itp for ivig presentation
TRANSCRIPT
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Managing ITP at Home with IVIG
Marilyn Hanchett RN PhD
Director of Clinical Affairs
IgG America
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Not All Cases of ITP Are The Same
ITP can be:Acute or ChronicImmune or Non-ImmunePrimary or Secondary
For this reason, statistics are limited!3,000-20,000 new cases per year, but
thought to be under-reported.More common in women.
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Role of Platelets
• Blood clotting (hemostasis)
• Aggregation (repair)
• Activate Factor VIII (part of the coagulation cascade)
• Release phospholipids (support coagulation)
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The Role of Platelets inImmune Thrombocytopenia Purpura
• Patients make auto-antibodies directed against their own platelets.
• Platelets are destroyed faster than the body can produce them.
• If PLT count drops too low, bleeding will occur.
• Bleeding can be serious.
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What is Normal?
150 – 400, 000 mm3
Many people tolerate PLT levels < 150, 000
without symptoms.
Many people have never had their PLT level checked.
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Platelet Activation
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Normal View of Platelets
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Platelets
Platelets in ITP
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Petechiae
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Purpura
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Intravenous Immunoglobulin (IVIG)also abbreviated IGIV, IVIg or IgG
• Immunoglobulins are antibodies (proteins) found in the plasma portion of blood.
• IgG is made by the body in response to exposure to bacteria, fungi & viruses.
• Very expensive to manufacture & use in treatment. Costs have increased
30% since 2002!
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ITP is an FDA Approved Indication for IVIG
• Immune Deficiencies
• ITP
• B Cell Chronic Lymphocytic
Leukemia (CLL)
• Kawasaki Syndrome
• Bone Marrow Transplant
• Pediatric HIV
The fastest growing area
of IVIG demand is in non FDA
approved dx or “off label” use.
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IVIG and Viral Safety
• No disease transmission by any product since 1994.
• Viral inactivation methods continue to improve.
• Solvent/Detergent remains the most commonly used method
of viral inactivation.
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Sterile Compounding of IVIG
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Why Receive IVIG at Home?
• More convenient.• More comfort, less stress.• 100% personalized service.• Flexible scheduling, including
weekends and/or evenings.• Less time away from work, school or
other planned activities.• Your nurse stays with you during the
entire home treatment.
AND usually less expensive!
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How Safe is Home IVIG?
Common side effects resemble a flu-like reaction (Headache, low grade fever, chills, muscle aches & fatigue).
Serious Reactions IncludeAnaphylaxisRenal FailureAseptic MeningitisBlood Clots, Stroke
But Serious Reactions are Rare!
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IVIG Brand Selection:Products are Similar But Not
Identical!
• There are currently 9 brands approved by the FDA.• Additional IgG products are under
review now by the FDA.• Factors in brand selection include
IgA levels, tolerability, insurance, clinical risk factors/med history and convenience.
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Current Theories of Product Tolerability
If the FDA considers all brands
therapeutically equivalent, why may you tolerate one brand better than another?
* Chemical Differences
* Administration (especially rate)
And . . .
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Does Preservation of the IgG Molecule During Processing
Improve Clinical Outcomes?
The Current “Hot Topic” in IVIG Safety and Tolerability:
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The Immunoglobulin Molecule
ConstantRegion
Variable Region
Antigen Binding Sites
Fc
Fab Fab
Isotypes: Differences in C Region Genes:
IgA, IgD, IgE, IgG, IgM
Quick Facts• Made of heavy and light polypeptide chains.•All molecules have 2 identical binding sites.•The isotype determines the functional property of the antibody.•This basic structure is the same for all antibodies.
Disulfide Bonds
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Demand for IVIG Continues to Increase
• Overall usage increases 10% annually.
• Most research focuses on “off label” use (diagnoses not approved by the FDA).
• Demand for specific brands exceeds existing supply, creating
a “domino effect” in terms of a national shortage.
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Analyzing the Cost of IVIG
Cost of IgG $ 15,000 – 250,000 per year per patient.
The actual cost depends on:1. The brand of IVIG prescribed
2. The amount (# grams) given per treatment.
3. How often treatments are done. 4. Where treatments are given.
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How Much IVIG Will I Need?
• Verify your current weight.• Divide by 2.2 to convert to kilograms. Example: 150 lbs/2.2 = 68.2 kg• Multiply your weight in kg X the prescribed dose (usually 1 or 2 grams
per kilogram for ITP). Example: 68.2 kg X 2 = 136.4 grams This will tell you how many grams per
day you will need.
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Why are Costs Related to IVIG So Difficult to Manage?
• Demand is not the only factor in setting product costs.
• No generic or synthetic alternatives to biologic products.
• Manufacturing is a high cost, low yield process.
• Wide variation in costs, depending the location where IVIG is given.
• Product substitutions are often required.
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IVIG Product Allocations
What is an allocation and how does it impact your care?
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Insurance and IVIG for ITP
Medicare
and Medicare Supplemental Plans (“Medigap” Insurance)
DO NOT COVER
IVIG at home for ITP.
Many other plans provide home IVIG.
Know what your insurance covers!
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What is WinRho?
• Anti D antibody specific to
the Rh+ red blood cell.
• Coats the RBC so that the spleen destroys it rather than platelets.
• Does not replace platelets – but prevents them from being destroyed.
• Given IV as short bolus infusion.
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WinRho SDFRho (D) Immune Globulin
Treatment Advantages
• As clinically effective as IVIG• Short administration time (< 10 min)
but MUST be given IV• On average, 70% less expensive than
IVIG• Fewer side effects
Now being marketed by Baxter!
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Pharmacoeconomic Model Comparison based therapeutically equivalent
doses for an adult with ITP weighing 150 lbs & requiring 2 grams/kg:
IVIG $ 15,709WinRho $ 5,678
Savings Per Treatment $ 10,031 Savings Per 6 Treatments $ 60,186
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Common Misperceptions about IVIG
• All IVIG brands are the same.
• IVIG is a high risk therapy.
• The most expensive place to receive IVIG treatment is at home.
• Most insurance plans do not cover IVIG at home.
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What We Know About This Therapy . . .
• Safe, effective treatment for ITP, but not a cure.
• Beneficial treatment in many other autoimmune chronic diseases BUT the extent of benefit varies widely and is almost impossible to predict.
• Wide variation in results of testing IVIG use in chronic disease management.
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What We Do Not Yet Know(What Scientists Are Trying to Discover)
• The exact mechanism of action is not fully understood.
• In people with similar conditions, why does IVIG help one but not the other?
• Why does an individual tolerate one brand better than others?
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How Does IgG America’s Service Delivery Model Address ITP?
• Access to ALL brands• Expertise in IgG therapy management• Strong relationships with prescribers,
payers and patients• Flexible & personalized infusion
schedules• Outstanding customer service• Proven track record of safety and
satisfaction
Some Examples
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Toll Free 877.674.9700
Visit Use On Line
www.iggamerica.com
Remember . . .IgG. It’s What We Do. It’s ALL We do.