Patients with ulcerative colitis respond to Simponi, study finds
SAN DIEGO — Findings from a new study indicate that more than half of the patients with ulcerative colitis who received subcutaneous injections of a drug used to treat autoimmune disorders responded to the treatment.
Johnson & Johnson subsidiary Janssen Research and Development announced results of a phase-3 trial of Simponi (golimumab) in ulcerative colitis patients whose condition had previously failed to improve with or who were intolerant to conventional drugs.
In one treatment group, patients received 200 mg of the drug subcutaneously at week zero and 100 mg at week two, while in another they received 400 mg at week zero and 200 mg at week two. A third group received placebo. Results indicated that 51.8% of patients in the first group responded to treatment after six weeks, compared with 55% in the second group and 29.7% in the placebo group.
"Therapeutic options for patients living with moderate to severe forms of ulcerative colitis who have failed or become intolerant to conventional treatments are quite limited today, which is particularly challenging in managing a disease that primarily affects a younger, active patient population," study investigator and University of California San Diego School of Medicine professor William Sandborn said.
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NCPA addresses adverse consequences regarding latest FUL guidance
ARLINGTON, Va. — The National Community Pharmacists Association on Monday drafted a letter to the Center for Medicaid and CHIP Services regarding the latest federal upper limit guidelines that the association characterizes as "getting worse with regard to the negative economic impact [to community pharmacies], not better."
"As we have communicated to you with all the lists that have been released, the implementation of these lists will be economically devastating for independent community pharmacies," the letter opens. "That means that patient care will suffer if access to pharmacy services is decreased because pharmacies have to close or shorten their hours."
According to NCPA’s evaluation, the total number of products with a FUL increased from 935 to 959 between January and February, while the percentage of products with a FUL below a small independent community pharmacy’s actual acquisition cost increased from 40% to 40.6% of all products. For those products with a FUL above AAC, the average gain increased from 41 cents per product to 42.6 cents per product, but the average loss for products with a FUL below AAC increased from 30 cents to 31.4 cents per product.
The average loss per product has increased steadily between July 2011 and February 2012, NCPA stated. "The loss of these revenues would be devastating for independent pharmacies that disproportionately rely on Medicaid revenues and serve Medicaid patients. Moreover, in analyzing the FULs of some of the top Medicaid multiple-source drugs, it is clear that there continues to be rampant volatility in the FULs from month to month, and significant losses to pharmacies on some popular products," the association noted.
NCPA recommends to the agency that a final regulation be issued "so all parties know how to calculate [the average manufacturer price], collect several months of data to calculate draft FULs based on the final regulation and then determine whether such volatility remains in the calculations after all players know the ‘rules of the road.’"
For a PDF of the letter, click here.
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Physician-authored JAMA article highlights importance of retail clinics, drug store medicine
NEW YORK — An article recently published in the Journal of the American Medical Association shed a highly positive light on the convenient care industry, and outlined significant ways in which retail-based clinics are playing an important role in today’s U.S. healthcare system by improving access, cost and coordination of care for patients.
In looking at access to care — which is exacerbated by the shortage of primary care physicians — and cost of care, the article, written by Christine K. Cassel, M.D., with the American Board of Internal Medicine in Philadelphia, stated that retail-based health clinics provide a solution as they can provide patients with timely, convenient and cost-effective access to care.
The article also pointed to a third significant challenge facing the U.S. healthcare system today: coordination of care, especially for those patients with multiple chronic conditions. “Lack of coordination is thought to cost the healthcare system billions of dollars. To date, this has not been a major area of expertise or availability of retail clinics but, as they consider a role in chronic care, it is coming into focus. Indeed, chronic care plans are an increasingly important priority for retail health clinics,” the article stated.
“With good communication between multiple specialists, convenient access in evenings and on weekends, and familiarity with local community resources, the retail clinic potentially could be an important component of coordination of care aimed at reducing disease exacerbations, unnecessary hospitalizations and adverse drug interactions," the article continued. "If this vision were realized, the retail clinic phenomenon could be transformative for a vast number of patients in the United States.”
Furthermore, the article highlighted the importance of other healthcare professionals — including nurse practitioners and pharmacists — as part of an “effective team of care.”
“The retail clinic is a site where first-line roles for advanced practice nurses and pharmacists have already been shown to be effective in managing acute uncomplicated conditions. Pharmacists’ skills are underutilized if they are limited to their role in filling prescriptions — the so-called behind-the-counter functions. In effective teamwork approaches to chronic illness, exemplified by many models of geriatric care, the pharmacist is an active part of the healthcare team — in both the inpatient and outpatient settings. In a retail clinic with a pharmacy, clinical expertise is expanded by access to the pharmacist and the pharmacy database available in that setting. This same team, with active physician involvement, could provide the nidus for better management of more complex chronic illnesses,” the article stated.
In looking at the future role of the retail clinic, the article stated, “There are challenges, but this is happening already. The question is whether this phenomenon will grow and flourish in the ways described here or whether 20th-century attitudes about physician and hospital dominance in health care will prevent market-based solutions to the healthcare access and cost crisis. This model is a challenge to medical and hospital leadership, as well as to leaders in the retail health clinic industry, as they pursue the potential opportunities and benefits for the American people.”
To read the entire article click here.
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May 31, 2012 Dear Editor: In her May 23 article, “Physician-authored JAMA article highlights importance of retail clinics, drug store medicine,” Antonionette Alexander highlights a recently published article that shares a vision for retail health clinics that completely outstrips the capability of these clinics as they are currently configured. The vision shared by JAMA author Christine Cassel, MD, fails to recognize the many shortcomings of retail health clinics, as well as the many patient-centered, convenient services provided by the majority of today’s primary care physicians. Patients prefer to receive care from primary care physicians, but the main reason they elect to use retail health clinics is they believe that their personal physician is unavailable, and they would be forced to wait.1 Today, however, nearly 75 percent of family physicians have same-day scheduling and nearly half offer extended hours. Effective “first-line” primary care is characterized by its comprehensive (not acute, episodic) nature and seamless continuity of care for patients. Retail health clinics, at this time, cannot effectively provide either of these fundamental elements in a true sense. Retail health clinics can reduce costs for patients at the episode of care2, but there is no substantial evidence that this immediate savings positively impact longer-term costs to patients and to the entire system. Due to the limited scope of practice, we are concerned that many retail health clinics refer patients unnecessarily to expensive subspecialists for care that can effectively, and more inexpensively, be delivered in primary care practices. Furthermore, the example of an elderly patient with multiple chronic-conditions that Cassel provides is precisely the type of high-risk, complex patient that needs comprehensive and continuous care the most! At this time, retail health clinics are not capable of meeting these intricate care coordination needs. Patients with chronic illnesses who utilize retail clinics often end up seeing other providers in order to manage their conditions at rates higher than those who seek care from primary care practices.3 The retail health business model is an over-the-counter medication aimed at temporarily treating one symptom of an ailing health care system. Retail health clinics cannot replace a trusted personal physician who is familiar with a patient’s medical and family history, provides and coordinates care over a spectrum of conditions with other health care professionals, and can perform much more sophisticated testing, diagnosis, treatment and procedures when appropriate. America must continue its efforts to build a true primary care foundation for our health care system and not accept the false hope that retail health clinics can fill this critical role. Sincerely, Glen R. Stream, MD, MBI President, American Academy of Family Physicians 1 Arif Ahmed, BDS, PhD, MSPH and Jack E. Fincham, PhD. Physician Office vs Retail Clinic: Patient Preferences in Care Seeking for Minor Illnesses. Annals of Family Medicine 8.2 (2010): 117-123. 2 Ateev Mehrotra, MD, et al. Comparing Costs and Quality of Care at Retail Clinics With That of Other Medical Settings for 3 Common Illnesses. Annals of Internal Medicine 151.5 (2009): 321-328. 3 Amy R. Wilson, PhD, et al. Retail Clinic Versus Office Setting: Do Patients Choose Appropriate Providers? The American Journal of Managed Care 16.10 (2010): 753-759.
Physicians need to realize that it takes a team to coordinate care for a complex chronic disease state. Amazing to me that many of them still think they are jacks of all trades. Good that the AMA starts to rethink the approach of care.
Congratulations to Dr. Cassel for her insights and to the AMA for publishing a thoughtful and objective article on this increasingly important port of entry to medical care. Five years ago, the AMA House of Delegates passed a vote criticizing retail clinics in general-- and CVS, Walgreens and Walmart in particular, for owning or hosting such clinics. While publication of Dr. Cassel's article does not imply a change of position or endorsement of her insights, it is nevertheless encouraging that it now appears in JAMA. Ron Hammerle Chairman Health Resources, Ltd. Tampa, Florida