Biologic agents for Rheumatoid Arthritis - policy criteria

[chantell.reagan]

Based on the popularity of our previous analyses, we extended the review of biologic agents to rheumatoid arthritis (RA). The latest treatment guidelines in this therapeutic area were issued by the American College of Rheumatology (ACR) in 2008. According to these guidelines, TNF-antagonists (Enbrel, Humira, Remicade) are recommended interchangeably in the following patients with RA:

•As first-line therapy in patients with early RA and high disease activity
•As second-line therapy (after MTX) in patients with intermediate/longer-acting RA and high disease activity or moderate disease activity in the presence of features of poor prognosis
•As third-line therapy (after MTX combo or sequential DMARDs) in patients with intermediate/longer-acting RA and moderate to high disease activity

Orencia and Rituxan are recommended as third-line therapy (after MTX combo or sequential DMARDs) in patients with intermediate/longer-acting RA and moderate to high disease activity in the presence of features of poor prognosis. Combinations of biologic agents was not recommended.

In an analysis of 6 regional and national plans, most plans use “failure of at least 1 DMARD” in their criteria for TNF-antagonists, and Orencia and Rituxan are more likely to be reserved after failure of a TNF antagonist. Additionally 5/6 plans institute quantity limits of these agents.

The following figure provides a comparative summary of the selected policies (click on the image to enlarge it).



Sources:

Blue Cross and Blue Shield of Florida. Medical coverage guidelines

The Regence Group. Enbrel policy

The Regence Group. Humira policy

The Regence Group. Orencia policy

The Regence Group. Remicade policy

BlueCross BlueShield of Alabama. Enbrel coverage criteria

BlueCross BlueShield of Alabama. Humira coverage criteria

BlueCross BlueShield of Alabama. TNF Antagonists and Other Biologics for Rheumatologic Diseases: Remicade policy

Wellpoint, NextRx. Enbrel policy

Wellpoint, NextRx. Orencia policy

Wellpoint, NextRx. Humira policy

Wellpoint, NextRx. Remicade policy

Atena. Clinical Policy Bulletin: Enbrel

Aetna. Clinical Policy Bulletin: Humira

Aetna. Clinical Policy Bulletin: Orencia

Aetna. Clinical Policy Bulletin: Remicade

Aetna. Clinical Policy Bulletin: Rituxan

Cigna. Enbrel Coverage Position

Cigna. Humira Coverage Position

Cigna Orencia Coverage Position

Cigna. Remicade Coverage Position

Cigna. Rituxan Coverage Position

[chantell.reagan]

We extended the review of biologic agents in rheumatoid arthritis (RA) to include recently-approved TNF-blockers, Cimzia (certolizumab pegol) and Simponi (golimumab). We analyzed 15 regional and national plans, 7 of which have publically available policies pertinent to this update. The following are our key findings:

•2/7 plans allow first-line use of TNF-blockers
•5/7 plans apply the same criteria for Cimzia and/or Simponi as for other TNF-blockers
•1/7 plans requires failure of a DMARD and a TNF-blocker before initiating Orencia

To view the full tabulated analysis, you must login first (if you haven't registered yet, please click here, registration is free). After you have logged-in, please scroll down and click on the attached PDF file at the bottom of this page.

Additional sources:
Aetna. Clinical Policy Bulletin: Cimzia: (see full link in the attached tabulated analysis)

Atena. Clinical Policy Bulletin: Enbrel: (see full link in the attached tabulated analysis)

Aetna. Clinical Policy Bulletin: Humira: (see full link in the attached tabulated analysis)

Aetna. Clinical Policy Bulletin: Orencia: (see full link in the attached tabulated analysis)

Aetna. Clinical Policy Bulletin: Remicade: (see full link in the attached tabulated analysis)

Aetna. Clinical Policy Bulletin: Rituxan: (see full link in the attached tabulated analysis)

Aetna. Clinical Policy Bulletin: Simponi: (see full link in the attached tabulated analysis)

BlueCross Blue Shield of Alabama. Cimzia coverage criteria: (see full link in the attached tabulated analysis)

BlueCross BlueShield of Alabama. Enbrel coverage criteria: (see full link in the attached tabulated analysis)

BlueCross BlueShield of Alabama. Humira coverage criteria: (see full link in the attached tabulated analysis)

BlueCross Blue Shield of Alabama. Simponi coverage criteria: (see full link in the attached tabulated analysis)

BlueCross BlueShield of Alabama. TNF Antagonists and Other Biologics for Rheumatologic Diseases: Medical policy: (see full link in the attached tabulated analysis)

BlueCross BlueShield of Alabama. Rituxan policy: (see full link in the attached tabulated analysis)

Blue Cross and Blue Shield of Florida. Medical coverage guidelines: (see full link in the attached tabulated analysis)

Excellus Clinical Review Prior Authorization (Orencia, Simponi): (see full link in the attached tabulated analysis)

Excellus Cimzia policy: (see full link in the attached tabulated analysis)

Excellus Enbrel policy: (see full link in the attached tabulated analysis)

Excellus Humira policy: (see full link in the attached tabulated analysis)

Excellus Remicade policy: (see full link in the attached tabulated analysis)

Excellus Rituxan policy: (see full link in the attached tabulated analysis)

The Regence Group. Cimzia policy: (see full link in the attached tabulated analysis)

The Regence Group. Enbrel policy: (see full link in the attached tabulated analysis)

The Regence Group. Humira policy: (see full link in the attached tabulated analysis)

The Regence Group. Orencia policy: (see full link in the attached tabulated analysis)

The Regence Group. Remicade policy: (see full link in the attached tabulated analysis)

The Regence Group. Simponi policy: (see full link in the attached tabulated analysis)

UnitedHealthcare, Oxford: Cimzia policy: (see full link in the attached tabulated analysis)

United Healthcare, Oxford: Enbrel policy: (see full link in the attached tabulated analysis)

United Healthcare, Oxford. Humira policy: (see full link in the attached tabulated analysis)

United Healthcare, Oxford, Orencia policy: (see full link in the attached tabulated analysis)

United Healthcare, Oxford. Remicade policy: (see full link in the attached tabulated analysis)

United Healthcare, Oxford: Simponi policy: (see full link in the attached tabulated analysis)

Wellpoint, NextRx. Cimzia policy: (see full link in the attached tabulated analysis)

Wellpoint, NextRx. Enbrel policy: (see full link in the attached tabulated analysis)

Wellpoint, NextRx. Orencia policy: (see full link in the attached tabulated analysis)

Wellpoint, NextRx. Humira policy: (see full link in the attached tabulated analysis)

Wellpoint, NextRx. Remicade policy: (see full link in the attached tabulated analysis)

Wellpoint, NextRx. Simponi policy: (see full link in the attached tabulated analysis)

[Pantablo]

Has there been any thought to updating the policy review to include Actemra in the mix as a novel agent in the class?

A NOTE FROM THE MODERATORS:

Tell us how your plan is covering Actemra.

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[chantell.reagan]

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

[diana.papshev]

Anonymous member response:

"plan to cover actemra for moderate to severe ra, same criteria as for tnf inhibitors except that pt will need to have tried and failed a tnf inhibitor"

[diana.papshev]

Anonymous response:

"We are requiring the criteria as our other biologic anti-TNFs plus the labs: ANC, platelet counts and transaminases"

[Nochmar]

In the absence of official criteria for the drug itself, we would look at it similarly to a anti-TNF; I suspect an anti-TNF drug would be recommended before going here.

[diana.papshev]

Anonymous response:

"We currently cover Actemra through the medical benefit. Our specialty team I'm sure will be evaluating for a drug policy after there is more utilization"