Loading...

PHARMACY POLICY STATEMENT Arkansas PASSE - OpenPayer

CurrentCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Arkansas PASSE

Defines medical-benefit coverage criteria, prior authorization, dosing, quantity limits, allowed sites of service, and not medically necessary indications for Inflectra (infliximab-dyyb) for Arkansas PASSE members under CareSource.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeNew policy (created 10/03/2019); effective 01/01/2022

Effective DateJan 1, 2022

Next Review Date

Key ActionPrior authorization is required for Inflectra as a non-preferred medical benefit product; approval contingent on meeting the indication-specific clinical criteria and prior therapy requirements.

SourceLink

POLICY UPDATE CHANGES

New policy for Inflectra created on 10/03/2019.

6Covered Indications (major categories listed)

45Not medically necessary indications listed

1200 mgQuantity limit per dose

Coverage Summary

Inflectra (infliximab-dyyb) is designated a non-preferred infliximab biosimilar and is covered only under the medical benefit with prior authorization required. Coverage is contingent on specialist prescribing (rheumatologist, gastroenterologist, or dermatologist as specified per indication), documented negative TB test (PPD or IGRA) within 12 months prior to initiation, and documented trial and treatment failures or contraindications to preferred biologics (Enbrel and Humira) as specified by indication. Dosing and quantity limits apply per policy (e.g., 5 mg/kg at weeks 0, 2, and 6 then every 8 weeks for most indications; 3 mg/kg schedule for RA; quantity limit 1200 mg (120 units) per dose); higher doses/frequencies require medical necessity justification. Allowed sites of service include office/non-hospital outpatient facility. This policy and scope apply to Arkansas PASSE CareSource members.

Initial Therapy Criteria (by indication)

General coverage prerequisites

Inflectra is non-preferred and covered under the medical benefit only when ALL of the following are met:

ALL of the following

General coverage prerequisites
- Drug is prescribed for a clinically diagnosed covered disease state listed in this policy (e.g., AS, CD, PsO, PsA, RA, UC).
- Prior authorization is obtained (Prior Authorization Required - Non-Preferred Product).
- Medication is prescribed by a specified specialist according to the indication (rheumatologist, gastroenterologist, or dermatologist as specified per disease state).
- Member has a documented negative TB test (PPD or IGRA) within 12 months prior to starting therapy.
- Member has documented trial and treatment failures or contraindications to preferred products (Enbrel and Humira) as specified per indication.
- Dosing and quantity limits must be within policy-allowed dosages; any higher doses or frequencies require medical necessity documentation.
  Quantity limit 1200 mg (120 units) per dose as stated in policy.

Ankylosing Spondylitis (AS) - Initial authorization

Covered when ALL of the following are met:

ALL of the following

Ankylosing Spondylitis (AS) - Initial authorization
- Member is 18 years of age or older.
- Documented negative TB test (PPD or IGRA) within 12 months prior to starting therapy.
- Medication prescribed by a rheumatologist.
- Member has had back pain for 3 months or more that began before age 50.
- At least one sign/symptom of Spondyloarthritis

Crohn's Disease (CD) - Initial authorization (pediatric and adult non-fistulizing)

Covered when ALL of the following are met:

ALL of the following

Crohn's Disease (CD) - Initial authorization (pediatric and adult non-fistulizing)
- Age and disease activity criteria
  - Member age 6-17 with moderately to severely active CD defined by PCDAI > 30.PCDAI > 30
  - Member age 18 or older with moderately to severely active non-fistulizing CD defined by CDAI > 220 and < 400.CDAI > 220 and < 400
- Prior immunomodulator/corticosteroid therapy

Crohn's Disease (CD) - Initial authorization (fistulizing)

Covered when ALL of the following are met:

ALL of the following

Crohn's Disease (CD) - Initial authorization (fistulizing)
- Member is 18 years of age or older with fistulizing CD.
- Member has documented trial and failure of or contraindication to Humira; treatment failure = at least 12 weeks.
- Documented negative TB test within 12 months prior to starting therapy.
- Medication prescribed by a gastroenterologist.

Psoriasis (PsO) - Initial authorization

Covered when ALL of the following are met:

ALL of the following

Psoriasis (PsO) - Initial authorization
- Member is 18 years of age or older.
- Documented negative TB test (PPD or IGRA) within 12 months prior to starting therapy.
- Medication prescribed by a dermatologist or rheumatologist.
- Member has psoriasis for 6 months or longer.
- Member will not receive systemic therapy or phototherapy while on Remicade (Inflectra).

Psoriatic Arthritis (PsA) - Initial authorization

Covered when ALL of the following are met:

ALL of the following

Psoriatic Arthritis (PsA) - Initial authorization
- Member is 18 years of age or older.
- Documented negative TB test (PPD or IGRA) within 12 months prior to starting therapy.
- Medication prescribed by a rheumatologist or dermatologist.
- Clinical scenarios (at least one)
  - Predominantly axial disease indicated by radiographic evidence (sacroiliitis or spondylitis).

Rheumatoid Arthritis (RA) - Initial authorization

Covered when ALL of the following are met:

ALL of the following

Rheumatoid Arthritis (RA) - Initial authorization
- Member is 18 years of age or older with moderate to severe active RA.
- Documented negative TB test (PPD or IGRA) within 12 months prior to starting therapy.
- Medication must be used in combination with methotrexate or, if intolerant, another immunosuppressant (e.g., azathioprine, hydroxychloroquine, cyclosporine).
- Medication prescribed by a rheumatologist.

Ulcerative Colitis (UC) - Initial authorization

Covered when ALL of the following are met:

ALL of the following

Ulcerative Colitis (UC) - Initial authorization
- Age and disease activity criteria
  - Member age 6-17 with moderate to severe active UC defined by PUCAI >= 35.PUCAI >= 35
  - Member age 18 or older with moderate to severe UC defined by Mayo score >= 6 with endoscopy subscore 2 or 3.Mayo score >= 6 with endoscopy subscore 2 or 3
- Documented negative TB test (PPD or IGRA) within 12 months prior to starting therapy.

Continuation / Reauthorization Criteria (by indication)

Ankylosing Spondylitis (AS) - Reauthorization

Covered for additional 12 months when ALL of the following are met:

ALL of the following

Ankylosing Spondylitis (AS) - Reauthorization
- Member is in compliance with all initial criteria.
- Retested for TB with a negative result within the past 12 months.
- Chart notes document improvement of signs and symptoms of disease.

Crohn's Disease (CD) - Reauthorization

Covered for additional 12 months when ALL of the following are met:

ALL of the following

Crohn's Disease (CD) - Reauthorization
- Must have been retested for TB with a negative result within the past 12 months.
- Member must be in compliance with all other initial criteria.
- Chart notes document improvement of signs and symptoms; documented improvement in PCDAI or CDAI score.PCDAI or CDAI improvement

Psoriasis (PsO) - Reauthorization

Covered for additional 12 months when ALL of the following are met:

ALL of the following

Psoriasis (PsO) - Reauthorization
- Member is in compliance with all initial criteria.
- Retested for TB with a negative result within the past 12 months.
- Chart notes document improvement of signs and symptoms (e.g., documented PASI improvement).

Psoriatic Arthritis (PsA) - Reauthorization

Covered for additional 12 months when ALL of the following are met:

ALL of the following

Psoriatic Arthritis (PsA) - Reauthorization
- Member is in compliance with all initial criteria.
- Retested for TB with a negative result within the past 12 months.
- Chart notes document improvement of signs and symptoms of disease.

Rheumatoid Arthritis (RA) - Reauthorization

Covered for additional 12 months when ALL of the following are met:

ALL of the following

Rheumatoid Arthritis (RA) - Reauthorization
- Member is in compliance with all initial criteria.
- Retested for TB with a negative result within the past 12 months.
- Chart notes document improvement of signs and symptoms of disease.

Ulcerative Colitis (UC) - Reauthorization

Covered for additional 12 months when ALL of the following are met:

ALL of the following

Ulcerative Colitis (UC) - Reauthorization
- Must have been retested for TB with a negative result within the past 12 months.
- Member must be in compliance with all other initial criteria.
- Chart notes document improvement of signs and symptoms of disease.