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Eleven questions.

1. Who should use Betaseron? The clinical studies were done on people with relapsing-remitting MS, and FDA approval is likely to be for use in that form of the disease. The ultimate decision about use must be made bewteen an individual and his/her personal physician.

2. How is it taken? By injection underneath the skin every other day. This is similar to what people with diabetes do if they use insulin.

3. What are the side effects? They are really quite few. People do have reactions at the site of injection -- generally redness of inflammation -- and most people experience flu-like symptoms (fever, malaise, chills) which tend to lessen over the first three to six months of use and are generally gone by one year.

4. How much will Betaseron cost? At the time of this writing, despite the many rumors, pricing has not been set by the manufacturer. Betaseron is a biologic agent -- not a true "drug" -- produced by sophisticated and expensive genetic engineering technology. This will contribute to the price structure.

We are all concerned that anyone who stands to benefit from Betaseron not be barred by price alone. The Society will follow this issue very closely.

5. Will it be covered by insurance? FDA approval is an important step to third-party reimbursement. Once covered by those insurance plans that include outpatient prescription medications. Not all do. Details of individual plans vary from carrier to carrier.

At this time, Medicare does not cover outpatient prescription medications for virtually any condition, and we cannot expect Medicare coverage for Betaseron.

6. Is this product the same as other interferons? No. Some like -- gamma interferon -- actually seem to make MS worse. There is no current evidence that any other interferon has the same benefit that has been shown for Betaseron.

7. How long does a person continue to take it? It is too soon to answer this question. The current studies were done over a three-year period, although a small number of people with MS who were in the pilot studies have been on the agent longer. If we assume that safety and efficacy continue for the term, Betaseron may be a life-long therapy.

8. It is a cure? No. The data show a reduction in frequency and serverity of acute attacks, and a reduction in the accumulation of new brain lesions as seen in MRI scans.

9. Will it improve functioning? The current studies do not indicate that people using Betaseron actually "improved". The results related to relapse frequency and severity and accumulated brain lesions.

10. Does Betaseron help people with chronic-progressive MS? Currently, there are no data that will answer this. A study for such individuals is expected to begin later this year.

11. Will it be widely available? After formal FDA approval, there will be a lag of several months while the company prepares and manufactures packaging and physician eduaction materials. This kind of delay is standard in the launch of any new pharmaceutical product. In addition, the company predicts an unspecfied period in which supplies will be insufficient to meet the expected demand. The company is developing a plan for distribution until the drug is widely available. It may be available in Europe in two years.
COPYRIGHT 1993 National Multiple Sclerosis Society
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Title Annotation:regarding Betaseron
Author:Reingold, Stephen
Publication:Inside MS
Article Type:Product/Service Evaluation
Date:Jun 22, 1993
Words:539
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