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Replies to post #404384 on NorthWest Biotherapeutics Inc (NWBO)
Rogue drug maker first inflates the price of lomustine, then says No to Medicare coverage
July 16, 2021
Over the past year, we have witnessed the awesome power of American pharmaceutical and biotechnology companies.
With unprecedented speed, at least three different U.S. companies created vaccines that will significantly curtail the spread of a deadly global pandemic.
Yet, while some headlines nearly deified these pharma giants, a darker story about the power of American pharmaceutical companies was unfolding in the world of brain cancer.
At the start of 2021, oncologists and patients learned that the vital chemotherapy drug lomustine (abbreviated as CCNU and now marketed as Gleostine) will no longer be covered by Medicare because the drug company NextSource Pharmaceuticals—the sole manufacturer of the drug—has decided to withdraw it from the nation’s safety net insurance program.
This is the only known time that a company with a drug eligible for coverage under the Medicare Part D drug benefit has made the radical choice to leave the program.
This decision by NextSource and company CEO Robert DiCrisci is potentially catastrophic for brain cancer patients who, according to research from the National Brain Tumor Society, may now face bills between $1,500 and $3,000 every six weeks.
Those kinds of bills force families to make wrenching choices between medication and other essential living expenses. These are choices that families should never have to make.
Lomustine—then called CeeNU—was first introduced in 1976 and has been part of standard treatment protocols for many patients with malignant brain tumors for nearly half a century. It is one of only a small handful of treatment options for patients with a recurrence of glioblastoma, the most common and most deadly malignant primary brain tumor, and it has also been shown to improve overall survival for certain other types of brain cancers.
The drug is also used against other cancers. For example, it is a second-line option in the treatment of Hodgkin Lymphoma.
NextSource acquired the rights to the drug (off-patent) in 2013 and promptly rebranded it as Gleostine. Since taking over manufacturing rights, NextSource has become the single-source manufacturer of lomustine in the U.S., a position the company has exploited by consistently and exponentially raising the drug’s price (The Cancer Letter, Sept. 29, 2017; Nov. 8, 2019; Nov. 8, 2019).
The path forward demands that action be taken to reduce the risk posed to patients by single source manufacturers. No single CEO should hold the power to so tangibly and dramatically impact health outcomes for tens of thousands of Americans.
Today, NextSource’s list price for the highest dose of lomustine is some 1,900% higher than it was just eight years ago, when it was being manufactured and sold by Bristol Myers Squibb.
Media reports indicate that, in 2020, tens of thousands of Americans, including hundreds of patients at Duke University, were prescribed lomustine, generating—by even the most conservative estimates—tens of millions in annual sales for NextSource.
With no approved generic alternatives to lomustine, patients have been forced to absorb these extortionately high price increases. And, since the average age at diagnosis for glioblastoma patients is 65, this includes many Medicare patients who have Part D drug coverage under which they are responsible for up to 25% of the price of a brand-name drug.
Think this smacks of price gouging?
A bipartisan group of U.S. senators did. In 2018, Sens. Susan Collins (R-ME) and Catherine Cortez Masto (D-NV) and then-Sen. Claire McCaskill (D-MO) sent an inquiry to NextSource about market share and revenue after observing the precipitous price increase for lomustine. Only then did the company stop raising the price, but also they did not lower it.
Now, NextSource has gone even further.
By withdrawing lomustine from Medicare, patients who already had few good options have even fewer. A small number of low-income patients are eligible for financial assistance from NextSource, but everyone else is left to pay the exorbitant out-of-pocket cost, come up with creative cost-saving solutions with their medical care provider or, unimaginably, forego treatment.
Even for well-resourced cancer centers, it is proving very difficult to quickly source lomustine from suppliers outside the U.S., to say nothing of the additional administrative burden on already stretched medical office staff.
And, switching patients to another chemotherapy drug can not only impact treatment plans but can also subject them to a host of harsh side-effects if they do not tolerate the new treatment as well.
Importantly, the implications of NextSource’s choice do not stop at current brain cancer patients. Removing lomustine from Medicare coverage could derail progress on the development of desperately needed brain cancer drugs far into the future.
Lomustine is currently being used as a control arm in more than 30 clinical trials. Now, with insurance coverage being denied and the cost skyrocketing, some important trials are already having trouble enrolling and maintaining patients.
So, what does this all mean? In the short term, it means that oncologists, oncology trialists and other medical providers and researchers need to speak up for our patients and progress in our field.
NextSource’s actions shine a light on the stranglehold pharmaceutical companies have on patients, providers and our federal government, particularly its capability to impose reasonable limits on drug pricing.
Organizations like the Society for Neuro-Oncology and the National Brain Tumor Society are actively engaged with a wide range of stakeholders from Congress and the executive branch of the U.S. federal government to experienced manufacturers of generic drugs and even with NextSource themselves in a near-frantic effort to resolve this complex problem.
Our patients don’t have time to wait.
Physicians and advocates hope that NextSource will reconsider and come back to the table for the many patients and families who are right now depending on lomustine to extend their precious time together. The company should put profits below the progress of science in the field of brain cancer and commit to making lomustine available and affordable for clinical trials.
But, even if NextSource were to reverse itself and begin participating in the Medicare program again, there is still a fundamental issue that is much, much bigger than NextSource.
NextSource’s actions shine a light on the stranglehold pharmaceutical companies have on patients, providers and our federal government, particularly its capability to impose reasonable limits on drug pricing.
This one company’s actions can be seen as a sort of parable, a reminder that the all-powerful just might choose to wield their strength against the powerless. If one company can giveth, one company can taketh away.
The path forward demands that action be taken to reduce the risk posed to patients by single source manufacturers. No single CEO should hold the power to so tangibly and dramatically impact health outcomes for tens of thousands of Americans.
Our policymakers can make us all less dependent on the generosity or greed, as the case may be, of pharmaceutical company leaders. Our government should, at a minimum, consider options for incentivizing drug companies to consistently enter the market for rare diseases and produce different, more affordable versions of drugs even when the underlying agent is no longer under patent protection.
As NextSource plainly shows, until we effectively protect the most vulnerable, the most powerful can threaten us all.
https://cancerletter.com/trials-and-tribulations/20210716_7/
