CurrentAvMedPolicy N/A

Cimzia SQ

Pharmacy prior authorization/step-edit form and clinical criteria for coverage of Cimzia (certolizumab) subcutaneous across multiple labeled indications; specifies required prior therapies, prescriber specialty, documentation, and specialty pharmacy provision. It also states that concomitant biologic immunomodulators are not permitted.

Policy Summary

PayerAvMed

PolicyCimzia SQ

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescribing physician must sign and clearly print name on request; fax completed form to 1-305-671-0200 with all documentation (labs, diagnostics, chart notes) to avoid delays.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes

8Indications with criteria (listed)

90 daysEstablished-on-Cimzia verification period

130 daysClaims lookback window for 90-day supply

Coverage Summary

This policy is a pharmacy prior authorization/step-edit for Cimzia® SQ (certolizumab) that is covered with criteria across multiple labeled indications and requires submission of the form with prescriber signature and supporting documentation. The request must be completed and faxed with required labs, diagnostics, and chart notes (per prescriber signature and documentation requirements), dispensing is handled by the specialty pharmacy Proprium Rx, and use of samples to initiate therapy does not meet step edit/preauthorization criteria.

Key thresholds and timelines

Established on CimziaAt least 90 days on Cimzia AND pharmacy claims show at least a 90-day supply dispensed within the past 130 days

Polyarticular JIA weight threshold>= 40 kg (88 lbs)

DMARD trial durationAt least three (3) months of a DMARD trial

NSAID trial countFailed, contraindication, or intolerance to TWO NSAIDs

General Criteria

General

All criteria must be met for approval. Documentation (labs, diagnostics, chart notes) must be provided to support each checked line.

ALL of the following

Use of concomitant therapy with more than one biologic immunomodulator for same or different indications is experimental/investigational and not permitted
Examples include Dupixent, Entyvio, Humira, Rinvoq, Stelara

Prescribing physician must sign and clearly print name on request; fax completed form to 1-305-671-0200 with all documentation (labs, diagnostics, chart notes) to avoid delays.

Moderate-to-Severe Crohn's Disease - Approval Criteria

Moderate-to-Severe Crohn's Disease (CD) - Approval Criteria

Covered when ALL of the following are met:

ALL of the following

Member has a diagnosis of moderate-to-severe Crohn's disease
Prescribed by or in consultation with a Gastroenterologist
ONE of
- Member has tried and failed budesonide or high dose steroids unless there is a contraindication or intolerance
- ALL of the following
  - 5-aminosalicylates (balsalazide, olsalazine, sulfasalazine)
  - oral mesalamine (Apriso, Asacol/HD, Delzicol, Lialda, Pentasa)
- Member has previously tried and failed at least one biologic medication other than the requested medication (e.g., Humira, Rinvoq, Stelara)
ONE of
- ALL of the following
  - Preferred adalimumab product
  - Skyrizi ®
  - Tremfya ®
  - Preferred ustekinumab product
  - Zymfentra ™
- Member has been established on Cimzia ® for at least 90 days AND prescription claims history indicates at least a 90-day supply of Cimzia was dispensed within the past 130 days (verified by chart notes or pharmacy paid claims)

Active Psoriatic Arthritis - Approval Criteria

Covered when ALL of the following are met:

ALL of the following

Member has a diagnosis of active psoriatic arthritis
Prescribed by or in consultation with a Rheumatologist
ALL of the following
- cyclosporine
- leflunomide
- methotrexate
- sulfasalazine
ONE of
- ALL of the following
  - Preferred adalimumab product
  - Enbrel ®
  - Otezla ® /Otezla XR ™
  - Rinvoq ® / Rinvoq ® LQ
  - Skyrizi ®
  - Taltz ®

Moderate-to-Severe Rheumatoid Arthritis - Approval Criteria

Covered when ALL of the following are met:

ALL of the following

Member has a diagnosis of moderate-to-severe rheumatoid arthritis
Prescribed by or in consultation with a Rheumatologist
ALL of the following
- hydroxychloroquine
- leflunomide
- methotrexate
- sulfasalazine
ONE of
- ALL of the following
  - Preferred adalimumab product
  - Enbrel ®
  - Rinvoq ®
  - Preferred tocilizumab product: Actemra ® SC or Tyenne ® SC
  - Xeljanz ® /XR ®
- Member has been established on Cimzia ® for at least 90 days AND prescription claims history indicates at least a 90-day supply of Cimzia was dispensed within the past 130 days (verified by chart notes or pharmacy paid claims)

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Provider Actions / Prior Authorization Requirements

Prior Authorization

Submit signed prior authorization/step-edit request

Prescribing physician must sign and clearly print name (preprinted stamps not valid) on the request. Fax the completed form with all documentation (labs, diagnostics, chart notes) to 1-305-671-0200 to avoid delays.

Documentation Required

Support prior therapy and failures

Provide chart notes or pharmacy paid claims to verify prior therapies, contraindications, intolerances, and dates. Previous therapies will be verified through pharmacy paid claims or submitted chart notes; include all documentation (labs, diagnostics, chart notes) to support each checked line.

Billing Rule

Specialty pharmacy dispensing

Medication is provided by Specialty Pharmacy Proprium Rx. Use of samples to initiate therapy does not meet step edit/preauthorization criteria.

Documentation Required

Concomitant biologic prohibition

Do not prescribe Cimzia concomitantly with another biologic immunomodulator for the same or different indications; combinations of more than one biologic immunomodulator are considered experimental/investigational and will not be permitted.

Documentation Required

Administration requirement for doses <200 mg

For doses less than 200 mg (no patient self-administration form available), administration must be by a health care professional using the vial kit. The provider must submit the request to the SHP medical department for these doses.

Definitions

Established on Cimzia: Member has been on Cimzia for at least 90 days and pharmacy claims show at least a 90-day supply dispensed within the past 130 days.

This is a form-based pharmacy prior authorization that requires the prescribing physician to sign and clearly print their name on the request and to fax the completed form with supporting documentation (labs, diagnostics, chart notes) to 1-305-671-0200; incomplete or illegible information may delay authorization. The form documents required prior therapies, prescriber specialty/consultation, and clinical criteria, notes that the medication is provided by the specialty pharmacy Proprium Rx, and explicitly states that samples cannot be used to satisfy step edits/preauthorization criteria.

OpenPayer

Cimzia SQ

Coverage Summary

General Criteria

Moderate-to-Severe Crohn's Disease - Approval Criteria

Active Psoriatic Arthritis - Approval Criteria

Moderate-to-Severe Rheumatoid Arthritis - Approval Criteria

Active Non-Radiographic Axial Spondyloarthritis - Approval Criteria

Active Ankylosing Spondylitis - Approval Criteria

Moderate-to-Severe Plaque Psoriasis - Approval Criteria

Active Polyarticular Juvenile Idiopathic Arthritis - Approval Criteria

Provider Actions / Prior Authorization Requirements

Applicable Codes

Definitions

Revision History