In January 2010, Genentech/Roche received FDA approval for a new interleukin-6 (IL-6) receptor inhibitor Actemra (tocilizumab) indicated for the treatment of adult patients with moderately-to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
•How is Actemra administered and dosed? It is a 1-hr IV infusion administered every 4 weeks (in a healthcare provider setting). It can be used alone or in combination with methotrexate or other non-biologic DMARDs. The recommended dosing range is 4-8 mg/kg (dose can be increased to 8 mg/kg based on clinical response); doses exceeding 800 mg per infusion are not recommended.
•Are there any risks associated with Actemra use? Actemra label contains a black box warning on the risk of serious infections that may lead to hospitalization or death; appropriate monitoring is recommended. Other serious ADRs include gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. A REMS program exists to address these issues.
•Was Actemra compared to other agents in clinical trials?
Approval was based on 5 phase III multicenter trials in patients with moderate to severe disease, including those naïve to MTX and those who have had inadequate response to MTX, >=1 DMARD, or TNF inhibitors. In these trials, Actemra was used alone or in combination with MTX other DMARDs, where at the dose of 8 mg/kg 50-70% of patients achieved ACR20, 29-44% achieved ACR50, and 12-28% achieved ACR70 at week 24 (lower response rates were observed with the 4mg/kg dose). Although there were no direct comparisons to current anti-TNF therapy, there are currently studies underway evaluating Actemra as first-line treatment in early moderate-to-severe RA.
•What is the cost of Actemra? Some news sources state that the price will range from $1060-$2025 per patient/per month, depending on the dose used (AWP has not been released in the public domain).
•Is Acemra part of a limited specialty pharmacy distribution program? Certain specialty pharmacies distribute Acemra. The
Genentech Access Solution Line can provide specific information. Specialty pharmacies include: Accredo, Aetna Specialty Pharmacy, BioScrip, Caremark, MMS Solutions, Icore, Precision Rx, Right source Rx, Tel Drug/ Cigna, Walgreens, Diplomat.
Actemra was launched 1/18/10. A policy comparison, including Actemra prior authorization criteria will be forthcoming, as policies become publically available.
Sources:
Genentech press release 1/10
Actemra REMS program
Actemra prescribing information
Trials registered with NIH
News article 1/10