PharmaTrax Cardiovascular Drug Market to Top $100 Billion by 2008 The worldwide market for prescription cardiovascular medications, which topped $75 billion in 2004, will surpass the $100 billion mark by 2008, according to a new report released by Kalorama Information titled The Worldwide Market for Prescription Cardiovascular Drugs. But growth in the market is uneven. The study, which examined eight major segments of the cardiovascular market, found certain therapeutic classes are on the decline while some niche areas show double-digit annual growth. The report suggests that generic competition will significantly impact established areas of cardiovascular therapy, such as diuretics, which will record negative growth over the next five years. Newer emerging therapeutic classes are driving the market forward and more than making up for the losses. Antiplatelet agents, for example, have shown nearly 20% annual growth over the past three years and will continue to post strong revenue growth through 2009, with at least six new drugs in late-stage clinical trials or awaiting approval. Off-Label Drug Use Important in Oncology Physicians who want to prescribe off-label drugs for cancer treatment may feel limited by coverage policies, which can delay patient care. These are the findings of a study conducted by Covance Market Access Services Inc. Oncologists consistently report that off-label use of anticancer therapies is essential in helping patients with rare and advanced cancers, according to the study, which was commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Association of Community Cancer Centers (ACCC). But many oncologists reported that restrictive coverage policies cause them to alter their decisions regarding preferred treatment. Fifteen of 28 oncologists interviewed reported that Medicare noncoverage frequently or very frequently causes them to alter their treatment decisions. Eight oncologists reported that private payer policies have this effect. “It is important to recognize that timely patient access to the full-range of up-to-date and medically appropriate uses of drugs approved for sale in the United States can be limited by reimbursement policies promulgated by both public and private insurance programs,” says Luis T. Gutierrez Jr., general manager of Covance Market Access Services. The study was based on a geographically representative sample of oncologists and oncology practice managers, and researched coverage and reimbursement policies followed by local Medicare carriers and private payers for off-label anticancer therapies. Further study is needed to assess the extent to which coverage and reimbursement policies impair patients’ ability to receive off-label anticancer therapies. Use of ADHD Medication Increasing Among Adults An analysis of nationwide data has revealed the diagnosis and treatment of ADHD has increased at a much faster rate among adults than among children. According to the analysis released by Medco Health Solutions Inc., the number of adults ages 20 to 44 using ADHD medications more than doubled from 2000 to 2004, outpacing increases in the pediatric population, those 19 years of age and under, by almost 44%. Also, spending on ADHD drugs for the 20-to-44 age group increased by more than 325% during the same period. The increase in adult patients ages 20 to 64 using ADHD medications from 2003 to 2004 (an 18% change in prevalence) was second among all drug categories, with only the growth in the number of rheumatologic drug users (25%) being greater. The number of children 9 years of age and under using ADHD medications increased almost 75%, and spending has grown five-fold (412%) in the last four years, with boys three times more likely to be taking ADHD medications than girls in this age group. The Medco analysis was based on prescription data of 2.4 million patients nationwide. Additional findings show a significant jump in the number of adult women taking medications to treat ADHD; among females 20 to 44 years of age, use of ADHD medications has increased 113% during the four-year analysis period, a growth rate 21% greater than their male counterparts. Further, in 2004, use of the ADHD medications among adult women between the ages of 20 and 64 was equal to that of men in the same age group. This is a major contrast to data from the pediatric population, which reveals use of ADHD medications is twice as high in boys as it is in girls. No Link Between drug safety and approval speed Quicker approval of new drugs by the U.S. Food and Drug Administration (FDA) has not increased the number of prescription drugs withdrawn for safety reasons in the United States, according to an analysis by the Tufts Center for the Study of Drug Development (CSDD). The study failed to establish a link between FDA approval times and drug safety, says Kenneth I. Kaitin, director of Tufts CSDD. “Given rising public concern over drug safety and assertions by FDA critics that drug safety in the United States has deteriorated since the adoption of user fees in 1993, we wanted to investigate the matter,” he says. “To date we have found no evidence that links the rate of drug safety withdrawals and the passage of legislation more than a dozen years ago aimed at speeding new drug approvals. Since 2000, the rate of safety withdrawals in the United States has dropped.” Passed in 1992, the Prescription Drug User Fee Act (PDUFA) authorized the FDA to collect fees from drug companies to be used, in part, to hire additional reviewers and improve the drug review process. PDUFA was reauthorized in 1997 and again in 2002. According to Tufts, 3.2% of all the drugs approved for sale in the United States in the 1980s were subsequently withdrawn. That rate increased slightly to 3.5% during the 1990s, and since then has dropped to 1.6%. Fewer Than Half of U.S. Seniors Are Confident About Medicare Drug Benefit With the new Medicare drug benefit becoming effective in just a few months, Medicare and private-sector Medicare plans could face an uphill battle, particularly during the initial enrollment period. This is the conclusion of a Harris Interactive online survey of 2,153 U.S. adults conducted in early June for The Wall Street Journal Online’s Health Industry Edition. Of all those who responded, 12% of people 65 years of age and older say they are very pleased the Medicare bill has passed; 30% of seniors indicate that they don’t know enough about the bill to have an opinion. Of those who believed they did know enough, more than one-third responded they did not feel confident that they would choose the drug plan to best suit their needs. Of all adults surveyed who believed they knew enough about the bill to have an opinion: 52% support a plan to help insurance and managed-care plan providers compete with traditional Medicare; 80% approve of a subsidy for lower-income seniors to reduce their out-of-pocket costs by lowering their monthly premiums for the drug benefit and lowering copayments for drugs; and 70% disapprove of prohibiting imports of less expensive drugs from Canada. Findings of the September/October Tufts CSDD Impact Report Average time between date of FDA approval and date of subsequent safety withdrawal dropped from 3.7 years in the 1980s to 1.4 years in the 1990s. That time has dropped to 0.7 years in the current decade but could change if recently approved drugs are later withdrawn. Longer approval times do not assure greater safety. The average approval time of 2.14 years for drugs withdrawn since 1980 compares with 2.08 years for all approvals during that time. Faster approval times also do not correlate with safety withdrawals within therapeutic classes. Source: Tufts Center for the Study of Drug Development, Boston. For more information, visit csdd.tufts.edu. Follow up Covance Market Access Services Inc., Princeton, N.J., a subsidiary of Covance Inc., offers global reimbursement policy and health economics consulting services that examine issues related to reimbursement policy and patient access to healthcare. For more information, visit covance.com. Harris Interactive Inc., Rochester, N.Y., is a global research company. For more information, visit harrisinteractive.com. Kalorama Information, New York, an imprint of MarketResearch.com, supplies the latest in independent market research for the life-sciences industry. For more information visit kaloramainformation.com. Medco Health Solutions Inc., Franklin Lakes, N.J., manages prescription drug benefit programs that are designed to drive down the cost of pharmacy healthcare for private and public employers, health plans, labor unions, and government agencies. For more information, visit medco.com. Tufts Center for the Study of Drug Development (CSDD), Boston, provides strategic information to help drug developers, regulators, and policymakers improve the quality and efficiency of pharmaceutical development, review, and use. For more information visit csdd.tufts.edu. October 2005 PharmaVOICE
