Actavis seeks approval for generic opioid-dependence drug
DUBLIN — Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug’s manufacturer.
The generic drug maker said it had filed a regulatory approval application with the Food and Drug Administration for buprenorphine hydrochloride and naloxone hydrochloride sublingual film in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The drug is a generic version of Reckitt Benckiser’s Suboxone.
In response to the filing, Reckitt Benckiser Pharmaceuticals, a subsidiary, and MonoSol Rx filed suit against Actavis last week in the U.S. District Court for the District of Delaware, seeking to prevent Actavis from commercializing its product before the expiration of certain patents on Suboxone. According to FDA records, the patents covering Suboxone will expire in 2023 and 2030. Under the Hatch-Waxman Act of 1984, the lawsuit places a stay of final FDA approval on Actavis’ product for 30 months, or until a settlement is reached.
Suboxone had sales of about $1.2 billion during the 12-month period that ended in August, according to IMS Health.
CVS/pharmacy’s new system to help patients compare Medicare Part D plans
WOONSOCKET, R.I. — CVS/pharmacy is offering its senior patients a new way to compare Medicare Part D prescription drug plans during the annual enrollment period from Oct. 15 to Dec. 7, the pharmacy retailer has announced.
All CVS/pharmacy locations nationwide will be able to create and print a Medicare Part D plan comparison in minutes for patients based on the current prescriptions they fill at CVS. In addition, patients who wish to conduct their plan comparison online or on the phone will receive their own personal code from CVS/pharmacy that they can enter at cvs.com/medicare or by calling CVS. Once entered, the personal code will automatically insert patients’ current prescriptions to provide a personalized plan comparison in minutes.
Annual enrollment is the one time a year that most Medicare beneficiaries can review their current prescription coverage and enroll in a new plan for 2014 if they choose. Because Medicare Part D plans change every year and people’s prescription needs may also change, comparing Part D plans could save patients hundreds of dollars, the retailer stated.
"CVS/pharmacy’s new plan comparison system provides patients with convenient ways to learn how much money they could save by choosing a new Medicare Part D plan based on their own prescription usage," stated Papatya Tankut, VP pharmacy affairs at CVS/pharmacy. "While pharmacists cannot recommend any specific Medicare Part D plan, we can help patients understand their options based on their individual needs."
Information from a selection of Medicare Part D plans in the local area will be available at Health Insurance Information Centers in all 7,500 CVS/pharmacy locations. In addition to Medicare Part D information, the display also features information about local health plans participating in the insurance marketplace under the Patient Protection and Affordable Care Act.
CVS/pharmacy’s dedicated Medicare website also provides resources and information for Medicare beneficiaries, including access to the Medicare Plan Finder, tips on when to consider choosing a new plan and how to lower prescription costs and information to help Medicare Part B patients save money.
"CVS/pharmacy provides several ways to help Medicare Part B beneficiaries save money, too. For example, we accept all Medicare coverage for diabetes testing supplies, flu shots are available at all of our pharmacies at no cost to Part B patients, and we offer a wide range of durable medical equipment covered by Medicare Part B online at CVS.com," Tankut said. "By combining this with our resources for Medicare Part D beneficiaries, CVS/pharmacy is a comprehensive destination to help Medicare patients on their path to better health."
NCPA: Buzz around future of community pharmacy not dampened by government shutdown
ORLANDO, Fla. — The National Community Pharmacists Association Tuesday morning spelled out its public policy agenda — including the push to get H.R. 3204, The Drug Quality and Security Act, enacted — and expressed optimism for the future of community pharmacy during a media briefing held in conjunction with NCPA’s 115th Annual Convention and Trade Exposition here.
But first the government needs to resume operations. "There’s been a lot of discussion … among the business owners that are members of NCPA with respect to the inability of Congress to act on both funding the government and also the larger threat of defaulting on our nation’s debt," commented Steve Pfister, NCPA SVP government affairs. "This is impacting everyone on Main Street and there is a high level of frustration among NCPA members on the inability of Congress to get their fiscal house in order."
NCPA’s top legislation priority regards the compounding bill that’s coupled with the track and trace legislation to strengthen the drug supply chain network. "NCPA has been working for months … to come up with a workable [solution]." However, due to the government shutdown, everything is currently on hold. "We are expecting that when the government reopens and the Senate resumes business, that the Senate will move expeditiously for consideration of The Drug Quality and Security Act."
The government furlough, aside, however, community pharmacists are excited about a future with outcomes-based medicine practices. "We had a great meeting; we had close to 3,000 attendees," reported NCPA CEO Douglas Hoey. "There is a real buzz in the air, a real excitement, for where pharmacy practice is going, especially with the way that integrated healthcare models [are forming with] pharmacists taking on a more responsible role for delivering that healthcare."
Independent pharmacists are looking to the number of opportunities opening to them, such as medication adherence initiatives.
According to the 2013 NCPA Digest, sponsored by Cardinal Health released Tuesday, independent community pharmacies are increasingly focused on helping patients stick to their medication and saving money through the appropriate use of lower-cost generic drugs. “Independent community pharmacists are playing a larger role than ever in improving health and cutting costs through the promotion of medication adherence and proper use of generic drugs,” Hoey said. “The Digest reinforces the value and diverse nature of the care provided by trusted, community pharmacists. Small business community pharmacy owners and pharmacists look forward to continuing to work to help policymakers and health plan sponsors enhance patient outcomes and reduce expenses.”
According to the NCPA Digest, community pharmacists are tackling the medication adherence issue head-on. Roughly half (48%) of all independent community pharmacies offer patients adherence counseling services, a notable increase from the 39% in the previous survey. The number of community pharmacies providing adherence phone call or text reminders nearly doubled, surging to 39% from 22%.
In addition, community pharmacists reached a new record high frequency in generic drug utilization, dispensing them 77% of the time. Community pharmacists routinely consult with physicians about proper prescription drug therapy, and pharmacists’ recommendations for generic drug use are accepted 83% of the time.
The number of total independent community pharmacies is estimated to be 23,029, slightly below the 23,106 of the previous year. Prescription sales volume decreased slightly, led by declining refill rates, possibly due to mandatory mail order pharmacy requirements or other limitations imposed on patient choice, NCPA surmised.
For the first time, a majority share of the prescription transactions at independent community pharmacies came from two programs: Medicare (33% of prescriptions) and Medicaid (18%). Independent community pharmacies continue to be a lifeline for underserved areas, particularly rural ones, as 53% of these pharmacies are located in areas populated by 20,000 people or less.