Reports: Court upholds Abilify patent
NEW YORK — A generic version of a schizophrenia drug made by Otsuka Holdings and Bristol-Myers Squibb can’t be launched until April 2015, according to published reports.
Bloomberg reported that the U.S. Court of Appeals for the Federal Circuit upheld the validity of patents covering Abilify (aripiprazole) in the two companies’ lawsuit against Teva Pharmaceutical Industries and Apotex.
According to IMS Health, Abilify was the fourth top-selling drug in the United States in 2011, with sales of $5.2 billion.
NCPA seeks legislative relief to the business challenges faced by community pharmacy
WASHINGTON — Community pharmacy operators are the "canary in the coal mine" when it comes to federal or state prescription programs, said Douglas Hoey, CEO for the National Community Pharmacists Association, during a press conference held Tuesday afternoon.
"[Independent pharmacies] serve a disproportionate share of Medicare and Medicaid patients," he said. And with 93% of community pharmacy revenue being derived from prescriptions versus the front-end, those pharmacists also share a greater sensitivity to any changes in prescription drug reimbursement. "[Consequently], any changes in federal or state programs disproportionately affect these small-business owners," Hoey added. The remarks were made in support of NCPA’s ongoing 2012 Legislative and Government Affairs Conference, which began on Monday and will continue through Wednesday.
Also on the call was Rep. Cathy McMorris-Rodgers, R-Wash., who talked briefly regarding two of her pieces of legislation currently before committees: H.R. 1971, the Pharmacy Competition and Consumer Choice Act; and H.R. 4125, the Medicare Pharmacy Transparency and Fair Audit Act.
And NCPA provided an update on its joint suit opposing the Express Scripts-Medco merger.
An annual cost of more than $290 billion is associated with the mismanagement of prescription remedies, Hoey said, and independent pharmacy owners play a significant role in helping to mitigate that cost — the more than 23,000 independent pharmacies dispense approximately 40% of all retail prescriptions, he said.
"[As many as] 80% of the reasons people go back to the hospital is they no longer manage their medicines properly," McMorris-Rodgers noted in support of community pharmacy’s role in helping to reduce overall healthcare costs. For the current congressional session, McMorris-Rodgers has sponsored two bills in the House that would help community pharmacies remain in place to do that common good by redefining the relationship between pharmacy benefit managers and the independent pharmacist. "There’s a lot of interest in the [H.R. 1971] legislation," she said. "Members are just waiting for the final score" before throwing their support behind the bill, she added.
Presently the bill is before the House of Representatives’ Subcommittee on Health, Employment, Labor and Pensions where it is undergoing a cost analysis to determine its potential impact on government health programs.
McMorris-Rodgers also introduced a similar piece of legislation that is more cost-neutral, H.R. 4125, that would help codify PBM audit practices and help provide transparency around generic pricing.
Community pharmacies face significant challenges from PBMs, Hoey said, such as contending with PBM-mandated restrictions on where certain prescriptions can be filled, contending with PBM-funneled prescriptions being redirected into in-house mandatory mail centers in exclusion of retail pharmacy, contending with PBM-negotiated take-it-or-leave-it prescription-reimbursement contracts and contending with PBM-fueled abusive auditing practices that go well beyond identifying potential fraud and waste practices.
The suit challenging the Express Scripts-Medco merger that NCPA filed in conjunction with the National Association of Chain Drug Stores and nine Pennsylvania-based pharmacy operations is currently in a holding pattern, noted Jennifer Mallon, NCPA VP and general counsel. A district court judge presided over a hearing on April 10 and ruled against NCPA et al.’s motion that Express Scripts and Medco continue to operate as separate entities until the case had been ruled upon. The next step will be a ruling on a motion filed by Express Scripts to dismiss the case, which has yet to happen, Mallon said.
That Express Scripts-Medco merger generated the most opposition letters from Congress members — around 80 — ever, said John Coster, NCPA SVP government affairs.
Coster noted that another piece of legislation supported by NCPA members is the Preserving Our Hometown Independent Pharmacies Act (H.R. 1946), which allows community pharmacies to join together to negotiate contracts with PBMs.
NACDS expresses to FDA cautious optimism on the ‘new paradigm’ for third class of drugs
ALEXANDRIA, Va. — The National Association of Chain Drug Stores submitted on Monday comments to the Food and Drug Administration regarding its position on the “new paradigm” for a third class of drugs.
The comments were submitted to the FDA in conjunction with the agency’s hearing titled, “Using Innovative Technologies and Other Conditions of Safe Use to Expand Which Drug Products Can Be Considered Nonprescription.”
In its comments, NACDS emphasized the value of community pharmacies as high-quality and accessible health-and-wellness centers. NACDS also emphasized the importance of current and future collaboration among healthcare professionals for the ultimate benefit of patient care and to reduce healthcare costs.
“In recent years retail community pharmacies have played an increasingly important role in providing patient care,” NACDS said in its comments. “Activities, such as the increased number of health screenings provided by pharmacists help educate patients and give them a better understanding of their health status and potential needs. Pharmacists also provide vital patient care through their participating in collaborative practice agreements and their expanding role in providing immunizations. Pharmacists are uniquely positioned and qualified to take on these expanded roles.”
NACDS noted that arrangements already exist in 34 states that allow pharmacists to engage in collaborative practice agreements with physicians. Such written agreements foster collaboration between a pharmacist or pharmacy and a physician or group of physicians to manage patients’ drug therapy. Under this type of arrangement, pharmacists serve as physician extenders and help to monitor and carry out physicians’ drug therapy plans for their patients.
Overall, NACDS also cited cautious optimism regarding the creation of a “new paradigm,” and indicated that it is eager to work with FDA to prevent unintended consequences of a “new paradigm” of third class drugs.
“Structured properly, this new paradigm has the potential to increase access, improve patient compliance, and reduce healthcare costs. However, a flawed structure could result in a group of drugs with limited access, reduced compliance, and lacking in a clear compensation policy for pharmacies, despite the additional clinical and administrative responsibilities that it would impose,” NACDS said.
One of the most critical unintended consequences is the impact on consumers — and their wallets — regarding what may occur when prescription-only medications become over-the-counter medications and potentially may not be covered by insurance or other third-party payers, according to NACDS.
“Costs for some of their medications that were previously covered by their third party payer might no longer be covered if dispensed under this new paradigm and would therefore be an out of pocket cost to them. This may be viewed as a positive for decreasing costs to healthcare system, but if the patient no longer can afford the product and adherence decreases, the costs associated with poor outcomes and increased hospitalizations and emergency room visits could increase,” NACDS said.
NACDS also expressed the importance of clear guidance on what types of drugs would qualify for this new status, so as not to disrupt medication regimens for patients, as well as medication management counseling between pharmacists and patients for these regimens.
“Consistency and predictability are needed to train pharmacists and other pharmacy staff, determine formulary placement and reimbursement policy, and ensure uninterrupted availability for patients. Consequently, NACDS advocates that this new paradigm should be a permanent class for drugs that require special counseling, monitoring, screening, lab testing, or other clinical intervention,” NACDS said.
NACDS has stated that it will continue to work with the FDA to address these issues and challenges as to ensure that patients benefit from community pharmacy’s care and services to help improve their health and reduce healthcare costs across the board.