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The seller of the brain-cancer drug Gleostine has pulled out of a federal discount program for Medicare patients, leaving some struggling to pay for a therapy that can cost as much as $1,000 per capsule.

NextSource Biotechnology LLC’s decision to leave the program, rendering its drug ineligible for the Medicare Part D drug benefit, comes after the Miami company raised the drug’s price exponentially since acquiring rights in 2013. Gleostine, which treats a tumor known as glioblastoma and other brain cancers, is off-patent but has no generic alternative.

“The problem is that patients with this terrible tumor now no longer have easy access to one of the few approved chemotherapies," said Dr. Patrick Wen, director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute in Boston.

Patients may seek financial assistance from Nextsource or third-party sources, and doctors can explore less-expensive treatment alternatives. However, the company’s move highlights the limits of federal actions to reduce drug prices as well as programs meant to help people pay for their medications.

Under federal law, drug companies must provide certain discounts to be eligible for reimbursement by the Medicare Part D drug benefit. With these discounts, patients pay no more than 25% of the price of a brand-name drug after they have reached a spending threshold on prescriptions each year. The manufacturer and Part D pay the rest.

NextSource stopped participating as of Jan. 1, according to the Centers for Medicare and Medicaid Services, the federal agency that runs the program for people over age 65 and the disabled. Most companies with drugs eligible for Part D participate in the program, a CMS spokeswoman said.

NextSource didn’t specify why it stopped participating in Part D but said in a statement that it is re-evaluating its participation in “various programs."

The company also said it is exploring a new contract with the Medicare Part D program and intends to participate again in the future. NextSource said that since Jan. 1, Medicare patients meeting certain income criteria are eligible to receive Gleostine at no cost under its patient-assistance program.

NextSource says it hasn’t denied any patients’ applications for assistance and isn’t aware of any issues with access to its product.

At least 8,606 prescriptions were written for Gleostine in the U.S. during 2020, generating roughly $13.4 million in sales, according to prescription data provider IQVIA. The firm said its estimates don’t account for a portion of the drug’s distribution through hospital channels.

Brain-tumor specialists and patient-advocacy groups say NextSource’s decision is jeopardizing patients’ access to the drug. Dr. Ashley Love Sumrall, section chief of neuro-oncology at the Levine Cancer Institute in Charlotte, N.C., said that even with financial assistance available, patients face a hard time navigating the application process of obtaining the aid. “If a patient is not fortunate enough to have a nurse navigator or a team to help them, then I can see where that would be a bigger obstacle," she said, referring to the search for financial assistance.

The National Brain Tumor Society has explored asking federal officials to switch Gleostine to another part of Medicare and is seeking drug companies willing to invest the time and money to make lower-cost copies, said David Aarons, CEO of the society.

The society also sent a letter to NextSource CEO Robert DiCrisci in February, urging the company to rejoin Part D. The society shared a copy of the letter with The Wall Street Journal. NextSource didn’t respond to the letter, said a spokesman for the society.

The list prices for dose levels of Gleostine range from $90 per capsule for the lowest dose level, 10 milligrams, to $1,004 per capsule for the highest dose, 100 milligrams, according to an analysis provided to the Journal by Elsevier, which tracks drug prices.

The drug—also known by its generic name lomustine and introduced in 1976—is usually given once every six weeks for patients with a recurrence of glioblastoma. Patients typically take a combination of dosages to reach a prescribed total. For many patients, this ranges between $1,500 and $2,300 every six weeks, according to doctors and the National Brain Tumor Society. Gleostine is also part of a regimen shown to improve overall survival for certain other types of brain cancers.

The list price of the highest dose is about 1,900% higher than the $50 Bristol-Myers Squibb Co. charged when it sold a version of lomustine under the brand name CeeNU. Bristol-Myers Squibb sold the product in 2013 to CordenPharma. CordenPharma joined with NextSource to sell and distribute lomustine in the U.S., and NextSource rebranded the drug as Gleostine.

An investigation by the Journal in 2017 showed how NextSource repeatedly hiked Gleostine prices, sparking outrage from doctors and patients and a probe by several U.S. senators. NextSource hasn’t raised prices since 2018, the company said.

In 2019, Medicare issued two fines to NextSource, totaling $117,206, for the company’s alleged failure to pay its share of drug costs under Part D within the required time frame in late 2018 and early 2019, according to letters the agency posted online. NextSource paid the penalties, a spokesman for the Medicare agency said. NextSource said the matters have been resolved.

About half of new glioblastoma cases are diagnosed in people 65 and older, according to the National Brain Tumor Society.

The lack of Medicare coverage for Gleostine has complicated enrollment in clinical trials to test potential new cancer treatments, doctors say. In a large study of patients with glioblastoma that started in 2019 called “GBM Agile," some patients are given newer drugs and their outcomes are compared with patients who receive standard treatments including Gleostine. The study is run by the Global Coalition for Adaptive Research, a nonprofit that doesn’t cover patients’ costs for Gleostine.

Several of the nearly 40 study sites have had difficulty enrolling patients because of Gleostine’s cost, said Ashley Powell, director of the trial’s operations. The organization is having discussions with NextSource to address the issue, Ms. Powell said. NextSource confirmed the discussions.

One patient in the study, Donna Kelley-Hall of Copper Canyon, Texas, paid more than $2,000 for the first round of Gleostine, even though she has a Medicare Part D plan. Ms. Kelley-Hall, a 68-year-old retired mortgage-loan officer, said she was able to afford the first round but was disappointed that the drug wasn’t covered by her plan.

For the second round, her doctor found a version of lomustine that cost only about $200 through an online Canadian pharmacy. Because the imported pills come in lower doses, Ms. Kelley-Hall had to take 20 capsules, versus two, in the first round.

Continuing to pay full price for subsequent rounds of NextSource’s Gleostine would have forced Ms. Kelley-Hall into some tough decisions.

“We would have been making choices between medicine and something else," she said.

This story has been published from a wire agency feed without modifications to the text

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