WHA

OLUMIANT (baricitinib)

Self-Administration – oral tablet

 

Indications for Prior Authorization:

 

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. 

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). 

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. 

 

Coverage Criteria:

 

For diagnosis of Rheumatoid Arthritis (RA):

  • Documented diagnosis of moderately to severely active RA; 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: 
    • methotrexate 
    • leflunomide 
    • sulfasalazine
    • hydroxychloroquine; 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: 
    • Both 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) 
        • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz 
        • Rinvoq (upadacitinib) 
        • Simponi (golimumab) 
        • Xeljanz/XR (tofacitinib/ER) 
      • Trial and failure, contraindication, or intolerance to BOTH of the following:
        • Actemra (tocilizumab) 
        • Orencia (abatacept) 
    • For continuation of prior Olumiant 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)**

 

For diagnosis of Coronavirus disease 2019 (COVID-19):

  • Documented 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)

 

For diagnosis of Alopecia Areata (AA):

  • Documented diagnosis of AA; AND
  • Prescribed by or in consultation with a dermatologist; AND
  • Patient has at least 50% scalp hair loss; AND
  • Other causes of hair loss have been ruled out (e.g., androgenetic alopecia, trichotillomania, tinea capitis, psoriasis); AND
  • Not used in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, cyclosporine, or potent immunosuppressants (e.g., azathioprine)**

 

* 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.

**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).

 
Reauthorization Criteria:

 

For diagnosis of RA:

  • Documentation of positive clinical response to therapy as evidenced by at least one of the following:
    • 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)**  

 

For diagnosis of AA:

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

**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).

 

Dosing:

 

RA (adults): 

  • 2 mg once daily.

 

AA: 

  • 2 mg once daily. Increase to 4 mg once daily, if the response to treatment is not adequate.
  • For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4 mg once daily.
    • Reduce the dose to 2 mg once daily when an adequate response has been achieved.

 

Coverage Duration:

 

RA, AA:

  • Initial: 1 year
  • Reauthorization: 1 year

COVID-19:

  • 14 days

 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 

Additional Information:
  • Olumiant for COVID19 is only for inpatient hospital use.
  • Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.

 

Policy Updates:
  • 02/18/2020 – New policy approved by P&T.
  • 04/01/2022 – Updated criteria.  Addition of criteria for the trial and failure of one or more TNF inhibitors due to the JAK safety update.
  • 08/16/2022 - Updated criteria to reflect P&T ad hoc decision.
  • 01/01/2023 – Update prerequisite drugs for RA; update use duration for prerequisite drugs; update coverage duration of initial authorization; add criteria for AA, COVID19; add reauthorization criteria for all indications.  (P&T 11/15/2022)
  • 09/01/2023 - Addition of Amjevita, Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred options for RA; Updated examples of TNF inhibitors to list generic names. (P&T 08/15/2023).
  • 11/14/2023 – Update Hyrimoz preferred agent to Sandoz manufacturer only.

 

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. 
  5. Meah N, Wall D, York K, et al. The Alopcia Areata Consensus of Experts (ACE) study: results of an international expert opinion on treatments for alopecia areata. J Am Acad Dermatol. 2020;83(1):123-130. 

Last review date: November 14, 2023