Primary Diagnosis: Diagnosis Code(s) (if known): Individual s Weight (lbs) (kg)

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1 Request Date: Initial Request Buy and Bill Individual s Name: Insurance Identification Number: Subsequent request Date of Birth: Individual s Phone Number: Primary Diagnosis: Diagnosis Code(s) (if known): Individual s Weight (lbs) (kg) Ordering Provider Name & Specialty: Provider ID Number: (if known): Office Address: Contact Name and Office Phone Number: Servicing Provider Name & Specialty (If different than Ordering Provider): Office Fax Number: Provider ID Number (if known): Office Address: Contact Name and Office Phone Number: Office Fax Number: Place of Service: Home Office Dialysis Center Outpatient Hospital Ambulatory Infusion Ambulatory Infusion Center Other: Drug Name/HCPCS Code (if known) Dose to be administered: Bivigam Carimune J1556 J1566 Cuvitru J3490 Flebogamma /Flebogamma DIF J1572 Gamma Globulin J1460 J1560 Gammaplex J1557 Gammagard J1569 J1566 (gm/kg) (mg/kg) (other) Gamunex-C /Gammaked J1561 Hizentra J1559 HyQviq J1575 IGHy J7799 Immune Globulin J1599 Octagam J1568 Privigen J1459 Other: When did the individual first start this drug? Frequency (Days, Wks, Months) Duration: Start Date For This Request: (Weeks) This Clinical Guideline based provider data collection tool is for a medical necessity review request for the use of immune globulin or immunoglobulin (Ig) in the treatment of: primary immunodeficiency diseases featuring low or dysfunctional antibody levels; certain inflammatory, autoimmune and other diseases featuring low antibody levels; and for removal of harmful antibodies; and blocking damage from immune cells. 1

2 This tool is NOT for submission of Ig use review requests for the following: Rho (D) Immune Globulin and WinRho SD injections for the prevention or treatment of Rh incompatibility Specific hyperimmune serum globulin after exposure to Botulinum, Cytomegalovirus, Diphtheria, Hepatitis B, Measles, Rabies, Tetanus, Vaccinia, or Varicella-Zoster Any Ig product for prophylaxis against disease (for example, GamaSTAN SD [Grifols Therapeutics Inc., Research Triangle Park, NC] for hepatitis A prophylaxis) Please check all of the following that apply to the individual: Immune Globulin (Ig) therapy for the treatment of an individual with the following: A. Antenatal Alloimmune Thrombocytopenia B. Auto-immune mucocutaneous blistering diseases (that are refractory) including: pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, and epidermolysis bullosa aquisita C. Autoimmune Neutropenia D. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (Please check the following that apply): Initial Authorization: As initial trial (up to 12 weeks) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and the clinical presentation is not consistent with other polyneuropathies (for example, IgM neuropathy, hereditary neuropathy, diabetic neuropathy) (Please check the following that apply): Proximal muscle weakness or sensory dysfunction caused by neuropathy and nerve conduction studies (NCS) confirm there is electrodiagnostic evidence of demyelinating neuropathy in at least 2 limbs Distal muscle weakness and results of diagnostic testing meet a recognized set of diagnostic criteria as established by the American Academy of Neurology (AAN), or Inflammatory Neuropathy Cause and Treatment (INTAC). (If checked, please indicate which criteria used and which diagnostic tests meet): Reauthorization: Clinically significant improvement in neurological symptoms is documented on physical examination. (If checked, please note improvements): Has been on treatment for less than 1 year Has been on treatment for at least 1 year and continued need is demonstrated by documentation that attempts on an annual basis to titrate the dose or the interval of therapy result in worsening symptoms. (If checked, please document dosage change and results): E. Dermatomyositis refractory to corticosteroid therapy (IVIG will be used as second line treatment after corticosteroid therapy failed) F. Eaton-Lambert Myasthenic Syndrome G. Guillain-Barre Syndrome (acute demyelinating polyneuropathy) as an alternative to plasma exchange H. Human immunodeficiency virus (HIV) infected pediatric individual - prevention of opportunistic bacterial infections I. Hyperimmunoglobulinemia E syndrome (HIE) treatment J. Hypogammaglobulinemia and recurrent bacterial infections associated with B-Cell Chronic Lymphocytic Leukemia (CLL) (Please check the following that apply): Documented history of recurrent bacterial infection or an active infection not responding to antimicrobial therapy Documented total IgG is less than 500 mg/dl 2

3 K. IgG sub-class deficiency (IgG1, IgG2, IgG3, IgG4) (Please check the following that apply): One or more serum IgG subclasses are below the lower limit of the age adjusted laboratory reference range or are more than two standard deviations below the age adjusted mean History of recurrent sinopulmonary infections requiring antibiotic therapy There is documentation of a lack of, or inadequate response to, immunization (for example, but not limited to pneumococcal antigen) L. Immune thrombocytopenia (idiopathic thrombocytopenic purpura (ITP) (Please check the following that apply): Symptomatic thrombocytopenia (for example, but not limited to hematuria, petechiae, bruising, gastrointestinal bleeding, gingival bleeding) Platelet count less than 20,000 per microliter (mcl) (adult) Platelet count less than 30,000 per mcl (microliter) (child) M. Kawasaki Syndrome (Please check the following that apply): Within 10 days of onset of symptoms Treatment planned for no more than 5 days N. Multifocal Motor Neuropathy (MMN) (Please check the following that apply): Initial Authorization: Initial trial (up to 4 weeks) Asymmetric weakness that predominately affects distal muscles (without upper motor neuron signs) and nerve conduction studies confirm a demyelinating neuropathy is present (conduction block, slowing, or abnormal temporal dispersion in at least one nerve) Clinical history and exam do not suggest upper motor neuron disease (no bulbar weakness, no upper motor neuron signs) Labs show GM-1 antibody titers are elevated. (If checked, please document GM-1 antibody titer): Clinical presentation suggests MMN but diagnosis remains uncertain following initial exam and electrodiagnostic testing Reauthorization: Continued use after initial trial Clinical results documented an improvement in strength and function within 3 weeks of the start of the infusion period. (If checked, please note improvements): Has been on treatment for less than 1 year Has been on treatment for at least 1 year and continued need is demonstrated by documentation that attempts on an annual basis to titrate the dose or the interval of therapy result in worsening symptoms. (If checked, please document dosage change and results): O. Myasthenia Gravis which is severe and refractory to standard therapy P. Neonates - To prevent infections in high-risk, preterm, low birth weight Q. Parvovirus B19 chronic infection and severe anemia associated with bone marrow suppression R. Severe Polymyositis when other treatments have been unsuccessful, intolerable, or are contraindicated (If checked, please list previous treatments and results): 3

4 S. Primary humoral immunodeficiency common Variable Immunodeficiency (CVID) (please check all that apply): Individual has a history of recurrent sinopulmonary infections requiring antibiotic therapy There is a lack of, or inadequate response to immunization (for example, but not limited to tetanus or pneumococcal antigen) There is no evidence of renal (nephrotic syndrome) and gastrointestinal (for example protein losing enteropathy, PLE) as causes of hypogammaglobulinemia The initial, pre-treatment total serum IgG is below the lower limit of the age adjusted laboratory reference range, or more than two standard deviations below the age adjusted mean T. Primary humoral immunodeficiency - Other (for example, congenital agammaglobulinemia, X-linked immunodeficiency, severe combined immunodeficiency [SCID], or Wiskott-Aldrich syndrome [WAS]) when (please check all that apply): There is no evidence of renal (nephrotic syndrome) and gastrointestinal (for example, protein losing enteropathy) as causes of hypogammaglobulinemia The initial, pre-treatment total serum IgG is below the lower limit of the age adjusted laboratory reference range, or more than two standard deviations below the age adjusted mean U. Stiff-person syndrome not controlled by other therapies V. Toxic shock syndrome caused by staphylococcal or streptococcal organisms refractory to several hours of aggressive therapy W. Transplant Hematopoietic stem cell transplant (Please check the following that apply): Allogeneic bone marrow transplant (BMT) recipient in the first 100 days after transplantation To reduce risk of graft-versus-host disease associated with interstitial pneumonia (infectious or idiopathic) and infections (cytomegalovirus infections, varicella-zoster virus infection, and recurrent bacterial infection) Secondary hypoglobulinemia in an immunosuppressed individual (for example, status post bone marrow transplant) Documented total IgG less than 500 mg/dl Solid organ transplant (Please check the following that apply): Prior to a medically necessary solid organ transplantation For suppression of panel reactive anti-hla antibodies and individuals with high panel reactive antibody (PRA) levels to human leukocyte antigens (HLA) Solid organ transplant recipients at risk for CMV Other Indications To prevent recurrent spontaneous abortions in pregnant women with a history of recurrent spontaneous abortion Alzheimer s disease Immune optic neuropathy Multiple sclerosis Other: 4

5 Provider Note: Clnically Equivalent Cost Effective Agents When immune globulin therapy is determined to be medically necessary based on the clinical criteria above, the benefit plan may have in addition a medically necessary criterion that the treatment be cost effective. When such language exists, the benefit plan may determine which immune globulin therapy is covered. A benefit plan may select any one or more of the following as clinically equivalent cost effective immune globulin agents: Bivigam ; Carimune NF ; Cuvitru; Flebogamma DIF ; Gammagard ; Gammagard S/D less IgA; Gammaked ; Gammaplex; Gamunex -C; Hizentra ; Hyqvia; Octagam; Privigen. A list of one or more cost effective immune globulin therapy agents for each plan is available here. In benefit plans where there is a requirement to use a cost effective immune globulin therapy agent, requests for an immune globulin therapy agent that is not cost effective may be approved when the following criteria are met: A. The individual has had a trial of and is intolerant to one cost effective agent; or B. For the prescribed indication, the cost effective agent is not FDA-approved or does not meet the off-label drug use criteria of CG-DRUG-01 Off-Label Drug and Approved Orphan Drug Use (see below); or C. Individual is currently receiving and stabilized on the requested agent; or D. The cost effective agent is not acceptable due to concomitant clinical condition(s), such as but not limited to the following: 1. Renal insufficiency/impairment; or 2. Non-O blood type; or 1. Severe IgA deficiency; or 2. Diabetes/prediabetes; or 3. Cardiovascular disease; or 4. Hyper-prolinemia; or 5. Hypernatremia; or 6. High-risk for thrombosis, such as but not limited to: a. Hyperviscosity syndromes (such as cryoglobulinemia, monoclonal gammopathies, polyclonal hyperglobulinemia); or b. Hypercoagulable conditions; or 7. Documented hypersensitivity, as manifested by a severe systemic/allergic or anaphylactic reaction, to any ingredient which is not also present in the requested agent; or 10. Other known disease state or medication contraindication which is not also associated with the requested agent; or E. If all subcutaneous Ig (SCIG)-only dose forms (Cuvitru, Hizentra, Hyqvia) are designated as not cost effective, the desired agent may be approved for individuals requesting for any of the following: 1. Difficult vein access that precludes use of an intravenous immune globulin (IVIG); or 2. History of serious systemic reaction to IVIG expected to be avoided by using SCIG; or 3. History of inconsistent serum levels of immunoglobulin G (IgG) with IVIG. 5

6 This request is being submitted: Pre-Claim Post Claim. If checked, please attach the claim or indicate the claim number I confirm that the information entered on this form is accurate and complete based on the records available at the time of this request. I understand the health plan or its designees may request medical documentation to verify the accuracy of the information reported on this form. Name & Title of Provider or Provider Representative Completing Form Date & attestation (Please Print)* *The attestation fields must be completed by a provider or provider representative in order for the tool to be accepted Anthem UM Services, Inc., a separate company, is the licensed utilization review agent that performs utilization management services on behalf of your health benefit plan or the administrator of your health benefit plan. 6