What is Harvoni?
Harvoni is a combination of ledipasvir and sofosbuvir, direct-acting antiviral (DAA) medications that prevent hepatitis C virus cells from multiplying in the body. Sofosbuvir is a nucleotide polymerase inhibitor that interferes with the reproduction of the virus’s genetic material, stopping the production of new Hep C virus. Ledipasvir interferes with a protein needed to complete the Hep C virus life cycle in the liver cell. Harvoni was approved by the U.S. Food & Drug Administration (FDA) on Oct. 10, 2014.
Hepatitis C Statistics
According to the Centers for Disease Control and Prevention (CDC), Hepatitis C is a liver infection caused by the Hepatitis C virus (HCV). Most people become infected with HCV by sharing needles or through sexual contact with an infected person. For some people, hepatitis C is a short-term illness, but for 70%–85% patients it develops into a long-term, chronic infection.
Chronic Hepatitis C is a serious disease than can cause adverse health consequences, including death. Many people with the illness are unaware they even have it due to a lack of symptoms. It is estimated that more than 3 million Americans have chronic hepatitis C, and 15,000 people die each year from liver disease caused by the illness.
Harvoni Bad Faith Insurance Claims
Some insurance companies have set restrictions on Hepatitis C patients who have been approved to use Harvoni, claiming that treatment isn’t “medically necessary.” However, state laws prohibit insurers from denying patients coverage to increase their own profits.
Patients with cirrhosis or whose liver is at stage 3 or 4 fibrosis (pre-cirrhotic) may be able to get Harvoni. However, patients with severe renal (kidney) damage or whose cirrhosis is so bad that it indicates liver failure are not eligible for treatment. This means you may be denied treatment if your liver disease is not very advanced, as well as if it is too advanced.
Hep C Treatment Guidelines
Across the U.S., state Medicaid programs and insurance companies are trying to figure out how to pay for hepatitis C medications. The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) ‘indadvertedly’ restricted access to these drugs by issuing guidelines giving treatment priority to patients with full-blown cirrhosis, or who are pre-cirrhotic. Healthy patients with minimal liver damage may be treated if “resources allow,” according to the guidelines.
These restrictions led to the denial of treatment for many patients who have been waiting years or even decades for the medication. In addition to proof of severe liver damage, insurance companies require documentation that patients have abstained from alcohol and drugs for at least 6 months before treatment. Therefore, authorization may be contingent upon drug and alcohol tests.
The AASLD has admonished insurance companies for their severe restrictions on approving Harvoni for hepatitis c treatment:
“Our recent addition to the Guidance prepared by a committee of leading liver experts from AASLD and The Infectious Diseases Society of America (IDSA) proposed that the sickest patients be treated first, but all patients who receive advice from their doctor to take newest medications should not be denied. The decision across the board should be in the hands of the clinician and the patient to make the decision. Unfortunately payers across America are denying treatment when a doctor has prescribed it for their patient. We adamantly disagree with this decision.”
Despite the AASLD’s position, the practice is still occurring and doors to treatment are closing. Treating only those patients with full-blown cirrhosis makes little sense because the disease is essentially irreversible.
Healthcare Pricing System Studies
A January 2015 study conducted by the Institute for Clinical and Economic Review (IECR) found that treatments such as Harvoni would yield tangible health and economic benefits over the next 20 years — reducing cirrhosis 6-fold and liver cancer diagnoses by up to 50%, while significantly reducing the need for liver transplants. However, the study still determined that the savings over time didn’t compensate for the current prices.
In another study conducted last year, IERC found that if only half of Hepatitis C patients in California sought treatment with Sovaldi (the precursor to Harvoni), that would raise drug expenditures in the state by $22 billion in a single year. Even after 2 decades, the gains from better health would offset only about three-quarters of the initial outlay. To be truly cost effective, the price would need to be cut by half to two-thirds, according to the institute.
Woman Denied Harvoni Hep C Insurance Claim Sues Blue Cross
A West Hollywood woman with Hepatitis C has filed a lawsuit against Anthem Blue Cross for allegedly refusing to cover the cost of Harvoni treatment, according to the Los Angeles Times. 42-year-old Shima Andre claims that Anthem has refused to pay the approximately $99,000 it would cost to be treated with the medication.
According to the lawsuit, Anthem denied Andre’s claim on the grounds that Harvoni was “not medically necessary” because she does not have advanced liver cancer.
“We may approve Harvoni when the liver has a certain amount of scarring on a liver biopsy,” Anthem said. “Records we received do not show that your liver has this amount of scarring.”
Andre was diagnosed with Hep C in 2011, and said she was thrilled when the FDA approved Harvoni last year. However, she hasn’t been able to obtain a prescription because Anthem declined to cover the cost, despite the recommendation from her doctor, who has unsuccessfully lobbied Anthem to approve her coverage. Andre said she has postponed becoming pregnant over fears she could pass the virus to her baby.
“I can’t believe that they demand that a person get sicker before they’ll pay for a cure,” she said. “If there’s a cure for something and you have health insurance, they should cover it.”
The complaint, which was filed May 15 in Los Angeles County Superior Court, accuses Anthem of breach of contract, infliction of emotional distress and unfair business practices. It seeks class action certification, which would add others denied Harvoni treatment to the claim.
FDA Sued Over Harvoni Trial Data
Two groups that campaign for wider access to prescription drugs have filed a lawsuit (PDF) against the FDA claiming the agency failed to disclose clinical trial data behind the approval of Harvoni and Sovaldi, according to the Wall Street Journal.
Last year, the Treatment Action Group (TAG) and Global Health Justice Partnership (GHJP) asked Gilead for patient-level trial data for the Hep C drugs. They requested the information because Harvoni and Sovaldi are widely prescribed, and because the medications were approved through breakthrough designation, which “may increase the risk that gaps in drug efficacy will go undiscovered, or that side effects or [interactions with other drugs] will go unnoticed,” according to the lawsuit. “Independent analysis of patient-level clinical trial data is essential to identify and bring to light unresolved safety and efficacy issues.”
Gilead never replied to the groups’ request for trial data, so they submitted a Freedom of Information request with the FDA. However, the agency denied their request for “expedited processing,” saying it would take up to 2 years analyze the data, according to the lawsuit.
“This delay will leave doctors and patients in the dark for too long,” said Amy Kapczynski, a Yale Law School professor who heads the GHJP. “Doctors write thousands of prescriptions for these drugs every week, straining budgets of state health care programs. Prompt disclosure of this information, which the FDA already collects, will allow doctors and policymakers to make more informed treatment choices with real and immediate consequences for public health and spending.”
Gilead Restricts Access to Hep C Drugs
Gilead has reportedly limited enrollment in its Support Path Assistance Program, which is designed to help patients obtain access to Harvoni when their insurance company won’t cover it. Under the restrictions, patients who have insurance but do not meet the insurer’s criteria will not be eligible for the program. An article published in the Wall Street on June 16 reported that the move might be an attempt to get patients to complain to insurance companies about the failure to cover treatment.
Managing Hepatitis C Treatment Restrictions
If you have hep C and are being denied treatment with Harvoni, there are a few things you can do to deal with the insurance restrictions:
- Read your health plan. Knowing what obstacles you face can help you address them before your claim is denied.
- Inform your medical provider about all your symptoms and how severe they are.
- Appeal all claim denials.
- Manage your health. Eat right, exercise and get lots of sleep. Abstain from alcohol and drugs except when prescribed.
- Complain to your insurance company, your state’s insurance commissioner and your congressional representative.
Harvoni Treatment Denied Lawsuit Filed in California
A Gilead Hep C Denied Insurance Claim Lawsuit was recently filed against Anthem Blue Cross in U.S. District Court for the Northern District of California, accusing the insurer of violating the Employee Retirement Income Security Act (ERISA) by withholding Harvoni treatment. Plaintiff Marina Sheynberg alleges that Anthem denied her because the company felt she was simply not sick enough to warrant treatment.
The complaint further alleges that Anthem is using its stance to avoid paying for a regimen with the highly effective but expensive Harvoni. The lawsuit is: Sheynberg v. Anthem Blue Cross Life and Health Insurance Co., Case No. 3:15-cv-03417.
Gilead to Pay $200 Million to Merck Over HCV Patent Dispute
March 28, 2016 – A federal jury has ordered Gilead Sciences to pay Merck & Co. $200 million in damages for infringing on patents for Harvoni and Sovaldi, according to the LA Times. The award is significantly below the damages Merck sought, but the trial moves to a new phase this week. The San Jose, Ca. jury will then decide whether Merck is due royalties on sales of the medications.
Senate Report Accuses Drugmaker of Putting Profits Ahead of Patients
December 1, 2015 – Gilead Sciences Inc., the company that makes Harvoni and Sovaldi, put profits before patients in pricing the Hepatitis C treatments, Senate investigators announced today. A bipartisan report from the Senate Finance Committee concluded that Gilead was focused on maximizing revenue even as the company’s own analysis showed that a lower price would allow more patients to be treated. Click here to learn more.