FDA approves Bristol’s cancer drug
SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.
The FDA approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for patients with melanoma that has spread to other parts of the body, also known as metastasis. More than 68,000 new cases of melanoma were diagnosed in the United States in 2010, and about 8,700 died from it, according to the National Cancer Institute, part of the National Institutes of Health.
“Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life,” FDA Office of Oncology Drug Products director Richard Pazdur said. “Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment.”
The news comes after the company reported that the drug boosted survival rates among patients in a late-stage clinical trial.
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Court: Watson’s generic Fentora infringes on branded counterpart
MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals infringes a patent covering the branded version, a U.S. District Court ruled.
Watson said Friday that the U.S. District Court for the District of Delaware decided that Watson’s generic version of Cephalon’s Fentora (fentanyl) buccal tablets infringes U.S. Patent No. 6,264,981, though the Food and Drug Administration had approved Watson’s version of the drug.
Cephalon sued Watson over the generic version of Fentora in 2008, though the Delaware court ruled that Watson’s version of the drug did not infringe U.S. Patent Nos. 6,200,604 and 6,974,590, and that those two patents are invalid.
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DAW Rxs drive up healthcare costs, study finds
WOONSOCKET, R.I. — "Dispense-as-written" prescriptions are exacerbating medication nonadherence and costing the U.S. healthcare system billions of dollars, according to a new study by researchers at Harvard University, Brigham and Women’s Hospital, and CVS Caremark.
According to the study, published this week in the American Journal of Medicine, researchers found that DAW designations for prescriptions — a practice whereby doctors or patients demand the dispensing of a specific brand-name drug and not a generic alternative — costs the healthcare system up to $7.7 billion annually.
The study estimates that patients would have saved $1.7 million and health plans would have spent $10.6 million less for the medications if effective generic alternatives had been provided in place of brand-specific medications. Assuming a similar rate of DAW requests for the more than 3.6 billion prescriptions filled in the United States annually, patient costs could be reduced by $1.2 billion, and overall health system costs could be reduced by $7.7 billion.
Researchers also found that when starting new essential therapy, particularly among chronically ill patients with DAW prescriptions, patients were 50% to 60% less likely to actually fill the more expensive brand-name prescriptions than generics.
"Previous to this study, little was know about the frequency with which doctors and patients request dispense-as-written prescriptions," stated Troyen Brennan, EVP and chief medical officer of CVS Caremark and a study author. "Those who advocate for dispense-as-written and argue that the practice provides patients and physicians with greater choice will probably be surprised to learn that the practice increases costs and exacerbates nonadherence."
The study reviewed 5.6 million prescriptions adjudicated by CVS Caremark for 2 million patients from Jan. 1 to 31, 2009. The review found that 2.7% of those prescriptions were designated DAW by doctors, while another 2% were requested DAW by patients.
Good story, particularly bringing out the impact on compliance. DAW occurs more frequently than plan sponsors think and creates an unnecessary impediment to higher generic fill rates, which creates higher costs for the plan sponsor and member.