Brain-tumor specialists and affected person advocates are amongst these decrying a choice by the vendor of a most cancers drug to exit a federal low cost program for Medicare sufferers, leaving some unable to afford a remedy that may run as a lot as $1,000 a capsule.
The transfer by Miami-based NextSource Biotechnology means the drug Gleostine no longer qualifies for Medicare Part D drug help, that means there may be one fewer option of a handful of accepted chemotherapies.
“There are lots of people right now who are not getting the drug,” and a few will probably die because of this, Henry S. Friedman, a neuro-oncologist and professor of neurosurgery at Duke University School of Medicine, instructed CBS MoneyWatch. “There are patients who can’t afford the drug, and other drugs may not be as effective.”
The Centers for Medicare & Medicaid Services, or CMS, confirmed NextSource had withdrawn from the Medicaid drug rebate program, that means states can not obtain federal funding reimbursement for Gleostine. However, states can nonetheless pay for the drug with their very own funds, with every state’s Medicaid program making these protection choices.
Used to deal with a tumor referred to as glioblastoma and different brain cancers, Gleostine’s patent has lapsed however there may be no generic model.
“The decision by the company to withdraw from public health insurance programs weakens the safety net for vulnerable brain cancer patients who already have few treatment options. Lomustine, (brand name: Gleostine ) is a medically-necessary part of the standard of care for patients with the most aggressive tumors and is also essential in many clinical trials,” acknowledged David Arons, CEO of the National Brain Tumor Society.
“We urge Nextsource to rejoin these programs and help reduce barriers for patients who require access to this therapy as well as for researchers and clinical trial participants participating in critical, ongoing brain cancer studies,” Arons continued.
The company had beforehand jacked up the value of Gleostine, an off-patent drug previously referred to as lomustine that first got here out greater than 4 many years in the past to deal with brain tumors and Hodgkin lymphoma. It was marketed under the model title CeeNu by Bristol-Myers Squibb, or BMS, which bought the product to NextSource in 2013.
“Lomustine is one of only three FDA-approved chemotherapies for patients with glioblastoma and the one that most patients receive when their tumor progresses on first line temozolomide chemotherapy. The median age for patients with glioblastoma is 65, meaning the decision to no longer participate in the Medicare program affects half of the glioblastoma population,” Dr. Patrick Wen, director of the Center for Neuro-Oncology on the Dana-Farber Cancer Institute in Boston, mentioned in emailed feedback.
“The only other treatment is avastin. Lomustine is also the standard-of-care treatment used in the control arm of most recurrent glioblastoma clinical trials, and not having easy access to this drug has an important impact on research to find better treatments for this devastating cancer,” the doctor added.
“It cost $50 per capsule since BMS sold it,” David Vanness, a professor of well being coverage and administration at Pennsylvania State University, tweeted on Thursday. “This is a drug from 1976.”
These days, a capsule can run as a lot as a grand a pop, after a number of worth will increase by NextSource.
NextSource didn’t reply to a request for remark from CBS MoneyWatch. It instructed the Wall Street Journal, which first reported it had pulled out of the Medicare Part D program, that it was reviewing its participation in numerous packages.
However, NextSource posted a press release on its web site about its worth will increase, citing product improvement prices, regulatory company charges and the profit the remedy affords to sufferers as among the many underlying elements.
Friedman, nonetheless, dismissed the reason. “It’s all greed. Why do you take a drug for which you do no research and development and raise the price 1,400%? All they did was rebrand it, a drug that was out there forever,” Friedman mentioned.
Other corporations together with Turing Pharmaceuticals and Valeant Pharmaceuticals have considerably raised costs after shopping for medicine that had been on the market for years.