Drug News from Preferred Medical …
In case you missed the notice on April 1, 2020, the FDA announced the following about Janssen Pharmaceuticals:
“The Company made a business decision to permanently discontinue all Duragesic/fentanyl transdermal system. Product should be maintained on the formularies until the last batch produced expires (31 July 2021), in order to maintain continuity of the reimbursement process.”
We recently checked in with Janssen and they confirmed the manufacturing process of Duragesic patches stopped on June 30, 2020. That means availability of these namebrand patches is limited to inventory that remains in the distribution pipeline or on pharmacy shelves. If a patient presents a script for Duragesic to a pharmacy without any in stock, the pharmacist should coordinate with the prescriber to evaluate options. Physicians should already be aware of this discontinuance and proactively prescribing a generic fentanyl transdermal system available from a variety of generic manufacturers (3M Drug Delivery, Aveve, Mylan Technologies, SpecGx LLC and Mayne Pharma Group Limited) with a DAW (dispense as written) code of 0 or 3. They could also pursue an alternative medication (less powerful opioids) or a non-pharma approach (after weaning).
It is difficult to imagine another “namebrand” manufacturer taking Janssen’s place. To start with, there are massive costs for R&D and testing that has to be different enough from current products to produce a patent. Add to that the multiple generic manufacturers already engaged. Add to that the current litigation liability associated with Rx opioids. Add to that a reduced demand for opioids in general due to regulatory/statutory restrictions and prescriber/patient demands. The marketplace for fentanyl patches is a highly scrutinized shrinking market with many generic options already. Taking all of that into account, the “business decision” makes more sense.
Prices are generally lower for generic vs. namebrand products and that is true in this instance as well. For example, based on public pricing for Duragesic, the generic equivalent can be more than 50 percent less expensive. That is good news from a cost containment standpoint. The few injured workers of our clients using fentanyl patches have been using the generic equivalent in 2020.
But that isn’t the full picture …
In case you’re not familiar with the uses of a fentanyl transdermal system, the FDA label says it is “used for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.” It is often associated with cancer pain. If you keep reading, drugs.com offers an extensive list of warnings (sometimes deadly breathing problems, risk for addiction & abuse & misuse, may be deadly if taken by someone else or by accident, many drugs interact with fentanyl, and withdrawal by newborn babies can be deadly are but a few). Go to MedlinePlus for more information on uses and concerns for fentanyl patches (including the potential need to co-prescribe Naloxone).
With a product this powerful (the MME factor is 2.4, which means it is 2.4 times more potent than morphine), the discussion around the discontinuance of Duragesic could be an excellent opportunity to evaluate whether this is the most clinically appropriate tool that effectively balances risk vs. benefits for this patient’s pain management. Just as with LYRICA going off-patent in 2019, don’t focus solely on cost savings but include collaboration with the prescriber to evaluate whether this is actually the right drug for this patient.