Targeted Immunomodulator Agents Tier-2 Approval Criteria:
- An FDA approved diagnosis; AND
- Prescriber must confirm that all baseline assessments and follow-up monitoring (e.g., laboratory assessment, infectious disease screening) will be performed as recommended in the package labeling for the requested product; AND
- A trial of at least one Tier-1 medication (appropriate to the member’s disease state) in the last 90 days that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; OR
- Prior stabilization on the Tier-2 medication documented within the last 100 days.
Targeted Immunomodulator Agents Tier-3 Approval Criteria:
- An FDA approved diagnosis; AND
- Prescriber must confirm that all baseline assessments and follow-up monitoring (e.g., laboratory assessment, infectious disease screening) will be performed as recommended in the package labeling for the requested product; AND
- Recent trials (within the last 360 days) of one Tier-1 medication (appropriate to the member’s disease state) and at least 2 Tier-2 medications (appropriate to the member’s disease state) that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; OR
- Prior stabilization on the Tier-3 medication documented within the last 100 days; OR
- A unique FDA-approved indication not covered by Tier-2 products (unique approval criteria may apply).
Targeted Immunomodulator Agents Special Prior Authorization (PA) Approval Criteria:
- An FDA approved diagnosis; AND
- Prescriber must confirm that all baseline assessments and follow-up monitoring (e.g., laboratory assessment, infectious disease screening) will be performed as recommended in the package labeling for the requested product; AND
- A recent trial (within the last 360 days) of 1 Tier-3 medication (appropriate to the member’s disease state) that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; OR
- Prior stabilization on the Special PA medication documented within the last 100 days; OR
- A unique FDA-approved indication not covered by lower-tiered medications (unique approval criteria may apply).
Additional criteria by for individual products:
apremilast (Otezla®) Approval Criteria [Behçet’s Disease (BD) Diagnosis]:
- An FDA approved indication for the treatment of oral ulcers associated with BD; AND
- Member must have had oral ulcers at least 3 times in the last 12 month period; AND
- Member must have had a 2 week trial of the following that resulted in inadequate efficacy or intolerable adverse effects (or be contraindicated for the member):
- Topical corticosteroids (applied topically to the mouth); AND
- Colchicine; AND
- Quantity limits according to package labeling will apply.
adalimumab (Humira®) Approval Criteria:
[Hidradenitis Suppurativa]
- A diagnosis of moderate-to-severe hidradenitis suppurativa (HS); AND
- Hurley Stage II or III disease; AND
- The member must have at least 3 abscesses or inflammatory nodules; AND
- Previous failure of at least two of the following: topical or systemic antibiotics, oral OR intralesional corticosteroids, dapsone, cyclosporine, antiandrogens (spironolactone OR oral contraceptives), finasteride, or surgery.
[Noninfectious Intermediate and Posterior Uveitis or Panuveitis]
- A diagnosis of noninfectious intermediate uveitis, posterior uveitis, or panuveitis in members 2 years of age and older; AND
- A failed trial with a corticosteroid injection or systemic corticosteroid in which member has had an inadequate response; OR
- A patient-specific, clinically significant reason a trial of corticosteroid treatment is inappropriate for the member.
Arcalyst® (Rilonacept) Approval Criteria [Cryopyrin-Associated Periodic Syndromes (CAPS) Diagnosis]:
- FDA approved indication of Cryopyrin-Associated Periodic Syndromes (CAPS) verified by genetic testing. This includes Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older; and
- A patient-specific, clinically significant reason the member cannot utilize Kineret® (anakinra) or Ilaris® (canakinumab) must be provided. Tier structure rules apply; and
- The member should not be using a tumor necrosis factor blocking agent (e.g. adalimumab, etanercept, and infliximab) or anakinra concomitantly with Arcalyst®;
- Documentation that the member does not have active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or tuberculosis must be provided; and
- The following dosing restrictions will apply:
- Dosing should not be more often than once weekly; and
- Approved dosing schedule for members 18 years of age and older:
- Initial treatment: Loading dose of 320mg delivered as (2) 2mL subcutaneous (sub-Q) injections of 160mg each given on the same day at 2 different injection sites; and
- Continued treatment: (1) 160mg injection given once weekly; or
- Approved dosing schedule for pediatric members 12 to 17 years of age (must have member weight in kilograms):
- Initial treatment: Loading dose of 4.4mg/kg, up to a maximum of 320mg, delivered as 1 or 2 sub-Q injections, with a maximum single-injection volume of 2mL (given at 2 different injection sites if administered as 2 injections); and
- Continued treatment: 2.2mg/kg, up to a maximum of 160mg, given once weekly; and
- Approvals will be for the duration of 1 year.\
Arcalyst® (Rilonacept) Approval Criteria [Deficiency of Interleukin-1 Receptor Antagonist (DIRA) Diagnosis]:
- An FDA approved indication of maintenance of remission of DIRA verified by genetic testing; and
- The member must weigh ≥10kg; and
- The member should not be using a tumor necrosis factor blocking agent (e.g., adalimumab, etanercept, infliximab) or anakinra concomitantly with Arcalyst®; and
- Documentation that the member does not have active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or tuberculosis must be provided; and
- Arcalyst® will be used for maintenance of remission following treatment with Kineret® (anakinra); and
- A patient-specific, clinically significant reason the member cannot continue to utilize Kineret® (anakinra) instead of switching to Arcalyst®; and
- The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling; and
- The following dosing restrictions will apply:
- Dosing should not be more often than once weekly; and
- Approved dosing schedule for adults and pediatric members weighing ≥10kg is 4.4mg/kg up to a maximum of 320mg, delivered as 1 or 2 injections (2mL/injection) once weekly; and
- Approvals will be for the duration of 1 year.
Arcalyst® (Rilonacept) Approval Criteria [Recurrent Pericarditis Diagnosis]:
- An FDA approved indication of recurrent pericarditis and reduction in risk of recurrence in members 12 years of age and older; and
- The member has had at least 2 episodes of pericarditis; and
- Member has failure with colchicine, non-steroidal anti-inflammatory drugs (NSAIDs), and corticosteroids defined as symptomatic pericarditis recurrence; and
- A patient-specific, clinically significant reason the member cannot utilize Kineret® (anakinra) must be provided; and
- The member should not be using a tumor necrosis factor blocking agent (e.g., adalimumab, etanercept, infliximab) or anakinra concomitantly with Arcalyst®; and
- Documentation that the member does not have active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or tuberculosis must be provided; and
- The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling for members 12 to 17 years of age; and
- The following dosing restrictions will apply:
- Dosing should not be more often than once weekly; and
- Approved dosing schedule for members 18 years of age and older:
- Initial treatment: Loading dose of 320mg delivered as (2) 2mL subcutaneous (sub-Q) injections of 160mg each given on the same day at 2 different injection sites; and
- Continued treatment: (1) 160mg injection given once weekly; or
- Approved dosing schedule for pediatric members 12 to 17 years of age (must have member weight in kilograms):
- Initial treatment: Loading dose of 4.4mg/kg, up to a maximum of 320mg, delivered as 1 or 2 sub-Q injections, with a maximum single-injection volume of 2mL (given at 2 different injection sites if administered as 2 injections); and
- Continued treatment: 2.2mg/kg, up to a maximum of 160mg, given once weekly; and
- Initial approvals will be for 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment as indicated by decreased recurrence of pericarditis or improvement in signs and symptoms of recurrent pericarditis (e.g., C-reactive protein, pericarditic chest pain, pericardial effusion). Subsequent approvals will be granted for the duration of 1 year.
Benlysta® (Belimumab) Approval Criteria:
- The intravenous (IV) formulation will be covered as a medical claim only benefit while the subcutaneous (subQ) formulation will be covered as a pharmacy only benefit; AND
- An FDA approved indication of 1 of the following:
- The treatment of members 5 years of age and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) already receiving standard therapy; OR
- The treatment of members 5 years of age and older with active lupus nephritis who are receiving standard therapy; AND
- Documented inadequate response to at least two of the following medications appropriate to the member's specific disease state:
- High-dose oral corticosteroids; OR
- Methotrexate; OR
- Azathioprine; OR
- Mycophenolate; OR
- Cyclophosphamide; OR
- Hydroxychloroquine/chloroquine; AND
- Member must not have severe active central nervous system lupus; AND
- Benlysta® will not be approved for combination use with biologic therapies; AND
- Benlysta® will not be approved for combination use with IV cyclophosphamide (exception for induction treatment with IV cyclophosphamide for members with a diagnosis of lupus nephritis).
brodalumab (Siliq™):
- Initial authorizations of Siliq™ (brodalumab) will be for the duration of 12 weeks at which time the prescriber must verify the member is responding to treatment. If an adequate response has not been achieved after 12 to 16 weeks of treatment with brodalumab, consideration should be given to discontinuing therapy.
- Members must also be enrolled in the Siliq™ REMS Program for approval.
- Members with a concomitant diagnosis of Crohn’s disease will not be approved.
canakinumab (Ilaris®) Approval Criteria:
Approval Criteria [Active Systemic Juvenile Idiopathic Arthritis (SJIA) or Adult-Onset Still’s Disease (AOSD) Diagnosis]:
- An FDA approved diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA) or Adult-Onset Still's Disease (AOSD); and
- Ilaris® will not be approved for concurrent use with a tumor necrosis factor blocking agent (e.g. adalimumab, etanercept, or infliximab) or anakinra; and
- Ilaris® should not be initiated in patients with active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus, or tuberculosis; and
- Dosing should not be more often than once every 4 weeks.
- Two years of age and older and body weight greater than 7.5kg: 4mg/kg every 4 weeks; max dose 300mg/dose; and
- Recent trials of one Tier-1 product and all appropriate Tier-2 products that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; or
- Prior stabilization on Ilaris® documented within the last 100 days.
- Approvals will be for the duration of one year.
Kevzara® (Sarilumab) Approval Criteria [Polymyalgia Rheumatica (PMR) Diagnosis]:
- An FDA approved diagnosis of PMR; and
- Member must be 18 years of age or older; and
- Prescriber must verify member has had an inadequate response to corticosteroids or cannot tolerate corticosteroid taper; and
- Prescriber must verify Kevzara® will be used in combination with a tapering course of corticosteroids, unless contraindicated.
Litfulo™ (Ritlecitinib) and Olumiant® (Baricitinib) Approval Criteria [Alopecia Areata Diagnosis]:
- An FDA approved diagnosis of severe alopecia areata; and
- For Litfulo™, member must be 12 to 20 years of age; or
- For Olumiant®, member must be 18 to 20 years of age; and
- Prescriber must confirm the member or caregiver has been counseled regarding the covered age range for the requested product and that the medication will no longer be covered once the member turns 21 years of age; and
- Member’s baseline Severity of Alopecia Tool (SALT) score must be provided and must be ≥50; and
- Must be prescribed by a dermatologist (or an advanced care practitioner with a supervising physician who is a dermatologist); and
- Prescriber must agree to screen for tuberculosis and viral hepatitis prior to initiating treatment; and
- Prescriber must agree to evaluate lymphocyte and platelet counts at baseline, 4 weeks after initiation, and as clinically indicated thereafter; and
- Prescriber must provide documentation of patient-specific, clinically significant information (e.g., impacting member’s mental health or ability to function in day-to-day living, reason why no treatment or cosmetic solutions are not appropriate) to demonstrate the medical necessity of this medication for this member; and
- Member must have documented trials within the last 6 months that resulted in failure with at least 2 of the following therapies (or have a contraindication or documented intolerance to all alternatives):
- Medium potency to very-high potency Tier-1 topical corticosteroid used for at least 12 weeks; or
- Oral corticosteroid used for at least 6 weeks; or
- Cyclosporine; or
- Methotrexate; or
- Contact immunotherapy (e.g., diphenylcyclopropenone, squaric acid dibutyl ester); and
- Concurrent use with other Janus kinase (JAK) inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants will not be approved; and
- Prescriber must verify female members are not breastfeeding; and
- If the member is pregnant or becomes pregnant, prescriber must verify member has been counseled on potential risks of this medication and will report the exposure to the pregnancy registry; and
- Initial approvals will be for a duration of 24 weeks of treatment; and
- Reauthorization may be considered if the prescriber documents the member is responding well to treatment as indicated by a reduction in the member’s SALT score (current SALT score must be provided).
Tavneos® (Avacopan) Approval Criteria:
- An FDA approved diagnosis as adjunctive treatment of adult members with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis [granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)] in combination with standard therapy including corticosteroids; AND
- Member must be 18 years of age or older; AND
- Tavneos® must be used in combination with standard immunosuppressive therapy including corticosteroids; AND
- Prescriber must agree to monitor liver function tests prior to initiating Tavneos®, every 4 weeks after the start of therapy for the first 6 months of treatment, and as clinically indicated thereafter; AND
- Prescriber must agree to screen the member for hepatitis B virus (HBV) infection prior to initiating treatment with Tavneos®; AND
- Prescriber must verify the member has no active, serious infections, including localized infections and will closely monitor member for the development of signs and symptoms of infection during and after treatment with Tavneos®; AND
- A quantity limit of 180 tablets per 30 days will apply.
Tofidence™ (Tocilizumab-bavi) Approval Criteria:
- Member must meet Special Prior Authorization (PA) approval criteria; and
- A patient-specific, clinically significant reason why the member cannot use Actemra® (tocilizumab) must be provided. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products.
[Cryopyrin-Associated Periodic Syndromes (CAPS)]
- FDA approved diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS) verified by genetic testing. This includes Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 4 and older.
- The member should not be using a tumor necrosis factor blocking agent (e.g. adalimumab, etanercept, and infliximab) or anakinra.
- Should not be initiated in patients with active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus, or tuberculosis.
[Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), or Familial Mediterranean Fever (FMF)]
- A diagnosis of tumor necrosis factor receptor associated periodic syndrome (TRAPS) with chronic or recurrent disease activity defined as six flares per year; OR
- A diagnosis of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD); OR
- A diagnosis of familial Mediterranean fever (FMF) with documented active disease despite colchicine therapy or documented intolerance to effective doses of colchicine; AND
- The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling.
Avsola® (Infliximab-axxq), Remicade® (Infliximab), and Renflexis® (Infliximab-abda) Approval Criteria:
- Member must meet Tier-3 trial requirements; AND
- A patient-specific, clinically significant reason why the member cannot use Inflectra® (infliximab-dyyb) must be provided. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products.
Orencia® (Abatacept) Approval Criteria [Acute Graft Versus Host Disease (aGVHD) Prophylaxis in Hematopoietic Stem Cell Transplant (HSCT) Diagnosis]:
- An FDA approved indication for the prophylaxis of aGVHD in members undergoing HSCT; AND
- Member must be 2 years of age or older; AND
- Member is undergoing HSCT with a matched or 1 allele-mismatched unrelated donor; AND
- Must be used in combination with a calcineurin inhibitor and methotrexate.
Cibinqo™ (Abrocitinib) and Rinvoq® (Upadacitinib) Approval Criteria [Atopic Dermatitis (AD) Diagnosis]:
- An FDA approved diagnosis of moderate-to-severe AD not adequately controlled with other systemic drug products, including biologics, or when those therapies are not advisable; AND
- For Cibinqo™, member must be 12 years of age or older; AND
- For Rinvoq®, member must be 12 years of age or older; AND
- Member must have a documented trial within the last 6 months for a minimum of 2 weeks that resulted in failure with both of the following topical therapies (or have a contraindication or documented intolerance):
- 1 medium potency to very-high potency Tier-1 topical corticosteroid; AND
- 1 topical calcineurin inhibitor [e.g., Elidel® (pimecrolimus), Protopic® (tacrolimus)]; AND
- Member must have a documented 16 week trial with Adbry™ (tralokinumab-ldrm) or Dupixent® (dupilumab) that resulted in inadequate response (or have a contraindication or documented intolerance); AND
- Requested medication must be prescribed by a dermatologist, allergist, or immunologist or the member must have been evaluated by a dermatologist, allergist, or immunologist within the last 12 months (or an advanced care practitioner with a supervising physician who is a dermatologist, allergist, or immunologist); AND
- For Cibinqo™, prescriber must verify the member will not use antiplatelet therapies (e.g., clopidogrel, prasugrel, ticagrelor) concurrently with Cibinqo™, except for low-dose aspirin, during the first 3 months of treatment; AND
- Cibinqo™ and Rinvoq® will not be approved for use in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, or with other immunosuppressant medications; AND
- Initial approvals will be for the duration of 3 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval; AND
- For Rinvoq®, the maximum approvable dose for AD is 30mg once daily.
rituximab (Rituxan®) Approval Criteria
[Pemphigus Vulgaris (PV) Diagnosis]:
- An FDA approved diagnosis of moderate-to-severe PV; AND
- Rituxan® must be used in combination with a tapering course of glucocorticoids; AND
- Initial approvals will be for two 1,000mg intravenous (IV) infusions separated by 2 weeks and a 500mg infusion at month 12. Subsequent approvals may be authorized based on 6-month evaluations or upon relapse. Subsequent infusions may be no sooner than 16 weeks after the previous infusion.
[Granulomatosis With Polyangiitis (GPA, Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) Diagnosis]:
- An FDA approved diagnosis of GPA or MPA in adult and pediatric patients 2 years of age and older; AND
- Rituxan® must be used in combination with corticosteroids; AND
- Approval quantity will be based on Rituxan® prescribing information and FDA approved dosing regimen(s).
Spevigo® (Spesolimab-sbzo) Approval Criteria:
- An FDA approved indication for the treatment of generalized pustular psoriasis (GPP) flares (GPP diagnosis should be verifiable in the member’s diagnosis history); AND
- Prescriber must verify at least 1 of the following:
- Member has experienced >1 flare (relapsing GPP); OR
- Member has symptoms persisting for >3 months (persistent GPP); AND
- Member must be currently experiencing a moderate-to-severe GPP flare meeting all the following criteria:
- Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) total score must be provided and must be ≥3; AND
- Presence of fresh pustules (new appearance or worsening of pustules); AND
- GPPPGA pustulation sub-score must be provided and must be ≥2; AND
- ≥5% of body surface area (BSA) covered with erythema and the presence of pustules; AND
- Member must be 21 years of age or older; AND
- Must be prescribed by a dermatologist or other specialist with expertise in the treatment of GPP (or an advanced care practitioner with a supervising physician who is a dermatologist or other specialist with expertise in the treatment of GPP); AND
- Prescriber must submit documentation of negative tuberculosis (TB) test or initiation of anti-TB therapy for latent TB prior to initiation of therapy with Spevigo®; AND
- Prescriber must verify the member does not have any clinically significant active infections and the member will be monitored for active infections prior to each dose of Spevigo®; AND
- Approvals will be for 1 dose of Spevigo®. A second dose of Spevigo® may be approved 1 week after the first dose if the prescriber submits documentation that the member has been evaluated and continues to experience GPP flare symptoms; AND
- A quantity limit of 2 doses per year will apply (the safety and efficacy of additional doses of Spevigo® have not been assessed); AND
- Requests for additional doses of Spevigo® to treat new GPP flares occurring within 1 year (after successful resolution of the previous flare) will be reviewed on a case-by-case basis and will require the prescriber to submit patient-specific, clinically significant information documenting the clinical necessity of additional treatment despite the lack of adequate safety and efficacy data; AND
- Subsequent requests for new GPP flares (after 1 year) will require the member to meet all initial approval criteria, and information regarding the member’s response to previous treatment with Spevigo® must be submitted. Members who did not experience resolution of pustules after previous treatment will not be approved for additional use of Spevigo®.
tocilizumab (Actemra®) Approval Criteria:
[Giant Cell Arteritis (GCA) Diagnosis]:
- An FDA approved diagnosis of GCA; AND
- Member must be 50 years of age or older; AND
- A history of erythrocyte sedimentation rate (ESR) of ≥30mm/hr or a history of C-reactive protein (CRP) ≥1mg/dL; AND
- Member should have a trial of glucocorticoids for a minimum of four weeks or a reason why this is not appropriate; AND
- Actemra® will be taken in combination with tapering course of a glucocorticoid upon initiation; AND
- Member must have baseline liver enzymes, absolute neutrophil count (ANC), lipid panel, and platelet count and verification that they are acceptable to prescriber; AND
- Member must not have severe hepatic impairment; AND
- Actemra® should not be initiated in patients with active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus, or tuberculosis; AND
- Approval quantity will be based on Actemra® prescribing information and FDA approved dosing regimen.
[Chimeric Antigen Receptor (CAR) T Cell-Induced Cytokine Release Syndrome (CRS) Diagnosis]:
- An FDA approved diagnosis of CAR T cell-induced CRS.
vedolizumab (Entyvio™) Approval Criteria
- An FDA approved diagnosis:
- For intravenous (IV) administration: Moderately-to-severely active Crohn’s disease (CD) or moderately-to-severely active ulcerative colitis (UC); or
- For subcutaneous (sub-Q) administration: Moderately-to-severely active UC; and
- Member must be 18 years of age or older; and
- A minimum of a 4 week trial of a Tier-2 tumor necrosis factor (TNF) blocker indicated for the treatment of CD or UC that did not yield adequate relief of symptoms or resulted in intolerable adverse effects. Current Tier-2 medications include the following:
- CD: Humira® (adalimumab), Inflectra® (infliximab-dyyb); or
- UC: Humira® (adalimumab), Inflectra® (infliximab-dyyb); or
- Prior stabilization on the medication documented within the last 100 days; and
- For Entyvio® sub-Q administration, member must have received at least 2 initial IV doses of Entyvio®; and
- A quantity limit of 300mg every 8 weeks will apply for the IV formulation and 108mg every 2 weeks will apply for the sub-Q formulation. Approvals will be granted for titration quantities required for initial dosing; and
- Initial approvals will be for the duration of 14 weeks as Entyvio® should be discontinued in patients who do not show evidence of therapeutic benefit by week 14.
Abrilada™ (Adalimumab-afzb), Amjevita™ (Adalimumab-atto), Cyltezo™ (Adalimumab-adbm), Hadlima™ (Adalimumab-bwwd), Hulio® (Adalimumab-fkjp), Hyrimoz™ (Adalimumab-adaz), Idacio® (Adalimumab-aacf), Yuflyma® (Adalimumab-aaty), and Yusimry™ (Adalimumab-aqvh) Approval Criteria:
- Member must meet Special Prior Authorization (PA) approval criteria; and
- A patient-specific, clinically significant reason why the member cannot use Humira® (adalimumab) must be provided. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products.
Actemra® (Tocilizumab) Approval Criteria [Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) Diagnosis]:
- An FDA approved diagnosis SSc-ILD; AND
- Member must be 18 years of age or older; AND
- Medication must be prescribed by, or in consultation with, a pulmonologist or pulmonary specialist (or an advanced care practitioner with a supervising physician who is a pulmonologist or pulmonary specialist); AND
- Approvals will be for subcutaneous administration using the FDA approved dosing of 162mg once weekly.
Erelzi® (Etanercept-szza) and Eticovo™ (Etanercept-ykro) Approval Criteria:
- Member must meet Special Prior Authorization (PA) approval criteria; and
- A patient-specific, clinically significant reason why the member cannot use Enbrel® (etanercept) must be provided. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products.
Ilaris® (Canakinumab) Approval Criteria [Gout Flare Diagnosis]:
- An FDA approved indication for the treatment of gout flare; and
- Member must have had ≥3 gout flares in the previous year; and
- Member must meet 1 of the following:
- Inadequate response or intolerance to recent trials of oral colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs), and corticosteroids (oral, intraarticular, and/or intramuscular) used for the treatment of previous gout flare(s); or
- Colchicine, NSAIDs, and corticosteroids are contraindicated for the member (specific information regarding contraindication must be submitted); and
- A patient-specific, clinically significant reason why the member cannot use Kineret® (anakinra) must be provided; and
- Approvals will be for (1) 150mg dose at a time. Subsequent approvals will require documentation that the member responded well to previous treatment with Ilaris®; and
- Approvals will not be granted more often than once every 12 weeks.
Lupkynis™ (Voclosporin) Approval Criteria:
- An FDA approved indication for the treatment of adults with active lupus nephritis (LN) in combination with a background immunosuppressive therapy regimen; and
- Lupkynis™ must be used in combination with mycophenolate mofetil and low dose oral corticosteroids; and
- Member must be 18 years of age or older; and
- Lupkynis™ must be prescribed by a nephrologist, rheumatologist, or other specialist with expertise in the treatment of LN; and
- Member’s current urine protein-to-creatinine ratio (UPCR) must be provided and must be ≥1.5mg/mg; and
- Member’s current estimated glomerular filtration rate (eGFR) must be provided and must be >45mL/min/1.73m2 prior to initiating treatment with Lupkynis™; and
- Prescriber must agree to monitor renal function regularly during treatment with Lupkynis™ and modify the dose as needed in accordance with the Lupkynis™ Prescribing Information; and
- Member’s current blood pressure (BP) must be ≤165/105mmHg prior to initiating treatment with Lupkynis™; and
- Prescriber must agree to monitor BP regularly during treatment with Lupkynis™ and agree to discontinue treatment if BP is >165/105mmHg or member experiences a hypertensive emergency; and
- Member must not be taking strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) concomitantly with Lupkynis™; and
- Prescriber must verify member has been counseled on proper administration of Lupkynis™ including taking it on an empty stomach every 12 hours; and
- Lupkynis™ will not be approved in combination with biologic therapies or cyclophosphamide; and
- A quantity limit of 180 capsules per 30 days will apply; and
- Initial approvals will be for the duration of 6 months. Further approval may be granted if the prescriber documents that the member is responding well to treatment as indicated by a reduction in the member’s UPCR. If the member does not experience therapeutic benefit by 6 months, discontinuation of Lupkynis™ should be considered; and
- The safety and efficacy of Lupkynis™ have not been established beyond 1 year of treatment. For continued authorization consideration after 1 year of treatment, a patient-specific, clinically significant reason why a longer treatment duration is appropriate for the member must be provided.
Saphnelo™ (Anifrolumab-fnia) Approval Criteria:
- An FDA approved indication for the treatment of adult patients with moderate-to-severe systemic lupus erythematosus (SLE), who are receiving standard therapy; and
- Member must be 18 years of age or older; and
- Documented inadequate response to at least 1 of the following medications appropriate to member’s specific disease state:
- High-dose oral corticosteroids; or
- Methotrexate; or
- Azathioprine; or
- Mycophenolate; or
- Cyclophosphamide; or
- Hydroxychloroquine/chloroquine; and
- Member must not have severe active lupus nephritis (LN) or severe active central nervous system lupus; and
- Saphnelo™ will not be approved for combination use with biologic therapies or cyclophosphamide; and
- Initial approvals will be for the duration of 6 months. Further approval may be granted if the prescriber documents that the member is responding well to treatment.
Prior Authorization Forms:
Targeted Immunomodulator Agents*
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TIER 1
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TIER 2
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TIER 3
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Special Authorization (PA) |
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DMARDs appropriate to disease state:
- 6-Mercaptopurine
- Azathioprine
- Hydroxychloroquine
- Leflunomide
- Mesalamine
- Methotrexate
- Minocycline
- Sulfasalazine
- Oral Corticosteroids
- NSAIDs
|
- adalimumab (Humira®)+
- anakinra (Kineret®)
- apremilast (Otezla®)ß
- etanercept (Enbrel®)
- infliximab-dyyb (Inflectra®)±
- rituximab (Rituxan®)~
- rituximab-abbs (Truxima®)±
- rituximab-arrx (Riabni®)±
- rituximab-pvvr (Ruxience®)±
|
- abatacept (Orencia®, Orencia® ClickJect™)¤
- brodalumab (Siliq™)**
- certolizumab (Cimzia®)
- golimumab (Simponi®)
- golimumab (Simponi® Aria™)
- infliximab (Remicade®)
- infliximab-axxg (Avsola™)±
- infliximab-abda (Renflexis™)±
- sarilumab (Kevzara®)
- tofacitinib (Xeljanz®, Xeljanz® XR, Xeljanz® oral solution)**
- vedolizumab (Entyvio™)**
|
- adalimumab-aacf (Idacio®)±
- adalimumab-aaty (Yuflyma®)±
- adalimumab-adaz (Hyrimoz®)±
- adalimumab-adbm (Cyltezo®)±
- adalimumab-afzb (Abrilada™)±
- adalimumab-aqvh (Yusimry™)±
- adalimumab-atto (Amjevita™)±
- adalimumab-bwwd (Hadlima™)±
- adalimumab-fkjp (Hulio®)±
- anifrolumab-fnia (Saphnelo®)**
- avacopan (Tavneos®)**
- baricitinib (Olumiant®)€
- belimumab (Benlysta®)**
- canakinumab (Ilaris®)¥
- deucravacitinib (Sotyktu™)
- etanercept-szzs (Erelzi®)±
- etanercept-ykro (Eticovo™)±
- guselkumab (Tremfya®)
- ixekizumab (Taltz®)
- rilonacept (Arcalyst®)**
- risankizumab-rzaa (Skyrizi®)
- ritlecitinib (Litfulo™)€
- secukinumab (Cosentyx®)
- spesolimab-sbzo (Spevigo®)**
- tildrakizumab-asmn (Ilumya®)
- tocilizumab (Actemra®)π
- tocilizumab-bavi (Tofidence™)±
- upadacitinib (Rinvoq®)#
- ustekinumab (Stelara®)
- voclosporin (Lupkynis®)**
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DMARDs = disease modifying anti-rheumatic drugs; NSAIDs = nonsteroidal anti-inflammatory drugs
*Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), Wholesale Acquisition Costs (WAC) or State Maximum Allowable Costs (SMAC). Products may be moved to a higher tier based on net cost if the manufacturer chooses not to participate in supplemental rebates.
±Biosimilars or reference products preferred based on lowest net cost product. Authorization of higher net cost biosimilars or reference products requires a patient-specific, clinically significant reason why the member could not use the preferred formulation.
+Unique criteria applies for a diagnosis of hidradenitis suppurativa (HS) and noninfectious intermediate and posterior uveitis and panuveitis.
β Unique criteria applies for a diagnosis of Behçet’s disease (BD).
¥Unique criteria applies for a diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS), Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), Familial Mediterranean Fever (FMF), Systemic Juvenile Idiopathic Arthritis (SJIA), Adult-Onset Still’s Disease (AOSD), or gout flare.
~Unique criteria applies for a diagnosis of pemphigus vulgaris (PV). Unique criteria applies for a diagnosis of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
πUnique criteria applies for a diagnosis of giant cell arteritis (GCA) and chimeric antigen receptor (CAR) T-cell-induced cytokine release syndrome (CRS), and systemic sclerosis-associated interstitial lung disease (SSc-ILD).
¤Unique criteria applies for acute graft versus host disease (aGVHD) prophylaxis in hematopoietic stem cell transplant (HSCT) recipients.
#Unique criteria applies for a diagnosis of atopic dermatitis (AD).
€Unique criteria applies for a diagnosis of alopecia areata.
§Unique criteria applies for a diagnosis of polymyalgia rheumatica (PMR).
** Unique criteria applies to this medication for approval.
