipeline, and competition should help drive down prices.
For example, the combination of ombitasvir, paritaprevir, ritonavir, dasabuvir, and ribavirin, which was not included in the Annals of Internal Medicine studies, was approved for treatment of genotype 1 HCV infection by the US Food and Drug Administration in December 2014. Its approval has already led to significant reductions in prices for some select groups, including the Veterans Administration Health Systems.
Schiff added that some insurance companies and state Medicaid programs have been striking exclusivity deals with drug makers in exchange for reduced prices.