PHARMACY

NACDS calls for expansion of MTM, pharmacy reimbursement system reform

BY Alaric DeArment

ALEXANDRIA, Va. An organization representing the country’s chain retail pharmacies is urging Congress to support pharmacy in its efforts to reform the healthcare system.

The National Association of Chain Drug Stores sent a letter to congressional leaders Monday calling for expansion of medication therapy management and the reform of the pharmacy reimbursement system for generic drugs.

The letter – addressed to Senate majority and minority leaders Harry Reid, D-Nev., and Mitch McConnel, R-Ky., and their House counterparts, Nancy Pelosi, D-Calif., and John Boehner, R-Ohio, and signed by NACDS president and CEO Steven Anderson – calls for reforms of the average manufacturer price payment metric for generic drugs. The organization noted that the Deficit Reduction Act of 2005 made “significant” cuts to Medicaid payments by authorizing AMP, expected to reduce payments to pharmacies by $8 billion over the next five years.

“We believe health reform legislation presents an important opportunity to address these systemic problems by expanding access to MTM services provided by community pharmacists throughout the healthcare system,” the letter read.

Other recommendations included provision of suitable reimbursement for MTM services and building on recent Medicare Part D MTM changes, such as a menu of MTM offerings recommended by the Centers for Medicare and Medicaid Services.

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Pfizer presents investigational cancer drug results at conference

BY Alaric DeArment

ORLANDO Data from a phase 2 study of an investigational lung cancer drug identify patients who may benefit from treatment with the drug, according to abstracts presented at a cancer conference.

Drug maker Pfizer presented three abstracts of a study on figitumumab (CP-751,871) at the 45th annual meeting of the American Society of Clinical Oncology in Orlando, Fla. The study showed a response rate of more than 60% in a single-arm extension cohort of 56 patients conducted to confirm preliminary findings from a 156-patient phase 2 study evaluating overall response with figitumumab when combined with carboplatin and paclitaxel in patients with non-small cell lung cancer.

“As we try to find the right drug to use in the right setting for each patient, we are encouraged by these data, suggesting a relationship between tumor histology and response to figitumumab,” Pfizer Oncology Business Unit SVP clinical development and medical affairs Mace Rothenberg said in a statement. “Given that patients with advanced NSCLC face a poor prognosis, it is important to be able to identify specific patients who may benefit most from different treatment options.”

The company recently started a phase 3 trial of the drug, an anti-insulin growth factor type 1 receptor antibody.

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FDA accepts NDA for epilepsy treatment

BY Allison Cerra

MARLBOROUGH, Mass. Sepracor announced Monday that the Food and Drug Administration has accepted the new drug application for its epilepsy treatment.

Stedesa (eslicarbazepine acetate) has been accepted for filing and is now under formal review. The NDA was submitted Mar. 31 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. Meanwhile, the Prescription Drug User Fee Act date for Stedesa is expected to be Jan. 30, 2010, subject to written confirmation, the drug maker said.

Sepracor is seeking approval of Stedesa  for adjunctive therapy with once-daily doses of 800 mg and 1200 mg in the treatment of partial-onset seizures in adults with epilepsy.

“We are very pleased to continue the advancement of Stedesa as a potential new adjunctive treatment for partial-onset epilepsy,” said Adrian Adams, president and CEO Sepracor. “Stedesa represents a significant and near-term opportunity for Sepracor, and the FDA acceptance of the NDA is yet another step forward in one of our near- and mid-term corporate objectives of expanding and advancing our pharmaceutical product pipeline.”

Stedesa, Sepracor said, was studied in three Phase III trials involving more than 1,000 patients in 23 countries. Sepracor acquired the rights to commercialize eslicarbazepine acetate in the U.S. and Canadian markets from BIAL, a privately-held Portuguese pharmaceutical company, in late 2007.

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