Cigna Won’t Pay for OxyContin in 2018

By John Burke, Guest Columnist

A major health insurance company -- Cigna -- announced this week that they it is removing OxyContin from its list of approved medications and replacing it with another extended release oxycodone product.

“Our focus is on helping customers get the most value from their medications — this means obtaining effective pain relief while also guarding against opioid misuse," said Jon Maesner, Cigna's chief pharmacy officer.

OxyContin is the only opioid-based prescription painkiller that Cigna is removing in 2018 as "a preferred option" from its formulary, a list of medications that its health plans will pay for.

On the surface, this declaration might appear to be a great stride toward reducing prescription drug abuse. Cigna is replacing OxyContin with Collegium’s product, Xtampza ER, which is also an abuse deterrent extended release oxycodone product. 

My problem with this announcement is that OxyContin, along with the other abuse deterrent formulations (ADFs), have very little abuse issues. OxyContin certainly did up until its reformulation in August 2010, but that was over 7 years ago! Since then, there is much documentation from a variety of sources that show the diversion of OxyContin has fallen extensively.

Xtampa ER and the other abuse deterrent formulations also have little to no abuse issues since they have been on the market. 

If Cigna wants to change drugs, that’s likely a financial decision and one they should make, but please don’t tout your move as striking a blow for reducing drug diversion.

It will do nothing to reduce drug diversion, since the clear majority of diversion falls into the immediate release opioids, primarily oxycodone and hydrocodone. 

What is even more concerning to me is the vilifying of any drug that hundreds of thousands of legitimate pain patients take to live a semblance of a normal life, especially when that drug does not have a recent history of abuse and diversion. It also tends to make suspect any and all abuse deterrent products, which is deceptive at best. 

One thing the abuse deterrent formulations have done is to help narrow their focus to legitimate pain patients. Those seeking to get “high” moved to immediate release opioids or black market heroin/fentanyl combinations, not the ADF products. That’s why the FDA is now considering requiring companies that produce generic opioids to develop ADF properties for their drugs. 

No matter what Cigna declares, the bottom line is that ADF’s have been successful. They are not an end all to diversion and abuse, but they do help pain patients get easier access to pain medication. I am hoping that is everybody’s ultimate goal. 

John Burke recently retired after nearly 50 years in drug and law enforcement in southwestern Ohio.

John is a former president of the National Association of Drug Diversion Investigators and current president of the International Health Facility Diversion Association.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Approves New Version of Oxycodone

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new extended released version of the opioid painkiller oxycodone that has abuse deterrent properties unlike anything else on the market.

The drug – called Xtampza – can be ingested in capsule form, but users can also sprinkle the capsule contents on soft foods or into a cup, and then directly into the mouth.

The medication, which can also be ingested through a feeding tube, is the sixth opioid pain medication with an abuse deterrent formula to be approved by the FDA.  

Xtampza is made by Massachusetts-based Collegium Pharmaceutical (NASDAQ: COLL) with proprietary technology that combines oxycodone with fatty acid and waxes to form small spherical beads that are placed inside the capsule.

The beads are designed to resist breaking, crushing, chewing, dissolving and melting, methods long used by drugs abusers to snort or inject opioids.  

collegium pharmaceutical image

That novel approach is different from other abuse deterrent formulas, which generally make it harder for tablets to be crushed or liquefied; or come with a chemical irritant to discourage tampering.

“The FDA approval of Xtampza ER is a major milestone for Collegium. Our DETERx technology platform was developed internally and our lead product completed an extensive battery of abuse-deterrent testing consistent with the FDA Guidance on Abuse-Deterrent Opioids,” said Michael Heffernan, CEO of Collegium.

Another advantage of Xtampza is that it gives an alternative to patients who have trouble swallowing tablets or capsules, a condition know as dysphagia.  

"People like me live with dysphagia that prevents us from swallowing normally all the time. Up until this new drug coming out, people not able to swallow have had to rely on liquids and patches for relief - not being able to take their oxycodone," said PNN columnist Ellen Lenox Smith, who suffers from Ehlers Danlos syndrome and sarcoidosis. She testified in favor of Xtampza's approval for the U.S. Pain Foundation.

"Although this is a medication not compatible to my body, I testified on it's behalf for those people around the country not able to take their medications and thus not getting the relief they deserve. I am thrilled that this got approved so soon and that people will have this as an option and hope that this safer  formula will help to calm the nerves of all the people out there concerned about addiction to opiates," Smith said.

“Xtampza ER also allows for flexible dosing administration for patients with difficulty swallowing. Patients or their caregivers often inadvertently crush their medication to facilitate swallowing, which can be very dangerous with currently marketed ER products,” said Dr. Jeffrey Gudin, Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center.

Xtampza, which is designed to be taken twice a day by patients who need around-the-clock pain relief, comes with an FDA warning to take the medication with food. Taking it on an empty stomach could lead to inadequate pain control.

Collegium plans to launch Xtampza ER in the U.S. in mid-2016 with five dosage strengths equivalent to 10 mg, 15 mg, 20 mg, 30 mg and 40 mg oxycodone.