Alcon launches Ilevro
NEW YORK — Eye care company Alcon has launched a treatment for pain and inflammation resulting from cataract surgery, the company said Monday.
The company said Ilevro (nepafenac) ophthalmic suspension was a nonsteroidal anti-inflammatory drug and once-daily treatment for cataract surgery patients.
"We are committed to developing products that continue to improve patient care," Alcon VP and general manager for U.S. pharmaceuticals Gary Menichini said. "This launch represents the dedication of the [research and development] team to engineer and efficacious, innovative formulation with a reduced dosing regimen."
GSK submits approval application for albiglutide
LONDON — Drug maker GlaxoSmithKline is seeking Food and Drug Administration approval for a new treatment for Type 2 diabetes, the drug maker said.
GSK announced the submission to the FDA of a regulatory approval application for albiglutide. The drug is not approved in any market yet, and the company plans to also seek approval in the European Union this year.
GSK assumed control of albiglutide with its $3.6 billion acquisition of Human Genome Sciences, announced last July.
NCPA monitoring new state health insurance exchanges
This will be a big year for implementation of the Patient Protection and Affordable Care Act, and the National Community Pharmacists Association will track the process closely on behalf of NCPA members and the patients they serve. NCPA recently submitted comments about the ACA’s Multi-State Plans, or MSPs, being designed by the Office of Personnel Management.
These MSPs will be offered in every state health insurance exchange and are a subset of the Qualified Health Plans that also will be offered in the exchanges. Specifically, NCPA’s comments called for “restating the PBM reporting requirements” mandated for all exchange plans under the ACA, and implementing “the PBM transparency provisions” that OPM recently put into place for the Federal Employees Health Benefit plan, or FEHBP, for the MSPs in any final rule.
MSPs must comply with the transparency provisions in the ACA regarding retail and mail order pharmacies. Applying that standard universally going forward will help MSPs to both manage the prescription benefit portion of the plan and better calculate “PBM fees into medical/quality expenses versus administrative expenses for the purpose of compliance with the required medical loss ratio calculation.”
Estimates from the PBM transparency provision implemented in 2011 for FEHBP discovered that the drug benefit accounted for one-third of the costs of the entire program. As a result OPM “responded by requiring PBMs that serve the FEHBP to make certain necessary disclosures that go above and beyond those required under the ACA.” NCPA wants that “lessons learned” approach applied to MSPs.
NCPA’s comments also suggested that the minimum pharmacy access standards — like those under Tricare and Medicare Part D — should be required in MSPs, because independent pharmacies are accessible, patient-centered, and offer the safety net of healthcare providers in many communities that are otherwise underserved.
In addition, NCPA urges that OPM not equate mail-order pharmacy with access to the face-to-face interaction of a local pharmacy. In other words, the issue of “limited network capacity in hard-to-serve regions” should not be an excuse for further promotion or incentivizing of mail-order pharmacies, which don’t necessarily meet the needs of all patients. MSPs also should comply with any applicable state provisions such as “any willing provider,” PBM audit, or mandatory mail-order pharmacy laws as well. Finally, NCPA suggested, in the interests of improving health, that MSPs include an annual pharmacist-provided, medication therapy review when appropriate.
NCPA’s efforts have been successful so far in getting standards put in place that work for patients and plan sponsors of prescription drug benefits, along with attempting to level the playing field so that independent pharmacies can continue to compete in the marketplace. We will remain engaged as the process winds its way to completion this year.