Plans look at $86,000 hepatitis treatment
State is advised to cover sickest
The health plans for teachers and state employees would begin covering two new drugs used to treat hepatitis-C under recommendations that a state board will consider Tuesday.
But because of the cost of the drugs — more than $86,000 for a 12-week course of treatment — the plans would continue to restrict the coverage of such treatment to patients determined to have the greatest medical need.
Drug companies have “priced these so ridiculously expensive, we’re trying to identify which patients need treatment right now,” said Jill Johnson, an associate pharmacy professor at the University of Arkansas for Medical Sciences.
Johnson advises the State and Public School Life and Health Insurance Board as part of the UAMS College of Pharmacy’s Evidence-Based Prescription Drug Program.
“Hopefully, in the future, competition and more drugs in the market will help drive the prices down,” she said.
The plans administered by the health insurance board 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.
Since 2011, the health plans for teachers and state employees have covered a 48-week hepatitis treatment regimen that includes Victrelis, manufactured by Whitehouse Station, N.J.-based Merck & Co., ribavirin and injections of interferon.
In August, the board approved covering the drug Sovaldi, manufactured by Gilead Sciences of Foster City, Calif., which was approved by the U.S. Food and Drug Administration in December 2013, for certain patients.
At the same meeting, the board restricted any treatment to eradicate hepatitis-C to patients with liver scarring, known as fibrosis, significant enough to be rated at least a 3 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.
Last month, the board’s drug utilization and evaluation committee recommended covering two other drugs: Harvoni, also manufactured by Gilead and approved by the FDA in October; and Viekira Pak, a two-pill combination manufactured by North Chicago, Ill.-based AbbVie Inc. and approved by the FDA in December.
The committee also recommended 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.
Under the recommendations, many patients would still have to take Sovaldi in combination with interferon, which can cause flu-like side effects, and ribavirin, but they would be able to complete the treatment in 12 weeks instead of the 48 required for the combination with Victrelis.
Patients who are unable to take interferon, or for whom interferon hasn’t worked, would be able to take Sovaldi, Harvoni or Viekira Pak, depending on the details of the patient’s condition and treatment history.
In cases in which evidence is not available to show which drug would be more effective, the least expensive combination would be covered. Any treatment would continue to be restricted to patients with a fibrosis score of F3 or higher.
To determine the score, patients would be required to have a liver biopsy, a procedure that involves inserting a needle through the abdomen to remove a small piece of liver tissue.
The patient also must have refrained from abusing drugs or alcohol for at least six months before starting treatment.
So far, no patient on the health plans has filled a prescription for Sovaldi, but six prescriptions were filled last year for Victrelis, a representative from Catamaran Corp., the plans’ pharmacy benefits manager, told the drug utilization and evaluation committee at a Feb. 24 meeting.
Dwight Davis, director of the Evidence-Based Prescription Drug Program, said last week that 11 patients filed appeals after their requests for Sovaldi were denied.
That included three patients who wanted to take Sovaldi in combination with another drug, Olysio, that the plan doesn’t cover. All the denials were upheld.
One retired state employee, who asked not to be identified, said the coverage criteria policy seems “penny wise and pound foolish” because the treatment could prevent even more costly complications, such as liver cancer.
A 63-year-old former public defender who lives near Texarkana said she tried a regimen involving interferon in the 1990s but stopped after about two weeks after experiencing side effects including confusion and suicidal thoughts.
She said she started looking into her treatment options again because having the disease makes her ineligible for stem-cell therapy at a clinic in Houston for a spine injury she suffered a year ago.
Last month, her gastroenterologist prescribed Harvoni before learning the state employee health plan doesn’t yet cover it.
On Feb 20, the retiree wrote to the State and Public School Life and Health Insurance Board asking it to change its policy.
“I am shocked and [appalled] that the State of Arkansas would deliberately deny what I understand to be a wonderfully successful treatment for the Hep C virus that has little or no side effects,” the retiree wrote.
She said she didn’t know whether she would qualify for treatment under the policy recommended to the state board.
Johnson said the coverage restrictions are necessary because the plans “don’t have an unlimited pot of money.”
Many patients infected with the blood-borne virus will never develop symptoms, she noted, and the disease can take decades to progress.
Advancing from a fibrosis score of F2 to F3 can take “not in days or weeks or months, but years,” Johnson said.
“We’re not in a huge hurry to treat patients,” she said.
The state Medicaid program, which covers Sovaldi, Harvoni and Viekira Pak, also limits coverage to patients with a fibrosis score of at least F3, although exceptions are made on a case-by-case basis for those with a high risk of complications.
Arkansas Blue Cross and Blue Shield plans offered through employers and the state’s health insurance exchange cover Sovaldi as well as Olysio, manufactured by New Brunswick, N.J.-based Johnson & Johnson, Blue Cross spokesman Max Greenwood said in an email.
Adding coverage for Harvoni and Viekira Pak is “under review,” she said.
She said patients must meet “certain medical criteria” to qualify for the coverage. That coverage policy is also under review, she said.
Andres Duarte-Rojo, director of the Viral Hepatitis Clinic at the University of Arkansas for Medical Sciences, said some insurers require patients to have a fibrosis score of at least F2, while others require at least F3.
Out of 130 patients who applied to have their treatment covered in the past few months, about 40 were successful, he said.
He said he would like to treat all patients with hepatitis-C but understands the cost constraints.
Limiting treatment to those with a fibrosis score of at least F3 is “not ideal, but it’s not bad, and it’s not late for the majority of patients,” Duarte-Rojo said.
The risk is that some patients may develop a complication such as liver cancer by the time they meet the criteria and are approved for treatment, he said.
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.
Infections in the United States peaked in the early 1990s. In recent years, complications and deaths among those who were infected decades ago have increased.
In 2012, the CDC recommended a one-time blood test for hepatitis-C for anyone born between 1945 and 1965. People in that age group are five times more likely than other adults to be infected and are believed to account for about 75 percent of Americans with the disease, according to the agency.
Since it began testing at its health units around the state in September, the Arkansas Department of Health has tested 1,116 people, 98 of whom tested positive for the disease, spokesman Kerry Krell said.
She added that most of those who were tested were members of population groups with a higher risk of infection than the general population.