REVIEW REQUEST FOR
Immune Globulin (Ig) Therapy
Provider Data Collection Tool Based on Medical Policy DRUG.00013 &
Clinical Guideline-DRUG-09
Policy Last Review Date:
11/05/2015
Request Date:
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Initial Request
Buy and Bill
Policy Effective Date:
01/01/2016
Provider Tool Effective Date:
01/01/2016
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Subsequent request
Individual’s Name:
Date of Birth:
/
/
Individual’s Phone Number:
Insurance Identification Number:
Primary Diagnosis:
Diagnosis Code(s) (if known):
Ordering Provider Name & Specialty:
Individual’s Weight
(lbs) (kg)
Provider ID Number: (if known):
Office Address:
Contact Name and Office Phone Number:
Office Fax Number:
Servicing Provider Name & Specialty (If different than Ordering Provider):
Provider ID Number (if known):
Office Address:
Contact Name and Office Phone Number:
Office Fax Number:
Place of Service:
Home
Office
Dialysis Center
Ambulatory Infusion
Ambulatory Infusion Center
Drug Name/HCPCS Code (if known)
Bivigam®
J1556
Carimune®
J1566
Outpatient Hospital
Other:
Dose to be administered:
(mg/kg)
Flebogamma®/Flebogamma DIF
J1572
Gamma Globulin
J1460
J1560
Gammaplex®
J1557
Gammagard®
J1569
Gamunex-C®/Gammaked
Hizentra®
J1559
HyQviq
J1575
IGHy
J7799
Immune Globulin
90281
Octagam®
J1568
Privigen®
Other:
J1459
(gm/kg)
(other)
J1561
90283
90284
When did the individual first start this drug?
/
/
Duration:
(Weeks)
J1599
Frequency (Days, Wks, Months)
Start Date For This Request:
/
/
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.
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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
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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
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
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(If checked, please list previous treatments and results):
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
X. Other Indications
To prevent recurrent spontaneous abortions
Alzheimer’s disease
Immune optic neuropathy
Multiple sclerosis
Other:
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This request is being submitted:
Pre-Claim
Post–Claim. If checked, please attach the claim or indicate the claim number
I attest the information provided is true and accurate to the best of my knowledge. I understand that the health plan or its
designee may perform a routine audit and request the medical documentation to verify the accuracy of the information reported
on this form.
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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.
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