PHARMACY

Walgreens, VA partner to improve care coordination

BY DSN STAFF

Walgreens and the Dept. of Veterans Affairs are working together to improve coordination of care for VA-enrolled patients. Through the partnership, which the agency and retailer announced Friday, VA providers will be able to see the entire medication and immunization history of the VA-enrolled patient if they receive prescriptions and immunizations at Walgreens.

“This arrangement is the first of its kind, and it’s a strong collaboration,” said VA Sec. Robert Wilkie. “Partnerships like this will help VA continue to improve the way we care for Veterans.”

The VA-Walgreens exchange eliminates the need for providers to gather medication history from patients who fill their scripts at Walgreens, the agency said. The collaboration is the latest partnership for Walgreens and the VA, who have teamed up for the past five years to provide no-cost flu shots to enrolled veterans.

The VA said it currently exchanges health information with more than 170 community healthcare partners, including 8,649 — more than 8,000 of which are Walgreens pharmacies — as well as 537 federally qualified health centers, 261 nursing homes, 1,288 hospitals and more than 22,341 clinics.

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Regeneron gets FDA nod for updated Eylea label

BY Sandra Levy

Regeneron Pharmaceuticals has received the green light from the Food and Drug Administration for a supplemental Biologics License Application for Eylea (aflibercept) injection in patients with wet age-related macular degeneration, or wet AMD.

The sBLA was based on second-year data from the Phase 3 View 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule — doses given at least every 12 weeks, and additional doses as needed. These data are now included in the updated Eylea label, according to the company.

“We are pleased that the FDA has approved an updated label for Eylea,” Regeneron president and chief scientific officer George Yancopoulos said in a press statement. “Providing information to retinal physicians about the visual outcomes with a modified 12-week dosing schedule will help physicians make the most informed choices in treating patients suffering from wet age-related macular degeneration.”

Eylea also is approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.

The product is a vascular endothelial growth factor inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor, two growth factors involved in angiogenesis.

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FDA OKs third Lenvima indication

BY Sandra Levy

Eisai and Merck have received the Food and Drug Administration’s blessing for its kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma, or HCC.

Lenvima was first approved in February 2015 for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. In May 2016, the drug was approved in combination with everolimus for patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy.

This new approval was based on results from REFLECT (Study 304), where Lenvima demonstrated a proven treatment effect on overall survival  by statistical confirmation of non-inferiority, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival and objective response rate when compared with sorafenib in patients with previously untreated unresectable HCC.

“Unresectable hepatocellular carcinoma is an extremely difficult-to-treat cancer, with no new first-line systemic therapy options for more than a decade,” Memorial Sloan Kettering Cancer Center medical oncologist Ghassan Abou-Alfa said in a press statement. “Reflect is the first-ever positive Phase 3 trial against an active comparator in unresectable HCC. The efficacy and safety data from Reflect are important findings for oncologists and others in the multidisciplinary teams who treat liver cancer, as well as for our patients who are affected by it.”

“Eisai strives to be a leading global R&D-based pharmaceutical company, driven by our human healthcare mission to improve the lives of patients and their loved ones,” said Shaji Procida, Eisai president, chief operating officer and commercial head of the oncology business group of the Americas, in a press statement. “That purpose is what has propelled us toward this win for patients with unresectable hepatocellular carcinoma. Our goal is to bring monumental solutions to patients and healthcare providers, changing expectations for the oncology landscape, and we look forward to continuing this work in our ongoing collaboration with Merck.”

“We are pleased by the FDA approval of Lenvima as it marks an important advancement in the treatment of unresectable hepatocellular carcinoma,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer at Merck Research Laboratories, in a statement. “With our shared mission to find solutions for difficult-to-treat cancers, we look forward to working with Eisai to help bring this needed option to patients and physicians.”

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