Subject: SCIG 2043-A SGM P2021a
| Subcutaneous Immune Globulin (SCIG) |
|
Hizentra®
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HyQvia®
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Cutaquig®
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Cuvitru™
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Xembify®
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Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that all the
approval criteria are met and the member has no exclusions to the
prescribed therapy.
A. FDA-Approved Indications
1. Cutaquig (Immune Globulin Subcutaneous [Human] - hipp,
16.5% Solution)
Cutaquig is indicated as replacement therapy for primary humoral
immunodeficiency (PI) in adults and pediatric patients 2 years of
age and older.
2. Cuvitru (Immune Globulin Subcutaneous [Human], 20%
Solution)
Cuvitru is indicated as replacement therapy for primary humoral
immunodeficiency in adult and pediatric patients two years of age
and older.
3. Hizentra (Immune Globulin Subcutaneous [Human], 20% Liquid)
a. Hizentra is indicated as replacement therapy for primary
humoral immunodeficiency in adults and pediatric patients 2
years of age and older.
b. Hizentra is indicated for the treatment of adult patients with
chronic inflammatory demyelinating polyneuropathy (CIDP) as
maintenance therapy to prevent relapse of neuromuscular
disability and impairment.
Limitations of Use:
Hizentra maintenance therapy in CIDP has been
systematically studied for 6 months and for a further 12
months in a follow-up study. Maintenance therapy beyond
these periods should be individualized based upon the
patient’s response and need for continued therapy.
4. HyQvia (Immune Globulin Infusion 10% [Human] with
Recombinant Human Hyaluronidase)
HyQvia is indicated for the treatment of primary
immunodeficiency in adults.
Limitation of Use:
Safety and efficacy of chronic use of recombinant human
hyaluronidase in HyQvia have not been established in conditions
other than primary immunodeficiency.
5. Xembify (Immune Globulin Subcutaneous [Human} – klhw, 20%
Solution)
Xembify is indicated for treatment of primary humoral
immunodeficiency (PI) in patients 2 years of age and older.
B. Compendial Uses
1. Idiopathic thrombocytopenic purpura (ITP)
2. Multifocal motor neuropathy
3. Kawasaki syndrome
4. B-cell chronic lymphocytic leukemia (CLL)
5. Prophylaxis of bacterial infections in pediatric human
immunodeficiency virus (HIV) infection
6. Prophylaxis of bacterial infections in bone marrow transplant
(BMT)/hematopoietic stem cell transplant (HSCT) recipients
7. Dermatomyositis
8. Polymyositis
9. Myasthenia gravis
10. Guillain-Barré syndrome
11. Lambert-Eaton myasthenic syndrome
12. Fetal/neonatal alloimmune thrombocytopenia
13. Parvovirus B19-induced pure red cell aplasia
14. Stiff-person syndrome
15. Management of immune checkpoint inhibitor-related nervous
system adverse events
16. Acquired red cell aplasia
17. Acute disseminated encephalomyelitis
18. Autoimmune mucocutaneous blistering diseases
19. Autoimmune hemolytic anemia
20. Autoimmune neutropenia
21. Birdshot retinochoroidopathy
22. BK virus associated nephropathy
23. Churg-Strauss Syndrome
24. Enteroviral meningoencephalitis
25. Hematophagocytic lymphohistiocytosis (HLH) or macrophage
activation syndrome (MAS)
26. Hemolytic disease of newborn
27. HIV-associated thrombocytopenia
28. Hyperimmunoblobulinemia E Syndrome
29. Hypogammaglobulinemia from chimeric antigen receptor T (CAR-
T) therapy
30. Multiple myeloma
31. Neonatal hemochromatosis, prophylaxis
32. Opsoclonus-myoclonus
33. Paraneoplastic opsonus-myoclonus ataxia associated with
neuroblastoma
34. Post-transfusion purpura
35. Rasmussen encephalitis
36. Renal transplantation from a live donor with ABO incompatibility
or positive cross match
37. Secondary immunosuppression associated with major surgery,
hematological malignancy, major burns, and collagen-vascular
diseases
38. Solid organ transplantation, for allosensitized members
39. Toxic epidermal necrolysis and Stevens-Johnson syndrome
40. Toxic shock syndrome
41. Systemic lupus erythematosus (SLE)
42. Toxic necrotizing fasciitis due to group A streptococcus
All other indications are considered experimental/investigational and not
medically necessary.
II. DOCUMENTATION
The following information is necessary to initiate the prior authorization
review:
A. Primary immunodeficiency
1. Diagnostic test results (when applicable)
a. Copy of laboratory report with serum immunoglobulin levels:
IgG, IgA, IgM, and IgG subclasses
b. Vaccine response to pneumococcal polysaccharide vaccine
(post-vaccination Streptococcus pneumoniae antibody titers)
c. Pertinent genetic or molecular testing in members with a
known genetic disorder
d. Copy of laboratory report with lymphocyte subset
enumeration by flow cytometry
2. IgG trough level for those continuing with IG therapy
B. Myasthenia gravis
1. Clinical records describing standard treatments tried and failed
C. Secondary hypogammaglobulinemia (CLL, HIV, BMT/HSCT recipients,
surgery, malignancy, burns, collagen-vascular disease)
1. Copy of laboratory report with pre-treatment serum IgG level
(when applicable)
D. Chronic inflammatory demyelinating polyneuropathy (CIDP) and
multifocal motor neuropathy (MMN)
1. Pre-treatment electrodiagnostic studies (electromyography [EMG]
or nerve conduction studies [NCS])
2. For CIDP, pre-treatment cerebrospinal fluid (CSF) analysis (when
available)
E. Dermatomyositis and polymyositis
1. Pre-treatment electrodiagnostic studies (EMG)
2. Pre-treatment muscle biopsy report (when available)
3. Clinical records describing standard treatments tried and failed
F. Lambert-Eaton Myasthenic Syndrome (LEMS)
1. Neurophysiology studies (e.g., electromyography) (when
applicable)
2. A positive anti- P/Q type voltage-gated calcium channel antibody
test (when applicable)
G. Idiopathic thrombocytopenic purpura
1. Laboratory report with pre-treatment/current platelet count
2. Chronic/persistent ITP: copy of medical records supporting trial
and failure with corticosteroid or anti-D therapy (unless
contraindicated)
H. Parvovirus B19-indicated Pure Red Cell Aplasia (PRCA)
1. Copy of test result confirming presence of parvovirus B19
I. Stiff-person syndrome
1. Anti-glutamic acid decarboxylase (GAD) antibody testing results
2. Clinical records describing standard treatments tried and failed
J. Toxic shock syndrome or toxic necrotizing fasciitis due to group A
streptococcus
1. Documented presence of fasciitis (when applicable)
2. Microbiological data (culture or Gram stain)
III. CRITERIA FOR INITIAL APPROVAL
A. Primary Immunodeficiency
Initial authorization of 6 months may be granted for members with
any of the following diagnoses:
1. Severe combined immunodeficiency (SCID) or congenital
agammaglobulinemia (eg, X-linked or autosomal recessive
agammaglobulinemia)
a. Diagnosis confirmed by genetic or molecular testing, or
b. Pretreatment IgG level < 200 mg/dL, or
c. Absence or very low number of T cells (CD3 T cells <
300/microliter) or the presence of maternal T cells in the
circulation (SCID only)
2. Wiskott-Aldrich syndrome, DiGeorge syndrome, or ataxia-
telangiectasia (or other non-SCID combined immunodeficiency)
a. Diagnosis confirmed by genetic or molecular testing (if
applicable), and
b. History of recurrent bacterial infections (eg, pneumonia,
otitis media, sinusitis, sepsis, gastrointestinal), and
c. Impaired antibody response to pneumococcal
polysaccharide vaccine (see Appendix A)
3. Common variable immunodeficiency (CVID)
a. Age 2 years or older, and
b. Other causes of immune deficiency have been excluded (eg,
drug induced, genetic disorders, infectious diseases such as
HIV, malignancy), and
c. Pretreatment IgG level < 500 mg/dL or ≥ 2 SD below the
mean for age, and
d. History of recurrent bacterial infections, and
e. Impaired antibody response to pneumococcal polysaccharide
vaccine (see Appendix A)
4. Hypogammaglobulinemia (unspecified), IgG subclass deficiency,
selective IgA deficiency, selective IgM deficiency, or specific
antibody deficiency
a. History of recurrent bacterial infections, and
b. Impaired antibody response to pneumococcal polysaccharide
vaccine (see Appendix A), and
c. Any of the following pre-treatment laboratory findings:
i. Hypogammaglobulinemia: IgG < 500 mg/dL or ≥ 2 SD
below the mean for age
ii. Selective IgA deficiency: IgA level < 7 mg/dL with normal
IgG and IgM levels
iii. Selective IgM deficiency: IgM level < 30 mg/dL with
normal IgG and IgA levels
iv. IgG subclass deficiency: IgG1, IgG2, or IgG3 ≥ 2 SD
below mean for age assessed on at least 2 occasions;
normal IgG (total) and IgM levels, normal/low IgA levels
v. Specific antibody deficiency: normal IgG, IgA and IgM
levels
5. Other predominant antibody deficiency disorders must meet a.,
b., and c.i. in section 4. above.
6. Other combined immunodeficiency must meet criteria in section
2. above.
Re-authorization of 6 months may be granted when the following
criteria are met:
1. A reduction in the frequency of bacterial infections has been
demonstrated since initiation of IG therapy, AND
2. IgG trough levels are monitored at least yearly and maintained
at or above the lower range of normal for age (when applicable
for indication), OR
3. The prescriber will re-evaluate the dose of IG and consider a
dose adjustment (when appropriate).
B. Myasthenia Gravis
1. Authorization of 1 month may be granted to members who are
prescribed IG for worsening weakness, acute exacerbation, or in
preparation for surgery.
a. Worsening weakness includes an increase in any of the
following symptoms: diplopia, ptosis, blurred vision, difficulty
speaking (dysarthria), difficulty swallowing (dysphagia),
difficulty chewing, impaired respiratory status, fatigue, and
limb weakness. Acute exacerbations include more severe
swallowing difficulties and/or respiratory failure
b. Pre-operative management (eg, prior to thymectomy)
2. Authorization of 6 months may be granted to members with
refractory myasthenia gravis who have tried and failed 2 or more
of standard therapies (eg, corticosteroids, azathioprine,
cyclosporine, mycophenolate mofetil, rituximab).
C. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
1. Initial authorization of 3 months may be granted when the
following criteria are met:
a. Disease course is progressive or relapsing/remitting for 2
months or longer
b. Moderate to severe functional disability
c. The diagnosis was confirmed by electrodiagnostic studies and
the evaluation of cerebrospinal fluid (CSF)
2. Re-authorization of 6 months may be granted when the following
criteria are met:
a. Significant improvement in disability and maintenance of
improvement since initiation of IG therapy
b. IG is being used at the lowest effective dose and frequency
D. Dermatomyositis or Polymyositis
1. Initial authorization of 3 months may be granted when the
following criteria are met:
a. Member has at least 4 of the following:
i. Proximal muscle weakness (upper or lower extremity and
trunk)
ii. Elevated serum creatine kinase (CK) or aldolase level
iii. Muscle pain on grasping or spontaneous pain
iv. Myogenic changes on EMG (short-duration, polyphasic
motor unit potentials with spontaneous fibrillation
potentials)
v. Positive for anti-synthetase antibodies (e.g., anti-Jo-1, also
called histadyl tRNA synthetase)
vi. Non-destructive arthritis or arthralgias
vii. Systemic inflammatory signs (fever: more than 37°C at
axilla, elevated serum CRP level or accelerated ESR of
more than 20 mm/h by the Westergren method)
viii. Pathological findings compatible with inflammatory
myositis (inflammatory infiltration of skeletal evidence of
active regeneration may be seen), and
b. Standard first-line treatments (corticosteroids) and second-line
treatments (immunosuppressants) have been tried but were
unsuccessful or not tolerated, or
c. Member is unable to receive standard first-line and second-
line therapy because of a contraindication or other clinical
reason.
2. Re-authorization of 6 months may be granted when the following
criterion is met:
a. Significant improvement in disability and maintenance of
improvement since initiation of IG therapy
E. Idiopathic Thrombocytopenic Purpura (Immune
Thrombocytopenia)
1. Newly diagnosed ITP (diagnosed within the past 3 months) or
initial therapy: authorization of 1 month may be granted when the
following criteria are met
a. Children (< 18 years of age)
i. Significant bleeding symptoms (mucosal bleeding or other
moderate/severe bleeding) or
ii. High risk for bleeding* (see Appendix B), or
iii. Rapid increase in platelets is required* (eg, surgery or
procedure)
b. Adults (≥ 18 years of age)
i. Platelet count < 30,000/mcL, or
ii. Platelet count < 50,000/mcL and significant bleeding
symptoms, high risk for bleeding or rapid increase in
platelets is required*, and
iii. Corticosteroid therapy is contraindicated and IG will be used
alone or IG will be used in combination with corticosteroid
therapy
2. Chronic/persistent ITP (≥ 3 months from diagnosis) or ITP
unresponsive to first-line therapy: authorization of 6 months may
be granted when the following criteria are met:
a. Platelet count < 30,000/mcL, or
b. Platelet count < 50,000/mcL and significant bleeding
symptoms, high risk for bleeding* or rapid increase in platelets
is required*, and
c. Relapse after previous response to IG or inadequate
response/intolerance/contraindication to corticosteroid or anti-
D therapy
3. Adults with refractory ITP after splenectomy: authorization of 6
months may be granted when either of the following criteria is
met:
a. Platelet count < 30,000/mcL, or
b. Significant bleeding symptoms
4. ITP in pregnant women: authorization through delivery may be
granted to pregnant women with ITP.
* The member’s risk factor(s) for bleeding (see Appendix B) or
reason requiring a rapid increase in platelets must be provided.
F. B-cell Chronic Lymphocytic Leukemia (CLL)
1. Initial authorization of 6 months may be granted when all of the
following criteria are met:
a. IG is prescribed for prophylaxis of bacterial infections.
b. Member has a history of recurrent sinopulmonary
infection requiring intravenous antibiotics or hospitalization.
c. Member has a pretreatment serum IgG level <500 mg/dL.
2. Re-authorization of 6 months may be granted when a reduction in
the frequency of bacterial infections has been demonstrated since
initiation of IG therapy.
G. Prophylaxis of Bacterial Infections in HIV-Infected Pediatric
Patients
1. Initial authorization of 6 months may be granted to pediatric
members with HIV infection when any of the following criteria are
met:
a. IG is prescribed for primary prophylaxis of bacterial infections
and pretreatment serum IgG < 400 mg/dL, or
b. IG is prescribed for secondary prophylaxis of bacterial
infections for members with a history of recurrent bacterial
infections (> 2 serious bacterial infections in a 1-year period),
or
c. Member has failed to form antibodies to common antigens,
such as measles, pneumococcal, and/or Haemophilus
influenzae type b vaccine, or
d. Member lives in an area where measles is highly prevalent
and who have not developed an antibody response after two
doses of measles, mumps, and rubella virus vaccine live, or
e. Member has been exposed to measles and request is for a
single dose, or
f. Member has chronic bronchiectasis that is suboptimally
responsive to antimicrobial and pulmonary therapy
2. Re-authorization of 6 months may be granted when a reduction
in the frequency of bacterial infections has been demonstrated
since initiation of IG therapy.
H. Prophylaxis of Bacterial Infections in BMT/HSCT Recipients
1. Initial authorization of 6 months may be granted to members
who are BMT/HSCT recipients when the following criteria are
met:
a. IG is prescribed for prophylaxis of bacterial infections.
b. Either of the following:
i. IG is requested within the first 100 days post-transplant.
ii. Member has a pretreatment serum IgG < 400 mg/dL.
2. Re-authorization of 6 months may be granted when a reduction in
the frequency of bacterial infections has been demonstrated since
initiation of IG therapy.
I. Multifocal Motor Neuropathy (MMN)
1. Initial authorization of 3 months may be granted when the
following criteria are met:
a. Member experienced progressive, multifocal,
asymmetrical weakness without objective sensory loss in 2 or
more nerves for at least 1 month
b. The diagnosis was confirmed by electrodiagnostic studies
2. Re-authorization of 6 months may be granted when significant
improvement in disability and maintenance of improvement have
occurred since initiation of IG therapy
J. Guillain-Barre Syndrome (GBS)
Authorization of 2 months total may be granted for GBS when the
following criteria are met:
1. Member has severe disease with significant weakness (eg
inability to stand or walk without aid, respiratory weakness)
2. Onset of neurologic symptoms occurred less than 4 weeks from
the anticipated start of therapy
K. Lambert-Eaton Myasthenic Syndrome (LEMS)
1. Initial authorization of 6 months may be granted for LEMS when
the following criteria are met:
a. Diagnosis has been confirmed by either of the following:
i. Neurophysiology studies (e.g., electromyography)
ii. A positive anti- P/Q type voltage-gated calcium channel
antibody test
b. Anticholinesterases (eg pyridostigmine) and amifampridine
(eg 3,4-diaminopyridine phosphate, Firdapse) have been
tried but were unsuccessful or not tolerated
c. Weakness is severe or there is difficulty with venous access
for plasmapheresis
2. Re-authorization of 6 months may be granted when member is
responding to therapy (i.e., there is stability or improvement in
symptoms relative to the natural course of LEMS).
L. Kawasaki Syndrome
Authorization of 1 month may be granted for pediatric members
with Kawasaki syndrome.
M. Fetal/Neonatal Alloimmune Thrombocytopenia (F/NAIT)
Authorization of 6 months may be granted for treatment of F/NAIT.
N. Parvovirus B19-induced Pure Red Cell Aplasia (PRCA)
Authorization of 6 months may be granted for severe, refractory
anemia associated with bone marrow suppression, with parvovirus
B19 viremia.
O. Stiff-person Syndrome
Authorization of 6 months may be granted for stiff-person syndrome
when the following criteria are met:
1. Diagnosis has been confirmed by anti-glutamic acid
decarboxylase (GAD) antibody testing
2. Member had an inadequate response to first-line treatment
(benzodiazepines and/or baclofen)
P. Management of immune checkpoint inhibitor-related nervous
system adverse events
Authorization of 1 month may be granted for management of
immune checkpoint-inhibitor toxicities when all of the following
criteria are met:
1. Member has experienced a moderate or severe adverse event to
a PD-1 or PD-L1 inhibitor (eg, pembrolizumab, nivolumab,
atezolizumab, avelumab, durvalumab)
2. The offending medication has been held or discontinued
3. Member experienced one or more of the following nervous
system adverse events: pneumonitis, myasthenia gravis,
peripheral neuropathy, encephalitis, transverse myelitis, or
severe inflammatory arthritis
Q. Acquired Red Cell Aplasia
Authorization of 6 months may be granted for acquired red cell
aplasia.
R. Acute Disseminated Encephalomyelitis
Authorization of 6 months may be granted for acute disseminated
encephalomyelitis in members who have had an insufficient response
or a contraindication to intravenous corticosteroid treatment.
S. Autoimmune Mucocutaneous Blistering Disease
Authorization of 6 months may be granted for autoimmune
mucocutaneous blistering disease (includes pemphigus vulgaris,
pemphigus foliaceus, bullous pemphigoid, mucous membrane
pemphigoid, and epidermolysis bullosa aquisita) when the following
criteria are met:
1. Diagnosis has been proven by biopsy and confirmed by pathology
report, and
2. Condition is rapidly progressing, extensive or debilitating, and
3. Member has failed or experienced significant complications (eg
diabetes, steroid-induced osteoporosis) from standard treatment
(corticosteroids, immunosuppressive agents).
T. Autoimmune Hemolytic Anemia
Authorization of 6 months may be granted for warm-type
autoimmune hemolytic anemia in members who do not respond or
have a contraindication to corticosteroids or splenectomy.
U. Autoimmune Neutropenia
Authorization of 6 months may be granted for autoimmune
neutropenia where treatment with G-CSF (granulocyte colony
stimulating factor) is not appropriate.
V. Birdshot Retinochoroidopathy
Authorization of 6 months may be granted for birdshot (vitiliginous)
retinochoroidopathy that is not responsive to immunosuppressives
(eg corticosteroids, cyclosporine).
W. BK Virus Associated Nephropathy
Authorization of 6 months may be granted for BK virus associated
nephropathy.
X. Churg-Strauss Syndrome
Authorization of 6 months may be granted for severe, active Churg-
Strauss syndrome as adjunctive therapy for members who have
experienced failure, intolerance, or are contraindicated to other
interventions.
Y. Enteroviral Meningoencephalitis
Authorization of 6 months may be granted for severe cases of
enteroviral meningoencephalitis.
Z. Hematophagocytic Lymphohistiocytosis (HLH) or Macrophage
Activation Syndrome (MAS)
Authorization of 6 months may be granted for treatment of
hypogammaglobulinemia in HLH or MAS when total IgG is less than
400 mg/dL or two standard deviations below the mean for age.
AA. Hemolytic Disease of Newborn
Authorization of 6 months may be granted for isoimmune hemolytic
disease in neonates.
BB. HIV-associated Thrombocytopenia
Authorization of 6 months may be granted for HIV-associated
thrombocytopenia when the following criteria are met:
1. Pediatric members with IgG < 400 mg/dL and has one of the
following:
a. 2 or more bacterial infections in a 1-year period despite
antibiotic chemoprophylaxis with TMP-SMZ or another active
agent, or
b. Received 2 doses or measles vaccine and lives in a region with
a high prevalence or measles, or
c. HIV-associated thrombocytopenia despite anti-retroviral
therapy, or
d. Chronic bronchiectasis that is suboptimally responsive to
antimicrobial and pulmonary therapy, or
e. T4 cell count ≥ 200/mm3
2. Adult members with significant bleeding, platelet count <
20,000/mcL, and failure of RhIG in Rh-positive patients
CC. Hyperimmunoglobulinemia E Syndrome
Authorization of 6 months may be granted to treat severe eczema in
hyperimmunoglobulinemia E syndrome.
DD. Hypogammaglobulinemia from CAR-T therapy
Authorization of 6 months may be granted for members with IgG <
400 mg/dL receiving treatment with CAR-T therapy (including but not
limited to idecabtagene vicleucel [Abecma], tisagenlecleucel
[Kymriah], or axicabtagene ciloleucel [Yescarta]).
EE. Multiple Myeloma
Authorization of 6 months may be granted for multiple myeloma in
members who have recurrent, serious infections despite the use of
prophylactic antibiotics.
FF. Neonatal Hemochromatosis
Authorization of 6 months may be granted for prophylaxis in
members who are pregnant with a history of pregnancy ending in
documented neonatal hemochromatosis.
GG. Opsoclonus-myoclonus
Authorization of 6 months may be granted for treatment of either of
the following:
1. Paraneoplastic opsoclonus-myoclonus-ataxia associated with
neuroblastoma
2. Refractory opsoclonus-myoclonus, as last-resort treatment
HH. Post-transfusion Purpura
Authorization of 1 month may be granted for post-transfusion
purpura.
II. Rasmussen Encephalitis
Authorization of 6 months may be granted for Rasmussen encephalitis
in members whose symptoms do not improve with anti-epileptic drugs
and corticosteroids.
JJ. Renal Transplantation
Authorization of 6 months may be granted for a member undergoing
renal transplantation from a live donor with ABO incompatibility or
positive cross match.
KK. Secondary Immunosuppression Associated with Major
Surgery, Hematological Malignancy, Major Burns, and
Collagen-Vascular Diseases
Authorization of 6 months may be granted to prevent or modify
recurrent bacterial or viral infections in members with secondary
immunosuppression (IgG < 400 mg/dL) associated with major
surgery, hematological malignancy, extensive burns, or collagen-
vascular disease.
LL. Solid Organ Transplantation
Authorization of 6 months may be granted for solid organ
transplantation for allosensitized members.
MM. Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome
Authorization of 1 month may be granted for severe cases of toxic
epidermal necrolysis or Stevens-Johnson syndrome.
NN. Toxic Shock Syndrome
Authorization of 1 month may be granted for staphylococcal or
streptococcal toxic shock syndrome when the infection is refractory
to several hours of aggressive therapy, an undrainable focus is
present, or the member has persistent oliguria with pulmonary
edema.
OO. Systemic Lupus Erythematosus
Authorization of 6 months may be granted for severe, active SLE in
members who have experienced inadequate response, intolerance or
have a contraindication to first and second line therapies.
PP. Toxic Necrotizing Fasciitis Due To Group A Streptococcus
Authorization of 1 month may be granted for members with
fasciitis due to invasive streptococcal infection.
IV. CONTINUATION OF THERAPY
Authorization may be granted for continuation of therapy when either the
following criteria is met:
A. For conditions with reauthorization criteria listed under section III:
Members who are currently receiving IG therapy must meet the
applicable reauthorization criteria for the member’s condition.
B. For all other conditions, all members (including new members) must
meet initial authorization criteria.
V. APPENDICES
Appendix A: Impaired Antibody Response to Pneumococcal
Polysaccharide Vaccine
• Age 2 years and older: impaired antibody response demonstrated to
vaccination with a pneumococcal polysaccharide vaccine
• Not established for children less than 2 years of age
• Excludes the therapy initiated in the hospital setting
Appendix B: Examples of Risk Factors for Bleeding (not all inclusive)
• Undergoing a medical or dental procedure where blood loss is
anticipated
• Comorbidity (eg, peptic ulcer disease, hypertension)
• Mandated anticoagulation therapy
• Profession or lifestyle predisposes patient to trauma (eg, construction
worker, fireman, professional athlete)
Place of Service:
Outpatient
The above policy is based on the following references:
- Cutaquig [package insert]. Hoboken, NJ: Octapharma USA Inc.; October 2021.
- Cuvitru [package insert]. Lexington, MA: Baxalta US Inc.; March 2021.
- Hizentra [package insert]. Kankakee, IL: CSL Behring LLC; April 2021.
- HyQvia [package insert]. Lexington, MA: Baxalta US Inc.; March 2021.
- Xembify [package insert]. Research Triangle Park, NC: Grifols Therapeutics LLC; August 2020.
- Asceniv [package insert]. Boca Raton, FL: ADMA Biologics; April 2019.
- Bivigam [package insert]. Boca Raton, FL: Biotest Pharmaceuticals Corporation; July 2019.
- Carimune NF [package insert]. Kankakee, IL: CSL Behring LLC; May 2018.
- Flebogamma 10% DIF [package insert]. Los Angeles, CA: Grifols Biologicals, Inc.; September 2019.
- Flebogamma 5% DIF [package insert]. Los Angeles, CA: Grifols Biologicals, Inc.; September 2019.
- Gammagard Liquid [package insert]. Westlake Village, CA: Baxalta US Inc.; March 2021.
- Gammagard S/D [package insert]. Lexington, MA: Baxalta US Inc.; March 2021.
- Gammagard S/D IgA less than 1 mcg/mL [package insert]. Westlake Village, CA: Baxalta US Inc.; September 2016.
- Gammaked [package insert]. Research Triangle Park, NC: Grifols Therapeutics LLC; June 2018.
- Gammaplex 5% [package insert]. Hertfordshire, United Kingdom: Bio Products Laboratory; September 2019.
- Gammaplex 10% [package insert]. Hertfordshire, United Kingdom: Bio Products Laboratory; September 2019.
- Gamunex-C [package insert]. Research Triangle Park, NC: Grifols Therapeutics Inc.; January 2020.
- Octagam 10% [package insert]. Hoboken, NJ: Octapharma USA, Inc.; July 2021.
- Octagam 5% [package insert]. Hoboken, NJ: Octapharma USA, Inc.; September 2019.
- Panzyga [package insert]. Hoboken, NJ: Octapharma USA.; August 2019.
- Privigen [package insert]. Kankakee, IL: CSL Behring LLC; March 2019.
- DRUGDEX® System (electronic version). Truven Health Analytics, Ann Arbor, MI. Available at http://www.micromedexsolutions.com [available with subscription]. Accessed June 14, 2021.
- AHFS Drug Information. http://online.lexi.com/lco. Accessed June 14, 2021.
- Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: a review of evidence by Work Group Report of the American Academy of Allergy, Asthma, and Immunology. J Allergy Clin Immunol. 2017;139:S1-46.
- Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Department of Health and Human Services. Available at https://clinicalinfo.hiv.gov/sites/default/files/inline-files/oi_guidelines_pediatrics.pdf. Accessed June 10, 2021.
- Tomblyn M, Chiller T, Einsele H, et al. Guidelines for preventing infectious complications among hematopoietic cell transplant recipients: a global perspective. Biol Blood Marrow Transplant. 2009;15(10):1143-1238.
- Feasby T, Banwell B, Bernstead T, et al. Guidelines on the use of intravenous immune globulin for neurologic conditions. Transfus Med Rev. 2007;21(2):S57-S107.
- Donofrio PD, Berger A, Brannagan TH 3rd, et al. Consensus statement: the use of intravenous immunoglobulin in the treatment of neuromuscular conditions report of the AANEM ad hoc committee. Muscle Nerve. 2009;40(5):890-900.
- Elovaara I, Apostolski S, van Doorn P, et al. EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases: EFNS task force on the use of intravenous immunoglobulin in treatment of neurological diseases. Eur J Neurol. 2008;15(9):893-908.
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Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
January 20, 2022
