 |
|
|
|
|
 |
|
 |
 |
Summary: Research reveals oncologists will largely use new agents as second-line therapy in high-risk CLL patients |
 |
|
 |
|
|
| |
Chronic Lymphocytic Leukemia (CLL) is the second-most treated hematologic disorder, with more than 95,000 people living with disease. The National Cancer Institute estimates that in 2008, more than 15,000 people will be diagnosed with CLL and nearly 4,500 will die from the disease. Fortunately, in the past year a number of new therapies, including Campath, Oral Fludara, Revlimid and Treanda, emerged on the treatment landscape and oncologists are eager to incorporate them into existing regimens, particularly as second-line therapy in high-risk patients, according to new research by GfK Market Measures.
In terms of treatment, 80 percent of low-risk CLL patients (Stage 0) tend to be monitored in a watch-and-wait mode. For those low-risk patients who progress after this conservative initial treatment, use of biologic-containing regimens is especially prevalent, with approximately 40 percent of patients in Stage 0 receiving such treatments. Conversely, intermediate-risk (Stage I-II) and especially high-risk (Stage III-IV) CLL patients more typically receive immediate systemic therapy. For nearly 60 percent of these high-risk patients, initial therapy consists of a combination regimen containing fludarabine and Rituxan. High-risk patients who progress on a fludarabine-Rituxan combination are managed with a variety of treatment options, including Campath, which is used by more than 25 percent of these patients. Notably, Campath use continues to be reserved for relapsed/refractory CLL, in spite of the fact it recently received an indication for first-line therapy.
GfK Market Measures’ 2008 Chronic Lymphocytic Leukemia Study revealed that overall, oncologists appear eager to incorporate newly emerging agents into treatment for CLL, but are most likely to use the new agents as second-line therapy in high-risk patients. Nearly 25 percent of oncologists are highly likely to use new agents that target CD-20, such as HuMax/ofatumumab. However, oncologists will most often turn to this agent after patients are first treated with Rituxan.
Other new agents that oncologists are likely to incorporate include Revlimid (expected increase in prescribing of 38 percent) and Treanda, which was approved in March for first-line treatment of CLL. Notably, study respondents perceive the regimen FCR (Fuldara/Cytoxan/Rituxan), which has an expected increase in prescribing of 16 percent, as offering a superior overall survival advantage versus virtually all other queried regimens.
The research revealed that oncologists are impatient for new therapeutic options and tend not to wait for reports of successful use from their peers to try new agents. FDA approval is the single most critical factor cited for trial of a new therapy, reported by more than 40 percent of oncologists. Further, about 20 percent of oncologists begin using the new agent after reports of successful use from peers, and a third segment of oncologists, representing 20 percent of respondents, execute use immediately upon availability of published clinical data supporting the new drug.
“It's clear that many oncologists are eager to adopt new therapies in the treatment of CLL, which will – at least initially – be predominately used as second-line therapy in high risk patients,” said Ruth Smith, Associate Vice President, Oncology Research, GfK Market Measures. “Yet despite the availability of these new therapies and a number of existing therapies such as Rituxan and Fludara that have proven successful, oncologists cite continued unmet needs for agents that improve overall survival, and prove efficacious in treating relapsed/refractory disease and transformed CLL. These voids in the market are obvious opportunities for manufacturers.”
| Reflecting insights from 151 hematologists/oncologists, fielded via Internet questionnaire in February 2008, GfK Market Measures’ 2008 Chronic Lymphocytic Leukemia (CLL) Study provides analysis and insights into the CLL market from the perspective of treating oncologists. |
Contact: Ruth Smith, Associate Vice President
rusmith@gfkmm.com
|
|
|
|
|
|
|
|
|
|
|
|
Summary: Research reveals hurdles for antibiotics competing with “preferred-in-class” agents and those subject to restrictions; needs persists for antimicrobial-resistant agents |
|
|
|
|
|
| |
Hospitals attempt to make as many antibiotic options available as possible and accordingly, formulary coverage for injectable antibiotics in the hospital is fairly generous. With a wide variety of brands currently reimbursed with or without restrictions, the hospital formulary presents an opportunity for manufacturers in this critical market, but needs remain for lower-resistant antibiotic agents, according to new research by GfK Market Measures.
The study revealed that hospitals frequently contract for one “preferred” agent in a given class of injectable antibiotics, which automatically replaces any other agent ordered in that class. Hospitals’ hard and fast rules also extend to those drugs not on formulary, as in the majority of cases “non-formulary” agents are simply not stocked. Accordingly, competing with a “preferred-in-class” injectable antibiotic as well as non-formulary placement presents the greatest risks for manufacturers of antibiotics agents in the hospital setting. Where formulary restrictions do exist, they typically encompass requiring consultation by an infectious disease specialist. However, when that occurs, approval to use the requested antibiotic happens 75 percent of the time. Antibiotics subject to restrictions are at a disadvantage; once a drug is subject to restrictions, the likelihood for removing the restriction is low.
Regarding decision making for formularly placemement, overall safety, high clinical cure rates and efficacy for indicated conditions emerge as the three top-rated attributes, according to respondents who rate these three attributes above 6.0 on a 7-point importance scale. Following closely in the ratings of top attributes for formularly decision making are the benefits of either preventing or addressing antimicrobial resistance. Notably, teaching hospitals and hospitals that are part of integrated health systems place a higher emphasis on resistance. In the future, the issue of resistance is expected to increase in importance as concerns around this topic persist.
“The increased prevalence of resistant pathogens in both the hospital and community setting and the overarching concerns about antimicrobial resistance have recently commanded notable media attention,” said Sue Ramspacher, Senior Vice President and Category Business Leader, Antibiotics, GfK Market Measures. “Once an issue primarily of concern to physicians in the hospital setting, it is now also distressing office-based doctors given the growing incidence of community-acquired MRSA. Both groups are looking for ‘not promoting resistance’ solutions and significant opportunities exist for manufacturers in this underserved market. New agents that can demonstrate lack of or lower resistance will be in a favorable position and, since efficacy and safety represent costs of market entry, new antibiotic agents must demonstrate clear clinical differentiation. Otherwise, formulary status will serve as a primary driver to product selection, especially in classes with generic availability.”
Additional findings from GfK Market Measures’ 2008 Reimbursement of Injectable Antibiotics in the Hospital Study indicate that the frequency of reviewing antibiotic formularies tends to be influenced by hospital size and type. Larger institutions conduct reviews more frequently than their smaller counterparts and are more likely to reevaluate the category formulary when new products are launched and new indications approved. Differences are also noted between teaching and non-teaching institutions. Regardless of size or type of hospital, formularies are reassessed when safety, in the form of black box warnings and product withdrawals, is an issue. Seventy percent of respondents indicated these events “always” lead to reassessment of the category; this compares to only 32 percent who always reassess upon the introduction of a new category entrant.
| Reflecting insights from 77 hospital Pharmacy and Therapeutics (P&T) committee members, including physicians and pharmacists, and fielded via Internet questionnaire in February 2008, GfK Market Measures’ 2008 Reimbursement of Injectable Antibiotics in the Hospital Study provides an in-depth understanding of injectable antibiotics in the hospital setting. |
Contact: Sue Ramspacher, Senior Vice President
sramspacher@gfkmm.com
|
|
|
Research Highlights: Oncology and Antibiotics
