Eleven questions.1. Who should use Betaseron? The clinical studies were done on people with relapsing-remitting MS, and FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 Side effects Effects of a proposed project on other parts of the firm. ? 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 malaise /mal·aise/ (mal-az´) a vague feeling of discomfort. mal·aise n. A vague feeling of bodily discomfort, as at the beginning of an illness. , chills) which tend to lessen less·en v. less·ened, less·en·ing, less·ens v.tr. 1. To make less; reduce. 2. Archaic To make little of; belittle. v.intr. To become less; decrease. 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 For other uses, see Rumor (disambiguation). Rumors is a farcical play by Neil Simon. At its start, several affluent couples gather in the posh suburban residence of a couple for a dinner party celebrating their tenth anniversary. , 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 Reimbursement Payment made to someone for out-of-pocket expenses has incurred. . 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 interferon (ĭn'tərfēr`ŏn), any of a group of proteins produced by cells in the body in response to an attack by a virus. A cell infected by a virus releases minute amounts of interferons, which attach themselves to neighboring cells, -- 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 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. 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 ac·cu·mu·late v. ac·cu·mu·lat·ed, ac·cu·mu·lat·ing, ac·cu·mu·lates v.tr. To gather or pile up; amass. See Synonyms at gather. v.intr. To mount up; increase. 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. |
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