Story Highlights Zevalin available on Medicaid in three states as part of post-grant review
Available for some patients on Medicare and some private insurance
Sought by immunotherapy-resistant cancers, who have high failure rates
NEW YORK (CNNMoney) — Celgene has received FDA approval for a drug it says will help more people with cancer survive — immune system problems.
Zevalin is now available to Medicaid patients and some Medicare patients, as well as some private insurance plans, in Missouri, Missouri, South Carolina and Texas.
Zevalin will be eligible in those states within a matter of weeks, according to AstraZeneca, the manufacturer.
The drug has a six-month head start over other treatments already on the market, though some patients may eventually be able to get it through earlier studies.
What is it?
Zevalin was initially developed for use against different types of blood cancers, including acute myeloid leukemia, lymphoma and myeloma.
About two years ago, AstraZeneca decided to open it up to any type of solid tumor, such as breast cancer, prostate cancer, non-small cell lung cancer, ovarian cancer and colorectal cancer.
No drug or treatment had been proven to improve survival rates for those with immune system problems, as well. But the results of clinical trials looked promising.
Those trials were able to reach people with less effective treatments already on the market, said Dr. Sharryn Somerville, chief medical officer for Alliance for Cancer Immunotherapy, a group of providers supporting research for cancer patients. The Alliance currently has Zevalin eligible for about 100 patients in its pipeline.
Like some other experimental immune-related drugs that have gotten the green light from the FDA, the unproven Zevalin is administered as an infusion. There are fewer side effects to consider, said Somerville.
It is available on private insurance plans that cover a portion of health care costs, but those plans have to approve treatments that pass muster, said Somerville.
Zevalin can cost up to $30,000 a month to administer, depending on whether patients have insurance coverage.
Studies have found that about 11% of patients treated with this type of drug to improve survival rates, and patients have shown good results after being followed for five years. Some patients have fared better than that — suggesting that it’s a better option for them than the current standard.
“We look at the big picture. Most patients take Zevalin for life because it has good safety and efficacy,” said Somerville. “We do not judge whether a patient should or should not take Zevalin by that number.”
She said that given the right therapy, she doesn’t think it’s a good idea to stop someone from taking the drug and putting them at risk of failing.
“Maybe in the back of their mind, they’re going to think they’re not eligible,” she said.
Also, said Somerville, studies have shown that about one-third of patients taking the drug didn’t have a response to their standard treatment. That’s why the best way to go for the most patients is to create a consensus based on an extensive study about which patients should be taking Zevalin and at what price.
First stage: Medicare use
In Medicare, the drug is currently being considered for use in the first stage of Medicare, said Michelle Klimt, spokesperson for the Medicare program.
We were notified earlier today that Zevalin is available for Medicare beneficiaries. As you know, coverage is based on clinical and cost data submitted for the drug within the research to the Medicare Evidence Development Program and the FDA submission was approved today. — Michelle Klimt (@MedicareMgr) June 25, 2018
Phase 2: Medicaid coverage
This is the first time that this drug has been approved for Medicaid, which covers 30 million people. But the drug already is approved by the Medicaid pharmaceutical user fee committee. However, it is not approved by the Centers for Medicare and Medicaid Services, or CMS.
“We started the review process in June 2017. That’s why it was about a year, but we are more than ready to go,” said Bridget Patton, a spokesperson for AstraZeneca.
What is the cost?
Part of Zevalin’s low price tag is because AstraZeneca has been able to get rebates on the part of various insurers to pay for it. The rebate is based on how much Medicare pays the drug.
“The cost is part