ReportersNotebook — Chain Pharmacy, 3/14/11
SUPPLIER NEWS — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment. The drug maker said the FDA approved its 150-mg doxycycline monohydrate capsules, a drug used to treat bacterial infections and a generic version of Adoxa, made by Nycomed subsidiary PharmaDerm. The 150-mg strength of Adoxa had sales of about $25 million during the 12 months ended in December 2010, according to Wolters Kluwer.
Mylan announced the launch, through subsidiary Mylan Pharmaceuticals, of voriconazole tablets in the 50-mg and 200-mg strengths. The drug is a triazole antifungal agent. The tablets are a generic version of Pfizer’s Vfend, which had sales of $186 million in 2010, according to IMS Health. Mylan launched its version of the drug under a settlement with Pfizer. As the first company to file for FDA approval, Mylan is entitled to 180 days of market exclusivity in which to compete with Pfizer’s product.
Teva Pharmaceutical Industries has launched a generic drug for treating symptoms of menopause. The company announced the availability of Jinteli (norethindrone acetate and ethinyl estradiol) tablets. The drug is a generic version of Warner Chilcott’s FemHRT and is available in the 1-mg/5-mcg strength.
The FDA announced the approval of Corifact, used to prevent bleeding in people with the rare genetic disorder congenital Factor XIII deficiency, which affects one in 3 million to 5 million people in the United States. The drug is manufactured by Marburg, Germany-based CSL Behring.
Amicus Therapeutics announced results of a 23-patient phase-2 extension study of the investigational drug Amigal (migalastat hydrochloride), designed to improve kidney function in patients with the genetic enzyme disorder Fabry disease. The study — an extension of the original, three- to six-month, 26-patient phase-2 study — used two criteria to measure kidney function: protein in the urine during a 24-hour period and a commonly used measure called estimated glomerular filtration rate, or eGFR. Amicus said preliminary data indicated that eGFR was stable after three to four years of treatment with Amigal, while protein levels in the urine also were reduced.
MTM can save lives; retailers, suppliers take notice
WHAT IT MEANS AND WHY IT’S IMPORTANT — Walgreens’ winning of an award for its MTM services came right before it joined the Care Continuum Alliance — a group of more than 200 stakeholders that provide such services as wellness and prevention programs and management of chronic conditions — of which CVS Caremark already was a member.
(THE NEWS: Walgreens takes top honors for MTM services. For the full story, click here)
On top of that, the National Community Pharmacists Association and National Association of Chain Drug Stores have expressed support for a bill going through Congress that would allow any Medicare Part D beneficiary with a chronic condition to qualify for MTM services.
One trend taking place amid all of this: the rapid development of mobile health technologies, as evidenced by the number of companies that showed up at the Consumer Electronics Show in Las Vegas in January. A patient with diabetes, for example, can perform a glucose test and then upload the results to a health information service, such as Google Health or Microsoft HealthVault. Then a pharmacist can review the information to help ensure that the patient is adhering to prescribed treatments.
MTM can save lives and money by making sure that patients take their drugs properly and on time, and the combination of increased access to MTM services and development of technologies that can help streamline those services will help drive further adoption of them in the future.
Good and bad news from CDC’s U.S. diabetes stats
Alarming statistics are as common in the healthcare world as healthcare workers themselves, but some of the latest numbers from the Centers for Disease Control and Prevention are particularly dramatic: Nearly 26 million Americans have diabetes, the agency said in late January, and an estimated 79 million U.S. adults — representing more than one-third of all adults in the country — have prediabetes.
“We’ve seen that diabetes has been on the rise for quite a while, but the new data from the CDC is a real wake-up call,” American Diabetes Association president for medicine and science Robert Henry said.
But one reason for the 2011 number’s substantial increase over the 23.6 million Americans estimated to have diabetes in 2008 is encouraging: In addition to more people developing diabetes, many people with the disease are living longer thanks to better management of the disease. Also, use of the hemoglobin A1C test, which measures blood-glucose levels over a two- to three-month period, has increased.
Many health providers have been doing their part to address the epidemic. Last month, the Pharmacy Benefit Management Institute awarded CVS Caremark and its pharmacy benefit management client, ArcelorMittal, with the 2011 Rx Benefit Innovation Award in recognition for its Pharmacy Advisor program, which uses CVS Caremark’s PBM and retail segments to improve medication adherence and to close care gaps for members with diabetes.
Suppliers have been getting in on the game also — in some cases, literally. Last month, French drug maker Sanofi-Aventis formed a partnership with the National Basketball Association and the American Diabetes Association to launch the “Dribble to Stop Diabetes” awareness campaign. The campaign, which includes public service announcements and educational materials, was launched on Feb. 18 at the NBA All-Star 2011 game in Los Angeles with assists from Dwight Howard of the Orlando Magic, Alana Beard of the WNBA team the Washington Mystics and NBA veterans Walt Frazier and Chris Dudley.
One trend whose effects on diabetes remain unclear is healthcare reform, even though it will increase access to care for millions of diabetics. “If there is a clearly defined episode of care, an emphasis on diagnosis, education and management of the disease early, and a flexible treatment algorithm that permits patients and physicians to customize regimens and keep patients at or below their target goals, then healthcare reform will be a great step in battling the diabetes epidemic,” IMS Health principal Brian Lasky told Drug Store News.
“However, if healthcare reform is only about controlling cost, using the lowest-cost therapies and processes in order to offset the increase of patient volume, … I have concerns that there is the potential that innovation in the research and management of the disease will be stifled. … Healthcare reform could wind up costing patients more than just dollars,” Lasky added.