Common Drug Review
The Canadian Agency for Drugs and Technologies in Health posted the Canadian Drug Expert Committee (CDEC) final recommendation for its first review of a subsequent entry biologic on its website yesterday. Below is an excerpt from the CDEC Final Recommendation.
Recommendation:
The Canadian Drug Expert Committee (CDEC) recommends that Inflectra (infliximab subsequent entry biologic [SEB]) be listed in accordance with the Health Canada–approved indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, and psoriatic arthritis, if the following conditions are met:
Conditions:
- For use in patients for whom infliximab is considered to be the most appropriate treatment option.
- List in a manner similar to Remicade.
Reasons for the Recommendation include:
- Two randomized controlled trials (RCTs) demonstrated that Inflectra and Remicade have similar efficacy, safety, and pharmacokinetic (PK) profiles in patients with rheumatoid arthritis and ankylosing spondylitis
- Extrapolation of the data from rheumatoid arthritis and ankylosing spondylitis to psoriatic arthritis and psoriatic plaques is supported by the similar pathophysiology of these conditions and the identical dosage regimen for infliximab for these indications.
- At the submitted price ($650.00 per 100 mg vial), Inflectra is less costly than Remicade ($987.56 per 100 mg vial) for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic plaques, and psoriatic arthritis.
For more information please see the CDEC Final Recommendation on the CADTH Website