Sovaldi has been hailed as a miracle cure for hepatitis C, but with a price-tag topping $84,000, treatment has been out of reach for all but the richest or sickest patients. Now, some patients are filing lawsuits against health insurers who deny coverage because they are not sick enough.
UPDATE: Gilead Priced Hep C Drugs to Maximize Profits
December 2, 2015 — Gilead Science’s pricing strategy for the hepatitis C drug Sovaldi focused on maximizing profits with little regard for accessibility and affordability, according to a Senate Finance Committee investigation.
According to Senate Finance Committee Member Ron Wyden:
“Gilead pursued a calculated scheme for pricing and marketing its Hepatitis C drug based on one primary goal, maximizing revenue, regardless of the human consequences. … Gilead knew these prices would put treatment out of the reach of millions and cause extraordinary problems for Medicare and Medicaid, but still the company went ahead.”
November 6, 2015 — Federal officials are warning that state Medicaid programs may be violating the law by restricting access to the hepatitis C drugs Sovaldi and Harvoni to all but the sickest patients. Click here to read more.
August 5, 2015 — Anthem Blue Cross has been hit with a class action lawsuit by a woman with hepatitis C who was denied coverage for Harvoni and Sovaldi. Click here to read more.
July 20, 2015 — Gilead Sciences will stop allowing insured patients to use its price-discounting assistance program for the hepatitis C drugs Sovaldi and Harvoni. Click here to read more.
July 9, 2015 — The FDA has been hit with a federa lawsuit (PDF) in Connecticut filed by two public health groups who are seeking access to raw clinical trial data Gilead Sciences used to gain approval for its hepatitis C drugs Harvoni and Sovaldi. Click here to read more.
What is Sovaldi?
Sovaldi (sofosbuvir) is an antiviral medication that helps treat chronic hepatitis C infection in adults. It works by stopping the hepatitis C virus from replicating in the body. It is made by Gilead Sciences and was approved by the FDA in December 2013.
Sovaldi cures more than 90% of patients and has far fewer side effects than less-effective drugs, but a 12-week course of treatment costs $84,000, or about $1,000 per pill.
One year after Sovaldi was approved, the Wall Street Journal reported that Gilead was hit with a class action lawsuit accusing the drug-maker of “price-gouging” and charging “excessive” prices for Sovaldi.
Denied Insurance Claim Lawsuits
In May 2015, a lawsuit was filed by a woman whose health insurance company denied coverage for the $95,000 hepatitis C drug Harvoni, which combines Sovaldi with ledipasvir. The woman, Shima Andre, says Blue Cross of California denied coverage because she was not sick enough. In the meantime, her health continues to deteriorate.
According to the lawsuit:
“Blue Cross told Shima that she would have to live with depression, chronic fatigue, and wait until her liver drastically worsened before it would approve the medication.”
What is the problem?
Because Sovaldi is so expensive, most private health insurers and state Medicaid programs restrict coverage to patients with advanced liver damage. As a result, only the richest or sickest fraction of the 3.2 million Americans with hepatitis C are getting cured.
Hepatitis C is an extremely contagious blood-borne virus. The longer a person goes without treatment, the higher the risk they will transmit hepatitis C to another person. Because hepatitis C is a progressive disease, patients may suffer for years or even decades before they are eligible for treatment.
What is Hepatitis C?
Hepatitis C is a viral disease that causes inflammation of the liver. Over years or even decades, it can damage the liver and cause liver failure. Most people with hepatitis C have no symptoms until they develop fibrosis or cirrhosis (scarring) of the liver, which can lead to complications like:
- Internal bleeding
- Jaundice (yellowing of the skin and eyes)
- Fluid accumulation in the abdomen
- Liver cancer
- Encephalopathy (confusion)