Kaléo Pharmaceuticals has dramatically increased the cost of an easy-to-use injection device for the opioid overdose reversal drug known as naloxone, and lawmakers believe the price hike could put lives at risk.
US Senator Kirsten Gillibrand (D-New York) and 31 other senators issued a stinging rebuke and call for answers on February 8 after the details of the price increase emerged.
The device, known as Evzio, was listed at $690 in 2014. It now reportedly costs $4,500. The drug company has previously said that it is increasing prices on products to meet the rising costs of manufacturing.
While it is true that naloxone has increased in price -- now somewhere around $150 per 10cc vial -- the senators pointed out that this does not come anywhere close to the near 700 percent increase on Evzio instituted by the company.
"At a time when Congress has worked to expand access to naloxone products and to assist state and local communities to equip first responders with this life-saving drug, this startling price hike is very concerning," the senators wrote in a letter to Kaléo Pharmaceuticals CEO Spencer Williamson.
As is standard for this kind of product, the company has provided free devices to first responders and drug treatment programs. Despite this gesture, Forbes notes:
With the supply of Evzio now depleted since last July, and patients often unable to afford the device if their insurance doesn’t participate to give them a $0 copay as they have advertised, the public will be left scrambling, just as occurred with the EpiPen drama this past fall.
In the letter, senators ask three specific questions of Kaléo. They ask the firm to clearly demonstrate its pricing structure and how it justifies this price increase, to quantify how many products it sets aside for donation and how it has informed customers of its donation programs and to reveal the "total amount Evzio received in reimbursements from the federal government in the past 12 months."
This latter point is a crucial one, as lawmakers have consistently argued that they should not -- and will not -- provide incentives, reimbursements or advantageous to firms that make massive profits from treating sick people.
As Care2 has previously explored, the opioid crisis represents an ongoing problem for the United States, and recent figures suggest that more than 52,000 people died from opioid overdose in 2015.
There is plenty of evidence to show that naloxone kits, when affordable, are an effective means of preventing opioid overdose deaths. However, insurers have indicated that, as with other drugs, they may no longer cover this vital overdose reversal drug because they simply cannot absorb increased cost.
Senators have begun to examine pharmaceutical pricing with increasing scrutiny, from the Turing Pharmaceuticals debacle of a few years ago to the ongoing issue of the EpiPen price hike that has left many parents distressed and scrambling for alternatives for their children.
Of course, drug firms are correct in saying that they must price competitively and with a mind to future development -- however that is not what appears to be happening in some cases.
Rather, certain companies seem to be using US law to ensure they are the only ones who can market key products. After an initial marketing period featuring low prices -- at which point the drug becomes the go-to option for consumers -- the company then raises the cost, often several times over.
This kind of practice is not only deeply disturbing in terms of business operations -- competitive pricing should provide lower costs to consumers -- but it is also ethically troubling. People may not be able to afford life-saving medicines.
In a separate but politically relevant comment, Senator Angus King noted his puzzlement as to why no Republican lawmakers signed the letter. In the past, issues involving pharmaceutical industry practices have garnered bipartisan support. King has said he always aims to cultivate both Republican and Democratic support in these circumstances to show that this is not a political issue, but rather one of fair treatment for consumers.
While it could simply be a matter of outrage fatigue as lawmakers have repeatedly pressed companies to justify price hikes, a lack of Republican support this time around may highlight the Trump administration’s impact. Trump heavily supports further deregulation, which could exacerbate what lawmakers have called "outrageous" price hikes.
A lack of congressional action on this issue would be a bitter pill to swallow and threatens to leave consumers at the mercy of price gouging.