Tier 2 Authorization Criteria
- An FDA approved diagnosis; AND
- A trial of at least one Tier-1 medication in the last 90 days that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; OR
- For a diagnosis of Crohn’s disease (CD) or ulcerative colitis (UC) authorization of a Tier-2 product requires history of failure of a mesalamine product (does not have to be within the last 90 days) and a trial of one Tier-1 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.
Tier 3 Authorization Criteria
- An FDA approved diagnosis; AND
- Recent trials of one Tier-1 medication and all available Tier-2 medications 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.
Additional criteria by for individual products: adalimumab (Humira®) Approval Criteria for 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.
Approval Criteria for Noninfectious Intermediate and Posterior Uveitis or Panuveitis:
- A diagnosis of noninfectious intermediate uveitis, posterior uveitis, or panuveitis in adults; 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.
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 for Systemic Juvenile Idiopathic Arthritis (SJIA):
- An FDA approved diagnosis of Systemic Juvenile Idiopathic Arthritis; 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.
Approval Criteria for 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.
Approval Criteria for 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.
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.
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.
Approval Criteria [Chimeric Antigen Receptor (CAR) T Cell-Induced Cytokine Release Syndrome (CRS) Diagnosis]:
- An FDA approved diagnosis of CAR T cell-induced CRS.
tofacitinib (Xeljanz®) safety criteria must also be met before approval of :
- Negative tuberculosis test, successful treatment of active tuberculosis, or close evaluation and appropriate treatment of latent tuberculosis.
- Severe hepatic impairment has been ruled out.
- Approval will be for 12 weeks, after which time, prescriber must confirm performance of the following tests for further approval:
- Lymphocytes
- Neutrophils
- Hemoglobin
- Liver enzymes
- Lipid panel
- Subsequent approvals will be for the duration of one year. Yearly approvals require performance of repeat tuberculosis test.
Xeljanz® XR (Tofacitinib) Approval Criteria:
- Member must meet Tier-3 trial requirements; AND
- A patient-specific, clinically significant reason why the member cannot take the twice-daily formulation of Xeljanz.
vedolizumab (Entyvio™) Approval Criteria
- Member must be 18 years of age or older; AND
- An FDA approved diagnosis of moderate-to-severely active Crohn’s disease (CD) or moderate-to-severely active ulcerative colitis (UC); AND
- History of failure of a mesalamine product (does not have to be within the last 90 days) and a trial of one Tier-1 in the last 90 days that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; 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 products include the following:
- UC: Humira® (adalimumab)
- CD: Humira® (adalimumab) OR
- Prior stabilization on the medication documented within the last 100 days.
- A quantity limit of 300mg every 8 weeks will apply. Approvals will be granted for titration quantities required for initial dosing.
- 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.
Prior Authorization Forms
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