Posted 07 June 2016 | By Zachary Brennan

Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) sent five identical letters late last week to opioid overdose antidote manufacturers Pfizer, Amphastar Pharmaceuticals, Mylan, Kaléo Pharma and Adapt Pharmaceuticals with new questions on the companies’ price hikes of the life-saving drug naloxone, which has been marketed in the US for decades.

The letters, which did not cite any official figures on price increases or make any specific demands of the manufacturers, cited two recent articles, one from Politico, noting a 17-fold increase in the price of one version of naloxone, and one from Healthline, which highlighted drug shortage issues at hospitals.

Daniel Raymond, policy director at the Harm Reduction Coalition, explained to Focus that he’s heard that a few of his coalition’s programs have run out of funds a few months into 2016 because of naloxone purchases.

Raymond explained that a number of manufacturers of the sterile injectable version of naloxone dropped out of the market, leaving Pfizer’s Hospira as the sole provider. Since then, Mylan has joined in the mix, he said, but, “You need at least three or four competing generics to lower prices.”

Pfizer told Focus in a statement: "As other manufacturers have exited the Naloxone market over the years, Hospira worked hard for more than three decades to maintain the availability of this important, medically necessary product as part of our commitment to patients and physicians. We are reviewing the letter that we received late Friday afternoon from Senators Collins and McCaskill and look forward to working with the Committee on this issue."

According to a CDC report from 2015, "Forty (29.4%) respondents reported that their organization has experienced problems obtaining naloxone. Prices of intranasal naloxone more than doubled in the second half of 2014 (10) and Opioid Safety and Naloxone Network members report that cost increases are reducing the quantity of naloxone purchased and provided to laypersons."

As far as the newer intranasal and auto-injector formulations of naloxone that have been approved by the US Food and Drug Administration (FDA), Raymond said those drugs are coming in at higher prices and although they might be easier to use and offer low co-pays for consumer purchases at pharmacies, it’s a different pricing model than the price of the injectables, like those offered by Pfizer, and purchased by hospitals and community-based organizations.

Questions

The price of the off-patent drug in the US, despite being first approved by FDA in 1971, has steadily increased, from $1 per dose about a decade ago to between $30 per dose and $45 per dose at CVS pharmacies in 14 states, though the formulations of the drug have changed and made it easier to administer.

But what’s different about naloxone, which still isn’t offered as an over-the-counter drug in the US, as opposed to other generic drugs that have been on the market for decades and remain cheap because of competition, is that even as different versions of naloxone become more available, the price of the drug continues to rise.

Amphastar, which offers a version of naloxone most frequently supplied to hospitals and emergency medical technicians across the US, said in its most recent quarterly earnings report that it’s seen its sales of the drug more than double, from $3.7 million in Q3 2014 to $10.5 million in Q3 2015 “as a result of increased unit volumes at higher average prices." Amphastar did not respond to a request for comment.

Other Companies

In July 2014, Kaléo, a privately held pharmaceutical company based in Virginia, also launched its naloxone auto-injector called Evzio, after FDA approval in April 2014, which was expedited and approved two months ahead of its Prescription Drug User Fee Act goal date, according to FDA.

In January 2015, Kaléo said it negotiated with the Clinton Health Matters Initiative, which is part of the Clinton Foundation, to offer the auto-injector “at a discount to colleges and universities, public safety organizations and community organizations,” though the actual price of what was negotiated was never disclosed.

FDA later approved another Amphastar competitor, Adapt Pharma’s Narcan nasal spray, the first FDA-approved nasal spray version of naloxone (and Amphastar is working on its own version of a nasal spray).

According to one account from June 2015, Evzio bought in a Boston CVS costs a total of $570 (co-pay was $70) while the nasal spray cost $20 ($8 co-pay).

In July 2015, Rep. Elijah Cummings (D-MD) sent a letter to Maryland state officials informing them that they might be over-paying for Amphastar’s naloxone as the price of the drug increased in Maryland by 111% between June 2014 and January 2015. Ohio and New York negotiated with Amphastar to get rebates of $6 per dose and additional rebates as any new price increases take effect.

That letter came just after FDA hosted a two-day public meeting on naloxone uptake, which also discussed the possibility of a new regulatory framework, known as the Nonprescription Safe Use Regulatory Expansion program (NSURE).

NSURE could allow the use of innovative technologies to help educate consumers about issues related to novel switch programs, though the agency said it will likely be several years before it is in place.

Chairman Collins, Ranking Member McCaskill Seek Information from Companies on Efforts to Preserve Accessibility of Opioid Overdose Reversal Drug