Pharmaceutical Commerce - April 2010 - (Page 14)

Brand Marketing | Communications 50 Years of Birth Control < continued from page 1 US Contraceptive Market 2005-2009, Categories and Category Leaders (Million $) 2009 All combo estro/prog pills Yaz-28 All non-pill options* Nuvaring All IUDs Mirena All Progest-only/EmergContraception Plan B SOURCE: IMS HEALTH 2008 3352 611 564 290 310 307 201 109 2007 3151 259 570 253 214 213 174 73 2006 2959 41 625 206 175 174 130 29 2005 2739 0 713 109 141 123 123 17 3460 782 617 362 315 313 232 95 “We all know that it’s ultimately about preventing pregnancy, but today, there are so many choices available brand teams have their work cut out for them to attract patients to their product over other options,” says Hans Plate, senior research director for Quintiles Consulting (Boston). “It’s more common than ever to see ads for competing for birth pills that tout their product’s ability to treat acne, relieve symptoms of menstruations or free women from having a period every month.” Choice begins with delivery mechanism. Long-acting, hormone-based contraceptives may be taken in pill form, absorbed through the Hans Plate, skin via a transderQuintiles mal patch, diffused to the bloodstream via sub-dermal implants, an intrauterine device (IUD) or a vaginal ring, or administered by intramuscular or subdermal injection. Frequency of administration varies widely, with the pill taken every day, and implants or IUDs inserted once every couple of months or years. Some methods can be self-administrated (the pill, patch or ring), while others (the IUD, subdermal implant or injection) must be administered by the healthcare provider. The former gives the consumer more control over the process but invites potential adherence issues; the latter give the clinician greater control, potentially improving proper administration and adherence, but may be less convenient for the consumer. “In terms of their ability to prevent pregnancy, doctors tend to view many hormonal birth control products as if they are essentially similar, so perhaps unlike many other therapeutic areas, consumer preference with regard to other desirable attributes (such as perceived safety issues, convenience, beneficial side effects or other competitive advantages and cost) tends to be a big driver in the final selection,” says Mickey Popli, senior research manager for Quintiles Consulting, which has conducted more than 100 marketresearch studied related to birth control and hormone-replacement treatments for clients throughout the biopharma industry. “This is an incredibly patient-driven marketplace and if the patient expresses a preference for a given product — unless there is a direct contraindication — the prescriber will generally follow that request.” Thus, the ability to identify and capitalize on key differentiators, and convey them in DTC outreach is a critical part of overall brand strategy. 14 APRIL 2010 Popli notes that pharma outreach to prescribers is important. While consumer preference often drives selection, when comes to contraception, physicians often do end up exerting some control over the selection process. For instance, she says: “If the patient cannot be expected to faithfully take the pill every day, the prescriber may want to push her toward the weekly patch or monthly vaginal ring, or they may want to exert even greater control by recommending the IUD or quarterly shot, which requires administration by the physician and thus helps to ensure greater long-term compliance.” to capture such patient-reported outcomes, it can provide a really powerful competitive advantage for the brand team and give them more to talk about in their marketing outreach,” Morel adds. Hormone dosage drops Drug makers are constantly looking for ways to improve and innovate their oral contraceptives. For instance, many newer formulations often aim to deliver lower dosages of hormones and more closely mimic a woman’s menstrual cycle, in order to reduce the incidence of common side effects or potential adverse events. “The implicit message with these lower-dose versions is ‘This is not your mother’s birth control pill, so you don’t have to worry about the traditional side effects profile you may have heard about,’” says Popli of Quintiles. While several progestin-only birth control pills are available, so-called combination pills dominate the market today. Combination pills include some form of estrogen and a progesterone or progestin (a synthetic hormone designed to mimic the action of progesterone), such as norethindrone, levonorgestrel, norgestrel, norehindrone acetate, ethynodiol diacetate, norgestimate, desogestrel, or drospirenone. The monthly cycle of pills typically involves 21 hormonally active pills followed by 7 placebo pills (to ease consistent daily pill taking). Today, the Yaz/Yasmin line of oral contraceptives from Bayer is the best-selling combination birth control pill in the US. In 2009, sales of Yaz reached $782 million, accounting for 23% of the top five products in the combined oral contraceptive category, according to IMS Health (Table). (Strong growth in demand for Ocella, the generic form of Yaz, appears to be siphoning sales away from Yaz; see below). The Ocella product from Barr Laboratories (Woodcliff Lake, NJ), a subsidiary of Teva Pharmaceuticals, is an authorized generic on the market since July 2008. Barr has also received FDA permission to manufacture Ocella itself, and that is expected to begin in 2011. Patient-reported outcomes “Because birth-control and HRT products are crowded classes, and consumer preference is so important, the ability to identify subtle findings via patient-reportedoutcomes studies, such as tolerability differences associated with competing therapies or beneficial side effects, can help brand teams to zero in on useful differentiators,” says Heather Morel, VP, Reimbursement and Access Services, for McKesson Specialty Care Solutions (Scottsdale, AZ). “Knowledge of subtle, subjective, Heather Morel, humanistic outMcKesson comes can help drug makers to better understand patients’ individual feelings about the product and its impact on their health and their overall quality of life.” “When patient-reported outcomes are able to verify, say, one oral contraceptive’s ability to address mood or irritability issues or treat acne, such insights can be very useful to help drug companies to sharpen or finetune their messaging, so we expect to see such companies increasingly carrying out these kinds of patient outcome studies,” adds James Kirk, VP of the Market Intelligence & Analytics Consulting Group of Quintiles (Boston). If the company can expand the label indication Among the marketing tactics used to catapult Yaz to its position as market leader was aggressive advertising that touts the drug’s ability to address acne and the symptoms of pre-menstrual dysphoric disorder (PMDD, a rare and severe condition of menstruationrelated depression, anxiety and irritability). All oral contraceptives have the potential to reduce acne and reduce hormone-related mood swings, but only Bayer pursued these indications as part of its FDA labeling. Once these indications were approved by FDA, Bayer marketed them heavily — too heavily, according to FDA, which claimed the company was overstating the benefits and capabilities of Yaz by implying, for instance, that Yaz could treat pre-menstrual syndrome (PMS) when it was only approved to treat the much more rare condition of PMDD, and downplaying the product’s risks. As part of a crackdown on deceptive drug advertising, FDA and the attorneys general of 27 states required Bayer to run a $20-million ad campaign, which began in February 2009, to set the record straight. The company must also submit future Yaz ads for pre-launch screening by FDA for the next six years. The new television spots do not mince words: “You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads.” When it comes to Yaz and Yasmin, Bayer’s troubles go beyond issues related to deceptive advertising. Over the past several years, the company has also been busy fighting an estimated 300 lawsuits in which plaintiffs have claimed a variety of serious side effects, including heart attacks, strokes, deep vein thrombosis, pulmonary embolism, gallbladder disease or sudden death related to the product. The suits claim that the risks associated with Yaz are related to drospirenone, which is a newer type of progestin that is unique to Yaz, its predecessor Yasmin and its generic form Ocella. Drospirenone is thought to create excessive potassium buildup in some users. Seasonale from Barr Laboratories’ Duramed Pharmaceuticals (and newer versions, Seasonique, which boasts less breakwww.PharmaceuticalCommerce.com http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - April 2010

Pharmaceutical Commerce - April 2010
Contents
Editorial
Op-Ed
Top News
Business & Finance
BrandMarketing | Communications
Supply Chain | Logistics
Information Technology
Packaging & Drug Delivery
Legal | Regulatory
Executive Training & Development
Editorial Index & Meetings

Pharmaceutical Commerce - April 2010

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