Evolving hepatitis C pipeline offers hope to patients

Hepatitis C is a contagious liver infection that can range in severity from a mild illness lasting a few weeks to a serious, lifelong condition. According to the CDC, an estimated 2.7 to 3.9 million people in the United States have chronic hepatitis C.

In the U.S., baby boomers account for more than 75% of all patients with hepatitis C; however, today, most people become infected with hepatitis C virus (HCV) by sharing needles or other equipment to inject drugs.

Chronic hepatitis C can cause serious complications including cirrhosis, liver failure and liver cancer. Hepatitis C is the leading cause of liver transplantation and contributes to more than 10,000 deaths annually in the U.S. It also causes other extra-hepatic manifestations, such as neurologic, endocrine, and cardiovascular effects.

Pipeline treatments

There is no vaccine against hepatitis C. Fortunately, a host of relatively expensive specialty drugs have been introduced to the market recently that are touted to be curative, according to Nadina Rosier, Health and Group Benefits Practice, Pharmacy, at Willis Towers Watson.

“The average cost of the drugs is $80,000 per year, however, real-world data confirm that these drugs are curing the disease in greater than 95% of patients,” says Rosier. “Given the cost that can result from extra-hepatic manifestations, insurers are covering these more costly drugs in favor of warding off a lifetime of chronic conditions and/or transplant.”

Tharaldson

According to Aimee Tharaldson, PharmD, senior clinical consultant in the Emerging Therapeutics department at Express Scripts, the pipeline is focused on pan-genotypic regimens that are effective in more difficult-to-treat populations, including as salvage therapy in patient who have failed prior treatment with direct-acting antivirals.

Current treatments in the hepatitis C pipeline expected to be approved in the near future, include:

1.   Glecaprevir/pibrentasvir (AbbVie)

This pan-genotypic regimen is a combination of 300 mg of glecaprevir and 130 mg of pibrentasvir, which is administered once-daily in three oral tablets. This investigational drug is being evaluated as a potential eight-week cure for HCV patients. Expected approval is in August 2017.

2.   Voxilaprevir/velpatasvir/sofosbuvir (Gilead)

This is an investigational, once-daily single-tablet therapy expected to be used as a 12-week regimen in patients who failed previous direct-acting antiviral therapy with direct-acting antiviral agent regimens. Expected approval date is August 2017.

3.   uprifosbuvir/grazoprevir/rusavir (Merck)

This investigational triple combination, fixed-dose once-daily therapy is being studied with or without ribavirin. Expected approval date is 2020.

Additionally, Janssen is pursuing short-duration oral combination regimens with odalasvir and Janssen’s own simeprevir and AL-335. These combination therapies are expected in 2020.

Looking ahead

Rosier

“The future for members suffering from HCV is improving with the evolving drug pipeline; the direct acting antivirals represent a cure for a once incurable disease,” says Rosier. “As this disease becomes cured, payers should expect to see lower medical costs from improved clinical results.”

Even though breakthrough cures for hepatitis C deliver promises of a cure, previous price points made this unmanageable for payers, according to Tharaldson. She says payers should consider appropriate utilization methods for the therapy class moving forward. For example, Express Scripts has a Hepatitis Care Value program to help payers effectively manage this therapy class while enabling access to specialized care for patients. Additionally, increased competition in the market is expected to continue to decrease costs for this therapy class.

“The future for members suffering from HCV is improving with the evolving drug pipeline; the direct acting antivirals represent a cure for a once incurable disease,” says Rosier. “As this disease becomes cured, payers should expect to see lower medical costs from improved clinical results.”

Erin Bastick, PharmD, RPh, is a staff pharmacist at Southwest General Health Center, Middleburg Heights, Ohio.