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$7 Billion in revenue predicted for ADVANCED DRUG DELIVERY SYSTEMS by 2005 The market for drugs employing advanced drug delivery technologies will surpass $7 billion by 2005,according to a study from Kalorama Information.The market segment has seen doubledigit growth over the past few years, and analysts predict that this trend should continue. Moreover,The Market for Advance Drug Delivery Systems study reveals that rev enue attributable to the delivery technologies themselves, separate from those attributable to the pharmaceutical component sales,are gaining ground faster than the segment as a whole. “There appear to be several factors driving the expansion,”says Steven Heffner,acquisitions editor at Kalorama Information. “Among them are the grow PHARMA TRAX SALES, MARKETING, AND R&D TRENDS AFFECTING THE HEALTHCARE INDUSTRY About 9,000 physicians participated in HPR’s Metropolitan Area Promo tional Audit — a monthly service providing insights and trends on pharma ceutical/healthcare company promotional activities and salesforce structure. Physicians were asked to rate the top three companies best supporting the overall needs of their practice,and the factors distinguishing these companies from the rest. Information was collected from November to December 2001.In total, 11 unique specialty segments were represented in the research. Among the broader general/family practitioner audience (1,115 respondents), Pfizer (54%), Merck (35%) and GlaxoSmithKline (32%) ranked one, two and three, respectively.The most common themes cited by physicians for ranking Pfizer were: availability of drug samples; frequency of seeing the rep;quality of patient educa tion; and the ongoing support of professional education through CME programs. Pfizer ranked No.1 among 5 of the 11 specialty segments covered in the research, including internal medicine, pediatrics, general surgery, cardiology, and general/family practice, and placed within the top 3 in 10 out of the 11 specialty segments covered (oncology being the only exception). Among pediatricians (1,470 respondents) participating in the research,Pfizer (34%) edged out Ross Products (32%) and GlaxoSmithKline (32%) for the top position. Physicians like the fact that Ross — a division of Abbott Laboratories — has a “full range of infant formula products,” in addition to providing excellent support of patient programs, including infant for mula samples, coupons, booklets,and growth charts. More than 60% of the 1,000plus OB/GYNs surveyed ranked OrthoMcNeil Pharmaceuticals as the company that best supports this specialty group. WyethAyerst (41%) and Pfizer (30%) followed. OB/GYNs frequently cited OrthoMcNeil as having “friend ly and courteous” sales representatives who are sensitive to PHYSICIANS RATE PHARMACEUTICAL COMPANIESTHATBEST SUPPORTTHEIR NEEDS Steven Heffner, acquisitions editor at Kalorama Information, identifies several trends driving growth of advanced drugdelivery systems: growing number of difficultto administer biopharmaceuticals, pharma’s everincreasing demand for sophisticated lifecycle management, and the advent of advanced technologies. 1. Pfizer 2. Merck 3. GlaxoSmithKline INTERNAL MEDICINE (1,300) 1. GlaxoSmithKline 2. Pfizer 3. Novartis NEUROLOGY (530) 1.OrthoMcNeil 2.WyethAyerst 3.Pfizer OB/GYNS (1,020) 1.Aventis 2. BristolMyers Squibb 3.OrthoBiotech ONCOLOGY/ HEMATOLOGY (195) 1.Merck 2.Pfizer 3.Pharmacia ORTHOPEDIC SURGEONS (925) 1.Pfizer 2.Ross Products 3.GlaxoSmithKline PEDIATRICIANS (1,470) 1. Lilly 2.Pfizer 3.GlaxoSmithKline PSYCHIATRISTS (1,025) 1. GlaxoSmithKline 2. Merck 3. Pfizer PULMONARYDISEASE (300) 1.Pfizer 2.Merck 3. BristolMyers Squibb CARDIOLOGY (520) 1. Pfizer 2. Merck 3. GlaxoSmithKline GENERAL/ FAMILY PRACTICE (1,115) 1. Pfizer 2. Merck 3. Bayer GENERAL SURGEON (475) PHYSICIANS HAVE RATED PFIZER, MERCK, GLAXOSMITHKLINE, ORTHOMCNEIL PHARMACEUTICALS, ELI LILLY, AND AVENTIS AS THE COMPANIES THAT BEST SUPPORT THE OVERALL NEEDS OF THEIR PRACTICES, ACCORDING TO INFORMATION COLLECTED BY HEALTH PRODUCTS RESEARCH INC.,A DIVISION OFVENTIV HEALTH INC. 61 PharmaVOICE A p r i l 2 0 02 ing number of difficulttoadminister biopharma ceuticals, pharma’s everincreasing demand for sophisticated lifecycle management, and the age old catchall — because the technologies are there.” The study,available at MarketResearch.com, is the final installment in a fivevolume study of drugdeliv ery technologies conducted over the past year. In addition to the main technologies covered — lipo somal, monoclonal antibodybased, and polymer based technologies — the current report discusses developments of a variety of newer technologies such as nanoparticles,molecular imprinted polymers, metallofullerenes, prodrug delivery, and others. Offlabel use of ANTIPSYCHOTIC DRUGS to drive market growth Atypical agents have emerged as the products of choice in the antipsychotic market, garnering more than 80% of sales in the seven major pharmaceutical markets — the U.S., France, Germany, Italy, Spain,the United Kingdom,and Japan — in 2000. In its study Overview of Antipsychotics, Decision Resources Inc. finds substantial growth is expected in on and offlabel use of atypical agents in the treat ment of bipolar disorder over the 20002010 forecast period.By the second half of the study period,Zyprexa (olanzapine), Eli Lilly’s medication, could be approved for longterm prophylaxis in bipolar disorder (BPD) if investigations confirm its longterm efficacy. The study, which examines the market for antipsychotics to treat schizophrenia,BPD,and other psychotic disorders, also predicts Janssen’s Risperdal (risperidone) will achieve significant gains in the BPD market.This drug is expected to be approved for the treatment of BPD by 2003 in the U.S. and in Europe and will compete headtohead with Zyprexa.Pfiz er’s Geodon/Zeldox (ziprasidone) and AstraZeneca’s Seroquel (quetiapine fumarate) also will compete effectively in the BPD arena, possibly taking market share from Zyprexa if they are shown to be effica cious for manic symptoms. The availability of atypical agents in shortacting intramuscu lar formulations will expand the use of these drugs in acute set tings. The commercial benefit of this strategy lies in the likelihood that physicians will opt to contin ue patients on an oral or depot version of the same drug that is administered in the acute setting. The report projects that sales of antipsychotic medications will sur pass $8.1 billion in 2005, with growth being driven primarily by continued transition from generi cally available typical antipsychotics to more expensive atypical agents and increased use of atypical antipsychotics in nonschizophrenic indications.The U.S. is the strongest and most dynamic market for the highercost atypical antipsychotics, but acceptance of these more tol erable drugs is growing in Europe. The Japanese market will evolve dramatically over the next five years as more atypical agents are launched. Public health overlooked in debate ONDTC ADVERTISING The public’s health may be taking a back seat in the national debate over directtoconsumer adver tising.The results of a nationwide fiveyear trend sur vey conducted by Preventionmagazine, a leading consumer magazine,along with technical assistance from the Food and Drug Administration suggests the public benefits from DTC advertising. “The study suggests that DTC informs consumers about both the benefits and the risks of advertised medicine,”says NancyOstrove,formerly deputy direc tor of FDA’s division of Drug Marketing, Advertising and Communications. “Although there is room for improvement, giving consumers information in a balanced way should help them participate in their own care and serve the public health. We enjoyed working with Preventionon this survey because it is one of the few public surveys available which tracks consumer reactions to DTC ads prior to and following the FDA August 1997 draft guidance for broadcast advertising. The Preventionsurvey helps both indus try and FDAunderstand how consumers react to this new form of health communication.” Ed Slaughter, director of market research at Rodale, the parent company of Prevention, adds,“The legitimate debate over the positive and negative results of DTC advertising seems to be coming down to cost versus public health.While there clear ly are cost implications, the fact is this form of adver tising informs millions of Americans about their treatment options, and helps them to have open discussions with their doctor about impor tant health issues.” This study builds on an ongo ing body of consumer research conducted by Prevention and Rodale that provides a broad based understanding of preven tive health and selfcare in the U.S. According to the study, Ameri cans are taking control of their health,with as many as 156 million (81%) saying DTC advertising informs them about new treat ments for a condition they maybe suffering from. Furthermore, 123 million (64%) say DTC advertising helps them be more involved in decisions about which medicine is right to take; 154 million (80%) say DTC informs them about the ben efits of the drug; and 135 million (nearly 70%) say it informs themof the risks of the drug. It also is believed that DTC advertising may help patients stay compliant with prescribed drug thera pies. The survey reveals that 55 million Americans (57%) who use prescription drugs have seen adver tising for their medicine; 22 million (40%) of those people say the ad makes them feel better about the benefits;19 million (34%) say the ad makes them feel better about safety; and 9 million (17%) say the ad makes them more likely to take their medicine. “Although the results are not 100% conclusive, the data seem to suggest a positive association between advertising and compliance,” Ms. Ostrove says.“That relationship is important because many of the advertised medicines treat longterm chronic disease. Anything to keep people compliant with their course of treatment should have public health benefits and might even reduce longterm health care costs.” PHARMA trax 191 million (99%) of Americans have seen a DTC advertisement 55 million (57%) of Americans who use pre scription drugs have seen advertising for “their” medicine 22 million (40%) of those people say the ad makes them feel better about the benefits 19 million (34%) say the ad makes them feel better about safety 9million (17%) say the ad makes them more like ly to take their medicine CONSUMER RESPONSETO DTCADVERTISING the physician’s time constraints, in addition to having an excellent women’s health product line, strong patient education support, and excellent sampling support for its product line. GlaxoSmithKline ranked No.1 among neurol ogists (57%), followed by Pfizer (44%),and Novar tis (35%). GlaxoSmithKline also ranked first among pulmonary disease specialists, with 82% of this audience citing the company — by far the highest percentage achieved by any company covered in the research. Merck achieved the top position among orthopedic surgeons, with 57% of physicians cit ing the company as best supporting their needs, followed by Pfizer (49%) and Pharmacia (33%). Lilly (52%) ranked first among psychiatrists, fol lowed by Pfizer (48%) and GlaxoSmithKline (30%). Within the oncology/hematology sector, Aventis Pharmaceuticals (41%) was rated No. 1, followed by BristolMyers Squibb (36%), and Ortho Biotech (33%). Interestingly, analysis of the research by physician segment did yield differences in com pany rank among certain specialty groups. For example, among cardiologists, Pfizer (64%) and Merck (58%) ranked No.1 and No.2 overall.How ever, among those cardiologists writing a larger number of prescriptions (decile 510 physicians), Merck was the top ranked company, accounting for 67% of the physician mentions among this segment, followed by Pfizer (58%). Based on information captured in the MPA service, Merck sales representatives are reaching a greater pro portion of these highervalue physicians than any other company. 62 A p r i l 2 0 02 PharmaVOICE PHARMA trax Survey data come from phone interviews with a nationally representative sample of 1,601 adults age 18 or older living in the continental U.S. Interviews were conducted by Princeton Survey Research Asso ciates from September 19,2001, to November 7,2001. The margin of error due to sampling and other ran dom effects is plus or minus three percentage points for results based on the total sample. Medical management evolving to targeted, HANDSON APPROACH A growing number of companies are turning to caremanagement approaches such as case man agement and disease management to complement utilization management oversight, according to a study into national trends in medical management from URAC. The study — Trends and Practices in Medical Management: 2001 Industry Profile — addresses the practice and evolution of utilization management and how that relates to case manage ment and disease management. More than 120 companies were included in URAC’s research,which consists of both company surveys and interviews with healthcare leaders. Casemanagement and diseasemanagement programs are being deployed to improve compli ance with evidencebased care recommendations and thus improve patient outcomes, the study finds. “We saw companies seeking to dramatically reduce the volume of precertifications they were doing by focusing only on those procedures likely to be overutilized or misused,” says Michael Hattwick, M.D., a consultant to the study who helped run URAC’s focus groups of medical management orga nization leaders.“Those companies took the staff and financial resources and invested them in more case management and disease management for high need patients.They are building a highreturn model by increasing care management and discharge plan ning,and reducing emphasis on prior authorizations. An intentional byproduct of this strategy is reduced administrative burden for physicians and,the compa nies hope,better relationships with physicians.” As evidence of the growing demand for an inte grated approach,96% of survey respondents believe that customers will want more discharge planning, and 97% believe they want more patient referral to case management and disease management. Almost 80% believe that customers will seek more telephonic demand management in the future. “For several years we’ve been hearing that utiliza tion management is becoming passe,” says Garry Carneal,URAC president and CEO. “Our study shows that companies still view utilization management as an important tool for evaluating medical necessity. However, companies are now using utilization man agement as a gateway — they are reviewing fewer procedures, but looking more closely at each encounter to identify opportunities to improve and coordinate care more effectively.Companies are hop ing that more targeted utilization management will improve patient outcomes and will also help restore relationships with physicians and other providers.” New Medicare drug DISCOUNT CARD PLAN unveiled Efforts to help senior citizens get more affordable drugs have taken another step forward with Medi care officials unveiling a new version of their pro posed drug discount card. However, pharmacy groups that have opposed the idea predict the pro posal will end up back in court. The plan envisions that senior citizens buy cards for $25 or less that would then entitle them to lower prices from drug companies and pharmacies, says Tom Scully, head of the Centers for Medicare and Medicaid Services. But drugstores have taken an earlier version of the plan to court, saying that the Medicare agency simply does not have the legal authority to create such a plan. They also fear the program could lure more seniors to mailorder prescription services, hurting their business. Many congressional Democrats have said the plan won’t domuch to help mostneedy seniors,and consumer groups also have expressed reservations, with one predicting the cost savings would be less than 12%. Medicare, established in 1965, does not generally cover outpatient drugs. Although many Medicare recipients do have some coverage through private insurance or government programs for the poor, 10 million or more elderly people have to pay the often hefty costs out of their ownpockets. Mr.Scully says changes in the structure will make sure that the discounts reach the actual patients.The new version also sets up an advisory council for the program. DECISION RESOURCES INC.,Waltham, Mass., is a world leader in pharmaceutical research publications,advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.For more information,visit dresources.com. HEALTH PRODUCTSRESEARCH,White house, N.J.,provides the pharmaceutical industry with consulting services, includ ing market research,promotion analyses, market segmentation,strategic planning, salesforce deployment,and call planning. HPR is a division of NewYork Citybased Ventiv Health Inc. For more information, visit ventiv.com. KALORAMA INFORMATION LLC, a divi sion of MarketResearch.com based in New York, supplies market research to the life sciences industry. For more information, visit MarketResearch.com. MEDICARE,Washington,D.C., is adminis tered by the Centers for Medicare & Medi caid Services. Medicare is the nation’s largest healthinsurance program,cover ing 39 million Americans.For more infor mation,visit Medicare.gov. PREVENTION MAGAZINE, is a division of Emmaus,Pa.based Rodale, a leading pub lisher of information on healthy,active lifestyles. For more information, visit pre vention.com. URAC,Washington,D.C.,also known as the American Accreditation HealthCare Com mission, is a nonprofit organization set up to establish standards for the healthcare industry. For more information,visit urac.org. Follow up Companies are developing more efficient approaches to utilization management by reducing the number of procedures certified, or concentrating on providers or procedures outside of utilization norms. Companies are linking or integrating medical management programs such as utilization management and care management, or care management and disease management, and are enhancing referral and information sharing capabilities between these programs. Staffing needs for medical management ser vices are changing as companies shift their emphasis to case management and peer con sultation and carry out fewer direct utilization managementrelated authorizations. Medicalmanagement companies rely heavily on externally developed criteria and guidelines to assist in medicalmanagement decision making.They expect developers of commercial criteria to incorporate the best available evi dence into review criteria. UTILIZATION MANAGEMENT: ANECESSARYTOOL