healthcare operations utilization protocols 2007 - Health Plan of ...

HEALTHCARE OPERATIONS
UTILIZATION PROTOCOLS 2007
PROCEDURE:
CPT:
Intravenous Immune Globulin (IVIG) (PHM028)
Not applicable
Prior Auth through Pharmacy Services Last Reviewed: 01/01/07
** Note: Always refer to the “Coverage Information” section of this protocol for detailed
coverage information per individual line of business.
Coverage Criteria:
1. If immune globulin is being requested for any of the following conditions / disease states
(must be primary immune deficiency disease), medication will be covered under Medicare
Part B and will be denied for any member in a Medicare Part D prescription drug plan:
• 279.04 – Congenital hypogammaglobulinemia:
Agammaglobulinemia – Bruton’s type or X-linked
• 279.05 – Immunodeficiency with increased IgM:
Immunodeficiency with hyper-IgM – autosomal recessive or X-linked
• 279.06 – Common variable immunodeficiency:
Dysgammaglobulinemia (acquired, congenital, primary)
Hypogammaglobulinemia – congenital non-sex-linked or sporadic
• 279.12 – Wiskott-Aldrich Syndrome
• 279.20 – Combined immunity deficiency:
Agammaglobulinemia – autosomal recessive or Swiss-type or X-linked
recessive
Severe combined immunodeficiency (SCID)
Thymic – alymphoplasia, aplasia or dysplasia with immunodeficiency
**Excludes: thymic hypoplasia (279.11)
Dosing and duration of therapy depend on the FDA approved indication above.
2. Member has a diagnosis of one of the following, and has failed conventional therapy (i.e.
systemic corticosteroids, dapsone, minocycline, or tetracycline, in combination with
nicotinamide; or immunosuppressive agents such as azathioprine, methotrexate,
cyclophosphamide, cyclosporine, gold, chlorambucil, or mycophenolate mofetil):
• Biopsy-proven mucocutaneous blistering diseases as listed below:
• Pemphigus vulgaris (PV)
• Pemphigus foliaceus (PF)
NVCMQISC: 5/23/02

HEALTHCARE OPERATIONS
UTILIZATION PROTOCOLS 2007
• Bullous pemphigoid (BP)
• Mucous membrane pemphigoid (MMP)(a.k.a., cicatricial pemphigoid)
• Epidermolysis bullosa acquista (EBA)
‣ ACTION: Will approve for 6 months
3. ** NOTE: May be approved in patients with rapidly progressive disease in whom a clinical
response could not be affected quickly enough using conventional agents. In such situations,
IVIg therapy should be given along with conventional treatment(s) and the IVIg would be
used only until conventional therapy could take effect.
4. Patient has a diagnosis of CIDP (Chronic Idiopathic Demyelinating
5. Approval for other, off-label indications will be considered on a case-by-case basis with
clinical information submitted.
6. For Approval for other, off-label indications will be considered on a case-by-case basis with
clinical information submitted.
7. Per Medicare coverage guidance, may be approved for other indications in Medicare
members if it is supported in the recognized compendia.
8. If the above criteria are not met, the request will be denied.
Coverage Information – IVIG
Senior Dimensions MA-PD plans – covered under the Medicare Part B benefit only if
medication is being used for one of the diagnoses listed in #1 above; applicable 20% coinsurance
will apply and will NOT apply to TrOOP. Covered under Medicare Part D
benefit for all other diagnoses with the applicable specialty drug co-insurance and WILL
apply to TrOOP. All claims will adjudicate through the pharmacy on-line claims system.
Sierra RX – covered under the Medicare Part B benefit only if medication is being used for
one of the diagnoses listed in #1 above; direct member to their Part B carrier. Covered
under Medicare Part D benefit for all other diagnoses with the applicable specialty drug coinsurance;
will adjudicate through the pharmacy online claims system and WILL apply to
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This guideline is to be used in the decision-making process and does not represent standards of care of an individual
patient. The use of this guideline should not substitute for the professional judgment of a provider which takes into
account the unique problems and circumstances of the individual patient. They are proprietary documents and may
not be copied or distributed without express permission.

HEALTHCARE OPERATIONS
UTILIZATION PROTOCOLS 2007
TrOOP.
Sierra Spectrum/Sierra Nevada Spectrum covered under the Medicare Part B benefit
only if medication is being used for one of the diagnoses listed in #1 above; applicable 20%
co-insurance will apply. Claims WILL adjudicate on-line and will NOT apply to TrOOP.
Covered under Medicare Part D benefit for all other diagnoses with the applicable specialty
drug co-insurance; will adjudicate through the pharmacy online claims system and WILL
apply to TrOOP.
All other lines of business: Covered as a Medical Benefit – prior authorization required
General Information
Intravenous immunoglobulin (IVIG) is used as replacement therapy in patients with a primary
humoral immune deficiency. IVIG products are also commonly used for off-label purposes. It
is estimated that 50% to 70% of all IVIG prescriptions are written for off-label purposes.
However, information on many of the off-label uses in the medical literature is from
inadequately uncontrolled studies and case reports.
FDA Approved Indications
1. Immunodeficiency syndrome: For the maintenance treatment of patients who are unable to
produce sufficient amounts of IgG antibodies. It may be used in disease states such as
congenital agammaglobulinemia, common variable hypogammaglobulinemia, x-linked
immunodeficiency with or without hyper IgM, Wiskott-Aldrich syndrome and combined
immunodeficiency
2. Idiopathic thrombocytopenia purpura (ITP) (Gamimune N, Gammagard S/D, Polygam S/D,
Sandoglobulin, Venoglobulin-S only): Treatment should not be considered curative.
Administer to patients who require a rapid, temporary rise in platelet count (e.g., prior to
surgery, to control excessive bleeding or to defer splenectomy)
3. B-cell chronic lymphocytic leukemia (CLL) (Gammagard S/D, Polygam S/D): For the
prevention of bacterial infections in patients with hypogammaglobulinemia or recurrent
bacterial infections associated with B-cell CLL.
4. Kawasaki syndrome (Iveegam only)
5. Bone marrow transplantation (BMT) (Gamimune N only): For the prevention of systemic
and local infections, interstitial pneumonia of infectious and idiopathic etiologies and acute
graft-vs-host disease in patients
6. Pediatric HIV infection (Gamimune N only)
-3-
This guideline is to be used in the decision-making process and does not represent standards of care of an individual
patient. The use of this guideline should not substitute for the professional judgment of a provider which takes into
account the unique problems and circumstances of the individual patient. They are proprietary documents and may
not be copied or distributed without express permission.

HEALTHCARE OPERATIONS
UTILIZATION PROTOCOLS 2007
Unlabeled uses: IGIVs may also be useful in chronic fatigue syndrome; quinidine-induced
thrombocytopenia; chronic inflammatory demyelinating polyneuropathy; Guillain-Barre
syndrome
Dosing Recommendations
1. Immunodeficiency syndrome
a. Sandoglobulin: Administer 100–400 mg/kg/month by infusion. Increase to 300mg/kg if
IgG serum level is 100mg/kg are
recommended.
c. Gammar-P IV: Administer 200 to 400mg/kg every 3 to 4 weeks in adults.
d. Gamimune N: Administer 100 to 200mg/kg/month. The dosage may be given more
frequently or increased as high as 400 mg/kg (8 mL/kg) if the clinical response is
inadequate or the level of IgG is insufficient
e. Iveegam: 200mg/kg/month. Doses of 800 mg/kg/month have been tolerated
f. Polygam S/D: 100mg/kg/month. An initial dose of 200 to 400 mg/kg may be
administered to individualize treatment.
g. Venoglobulin-S: 200mg/kg/month
-4-
This guideline is to be used in the decision-making process and does not represent standards of care of an individual
patient. The use of this guideline should not substitute for the professional judgment of a provider which takes into
account the unique problems and circumstances of the individual patient. They are proprietary documents and may
not be copied or distributed without express permission.

HEALTHCARE OPERATIONS
UTILIZATION PROTOCOLS 2007
2. ITP
a. Sandoglobulin: 400mg/kg for 2 to 5 consecutive days
b. Venoglobulin-S: 2000mg/kg over < 5 days for induction therapy. Maintenance therapy:
1000 mg/kg may be administered as needed to maintain platelet counts of 30,000/mm 3 in
children and 20,000/mm 3 in adults or to prevent bleeding episodes in the interval
between infusions.
c. Gamimune N: 400mg/kg may be given as a single infusion. If an adequate response
does not result, the dose can be increased to 800 to 1000mg/kg given as a single infusion.
Maintenance: If platelet count falls to < 30,000/mm 3 or if the patient manifests clinically
significant bleeding, 400mg/kg may be given as a single infusion. If an adequate
response does not result, the dose can be increased to 800 to 1000mg/kg given as a single
infusion. Maintenance infusions may be administered intermittently as clinically
indicated to maintain a platelet count > 30,000/mm 3 .
d. Gammagard S/D: 1000mg/kg. Need for additional doses can be determined by clinical
response and platelet count. Give up to 3 doses on alternate days if required.
e. Polygam S/D: 1g/kg. A need for additional doses can be determined by clinical
response and platelet count. Give up to three separate doses on alternate days, if required
3. CLL
a. Gammagard S/D: 1000mg/kg
b. Polygam S.D: 1g/kg
4. Kawasaki syndrome – Iveegam only: 400mg/kg/day for 4 consecutive days or a single dose
of 2000mg/kg given over a 10-hour period. Initiate treatment within 10 days of onset of the
disease. Treatment regimen should include aspirin, 100mg/kg each day through the 14 th day
of illness, then 3 to 5mg/kg/day thereafter for 5 weeks.
5. Bone Marrow Transplantation - Gamimune N only: 500mg/kg (10ml/kg) beginning on days
7 and 2 pre-transplant or at the time conditioning therapy for transplantation is begun, then
weekly through the 90-day post-transplant period.
6. Pediatric HIV infection - Gamimune N only: 400mg/kg (8ml/kg) every 28 days.
Bibliography
1. NIH Consensus Development Conference. Intravenous Immunoglobulin Prevention and
Treatment of Disease. JAMA; December 26, 1990-Vol 264. No.24; 3189-3193
2. Knapp MJ, et al. Drug Reviews: Clinical uses of intravenous immune globulin. Clinical
Pharmacy; Vol 9 Jul 1990:509-529
3. Consensus Statement. Recommendations for Off-Label Use of Intravenously
Administered Immunoglobulin Preparations. JAMA, June 21, 1995-Vol 273. No.23;
-5-
This guideline is to be used in the decision-making process and does not represent standards of care of an individual
patient. The use of this guideline should not substitute for the professional judgment of a provider which takes into
account the unique problems and circumstances of the individual patient. They are proprietary documents and may
not be copied or distributed without express permission.

HEALTHCARE OPERATIONS
UTILIZATION PROTOCOLS 2007
1865-1870
4. UHC Updates Off-Label Use Recommendations for Intravenous Immunoglobulin.
Clinical Practice Alert, February/March 1999-Volume 8, Number 2; 1-2.
5. Immune Globulin Intravenous (IVIG), Facts and Comparisons, Inc., St. Louis, MO,
2004.
6. Micromedex HealthCare Series, Drugdex® 2005
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This guideline is to be used in the decision-making process and does not represent standards of care of an individual
patient. The use of this guideline should not substitute for the professional judgment of a provider which takes into
account the unique problems and circumstances of the individual patient. They are proprietary documents and may
not be copied or distributed without express permission.