March 2008

Research Highlights: Cardiology, Oncology, Depression and
Medicare Part D


Data Download provides highlights of recently released data from GfK Market Measures’ Therapeutic Class Studies (TCS). Based on primary market research, TCS provide in-depth analysis of market trends, physician practice patterns and competitive brand positioning.

This month’s selections cover research from studies conducted in the areas of cardiology, renal cell carcinoma, depression and Medicare Part D.

Click on the headlines below to read these TCS findings:

Physicians Expect to Decrease First- and Second- Line Use of Vytorin in Wake of ENHANCE Trial Results, According to Study by GfK Market Measures

Summary: Research reveals negative effects of ENHANCE trial results on anticipated Vytorin prescribing among physicians, with general/family practitioners reporting most negative response
  Reacting to the release of the ENHANCE trial results that showed Vytorin, a combination of the statin simvastatin (Zocor) and ezetimibe (Zetia), provides no benefit over simvastatin alone in preventing the progress of arterial plaque buildup, physicians indicate they will shift Vytorin heavily to third-line, rather than first- or second- line use, in treating patients at risk for coronary heart disease, according to new research by GfK Market Measures.

While the research showed universal awareness of the ENHANCE results across all specialties—internists, general/family practitioners and cardiologists—general/family practitioners assert the most negative response to the trial findings. Respondents in this group anticipate nearly double the decline in first-line use of Vytorin (net change of -20 percent of patients), compared to those intended first-line prescribing figures reported by cardiologists (-9 percent of patients) and internists (-7 percent of patients). Use of Vytorin as second-line therapy is anticipated to decrease across all specialties, ranging from -8 percent to -14 percent of patients. Conversely, all specialties indicated an increase in third-line use of Vytorin, with a positive net change ranging from +20 percent to nearly +30 percent of patients.

As a further indication of general/family practitioners’ particularly negative response to ENHANCE, respondents from this group participating in GfK Market Measures’ 2008 Vytorin Market Event Study reported they will switch more than 40 percent of their patients currently on Vytorin or Zetia to other therapies over the next few months. In comparison, cardiologists and internists participating in the research study anticipate making the switch among a smaller portion of their patients (ranging from 25 percent to 30 percent).

"In light of the ENHANCE trial results’ impact, there is obviously an opportunity over the next several months for Lipitor and Crestor to capture additional market share,” said Anna Marie Napolitano, Vice President and Category Business Leader, Cardiovascular, GfK Market Measures. "On the other hand, for Vytorin and Zetia, our research shows a window of opportunity to mitigate the negative impact of the trial results. With physicians counseling patients to wait until their next visit to discuss alternative therapies, Merck and Schering are challenged to provide credible evidence of advantages to maintain existing patients on the drugs, particularly as the FDA’s review and report on the trial are not expected until later this year. As evidenced by this study, general/family practitioners will be critical targets for such efforts, as they show the strongest propensity to transition patients to other therapies.”

Reflecting insights from 150 physicians including general/family practitioners, internists and cardiologists, fielded via Internet questionnaire during January 2008, GfK Market Measures’ 2008 Vytorin Market Event Study provides insights into physicians’ reactions to the ENHANCE trial (examining the effects of the combination ezetimibe and high-dose simvastatin vs. simvastatin alone on the atherosclerotic process in patients with Heterozygous Familial Hypercholesterolemia) results, which were released on Jan. 14, 2008.

Contact: Anna Marie Napolitano, VP, Category Business Leader, Cardiovascular
anapolitano@gfkmm.com


 
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Newly Launched Targeted Therapies Have Significantly Impacted Treatment Algorithm for Advanced Renal Cell Carcinoma, According to Study by GfK Market Measures

Summary: Research reveals that Sutent and Nexavar have largely replaced cytokines, becoming the new standard of therapy for patients in advanced stages of disease
  The treatment paradigm for advanced renal cell carcinoma (RCC) has undergone a dramatic shift since the launch of new targeted therapies, with oral agents Sutent and Nexavar making notable gains to largely supplant cytokines Proleukin and interferon-alfa as the standard initial treatment, according to new research by GfK Market Measures.

"Sutent has quickly become the oral multikinase inhibitor of choice in first-line therapy, owing to its perceived survival advantage, whereas Nexavar tends to be used more often in second-line therapy,” said Bill Bowman, Vice President and Category Business Leader, Oncology, GfK Market Measures. "Even though Torisel, another new targeted therapy, is proven to increase survival when administered first-line in patients with metastatic disease who have a poor prognosis, it tends to be reserved for patients who fail treatment with Sutent and Nexavar.”

While the study shows a similar uptake of Sutent and Nexavar as standard initial treatments among different types of oncologists, the research uncovered some differences in selection of third-line therapies administered to patients with advanced RCC. Both medical/hematologist oncologists and urologic oncologists participating in the study reported that almost half of Stage IV RCC patients received Sutent as first-line therapy and more than one-third of Stage IV RCC patients received Nexavar as second-line therapy. However, for third-line therapy for patients with the advanced disease, medical/hematologist oncologists are more likely to administer Avastin (more than one-quarter of patients), perhaps owing to experience using this brand in other tumors, whereas urologic oncologists are more likely to increase Nexavar- and Sutent-based regimens (approximately one-fifth of patients, in both cases), suggesting they are more comfortable with these orally administered therapies.

These data points and others revealed through research from GfK Market Measures’ 2007 Medical Treatment of Advanced Renal Cell Carcinoma Study point to the significant impact newly launched targeted therapies have made on the treatment algorithm for advanced RCC. In particular, the findings underscore how the introduction of new oral agents has caused a dramatic shift in the migration of RCC disease management from office-based or off-site intravenous therapy to self-administered home therapy with oral agents, as almost two-thirds of medical/hematologist oncologists and half of urologic oncologists reported an increase over the previous year in the use of oral therapy to treat patients.

Reflecting insights from 150 medical/hematologist oncologists and urologic oncologists, fielded via Internet questionnaire October-December 2007, GfK Market Measures’ 2007 Medical Treatment of Advanced Renal Cell Carcinoma Study provides insights into how physicians classify patients with metastatic RCC, plus insight into awareness and perceptions of new regimens and new agents in development.

Contact: Bill Bowman, VP, Category Business Leader, Oncology
bbowman@gfkmm.com



 
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Prevalence of Co-Morbid Conditions Such as Insomnia and Cognitive Deficits Prevents Physicians’ Effective Treatment of Depression, According to Study by GfK Market Measures

Summary: Multiple symptoms and co-morbid conditions in depression patients represent opportunity for drug manufacturers to improve patient compliance and persistence through education
  Physicians report insomnia/sleep problems and low energy/fatigue to be some of the most common – and yet most difficult to treat – symptoms of depression patients. While primary care physicians (PCPs) are more likely to report the add-on use of sleep medications to help manage these symptoms, psychiatrists tend to rely instead on the sedating qualities of certain antidepressants, according to new research by GfK Market Measures.

The diagnosis and treatment of depression is confounded by multiple underlying, contributing factors, with insomnia in particular known to be an exacerbating factor in preventing physicians’ effective treatment of depression. A recent study from GfK Market Measures reinforces this notion, as both psychiatrists and PCPs participating in the research reported a large portion of their patients with depression experience insomnia/sleep problems (47 percent of psychiatrists’ patients and 36 percent of PCPs’ patients) and low energy/fatigue (39 percent of both psychiatrists’ and PCPs’ patients). The prescribing of an add-on therapy to treat these and other co-morbid conditions experienced with depression is common with both specialists, though more frequently executed by psychiatrists (37 percent of patients) than PCPs (24 percent of patients). PCPs opt more often than psychiatrists to use sleep medications to treat these symptoms (41 percent of PCPs’ patients compared with 27 percent of psychiatrists’ patients).

“This research signals an opportunity for manufacturers to encourage PCPs, in particular, to screen for co-morbid conditions and exacerbating symptoms and consider them when selecting add-on therapies. Appropriate therapies can sustain the use of an antidepressant that, while effectively treating the core symptoms of depression, may be perceived by physician and patient as ineffective, given the suboptimal management of these other factors,” said Geoff Penney, Vice President and Category Business Leader, Psychiatry, GfK Market Measures. “By acknowledging these other factors, antidepressant manufacturers can help educate physicians and patients to support a holistic treatment approach that creates better compliance and persistence for the patient and better outcomes for their brand.”

In addition to the prevalence of insomnia and its impact on the effective treatment of depression, the focus on cognitive deficits in patients with depression has recently taken on greater prominence, driven by several medications in development for the management of cognitive deficits in schizophrenia. Prompted by industry data showing a higher prevalence of depression among attention deficit disorder patients, GfK Market Measures began to explore the issue of cognitive deficits as a depression co-morbidity in last year’s research.

“There are several dimensions to cognitive deficits which researchers are now beginning to understand in the context of psychiatric disorder treatment,” said Mr. Penney. “Our research has shown that symptoms such as motivation and task completion and difficulty with focus and concentration are relatively common co-morbidities (31 percent and 29 percent of physicians’ patients, respectively). Furthermore, about 20 percent of physicians participating in this study reported motivation and task completion to be among the most difficult aspects of depression to treat effectively.”

Reflecting insights from 260 physicians including general/family practitioners, internists and psychiatrists, fielded via Internet questionnaire in December 2007, GfK Market Measures’ 2008 Treatment of Depression Physician Study provides a comprehensive analysis of the depression market from the perspective of treating physicians.

Contact: Geoff Penney, VP, Category Business Leader, Psychiatry
gpenney@gfkmm.com



 
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Two Years After Medicare Part D’s Launch, Physicians, Pharmacists and MCOs Still Adjusting to Environment, Counseling Seniors Along the Way, According to Study by GfK Market Measures

Summary: Research reveals confusion around Part D persists as physicians, pharmacists spend more time resolving patient issues; need for support is heightened by heavy prescription switching because of formulary coverage
  Almost two years after the launch of Medicare Part D, key stakeholders express strong agreement that the plan’s benefits remain confusing for seniors, with physicians and office managers reporting a marked increase in time spent daily to counsel and resolve patients’ Part D-related issues, according to new research by GfK Market Measures.

In an average week, more than one-quarter of Part D patients/families/ guardians raise issues regarding prescription coverage, most often about co-pay and prior authorization. Time required to resolve these issues, search for alternative medications for patients experiencing cost issues and counsel patients on product-related features continues to increase for physicians and their office staff, and remains steady for pharmacists. GfK Market Measures’ 2007 study, Outlook 360: Impact of Medicare Part D, shows physicians are now spending on average more than one hour (77 minutes) each day on Medicare Part D-related counseling, assisting and resolution issues (compared to 69 minutes in 2006). Office managers spend an average of almost two hours (110 minutes) each day on these issues. Pharmacists spend the most time with patients on Part D matters although their time allocation has declined somewhat versus a year ago, largely because issues that were challenging early on, have now become routine and require less time. Currently, pharmacists spend almost three hours (170 minutes) each day (compared to 190 minutes in 2006).

A key reason that significant time is needed to support patients’ issues is the noteworthy boost in switching to generics and alternative agents in the second year of Part D. About 20 percent of Part D prescriptions were changed to alternative agents in 2007 because of formulary coverage, compared to only 10 percent in 2006. And because under Part D physicians now allow more direct generic substitutions (e.g., fewer dispense as written mandates), the research showed that more than 33 percent of patients are now switched from a brand-name agent to a different generic agent.

Despite the portrayal of a confused environment as evidenced by the increasing time stakeholders report they act as "Medicare Part D counselors,” nearly all managed care organization (MCO) decision makers plan to maintain their current approach to Part D program management in the coming year, according to GfK Market Measures’ research. Specific to formulary and drug utilization management, plan sponsors typically maintain similar approaches across both Part D and commercial books of business. Firewalls between the groups remain weak, as very few MCOs follow the strictest interpretation of "separate” decision making. Most plans (67 percent) use the same Pharmacy & Therapeutics (P&T) Committee for both benefits, with the addition of a few key members for Part D, and simply decide on Part D formularies in a separate vote. Despite similarity in overall management, in some cases MCOs have increased their levels of control on the Part D benefit for 2008, implementing tools such as prior authorization and step therapy.

One area that is changing is MCOs’ reaction to the coverage gap issue (the "doughnut hole”). Plan sponsors have become far more proactive in alerting members to their coverage gap status. Just over half of participating MCOs developed a benefit to provide coverage through the doughnut hole in 2007, and more are planned for 2008. Many of these benefits focus on coverage of generics through the gap. Respondents also said they had increased communication with Part D members on this issue, including distributing alerts through monthly explanation-of-benefits letters.

Fielded via Internet questionnaire and in-depth interviews through September 2007, GfK Market Measures’ Outlook 360: Impact of Medicare Part D research program provides an individual as well as integrated perspective of the Medicare Part D environment. The physician module provides insights from 414 physicians and 197 office managers. The pharmacist module represents responses from 300 community and 40 long-term care pharmacists. The MCO module reveals insights from 25 pharmacy directors and medical directors at MCOs that are Part D plan sponsors. These respondents are P&T committee members and thus are involved in formulary decision making for Part D.

Contact: Sue Ramspacher, Senior VP, Managed Care Research
sramspacher@gfkmm.com



 
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