Zohydro ER – The New Actiq

CMS, Commentary, Medicare Set-Aside Blog, Rx/Pharmacy on April 4, 2014 | Posted by Jennifer Jordan, JD, MSCC

Yesterday MEDVAL did its first MSA evaluation for a California applicant taking Zohydo ER. We were genuinely shocked as this drug was not even expected to hit the market until March so we didn’t really anticipate seeing it included in MSAs until maybe the end of the year, if at all if common sense prevailed. The average wholesale price hasn’t even been posted to RedBook yet. But here we are.

Zohydro ER, a hydrocodone bitartrate extended-release capsule, was approved by the FDA on October 25, 2013 for the “management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.” It is a Schedule II controlled substance and the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product. Note that the FDA approved this drug despite strong objections by its advisory board that voted 11-2 against it, and this is the first time that the FDA has ever done that. Black Box Warnings issued by the FDA for Zohydro ER include abuse potential; life-threatening respiratory depression; fatal overdose if accidentally ingested by children; potential neonatal opioid withdrawal syndrome; and avoidance of alcohol or alcohol containing products.

Zohydro will be manufactured in an easily crushable capsule and contain up to 50 milligrams of pure hydrocodone. That’s 10 times the amount of hydrocodone contained in a regular Vicodin. Short of easing end of life suffering or severe acute pain, there is no medical indication that can justify the use of a self-administered pill that packs enough hydrocodone in one pill to kill a child. Reports also state that 2 pills could kill an adult lacking opioid tolerance. Anyone in this much pain should be on a morphine pump and not popping pills at their discretion like candy.

On March 27, 2014, the Governor of Massachusetts declared a public health emergency in response to the growing opioid addiction epidemic. Among the four mandates, one expressly prohibits the prescribing and dispensing of any hydrocodone-only formulations [recall above when I mentioned that this was the first ever approved by the FDA]. When an entire state bans the use of your drug because of its obvious potential for abuse, big pharma needs to stop and think long and hard about its intent to market its drug for chronic pain.

This was taken from the FDA press release announcing the approval: “The safety of Zohydro ER is based on clinical studies of more than 1,100 people living with chronic pain. The efficacy of Zohydro ER is based on a clinical study that enrolled over 500 patients with chronic low back pain and showed significant improvement in chronic pain compared to placebo.” Yes and my car runs better when I use gas as opposed to water. Seriously?

So WC adjusters be on the lookout. Without RedBook we can’t be sure what price CMS will be using, but the manufacturer’s website lists a unit cost of $7.50 so it appears it is priced very similarly to an OxyContin 30mg tablet. Schedule II drugs can only be dispensed through a physician’s written prescription and no refills are allowed so this also means more frequent office visits. If you are working in a jurisdiction that permits you to call into question the medical necessity of such a drug before approving such an expense, do so before this drug hits your payment history and will forever belong to you in the eyes of CMS.