Q&A: DAA restrictions impact patient care

In a recent article, Alexander Breskin, PhD, a postdoctoral fellow in the department of epidemiology at the University of North Carolina, and colleagues noted that direct-acting antiviral treatment has “dramatically changed the outlook” for patients with HIV and hepatitis C virus coinfection, among whom liver-related complications are a major cause of death.

According to Breskin and colleagues, DAAs have been recommended for nearly all patients with HCV, but treatment denials remain common as payers continue to restrict therapy to those who meet specific “non-evidence-based criteria.”

Writing in Clinical Infectious Diseases, Breskin and colleagues said understanding what effect these policies have on mortality may help policymakers when deciding future criteria for HCV treatment in patients with HIV.

Infectious Disease News spoke with Breskin about why DAAs restrictions were enacted, the current state of treatment denials and how DAA policies should be changed. – by Marley Ghizzone

Why and how was treatment with DAAs restricted?

When DAAs were first introduced to the market, they came at an exceptionally high price. Sovaldi (sofosbuvir, Gilead Sciences), the first drug in this class that was demonstrated to be effective in interferon-free regimens, carries a list price of $84,000 for a course of treatment, with other drugs that were introduced later following suit. Even with negotiated discounts for payers, the high prevalence of HCV infection (the CDC estimates that 2.4 million people have HCV in the United States) and the high cost of the treatments put a substantial strain on the health care system. Many payers simply did not have the resources to treat all individuals who needed treatment.

To reduce costs, payers restricted, and continue to restrict, reimbursement for treatment to those who meet certain clinical criteria. These include having severe liver fibrosis or cirrhosis, being under the care of a specialist, abstaining from alcohol or illicit substances and, for those with HIV, achieving benchmarks such as having an undetectable HIV viral load or a sufficiently high CD4 cell count.

It is important to note that these restrictions run counter to guidelines from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, which recommend DAA treatment for all chronically infected patients. Universal treatment access will not only benefit the greatest number of patients who have HCV infection, but it may also reduce the number of new infections, a concept known as “treatment as prevention.”

CMS has issued a statement that Medicaid restriction of access to DAAs based on cost containment violates federal law. This statement led to several lawsuits that prompted many Medicaid programs to drop their restrictions. Unfortunately, the restrictions remain in effect in many states across the U.S.

Are treatment denials still common?

Many state Medicaid programs are loosening their restrictions on DAA access. Between October 2017 and October 2018, 21 states reduced their fibrosis restrictions, eight reduced their sobriety restrictions, and four reduced their prescriber prescriptions. Unfortunately, even as costs have come down substantially and restrictions have been dropped, treatment denials remain common. A recent study by Gowda and colleagues found that, between January 2016 and April 2017, 36% of patients prescribed DAAs included in their study were denied treatment, with the percentage of denials increasing over time.

Treating all patients co-infected with HCV and HIV with DAAs increases survivability by fourfold. Why is access to HCV medication still an issue?

Although treatment access restrictions are rapidly being dropped, they continue to be used for cost containment by Medicaid programs. The National Viral Hepatitis Roundtable and the Center for Health Law and Policy Innovation at Harvard Law School have put together a fantastic resource that complies with and displays the current treatment policies used by Medicaid in each state. The map looks much better than it did even 1 year ago, but there is still substantial room for improvement.

Additionally, policies used by private payers are less well-documented. In the study by Gowda and colleagues, absolute denial of treatment was most common among patients with commercial insurance. Easing treatment restrictions among private payers may thus be a next step in broadening treatment access in the U.S.

How should DAA policies be changed to improve patient outcomes?

Ideally, treatment should be provided to all patients for whom it is indicated. According to current guidelines, this means that essentially all chronically infected patients would be treated with DAAs. As our study demonstrated, however, modifications to existing policies can be made that will improve outcomes without increasing the number of treatments provided. Our results showed that by simply treating the same proportion of people as treated under the restricted policies at baseline, with treatment assigned at random, we would expect a decrease in mortality over 10 years. Policies can almost certainly be developed that improve upon our random treatments.

What should future studies explore?

Given the fact that all individuals with HCV should receive treatment, future studies should focus on developing funding and delivery models to achieve universal treatment access. If universal access is not possible, studies should focus on identifying patients most likely to benefit from treatment and ways to educate patients, clinicians and payers in ways to improve the chances that treatment will be approved.

References:

Breskin A, et al. Clin Infect Dis. 2019;doi:10.1093/cid/ciz008.

Gowda C, et al. Open Forum Infect Dis. 2018;doi:10.1093/ofid/ofy076.

National Viral Hepatitis Roundtable and Center for Health Law and Policy Innovation. Hepatitis C: State of Medicaid Access. https://stateofhepc.org/.

Disclosures: Breskin reports no relevant financial disclosures. Please see the article for all other authors’ relevant financial disclosures.

In a recent article, Alexander Breskin, PhD, a postdoctoral fellow in the department of epidemiology at the University of North Carolina, and colleagues noted that direct-acting antiviral treatment has “dramatically changed the outlook” for patients with HIV and hepatitis C virus coinfection, among whom liver-related complications are a major cause of death.

According to Breskin and colleagues, DAAs have been recommended for nearly all patients with HCV, but treatment denials remain common as payers continue to restrict therapy to those who meet specific “non-evidence-based criteria.”

Writing in Clinical Infectious Diseases, Breskin and colleagues said understanding what effect these policies have on mortality may help policymakers when deciding future criteria for HCV treatment in patients with HIV.

Infectious Disease News spoke with Breskin about why DAAs restrictions were enacted, the current state of treatment denials and how DAA policies should be changed. – by Marley Ghizzone

Why and how was treatment with DAAs restricted?

When DAAs were first introduced to the market, they came at an exceptionally high price. Sovaldi (sofosbuvir, Gilead Sciences), the first drug in this class that was demonstrated to be effective in interferon-free regimens, carries a list price of $84,000 for a course of treatment, with other drugs that were introduced later following suit. Even with negotiated discounts for payers, the high prevalence of HCV infection (the CDC estimates that 2.4 million people have HCV in the United States) and the high cost of the treatments put a substantial strain on the health care system. Many payers simply did not have the resources to treat all individuals who needed treatment.

To reduce costs, payers restricted, and continue to restrict, reimbursement for treatment to those who meet certain clinical criteria. These include having severe liver fibrosis or cirrhosis, being under the care of a specialist, abstaining from alcohol or illicit substances and, for those with HIV, achieving benchmarks such as having an undetectable HIV viral load or a sufficiently high CD4 cell count.

It is important to note that these restrictions run counter to guidelines from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, which recommend DAA treatment for all chronically infected patients. Universal treatment access will not only benefit the greatest number of patients who have HCV infection, but it may also reduce the number of new infections, a concept known as “treatment as prevention.”

CMS has issued a statement that Medicaid restriction of access to DAAs based on cost containment violates federal law. This statement led to several lawsuits that prompted many Medicaid programs to drop their restrictions. Unfortunately, the restrictions remain in effect in many states across the U.S.

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Are treatment denials still common?

Many state Medicaid programs are loosening their restrictions on DAA access. Between October 2017 and October 2018, 21 states reduced their fibrosis restrictions, eight reduced their sobriety restrictions, and four reduced their prescriber prescriptions. Unfortunately, even as costs have come down substantially and restrictions have been dropped, treatment denials remain common. A recent study by Gowda and colleagues found that, between January 2016 and April 2017, 36% of patients prescribed DAAs included in their study were denied treatment, with the percentage of denials increasing over time.

Treating all patients co-infected with HCV and HIV with DAAs increases survivability by fourfold. Why is access to HCV medication still an issue?

Although treatment access restrictions are rapidly being dropped, they continue to be used for cost containment by Medicaid programs. The National Viral Hepatitis Roundtable and the Center for Health Law and Policy Innovation at Harvard Law School have put together a fantastic resource that complies with and displays the current treatment policies used by Medicaid in each state. The map looks much better than it did even 1 year ago, but there is still substantial room for improvement.

Additionally, policies used by private payers are less well-documented. In the study by Gowda and colleagues, absolute denial of treatment was most common among patients with commercial insurance. Easing treatment restrictions among private payers may thus be a next step in broadening treatment access in the U.S.

How should DAA policies be changed to improve patient outcomes?

Ideally, treatment should be provided to all patients for whom it is indicated. According to current guidelines, this means that essentially all chronically infected patients would be treated with DAAs. As our study demonstrated, however, modifications to existing policies can be made that will improve outcomes without increasing the number of treatments provided. Our results showed that by simply treating the same proportion of people as treated under the restricted policies at baseline, with treatment assigned at random, we would expect a decrease in mortality over 10 years. Policies can almost certainly be developed that improve upon our random treatments.

What should future studies explore?

Given the fact that all individuals with HCV should receive treatment, future studies should focus on developing funding and delivery models to achieve universal treatment access. If universal access is not possible, studies should focus on identifying patients most likely to benefit from treatment and ways to educate patients, clinicians and payers in ways to improve the chances that treatment will be approved.

References:

Breskin A, et al. Clin Infect Dis. 2019;doi:10.1093/cid/ciz008.

Gowda C, et al. Open Forum Infect Dis. 2018;doi:10.1093/ofid/ofy076.

National Viral Hepatitis Roundtable and Center for Health Law and Policy Innovation. Hepatitis C: State of Medicaid Access. https://stateofhepc.org/.

Disclosures: Breskin reports no relevant financial disclosures. Please see the article for all other authors’ relevant financial disclosures.