Amid all the outcry over the high cost of new hepatitis C therapies, including congressional hearings, a simple fact has been overlooked: The VA expects to save money in the long run because of the drugs’ high cure rates.
By Annette M. Boyle
WASHINGTON — Despite congressional hearings held to decry the high costs of drugs that essentially cure hepatitis C, at the VA, those therapies are likely to translate into significant savings, both for immediate treatment costs and long-term care.
To start with, the cost of the latest treatments is not significantly higher than the previously recommended therapy. The VA generally enjoys a 24% discount off the standard price for HCV drugs. The new drugs have a steeper discount.
Even accounting for fluctuations in treatment costs between October 2014 and January 2015, “the cost of a 12-week Harvoni course is cost neutral compared to a 12-week course of the previous triple therapy Sofosbuvir-peginterferon-ribavirin based regimen,” said David Ross, MD, director of the VHA’s HIV/HCV and public health pathogens program.
“Using current VA costs, the cost of 12 weeks of Viekira Pak is 53% less than the cost of a 12-week course of the previous triple therapy Sofosbuvir-peginterferon-ribavirin based regimen,” he added, cautioning that not all veterans with HCV will qualify for the less-expensive treatment because of their stage of disease or interactions with other drugs they take.
Still, treating every eligible patient with HCV comes with a big price tag, especially since, as of 2014, only about 17% of current VA patients with the infection have ever received any kind of antiviral treatment. In some cases, administration of the toxic drugs was delayed in anticipation of availability of the new treatments with higher cure rates and lower side effects.
Now, with the new drugs, 50% of HCV-infected veterans are expected to be treated and cured by 2023, according to a budget developed by the Obama administration, although many at the VA have suggested that will occur more quickly.
The VA estimates that 233,000 veterans have HCV, with about 180,000 of them having received a diagnosis. As of June 2014, approximately 108,810 patients were treatment candidates, meaning they had been diagnosed, had their genotype of HCV determined and had not been cured.
“Because of the large number of veterans infected with HCV, the costs of treating this many veterans will be substantial, regardless of the regimen used,” Ross told U.S. Medicine.
For FY 2015, the VA has allocated $696 million for the purchase of HCV drugs, roughly 16% of a total outpatient pharmacy budget of $4.3 billion. As of Feb. 28, the VA had spent more than $300 million on HCV drugs this fiscal year, as much as it spent on HCV treatment for all of FY 2014, Ross said.
There’s little question all of the funds allocated will be used. As of the end of February, more than 14,000 patients had initiated treatment on one of the four new treatment regimens (Sovaldi, Sovaldi plus Olysio, Harvoni or Viekira) and 8,000 of them had received an interferon-free therapy. The VA is starting 733 new patients on HCV therapy each week.
Ross noted that “it is the policy of the U.S. Department of Veterans Affairs to offer anti-viral treatment for chronic hepatitis C virus infection based solely on clinical benefit, without consideration of cost. VA does not restrict anti-viral treatment based on stage of liver disease.”
Just more than half of the patients who initiated new drug regimes this year do not have advanced liver disease (ALD), defined as a Fibrosis-4 score greater than 3.5, but the VA is especially eager to treat the 27,000 treatment candidates who do.
“We are focusing on treating those patients as quickly as we can. Some of these patients have other medical conditions, particularly alcohol and substance use disorders, that may affect their ability to adhere to treatment — in these cases, we are working to address those treatment limiting conditions,” Ross said.
Prioritizing patients with advanced liver diseases has the potential to substantially and speedily reduce the VA’s long-term cost of care. Unlike other healthcare systems or insurance plans that may cover a patient’s treatment for a year or two, the VA serves many veterans for decades and bears the cost of the long-term sequelae of HCV infection.
Curing HCV reduces the risk of patients progressing from fibrosis to cirrhosis, decompensated liver disease or liver failure as well as the risk of developing hepatocellular carcinoma. For example, as many as 20% of patients with HCV infection will develop cirrhosis. At the VA, the number of veterans in VHA care with HCV and cirrhosis increased 138% from 2002 to 2013, rising from 12,404 to 29,578 veterans.
“The large numbers of veterans with cirrhosis combined with the increasingly important role HCV infection plays in causing cirrhosis among veterans highlights the importance of rapid expansion of HCV antiviral therapy in this population,” according to the State of Care for Veterans with Hepatitis C, 2014.
From 2002-2013, the number of veterans with HCV who had ever been diagnosed with hepatocellular cancer rose nine-fold, and the number ever diagnosed with decompensate liver disease more than doubled.
The VHA is studying the short- and long-term impact on overall health costs associated with veterans who do and do not have their hepatitis C infection cured. “Early results on the 14,206 veterans who received therapy beginning in FY 05 with at least five years of time after finishing treatment shows that those who experienced a cure for hepatitis C had lower VHA health care costs over the five-year period when compared to those veterans who were not cured. The cost savings per patient for five years is $27,000,” Ross noted.
Because the new drugs have not been available for five years, such an analysis is not yet available for them. But, with equivalent or lower costs and high cure rates, the economics look quite favorable for the new therapies.
In patients who do not have liver disease and who have never been treated before, the new interferon-free regimens are estimated to have cure rates of about 85%. These patients can begin treatment now but may want to wait.
“Although we feel reasonably confident that no new serious side effects will emerge from use of these new drugs, it is still possible that we could see some unanticipated rare but serious toxicities,” Ross cautioned. “This has certainly happened with HIV drugs. For this reason, it would be prudent not to rush treatment for patients who do not have advanced liver disease.”
Cirrhosis Risk Persists in Co-infected HIV/HCV Patients on Antiretrovirals
PHILADELPHIA – Even though antiretroviral therapy benefits patients co-infected with human immunodeficiency virus (HIV) and hepatitis C (HCV), the risk of serious liver disease persists, according to a VA study.
According to the report published earlier this year in Annals of Internal Medicine, earlier research has suggested that ART slows hepatitis C-associated liver fibrosis. The study, led by researchers from the Philadelphia VAMC and the University of Pennsylvania sought to determine whether rates of severe liver complications in patients co-infected with HIV and HCV receiving ART were similar to those with just hepatitis C.
To do so, they examined electronic medical record data of 4,280 VHA patients infected with both viruses who were receiving ART, and 6,079 HCV-only patients receiving care between 1997 and 2010.
Results indicate that the co-infected patients had an 80%t higher rate of decompensated cirrhosis than HCV-only patients. Even co-infected patients where ART had brought their HIV under control had a 60% higher rate of serious liver disease compared to those with hepatitis C alone.
“Our results suggest that serious consideration should be given to initiating hepatitis C treatment in patients co-infected with HIV and hepatitis C — particularly among those with advanced liver fibrosis or cirrhosis — in order to try to reduce the risk of serious, potentially life-threatening liver complications,” said the study’s lead author, Vincent Lo Re III, MD, MSCE. “By taking action sooner, we may be able to reduce the risk of advanced liver disease in co-infected patients.”
This study is the largest comparison to date of liver-related complications between antiretroviral-treated HIV/HCV co-infected patients and those with hepatitis C alone. The authors also report that rates of decompensation were higher for co-infected patients with advanced liver fibrosis, severe anemia, diabetes, and non-black race.
Researchers from VAMCs in West Haven, CT; Los Angeles, Atlanta, Houston; Pittsburgh, Washington, DC and New York also were involved in the study.
- Lo Re V 3rd, Kallan MJ, Tate JP, Localio AR, et al. Hepatic decompensation in antiretroviral-treated patients co-infected with HIV and hepatitis C virus compared with hepatitis C virus-monoinfected patients: a cohort study. Ann Intern Med. 2014 Mar 18;160(6):369-79. doi: 10.7326/M13-1829. PubMed PMID: 24723077; PubMed Central PMCID: PMC4254786.