Biotechnology Healthcare - September/October 2008 - (Page 7)

CLINICAL BURDEN Symptoms and progression Symptoms of MS vary widely (right). Researchers conducting the Sonya Slifka longitudinal study of about 2,000 Americans with MS found that about 3 in 8 require assistive devices for mobility (chart, below), and more than half need help from another person for personal care activities. Bedridden >1% Requires wheelchair or scooter Requires bilateral support to walk 25 feet 15% 7% 24% Symptoms that do not limit activity 18% Symptoms Fatigue Difficulty walking Stiffness and spasms Memory/other cognitive problems Bladder problems Pain/unpleasant sensations Emotional/mood problems Vision problems Dizziness or vertigo Bowel problems 14% Requires cane to walk 25 feet 9% Can walk 25 feet without cane Mild symptoms that do not affect walking Tremors Sexual problems Difficulty moving arms Swallowing problems Speech problems 38 37 36 35 30 30 24 22 20 67 63 55 55 54 Percentage 83 10% Problem with walking but no assistive device Percentages do not add up to 100 because of rounding. Source: Minden 2006 Et cetera: More than half of MS patients have a relapsing/remitting form of the disease in which symptoms appear for several days to weeks, then recede or disappear. Tissue damage accumulates over time, and patients usually enter a secondary progressive stage in which neurologic problems become worse. About 15 percent of patients have primary progressive MS, meaning that their symptoms gradually worsen but with no clinical relapses. ROLE OF BIOTECHNOLOGY TREATMENTS FDA-approved therapies Some patients do well with no therapy at all, but four biologic products have proven effective in treating the disease, according to the National Institute of Neurological Disorders and Stroke. The U.S. Food and Drug Administration has approved three forms of beta interferon, which reduce the number and severity of relapses and may slow the progression of disability. The FDA also has approved a synthetic form of myelin basic protein, which has been shown to reduce the MS relapse rate by almost one third. Biologic treatments in the pipeline Number in development, by phase 16 9 6 2 Et cetera: The incremental cost per quality-adjusted life year (QALY) for the synthetic form of myelin basic protein was recently estimated at $258,000, compared with symptom management alone, according to a costeffectiveness study published in the Journal of Managed Care Pharmacy (April 2007 using 2005 data) (Bell 2007). The incremental cost per QALY for the three forms of beta interferon ranged from $304,000 to $416,000. 0 Preclinical Phase 1 Phase 2 Phase 3 Preregistration Source: PhRMA 2008 SEPTEMBER/OCTOBER · BIOTECHNOLOGY HEALTHCARE 7

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - September/October 2008

Biotechnology Healthcare - September/October 2008 Openers Editorial/David B. Nash, MD, MBA Contents At a Glance: Multiple Sclerosis Drug Track Personalized Medicine Healthcare Reform’s Effects on Biologic Access Breast Cancer Status Testing: A Crapshoot With Deadly Odds Trends, Issues, and Perspectives In the Management of MS So High-Tech, Yet So Simple The Evolution of Ascertaining the Value Proposition Specialty Pharmacy Employer to Employer Health Plan Confidential Trends

Biotechnology Healthcare - September/October 2008

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