Health insurers are restricting coverage for the hepatitis C drug Sovaldi for all but the sickest patients. Now, many patients who do not wish to suffer through years of liver damage are fighting back by filing lawsuits.
UPDATE: Gilead Priced Hep C Drugs to Maximize Profits
December 2, 2015 — The Senate Finance Committee has released a report concluding that Gilead Sciences priced its hepatitis C drugs to maximize profit knowing that patient access and affordability would be compromised.
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 — State Medicaid programs may be illegally restricting coverage for the hepatitis C drugs Sovaldi and Harvoni to all but the sickest patients, federal officials warn. 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 federal 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 treats chronic hepatitis C by preventing the virus from replicating inside a patient’s body. It was created by Gilead Sciences and has been approved by the FDA since December 2013.
What is the problem?
Sovaldi costs $84,000 for a 12-week course of treatment, or about $1,000 for each once-daily pill, and it cures over 90% of patients with very few side effects compared to other treatments, which are only 70% effective at best.
Most people with hepatitis C cannot afford to pay for Sovaldi out-of-pocket. Because it is so expensive, most state Medicaid programs restrict access to patients who have advanced liver disease and abstain from using illegal drugs and alcohol. Most private health insurers impose similar restrictions.
As a result, only a tiny fraction of the estimated 3.2 million Americans who have hepatitis C are getting the cure they need. In the meantime, the highly-contagious hepatitis C virus continues to spread in the general population.
By law, health insurers cannot deny access to new drugs or discriminate against patients who need treatment, leaving drug-makers with the upper hand in most price discussions. What happens when drug-makers set exorbitant prices?
One year after Sovaldi hit the market, the Wall Street Journal reported that the company was hit with a class action lawsuit accusing the company of “price-gouging” their customers.
Lawsuits Filed Against Health Insurers for Restricting Coverage
Health insurers are also facing a growing number of lawsuits from people demanding access to new drugs. Harvoni, another drug from Gilead Sciences that combines Sovaldi with ledipasvir, costs upwards of $95,000 and is also restricted to the sickest patients.
One patient is fighting back. Shima Andre, a woman who was diagnosed with hepatitis C in 2011, has filed a lawsuit against Blue Cross of California for denying coverage for Harvoni until she has fibrosis of the liver. In the meantime, her health continues to decline. 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 Hepatitis C?
Hepatitis C is a highly-contagious blood-borne virus that causes liver inflammation. Over time, chronic hepatitis C causes fibrosis and cirrhosis (scarring) of the liver, which can lead to liver failure and death.
Complications of hepatitis C may include:
- Internal bleeding
- Jaundice (yellowing of the skin and eyes)
- Fluid accumulation in the abdomen
- Liver cancer
- Encephalopathy (confusion)