3. Does the patient have a diagnosis of warm-type autoimmune hemolytic anemia?

Transcription

1 Pharmacy Prior Authorization AETA BETTER HEALTH FLORIDA IVIG (Medicaid) This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information, sign and date. Fax signed forms to Aetna Better Health Florida at When conditions are met, we will authorize the coverage of IVIG (Medicaid). Please note that all authorization requests will be reviewed as the AB rated generic (when available) unless states otherwise. Drug ame Please specify Quantity Frequency Strength Route of Administration Patient Information Patient ame: Patient ID: Patient Group o.: Patient DOB: Patient Phone: Prescribing Physician Expected Length of therapy Physician ame: Specialty: PI umber: Physician Fax: Physician Phone: Physician Address: City, State, Zip: Diagnosis: ICD Code: Please circle the appropriate answer for each question. 1. Is the request for Gammagard liquid? [If yes, skip to question 3.] 2. Has the provider submitted a rationale as to why preferred product (Gammagard Liquid) is not being requested? ote to provider: Hizentra is another preferred agent. 3. Does the patient have a diagnosis of warm-type autoimmune hemolytic anemia? [If no, skip to question 5.] Reference umber: C5030-A / Effective Date: 10/02/2017 1

2 4. Does the patient meet EITHER of the following requirements? -Failure to respond to steroid therapy or splenectomy OR -The patient has a contraindication to these treatments [o further questions.] 5. Does the patient have a diagnosis of an autoimmune mucocutaneous blistering disease (e.g., pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, epidermolysis bullosa acquisita)? [If no, skip to question 10.] 6. Has the diagnosis been proven by biopsy and confirmed by pathology report? 7. Is the condition rapidly progressing, extensive, or debilitation? 8. Has the patient failed corticosteroids or immunosuppressive agents? 9. Did the patient experience significant complications from corticosteroids or immunosuppressive agents such as diabetes or steroid-inducted osteoporosis? [o further questions.] 10. Is the patient a HIV-infected child with a bacterial infection? [If no, skip to question 12.] 11. Does the patient meet A of the following criteria? -The patient has an IgG concentration less than 250 mg/dl -The patient has recurrent bacterial infections defined as two or more infections such as bacteremia, meningitis, or pneumonia in a 1-year period -The patient has failed to form antibodies to common antigens, such as measles, pneumococcal, and/or Haemophilus influenzae type b vaccine -The patient is living in an area with a high prevalence of measles and who have not developed an antibody response after two doses of measles, mumps, and rubella virus vaccine-live -The patient has been exposed to measles -The patient has chronic bronchiectasis that is suboptimally responsive to Reference umber: C5030-A / Effective Date: 10/02/2017 2

3 antimicrobial and pulmonary therapy [o further questions.] 12. Does the patient have a diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP)? [If no, skip to question 14.] 13. Does the patient have symmetric or focal neurologic deficits with a slowly progressive or relapsing course over 2 months or longer (with neurophysiological abnormalities)? [o further questions.] 14. Does the patient have a diagnosis of chronic lymphocytic leukemia (CLL)? [If no, skip to question 17.] 15. Does the patient have an IgG level less than 600 mg/dl? 16. Does the patient meet A of the following criteria? -One severe bacterial infection within the preceding 6 months -Two or more bacterial infections within 1 year -Evidence of specific antibody deficiency [o further questions.] 17. Does the patient have a diagnosis of dermatomyositis or polymyositis (includes juvenile)? [If no, skip to question 21.] 18. Does the patient meet at least 4 of the following criteria: -Proximal muscle weakness (upper or lower extremity and trunk) -Elevated serum creatinine kinase (CK) or aldolase level -Muscle pain on grasping or spontaneous pain -Myogenic changes on EMG (short-duration, polyphasic motor unit potentials with spontaneous fibrillation potentials) -Positive anti-jo-1 (histadyl tra synthetase) antibody -on-destructive arthritis or arthralgias -Systemic inflammatory signs (fever of more than 37 degrees Celcius at axilla, elevated serum CRP level, or accelerated erythrocyte sedimentation rate (ESR) of more than 20 mm/h by the Westergren method) -Pathological findings compatible with inflammatory myositis (inflammatory infiltration of skeletal evidence of active regeneration may be seen) Reference umber: C5030-A / Effective Date: 10/02/2017 3

4 19. Does the patient have severe active disease? 20. Is the patient intolerant or refractory to first and second line therapies? -First line: Corticosteroids -Second line: Immunosuppressants (e.g., methotrexate, azathioprine, cyclophosphamide, and cyclosporine) [o further questions.] 21. Does the patient have a diagnosis of enteroviral meningocephalitis? [If no, skip to question 23.] 22. Does the patient have severe disease lacking other therapeutic options? [o further questions.] 23. Does the patient have neonatal alloimmune thrombocytopenia (AIT) (also known as Fetal Alloimmune Thrombocytopenia (FAIT))? [If no, skip to question 26.] 24. Has the mother had a previous pregnancy affected by FAIT? 25. At 20 weeks of pregnancy or later, did cordocentensis reveal fetal platelets less than 20 x 1000/ml? [o further questions.] 26. Does the patient have a diagnosis of Guillain Barre syndrome (GBS)? [If no, skip to question 30.] 27. Does the patient have severe GBS with significant weakness such as inability to stand or walk without aid, respiratory or bulbar weakness, or Miller-Fisher syndrome? 28. The disorder has been diagnosed during the first 2 weeks of illness? Reference umber: C5030-A / Effective Date: 10/02/2017 4

5 29. Will the medication be initiated within one month of symptom onset? [o further questions.] 30. Does the patient have a diagnosis of hematopoietic stem cell transplant (HSCT) or bone marrow transplant (BMT)? [If no, skip to question 39.] 31. Will the medication by started within the first 100 days post-transplant? [If no, skip to question 37.] 32. Does the patient have a diagnosis of graft-versus-host disease (GVHD)? [If no, skip to question 36.] 33. Is the disease corticosteroid resistant? 34. Is the patient 20 years of age or older? 35. Does the patient have an IgG level less than 400 mg/dl? [o further questions.] 36. Did the patient receive an allogenic (related donor) or a syngenic (twin donor) transplant? [o further questions.] 37. Does the patient have an IgG level less than 400 mg/dl? 38. Does the patient have a primary immunodeficiency disease, cytomegalovirus (CMV) infection, Epstein-Barr virus (EBV) infection, or respiratory syncytial virus (RSV) infection? 39. Does the patient have a diagnosis of HIV-associated thrombocytopenia? [If no, skip to question 46.] 40. Is the patient 13 years of age or older? Reference umber: C5030-A / Effective Date: 10/02/2017 5

6 [If no, skip to question 44.] 41. Does the patient have significant bleeding or a platelet count less than 20,000 per microliter? 42. Is the patient Rh-positive? 43. Has the patient tried and failed RhIG? [o further questions.] 44. Does the patient have an IgG level of less than 400 mg/dl? 45. Does the patient meet A of the following criteria? -The patient has two or more bacterial infections in a 1-year period despite antibiotic chemoprophylaxis -The patient has received 2 doses of measles vaccine and lives in a region with a high prevalence of measles -The patient has HIV-associated thrombocytopenia despite anti-retroviral therapy -The patient has chronic bronchiectasis that is suboptimally responsive antimicrobial and pulmonary therapy -The patient has a T4 cell count greater than or equal to 200 per mm3. [o further questions.] 46. Does the patient have a diagnosis of immune/idiopathic thrombocytopenia purpura (ITP)? [If no, skip to question 64.] 47. Is the patient pregnant? [If no, skip to question 49.] 48. Does the patient meet A of the following criteria? -The patient is refractory to steroids with a platelet count of less than 10,000 per microliter in the third trimester -The patient has a platelet count of less than 30,000 per microliter associated with bleeding before vaginal delivery or C-section -The patient has previously delivered infants with autoimmune Reference umber: C5030-A / Effective Date: 10/02/2017 6

7 thrombocytopenia -The patient has a platelet could of less than 50,000 per microliter -The patient has a history of splenectomy [o further questions.] 49. Does the patient have chronic disease? [If no, skip to question 58.] 50. Is the patient 10 years of age or older? [If no, skip to question 55.] 51. Is the duration of illness greater than 6 months? 52. Does the patient have an illness or disease explaining thrombocytopenia? 53. Has the patient failed prior treatment with corticosteroids and splenectomy? 54. Is the patient at high risk for post-splenectomy sepsis? [o further questions.] 55. Is the patient at high-risk with a low platelet count or exhibiting symptoms? 56. Has the patient failed other therapies? 57. Is the patient at high risk for post-splenectomy sepsis? [o further questions.] 58. Is the patient an adult? [If no, skip to question 62.] 59. Have other causes of thrombocytopenia been ruled out by history and peripheral smear? Reference umber: C5030-A / Effective Date: 10/02/2017 7

8 60. Is the patient unresponsive to corticosteroid therapy? 61. Does the patient meet A of the following criteria? -The patient requires management of acute bleeding due to severe thrombocytopenia defined as a platelet count less than 30,000 per microliter -The medication will be used to increase platelet counts prior to invasive major surgical procedure (e.g., splenectomy) -The medication will be used to defer or avoid splenectomy -The patient has severe thrombocytopenia (platelet count less than 20,000 per microliter) and is considered to be at risk for intra-cerebral hemorrhage [o further questions.] 62. Are the platelet levels less than 20,000 per microliter? 63. Does the patient meet A of the following criteria? -The patient has emergent bleeding -The patient is at risk for severe, life-threatening bleeding -The patient is at risk for intracranial bleeding [o further questions.] 64. Is the patient immunosuppressed? [If no, skip to question 67.] 65. Will the medication be used to prevent or modify recurrent bacteria or viral infections in patient with iatrogenically induced, or disease associated, immunosuppression defined as an IgG level less than 400 mg/dl? 66. Does the patient meet A of the following criteria? -The patient has undergone solid organ transplant -The patient has undergone extensive surgery with immunosuppression -The patient has hematological malignancy -The patient has collagen-vascular disease [o further questions.] 67. Does the patient have a diagnosis of Kawasaki disease (mucocutaneous lymph node syndrome [MCLS])? Reference umber: C5030-A / Effective Date: 10/02/2017 8

9 [If no, skip to question 70.] 68. Has the patient had a fever for at least 5 days? 69. Does the patient meet at least 4 or the following 5 criteria? -The patient has mucous membrane changes such as a red tongue and dry fissured lips -The patient has swelling in the hands and feet -The patient has enlarged lymph nodes in the neck -The patient has a diffuse red rash covering most of the body -The patient has redness of the eyes [o further questions.] 70. Does the patient have a diagnosis of Lambert-Eaton Myasthenic Syndrome (LEMS)? [If no, skip to question 74.] 71. Has the patient failed to respond to anti-cholinesterases and dalfampridine (Ampyra)? 72. Will the medication be used as an alternative to plasma exchange in a patient with severe weakness? 73. Is there difficulty establish the venous access necessary for plasmapheresis? [o further questions.] 74. Does the patient have a diagnosis of myasthenia gravis? [If no, skip to question 77.] 75. Will the medication be used for the treatment of acute myasthenic crisis with decompensation (e.g., respiratory failure, disabling weakness requiring hospitalization)? 76. Have other treatments (e.g., azathioprine, cyclosporine, cyclophosphamide) been unsuccessful or are contraindicated? Reference umber: C5030-A / Effective Date: 10/02/2017 9

10 [o further questions.] 77. Does the patient have a diagnosis of multifocal motor neuropathy with conduction block? [If no, skip to question 80.] 78. Does the patient have progressive, symptomatic disease? 79. Has the disease been diagnosed on the basis of electrophysiologic findings that rule out other conditions that may not respond to IVIG? [o further questions.] 80. Does the patient have a diagnosis of multiple myeloma? [If no, skip to question 84.] 81. Was multiple myeloma diagnosed greater than 3 months ago? 82. Does the patient have an IgG level less than 600 mg/dl? 83. Does the patient meet EITHER of the following criteria? -The patient had two or more significant infections in the last year -The patient had a single life threatening infection -The patient has evidence of specific antibody deficiency [o further questions.] 84. Does the patient have a diagnosis of relapsing-remitting multiple sclerosis? [If no, skip to question 87.] 85. Is the patient experiencing severe manifestations of the disease? 86. Have standard FDA approved multiple sclerosis therapies (e.g., interferons, glatiramer) have failed, become intolerable, or are contraindicated? [o further questions.] 87. Is the patient a pregnant woman with a documented history of a pregnancy Reference umber: C5030-A / Effective Date: 10/02/

11 ending with neonatal hemochromatosis? 88. Does the patient have a diagnosis of neuroblastoma associated paraneoplastic opsoclonus-myoclonus-ataxia syndrome? 89. Does the patient have a diagnosis of opsoclonus-myoclonus? [If no, skip to question 91.] 90. Is IVIG being requested as the last resort treatment for refractory opsoclonus-myoclonus)? [o further questions.] 91. Does the patient have a diagnosis of parovirus B19 infection? [If no, skip to question 94.] 92. Does the patient have severe, refractory anemia? 93. Does the patient have documented Parvo B19 viremia? [o further questions.] 94. Does the patient have a diagnosis of post-transfusion purpura? [If no, skip to question 97.] 95. Does the patient have decreased platelets (i.e., less than 10,000/microliter)? 96. Did the decrease in platelets occur two to fourteen days after the transfusion and occur with bleeding? [o further questions.] 97. Does the patient have a diagnosis of primary humoral immunodeficiency (e.g., selective IgM immunodeficiency, congenital hypogammaglobulinemia, immunodeficiency with near/normal IgM [absent IgG, IgA] also known as hyper IgM syndrome, other deficiency of humoral immunity, combined immunodeficiency disorders such as X-SCID, jak3, ZAP70, ADA, PP, RAG defects, Ataxia Telangiectasia, DiGeorge syndrome, common variable immunodeficiency)? Reference umber: C5030-A / Effective Date: 10/02/

12 [If no, skip to question 118.] 98. Does the patient have agammaglobulinemia? [If no, skip to question 100.] 99. Does the patient meet A of the following criteria? -The patient has an IgG level less than 200 mg/dl -The patient is an infant with the BTK gene -The patient is an infant with absence of B lymphocytes [o further questions.] 100. Does the patient have persistent hypogammaglobulinemia defined as an IgG level less than 400 mg/dl or two standard deviations below the mean for age? [If no, skip to question 103.] 101. Does the patient experience recurrent bacterial infections? 102. Does the patient have a lack of response to protein or polysaccharide antigens (e.g., inability to make IgG antibody against diphtheria and tetanus toxoids, pneumococcal polysaccharide vaccine, or both)? Inadequate response is defined by the following: -For protein antigens: Serum titers 3 to 4 weeks after vaccination of less than 0.1 international units per ml for diptheria or tetanus -For polysaccharide antigens: Serum titers 4 to 6 weeks after vaccination with polyvalent pneumococcal polysaccharide vaccine show a lack of protective antibody titer (specific IgG antibody titer less than 1.3 mcg/ml) in greater than 70% of antigens tested (more than 50% in children aged 2 to 5 years) [o further questions.] 103. Does the patient have selective IgG subclass deficiency defined as an IgG levels less than 2 standard deviations below the age-specific mean for one or more subclasses? [If no, skip to question 108.] 104. Were the levels assessed on two separate occasions when the patient was free of infections? Reference umber: C5030-A / Effective Date: 10/02/

13 105. Does the patient have unexplained recurrent or persistent severe bacterial infections despite adequate treatment? 106. Does the patient meet ALL of the following criteria? -Patient has received aggressive management of other conditions predisposing the patient to recurrent sinopulmonary infections (e.g., asthma, allergic rhinitis) -The patient has received prophylactic antibiotics -There is increased vigilance and appropriate antibiotic therapy for infections -The patient has received immunization with conjugate vaccines in patients who have not responded to polysaccharide vaccines 107. Has the patient demonstrated an inability to mount an inadequate response to protein or polysaccharide antigens? Inadequate response is defined by the following: -For protein antigens: Serum titers 3 to 4 weeks after vaccination of less than 0.1 international units per ml for diptheria or tetanus -For polysaccharide antigens: Serum titers 4 to 6 weeks after vaccination with polyvalent pneumococcal polysaccharide vaccine show a lack of protective antibody titer (specific IgG antibody titer less than 1.3 mcg/ml) in greater than 70% of antigens tested (more than 50% in children aged 2 to 5 years) [o further questions.] 108. Does the patient have normal total IgG levels with severe polysaccharide non-responsiveness? 109. Does the patient have evidence of recurrent severe difficult-to-treat infections (e.g., recurrent otitis media, bronchiectasis, recurrent infections requiring IV antibiotics)? 110. Have the unexplained recurrent or persisted severe bacterial infections occurred despite adequate treatment, including all of the following? Reference umber: C5030-A / Effective Date: 10/02/

14 -Patient has received aggressive management of other conditions predisposing the patient to recurrent sinopulmonary infections (e.g., asthma, allergic rhinitis) -The patient has received prophylactic antibiotics -There is increased vigilance and appropriate antibiotic therapy for infections -The patient has received immunization with conjugate vaccines in patients who have not responded to polysaccharide vaccines 111. Has the patient demonstrated an inability to mount an inadequate response polysaccharide antigens defined as serum titers 4 to 6 weeks after vaccination with polyvalent pneumococcal polysaccharide vaccine showing a lack of protective antibody titer (specific IgG antibody titer less than 1.3 mcg/ml) in greater than 70% of antigens tested (more than 50 % in children aged 2 to 5 years)? 112. Has the patient received IVIG therapy for one year or more? [If no, skip to question 116.] 113. Has the number or severity of infections been reduced? 114. Is the patient 12 years of age or younger? 115. Has the medical necessity of continuation of IVIG therapy been evaluated by discontinuing and re-assessing immune response to protein and polysaccharide antigens 1 year after initiating therapy and every 2 years (if applicable)? [o further questions.] 116. Is the patient 12 years of age or younger? 117. Will the member be evaluated for continuation of therapy by discontinuing and re-assessing immune response to protein and polysaccharide antigens 1 year after initiating therapy and every 2 years? [o further questions.] 118. Does the patient have a diagnosis of Rasmussen encephalitis? Reference umber: C5030-A / Effective Date: 10/02/

15 [If no, skip to question 120.] 119. Has the patient s symptoms failed to improve with anti-epileptic drugs and corticosteroids? [o further questions.] 120. Does the patient have a diagnosis of staphylococcal toxic shock syndrome? [If no, skip to question 122.] 121. Does the disease failed to respond to fluids and vasopressors? [o further questions.] 122. Does the patient have a severe case of toxic epidermal necrolysis and Stevens-Johnson syndrome? 123. Does the patient have diagnosis of toxic shock syndrome or toxic necrotizing fasciitis due to group A streptococcus? 124. Does the patient require critical care support? 125. Does the patient have documented presence of fasciitis and microbiological data consistent with streptococcal infection? Comments: I affirm that the information given on this form is true and accurate as of this date. Prescriber (Or Authorized) Signature Prescriber (Or Authorized) Signature Date Date Reference umber: C5030-A / Effective Date: 10/02/