FDA advisory committee votes in favor of GSK’s Votrient
PHILADELPHIA — A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.
GSK announced that the FDA Oncologic Drugs Advisory Committee voted 11-2 that clinical trial data indicated a favorable risk-benefit profile of the drug Votrient (pazopanib) in patients with advanced soft-tissue sarcoma who have received chemotherapy. The drug is already approved for treating the kidney cancer renal cell carcinoma.
"Treatment options for patients with advanced soft-tissue sarcoma are limited," GSK Oncology SVP Rafael Amado said. "We are therefore pleased that the committee took a favorable view of the clinical data for Votrient."
The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug but usually follows them.
Study examines long-term efficacy of dapagliflozin use in Type 2 diabetes management
NEW YORK — An investigational Type 2 diabetes drug may improve glycemic control among patients that are unable to improve their blood sugar with high doses of insulin alone, according to a new study.
Published in the Annals of Internal Medicine, researchers led by John Wilding of University Hospital Aintree in Liverpool, England, found that when Type 2 diabetes patients added dapagliflozin — a selective inhibitor of sodium-glucose cotransporter 2 — in either 5-mg or 10-mg strengths to their daily medication regimen, the patients saw a reduction in their hemoglobin A1C levels and weight at 24 weeks, compared with those who added placebo. These results were maintained by the 48th week of the study; however, patients in the pooled dapagliflozin groups had a higher rate of hypoglycemic episodes (56.6% versus 51.8%), events suggesting genital infection (9% versus 2.5%) and events suggesting urinary tract infection (9.7% versus 5.1%). A total of 800 patients were analyzed in the study.
The researchers added that the study "was not designed to evaluate long-term safety."
The primary funding sources for the study were drug makers AstraZeneca and Bristol-Myers Squibb, which filed for regulatory approval for dapagliflozin with the Food and Drug Administration. In January, the agency declined to approve the drug.
Legislation introduced to standardize, improve PBM Medicare audits
WASHINGTON — Industry-supported legislation designed to improve pharmacy benefits manager standards under the Medicare prescription drug program — standards that will further provide fair audits of and payments to pharmacies — was presented before the House of Representatives on Tuesday.
The Medicare Pharmacy Transparency and Fair Auditing Act, introduced by Rep. Cathy McMorris Rodgers, R-Wash., after 2013 would preclude prescription drug plan sponsors from contracting with a PBM unless they submit to a series of pharmacy audit requirements. For example, the period covered by the audit would not exceed two years from the date a claim was submitted to, or adjusted by, the pharmacy benefits manager; the PBM would not apply recordkeeping requirements that are more stringent than those required by federal or state law; and PBMs would not be able to disallow or reduce payments with respect to a claim submitted by the pharmacy because of clerical or recordkeeping errors.
The legislation also would give local pharmacists some basic insight into a part D plan’s “maximum allowable cost” or MAC. "Currently, independent pharmacies must evaluate ‘take-it-or-leave-it’ contract offers from part D plans or pharmacy benefit managers that leave pharmacists in the dark as to how reimbursement caps, or MACs, are determined for many common generic medications," the National Community Pharmacists Association noted in a statement released in support of the legislation. "As a result, independent pharmacies are increasingly — and without warning — reimbursed at rates that fluctuate and fail to cover either the pharmacy’s cost of dispensing or its cost of acquiring that particular drug."
An August 2011 survey of 1,850 community pharmacists conducted by NCPA illustrated the need for the reforms embodied by H.R. 4215, the association said. "[As much as] 62% of pharmacists considered the audit requirements to be completely inconsistent from one health plan to another; 48% of pharmacists reported auditors asking them to justify claims that are two years old or older; and, of the pharmacists who report having appealed a PBM audit, 81% described that process as burdensome and unsatisfactory."
Nearly all (91%) community pharmacists reported receiving little or no information justifying how PBMs arrive at reimbursement rates for generic drugs and how often the prices will be updated to reflect a pharmacy’s cost.
The bill, H.R. 4215, was referred to both the House Committee on Energy and Commerce and to the House Committee on Ways and Means.