Biologics

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

Benlysta^® (Belimumab) Approval 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
• An FDA approved indication of 1 of the following:
  • The treatment of members 5 years of age and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) already receiving standard therapy; or
  • The treatment of members 18 years of age and older with active lupus nephritis who are receiving standard therapy; and
• Documented inadequate response to at least two of the following medications appropriate to the member's specific disease state:
  • High-dose oral corticosteroids; or
  • Methotrexate; or
  • Azathioprine; or
  • Mycophenolate; or
  • Cyclophosphamide; or
  • Hydroxychloroquine/chloroquine; and
• Member must not have severe active central nervous system lupus; AND
• Benlysta^® will not be approved for combination use with biologic therapies; and
• Benlysta^® will not be approved for combination use with IV cyclophosphamide (exception for induction treatment with IV cyclophosphamide for members with a diagnosis of lupus nephritis).

(BOTOX® MYOBLOC® DYSPORT® XEOMIN®)*MEDICAL BILLING ONLY 

Dysport® (abobotulinumtoxinA) and Botox® are now both preferred agents. Botulinum injections require a Prior Authorization for all diagnoses.

Botulinum Toxins Approval Criteria:

• For approval of Xeomin^® or Myobloc^®, a patient-specific, clinically significant reason the member cannot use Botox^® or Dysport^® must be provided; and
• Cosmetic indications will not be covered; and
• A diagnosis of chronic migraine (tension headaches are not a covered diagnosis), neurogenic detrusor overactivity, and non-neurogenic overactive bladder will require manual review (see specific criteria below); and
• The following indications have been determined to be appropriate and are covered: 

            a.    Spasticity associated with:

                                            i.     Cerebral palsy; or

                                           ii.     Paralysis; or

                                          iii.     Generalized weakness/incomplete paralysis; or

                                          iv.     Larynx; or

                                           v.     Anal fissure; or

                                          vi.     Esophagus (achalasia and cardiospasms); or

                                         vii.     Eye and eye movement disorders; or 

           b.    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. Trials must be at least 8 weeks in duration (or documented adverse effects) within the last 365 days. 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 Detrusor Overactivity (NDO) (other botulinum toxins will not be approved for this use):

• Diagnosis of 1 of the following:
• a.     Urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury, multiple sclerosis] in adult members; or
• b.     NDO in pediatric members; and 
• Underlying pathological dysfunction subtype confirmed by:
• a.    Urodynamic studies to determine pathology and serve to provide objective evidence of bladder and external sphincter function; AND
• b.    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 5 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

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

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

Dupixent^® (Dupilumab Injection) Approval Criteria [Atopic Dermatitis Diagnosis]: 

• An FDA approved diagnosis of moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies; AND
• Member must be 6 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. 

Enspryng™ (Satralizumab-mwge) Approval Criteria:

• An FDA approved indication of neuromyelitis optica spectrum disorder (NMOSD) in adult members who are anti-aquaporin-4 (AQP4) antibody positive; and
• Member must be 18 years of age or older; and
• Member must have experienced at least 1 acute NMOSD attack in the prior 12 months; and
• Member must have an Expanded Disability Severity Scale (EDSS) score ≤6.5; and
• Prescriber must verify hepatitis B virus (HBV) and tuberculosis (TB) screening are negative before the first dose; and
• Approvals will not be granted for members with active HBV infection or active or untreated latent TB; and
• Prescriber must verify liver function tests have been assessed prior to initiation of treatment with Enspryng™ and levels are acceptable to prescriber; and
• Prescriber must agree to counsel the member to monitor for clinically significant active infection(s) prior to each dose (for active infections, the dose should be delayed until the infection resolves); and
• Prescriber must agree to monitor neutrophil counts 4 to 8 weeks after initiation of therapy and thereafter as clinically appropriate; and
• Prescriber must verify member has not received any vaccinations within 4 weeks prior to initiation of therapy; and
• Member and/or caregiver must be trained by a health care professional on subcutaneous administration and storage of Enspryng™; and
• A quantity limit override for the loading dose will be approved upon meeting the Enspryng™ approval criteria. A quantity limit of 1 syringe per 28 days will apply for the maintenance dose, according to the package labeling; and
• Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment.

Fulphila® (pegfilgrastim-jmdb), Nyvepria™ (Pegfilgrastim-apgf), and Udenyca™ (pegfilgrastim-cbqv) Approval Criteria:   

• An FDA approved diagnosis; AND  
• A patient-specific, clinically significant reason why the member cannot use Granix^® (tbo-filgrastim), Neulasta^® (pegfilgrastim), Neupogen^® (filgrastim), Zarxio^® (filgrastim-sndz), or Ziextenzo^® (pegfilgrastim-bmez) must be provided. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products.

 Nivestym™ (Filgrastim-aafi) Approval Criteria:

• An FDA approved diagnosis; AND
• A patient-specific, clinically significant reason why the member cannot use Granix^® (tbo-filgrastim), Neupogen^® (filgrastim), or Zarxio^® (filgrastim-sndz) must be provided. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products.

Prior Authorization Forms 

Erythropoietin Stimulating Agents  

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 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

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

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.  

Rasuvo^®, RediTrex^®, and Otrexup^® (Methotrexate Injection Solutions) Approval 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 
• A patient-specific, clinically significant reason why the oral tablets or and the generic injectable formulation cannot be used must be provided; and

•     Authorization of Otrexup^® will also require a patient-specific, clinically significant reason why the member cannot use Rasuvo^® or RediTrex^®. 

omalizumab (Xolair®)

palivizumab (Synagis®)

reslizumab (Cinqair®)

dupilumab (Dupixent®)

benralizumab (Fasenra®)

mepolizumab (Nucala)

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. 

DENOSUMAB (XGEVA®)*MEDICAL BILLING ONLY

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

• An FDA approved indication of NMOSD in adult members who are anti-aquaporin-4 (AQP4) antibody positive; and
• Member must be 18 years of age or older; and
• Member must have a history of at lest 2 NMOSD attacks in the last 12 months or 3 attacks in the last 24 months, with at least 1 attack in the past 12 months; and 
• Member must have an Expanded Disability Severity Scale (EDSS) score ≤7; and
• Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment.

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.

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. 

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

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      

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.

Uplizna^® (Inebilizumab-cdon) Approval Criteria:

• An FDA approved indication of neuromyelitis optica spectrum disorder (NMOSD) in adult members who are anti-aquaporin-4 (AQP4) antibody positive; and
• Member must be 18 years of age or older; and
• Member must have experienced at least 1 acute NMOSD attack in the prior 12 months, or at least 2 attacks in the prior 24 months, requiring rescue therapy; and
• Member must have an Expanded Disability Severity Scale (EDSS) score ≤8; and
• Prescriber must verify hepatitis B virus (HBV) and tuberculosis (TB) screening are negative before the first dose; and
• Approvals will not be granted for members with active HBV infection or active or untreated latent TB; and
• Prescriber must agree to monitor member for clinically significant active infection(s) prior to each dose (for active infections, the dose should be delayed until the infection resolves); and
• Prescriber must verify testing for quantitative serum immunoglobulins has been performed before the first dose and levels are acceptable to prescriber; and
• Prescriber must agree to monitor the level of serum immunoglobulins during and after discontinuation of treatment with Uplizna^® until B-cell repletion; and
• The infusion must be administered under the supervision of a health care professional with access to appropriate medical support to manage potential severe reactions, and the patient must be observed for at least 1 hour after the completion of each infusion; and
• Female members of reproductive potential must not be pregnant and must have a negative pregnancy test prior to initiation of treatment; and
• Female members of reproductive potential must use contraception while receiving Uplizna^® and for 6 months after the last infusion; and
• Prescriber must verify member has not received any vaccinations within 4 weeks prior to initiation of therapy; and
• A quantity limit override for the loading dose will be approved upon meeting the Uplizna^® approval criteria. A quantity limit of 30mL per 180 days will apply for the maintenance dose; and
• Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment.