A federal judge dismissed a class action against Blue Shield Life & Health and Blue Shield of California alleging the insurers unfairly denied patients coverage for the expensive hepatitis C drug Harvoni.
The U.S. District Court judge, William H. Orrick, wrote in an opinion last week that because Blue Shield recently changed its policies to broaden coverage for Harvoni, the plaintiffs' claims are now moot.
“Given these actions, recurrence of the challenged practice is unlikely and plaintiffs' claims against Blue Shield of California for denial of benefits are moot,” the court opinion states.
The class action was first filed in October 2015 in the U.S. District Court of the Northern District of California. Plaintiffs Aram Homampour, John Bartels, and Jon Naka, who suffer from hepatitis C, each requested and were denied coverage for Harvoni under their employee benefit plan, on the grounds that the drug was not medically necessary because the patients' liver damage was not severe enough.
Under Blue Shield of California's policies, to qualify for Harvoni, members were required to have advanced liver damage or show a contraindication to another hepatitis C drug, Abbvie's Viekira Pak. Viekira Pak is less expensive at $84,000 for a full course of treatment, but it also may cause serious side effects.
Blue Shield was not available for comment by deadline.
The patients argued that denying them the life-saving drug violates the Employee Retirement Income Security Act of 1974, the federal law governing employer-sponsored health benefit plans.
Harvoni and other such expensive drugs have come under fire for driving up the nation's total health spending. A 12-week treatment course of Harvoni costs about $99,000. The drug, made by manufacturer Gilead, cures hepatitis C.
At the end of 2015, Blue Shield updated its policies to expand coverage for Harvoni to patients with less advanced liver damage. And a few months later, it removed the requirement that patients must show a contraindication to Viekira Pak.
Blue Shield in April and May sent letters to current plan members who were previously denied Harvoni coverage and invited them to resubmit requests.
According to the opinion, one of the plaintiffs was granted coverage for Harvoni after the Blue Shield policy was expanded. The other two took Viekira Pak and so were no longer suffering from hepatitis C.
“As none of the named plaintiffs have an ongoing medical need for Harvoni, and therefore have no right to Harvoni related-coverage, they are not entitled to compel Blue Shield to re-review their years old requests,” the opinion states.
Many insurers have tried to limit access of expensive hepatitis C drugs to only the sickest patients. In May, a U.S. District judge ordered Washington Medicaid to give Harvoni to all hepatitis C patients, not just those with the worst liver damage.
Because of the threat of legal battles, private insurers and states have been lifting restrictions that limit who can receive expensive hepatitis C drugs.