Download IVIG (Intravenous Immunoglobulins): Bivigam—J1556 Carimune

PHARMACY PRE-AUTHORIZATION CRITERIA
DRUG
IVIG (Intravenous Immunoglobulins):
Bivigam—J1556
Carimune—J1566
Cytogam—J0850
Flebogamma—J1572
Gammagard—J1569
Gamunex—J1561
Octagam—J1568
Privigen—J1459
POLICY #
23106
INDICATIONS
FDA Labeled Indications:
• Primary humoral immunodeficiency (hypogammaglobulinemia, congenital X-linked
agammaglobulinemia, common variable immunodeficiency, X linked
immunodeficiency with hyper IgM, Wiskott-Aldrich syndrome, and severe
combined immunodeficiences.
• Idiopathic thrombocytopenia
• Kawasaki disease
• Chronic B-Cell lymphocytic leukemia
• Bone marrow transplantation
• ITP Secondary to HIV infection
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Gammagard only:
•
Multifocal motor neuropathy
PHARMACY PRE-AUTHORIZATION CRITERIA
DRUG (S)
IVIG (Intravenous Immunoglobulins):
#23106
CRITERIA
ConnectiCare will consider to IVIG be medically necessary, when prescribed by a specialist, in
patients who meet any of the following criteria. Authorization for IVIG infusions shall be limited to
no more frequently than one infusion per month unless otherwise noted:
A. Primary humoral immunodeficiencies:
1. X-linked agammaglobulinemia (congenital agammaglobulinemia)
2. Hypogammaglobulinemia ( IgG level is < 600 mg/dl)
3. Common variable immunodeficiency (CVID)
4. X-linked immunodeficiency with hyper IgM
5. Wiskott-Aldrich syndromes and other severe combined immunodeficiencies
B. Idiopathic thrombocytopenia (ITP)
1. Acute ITP- For patients as initial therapy if platelet count is < 20,000/µl, especially
when patient has emergency bleeding or is at risk for severe life-threatening
bleeding or
For patients with severe thrombo-cytopenia (platelet counts less than 20,000/ ul)
considered to be at risk for intracranial hemorrhage.
2. Chronic ITP- For patients with dangerously low platelet counts, less than 30,000
cells/mm 3 in children and less than 20,000 cells/ mm 3 in adults, where prior
treatment with corticosteroids or splenectomy.
According to ASH guidelines if platelet count is <20,000 to 30,000 initial therapy is
corticosteroids. Usual dose is 1 to 2 gm/kg divided into equal amounts and given
over 2 to 5 days.
3. ITP in pregnancya. For patients refractory to steroids with platelet counts <10,000/ mm 3 in
the third trimester
OR
b.
Platelet counts < 30,000/ mm 3 associated with bleeding before vaginal
delivery or C-section
OR
c. Pregnant women who have previously delivered infants with
autoimmune thrombocytopenia
OR
d. Pregnant women who have platelet counts < 75,000/ mm 3 during the
current pregnancy
OR
e. Pregnant women with a past history of splenectomy
C. Kawasaki Syndrome- Approve in the acute phase- administer within 7 days of the onset of
fever, concomitantly with appropriate aspirin therapy (A single 2 g/kg dose or a dose of
400 mg/kg for 4 consecutive days.
PHARMACY PRE-AUTHORIZATION CRITERIA
D. Aquired hypogammaglobulinemia associated with chronic B-cell lymphocytic leukemia-For
patients with IgG level < 640 mg/dL with previous history of a serious bacterial infection.
Monthly maintenance infusions of 400 mg/kg are recommended to maintain serum IgG
level.
E. Bone Marrow transplant recipients- Approve at any time after transplantation in patients
who have severe hypogammaglobulinemia (IgG < 600 mg/dl). The requirement for IgG <
600 mg/dL does not apply to patients who underwent transplantion for multiple myeloma
or malignant macroglobulinemia because their total IgG concentration is affected by their
underlying paraproteinemia. In the first 100 days after transplantation, IVIG should not be
given to hematopoietic stem cell transplant (HSCT) recipients to prevent bacterial
infection. However, IVIG is recommended for routine use in HSCT recipients (adults,
adolescents, pediatric) with unrelated marrow grafts (allogenic) who experience severe
hypogammaglobulinemia (IgG <600 mg/dl) within the first 100 days of transplant.
Note: Gamimune N, a brand of IVIG that has been discontinued, was FDA-approved for
the treatment of bone marrow transplant patients ≥ 20 years of age to decrease the risk
of septicemia and other infections, interstitial pneumonia of infectious or idiopathic
etiologies, and acute GVHD in the first 100 days posttransplant.
F. Pediatric HIV infection- May approve in HIV infected infants and children < 13 years of age
when:
a. 2 or more serious bacterial infections, such as bacteremia, meningitis,
or pneumonia during a one year period despite administration of
antiretroviaral therapy with chemoprophylaxis with TMP-SMZ or other
active agent.
OR
b. Child has hypogammaglobulinemia ( IgG level is < 600 mg/dl)
OR
c. Child has absence of detectable antibody to measles who have received
two measles immunizations and who live in regions with a high
prevalence of measles
OR
d. Child has T4 count greater than 200/ mm 3
OR
d. Child has bronchiectasis that is not optimally responsive to antibiotics
and pulmonary therapy.
G. Chronic inflammatory demyelinating polyneuropathy (CIDP)- May approve when patient
has significant functional disability, documentation of slowing nerve conduction
velocity on EMG/NCS.
IVIG is recommended as an equivalent alternative to plasma exchange in children and
adults. Neurological disability score improved similarly with IVIG and plasma exchange.
PHARMACY PRE-AUTHORIZATION CRITERIA
Initial dose: 2 g/kg (20 mL/kg) given in divided doses over two to four consecutive days.
Maintenance: 1 g/kg (10 mL/kg) over 1 day or divided into two doses of 0.5 g/kg
(5mL/kg) given on two consecutive days, every 3 weeks.
H. Multifocal motor neuropathy- Approve in patients with symptomatic progressive
multifocal motor neuropathy diagnosed on the basis of electrophysiologic findings that
rule out other possible conditions that may respond to IVIG treatment. Several placebo
controlled trials have shown IVIG improves muscle strength and neurological disability
scores.
Non-FDA approved Indications for which IVIG may be appropriate
I. Guillian-Barre Syndrome- Approve if IVIG is initiated within 2 weeks and no longer than
4 weeks of onset of neuropathic symptoms (weakness, inability to stand or walk without
assistance, respiratory or bulbar weakness). Treatment with IVIG after 4 weeks from onset
will be considered on a case by case basis since some patients may relapse and the relapse
may be severe enough to warrant a repeat course of IVIG. IVIG is recommended as an
equivalent alternative to plasma exchange in children and adults.
J. Myasthenia Gravis- Approve for patients who are in crisis and have severe weakness when
other treatments have been unsuccessful or are contraindicated. Alternate treatments
include, but are not limited to plasma exchange, and immunosuppressive therapy (e.g.
azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, cyclophasphamide).
Routine use is not recommended.
K. Multiple Myeloma-Approve for patients with stable “plateau phase” disease (> 3 months
since diagnosis) and IgG level < 600 mg/dl and has had 2 or more significant infections in
the last year despite prophylactic antibiotic therapy or evidence of specific antibody
deficiency.
L. Systemic lupus erythematosus- Approve if patient has severe active SLE when first and
second line therapies have been unsuccessful, intolerable, or are contraindicated.
Note: Standard first-line therapy of active SLE include non steroidal anti-inflammatory
drugs, followed by low-dose corticosteroids and antimalarial compounds. Second-line
therapeutic alternatives include cytotoxic agents methotrexate, azathioprine, or
cyclosporine
M. Post-transfusion purpura- Approve. IVIG may be considered as first line therapy in
severely affected patients with platelets <10,000/µl and 2-4 days post transfusion with
bleeding.
N. Polymyostis/Dermatomyositis- Approve in patients who have not responded to
conventional therapy (steroids, immunosuppressants, eg, azathioprne, methotrexate) or if
these therapies are contraindicated. Initial authorization may be given for 3 months.
PHARMACY PRE-AUTHORIZATION CRITERIA
When additional IVIG treatment is requested, the physician must submit objective
evidence of the efficacy of the initial three- month treatment (eg. Continued decrease in
muscle strength elevated CPK levels, and/or EMG abnormalities).
O. Autoimmune mucocutaneous blistering disease (pemphigus vulgaris, pemphigus
foliaceus, bullosa pemphigoid) Approve if patient has tried conventional therapy
(systemic corticosteroids, immunosuppressive agents, [eg. Azathioprine,
cyclophosphamide, methotrexate, cyclosporine, mycophenolate mofetil] ,or has
contraindications to conventional therapy, OR the disease is rapidly progressive,
extensive, or debilitating.
Note: IVIG for the treatment of autoimmune mucocutaneous blistering disease is
considered medically necessary only for short term therapy and not as maintenance
therapy.
P. Selective IgG subclass deficiency. Approve if patient meets all of the following criteria:
Patient has a history of recurrent or persistent, severe bacterial infections that are not
responding adequately to treatment and prophylaxis with antibiotics and patient has
impaired antibody response to either protein (eg, tetanus, diphtheria) and/or
polysaccharide antigens(pneumococcus, meningococcus, Hemophilus influenza type B.
Q. Autoimmune hemolytic anemia- Approve inpatients with warm-antibody AIHA who have
tried corticosteroids or had a splenectomy or if these treatments are contraindicated.
R. Stiff-person syndrome—Approve for patients who have significant stiffness of the whole
body, preventing ambulation, and who do not respond to oral medications such as Valium
and Baclofen
LIMITATIONS
Some off-label use may be medically appropriate and rational in certain circumstances. Off-label
drug use will be reviewed for evidence of therapeutic value according to the following criteria:
OR
1. The drug is FDA-approved
2. The member has tried and failed established FDA approved and/or clinical guideline
recommended therapy unless contraindicated
3. Phase III* FDA clinical studies to support the non-FDA approved use.
4. A. The drug is recognized for treatment of the requested indication in one of the standard
reference compendia
• American Hospital Formulary Service – Drug Information (AHFS-DI)
• Thomson Micromedex DrugDex
• Clinical Pharmacology (Gold Standard)
• National Comprehensive Cancer Network (NCCN)
• Facts & Comparisons
B. In the absence of being listed in above named sources, a minimum of at least two
articles from major peer-reviewed journals (from the United States or great Britain) which
PHARMACY PRE-AUTHORIZATION CRITERIA
supports the proposed use for the specific medical condition as safe and effective.
Note: ConnectiCare requires prescribers to submit clinical documentation supporting the
drug's effectiveness in treating the intended indication.
*In Phase III trials, the experimental study drug or treatment is given to large groups of people
(1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used
treatments and collect information that will allow the experimental drug or treatment to be used
safely.
If any of the above criteria are met initial authorization is limited to 3 months. Subsequent
authorization up to one year will be based on documentation of efficacy.
Site of Care Management:
• The first dose of IVIG may be given at the facility of choice by the physician; all subsequent
doses will be given by home infusion coordinated by ConnectiCare’s preferred vendors.
• ConnectiCare’s preferred site of care for IVIG is home infusion. Clinical rationale and
documentation must be provided for review for exceptions. The following are
considerations for services outside the home:
1. Documented history of a severe reaction to IVIG or blood products. Severe
reaction is defined as anaphylactic reaction. The patient should have a history of
reactions and not be based on the potential of IVIG to induce such reactions.
2. Documented intolerance to IVIG requiring constant telemetry monitoring of vitals.
3. Unsafe home environment.
4. No access to 911 services.
5. Documented presence of IGA auto antibodies.
6. Patient is severely decompensated e.g. respiratory failure in a myasthenic crisis.
The use of IVIG is considered investigation for all other indications, including but not limited to:
Alzheimer’s disease
Aplastic anemia
Asthma
Atopic dermatitis
Autism
Bechet’s syndrome
Chromic fatigue syndrome
Cystic fibrosis
Diabetis mellitus
In vitro fertilization
Lyme Disease
Multiple sclerosis
Rheumatoid arthritis
Toxic shock syndrome
PHARMACY PRE-AUTHORIZATION CRITERIA
DRUG (S)
IVIG (Intravenous Immunoglobulins):
#23106
REFERENCES
1. Immune globulin intravenous (human) In: Drug information for the health care professional.
USPDI—Volume I. 25rd ed. Greenwood Village, CO: 2005; Thomson Micromedex; 2005:16521658.
2. Carimune NF [package insert]. Kankakee, IL: ZLB Behring LLC (manufactured by ZLB Behring
AG, Switzerland)
3. Flebogamma 5% solution [package insert]. Los Angeles, CA: Grifols USA, Inc (manufactured
by Instituto Grifols, SA, Barcelona, Spain).
4. Gammagard S/D [package insert]. Westlake Village, CA: Baxter Healthcare Corporation
5. Gamunex 10% [package insert]. Elkhart, IN: Bayer Corporation.
6. Iveegam EN [package insert]. Westlake Village, CA: Baxter Healthcare Corporation.
7. Octagam [package insert]. Herndon, VA: Octapharma USA, Inc (manufactured by Octapharma
Pharmazeutika, Vienna, Austria).
8. Panglobulin [package insert]. Washington, DC: American Red Cross Blood Services
(manufactured by ZLB Bioplasma AG, Switzerland)
9. Polygam S/D [package insert]. Washington, DC: American Red Cross Blood Services
(manufactured by Baxter Healthcare Corporation)
10. Gammagard® Liquid 10% [package insert]. Westlake Village, CA: Baxter Healthcare
Corporation.
11. Gammar-P I.V. [package insert]. Kankakee, IL: ZLB Behring.
P&T REVIEW
HISTORY
06/04, 6/07, 6/08, 10/08, 12/08, 9/09, 9/10, 12/11, 10/13, 10/14, 11/15, 8/16
REVISION
3/06, 12/08, 8/12, 11/12, 10/13, 7/15, 8/16
RECORD