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“Products for the Treatment of Factor VIII Deficiency”

Conference Call

August 24, 2004

7pm-8pm

Presenters:

Marcus E. Carr, MD, PhD

&

Gita V. Massey, MD

I. Overview of Factor VIII products currently on the market Advate (Baxter)

Helixate FS (ZLB Behring) Kogenate FS (Bayer) ReFacto (Wyeth)

Recombinate (Baxter)

II. Thoughts to consider when choosing a factor product

• Cost • Infusion

III. Question and answer time

This program is brought to you to with support from Hemophilia Health

Services, a specialty homecare pharmacy that serves the bleeding disorders

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8/2004

Advate® Helixate®FS Kogenate®FS ReFacto® Recombinate®

(Third generation) (Second generation) (Second generation) (Second generation) (First generation)

Distributor Baxter Bioscience ZLB Behring Bayer Corporation Wyeth Baxter Bioscience

Efficacy

*86% good/excellent response rate (100% in surgeries)

*80-90% excellent/good response rate (100% for surgeries)

*80-90% excellent/ good response rate (100% for surgeries) *92% excellent/good response rate *92-95% excellent/good response rate

Studies *No PUP studies *PUP and PTP *PUP and PTP *PUP and PTP *PUP and PTP

Half-Life 11.98 +/- 4.28 hours 13.3 +/- 1.6 hours 13.3 +/- 1.6 hours 14.5 +/-5.3 hours 14.6 +/- 4.9 hours

Inhibitors

No PUP studies; no inhibitors in patients under 6 years

16% in PUP studies 16% in PUP studies 30% in PUP studies 32% in PUP studies

Safety MAIC** MAIC** and solvent

detergent

MAIC** and solvent detergent

MAIC** MAIC**

Exposure to Human Albumin

None; uses a sugar (trehalose) as stabilizer

Uses albumin in

fermentation; no albumin in final form; sugar (sucrose) as stabilizer

Uses albumin in

fermentation; no albumin in final form; sugar (sucrose) as stabilizer

Uses albumin in fermentation; no albumin in final form; sugar (sucrose) as stabilizer

Uses human albumin and bovine protein as stabilizers Vial Ranges 250, 500, 1000, 1500 IU 250, 500, 1000 IU 250, 500, 1000 IU 250, 500, 1000 1500, 2000 IU 250, 500, 1000 IU Reconstituted Volume 5 ml 2.5 ml 2.5 ml 4 ml 10 ml Storage Refrigeration

or room temp for 6 months

Refrigeration Refrigeration Refrigeration or

room temp for 6 months

Refrigeration or room temp

Other Features

Peel off label

Butterfly needle included

Letter coded packaging

Peel off label

Butterfly needle included

Color coded packaging

Peel off label

Butterfly needle included

Color coded packaging

Butterfly needle included

Color coded packaging

Peel off label

Color coded packaging

* PUP- Previously Untreated Patients; PTP- Previously Treated Patients ** MAIC- Monoclonal antibody immunoaffinity chromography

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CONSIDERATIONS WHEN CHOOSING

A FACTOR PRODUCT: COST

I.

Cost of factor to the family is determined by several factors

:

1. Co-pays dictated by insurance

a. Some carriers require a percent of cost co-pay to the family for every order of factor concentrate;

b. More expensive products would therefore lead to higher costs for families;

c. Some home infusion companies will consider financial waivers for co-pays or will work with a third party to waive or reduce co-pays.

2. Insurance formularies

a. Some insurance companies cover only certain medications on their routine medication list. Those medications not on the list may be more expensive or not covered.

b. Some insurance companies require special authorization for more expensive medications and may limit the amount of medication available at a time. 3. Insurance caps

a. Some insurance carriers have a ceiling or maximum amount that they will pay for a patient for their lifetime. “Lifetime caps” can be expended more quickly for more expensive medications.

II.

Cost of factor to the insurance company is determined by several factors:

1. Average wholesale price of the medication

a. Affected by manufacturer’s pricing

2. Contractual agreements between home infusion companies and insurance companies a. Based on size of company, partnerships with manufacturer etc

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1. What is the cost per unit charged to your insurance company of the factor concentrate that you are currently using?

2. What is the cost per unit of the factor concentrate that you are considering?

Recall that different home infusion companies may charge different prices for the same product. However, some companies will charge less for a unit of factor, but bill for every ancillary supply (needles, syringes, port supplies, Sharps container) and for nursing services not covered by insurance.

3. Can your home care company obtain the factor concentrate that you desire in the assays that you need?

Remember that using assays (number of units in a vial) that are much larger than what you need can dramatically increase the cost of the infusion of factor concentrate. For example, if your prescribed dose is 750 units, but you can only get 900 unit vials, you are being charged for the extra 150 units of factor that you may not need.

Questions to ask your insurance company when selecting a factor product:

1. Do you have a lifetime cap on your insurance policy? If so, how much have you used toward the cap?

Many insurance policies have a lifetime cap (limit) for payments, meaning there is a maximum amount the policy will pay for an individual. Once the policy has reached this limit, the patient “caps out”, meaning their insurance company will no longer pay for coverage.

2. Which home infusion companies are covered on your policy?

Insurers contract with home infusion companies to provide factor. Some insurance policies may allow patients to choose between several companies, while others may have only one designated home infusion company.

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CONSIDERATIONS WHEN CHOOSING

A FACTOR PRODUCT: INFUSION

1. Volume of the Factor VIII to be Infused:

Different factor VIII products offer the same dose in different volumes to infuse. It may be easier to infuse a smaller volume. If the factor VIII product you are infusing is one that is a smaller volume, such as 2.5cc, it is very important to make sure the entire product is infused, leaving none of the medicine in the butterfly tubing. To insure this, you must flush the tubing with a small amount of saline into the vein, after infusing the factor.

2. Butterfly Infusion Sets:

For convenience, all of the factor VIII products come packaged with a butterfly

infusion set, except for Recombinate. For this product, infusion sets can be sent from the home care company separately.

3. Type of Diluent Mixed with Factor VIII Product:

Refacto brand of factor VIII uses saline as its diluent to mix with the powdered factor. The other brands we mentioned in the table use sterile water. It is important to use the correct diluent when mixing factor to be infused.

4. Peel Off Label:

All of the factor VIII products mentioned, except for Refacto, have a peel off label on the bottle with the lot number and expiration date. This makes it convenient to put infusion information in a log.

.

All of the Factor VIII products mentioned should be infused within three hours

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Question: Is there an increased risk of inhibitor formation as you switch from product to product? Should

this limit one’s participation in the “free trial” offerings from companies/distributors?

Answer: There is very little scientific data that supports the theory that switching products leads to

development of inhibitors. There have been several anecdotal reports of this occurring, but so far there is no evidence to show this is related to switching products.

It was noted that patients are frequently switched in emergency situations (hospital may have different product) as well as during the factor shortage a few years ago.

Factor sample programs require a prescprition from a physician. Concerns about changing products should be reviewed on an individual basis between physician and patient

Question: Is there increased risk of impotence with Advate? (Participant was told by two friends that they

developed difficulty with erections while on the Advate trial, and this problem went away when they returned to their former products).

Answer: This is not listed as a side effect on the prescribing insert for Advate. As a follow up, HTC staff

presented this question to Baxter representatives who also were not aware of this side effect. Patients should call Baxter medical affairs department to inquire further or to report side effects.

Question: What is the closest agent to Recombinate? Is it Refacto?

Answer: Refacto is the least similar to Recombinate. Kogenate FS and Helixate FS are probably the most

similar to Recombinate.

Question: Is Recombinate going away?

Answer: Baxter has not made any official announcements about discontinuing Recombinate. It is expected

that distribution of Recombinate will eventually be reduced or eliminated, as Baxter has put time and resources into developing a 3rd generation product, Advate. When/if this happens, Baxter is

expected to provide notice to patients well in advance so they can consider other options.

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PRODUCT INFORMATION FROM MANUFACTURERS

Please visit the manufacturer websites for more information about factor products and services: Baxter (Advate & Recombinate)

www.hemophiliagalaxy.com Bayer (Kogenate FS) www.bayerbiologicals.com Wyeth (ReFacto) www.hemophiliavillage.com ZLB Behring (Helixate FS) www.aventisbehring.com

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References

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