Managing ITP at Home with IVIG

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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 Chronic
• Immune or Non-Immune
• Primary 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?
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• 150 400, 000 mm

Many people tolerate PLT levels 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 in ITP
Platelets
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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 Include
• Anaphylaxis
• Renal Failure
• Aseptic Meningitis
• Blood 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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The Current Hot Topic in IVIG Safety and
Tolerability
Does Preservation of the IgG Molecule During
Processing Improve Clinical Outcomes?
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The Immunoglobulin Molecule
Antigen Binding Sites

• 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.

Variable Region
Fab
Fab
Disulfide Bonds
Fc
Isotypes Differences in C Region Genes IgA,
IgD, IgE, IgG, IgM
Constant Region
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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 GlobulinTreatment
Advantages

• As clinically effective as IVIG
• Short administration time (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 15,709
• WinRho 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 Americas Service Delivery Model
Address ITP?
Some Examples

• 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

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Toll Free 877.674.9700 Visit Use On
Line www.iggamerica.com Remember . . . IgG. Its
What We Do. Its ALL We do.