Biologics

PA Criteria:

Approval Criteria [Neuromyelitis Optica Spectrum Disorder (NMOSD) Diagnosis]: 

• An FDA approved diagnosis of NMOSD; AND
• Member is anti-aquaporin-4 (AQP4) antibody positive; AND
• Member must be 18 years of age or older.

Approval Criteria [Generalized Myasthenia Gravis (gMG) Diagnosis]:

• An FDA approved diagnosis of gMG; AND
• Positive serologic test for anti-acetylcholine receptor (AchR) antibodies; AND
• Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV; a AND
• Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score ≥6; AND
• Member must meet one of the following:
  
  • Failed treatment over one year or more with two or more immunosuppressive therapies (ISTs) either in combination or as monotherapy; OR  
  • Failed at least one IST and required chronic plasmapheresis or plasma exchange (PE) or intravenous immunoglobulin (IVIG); AND
   
• Initial approvals will be for the duration of six months at which time an updated MG-ADL score must be provided. Continued authorization requires improvement in the MG-ADL score from baseline. Subsequent approvals will be for the duration of one year.

Prior Authorization Form

ravulizumab (Ultomiris®)

ravulizumab (Ultomiris®) Approval Criteria:

[Paroxysmal Nocturnal Hemoglobinuria Diagnosis]:

• Member must have an established diagnosis of paroxysmal nocturnal hemoglobinuria via international classification of disease (ICD) coding in member’s medical claims history; AND
• An age restriction of 18 years and older will apply.   

[Atypical Hemolytic Uremic Syndrome (aHUS) Diagnosis]:

• Member must have a documented diagnosis of aHUS.

caplacizumab-yhdp (Cablivi®) Approval Criteria:

• An FDA approved diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP); AND
• Member must be undergoing plasma exchange therapy; AND
  
  • Dates of initiation of plasma exchange therapy must be listed on the prior authorization request; AND
  • Authorizations will be for the duration of plasma exchange and for 30 days after discontinuation of plasma exchange; AND
   
• Member must be utilizing immunosuppressant therapy; AND
• Cablivi® must be prescribed by, or in consultation with, a hematologist; AND
• A quantity limit of 11mg per day will apply. Initial approvals will be for the duration of plasma exchange plus 30 days. Reauthorization, after completing 30 days post-plasma exchange, may be considered if the prescriber documents sign(s) of persistent underlying disease remain. Reauthorization will be for a maximum of 28 days.  

Prior Authorization Forms

•  
  • Pharmacy  
  • Physician/Outpatient Administered    

Tavalisse™ (Fostamatinib) Approval Criteria:

• An FDA approved indication for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment; AND
• Member must be 18 years of age or older (Tavalisse™ is not recommended for use in patients younger than 18 years of age because adverse effects on actively growing bones were observed in nonclinical studies); AND
• Member must have a clinical diagnosis of persistent/chronic ITP for at least 3 months; AND
• Previous insufficient response with at least 2 of the following treatments:
  • Corticosteroids; OR  
  • Immunoglobulins; OR
  • Splenectomy; OR
  • Thrombopoietin receptor agonists; AND  
• Degree of thrombocytopenia and clinical condition increase the risk for bleeding; AND
• Must be prescribed by, or in consultation with, a hematologist or oncologist; AND
• Prescriber must verify the member’s complete blood count (CBC), including platelet counts, will be monitored monthly until a stable platelet count (at least 50 X 10⁹/L) is achieved and will be monitored regularly thereafter; AND
• Prescriber must verify liver function tests (LFTs) (e.g., ALT, AST, bilirubin) will be monitored monthly; AND
• Prescriber must verify member’s blood pressure will be monitored every 2 weeks until establishment of a stable dose, then monthly thereafter; AND
   Female members must not be pregnant and must have a negative pregnancy test immediately prior to therapy initiation. Female members of reproductive potential must be willing to use effective contraception while on therapy and for at least 1 month after therapy completion; AND
• Prescriber must verify member is not breastfeeding; AND
• Member must not be taking strong CYP3A4 inducers (e.g., rifampicin) concurrently with Tavalisse™; AND
• Initial approvals will be for the duration of 12 weeks; AND
• Discontinuation criteria: 
  • Platelet count does not increase to a level sufficient to avoid clinically important bleeding after 12 weeks of therapy; AND 
• A quantity limit of 2 tablets daily will apply.   

Prior Authorization Forms

• • Pharmacy  
  • Physician/Outpatient Administered    

avatrombopag (Doptelet®) Approval Criteria [Chronic Liver Disease (CLD) Scheduled to Undergo a Procedure]:

• An FDA approved indication for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure; AND
• Date of procedure must be listed on the prior authorization request; AND
• Prescriber must verify the member will have the procedure within 5 to 8 days after the member receives the last dose of Doptelet®; AND
• Member must have a baseline platelet count <50 X 10⁹/L (recent baseline platelet count must be provided); AND
• Must be prescribed by, or in consultation with, a hematologist, gastroenterologist, or hepatologist; AND
• Doptelet® must not be used in an attempt to normalize platelet counts; AND
• Female members must not be pregnant and must have a negative pregnancy test prior to therapy initiation; AND
• Prescriber must verify member is not breastfeeding; AND
• A quantity limit of 15 tablets per scheduled procedure will apply. 

avatrombopag (Doptelet®) Approval Criteria [Chronic Immune Thrombocytopenia Diagnosis]:

• An FDA approved indication for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment; AND
• Member must be 18 years of age or older; AND
• Previous insufficient response with at least 1 of the following treatments:
  • Corticosteroids; OR
  • Immunoglobulins; OR
  • Splenectomy; AND  
• A patient-specific, clinically significant reason why the member cannot use an alternative thrombopoietin (TPO) receptor agonist available without a prior authorization must be provided; AND
• Prescriber must verify the degree of thrombocytopenia and clinical condition increase the risk for bleeding; AND
• Prescriber must verify platelet counts will be assessed weekly until a stable platelet count greater than 50 x 109/L has been achieved, and then obtained monthly thereafter; AND
• Must be prescribed by, or in consultation with, a hematologist or oncologist; AND
• Doptelet® must not be used in an attempt to normalize platelet counts; AND
• Female members must not be pregnant and must have a negative pregnancy test prior to therapy initiation; AND
• Prescriber must verify member is not breastfeeding; AND
• A quantity limit of 60 tablets per 30 days will apply. 

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     

PA Criteria:

• An FDA approved indication for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure; AND
• Date of procedure must be listed on the prior authorization request; AND
• Prescriber must verify the member will have the procedure 2 to 8 days after the member receives the last dose of Mulpleta®; AND
• Member must have a baseline platelet count <50 X 10⁹/L (recent baseline platelet count must be provided); AND
• Must be prescribed by, or in consultation with, a hematologist, gastroenterologist, or hepatologist; AND
• Mulpleta® must not be used in an attempt to normalize platelet counts; AND
• A quantity limit of 7 tablets per scheduled procedure will apply. 

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), 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:   

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.

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:

    [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.

      [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. 

infliximab-dyyb (Inflectra™) and infliximab-abda (Renflexis™) Approval Criteria:

• Member must meet Tier-3 trial requirements; AND
• A patient-specific, clinically significant reason why the member cannot use Remicade® (infliximab). 

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).  

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.
  

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.

tofacitinib (Xeljanz® XR) 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

• Pharmacy  
• Physician/Outpatient Administered      

Tier 1

Tier 2

Tier 3

DMARDs appropriate to disease state:

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

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

• abatacept (Orencia®)
• adalimumab-adbm (Cyltezo™)
• adalimumab-atto (Amjevita™) 
• anakinra (Kineret®)
• apremilast (Otezla®)
• baricitinib (Olumiant®)
• brodalumab (Siliq™) 
• canakinumab (Ilaris®)
• certolizumab (Cimzia®)
• etanercept-szzs (Erelzi™) 
• golimumab (Simponi®)
• golimumab (Simponi® Aria™)
• guselkumab (Tremfya™)
• infliximab (Remicade®) 
• infliximab-abda (Renflexis™)
• infliximab-dyyb (Inflectra™)
• ixekizumab (Taltz®)
• risankizumab-rzza (Skyrizi™)
• rituximab (Rituxan®)
• sarilumab (Kevzara®)
• secukinumab (Cosentyx®)*
• tildrakizumab-asmn (Ilumya™)
• tocilizumab (Actemra®)
• tofacitinib (Xeljanz®, Xeljanz® XR)
• upadacitinib (Rinvoq™)
• 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:

• 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; AND
• Documented inadequate response to at least two of the following medications:
  • High-dose oral corticosteroids; OR
  • Methotrexate; OR
  • Azathioprine; OR
  • Mycophenolate; OR
  • Cyclophosphamide; AND
• Member must not have severe active lupus nephritis or severe active central nervous system lupus; AND
• No combination use with biologic therapies or intravenous cyclophosphamide.

Prior Authorization Form:

Physician/Outpatient Administered    

PA Criteria:

• An FDA approved diagnosis of Multicentric Castleman’s Disease (also known as giant lymph node hyperplasia); AND
• Member must be Human Immunodeficiency Virus (HIV) and Human Herpesvirus-8 (HHV-8) negative; AND
• Member must be 18 years of age or older; AND
• The following FDA approved dosing restrictions will apply
  • 11 mg/kg via intravenous (IV) infusion every three weeks until treatment failure (defined as disease progression based on increase in symptoms, radiologic progression, or deterioration in performance status); AND  
• Sylvant™ must be administered in a clinical setting able to provide resuscitation equipment, medications, and trained personnel; AND
• The prescriber must verify that a complete blood count (CBC) will be done prior to each dose for the first 12 months and for an additional three doses thereafter; AND
• Approvals will be for the duration of six months. 

PA Criteria:

• An FDA approved diagnosis of Multiple Sclerosis (MS) or Crohn’s disease; AND
• For a diagnosis of MS the following criteria will apply:
  • Prescriber must be a neurologist or be an advanced care practitioner with a supervising prescriber that is a neurologist; AND
  • Approvals will not be granted for concurrent use with other disease-modifying therapies; AND 
• For a diagnosis of Crohn’s disease the following criteria will apply:  
  • Treatment with at least two different first line therapeutic categories for 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. 

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   

pegfilgrastim-jmdb (Fulphila®) and pegfilgrastim-cbqv (Udenyca™) Approval Criteria:   

• An FDA approved diagnosis; AND  
• A patient-specific, clinically significant reason why the member cannot use Neulasta® (pegfilgrastim) or Neupogen® (filgrastim) must be provided.  

tbo-filgrastim (Granix®), Nivestym™ (Filgrastim-aafi), and filgrastim-sndz (Zarxio™)Approval Criteria:

• An FDA approved diagnosis; AND
• A patient-specific, clinically significant reason why the member cannot use Neupogen® (filgrastim).

Prior Authorization Forms 

• Pharmacy  
• Physician/Outpatient Administered     

Ruconest® (C1 esterase inhibitor) and Kalbitor® (ecallentide) PA Criteria:

• An FDA approved diagnosis of hereditary angioedema (HAE); AND
• Ruconest® and Kalbitor® must be used for treatment of acute attacks of HAE; AND
• For authorization of Kalbitor® (ecallantide), a patient-specific, clinically significant reason why the member cannot use Berinert® (C1 esterase inhibitor) and Firazyr® (icatibant) must be provided.

Cinryze® (C1 Esterase Inhibitor), Haegarda® (C1 Esterase Inhibitor), Takhzyro™ (Lanadelumab-flyo) Approval Criteria:

• An FDA approved diagnosis of hereditary angioedema (HAE); AND
• Must be used for prophylaxis of HAE; AND
• 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; AND
• Not currently taking an angiotensin converting enzyme (ACE) inhibitor or estrogen replacement therapy; AND
• Approval consideration will be given if the member has a recent hospitalization for a severe episode of angioedema; AND
• Authorization of Takhzyro™ (lanadelumab-flyo) will also require a patient-specific, clinically significant reason why the member cannot use Cinryze® or Haegarda® (C1 esterase inhibitor); AND  
• Cinryze® Dosing:
  • The recommended dose of Cinryze® is 1,000 units IV every 3 to 4 days, approximately two times per week, to be infused at a rate of 1mL/min; AND
  • Initial doses should be administered in an outpatient setting by a healthcare provider.  Patients can be taught by their healthcare provider to self-administer Cinryze® intravenously; AND
  • A quantity limit of 8,000 units per month will apply (i.e., two treatments per week or eight treatments per month); OR
• Haegarda® Dosing: 
  • 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
  • A quantity limit of two treatments per week or eight treatments per month will apply.
• Takhzyro™ Dosing:
  
  • The recommended dose of Takhzyro™ is 300mg sub-Q every 2 weeks (dosing every 4 weeks may be considered in some members); AND
  • Prescriber must verify member or caregiver has been trained by a health care professional on proper storage and sub-Q administration of Takhzyro™; AND
  • A quantity limit of (2) 300mg/2mL vials per 28 days will apply.  

Prior Authorization Forms 

• Pharmacy  
• Physician/Outpatient Administered     

PA Criteria:

• An FDA approved diagnosis of Sly syndrome (mucopolysaccharidosis type VII; MPS VII) confirmed by:
  • Enzyme assay demonstrating a deficiency of beta-glucuronidase (GUS) activity; OR  
  • Genetic testing to confirm diagnosis of MPS VII; AND  
• Mepsevii™ must be administered by a healthcare professional prepared to manage anaphylaxis; AND
• Initial approvals will be for the duration of twelve months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. 
• 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.  

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   

denosumab (Prolia®) 

PA Criteria:

• An FDA approved diagnosis of moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies; AND
• Member must be 12 years of age or older; AND
• Member must have documented trials within the last six months for a minimum of two weeks that resulted in failure with both of the following therapies (or have a contraindication or documented intolerance):
  • One medium potency to very-high potency Tier-1 topical corticosteroid; AND
  • One topical calcineurin inhibitor [e.g., Elidel® (pimecrolimus), Protopic® (tacrolimus)]; AND
• Dupixent® 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 twelve months (or be an advanced care practitioner with a supervising physician who is a dermatologist, allergist, or immunologist); AND
• Requests for concurrent use of Dupixent® with other biologic medications will be reviewed on a case-by-case basis and will require patient-specific information to support the concurrent use. (Dupixent® has not been studied in combination with other biologic therapies.); AND
• Initial approvals will be for the duration of 16 weeks. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval. 

Prior Authorization Form

Dysport® (abobotulinumtoxinA) and Botox® are now both preferred agents. 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 

Botox® only criteria (effective April 24, 2013)

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 headache days per month with 8 or more migraine days per month and occurring for more than 3 months; AND
    • Duration of 4 hours per day or longer; AND 
• The member has failed medical migraine preventive therapy including at least two agents with different mechanisms of action. This includes, 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) (≥10 days/month for >3 months); AND
  • Combination analgesics containing caffeine and/or butalbital (≥10 days/month for >3 months); AND
  • Opioids (≥10 days/month for >3 months); AND
  • Analgesic medications including acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDS) (≥15 days/month for >3 months); AND
  • Ergotamine-containing medications (≥10 days/month for >3 months); AND
  • Triptans (≥10 days/month for >3 months); 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
• Prescriber must verify that other aggravating factors that are contributing to the development of chronic migraine headaches are being treated when applicable (e.g., smoking); AND
• Member will not use the requested medication concurrently with a calcitonin gene-related peptide (CGRP) inhibitor for the prevention of migraine headaches. 

 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.  

Prior Authorization Form - Botulinum Toxins