PHARMACY

Study shows effectiveness of HPV vaccine candidate

BY Drew Buono

TAMPA, Fla. A new study of 776 women has shown that GlaxoSmithKline’s cervical cancer vaccine candidate, Cervarix, provides significant protection for women for almost seven years against the four most common cancers causing human papillomavirus types. The types of the virus included in the study were types 16, 18, 31 and 45, which account for about 80 percent of cervical cancers globally.

Virus types 18 and 45 are responsible for a significant percentage of a particularly aggressive and deadly form of cervical cancer, known as adenocarcinoma. This type of cervical cancer tends to occur in younger women and is not well detected by routine screening methods.

For virus types 16 and 18, nearly 100 percent of the women, who were aged 15 to 25, maintained high level of both antibodies for six and a half years. For virus type 45, the vaccine showed 78 percent effectiveness over the course of the study. Virus type 31 was the weakest of the four viruses, showing a 60 percent efficacy in preventing infection.

“We specifically designed our cervical cancer vaccine with the goal of providing long-lasting protection from cervical cancer,” said James Tursi, director of medical affairs in North America for GlaxoSmithKline. “These study results are important because women remain at risk for infection with cancer-causing virus types throughout their lives, and long-term protection will be an essential component of a successful vaccination strategy.”

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Pharmacy organizations in California request CMS examination of Medi-Cal cuts

BY Adam Kraemer

SACRAMENTO, Calif. The National Association of Chain Drug Stores, the California Pharmacists Association and the California Retail Association called on federal regulators Friday to carefully examine a state plan amendment for a 10 percent “across-the-board” cut to Medi-Cal reimbursements.

In a joint letter to the administrator of the Centers for Medicare and Medicaid Services, Kerry Weems, the groups highlighted potential consequences of the reduction, which was enacted last month.

“We urge that CMS ensure that DHCS and the Medi-Cal program have performed their statutorily required due diligence under the Medicaid statute in evaluating the impact of each component provider reduction on beneficiary access. If they have not done so, we urge that the SPA be rejected,” the groups stated.

“Maintaining pharmacy access is important not only to Medi-Cal beneficiaries’ health and safety, but also to the Medicaid program’s overall ability to constrain costs at the ‘macro’ level,” they noted, citing studies that have found reduced access to prescriptions can result in increased emergency room visits and prolonged hospital stays, which are more costly forms of healthcare.

Pharmacies fill over 22 million prescriptions for Medi-Cal patients every year, and NACDS, CPhA, and the CRA represent approximately 5,000 pharmacies operating in California.

“Many California providers—and particularly pharmacy providers—have experienced repeated reductions in Medi-Cal reimbursement over the last few years,” the groups wrote. “[It] it is crucial that any additional cuts be performed in a measured and rational manner that takes beneficiary access levels into consideration. We trust that if the supportive documentation submitted by the state with the proposed SPA fails to meet the federal statutory standard, CMS will reject that submission and insist that the federal standard be met through a provider-by-provider evaluation of beneficiary access levels.”

The full text of the letter is available here.

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Merck inks deal to commercialize future Marcadia products

BY Drew Buono

INDIANAPOLIS Marcadia Biotech and Merck have signed a deal under which Merck will help the company test and commercialize its products.

Under the terms of the agreement, Merck will pay Marcadia an initial upfront fee, as well as payments for exclusivity and ongoing research. Marcadia will also be eligible to receive future milestone and royalty payments associated with research, development and commercialization of certain new drugs. Financial terms were not disclosed.

Marcadia does not have any products on the market yet. It is developing a synthetic hormone that will be supplied in an injector pen, making it ready for quick use in emergency treatment of hypoglycemia.

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