itp for ivig presentation

Managing ITP at Home with IVIG

Marilyn Hanchett RN PhD

Director of Clinical Affairs

IgG America

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.

Role of Platelets

• Blood clotting (hemostasis)

• Aggregation (repair)

• Activate Factor VIII (part of the coagulation cascade)

• Release phospholipids (support coagulation)

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.

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.

Platelet Activation

Normal View of Platelets

Platelets

Platelets in ITP

Petechiae

Purpura

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!

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.

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.

Sterile Compounding of IVIG

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!

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!

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.

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 . . .

Does Preservation of the IgG Molecule During Processing

Improve Clinical Outcomes?

The Current “Hot Topic” in IVIG Safety and Tolerability:

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

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.

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.

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.

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.

IVIG Product Allocations

What is an allocation and how does it impact your care?

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!

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.

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!

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

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.

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.

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?

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

Toll Free 877.674.9700

Visit Use On Line

www.iggamerica.com

Remember . . .IgG. It’s What We Do. It’s ALL We do.