Biologics

PA Criteria:

• Pharmacy:
  • Established diagnosis of paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic.
  • For members under 18 years of age, approval can be granted with a documented diagnosis of atypical hemolytic uremic syndrome.
• 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.
    

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).

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.

• 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.
  

• 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: Cimzia® (certolizumab), 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.
  

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.

• 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.
  

DMARDs appropriate to disease state:

• 6-Mercaptopurine
• Azathioprine
• Hydroxychloroquine
• Leflunomide
• Mesalamine
• Methotrexate
• Minocycline
• Sulfasalazine
• Oral Corticosteroids
• NSAIDs

• adalimumab (Humira®)
• certolizumab (Cimzia®)
• etanercept (Enbrel®)

• abatacept (Orencia®)
• alefacept (Amevive®)
• anakinra (Kineret®)
• apremilast (Otezla®)
• canakinumab (Ilaris®)
• golimumab (Simponi®)
• golimumab (Simponi® Aria™)
• infliximab (Remicade®)
• rituximab (Rituxan®)
• tocilizumab (Actemra®)
• tofacitinib (Xeljanz®)
• ustekinumab (Stelara®)
• vedolizumab (Entyvio™)   

PA Criteria:

• An FDA approved diagnosis of one of the following:
  • Adults with severe, active rheumatoid arthritis (RA); OR
  • Children with active polyarticular juvenile idiopathic arthritis (pJIA); OR
  • Severe, recalcitrant, disabling psoriasis confirmed by biopsy or dermatologic consultation; AND
• Members with a diagnosis of RA or pJIA must have had an adequate trial of full dose NSAIDs; AND
• A patient-specific, clinically significant reason why the oral tablets or the generic injectable formulation cannot be used.       

PA Criteria:

• An FDA approved diagnosis of acute lymphoblastic leukemia (ALL); AND
• An age restriction on members older than 10 years of age will apply. Members 10 years of age and younger would not require prior authorization for Purixan® therapy; AND
• Members older than 10 years of age would require a patient-specific, clinically significant reason why the oral tablet formulation cannot be used.  

PA Criteria:

• FDA approved indication of adults 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
  • Cyclophosphamide
• Member must not have severe active lupus nephritis or severe active central nervous system lupus.
• No combination use with biologic therapies or intravenous cyclophosphamide.

PA Criteria:

• Consideration for approval will be based on all the following criteria:
  • An FDA approved diagnosis of multiple sclerosis or Crohn's disease; AND
  • Treatment with at least two different first line therapeutic categories for multiple sclerosis or Crohn's disease that have failed to yield an adequate clinical response, or a patient specific, clinically significant reason why the member  cannot use all available first and second line alternatives; AND
  • Prescriber, infusion center, and member must enroll in the TOUCH Prescribing Program.

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.

Cinryze® PA Criteria:

• Documented 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 androgens (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

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.

Cinryze® PA Criteria:

• Documented 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 androgens (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

Botulinum injections require a Prior Authorization for all diagnoses. Covered diagnoses for all products.

• Spasticity associated with:
  • Cerebral Palsy
  • Paralysis
  • Generalized weakness/incomplete paralysis
  • Larynx
  • Anal fissure
  • Esophagus (achalasia and cardiospasms)
  • Eye and Eye movement disorders
• Cervical Dystonia
  

Consideration for approval requires the following critria for Botox for Prevention of Migraine Headaches (other botulinum toxins will not be approved for this use):

• Non-migraine medical conditions known to cause headache have been ruled out and/or have been treated. This includes but is not limited to:
  • Increase intracranial pressure (e.g. tumor, pseudotumor cerebri, central venous thrombosis, etc.)
  • Decrease intracranial pressure (e.g. post-lumbar puncture headache, dural tear after trauma, etc.) AND
• Migraine headache exacerbation secondary to other medical conditions or therapies have been ruled out and/or treated. This includes but is not limited to:
  • Hormone replacement therapy or hormone-based contraceptives
  • Chronic insomnia
  • Obstructive sleep apnea; AND
• Member has no contraindications to Botox injections; AND
• FDA indications are met:
  • Member is 18 or older; AND
  • Member has a documented chronic migraine headaches
    • Frequency of 15 or more days per month; AND
    • Duration of 4 hours per day or longer; AND
• The member has failed medical migraine preventive therapy including at least 3 agents in 3 or more categories, but not limited to:
  • Select antihypertensive therapy such as beta-blocker therapy
  • Select anticonvulsant therapy
  • Select antidepressant therapy ( e.g. TCA or SNRI); AND
• Member is not frequently taking medications which are known to cause medication overuse headaches (MOH or rebound headache) in the absence of intractable conditions known to cause chronic pain. MOH are a frequent cause of chronic headaches. A list of prescription or non-prescription medications known to cause MOH includes but is not limited to:
  
  • Decongestants (alone or in combination product)
  • Combination analgesics containing caffeine and/or butalbital (>5 day/mo)
  • Narcotics
  • Analgesic medications including acetaminophen and most NSAIDS
  • Ergotamine-containing medications (>8 day/mo)
  • Triptans (>8 day/mo); AND  Member is not taking any medications that are likely to be the cause of the headaches; AND
• Member must have been evaluated within the last 6 months by a neurologist for chronic migraine headaches and Botox recommended as treatment. (Not necessarily prescribed or administered by neurologists.); AND
• Members who smoke or use tobacco products will not be approved.
  

Consideration for approval requires the following criteria for Botox® for Non-Neurogenic Overactive Bladder (other botulinum toxins will not be approved for this use):

• Member must have severe disease (≥ 5 urinary incontinence episode per day on medication) and specific pathology determined via urodynamic studies;
• Member must have participated in behavioral therapy for at least 12 weeks that did not yield adequate clinical results; AND
• Member must have had compliant use of at least 3 antimuscarinic medication(s) for at least 12 weeks each, alone or in combination with behavioral therapy, that did not yield adequate clinical results. One of those trials must have been an extended release formulation; AND
• Member must be 18 years of age or older, and have adequate hand function and sufficient cognitive ability to know when the bladder needs emptying and to self-catheterize, or have a caregiver able to catheterize the member when necessary; AND
• Only Urologists will be approved for administration of this procedure.

Consideration for approval requires the following criteria for Botox for Neurogenic Overactive Bladder (other botulinum toxins will not be approved for this use):

• Diagnosis of neurogenic bladder including underlying pathological dysfunction subtype confirmed by:
• Urodynamic studies to determine pathology and serve to provide objective evidence of bladder and external sphincter function; AND
  • A diary of fluid intake, incontinence, voiding, and catheterization times and amounts to provide a record of actual occurrences; AND
• Must have a clinically significant reason why anticholinergic medications are no longer an option for the member; AND
• Member must be 18 years of age or older, and have adequate hand function and sufficient cognitive ability to know when the bladder needs emptying and to self-catheterize, or have a caregiver able to catheterize the member when necessary; AND
• Only Urologists will be approved for administration of this procedure.