GUILFORD — The battle has been won, but the war continues.
That is the best way to put into perspective a recent decision by the Vermont Department of Financial Regulation to overturn a treatment decision by Blue Cross-Blue Shield of Vermont.
A Vermonter with hepatitis C, whom I will call Patient X, insured through BCBS, asked the insurer to pay for a drug recommended by the patient's primary-care doctor as well as by a gastroenterology expert at Massachusetts General Hospital in Boston.
That drug, Epclusa, can be 99 percent effective in patients with genotype 2 hepatitis C. (Genotypes are methods of classifying the disease.)
That is a remarkable cure rate, but the cost of drug is $74,760, or $890 per pill for a 12-week course of treatment.
With hepatitis C, a fibrosis score determines the degree of liver damage - specifically cirrhosis. Determining an accurate fibrosis score requires a liver biopsy, and many guidelines don't mention the need for determining a fibrosis score when deciding on treatment for hep C.
In BCBS's rejection of Patient X's claim, the company determined that the fibrosis score wasn't high enough.
In other words, BCBS didn't want to pay for the costly treatment, so they denied Patient X's request, on the grounds that the insurance company wanted the patient's liver to be more damaged before paying for the cure.
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Hepatitis C is a viral infection of the liver with variable progression.
According to the Centers for Disease Control and Prevention: “Of every 100 persons infected with [the hepatitis C virus], approximately 75–85 will go on to develop chronic infection, 60–70 will go on to develop chronic liver disease, 5–20 will go on to develop cirrhosis over a period of 20–30 years, and 1–5 will die from the consequences of chronic infection (liver cancer or cirrhosis).”
The scientific literature makes it clear that hepatitis C isn't only a public health threat because it can be transmitted via blood from person to person. It also is a disease that causes significant morbidity and mortality.
The cost of a liver transplant can be in the range of $400,000 to $500,000, and the cost of treating someone with hepatitis C who progresses to the point of transplantation can be almost as costly as the transplant.
Epclusa and other newer drugs, known as direct-acting antivirals, or DAAs, developed to treat hepatitis C, have cure rates at 99 percent for patients with genotype 2 and 95 percent for genotype 3. The CDC also lists 11 different drugs or drug combinations that can be used to treat and cure hepatitis C.
Patient X did a lot of research and then mounted an appeal with BCBS.
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In Vermont, the health insurance appeals process requires a subscriber to first file an internal appeal. If that isn't successful, the insured party can go to the next level: an external appeal mediated by the Vermont Department of Financial Regulation.
The state hires an impartial expert to review the evidence from both sides and then a determination is made.
In the case of Patient X, it was determined that BCBS's standard of a high fibrosis score as the determining factor in treatment didn't stand up to scrutiny when compared to treatment standards for hepatitis C developed by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.
Those organizations made it clear that “The goal of treatment is to reduce all-cause mortality and liver-related health adverse consequences, including end-stage liver disease and hepatocellular carcinoma, by the achievement of virologic cure as evidenced by a Sustained Viral Response.”
An expert from Massachusetts General Hospital determined that the drug Epclusa would be best for Patient X.
And there is compelling medical evidence that the population of people infected with hepatitis C should be treated aggressively.
Ira Jacobson, M.D., chair of the Department of Medicine at Mount Sinai Beth Israel in New York City and a principal investigator in the Epclusa clinical trials, noted, “The approval of Epclusa represents an important step forward in the global effort to control and potentially eliminate [the hepatitis C virus] as it provides a safe, simple, and effective cure for the majority of HCV-infected patients, regardless of genotype.”
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So the question remains: If the battle was won, why does the war continue?
One reason is a Vermont insurance rule.
According to Rule H-2011-02, “Independent External Review of Health Care Service Decisions,” the “determinations of an independent review organization on individual cases shall have no precedential value as to any other independent external review filed with the Department.”
This means that BCBS isn't required to treat other subscribers with hepatitis C with the same class of drugs as Patient X.
However, BCBS would likely lose any appeal based on the same information provided by Patient X.
So for now, BCBS subscribers with hepatitis C will have to go through the appeals process, but they will have a near-100 percent guarantee of success.
If BCBS decided to change their hepatitis C treatment policy based on this decision, it would make life easier for a lot of people. It would actually save the insurer money in the long run and also keep some of their subscribers healthy.
Unfortunately, there is another potential impediment to treatment: The BCBS plans that have drug coverage require co-pays that could range from a flat $40 up to 60 percent of the cost of the drug, depending on which category a drug is placed in by the insurer.
Alison Partridge, who works in management at BCBS of Vermont, was involved in the appeals process.
When asked if BCBS was considering changing its policy as a result of Patient X's successful external appeal, Partridge responded that “as part of the ongoing process for all of our policies, please be assured that we take all new information under consideration. We are reviewing the information received and are continuing to evaluate our policies.”
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A number of state Medicaid programs, including Massachusetts and Connecticut, have decided to cover hepatitis C treatment. Vermont might soon be added to the list.
On Dec. 6, Vermont Medicaid Drug Utilization Review Board, or DURB, voted to lift some of the restrictions on hepatitis C medications. A coalition of Vermont organizations, including the AIDS Project of Southern Vermont, supported this measure.
Julia Shaw, a policy analyst with the Office of the Health Care Advocate, said in a news release that Vermont has used the cost of the new class of medications “to justify restricting access to these cures. Concern about short-term costs is not an acceptable reason to deny people treatment for a deadly disease. We would not allow this kind of rationing of care for any other condition, and we will not accept it for hepatitis C.
“These restrictions are ethically and morally wrong and violate federal Medicaid law,” Shaw continued. “Similar restrictions have been challenged in court in several states. In some states, courts have ruled that the restrictions are illegal. Other states have changed their restrictions because they were facing lawsuits.”
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If DURB's recommendation is accepted by Department of Vermont Health Access Commissioner Steven Costantino, many more Vermonters on Medicaid who have hepatitis C will gain access to treatment.
At the Dec. 6 meeting, DURB voted to stop excluding people from treatment simply because they have used alcohol or drugs within the past six months.
DURB also voted to treat those with a fibrosis score - the measure of the extent of liver disease - of F2. Vermont Medicaid currently requires six months of sobriety, drug and alcohol testing throughout treatment, and a fibrosis score of F3 or F4 to access treatment. DURB left intact the requirement that patients see a specialist in order to get treatment.
“A number of states provide treatment to people with [chronic hepatitis C] with no restrictions, and most states have less-restrictive criteria than Vermont,” Julia Shaw noted. “The Office of the Health Care Advocate believes that Vermonters will be better served in the short and long term if Medicaid removes these unreasonable restrictions.”