A state board on Tuesday approved a committee's recommendations for covering two new hepatitis-C drugs for teachers and state employees while continuing to restrict such coverage to patients with a certain severity of liver disease who meet other criteria.
The State and Public School Life and Health Insurance Board also asked that officials with the Department of Health and University of Arkansas for Medical Sciences' Viral Hepatitis Clinic review the coverage policy and give their opinion of it at the board's meeting next month.
Jill Johnson, an associate pharmacy professor at UAMS, has said the restrictions are necessary because of the drugs' high cost -- more than $86,000 for a 12-week course of treatment.
Johnson advises the board as part of the UAMS College of Pharmacy's Evidence-Based Prescription Drug Program.
Board member Joe Thompson, director of the Arkansas Center for Health Improvement and the state's former surgeon general, said the policy was the first time the board had restricted coverage to "evidence-based, proven, curative care for individuals based on their severity of disease."
Other insurers are making similar decisions, he added.
"I think what's transpiring is the cost of this drug is the single reason people are restricting access," Thompson said. "It's not a clinical decision, necessarily. It's a cost-based decision."
The plans cover about 45,000 school employees and 28,000 state employees, as well as retirees and family members of employees and retirees.
While some other drugs also command high prices, the cost of hepatitis-C drugs concerns insurers because more than 3 million people nationwide, including about 38,000 in Arkansas, are estimated to be infected with the disease.
In August, the board approved coverage of Sovaldi, manufactured by Gilead Sciences of Foster City, Calif. At the same time, the board restricted access to any treatment to eradicate hepatitis-C to only patients with liver scarring, known as fibrosis, significant enough to be rated at least an F3 under a scoring system that rates scarring on a scale of F0 to F4.
A score of F4 means the patient has cirrhosis, the most severe level of scarring.
On Tuesday, the board approved recommendations from its drug utilization and evaluation committee to add coverage of Harvoni, also manufactured by Gilead, and Viekira Pak, a two-pill combination manufactured by North Chicago, Ill.-based AbbVie Inc.
The U.S. Food and Drug Administration approved Sovaldi in December 2013. Harvoni was approved in October, and Viekira Pak was approved in December.
The board also approved broadening the criteria for coverage of Sovaldi. Currently, patients with the most common type of hepatitis-C, known as genotype 1, are eligible only if they have cirrhosis and are on a waiting list for a liver transplant.
To qualify for coverage of any of the drugs, patients must sign a statement indicating that they have not abused drugs or alcohol within the past six months.
Any treatment will continue to be restricted to patients with a fibrosis score of F3 or higher. The drug evaluation and utilization committee had recommended that patients be required to have a liver biopsy to determine the score, but the criteria approved Tuesday allow the score to be determined using noninvasive blood tests.
Patients also would be required to enroll in a case management program administered by New Albany, Ohio-based American Health Holding Inc.
Bob Alexander, director of the state Department of Finance and Administration's Employee Benefits Division, said the criteria approved by the board are "identical" to those used by the state Medicaid program and similar to other insurers' policies, except for the case management requirement.
Recommendations issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America call for the highest priority for treatment to be given to patients who have a fibrosis score of at least F3 as well as those with severe medical conditions, such as kidney disease, caused by hepatitis.
Other categories of patients, such as those with a fibrosis score of F2 and those infected with HIV, should also be given priority, according to the recommendations.
According to the Centers for Disease Control and Prevention, 5 percent to 20 percent of people infected with hepatitis-C will develop cirrhosis after 20 to 30 years, and 1 percent to 5 percent will die of cirrhosis or liver cancer.
The disease is most commonly spread through sharing contaminated needles. Many people also were infected through blood transfusions before widespread screening of the blood supply began in 1992.
Mike Galbraith, a history teacher and volleyball coach at Rogers High School, said in a phone interview Tuesday that the board's coverage policy should be flexible.
Galbraith, 61, said he was diagnosed with hepatitis-C after visiting a doctor for a routine physical about a year ago. His doctor prescribed a combination of Olysio, manufactured by New Brunswick, N.J.-based Johnson & Johnson, and Sovaldi, but the health plan denied coverage because the combination has not been approved by the FDA.
Galbraith said his doctor then prescribed Harvoni, but the plan rejected coverage for that drug because it had not yet been approved by the board.
Although his fibrosis score is only F1, Galbraith said he suspects the disease is the cause of severe indigestion that often keeps him awake at night.
He said can't afford to pay the full price for Harvoni out of his pocket, but would be willing to pay more than the normal specialty drug copayment of $100 if the plan would pick up some of the cost or allow him to pay a discounted price.
"I just feel like they need to work with each individual member," Galbraith said. "A one-size-fits-all policy, I don't think, is the right way to go."
Metro on 03/18/2015