PHARMACY

Pharmacy groups file lawsuit to preserve patient access to Rx meds in Washington

BY Allison Cerra

OLYMPIA, Wash. Three pharmaceutical organizations have banned together to file a lawsuit against Washington, challenging the state’s plan to cut Medicaid reimbursement for brand-name drugs.

The Washington State Pharmacy Association, National Association of Chain Drug Stores and National Community Pharmacists Association argue that the state is departing from federal rules by ignoring the negative impact that the reimbursement cuts will have on patient access to quality care.

The lawsuit maintains that the state failed to comply with the requirements of several state laws regarding the proper methods and standards for implementing Medicaid reimbursement cuts. It was filed in the U.S. District Court for the Western District of Washington against Gov. Christine Gregoire; Interim Secretary of Washington State Department of Social and Health Services Stan Marshburn; and the Washington State Department of Social and Health Services.

WSPA, NACDS and NCPA also filed a motion for a temporary restraining order, asking a federal court to halt the cuts, which are scheduled to begin April 1. A hearing on the TRO was scheduled for 1:30 p.m. PT Tuesday.

“In these times of economic struggle, [Washington state’s] rate-cutting tactic can hurt the state’s patients enormously,” says WSPA CEO Jeff Rochon. “Patients and taxpayers will bear the brunt of the fallout from this decision. We are deeply concerned for the health of our patients. In underserved rural and urban areas, patients’ health is compromised without immediate access to cost-effective, life-saving medicines, ultimately leading to expensive emergency room and doctor’s office visits. Not only can patients suffer, but the taxpayers pick up the extra costs. We are asking the courts to stop the cuts before people get hurt.”

As previously reported by Drug Store News, Washington’s plan is to cut Medicaid reimbursement for brand name drugs to average wholesale prices minus 20%. WSPA, NACDS, and NCPA estimate that the scheduled cuts could force 72 pharmacies serving more than 430,000 Washington patients to choose between losing money to provide medications and services to their patients on Medicaid, and closing their doors. These 72 pharmacies serve an estimated 6,000 patients each and fill more than 66,300 prescriptions annually.

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FDA approves fast-track designation for Hodgkin lymphoma treatment

BY Alaric DeArment

BOTHELL, Wash. An investigational drug for treating Hodgkin lymphoma has received fast-track designation from the Food and Drug Administration, the maker of the drug has announced.

Seattle Genetics, based in the Seattle suburb of Bothell, Wash., said it received the designation for SGN-35, for which it hopes to soon start a phase 2 study.

“Receiving fast-track designation is another important component of our regulatory strategy for SGN-35 and a key step for this program,” Seattle Genetics president and CEO Clay Siegall said. “With our pivotal trial underway, we expect data in 2011.”

That year, Siegall said, the company hopes to file for regulatory approval, possibly launching the drug in 2012. So far, the drug has received orphan drug designation in the United States and Europe for Hodgkin lymphoma and anaplastic large cell lymphoma.

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GSK submits study results for HPV, cervical cancer vaccination

BY Alaric DeArment

PHILADELPHIA British drug maker GlaxoSmithKline has submitted data from a phase 3 efficacy study on a vaccine for human papillomavirus and cervical cancer to the Food and Drug Administration, the company announced Monday.

The drug, Cervarix (human papillomavirus vaccine [Types 16, 18] recombinant, adjuvanted, adsorbed), is designed to prevent HPV types 16 and 18. The study, called HPV-008, enrolled more than 18,600 girls and women aged 15 to 25 from 14 countries in North America, Latin America, Europe and the Asia-Pacific region. Cervarix already has approval in more than 90 countries, including the member countries of the European Union, Mexico, Australia, Singapore and the Philippines.

“We are pleased to have reached this significant milestone for Cervarix,” GSK VP and director North American vaccine development Barbara Howe said in a statement. “The data submitted to the FDA reaffirm our confidence in the vaccine’s safety and efficacy profile.”

Merck & Co. already has FDA approval for its vaccine, Gardasil (human papillomavirus quadrivalent [Types 6, 11, 16, 18]).

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