Pharmacy Prior Authorization Criteria

Olumiant (baricitinib)

Indications for Prior Authorization

Olumiant (baricitinib)

• For diagnosis of Rheumatoid Arthritis (RA)
  Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.

  Limitation of Use: Not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

• For diagnosis of Coronavirus Disease 2019 (COVID-19)
  Indicated for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

• For diagnosis of Alopecia Areata (AA)
  Indicated for the treatment of adult patients with severe alopecia areata.

  Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

Criteria

Olumiant

*Includes attestation that a total of two TNF inhibitors have already been tried in the past, and the patient should not be made to try a third TNF inhibitor. ** For review process only: Refer to the table in the Background section for carrier-specific formulary adalimumab products ^ Olumiant may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Rheumatoid Arthritis

• Diagnosis of moderately to severely active rheumatoid arthritis
AND
• Prescribed by or in consultation with a rheumatologist
AND
• Minimum duration of a 3-month trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [2, 3]:
• methotrexate
• leflunomide
• sulfasalazine
AND
• Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, certolizumab pegol, etanercept, golimumab)
AND
• One of the following:
• All of the following:
• Trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*
• Cimzia (certolizumab pegol)
• Enbrel (etanercept)
• One formulary adalimumab product**
• Simponi (golimumab)
• Rinvoq (upadacitinib)
• Xeljanz/XR (tofacitinib/ER)
AND
• Trial and failure, contraindication, or intolerance to BOTH of the following:
• Actemra (tocilizumab)
• Orencia (abatacept)
OR
• For continuation of prior therapy, defined as no more than a 45-day gap in therapy
AND
• Not used in combination with other Janus kinase (JAK) inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine or cyclosporine)^

Olumiant

^ Olumiant may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Rheumatoid Arthritis

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1-3]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
AND
• Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine or cyclosporine)^

Olumiant

Prior Authorization, Non Formulary

Length of Approval: 14 Day(s)
For diagnosis of Coronavirus disease 2019 (COVID-19)

• Diagnosis of COVID-19
AND
• Patient is hospitalized
AND
• Patient requires one of the following:
• Supplemental oxygen
• Non-invasive mechanical ventilation
• Invasive mechanical ventilation
• Extracorporeal membrane oxygenation (ECMO)

Olumiant

*Olumiant may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Alopecia Areata

• Diagnosis of alopecia areata
AND
• Patient has at least 50% scalp hair loss [1, 4]
AND
• Other causes of hair loss have been ruled out (e.g., androgenetic alopecia, trichotillomania, other scalp disease) [4]
AND
• Prescribed by or in consultation with a dermatologist
AND
• Not used in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, cyclosporine, or potent immunosuppressants (e.g., azathioprine)*

Olumiant

*Olumiant may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids (equivalent to 10 mg or less of prednisone daily).

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Alopecia Areata

• Patient demonstrates positive clinical response to therapy
AND
• Not used in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or potent immunosuppressants (e.g., azathioprine)*

P & T Revisions

2024-12-02, 2024-06-24, 2024-05-30, 2024-04-23, 2024-04-04, 2024-03-06, 2023-11-30, 2023-07-06, 2023-04-05, 2023-01-31, 2022-10-23, 2022-08-05, 2022-06-29, 2022-06-02, 2022-04-24, 2022-03-01, 2021-09-17, 2021-07-01, 2021-04-08, 2020-09-15, 2020-08-11, 2020-03-17, 2019-12-02, 2019-10-23

References

1. Olumiant Prescribing Information. Eli Lilly and Company. Indianapolis, IN. June 2022.
2. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2015;68(1):1-25.
3. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. 2021;73(7):924-939.
4. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med 2022;386:1687-99.

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Revision History

• 2024-12-02: Update to remove manufacturer information from "one formulary adalimumab product"; updated background table
• 2024-06-24: No criteria changes; updated background table to specify BI manufacturer for adalimumab-adbm
• 2024-05-30: Updated background table to include CalPERS formulary; no criteria changes
• 2024-04-23: Annual review - no criteria changes
• 2024-04-04: Annual review - no criteria changes
• 2024-03-06: Updated verbiage in the RA step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
• 2023-11-30: Removed drug-specific non-formulary criteria; in alopecia criteria, updated examples listed for "other causes of hair loss have been ruled out"; updated reauth verbiage to "patient demonstrates"
• 2023-07-06: Addition of Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred step options for RA; Updated examples of TNF inhibitors to list generic names
• 2023-04-05: Annual review - no criteria changes; background updates
• 2023-01-31: Addition of Amjevita as another preferred step option for RA
• 2022-10-23: Addition of Enbrel as another preferred step option for RA. Addition of previous TNF requirement for RA based on the labeling. Addition of further clinical detail for RA conventional step and reauth criteria.
• 2022-08-05: Addition of criteria for alopecia areata
• 2022-06-29: Added Non-Formulary criteria for new COVID-19 criteria.
• 2022-06-02: Addition of criteria for COVID-19; updated the RA concomitant use criterion to align with the label; background updates
• 2022-04-24: Annual review - no criteria changes; background updates
• 2022-03-01: Updated NF COT criteria to include documentation of positive response to therapy.
• 2021-09-17: Update to Olumiant NF criteria.
• 2021-07-01: Addition of NF criteria
• 2021-04-08: Annual review - Removed drug name from a reauth criterion; background and reference updates
• 2020-09-15: Formulary strategy update to remove Simponi Aria as a preferred step option for RA
• 2020-08-11: Addition of internal note to clarify criterion regarding concomitant use with potent immunosuppressants.
• 2020-03-17: Annual review - no clinical changes; updated references
• 2019-12-02: Addition of 1 mg GPI.
• 2019-10-23: Added Rinvoq (upadacitinib) as a step option for RA.

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