Soaring Prices Limit Access to Lifesaving Drug, Experts Say

Nancy A. Melville

December 08, 2016

Ongoing efforts to develop policies that increase access to the lifesaving opioid overdose drug naloxone (multiple brands) must address skyrocketing price increases, a critical factor that is undermining these efforts, experts say.

"We believe that policies [to increase the availability of naloxone] should explicitly call on manufacturers to reduce the price of naloxone and increase transparency regarding their costs, particularly those related to the development of new formulations," the authors of a commentary published online December 8 in the New England Journal of Medicine write.

Several formulations of naloxone are available. These include formulations that allow the drug to be taken by injection, autoinjection, and nasal spray. Each formulation has essentially only one supplier, and recent price hikes reflect a lack of competition. The commentary authors, led by Joseph S. Ross, MD, note the following:

  • The price for the 0.4 mg/mL dose injections sold mainly by Hospira has increased 129% since 2012.

  • The price of 1 mg/mL injections made by Amphastar and used off label as a nasal spray saw a 95% increase in 2014 to the current price of $39.60.

  • A newer and easier-to-use nasal spray formulation, Narcan (Adapt Pharma), costs $150 for two spray-doses.

  • The two-dose autoinjector formulation Evzio (Kaleo), introduced in 2014 as a fixed-dose injection that is easy to use by people without medical training, skyrocketed in price from $690 in 2014 to its current price of $4500, an increase of more than 500%.

They add that in the case of Evzio, the staggering price increase for the autoinjector was made just before the the Centers for Disease Control and Prevention released guidelines recommending that clinicians coprescribe naloxone to patients being treated with opioids and benzodiazepines concurrently, in addition to patients receiving higher opioid dosages or those with a history of overdose or substance use disorder.

Most manufacturers do offer discount programs to make naloxone more affordable to patients and community organizations. Kaleo, for example, offers a savings program for Evzio. The program provides the product at no cost to anyone with commercial insurance, even if their insurance does not cover the drug, as well as to those with no commercial drug coverage who qualify as having financial need.

Adapt Pharma has a partnership with the Clinton Foundation to provide a free Narcan kit to every high school in the United States. It also offers a "public interest price" to state police, first responders, and state or local government agencies when purchasing in bulk.

But those measures, though beneficial, ultimately do not decrease drug prices. In fact, in Kaleo's case, they are the reason for the price increases. According to Kaleo's vice-president of corporate affairs, Mark Herzog, the price hike on Evzio was necessary to cover the losses incurred through the savings program.

"In the first 18 months following the launch of Evzio, more than 60% of physicians' prescriptions for Evzio were never filled, denying patients' access to this potentially lifesaving medication," he told Medscape Medical News. Herzog attributed the low rates to insurance coverage restrictions and high out-of-pocket costs.

"To cover the cost of this program for patients, we increased the list price for Evzio," he added.

Death Spiral?

But according to Dr Ross, the need to increase a product's price in order to sustain the discount program sets up a highly troublesome cycle.

"To me, this suggests they are in a 'death spiral' that further questions the long-term use of discount programs," Dr Ross, associate professor of medicine and of public health at the Yale University School of Medicine and School of Public Health, in New Haven, Connecticut, told Medscape Medical News.

"If the drug is too expensive, the need for the discount program grows. As it grows, the company increases the drug price. As the price continues to rise, more people need the discount program...where does this end?"

Among those left paying the full price are insurance companies, meaning the high cost is ultimately passed on to the public through higher premiums, said Dr Ross, who has taken on the issue of drug company discounts and coupons in a previous article published in the New England Journal of Medicine.

"Coupons and savings programs are a temporary solution at best, but at worst are used as an excuse to justify high drug prices while passing on the rising costs to insurers, who in turn will pass them along to beneficiaries in future years," Dr Ross said.

Herzog countered that negotiated prices and discounts are factored into the true cost to the healthcare system.

"It is important to note that the list price for a pharmaceutical product is not a true gauge of the cost to the healthcare system, as it does not account for the numerous rebates, discounts, charge-backs, and various price concessions that are routinely negotiated by the various stakeholders," he said.

"The actual price, after these rebates and discounts, is the true net price of the drug to the insurance company."

Herzog added that since the implementation of the savings program, the percentage of prescriptions filled for Evzio has more than doubled.

Altogether, Kaleo has donated more than 150,000 autoinjectors to more than 250 first-responder agencies, public health departments, and nonprofit community groups across 34 states, he said.

"Based on voluntary reports from Kaleo's donation program grantees, more than 2000 lives have been saved with the help of Evzio, or an average of approximately 20 lives per week since October 2014," Herzog said.

Not a Permanent Fix

Discounts and donations are tenuous by nature and therefore are not ideal as long-term solutions for cities plagued with opioid overdose deaths, said Baltimore City Health Commissioner Leana Wen, MD, in testimony before the House Oversight and Government Reform Committee last March in a hearing on the heroin and opioid abuse epidemic.

"Last year we were fortunate enough to receive a generous donation from a pharmaceutical company," she said. "But we cannot be dependent forever on the generosity and donations from companies.

"We have to have the medication that is a generic medication and is on the World Health Organization's list of essential medications available to everyone so that we can save lives," Dr Wen added.

Ravi Gupta, first author of the New England Journal commentary, noted that the 2016 Comprehensive Addiction and Recovery Act, if funded by Congress, would include a plan to provide state grants to purchase naloxone, but again, such a measure would provide only temporary relief.

"Limited funds for a limited time period do not offer a sustainable solution to state/local governments struggling to simultaneously pay for naloxone and other needed public services," Gupta, a fourth-year medical student at Yale University School of Medicine, told Medscape Medical News.

"The actual problem of high naloxone prices remains."

Alternative Solutions

The authors suggest other options for reducing naloxone prices, including the government's purchasing the drug in bulk or invoking a federal law ― federal law 28 USC, section 1498 ― to contract to produce less costly versions in exchange for reasonable royalties.

The government considered invoking that law to obtain ciprofloxacin during the anthrax threat in 2001, Gupta noted. "This led the manufacturer to guarantee an adequate supply of ciprofloxacin and a price discount."

In addition, naloxone was recently approved as an over-the-counter drug in Canada on condition of approval by its provinces. This move could be beneficial not only in expanding patient access to the drug but also in attracting additional manufacturers, the authors note.

Large drug store chains, including Walgreens and CVS, have started selling naloxone without a prescription in various states, but the lack of a prescription could result in customers paying more, Kelly J. Clark, MD, president-elect of the American Society of Addiction Medicine, told Medscape Medical News.

"Making naloxone available over the counter may have unintended consequences," she said. "Typically, health plans do not cover the cost of over-the-counter medications, which would make it more expensive for people to obtain naloxone than if they could utilize their insurance."

She added that the importance of public access needs to be considered when it comes to the pricing of lifesaving drugs.

"While all new technological advances, including those in pharma, typically come with increased pricing needed to support the investment in their research and development, it is imperative that naloxone be easily and readily available in the community to help save lives of those who unintentionally overdose."

Sharp increases in other prescription drugs and products, perhaps most notoriously involving Mylan, the manufacturer of the EpiPen, which also makes injectable naloxone, have led to efforts to control costs in a number of states, including Vermont and California, as well as to the proposed, bipartisan-supported Fair Accountability and Innovative Research Drug Pricing Act.

Although US senators Susan Collins (R-Maine) and Claire McCaskill (D-Mo) sent a letter on behalf of the Senate Aging Committee to naloxone manufacturers requesting explanations for the price increases, public outrage over the issue has not come close to that expressed in response to other drug increases, possibly reflecting the stigma of involvement with opioid addiction, the authors note.

"Preventing individuals from becoming addicted to heroin and prescription opioids would obviously be the best solution," Gupta said.

"However, when individuals are overdosing, they should undoubtedly have access to affordable naloxone to save their lives, which is ultimately a moral imperative."

Dr Ross, Dr Kelly, and Ravi Gupta have disclosed no relevant financial relationships.

N Engl J Med. Pulished online December 8, 2016. Full text

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