Denied Treatment and Real-World Outcomes: Most-Read HCV Stories

Innovations have made life-threatening illnesses like hepatitis C curable, but new drugs that treat the virus come at a hefty price. In May, which happens to be Hepatitis Awareness Month, The American Journal of Managed Care (AJMC) published a special issue of peer-reviewed research covering issues of access and the cost of treatment among other topics.

Over the last year, AJMC has covered many aspects of the hepatitis C issue: access to treatment, the cost of drugs, exclusivity deals, and more. Here are the most-read articles from the last year.

10. VA Will Treat All Veterans for HCV Regardless of Disease Stage

Access to treatment has been a source of controversy as insurers try to hold down costs associated with the expensive hepatitis C drugs by limiting access to only the sickest of patients. However, additional funding from Congress enabled the Department of Veterans Affairs (VA) to expand access to all veterans with hepatitis C, which accounts for nearly 174,000 veterans in the system.

Throughout 2016, it was estimated that the VA would spend $1 billion on hepatitis C drugs.

9. What We're Reading: Tufts Health Plan Removes Hepatitis C Drug Restrictions

A month after the VA expanded access for all veterans, Tufts Health Plan, based in Massachusetts, announced that it would also pay for hepatitis C drugs regardless of the patient’s disease stage. Most other insurers in Massachusetts, with the exception of Blue Cross Blue Shield of Massachusetts, still required evidence of advanced liver disease before they would pay for the costly treatment.

8. Improving HCV Cure Rates in HIV-Coinfected Patients—A Real-World Perspective

As part of the special issue published in May 2016, researchers examined the real-world hepatitis C virus cure rates among patients who also had HIV and found that these cure rates were lower than what had been seen in clinical trials. The authors determined that future studies should evaluate predictors of attendance to follow-up visits and other factors that are associated with cure rates.

7. Sofosbuvir Initial Therapy Abandonment and Manufacturer Coupons in a Commercially Insured Population

When member cost of a 30-day supply of sofosbuvir reached more than $2500, initial therapy abandonment increased. However, manufacturer coupons could offset the amount members pay by 98%, reducing the average member cost on an initial 30-day supply claim from $1349 to just $28 on average. Overall, odds of abandonment was 1.9 times when member cost share was between $2500 and $5000 compared with a cost share of less than $50.

6. It’s Time to End Insurance Restrictions on Life-Saving Hepatitis C Treatments

In this commentary for the special issue, Ryan Clary, executive director of the National Viral Hepatitis Roundtable, outlines the problem with placing restrictions on life-saving treatments for hepatitis C. These restrictions put patients’ lives at risk, allow the disease to continue to spread, and drive up healthcare costs in the long term.

This situation has repercussions beyond just hepatitis C, according to Clary. How insurers and Medicaid programs handle the response of patients seeking quality hepatitis C treatments will serve as a template for how we respond to patients seeking cures for even more challenging diseases in the future.

5. Value of Expanding HCV Screening and Treatment Policies in the United States

Expanding screening policies for hepatitis C is valuable to society, but some of the value is lost as a result of the restrictions on treatments. According to researchers, increasing screening for the hepatitis C virus needs to be paired with expanded access to treatments for the virus at earlier stages of the disease in order to produce a considerable value to society.

“Our findings suggest that expansions in screening coupled with treatment of all infected patients could break even within 8 years and accrue an additional $823.53 billion in discounted net social benefits over a 20-year horizon,” the authors wrote.

4. Real-World Outcomes of Ledipasvir/Sofosbuvir in Treatment-Naïve Patients With Hepatitis C

Studies of hepatitis C virus treatments in the real-world compared with clinical trials have found a reduced effectiveness. In this study, researchers found that similar sustained virologic rates can be achieved for the all-oral, peginterferon-free and ribavirin-free regimen of ledipasvir/sofosbuvir. In addition, the real-world cost for each cure was not associated with excess treatment costs.

3. Accessing the Cure: Helping Patients With Hepatitis C Overcome Barriers to Care

This AJMC supplement presented a case study from the National Viral Hepatitis Roundtable and Project Inform. Cost-sharing mechanisms have popped up in response to the high prices of new hepatitis C treatments, but these mechanisms have produced a pool of patients who are willing but unable to access a cure.

The 2 organizations are pursuing strategies at the individual, state policy, and federal policy levels in response to cost sharing as outlined in this paper.

2. Comparing 3 Direct-Acting Antiviral Agents for HCV: A Review of the Evidence

At the beginning of 2016, a third competitor entered the hepatitis C treatment market: Zepatier. The regimen competed with Sovaldi and Harvoni, and a report from Advera Health Analytics determined that Zepatier has a less risky safety profile than Sovaldi and a similar safety profile as Harvoni. In addition, Zepatier is less expensive while being as effective in treatment-experienced patients. While a 12-week regimen of Harvoni is estimated to cost $95,000, Zepatier is priced at $54,600 for a 12-week course.

1. Blue Cross Sued Over Denying Patients Hepatitis C Treatment

Thousands of beneficiaries of Blue Cross in California living with hepatitis C were part of a class action lawsuit for being denied treatment. A study from Yale University found that one-fourth of patients are initially denied life-saving hepatitis C drugs, and being denied again after appeal means all that is left for them is to get sicker until the insurer is willing to pay for the treatment. The lawsuit alleged that Blue Cross was limiting authorization to only its sickest patients. This is by no means the first lawsuit of its kind: in Florida a lawsuit was filed against Blue Cross and Blue Shield of Florida alleging that beneficiaries were being wrongly denied treatment.