FDA: Certain TNF blockers could be linked to rare cancer
SILVER SPRING, Md. — The Food and Drug Administration has received reports of a rare and usually deadly cancer in patients using a class of biotech drugs to treat autoimmune and inflammatory diseases, the agency said Thursday.
The FDA warned that some patients taking tumor necrosis factor blockers had developed hepatosplenic T-cell lymphoma, or HSTCL, a fast-spreading cancer of the white blood cells. Most of the cases were in adolescents and young adults using TNF blockers to treat Crohn’s disease and ulcerative colitis, but cases of patients treating psoriasis and rheumatoid arthritis had emerged as well.
TNF blockers include Remicade (infliximab) and Simponi (golimumab), both made by Johnson & Johnson, Abbott’s Humira (adalimumab), UCB’s Cimzia (certolizumab pegol), and Enbrel (etanercept), made by Amgen and Pfizer. The agency said some cases also had emerged in patients taking azathioprine and mercaptopurine, immune-suppressant pharmaceutical drugs available as generics, alone and in combination with the TNF blockers. However, the agency also said that patients with the diseases those drugs treat are at higher risk of developing lymphoma than the general population.
Over the years, the FDA has received a number of reports of patients developing cancers or deadly viral infections like progressive multifocal leukoencephalopathy after taking immune-suppressant drugs for autoimmune and inflammatory disorders, though such cases are rare enough that the FDA generally has recommended that the drugs stay on the market.
CVS Caremark to implement new management service for PBM, specialty pharmacy clients
WOONSOCKET, R.I. — CVS Caremark has unveiled a new medical benefit drug management service for its pharmacy benefit manager and specialty pharmacy clients.
According to the company, the offering is the first of its kind to provide a comprehensive management solution for the buy-and-bill drug model currently used by physicians — whereby the physician purchases specialty medications, administers them to the patient and directly bills the payer. The payer-centric offering will employ both prospective and retrospective drug utilization management strategies to drugs billed under the medical benefit, while ensuring minimal disruption to the physician’s workflow and facilitating the delivery of evidence-based care.
CVS Caremark stated that it will work with New Century Health, a specialty care management company, to offer its clients integrated evidence-based medicine, treatment care pathways, quality improvement programs and peer-to-peer review through an innovative Web-based decision support platform.
This offering broadly will be available to CVS Caremark customers for implementation beginning Jan. 1, 2012.
Management of specialty drugs under the medical benefit poses a significant challenge to health plans and employers today. In fact, more than 50% of specialty drugs are billed under the medical benefit, many of which are administered in a physician’s office. Payers are less able to identify and apply effective clinical and cost-management strategies, similar to those applied to specialty drugs billed under the pharmacy benefit, because of current medical claims, processing limitations and limited visibility to its clinical applications, according to CVS Caremark.
Through analysis of CVS Caremark data, the company found that among its PBM clients, cancer and associated supportive care specialty drugs — such as hematopoietics for anemia and neutropenia — accounted for approximately 53% of the total specialty drug spend billed to the medical benefit. As a result, CVS Caremark’s new offering initially will focus on improving the quality, safety and management of oncology drugs billed under the medical benefit. Estimated savings of up to 15% of a payer’s oncology spend are expected.
"This offering will enable CVS Caremark to identify the unrecognized specialty pharmacy spend currently billed through the medical benefit for oncology patients," stated Per Lofberg, president of CVS Caremark’s PBM business. "By systematically tracking and analyzing this activity, we can provide our clients with an opportunity to better manage these expensive drugs while also improving the quality of care for their members."
CVS Caremark’s report highlights lowest drug trend in six years
WOONSOCKET, R.I. — Despite a difficult economy and rising health costs, the benefits of an integrated pharmacy service were evident as CVS Caremark helped its pharmacy benefit manager clients — employers, health plans and third-party administrators — manage pharmacy costs, according to the company’s annual "Insights Report."
CVS Caremark’s annual Insights Report reviews drug trends and highlights key areas to watch in pharmacy care. In 2010, the average drug trend for the company’s PBM client segments was 2.4%, the lowest trend in six years. The company’s 2010 drug trend was held in check by the increasing use of generics — as more of these less-expensive medications became available, more physicians prescribed them and more members were willing to use generics, according the CVS Caremark. The company’s generic dispensing rate was 71.5%.
Other trend drivers included continued growth in the utilization of complex specialty pharmaceuticals, as well as an increase in utilization of prescription drugs overall. CVS Caremark anticipated these trends will continue this year and, when coupled with the growing impact of chronic disease, sees a need to integrate and coordinate pharmacy care in a centralized location — a pharmacy home — to help members coordinate and simplify their medication management.
"Last year was one of uncertainty and change for our clients as they worked to understand the impact of healthcare reform while also dealing with a sluggish economic recovery," stated Per Lofberg, president of CVS Caremark’s PBM business. "One of our priorities is to help our clients navigate healthcare reform and determine how best to implement necessary changes. Even with this added layer of complexity, we helped our clients manage costs and maintain quality care for their members."
In addition to the 2.4% overall trend, the more notable 2011 Insights findings are:
Nonspecialty trend — the cost increase for prescriptions excluding expensive biologic pharmaceuticals — was 0.8%, driven by the increased use of generics;
Specialty pharmaceuticals continued to be the fastest-growing area of spending in medications, increasing 13.7% from the year before; and
About one-quarter of CVS Caremark’s clients experienced a reduction in medication costs year-over-year, or a negative trend; one-third of the clients experienced a trend of less than 2.5%.
"The continuing increase in the use of expensive specialty drugs, as well as the growing prevalence of chronic disease, calls for innovative healthcare solutions, such as an integrated pharmacy home to help patients deal with complex therapy regimens and [to help them] stay adherent," added Troyen Brennan, EVP and chief medical officer for CVS Caremark. "Developing a pharmacy home was one of the recommendations raised by our recent research conducted with Harvard Medical School and Brigham & Women’s Hospital. That work and this report make it clear we must devise better ways to serve the chronically ill. This trend report shows we are making headway in that fight."
According to CVS Caremark, its programs that maximize the benefits of the integrated enterprise already have been embraced by its PBM clients and their members. For example, Maintenance Choice provides members with two options for receiving 90-day supplies of maintenance medications for chronic conditions, either by using a convenient mail-order pharmacy or by maintaining their face-to-face connection with their local CVS pharmacist, while paying less out-of-pocket for their medications. In addition, the recently launched Pharmacy Advisor program enables members with diabetes to build a relationship with their mail-order pharmacist or local CVS pharmacist, providing information and support that closes gaps in care, can reduce costs and promotes mediation adherence.