FDA to review ulcer gel, HIV medications
WASHINGTON The Food and Drug Administration is conducting two safety reviews of the drugs Regranex gel, used for leg and foot ulcers and the HIV medications Ziagen and Videx.
Diabetic patients using Johnson & Johnson’s Regranex face an increased risk of cancer from using the gel.
Data analyses from another study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking GlaxoSmithKline’s Ziagen or Bristol-Myers Squibb’s Videx as part of their drug therapy.
FDA OKs Dendreon’s phase III Provenge trial
SEATTLE The Food and Drug Administration has agreed to allow Dendreon to get the final results from its phase III trial for its prostate cancer drug Provenge.
Last May, the FDA requested additional clinical data from Dendreon to support its effectiveness claim for Provenge despite a vote by the Cellular, Tissues and Gene Therapies Advisory Committee in favor of approving the drug. The committee voted 13 to 4 that the product was effective and 17 to 0 that it was safe.
That request led three congressmen: Reps. Mike Michaud, D-Maine, Dan Burton, R-Ind., and Tim Ryan, D-Ohio, to point accusations that conflicts of interest on the advisory committee might have led some of its members to send written requests to the FDA asking that the drug not be approved. One of the members of the committee is a lead investigator for a competing cancer drug made by Novacea.
According to the company, interim results from the IMPACT study of Provenge still are expected later this year, but final results are now expected in the second half of next year rather than the second half of 2010.
Avalere study shows Part D alleviates financial burden on those with diabetes
WASHINGTON According to a new study by Avalere Health, Medicare Part D has improved drug coverage and lessened the financial burden for many beneficiaries with Type 2 diabetes. The study also focused on drug utilization and the impact the “doughnut hole” coverage had on patients staying on their drug regimen.
Some of the results of the study were: most drugs used to treat diabetes and its two most common co-occurring conditions, hypertension and dyslipidemia, are widely covered by Part D health plans, at rates of 85 percent to 88 percent, and on tiers 1 and 2 of plan formularies, which are associated with the lowest co-payments. By comparison, previous Avalere analysis showed that Part D formularies included an average of 75 percent of antipsychotic drugs and 88 percent of antidepressants.
In terms of drug utilization and costs for the medications, out-of-pocket diabetes drug costs per prescription were 35 percent lower for stand-alone prescription drug plan enrollees and 25 percent lower for Medicare Advantage prescription drug plan enrollees, as compared with fellow Medicare beneficiaries who chose not to enroll in Part D. PDP enrollees were taking 11.2 percent more prescriptions and MA-PD enrollees 6.2 percent more prescriptions than before they had Part D coverage.
The study also showed that once beneficiaries hit the “doughnut hole” for coverage, there was no reduction in the number of prescriptions filled by the patient. The results are noteworthy considering that the scare of the “hole” was that once patients would have to pay out-of-pocket, they would cease taking their medications regularly, if not altogether.
“Knowing when people with diabetes may hit the coverage gap is important for physicians who can look for signs of non-compliance, and for individuals who can use this data for financial planning purposes,” said Valerie Barton, vice president of Avalere Health and co-author of the study. “The lack of change in the number of prescription drugs used invites more research on whether patients with Type 2 diabetes tend to enroll in Part D plans that offered gap coverage, the financial sensitivity of patients with chronic illness and generic switching patterns for patients in the coverage gap.”