As a physician, I am watching the growing field of Democratic challengers for the 2020 presidential campaign and hoping that these candidates will elevate the crucial issue of sky-rocketing drug prices in our healthcare system. I am looking for real ideas that will impact Americans faced with prohibitive costs for medications. As a brain tumor specialist, I hope Biden and the other 2020 candidates are paying attention to the recent report on the 1500% price hike of the generic chemotherapy drug for brain and blood tumors lomustine, now sold only as branded Gleostine. I am witnessing in real time the terrible consequences that unaffordable drugs are causing for my patients.    

I worry about my patients, like the 35-year-old man in rural New Hampshire who I recently treated for an Oligodendroglioma brain tumor who struggled to afford Gleostine, the 40-year-old generic drug whose price has been increased astronomically since 2013. The drug was so prohibitively expensive he only took two of the recommended six cycles. He was one of Biden’s regular guys – uninsured, working for himself as a construction contractor making more than the limit to be eligible for Medicaid and unable to afford alternative insurance.

His tumor grew back after he stopped the Gleostine. He died some months later.

Unfortunately, generic drug price gouging happens far too often in this country. Recall the recent scandals over the exorbitant prices of injectable Epinephrineand pyrimethamine/Daraprim. As the current drug pricing conversation plays out between Congress and the Trump administration, it’s worth asking why a generic drug suddenly costs so much. In this tragic story, Gleostine’s crazy price provides a painful example of why there is no rational justification for a generic drug to be subject to exponential price increases. The example of the generic lomustine is instructive. Prior to 2013, lomustine, then branded as CeeNu, cost $50 for a 100 mg tablet. The same 100 mg of lomustine branded as Gleostine now costs more than $1,000 at most American pharmacies, making the typical treatment plan of 6 cycles of a 240 mg dosage cost more than $15,000. Until 2013, the same exact treatment cost approximately $1500. The recently published survey about the impact of this price increase reveals that physicians prescribing Gleostine have encountered new barriers to getting this for patients; 34% of physicians reporting insurance denials, and 64% reporting increased office staff time and resources to getting insurance approval. They also report that 53% of their patients have told them that the price of the drug caused financial distress. This pattern is replicated throughout our American healthcare system with little notice.

NEXTSource, the manufacturer of Gleostine, has defended the pricing by arguing that it reflects the cost of bringing the drug to market, including research and development and FDA regulatory hurdles that are lengthy, expensive, and often unsuccessful.  NEXTsource, however, did not develop or research lomustine nor obtain FDA approval for marketing for an approved use and is not conducting any ongoing research to combat brain tumors or any other condition.

They are making an argument commonly offered by the pharmaceutical industry to justify the high pricing of novel treatments.

Still, it is ethically corrupt to cite the market as justification to jack up the generic price to match the highest priced patent-protected alternative, especially for drugs that treat rare and vulnerable diseases without viable alternative treatments.

Unpacking who owns the Gleostine product exemplifies the predatory profit motive driving spectacular generic price increases. There is a well-developed industry of investors who buy and monopolize the manufacture of a generic drug that has become “non-core” to a big Pharma company. Analysis of pricing after the loss of patent protection for a variety of drugs has shown that prices remained similar for drugs with just one manufacturer of the generic version. For drugs with two manufacturers of the generic version, the relative price decreased by 10 percentage points, followed by another 17 percentage points with a third manufacturer. For this reason, investors in these “non-core” generic drug products have clear incentives to monopolize generic production.

Another tactic that big Pharma uses to boost profits happens when a drug maker signs a contract with a generic manufacturer where they agree to delay a generic drug from coming on the market for a set time, often referred to as “Pay-to-delay settlements.” The original producer of the formerly patent-protected product thereby remains the sole producer beyond the protected time. A California congressman has introduced proposed new legislation  that would make it illegal for drug companies to engage in the tactic of paying generic competitors to delay introduction of less expensive medications that would cut profits for pharmaceutical firms with patents on brand name drugs.

That $1000 100mg tablet of Gleostine produced by NEXTsource sells for $36 in Canada, in part because the government there has mechanisms to control drug prices such as formulary management, use of generics, reference-based pricing, price freezes, and limits on markups.

Americans, on the other hand, have a patchwork of individual options to cope with unaffordable treatments and medication, including philanthropic patient assistance programs, co-pay reimbursements from Big Pharma for high cost patent-protected drugs, and GoFundMe campaigns.

I practice at a hospital that employs multiple “resource specialists” whose full-time job is searching for funding sources to improve patient access to expensive medications. Across the country, there are thousands more nurses, social workers, and patient advocates tirelessly working to source doctor-recommended and evidence-based medications. These are inadequate safety nets. The financial and emotional cost of intricate work-around strategies is staggering for patients and the healthcare system as a whole.

A bold approach to contain the greed that profits on the backs of suffering Americans desperately needs to result from the White House and Congress discussions. Our American healthcare system is ultimately structured around guidance from the federal Centers for  Medicare and Medicaid services.  A non-governmental approach to radically change healthcare might prove to be Haven, the new organization serving employees of Amazon, Berkshire Hathaway, and JPMorgan Chase. Haven has announced that taking on excessive drug pricing within their plans is a priority.

But that private effort is not enough. What Medicare does about this issue sets the tone and direction for private insurers and defines the ground rules for the pharmaceutical industry. For that reason, Congress and the White House must take measures to rein in drug pricing by passing legislation that promotes the production of less expensive generic medications and negotiates reasonable rates for drugs still on patent protection.

Lara Ronan, MD is an Associate Professor of Neurology and Medicine at Geisel School of Medicine Dartmouth College, and Vice-Chair for Education in the Department of Neurology Dartmouth-Hitchcock. She has practiced Neuro-oncology since 2000. She is a 2019 Public Voices Fellow of the OpEd Project

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Photo License: https://creativecommons.org/licenses/by/2.0/

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