Thousands of Massachusetts residents who have health insurance through Harvard Pilgrim Health Care are learning that the company will no longer cover specialty medications known as compounded drugs, because of safety and cost concerns, a decision that has infuriated pharmacists and worried patient advocates.
The action follows last year’s deadly fungal meningitis outbreak linked to a Massachusetts compounding pharmacy.
In a letter to patients, Harvard Pilgrim, the state’s second-largest insurer, said it will end coverage of these medications Aug. 7, but will consider appeals case by case.
“If your physician believes that there are no other available treatment options for you, your physician may submit an exception request on your behalf,” the letter said.
According to the letter, the appeal process would require physicians to send information about the compounded drug that is being sought including its ingredients, other prescription medications that have been tried to treat the patient’s condition, and other details.
Compounded drugs are mixed for individual patients who need formulations or doses not widely available off the shelf. The US Food and Drug Administration, which oversees quality and safety at pharmaceutical manufacturers, does not monitor operations at compounding companies.
Dr. Michael Sherman, Harvard Pilgrim’s chief medical officer, said the insurer’s new policy stems from its safety review after the meningitis outbreak. More than 700 people were sickened and 58 died as a result of taking tainted steroids produced at New England Compounding Center in Framingham.
Sherman said his company’s review found that most of the insurance claims it received from patients for compounded drugs were for medications that should not be covered by a health insurer, such as cosmetic, anti-aging, weight loss, and homeopathic remedies.
He said Harvard Pilgrim will continue to cover compounded drugs for children under age 18 because the company’s review found appropriate use of the drugs in youngsters, who often need medications in a different dose or in a liquefied form that is not commercially available.
“This is not about denying care,” Sherman said, “It’s about eliminating costs that don’t add value.”
Harvard Pilgrim said that 4,200 of its members over age 18 have filled a prescription for a compounded medication in the last six months.
Sherman noted that state leaders are striving to control soaring medical costs and that Harvard Pilgrim’s review found that from 2011 through 2012 the company experienced a 171 percent increase in claims for compounded drugs and a threefold jump in costs for these medications.
Sherman said he believed the rising costs were in part driven by some compounders who are trying to “take advantage of loopholes” in an area that is “poorly regulated.”
Brian Rosman — research director at Health Care for All, a Boston patient advocacy organization — said he understands safety concerns, but believes Harvard Pilgrim’s approach is unwarranted.
“For those who need these drugs, to make them go through extra hoops seems to be unfair and makes no sense because it’s coverage they have paid for,” Rosman said. “We hope Harvard Pilgrim would reconsider.”
Mark and Mary Kay Foley of West Roxbury are among those receiving a letter from the insurer. Their 19-year-ol son, Korey, is paralyzed from the chest down, and relies on a local compounding pharmacy to liquefy about eight medications daily that are given to him through a feeding tube.
The Foleys have fought insurance cutbacks that limited the number of replacement tubes and filters Korey needs for his breathing machine.
“You are just not sure what’s going to happen,” said Mark Foley, a Boston firefighter. “We have run into problems before, even though we had some stuff approved.”
Two Massachusetts pharmacist groups are urging Harvard Pilgrim to reconsider its policy, saying in a letter sent Monday that a compounded medication is sometimes the only drug available for patients because of drug shortages nationwide.
It also said Harvard Pilgrim is being disingenuous in claiming that its policy change is in part motivated by safety concerns, because the insurer will still cover compounded drugs for children.
“If there were safety concerns, why would you continue to cover it for children?” said Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, one of the pharmacists groups opposing the insurer’s move.
“Children get stabilized on a compounded product and then suddenly turn 18 and they are not covered anymore,” Brown said. “The whole thing doesn’t make a lot of sense on multiple levels.”
Blue Cross Blue Shield of Massachusetts, the state’s largest insurer, said it will continue to cover compounded medications, as will Tufts Health Plan, the state’s third-largest insurer.