AstraZeneca-Bristol drug just as effective as generic on market, trial results show
STOCKHOLM An investigational diabetes drug works as well as a generic already on the market, according to results of a late-stage clinical trial announced Friday by AstraZeneca and Bristol-Myers Squibb.
The two companies said phase-3 trial results showed that their investigational drug dapagliflozin combined with the widely available generic metformin was as effective as glipizide combined with metformin, compared with metformin alone. In addition, patients in the dapagliflozin group experienced weight loss, compared with weight gain in those taking glipizide, as well as a reduced number of patients experiencing abnormally low blood sugar, known as hypoglycemia.
Results from the study were presented at the 46th annual meeting of the European Association for the Study of Diabetes.
Bionovo receives CMC approval for Menerba
EMERYVILLE, Calif. The Food and Drug Administration has approved a manufacturing plan for a drug to treat hot flashes in menopausal women.
Bionovo said Thursday that the FDA had accepted its chemistry, manufacturing and controls plan for the drug Menerba. The decisions and agreements are considered binding on the company and the FDA.
“This CMC approval represents a revolutionary set of ‘firsts,’” Bionovo chairman and CEO Isaac Cohen said. “This is the first time that the FDA’s botanical drug development CMC guidance has been applied to an oral drug in a major indication.”
Efforts to combat Medicare fraud draw mixed signals from indies, PBMs
WASHINGTON The independent pharmacy and pharmacy benefit management industries both praised new efforts by Congress and the Obama administration to end the fraudulent and abusive billing practices that plague Medicare and Medicaid and cost U.S. taxpayers tens of billions of dollars. But their recommendations for combating the problem are as different as their approaches to the pharmaceutical market.
The Centers for Medicare & Medicaid Services proposed new regulations to help prevent what the agency said is $55 billion in annual improper payments to providers and health plans. In a related development, the House Energy and Commerce Subcommittee on Health is looking at ways to attack the problem, and held a hearing Thursday titled, “Cutting Fraud, Waste and Abuse in Medicare and Medicaid.”
The National Community Pharmacists Association weighed in with a statement to the House panel that accused the pharmacy benefit management industry of responsibility for much of the abuse, which the group attributed to a “past record of alleged systematic chicanery.”
In its statement, the independent pharmacy lobby reminded lawmakers of numerous allegations of fraud by major PBMs, as well as “misrepresentation to plans, patients and providers; improper therapeutic solutions; unjust enrichment through secret kickback schemes; and failure to meet ethical and safety standards.” The group urged Congress to pass legislation “to rein in the waste being generated by the business practices of pharmacy benefit managers under Medicare and Medicaid,” and to increase the transparency of PBM audit practices.
Not surprisingly, the response from the Pharmaceutical Care Management Association, the main PBM industry advocacy group, was markedly different. Responding to new proposed regulations from CMS to combat fraud and abuse, PCMA president and CEO Mark Merritt said the government’s focus should be on preventing abuse rather than on pursuing wrongdoers after the fact for fraudulent billing practices. “Pharmacy benefit managers agree that prevention, not ‘pay and chase,’ is the key to fighting fraud,” Merritt noted. “Unfortunately, some public policies undermine the fight against fraud by requiring payers to include pharmacies in their networks that have been banned from federal programs.”
Merritt also reiterated PCMA’s call for legislation to eliminate legislative “prompt-pay” requirements that force pharmacy benefit plans to quickly pay prescription claims, raising again a major source of friction between the PBM and retail pharmacy industries. Policies that require payers to “accelerate payments,” PCMA’s leader charged, leave “less time to detect and prevent fraudulent Medicare claims before payments are made.”