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Biologics

Hematopoetic Agents
eculizumab (Soliris®)

PA Criteria:

  • Pharmacy:
    • Established diagnosis of paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome.
    • For members under 18 years of age, approval can be granted with a documented diagnosis of atypical hemolytic uremic syndrome.
    • Pharmacy
     
  • Physician and Outpatient administered:
    • Medical claims do NOT require a PA but are covered for an appropriate diagnosis  
Erythropoietin Stimulating Agents
romiplostim (Nplate®)

PA Criteria:

  • FDA approved indication of chronic immune (idiopathic) thrombocytopenia purpura (ITP).
  • Previous insufficient response with at least two of the following treatments: corticosteroids, immunoglobulins, or splenectomy.
  • Recent platelet count of < 50 x 10⁹/L.
  • Continuation criteria:
    • Weekly CBCs with platelet count and peripheral blood smears until stable platelet count (≥ 50 x 10⁹/L for at least 4 weeks without dose adjustment) has been achieved; then obtain monthly thereafter.
  • Discontinuation criteria:
    • Platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of therapy at the maximum weekly dose of 10 mcg/kg.
  • Prior Authorization Forms
plerixafor (Mozobil®)

PA Criteria:

  • FDA approved indication of use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM).
  • MUST have a cancer diagnosis of non-Hodgkins’s lymphoma (NHL) or multiple myeloma (MM).  This medication is NOT covered for the diagnosis of leukemia.
  • Prescribed by an oncologist only.
  • Patient must be at least 18 years of age.
  • Must be given in combination with the granulocyte-colony stimulating factor (G-CSF) Neupogen® (filgrastim).
  • Prior Authorization Forms

 

Immunomodulating Agents
Rheumatoid Arthritis, Plaque Psoriasis,  Crohn's Disease & Ankylosing Spondylitis

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.

Prior Authorization Forms

Tier 1

Tier 2

Tier 3

DMARDs appropriate to disease state:

  • 6-Mercaptopurine
  • Azathioprine
  • Hydroxychloroquine
  • Leflunomide
  • Mesalamine
  • Methotrexate
  • Minocycline
  • Sulfasalazine
  • certolizumab (Cimzia®)
  • etanercept (Enbrel®)
  • adalimumab (Humira®)
  • golimumab (Simponi®)
  • ustekinumab (Stelara®)
  • tocilizumab (Actemra®)
  • alefacept (Amevive®)
  • anakinra (Kineret®)
  • abatacept (Orencia®)
  • infliximab (Remicade®)
  • rituximab (Rituxan®)
  • tofacitinib (Xeljanz®)
belimumab (Benlysta®)

PA 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
  • FDA approved indication of members 5 years of age and older with active, autoantibody-positive, systemic lupus erythematosus already receiving standard therapy.
  • Documented inadequate response to at least two of the following medications:
    • High-dose oral corticosteroids.
    • Methotrexate
    • Azathioprine
    • Mycophenolate
    • CyclophosphamideMember must not have severe active lupus nephritis or severe active central nervous system lupus.
  • No combination use with biologic therapies or intravenous cyclophosphamide. 
  • Prior Authorization For

Physician/Outpatient Administered    

       

canakinumab (Ilaris®)

PA Criteria:

  • 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 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.
  • Prior Authorization Forms
rilonacept (Arcalyst®)

PA Criteria:

  • 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.
  • 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.
  • Prior Authorization Forms
Replacement Therapy

C1 esterase inhibitor  (Cinryze®, Berinert®) 

Cinryze® PA Criteria:

  • Documneted diagnosis of Hereditary Angioedema (HAE).
  • For prophylaxis of Hereditary Angioedema.
  • History of at least one or more abdominal or respiratory HAE attacks per month, or history of laryngeal attacks, or three or more emergency medical treatments per year.
  • Documented intolerance, insufficient response, or contraindication to:
    • attenuated androgends (e.g. danazol, stanozolol, oxandrolone, methyltestosterone) AND
    • antifibrinolytic agents (e.g. e-aminocaproic acid, tranexamic acid) OR
    • recent hospitalization for severe episode of angioedema
  • Not currently taking an angiotensin converting enzyme (ACE) inhibitor or estrogen replacement therapy.

Berinert® PA Criteria

Skeletal Agents
clostridium histolyticum colagenase(Xiaflex®) *Medical billing only

PA Criteria:

  • FDA approved indication of Dupytren's contracture with palpable cord, functional impairment and fixed-flexion contractures of the metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of 30 degrees or more.
  • Must be 18 years or older.
  • Not a candidate for needle aponeurotomy.
  • Physician must be trained in treatment of Dupuytren's contractures and injections of the hand.
  • Quantity limit of 3 doses (one dose per 4 weeks) per cord.

Xiaflex® (Collagenase Clostridium Histolyticum) Approval Criteria (Peyronie’s Disease):

  • A diagnosis of stable Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees and less than 90 degrees at the start of therapy; AND 
  • Member must be 18 years or older; AND 
  • Member must have pain outside the circumstances of intercourse that is refractory to other available treatments; AND 
  • Peyronie’s plaques must not involve the penile urethra; AND 
  • Member must have intact erectile function (with or without the use of medications); AND 
  • Prescriber must be certified to administer Xiaflex® through the Xiaflex® REMS program; AND 
  • A maximum of 8 injection procedures will be approved. 

Prior Authorization Forms

        

If you have questions please call the Pharmacy Help Desk at (800) 522-0114 option 4 or (405) 522-6205 option 4.

Last Modified on Dec 21, 2020
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