WHA

RINVOQ (upadacitinib)

Self-Administration – oral 

 

Indications for Prior Authorization:

 

Rheumatoid Arthritis (RA): Indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Use of Rinvoq in combination with other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended. 

Psoriatic Arthritis (PsA): Indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Use of Rinvoq/Rinvoq LQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended. 

Ankylosing Spondylitis (AS): Indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Use of Rinvoq in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended. 

Atopic Dermatitis (AD): Indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. Limitations of Use: Rinvoq is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants. 

Crohn's Disease (CD): Indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Rinvoq is not recommended for use in combination with other JAK inhibitors, biological therapies for Crohn’s disease, or with potent immunosuppressants such as azathioprine and cyclosporine.

Ulcerative Colitis (UC): Indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Rinvoq is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis, or with potent immunosuppressants such as azathioprine and cyclosporine.

Non-radiographic axial spondyloarthritis (nr-axSpA): Indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. Limitations of Use: Rinvoq is not recommended for use in combination with other JAK inhibitors, biological DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.

Polyarticular Juvenile Idiopathic Arthritis (PJIA): Indicated for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Use of Rinvoq/Rinvoq LQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended.

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
  • Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants such as azathioprine and cyclosporine.*

 

For diagnosis of psoriatic arthritis (PsA):

  • Documented diagnosis of active PsA; AND
  • One of the following:
    • actively inflamed joints 
    • dactylitis 
    • enthesitis 
    • axial disease 
    • active skin and/or nail involvement; AND
  • Prescribed by or in consultation with a dermatologist or rheumatologist; AND
  • Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, certolizumab pegol, etanercept, golimumab); AND
  • Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants such as azathioprine and cyclosporine.*

 

For diagnosis of ankylosing spondylitis (AS):

  • Documented diagnosis of active AS; AND
  • Prescribed by or in consultation with a rheumatologist; AND
  • Minimum duration of one-month trial and failure, contraindication, or intolerance to TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, indomethacin, meloxicam, diclofenac) at maximally tolerated doses; AND
  • Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, certolizumab pegol, etanercept, golimumab); AND
  • Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine or cyclosporine).*

 

For diagnosis of atopic dermatitis (AD):

  • Documented diagnosis of moderate-to-severe atopic dermatitis; AND
  • Patient is 12 years of age or older; AND
  • Patient meets one of the following:
    • Involvement of at least 10% body surface area (BSA) 
    • SCORing Atopic Dermatitis (SCORAD) index value of at least 25; AND
  • Prescribed by or in consultation with one of the following:
    • Dermatologist 
    • Allergist/Immunologist; AND
  • Trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to at least ONE of the following:
    • Medium or higher potency topical corticosteroid 
    • Pimecrolimus cream 
    • Tacrolimus ointment 
    • Eucrisa (crisaborole) ointment; AND
  • Patient meets one of the following:
    • Trial and failure of a minimum 12-week supply of at least one systemic drug product for the treatment of atopic dermatitis (e.g., Dupixent [dupilumab], etc.)
    • Patient has a contraindication, intolerance, or treatment is inadvisable with Dupixent (dupilumab); AND
  • Not used in combination with other JAK inhibitors, biologic immunomodulators (e.g., Dupixent), or potent immunosuppressants such as azathioprine and cyclosporine. *

 

For diagnosis of Ulcerative Colitis (UC):

  • Diagnosis of moderately to severely active UC; AND
  • Diagnosis confirmed by a gastroenterologist; AND
  • One of the following:
    • Greater than 6 stools per day 
    • Frequent blood in the stools 
    • Frequent urgency 
    • Presence of ulcers 
    • Abnormal lab values (e.g., hemoglobin, ESR, CRP) 
    • Dependent on, or refractory to, corticosteroids; AND
  • Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies:
    • 6-mercaptopurine
    • Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
    • azathioprine
    • corticosteroids (e.g., prednisone, methylprednisolone, budesonide) 
  • Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, golimumab); AND
  • Not used in combination with other JAK inhibitors, biological therapies for UC, or with potent immunosuppressants (e.g., azathioprine, cyclosporine).*

 

For diagnosis of Non-radiographic Axial Spondyloarthritis (nr-axSpA):

  • Documented diagnosis of active nr-axSpA; AND
  • Prescribed by or in consultation with a rheumatologist; AND
  • Patient has objective signs of inflammation (e.g. C-reactive protein [CRP] levels above the upper limit of normal, or sacroiliitis on magnetic resonance imaging [MRI], indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints); AND
  • Minimum duration of one-month trial and failure, contraindication, or intolerance to TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, indomethacin, meloxicam, diclofenac) at maximally tolerated doses; AND
  • Patient has had an inadequate response or intolerance to a TNF inhibitor (e.g., certolizumab pegol); AND
  • Not used in combination with other JAK inhibitors, biological DMARDs, or potent immunosuppressants (e.g., azathioprine, cyclosporine).*

 

For diagnosis of Crohn’s disease (CD):

  • Diagnosis of moderately to severely active CD; AND
  • Prescribed by or in consultation with a gastroenterologist; AND
  • One of the following:
    • Frequent diarrhea and abdominal pain
    • At least 10% weight loss
    • Complications such as obstruction, fever, abdominal mass
    • Abnormal lab values (e.g., C-reactive protein [CRP])
    • CD Activity Index (CDAI) greater than 220; AND
  • Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies:
    • 6-mercaptopurine
    • azathioprine
    • corticosteroids (e.g., prednisone, methylprednisolone, budesonide)
    • methotrexate; AND
  • Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, certolizumab pegol); AND
  • Not used in combination with other JAK inhibitors, biological therapies for Crohn’s disease, or with potent immunosuppressants (e.g., azathioprine, cyclosporine).*

 

For diagnosis of polyarticular juvenile idiopathic arthritis (PJIA):

  • Diagnosis of active polyarticular juvenile idiopathic arthritis (PJIA), AND
  • Prescribed by or in consultation with a rheumatologist, AND
  • Minimum duration of a 6-week trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses: 
    • leflunomide 
    • methotrexate; AND
  • Patient has had an inadequate response or intolerance to one or more TNF inhibitors (e.g., adalimumab, etanercept), AND
  • Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine or cyclosporine)*

 

* Rinvoq 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 PsA:

  • 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, pruritus, inflammation) from baseline 
    • Reduction in the body surface area (BSA) involvement from baseline; AND
  • Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine or cyclosporine). *  

 

For diagnosis of AS:

  • Documentation of positive clinical response to therapy as evidenced by improvement from baseline for least one of the following: 
    • Disease activity (e.g., pain, fatigue, inflammation, stiffness) 
    • Lab values (erythrocyte sedimentation rate, C-reactive protein level) 
    • Function 
    • Axial status (e.g., lumbar spine motion, chest expansion) 
    • Total active (swollen and tender) joint count; AND
  • Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine or cyclosporine).*  

 

For diagnosis of AD:

  • Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
    • Reduction in BSA-involvement from baseline
    • Reduction in SCORAD index value from baseline; AND
  • Not used in combination with other JAK inhibitors, biologic immunomodulators (e.g., Dupixent), or potent immunosuppressants (e.g., azathioprine or cyclosporine).*  

 

For diagnosis of UC, CD:

  • Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
    • Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline 
    • Reversal of high fecal output state; AND
  • Not used in combination with other JAK inhibitors, biologic therapies for UC, or potent immunosuppressants (e.g., azathioprine or cyclosporine).*  

 

For diagnosis of nr-axSpA:

  • Documentation of positive clinical response to therapy as evidenced by improvement from baseline for least one of the following: 
    • Disease activity (e.g., pain, fatigue, inflammation, stiffness) 
    • Function 
    • Lab values (erythrocyte sedimentation rate, C-reactive protein level) 
    • Axial status (e.g., lumbar spine motion, chest expansion) 
    • Total active (swollen and tender) joint count; AND
  • Not used in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine or cyclosporine).*  

 

For diagnosis of PJIA:

  • 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)*

 

* Rinvoq 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, AS, nr-axSpA (adults):

  • 15 mg once daily.

PsA (adults and pediatrics):

  • Adults (18 years of age and older): 15 mg once daily
  • Pediatric patients (2 years to 17 years of age): 
    • 10 to <20 kg: Oral solution: 3 mg twice daily
    • 20 to <30 kg: Oral solution: 4 mg twice daily
    • ≥30 kg:
      • Oral solution: 6 mg twice daily
      • Extended-release tablet: 15 mg once daily

PJIA (Children 2 years of age and older and Adolescents):

  • 10 to <20 kg: Oral solution: 3 mg twice daily.
  • 20 to <30 kg: Oral solution: 4 mg twice daily.
  •  ≥30 kg:
    • Oral solution: 6 mg twice daily
    • Extended-release tablet: 15 mg once daily

AD (adults and pediatrics):

  • Adults (less than 65 years of age): Initiate treatment with 15 mg orally once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg orally once daily.
  • Pediatric patients (12 years of age and older and weighing at least 40 kg): Initiate treatment with 15 mg orally once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg orally once daily.
  • Adults (65 years of age and older): Recommended dosage is 15 mg once daily.

 

UC (adults):

  • The recommended induction dosage: 45 mg once daily for 8 weeks. 
  • The recommended maintenance dosage: 15 mg once daily. 
    • A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.
  • Discontinue Rinvoq if adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.

 

CD (adults):

  • The recommended induction dosage: 45 mg once daily for 12 weeks.
  • The recommended maintenance dosage: 15 mg once daily.
    • A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.
  • Discontinue Rinvoq if adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.

 

Coverage Duration:

 

RA, PsA, AS, nr-axSpA:

  • Initial: 1 year.
  • Reauthorization: 1 year.

 

UC, CD, AD, PJIA:

  • Initial: 6 months.
  • Reauthorization: 1 year.

 

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 Committee.

 

Additional Information:
  • Rinvoq initiation is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, absolute neutrophil count (ANC) less than 1,000 cells/mm3, or hemoglobin level less than 8 g/dL.
  • Patients should be tested for latent tuberculosis before Rinvoq use and during therapy. Treatment for latent infection should be considered prior to Rinvoq use.
  • Rinvoq LQ oral solution is not substitutable with Rinvoq extended-release tablets
  • Changes between Rinvoq LQ oral solution and Rinvoq extended-release tablets should be made by the health care provider
  • Rinvoq LQ should be administered using the provided press-in bottle adapter and oral dosing syringe
  • Rinvoq LQ is dosed twice daily
     

 

Policy Updates:
  • 02/18/2020: Original review 
  • 12/11/2020: Annual review. Criteria and format updated
  • 04/20/2021: Initial approval duration updated from 3 months to 1 year
  • 04/05/2022: New criteria for new indication of PsA. Addition of criteria for the trial and failure of one or more TNF inhibitors due to the JAK safety update.
  • 05/17/2022: New criteria approved by P&T for UC and AS. Updated oral DMARD examples supported in guidelines to treat AD. Updated format.
  • 07/05/2022 - Updated UC criteria. Updated wording about trial of preferred agent to match other immunomodulators for UC. 
  • 08/16/2022 - Updated UC and AS criteria to match the manufacturer's limitation of use.
  • 01/01/2023 – Add criteria for nr-axSpA; add reauthorization criteria for all indications; update prerequisite drugs for RA, PsA, AS; add symptom requirements for PsA, UC. (P&T 11/15/2022)
  • 06/01/2023-Class review for systemic atopic dermatitis medications. Updated criteria and prerequisite drugs for the AD criteria.
  • 09/01/2023 - Updated examples of TNF inhibitors to list generic names. Addition of criteria for CD. (P&T 08/15/2023)
  • 09/01/2024 – Update PsA to include pediatric patients. Addition of PJIA indication and Rinvoq LQ formulation (P&T 08/20/2024) (P&T Meeting August)

 

References:
  1. Rinvoq Prescribing Information. AbbVie Biotechnology Ltd. North Chicago, IL. April 2024. 
  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. Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis. Arthritis Rheumatol. 2019;71(6):846-863. 
  5. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32. 
  6. Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/spondyloarthritis research and treatment network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613. 
  7. Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG clinical guideline: management of Crohn's disease in adults. Am J Gastroenterol. 2018;113:481-517. 
  8. Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021;160(7):2496-2508. 
  9. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413. 
  10. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterol. 2020;158:1450-1461. 
  11. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014; 71(1):116-32. 
  12. European Task Force on Atopic Dermatitis. Severity scoring of atopic dermatitis: the SCORAD index. Consensus report of the European Task Force on atopic dermatitis. Dermatology. 1993; 186:23-31. 
  13. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet 2017; 389(10086)(suppl):2287-2303. 
  14. Oranje AP. Practical issues on interpretation of scoring atopic dermatitis: SCORAD index, objective SCORAD, patient-oriented SCORAD and three-item severity score. Curr Probl Dermatol. 2011; 41:149-55.

Last review date: September 1, 2024