Biologics

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  

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
  • Pharmacy  
  • Physician/Outpatient Administered

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
  • Pharmacy  
  • Physician/Outpatient Administered    

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

• Pharmacy  
• Physician/Outpatient Administered      

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®)

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    

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
  • Pharmacy  
  • Physician/Outpatient Administered

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
  • Pharmacy  
  • Physician/Outpatient Administered

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

• Documented diagnosis of HAE
• Only for acute attacks
• Prior Authorization Forms
  • Pharmacy  
  • Physician/Outpatient Administered

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

• Pharmacy  
• Physician/Outpatient Administered