Friday, July 17, 2009

New Fentanyl REMS – FDA Adds Pain to Pain Relief

The U.S. FDA announced approval yesterday (7/16/09) of a new buccal-soluble fentanyl product (Onsolis®) to treat breakthrough cancer pain in opioid-tolerant adults. The strong opioid medication, fentanyl, is embedded in a dime-sized film that adheres to the user’s cheek and is absorbed through the mouth’s mucus membranes. Having an added treatment option for severe pain would be good news were it not for very extensive restrictions surrounding the product’s prescribing and distribution.

Since Onsolis, as with all opioids, may be misused or abused, it is subject to the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program, requiring the drugmaker to have a plan for managing risks. The FDA claims there are special risks with transmucosal fentanyl products, although they have not provided data to fully explain this. Nevertheless, this new product will only be available through a restricted-distribution program called FOCUS (Full Ongoing Commitment to User Safety). Complying with the FOCUS Program includes: [also see Onsolis Q&A]

  • Each prescriber and patient must complete an enrollment process for the FOCUS Program. Prescribers must become trained and pass a qualifying test of competency. Patients must study provided educational materials. Qualified prescribers and patients are entered into a database at a FOCUS program support center.

  • Registered prescribers fax prescriptions for Onsolis to the FOCUS support center to start the verification process and also send via courier an original, hardcopy prescription for Onsolis to a FOCUS-authorized pharmacy. There will be a limited number of participating pharmacies in each part of the country (not community pharmacies).

  • Meanwhile, the patient receives a followup counseling call from the FOCUS support center to be certain the patient is properly qualified and all educational materials and instructions were understood.

  • The FOCUS pharmacy must confirm that the patient and prescriber are active in the FOCUS program database and the patient-counseling call has been successfully completed. If everything is in order, and the original, hardcopy prescription has been received, the FOCUS pharmacy dispenses Onsolis and ships the medication directly to the patient’s home via a secure courier. The whole process is expected to take no more than 5-days. (Inpatient facilities — hospitals, nursing homes, hospices — cannot participate.)

During a hastily-called conference call, not announced to the general public, FDA representatives conceded that the FOCUS program was not field tested in advance. So, it is completely unknown if the program will work and how many prescribers, patients, or pharmacies might be willing to overcome the obstacles of time and inconvenience to qualify — or whether it will actually minimize drug misuse and abuse. The sponsor of Onsolis has been charged with the burden of gathering necessary data to assess and justify the program’s effectiveness.

An added barrier may be cost. The FDA does not seem to concern itself with costs; however, there surely will be much added expense to the drug’s sponsor and the entire healthcare system for the FOCUS program, which no doubt will be passed along to consumers. Will insurance plans pay the price? Or, will Onsolis be a product for elite patients who can qualify and afford it?

And, according to the FDA, similar REMS programs will be extended to the two other approved transmucosal fentanyl formulations — Actiq® and Fentora®. The agency hopes, but cannot demand, that the individual manufacturers will cooperate in a unified approach to avoid 3 separate (and incompatible?) REMS programs.

Is this a harbinger of what lies ahead for a REMS under consideration by the FDA that will cover extended-release opioids? The FDA claims that, since Onsolis is much different than extended-release opioids, they do not foresee the FOCUS program setting a precedent for other types of opioids. They also have stated in the past that their objective with REMS is to reduce opioid medication misuse, abuse, overdose, and addiction while maintaining access to opioid analgesics for all patients with pain who need them. However, the FOCUS program may be indicative of the lengths to which the FDA is willing to go, a mindset of sorts, to achieve their REMS mission. And, to some, this may be viewed as tantamount to limiting access, as well as adding much pain to pain relief in America.

What do you think? (Add a comment.)