Subject: Xeljanz-Xeljanz XR 2011-A SGM P2021c

Drug

XELJANZ  (tofacitinib tablets; oral solution)

XELJANZ XR  (tofacitinib extended release tablets)

Policy:

      I.  INDICATIONS

           The indications below including FDA-approved indications and
           compendial uses are considered a covered benefit provided that all the
           approval criteria are met and the member has no exclusions to the
           prescribed therapy.

           A.  FDA-Approved Indications
                1.  Xeljanz/Xeljanz XR is indicated for the treatment of adult
                     patients with moderately to severely active rheumatoid arthritis
                     (RA) who have had an inadequate response or intolerance to one
                     or more tumor necrosis factor (TNF) blockers.
                2.  Xeljanz/Xeljanz XR is indicated for the treatment of adult
                     patients with active psoriatic arthritis (PsA) who have had an
                     inadequate response or intolerance to one or more TNF blockers.
                3.  Xeljanz/Xeljanz XR is indicated for the treatment of adult
                     patients with active ankylosing spondylitis (AS) who have had an
                     inadequate response or intolerance to one or more TNF blockers.
                4.  Xeljanz/Xeljanz XR is indicated for the treatment of adult
                     patients with moderately to severely active ulcerative colitis (UC)
                     who have had an inadequate response or intolerance to one or
                     more TNF blockers.
                5.  Xeljanz/Xeljanz Oral Solution is indicated for the treatment of
                     active polyarticular course juvenile idiopathic arthritis (pcJIA) in
                     patients 2 years of age and older who have had an inadequate
                     response or intolerance to one or more TNF blockers         

           B.  Compendial Uses
                1.  Oligoarticular juvenile idiopathic arthritis
                2.  Immune checkpoint inhibitor related toxicity

           All other indications are considered experimental/investigational and
           not medically necessary.

 
     II.  DOCUMENTATION

           Submission of the following information is necessary to initiate the prior
           authorization review:

           A. Rheumatoid arthritis (RA)
               1. For initial requests: Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy (if applicable).
               2. For continuation requests: Chart notes or medical record documentation supporting positive clinical response.

 
          B. Psoriatic arthritis (PsA)
              1. For initial requests: Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy.
              2. For continuation requests: Chart notes or medical record documentation supporting positive clinical response.

 
          C. Ankylosing spondylitis (AS)
              1. Initial requests: Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy (if applicable).
              2. Continuation requests: Chart notes or medical record documentation supporting positive clinical response.

 
          D. Ulcerative colitis (UC)
              1. Initial requests:
                  i. Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
                  ii. Chart notes or medical record documentation of hospitalization due to acute, severe ulcerative colitis (if applicable).
              2. Continuation requests: Chart notes or medical record documentation supporting positive clinical response to therapy or remission.

 
         E. Articular juvenile idiopathic arthritis:
             1. Initial requests: Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy (if applicable).
             2. Continuation requests: Chart notes or medical record documentation supporting positive clinical response.

         F.  Immune checkpoint inhibitor-related toxicity: Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy or intolerance to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.

 

   III. CRITERIA FOR INITIAL APPROVAL

          A.  Moderately to severely active rheumatoid arthritis (RA)           
               1. Authorization of 12 months may be granted for treatment of moderately to severely active rheumatoid arthritis (RA) when the member has experienced an inadequate response or intolerance to at least one tumor necrosis factor (TNF) inhibitor.
               2. Authorization of 12 months may be granted for members who have previously received a biologic (other than a TNF inhibitor) or targeted synthetic drug (e.g., Rinvoq, Olumiant) indicated for moderately to severely active RA.

         B.  Active psoriatic arthritis (PsA)
              Authorization of 12 months may be granted for treatment of active
              psoriatic arthritis (PsA) when both of the following criteria are met:
               1.  The requested drug will be used in combination with a conventional synthetic drug.
               2.  The member has experienced an inadequate response or intolerance to at least one TNF inhibitor.

          
         C.  Active ankylosing spondylitis (AS)
              1. Authorization of 12 months may be granted for treatment of active ankylosing spondylitis when the member has experienced an inadequate response or intolerance to at least one TNF inhibitor.
              2. Authorization of 12 months may be granted for members who have previously received a biologic (other than a TNF inhibitor) or targeted synthetic drug (e.g., Rinvoq) indicated for active ankylosing spondylitis.

         D.  Moderately to severely active ulcerative colitis (UC)
               1. Authorization of 12 months may be granted for the treatment of moderately to severely active UC when the member has had an inadequate response, intolerance, or contraindication to at least one TNF inhibitor.

               2. Authorization of 12 months may be granted for members who have previously received a biologic (other than a TNF inhibitor) or targeted synthetic drug (e.g., Rinvoq) indicated for moderately to severely active ulcerative colitis.

               3. Authorization of 12 months may be granted for members who have been hospitalized for acute, severe UC (e.g., continuous bleeding, severe toxic symptoms, including fever and anorexia).

          E.  Active articular juvenile idiopathic arthritis
               1. Authorization of 12 months may be granted for treatment of active articular juvenile idiopathic arthritis when the member has experienced an inadequate response or intolerance to at least one TNF inhibitor.

               2. Authorization of 12 months may be granted for members who have previously received a biologic (other than a TNF inhibitor) or targeted synthetic drug indicated for active articular juvenile idiopathic arthritis.

           F.  Immune checkpoint inhibitor-related toxicity
               Authorization of 1 month may be granted for treatment of immune
               checkpoint inhibitor-related colitis when the member has
               experienced an inadequate response, intolerance, or contraindication
               to infliximab or vedolizumab.

 

   IV.  CONTINUATION OF THERAPY

          A.  Moderately to severely active rheumatoid arthritis (RA)
               Authorization of 12 months may be granted for all members
               (including new members) who are using the requested medication
               for moderately to severely active rheumatoid arthritis and who
               achieve or maintain a positive clinical response as evidenced by
               disease activity improvement of at least 20% from baseline in tender
               joint count, swollen joint count, pain, or disability.

          B.  Active psoriatic arthritis (PsA)
               Authorization of 12 months may be granted for all members
               (including new members) who are using the requested medication
               for active psoriatic arthritis and who achieve or maintain a positive
               clinical response as evidenced by low disease activity or
               improvement in signs and symptoms of the condition when there is
               improvement in any of the following from baseline:
               1.  Number of swollen joints
               2.  Number of tender joints
               3.  Dactylitis
               4.  Enthesitis
               5.  Skin and/or nail involvement

          C.  Active ankylosing spondylitis (AS)
               Authorization of 12 months may be granted for all members
               (including new members) who are using the requested medication
               for active ankylosing spondylitis and who achieve or maintain a
               positive clinical response with the requested medication as evidenced
               by low disease activity or improvement in signs and symptoms of the
               condition when there is improvement in any of the following from
               baseline:
               1.  Functional status
               2.  Total spinal pain
               3.  Inflammation (e.g., morning stiffness)

          D.  Moderately to severely active ulcerative colitis (UC)
               1.  Authorization of 12 months may be granted for all members
                    (including new members) who are using the requested
                    medication for moderately to severely active ulcerative colitis and
                    who achieve or maintain remission.

               2.  Authorization of 12 months may be granted for all members
                    (including new members) who are using the requested
                    medication for moderately to severely active ulcerative colitis and
                    who achieve or maintain a positive clinical response as evidenced
                    by low disease activity or improvement in signs and symptoms of
                    the condition when there is improvement in any of the following
                    from baseline:
                    i.    Stool frequency
                    ii.   Rectal bleeding
                    iii.  Urgency of defecation
                    iv.  C-reactive protein (CRP)
                    v.   Fecal calprotectin (FC)
                    vi.  Endoscopic appearance of the mucosa
                    vii. Improvement on a disease activity scoring tool (e.g.,
                         Ulcerative Colitis Endoscopic Index of Severity [UCEIS], Mayo
                         score)

          E.  Active articular juvenile idiopathic arthritis
               Authorization of 12 months may be granted for all members
               (including new members) who are using the requested medication
               for active articular juvenile idiopathic arthritis and who achieve or
               maintain a positive clinical response as evidenced by low disease
               activity or improvement in signs and symptoms of the condition
               when there is improvement in any of the following from baseline:
               1.  Number of joints with active arthritis (e.g., swelling, pain,
                    limitation of motion)
               2.  Number of joints with limitation of movement
               3.  Functional ability

          F.  Immune checkpoint inhibitor-related toxicity
              All members (including new members) requesting authorization for
              continuation of therapy must meet all initial authorization criteria.

 

     V.  OTHER
          For all indications: Member has had a documented negative TB test (which can include a tuberculosis skin test [PPD], an interferon-release assay [IGRA], or a chest x-ray)* within 6 months of initiating therapy for persons who are naïve to biologic drugs or targeted synthetic drug associated with an increased risk of TB.

          * If the screening testing for TB is positive, there must be further
           testing to confirm there is no active disease. Do not administer the
           requested drug to members with active TB infection. If there is latent
           disease, TB treatment must be started before initiation of the requested
           drug.

           For all indications: Member cannot use the requested medication
           concomitantly with any other biologic drugs, targeted synthetic drugs,
           or potent immunosuppressants such as azathioprine or cyclosporine.

 

  VI.  DOSAGE AND ADMINISTRATION

         Approvals may be subject to dosing limits in accordance with FDA-
         approved labeling, accepted compendia, and/or evidence-based practice
         guidelines.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xeljanz/Xeljanz XR [package insert]. New York, NY: Pfizer, Inc.; December 2021.
2. Singh JA,Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis  2016;68(1)1-26.     
3. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79:685-699.
4. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6: Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137-174.
5. Gossec L,Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016;75(3):499-510.
6. Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25.
7. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheum. 2018;71:5-32.
8. Rubin DT, Ananthakrishnan AN, et al. 2019 ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroentrol. 2019;114:384-413.
9. Tuberculosis (TB). TB risk factors. Centers for Disease Control and Prevention. Retrieved on November 15, 2021 from: https://www.cdc.gov/tb/topic/basics/risk.htm.
10. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology 2020; 158:1450.
11. Ringold S, Angeles-Han S, 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 Care Res (Hoboken). 2019; 71(6):717-734.
12. Aletaha D, Neogi T, Silman, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569-81.
13. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthrit Care Res. 2021.
14. The NCCN Drugs & Biologics Compendium^® © 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed June 6, 2021.
15. 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. doi:10.1002/art.41042.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

December 15, 2022