Indication(s)
Symptomatic relief of major depressive disorder (MDD), generalized anxiety disorder (GAD), neuropathic pain associated with diabetic peripheral neuropathy (DPN), fibromyalgia, chronic low back pain (CLBP) and osteoarthritis (OA) of the knee.
Formulary status
The Drug Advisory Committee (DAC) recommended generic duloxetine be listed on the following WSIB formularies: persistent pain (02WS), central nervous system (03WS), burn (05WS), psychotraumatic injury (22WS), and chronic pain disability (23WS).
The WSIB has decided to accept the DAC recommendation.
Generic duloxetine (strengths: 30 mg, 60 mg capsules) is listed on WSIB formularies 02WS, 03WS, 05WS, 22WS and 23WS.
Drug profile
Products available in Canada:
Cymbalta®, generic duloxetine delayed- release products
Recommendation highlights
- Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI).
- External, independent reviews of randomized controlled studies in conditions relevant to WSIB have shown that, versus placebo, duloxetine is effective in reducing pain scores associated with OA of the knee, somewhat effective in fibromyalgia, and mixed results have been found in the treatment of CLBP. One study investigated the use of duloxetine in central neuropathic pain and reported no difference between the drug and placebo.
- Duloxetine has not been compared to any other pain-relieving medication in good-quality randomized controlled trials for CNCP.
- Clinical guidelines for neuropathic pain recommend duloxetine, along with other SNRIs, tricyclic antidepressants, and gabapentinoids as first line option.
- In the treatment of depression, SNRIs, such as duloxetine, have been identified as effective and safe in randomized controlled trials and key clinical guidelines.
- The daily cost of generic duloxetine in the treatment of MDD and CNCP is slightly more than other formulary alternatives that have also been proven effective and safe. There are no pharmacoeconomic studies evaluating the cost effectiveness of generic duloxetine.
- The Ontario Drug Benefit Program lists duloxetine as “general benefit”.
- Based on the published evidence and the introduction of generic duloxetine, the DAC recommended formulary addition of generic duloxetine.
Original date: February 16, 2009
Update: October 18th, 2015
Update: June 30th, 2016
The WSIB will consider all relevant facts and circumstances, and shall make its decision based upon the merits and justice of a particular case.
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