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Cost of overdose drug could hamper access in Maryland and elsewhere

Price increases may hamper access to a drug that reverses overdoses.

The price of a drug that has saved the lives of more than 800 people overdosing on heroin or other opioids in Baltimore is rising rapidly.

The antidote known as naloxone revives addicts after they've stopped breathing, with either a simple spray in their nose or an injection.

The use of naloxone is a centerpiece of Baltimore public health officials' wide-ranging efforts to battle the growing heroin epidemic, but the rising price of the antidote could constrain the campaign to stop or at least slow the rate of overdose deaths.

"We shouldn't be priced out of saving lives," said Dr. Leana Wen, Baltimore's health commissioner. "In a time of a public health emergency, we should be making it more affordable and available."

Instead, the price of a popular injectable version jumped 500 percent in the past two years and the cost of a nasal spray used in Baltimore has increased nearly 63 percent. The drug makers say consumers rarely pay the list price and that sales also go to fund charitable programs to give the drug away.

Wider use of naloxone could save even more people, health officials say, but the price increases are leaving hard-hit cities like Baltimore in a constant scramble to purchase and distribute the drug without breaking the bank.

Eye-popping drug price increases have become more common, including the widely publicized 500 percent price increase for EpiPens, used for severe allergic reactions, and a 5,000 percent jump for Daraprim, an antiparasitic. Congress and local legislatures, including in Maryland, are investigating the price increases and considering various remedies.

Price hikes can be problematic for people with private and public health insurance, but for the large number of the city's addicts who rely on Medicaid, the public health program for low-income people, the burden falls on the state and federal government. In Maryland, Medicaid has paid more claims for naloxone every quarter for the past two years, paying 4,631 claims last year compared with 921 claims in 2015.

To pay for the drug in the meantime, local health officials are seeking government grants, charitable gifts and donations of free drugs from manufacturers — or squeezing department budgets.

Several manufacturers say they have extensive rebate and donation programs, but Wen and other health officials say this system is unreliable and unsustainable. The Baltimore City Health Department has received grants, but it also spent $118,236 for 3,340 doses in fiscal 2016. That was up from $33,540 for 1,540 doses in fiscal 2014 — an increase of almost 63 percent per dose.

Baltimore is far from alone. The opioid addiction epidemic that began largely with prescription painkillers such as oxycodone and morphine but now centers more on cheaper, illicit heroin and the more powerful fentanyl has affected cities, towns and counties large and small.

The Open Society Institute gave $25,000 in 2015 to equip Baltimore police with naloxone after hearing the force was lagging behind neighboring county forces in training and use of the drug because of costs, said Scott Nolen, director of the Baltimore nonprofit's drug addiction treatment program.

The institute also funded other groups to train the public to use naloxone. Additional grants are possible, but, Nolen said, the institute won't be able to pay the recurring costs as supplies are used and expire.

"There is a constant need," he said. "And the rising costs over the last couple of years is really concerning."

Baltimore has some of the biggest needs in Maryland. About a third of all the state's drug- and alcohol-related deaths occurred in the city in recent years, and fatalities from heroin and fentanyl in particular continue to mount. In the first nine months of 2016, the latest data available, there were 481 overdose deaths in Baltimore, up from 393 the year before.

Wen, Nolen and others do not consider naloxone the answer to the opioid addiction epidemic, but they say it's a crucial to keeping people alive long enough to get into addiction treatment.

Some cities and states, including Baltimore and Maryland, have passed legislation to permit standing prescriptions of naloxone so people with training can get the drug at any time from a pharmacy, and to give legal protection to clinicians and bystanders who administer it. The U.S. Centers for Disease Control and Prevention also now advises doctors who prescribe opioids to also prescribe naloxone to some patients. And a landmark federal drug treatment law passed last year calls for expanded access to naloxone.

Health departments and nonprofit groups across Maryland have been supplying the antidote to individuals trained to administer it. More people appear to be keeping it on hand, according to Maryland's Medicaid program, whose recipients make up a disproportionate number of those in the state who overdose.

Medicaid charges recipients a $1 co-pay for the drug but gives it away for free to those who can't afford to pay, said Shannon McMahon, a deputy Maryland health secretary. She wouldn't say how much the program pays for naloxone because the price is negotiated and the state receives various rebates. She said the state would continue making the drug available.

When asked about the price increases, drug makers said they provide many free and discounted doses of naloxone to ensure first responders, health departments and even consumers get a reasonable deal.

Kaleo Inc. had the biggest price increase on its two-pack auto-injector of naloxone called Evzio, which jumped to $4,500 from $690 in 2014, according to an article published in December in the New England Journal of Medicine.

Kaleo CEO Spencer Williamson said the price increase helps pay for a patient access program launched a year ago that eliminates co-pays for some with insurance and makes the injectors free for some without.

"To date, we have donated nearly 200,000 naloxone auto-injectors to public health departments, first responders and non-profits serving patients in need, including 20,000 to the City of Baltimore," he said in a statement. "We have never turned away a health department who has submitted an application for a donation and look forward to helping other health departments in the future."

Hospira's injectable version of the drug, a 10-dose vial, more than doubled to $142.49 last year from $62.29 in 2012. Pfizer Inc., which bought Hospira in 2015, said in a written statement that the list prices don't reflect far lower prices many people pay for its product, which is meant to be used by medical providers. The company also has committed to donate 1 million doses over four years.

Amphastar, which makes a version that Baltimore City uses as a spray with an atomizer, has nearly doubled in price to $39.60 from $20.34 in 2009. The company could not be reached for comment.

Adapt, whose Narcan nasal spray has remained $125 for two doses since it was approved in 2015, said about three-quarters of those with insurance only have a $10 co-pay or less. The company offers discounts for those paying out-of-pocket.

Nonetheless, the costs still may be limiting access and may not be sustainable, according to the New England Journal of Medicine article.

Newer formulations have led to increases in the cost of naloxone, first approved in 1971, wrote researchers from Yale University's School of Medicine in Connecticut and the Mayo Clinic in Minnesota.

With all the attention paid to the drug epidemic and the recommendations for use of naloxone, the researchers wrote that they expected a large jump in its use. But naloxone prescriptions grew only to 3.2 million in 2015 from 2.8 million in 2009.

"The relatively slow adoption of naloxone may be due in large part to stigmatization and lack of familiarity with the treatment among clinicians and opioid users," the researchers wrote in the article. "Another reason, however, may be its rising cost, which is probably enabled by the small number of manufacturers producing it."

The researchers suggested directly calling on manufacturers to reduce prices and explain price increases. They also said the U.S. government could use the same strategy it has used with vaccines and buy naloxone from manufacturers in bulk to create stable demand and encourage new entrants to the market. The government also could contract with a manufacturer to produce a less costly version of the drug for reasonable royalties, an approach used for the antibiotic ciprofloxacin during the 2001 anthrax scare.

Other options would be allowing importation of generic naloxone from international manufacturers, offering other manufacturers incentives to seek approval to market generic naloxone products, and allowing the drug to be sold over the counter.

Unless more attention is given to the prices and not just training and availability, said Ravi Gupta, a fourth-year medical student at Yale who co-authored the Journal article, "it's certainly possible that local and state governments will pull back on their use of naloxone because of its costs."

meredith.cohn@baltsun.com

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