How Can U.S. Fight the Opioid Crisis? Try Antidote Patents

(Bloomberg) -- The Trump administration should fight the opioid epidemic with a novel weapon, say the city of Baltimore and a consumer advocacy group: overriding patents on the widely-used overdose antidote naloxone.

By overriding patents for naloxone treatments including Kaleo Inc.’s injectable Evzio and Adapt Pharma Inc.’s Narcan nasal spray, the government could lower the cost and increase availability of the antidote, Baltimore’s health department and Public Citizen said in a letter to the White House on Thursday.

“They can choose to lower prices and make these products available, accessible, and save lives,” Robert Weissman, president of Public Citizen, said at a press conference in Washington on Thursday. “Or they can choose not to offend Big Pharma, and let people die for no reason at all except their political consideration for the pharmaceutical industry.”

Overdoses from opioids -- including prescription drugs, heroin and the synthetic drug fentanyl -- kill 115 Americans every day, according to the Centers for Disease Control. The U.S. Surgeon General has advised that more Americans carry doses of naloxone, which could lead to shortages and could burden local governments that supply their employees and the public.

Anthrax Precedent

The U.S. government has authority to make or buy a patented invention without the permission of the patent holder, in exchange for reasonable compensation. When it does so, the patent holder cannot block use of the patent, and government contractors or subcontractors cannot be held liable for infringement.

The federal government has used this tactic in the past to increase availability of drugs to protect public health. In 2001, in the wake of anthrax attacks that killed five people, including two postal workers, it threatened to override Bayer AG’s patent on Cipro, the most powerful drug to treat anthrax.

Kaleo in early 2017 raised the price of a two-pack of Evzio to $4,500 from $690. The price of a Narcan two-pack has been steady at $150 since its 2015 introduction, but vials of generic naloxone are significantly cheaper. Adapt provides some buyers, such as first responders, a 50 percent discount on Narcan, but others don’t have the same access.

Pricey Antidote

“The problem in Baltimore is not the policy. It’s the price,” Baltimore Health Commissioner Leana Wen said at Thursday’s event. She said all 620,000 Baltimore residents should have naloxone in their medicine cabinets, “and we should be able to provide it to them.” But even with the city’s discounted price of $75 per Narcan kit, that would cost $47 million a year, while the city has budgeted only $1 million annually to spend on the antidote.

In Baltimore, first responders have reversed more than 10,000 overdoses since 2015, according to its health department. City residents, meanwhile, have used naloxone to save more than 1,800 lives.

“It’s really crazy that it costs five to 10 times more to save my life than it does for me to lose it,” Perry Hopkins, 57, a Baltimore resident who required three doses of Narcan to be revived after an overdose eight months ago, said at the press conference. Hopkins said he’d been drug free since the incident.

Baltimore and Washington-based Public Citizen made their suggestion in a letter to Kellyanne Conway, the White House adviser asked by President Donald Trump to lead the administration’s response to the opioid addiction epidemic, an issue that Trump has campaigned on.

Lengthy Patents

“Kaleo agrees that the out-of-pocket cost can be a major barrier to access to naloxone,” said Jennifer Corrigan, a Kaleo spokeswoman. Any Baltimore citizen with insurance can get Evzio at no out-of-pocket cost through Kaleo’s direct delivery service, even if the insurance company doesn’t cover it. Baltimore residents without insurance who earn less than $100,000 annually also can get Evzio at no cost to them. Kaleo, which is based in Richmond, Virginia, has donated more than 30,000 Evzio auto-injectors to the city since 2014.

Health and Human Services Secretary Alex Azar has acknowledged that drug prices are too high, HHS said in an email. The department has developed a five-point strategy to address the opioid epidemic, it said, with one point including increasing access to overdose-reversing drugs.

Officials at the White House and at Radnor, Pennsylvania, based Adapt, which is closely held, didn’t immediately respond to requests for comment.

Fourteen Doses

Seven patents protect Narcan through their expiration in March 2035, according to the U.S. Food and Drug Administration’s registry of information on approved drugs. Evzio is protected by 25 patents, the latest of which expires in July 2034.

The drugs have been successful in reviving people who’ve overdosed on heroin or prescription drugs, but the synthetic opioid fentanyl often requires far more doses to have the same effect -- in at least one incident, a patient required 14 doses to be revived.

Fentanyl overdoses have surged more than 500 percent since 2013, killing roughly 20,000 people in the U.S. in 2016 and outpacing deaths from heroin, according to the National Institutes of Health.

In certain circumstances, the FDA could approve a generic version of a drug in six months or less, though most applications take several years, according to information on the agency’s website.

Bayer’s Cipro

Such federal intervention wouldn’t be unprecedented.

The federal government used its power to obtain cheaper generic drugs in the 1960s, according to a 2016 report by researchers at Yale University.

In 2001, following the anthrax attacks in the U.S., the administration of President George W. Bush considered overriding Bayer’s patent on Cipro, the most powerful drug to treat the infection.

The threat worked. Bayer cut the price of Cipro in half, to 95 cents a pill for the first 100 million tablets, followed by 100 million for 85 cents and 100 million for 75 cents. The company at the time said it would still make a profit on the drug.

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