Aetna
Aetna Aetna
Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: infliximab-Remicade and Biosimilars 2182-A SGM P2022

Drug
REMICADE  (infliximab)
AVSOLA  (infliximab-axxq)
INFLECTRA  (infliximab-dyyb)
RENFLEXIS  (infliximab-abda)
infliximab


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.  Adult patients with moderately to severely active Crohn’s
                    disease (CD) and fistulizing CD who have had an
                    inadequate response to conventional therapy
               2.  Pediatric patients 6 years of age and older with
                    moderately to severely active Crohn’s disease who have
                    had an inadequate response to conventional therapy
               3.  Moderately to severely active ulcerative colitis (UC) in
                    patients 6 years of age or older who have had an
                    inadequate response to conventional therapy
               4.  Adult patients with moderately to severely active
                    rheumatoid arthritis (RA), in combination with
                    methotrexate
               5.  Adult patients with active ankylosing spondylitis (AS)
               6.  Adult patients with active psoriatic arthritis (PsA)
               7.  Adult patients with chronic severe plaque psoriasis (PsO)
                    who are candidates for systemic therapy and when other
                    systemic therapies are medically less appropriate

           B.  Compendial Uses
                1.    Axial spondyloarthritis
                2.    Behcet’s disease
                3.    Hidradenitis suppurativa
                4.    Pyoderma gangrenosum
                5.    Sarcoidosis
                6.    Takayasu’s arteritis
                7.    Uveitis
                8.    Reactive arthritis
                9.    Immune checkpoint inhibitor toxicity
                10.  Acute graft versus host disease
                11.  Moderate to severe plaque psoriasis

           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.  Crohn’s disease (CD)
                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
                             supporting diagnosis of fistulizing Crohn’s disease
                             (if applicable).
                 2. Continuation requests: Chart notes or medical record
                     documentation supporting positive clinical response to
                     therapy or remission

            B.  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.

            C.  Rheumatoid arthritis (RA)
                 1.  For 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.     Laboratory results, chart notes, or medical record
                              documentation of biomarker testing (i.e.,
                              rheumatoid factor [RF], anti-cyclic citrullinated
                              peptide [anti-CCP], and C-reactive protein [CRP]
                              and/or erythrocyte sedimentation rate [ESR]) (if
                              applicable).
                 2.  For continuation requests: Chart notes or medical record
                     documentation supporting positive clinical response.

           D.  Ankylosing spondylitis (AS), axial spondyloarthritis (axSpA),
                psoriatic arthritis (PsA), reactive arthritis, hidradenitis
                suppurativa, and uveitis:
                1.  Initial requests: 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.
                2.  Continuation requests: Chart notes or medical record
                     documentation supporting positive clinical response.

            E.  Plaque psoriasis (PsO)
                 1.  Initial requests:
                      i.      Chart notes or medical record documentation of
                              affected area(s) and body surface area (BSA)
                              affected (if applicable).
                      ii.     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.
                 2.  Continuation requests: Chart notes or medical record
                      documentation of decreased body surface area (BSA)
                      affected and/or improvement in signs and symptoms.

           F.  Behcet’s disease (initial requests only): Chart notes, medical
               record documentation, or claims history supporting previous
               medications tried, including response to therapy (if
               applicable).

           G. Pyoderma gangrenosum, sarcoidosis, Takayasu’s arteritis,
               immune checkpoint inhibitor toxicity, and acute graft versus
               host disease (initial requests only): 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.


    III.  PRESCRIBER SPECIALTIES

            This medication must be prescribed by or in consultation with
            one of the following:

            A.  Crohn’s disease and ulcerative colitis: gastroenterologist
            B.  Rheumatoid arthritis, ankylosing spondylitis, axial
                 spondyloarthritis, Behcet’s disease, Takayasu’s arteritis, and
                 reactive arthritis: rheumatologist
            C.  Psoriatic arthritis and hidradenitis suppurativa:
                 rheumatologist or dermatologist
            D.  Plaque psoriasis and pyoderma gangrenosum:
                 dermatologist
            E.  Sarcoidosis: dermatologist or pulmonologist
            F.   Uveitis: ophthalmologist or rheumatologist
            G.  Immune checkpoint inhibitor toxicity and acute graft versus
                 host disease: oncologist or hematologist

     IV.  CRITERIA FOR INITIAL APPROVAL

            A.  Crohn’s disease (CD)
                 1.  Authorization of 12 months may be granted for adult
                      members who have previously received a biologic
                      indicated for treatment of moderately to severely active
                      Crohn’s disease.

                 2.  Authorization of 12 months may be granted for adult
                      members for treatment of moderately to severely active
                      CD when the member has had an inadequate response,
                      intolerance, or contraindication to at least one
                      conventional therapy option (see Appendix A).

                 3.  Authorization of 12 months may be granted for
                      treatment of fistulizing CD in adult members.

                 4.  Authorization of 12 months may be granted for
                      treatment of moderately to severely active CD when the
                      member is less than 18 years of age.

           B.  Ulcerative colitis (UC)
                1.  Authorization of 12 months may be granted for members
                     6 years of age and older who have previously received a
                     biologic or targeted synthetic drug (e.g., Xeljanz)
                     indicated for moderately to severely active ulcerative
                     colitis.

                2.  Authorization of 12 months may be granted for members
                     6 years of age and older for the treatment of moderately
                     to severely active UC when the member has had an
                     inadequate response, intolerance, or contraindication to
                     at least one conventional therapy option (see Appendix
                     B).

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

            C.  Rheumatoid arthritis (RA)
                 1.  Authorization of 12 months may be granted for adult
                      members who have previously received a biologic or
                      targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated
                      for moderately to severely active rheumatoid arthritis.
                      The requested medication must be prescribed in
                      combination with methotrexate or leflunomide unless
                      the member has a clinical reason not to use
                      methotrexate or leflunomide (see Appendix C).

                 2.  Authorization of 12 months may be granted for adult
                      members for treatment of moderately to severely active
                      RA when all of the following criteria are met:
                      i.      Member meets either of the following criteria:
                              a.  Member has been tested for either of the
                                   following biomarkers and the test was positive:
                                   1.  Rheumatoid factor (RF)
                                   2.  Anti-cyclic citrullinated peptide (anti-CCP)
                              b.  Member has been tested for ALL of the
                                   following biomarkers:
                                   1.  RF
                                   2.  Anti-CCP
                                   3.  C-reactive protein (CRP) and/or erythrocyte
                                        sedimentation rate (ESR)
                                        ii.     Member is prescribed the requested
                                                medication in combination with
                                                methotrexate or leflunomide, or has a
                                                clinical reason not to use
                                                methotrexate or leflunomide (see
                                                Appendix C).
                                        iii.    Member meets any of the following
                                                criteria:
                                                a.  Member has experienced an
                                                     inadequate response to at least a
                                                     3-month trial of methotrexate
                                                     despite adequate dosing (i.e.,
                                                     titrated to at least 15 mg/week).
                                                b.  Member has an intolerance or
                                                     contraindication to methotrexate
                                                     (see Appendix C).

            D.  Ankylosing spondylitis (AS) and axial
                  spondyloarthritis (axSpA)
                 1.  Authorization of 12 months may be granted for adult
                      members who have previously received a biologic or
                      targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated
                      for active ankylosing spondylitis or active axial
                      spondyloarthritis.

                 2.  Authorization of 12 months may be granted for adult
                      members for treatment of active ankylosing spondylitis
                      or active axial spondyloarthritis when any of the
                      following criteria is met:
                      i.      Member has experienced an inadequate response
                              to at least two non-steroidal anti-inflammatory
                              drugs (NSAIDs).
                      ii.     Member has an intolerance or contraindication to
                              two or more NSAIDs.

            E.  Psoriatic arthritis (PsA)
                1.  Authorization of 12 months may be granted for adult
                     members who have previously received a biologic or
                     targeted synthetic drug (e.g., Rinvoq, Otezla) indicated
                     for active psoriatic arthritis.
 
                2.  Authorization of 12 months may be granted for adult
                     members for treatment of active psoriatic arthritis when
                     either of the following criteria is met:
                     i.      Member has mild to moderate disease and meets
                             one of the following criteria:
                             a.  Member has had an inadequate response to
                                  methotrexate, leflunomide, or another
                                  conventional synthetic drug (e.g., sulfasalazine)
                                  administered at an adequate dose and duration.
                             b.  Member has an intolerance or contraindication
                                  to methotrexate or leflunomide (see Appendix
                                  C), or another conventional synthetic drug
                                  (e.g., sulfasalazine).
                             c.  Member has enthesitis or predominantly axial
                                  disease.
                     ii.     Member has severe disease.

            F.  Plaque psoriasis (PsO)
                1.  Authorization of 12 months may be granted for adult
                     members who have previously received a biologic or
                     targeted synthetic drug (e.g., Sotyktu, Otezla) indicated
                     for the treatment of moderate to severe plaque
                     psoriasis.

                2.  Authorization of 12 months may be granted for adult
                     members for treatment of moderate to severe plaque
                     psoriasis in members when any of the following criteria
                     is met:
                     i.      Crucial body areas (e.g., hands, feet, face, neck,
                             scalp, genitals/groin, intertriginous areas) are
                             affected.
                     ii.     At least 10% of the body surface area (BSA) is
                             affected.
                     iii.    At least 3% of body surface area (BSA) is affected
                            and the member meets any of the following
                            criteria:
                            a.  Member has had an inadequate response or
                                 intolerance to either phototherapy (e.g., UVB,
                                 PUVA) or pharmacologic treatment with
                                 methotrexate, cyclosporine, or acitretin.
                            b.  Member has a clinical reason to avoid
                                 pharmacologic treatment with methotrexate,
                                 cyclosporine, and acitretin (see Appendix D).

            G.  Behcet’s disease
                 1.  Authorization of 12 months may be granted for
                      members who have previously received Otezla or a
                      biologic indicated for the treatment of Behcet’s disease.

                 2.  Authorization of 12 months may be granted for the
                      treatment of Behcet’s disease when the member has
                      had an inadequate response to at least one non-biologic
                      medication for Behcet’s disease (e.g., apremilast,
                      colchicine, systemic glucocorticoids, azathioprine).

            H.  Hidradenitis suppurativa
                 1.  Authorization of 12 months may be granted for
                      members who have previously received a biologic
                      indicated for the treatment of severe, refractory
                      hidradenitis suppurativa.

                 2.  Authorization of 12 months may be granted for
                      treatment of severe, refractory hidradenitis suppurativa
                      when either of the following is met:
                      i.      Member has experienced an inadequate response
                              to an oral antibiotic for at least 90 days.
                      ii.     Member has an intolerance or contraindication to
                              oral antibiotics.

            I.  Pyoderma gangrenosum
                1.  Authorization of 12 months may be granted for members
                     who have previously received a biologic indicated for
                     pyoderma gangrenosum.

                2.  Authorization of 12 months may be granted for
                     treatment of pyoderma gangrenosum when either of the
                     following is met:
                     i.      Member has experienced an inadequate response
                             to corticosteroids or immunosuppressive therapy
                             (e.g., cyclosporine or mycophenolate mofetil).
                     ii.     Member has an intolerance or contraindication to
                             corticosteroids and immunosuppressive therapy
                             (e.g. cyclosporine, mycophenolate mofetil).

            J.  Sarcoidosis
                Authorization of 12 months may be granted for treatment of
                sarcoidosis in members when any of the following criteria is
                met:
                1.  Member has experienced an inadequate response to
                     corticosteroids or immunosuppressive therapy.
                2.  Member has an intolerance or contraindication to
                     corticosteroids and immunosuppressive therapy.

            K.  Takayasu’s arteritis
                 Authorization of 12 months may be granted for treatment
                 of refractory Takayasu’s arteritis when any of the follow
                 criteria is met:
                 1.  Member has experienced an inadequate response to
                      corticosteroids or immunosuppressive therapy (e.g.,
                      methotrexate, azathioprine, or mycophenolate mofetil).
                 2.  Member has an intolerance or contraindication to
                      corticosteroids and immunosuppressive therapy (e.g.,
                      methotrexate, azathioprine, or mycophenolate mofetil).

            L.  Uveitis
                 1.  Authorization of 12 months may be granted for
                      members who have previous received a biologic
                      indicated for uveitis.

                 2.  Authorization of 12 months may be granted for
                      treatment of uveitis when any of the following criteria is
                      met:
                      i.      Member has experienced an inadequate response
                              to corticosteroids or immunosuppressive therapy
                              (e.g., methotrexate, azathioprine, or
                              mycophenolate mofetil).
                      ii.     Member has an intolerance or contraindication to
                              corticosteroids and immunosuppressive therapy
                              (e.g., methotrexate, azathioprine, or
                              mycophenolate mofetil).

            O.  Reactive arthritis
                 1.  Authorization of 12 months may be granted for
                      members who have previously received a biologic
                      indicated for reactive arthritis.

                 2.  Authorization of 12 months may be granted for
                      treatment of reactive arthritis when any of the following
                      criteria is met:
                      i.      Member has experienced an inadequate response
                              to at least a 3-month trial of one of the following
                              despite adequate dosing or maximally tolerated
                              dose:
                              a.  Sulfasalazine (i.e., titrated to 1000 mg twice
                                   daily)
                              b.  Methotrexate (i.e., titrated to at least 15
                                   mg/week)
                      ii.     Member has an intolerance or contraindication to
                              methotrexate (see Appendix C) and sulfasalazine
                              (e.g., porphyria, intestinal or urinary obstruction).

            P.  Immune checkpoint inhibitor toxicity
                 1.  Authorization of 1 month may be granted for treatment
                      of immune checkpoint inhibitor toxicity when either of
                      the following criteria is met:
                      i.       Member has experienced an inadequate response,
                               intolerance, or contraindication to corticosteroids.
                      ii.      Member has moderate or severe diarrhea or
                               colitis.

                 2.  Authorization of 12 months may be granted for
                      treatment of immune checkpoint inhibitor toxicity when
                      the member has severe inflammatory arthritis and has
                      experienced an inadequate response, intolerance, or
                      contraindication to corticosteroids.

            Q.  Acute graft versus host disease
                 Authorization of 12 months may be granted for treatment
                 of acute graft versus host disease when either of the
                 following criteria is met:
                 1.  Member has experienced an inadequate response to
                      systemic corticosteroids.
                 2.  Member has an intolerance or contraindication to
                      corticosteroids.

 
      V.  CONTINUATION OF THERAPY

            A.  Crohn’s disease (CD)
                 1.  Authorization of 12 months may be granted for all
                      members 6 years of age and older (including new
                      members) who are using the requested medication for
                      moderately to severely active or fistulizing Crohn’s
                      disease and who achieve or maintain remission.

                 2.  Authorization of 12 months may be granted for all
                      members 6 years of age and older (including new
                      members) who are using the requested medication for
                      moderately to severely active or fistulizing Crohn’s
                      disease 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.      Abdominal pain or tenderness
                      ii.     Diarrhea
                      iii.    Body weight
                      iv.    Abdominal mass
                      v.     Hematocrit
                      vi.    Endoscopic appearance of the mucosa
                      vii.   Improvement on a disease activity scoring tool
                             (e.g., Crohn’s Disease Activity Index [CDAI] score)

            B.  Ulcerative colitis (UC)
                 1.  Authorization of 12 months may be granted for all
                      members 6 years of age and older (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 6 years of age and older (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)

            C.  Rheumatoid arthritis (RA)
                 Authorization of 12 months may be granted for all adult
                 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.

            D.  Ankylosing spondylitis (AS) and axial
                  spondyloarthritis (axSpA)
                 Authorization of 12 months may be granted for all adult
                 members (including new members) who are using the
                 requested medication for active ankylosing spondylitis or
                 active axial spondyloarthritis 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)

             E.  Psoriatic arthritis (PsA)
                  Authorization of 12 months may be granted for all adult
                  members (including new members) who are using the
                  requested medication for 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.  Axial disease
                  6.  Skin and/or nail involvement

            F.  Plaque psoriasis (PsO)
                 Authorization of 12 months may be granted for all adult
                 members (including new members) who are using the
                 requested medication for moderate to severe plaque
                 psoriasis 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
                 any of the following is met:
                 1.  Reduction in body surface area (BSA) affected from
                      baseline
                 2.  Improvement in signs and symptoms from baseline
                      (e.g., itching, redness, flaking, scaling, burning,
                      cracking, pain)

            G.  Hidradenitis suppurativa
                 Authorization of 12 months may be granted for all members
                 (including new members) who are using the requested
                 medication for severe, refractory hidradenitis suppurativa
                 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 any of the following is
                 met:
                 1.  Reduction in abscess and inflammatory nodule count
                      from baseline
                 2.  Reduced formation of new sinus tracts and scarring
                 3.  Decrease in frequency of inflammatory lesions from
                      baseline
                 4.  Reduction in pain from baseline
                 5.  Reduction in suppuration from baseline
                 6.  Improvement in frequency of relapses from baseline
                 7.  Improvement in quality of life from baseline
                 8.  Improvement on a disease severity assessment tool
                      from baseline

            H.  Uveitis
                 Authorization of 12 months may be granted for all members
                 (including new members) who are using the requested
                 medication for uveitis 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 the patient meets any of the following:
                 1.  Reduced frequency of recurrence compared to baseline
                 2.  Zero anterior chamber inflammation or reduction in
                      anterior chamber inflammation compared to baseline
                 3.  Decreased reliance on topical corticosteroids

             I.  Reactive arthritis
                 Authorization of 12 months may be granted for all members
                 (including new members) who are using the requested
                 medication for reactive 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 (e.g., tender joint count, swollen joint count,
                 or pain).

            J.  Immune checkpoint inhibitor toxicity and acute graft
                 versus host disease
                All members (including new members) requesting
                authorization for continuation of therapy must meet all
                initial authorization criteria.

            K.  All other indications
                 Authorization of 12 months may be granted for all members
                 (including new members) who are using the requested
                 medication for an indication outlined in Section IV and who
                 achieve or maintain positive clinical response with the
                 requested medication as evidenced by low disease activity
                 or improvement in signs and symptoms of the condition.

 
     VI.  OTHER

            For all indications: Member has had a documented negative
            tuberculosis (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 drugs 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 medication to members with active
            TB infection. If there is latent disease, TB treatment must be
            started before initiation of the requested medication.

            For all indications: Member cannot use the requested
            medication concomitantly with any other biologic drug or
            targeted synthetic drug.

 
   VII.  DOSAGE AND ADMINISTRATION

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


  VIII.  APPENDICES

            Appendix A: Examples of Conventional Therapy Options
            for CD
            1.  Mild to moderate disease – induction of remission:
                 a.  Oral budesonide
                 b.  Alternatives: metronidazole, ciprofloxacin, rifaximin
            2.  Mild to moderate disease – maintenance of remission:
                 a.  Azathioprine, mercaptopurine
                 b.  Alternatives: oral budesonide, methotrexate
                      intramuscular (IM) or subcutaneous (SC), sulfasalazine
            3.  Moderate to severe disease – induction of remission:
                 a.  Prednisone, methylprednisolone intravenously (IV)
                 b.  Alternatives: methotrexate IM or SC
            4.  Moderate to severe disease – maintenance of remission:
                 a.  Azathioprine, mercaptopurine
                 b.  Alternative: methotrexate IM or SC
            5.  Perianal and fistulizing disease – induction of remission
                 a.  Metronidazole ± ciprofloxacin, tacrolimus
            6.  Perianal and fistulizing disease – maintenance of remission
                 a.  Azathioprine, mercaptopurine
                 b.  Alternative: methotrexate IM or SC

            Appendix B: Examples of Conventional Therapy Options
            for UC
            1.  Mild to moderate disease – induction of remission:
                 a.  Oral mesalamine (e.g., Apriso, Asacol, Asacol HD, Lialda,
                      Pentasa), balsalazide, olsalazine
                 b.  Rectal mesalamine (e.g., Canasa, Rowasa)
                 c.  Rectal hydrocortisone (e.g., Colocort, Cortifoam)
                 d.  Alternatives: prednisone, azathioprine, mercaptopurine,
                      sulfasalazine
            2.  Mild to moderate disease – maintenance of remission:
                 a.  Oral mesalamine, balsalazide, olsalazine, rectal
                      mesalamine
                 b.  Alternatives: azathioprine, mercaptopurine,
                     sulfasalazine
            3.  Severe disease – induction of remission:
                 a.  Prednisone, hydrocortisone IV, methylprednisolone IV
                 b.  Alternatives: cyclosporine IV, tacrolimus, sulfasalazine
            4.  Severe disease – maintenance of remission:
                 a.  Azathioprine, mercaptopurine
                 b.  Alternative: sulfasalazine 
 
            Appendix C: Examples of Contraindications to
            Methotrexate or Leflunomide
            1.    Clinical diagnosis of alcohol use disorder, alcoholic liver
                   disease or other chronic liver disease
            2.    Breastfeeding
            3.    Blood dyscrasias (e.g., thrombocytopenia, leukopenia,
                   significant anemia)
            4.    Elevated liver transaminases
            5.    History of intolerance or adverse event
            6.    Hypersensitivity
            7.    Interstitial pneumonitis or clinically significant pulmonary
                   fibrosis
            8.    Myelodysplasia
            9.    Pregnancy or currently planning pregnancy
            10.  Renal impairment
            11.  Significant drug interaction

            Appendix D: Examples of Clinical Reasons to Avoid
            Pharmacologic Treatment with Methotrexate,
            Cyclosporine, or Acitretin
            1.  Clinical diagnosis of alcohol use disorder, alcoholic liver
                 disease or other chronic liver disease
            2.  Breastfeeding
            3.  Drug interaction
            4.  Cannot be used due to risk of treatment-related toxicity
            5.  Pregnancy or currently planning pregnancy
            6.  Significant comorbidity prohibits use of systemic agents (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension)


Place of Service:

Outpatient

The above policy is based on the following references:
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  42. Elmets C, Korman N, et al. Guidelines of Care for the Management and Treatment of Psoriasis with Topical Therapy and Alternative Medicine Modalities for Psoriasis Severity Measures. J Am Acad Dermatol. 2021;84:432-470.
  43. Onel KB, Horton DB, Lovell DJ, et al. 2021 American College of Rheumatology guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for oligoarthritis, temporomandibular joint arthritis, and systemic juvenile idiopathic arthritis. Arthritis Rheumatol. 2022;74(4):553-569.
  44. Angeles-Han ST, Ringold S, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the screening, monitoring, and treatment of juvenile idiopathic arthritis-associated uveitis. Arthritis Care Res. 2019; 71(6):703-716.
  45. Mehta, NA, Emani-Naeini P. A review of systemic biologics and local immunosuppressive medications in uveitis. J Ophthalmic Vis Res. 2022;17(2):276-289.
  46. Azulfidine [package insert]. New York, NY: Pfizer; August 2021.
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.

February 12, 2023
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