ReportersNotebook — Chain Pharmacy, 1/10/11
Supplier News — The Food and Drug Administration has approved a generic drug for hypertension made by Mylan. Mylan announced the approval of nifedipine extended-release tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Bayer’s Adalat CC. Nifedipine tablets had sales of around $82 million during the 12-month period ended June 2010, according to IMS Health.
U.S. generic drug maker Watson Pharmaceuticals and Indian drug maker Natco Pharma will work together to develop and commercialize a generic drug used for bone marrow disorders, the two companies said. The agreement concerns lenalidomide tablets in the 5-mg, 10-mg, 15-mg and 25-mg strengths. The drug is a generic version of Celgene’s Revlimid, used to treat the plasma cell cancer multiple myeloma and myelodysplastic syndrome.
T he FDA has approved Sagent Pharmaceuticals’ topotecan hydrochloride for injection, a generic version of GlaxoSmithKline’s chemotherapy drug Hycamtin, Sagent said. The U.S. market for injectable topotecan was around $158 million in 2010, according to IMS Health. Topotecan is used in patients who have recurrent small-cell lung cancer sensitive disease or cervical cancer.
An FDA advisory committee has recommended approval for an investigational diet pill. Orexigen Therapeutics and Takeda Pharmaceutical announced that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 that clinical trial data demonstrated that the benefits of the drug Contrave (naltrexone and bupropion) outweighed its risk and supported approval. The committee also voted 11-8 to recommend a study to examine Contrave’s effect on risk for cardiac disease.
In the past, the agency declined to approve such diet pills as Vivus’ Qnexa (phentermine and topiramate) and Arena Pharmaceuticals’ Lorquess (lorcaserin), while requesting that Abbott’s Meridia (sibutramine) be removed from the market due to safety concerns.
Johnson & Johnson made its courtship with Dutch biotech company Crucell official by acquiring all of the company for $2.3 billion, the two companies said.
J&J said it would maintain Crucell’s headquarters in Leiden, Netherlands, and keep it as the center for vaccines within J&J’s pharmaceuticals division. It also would keep the company’s senior management and “generally” keep its current staff intact.
Retail pharmacy can rest easy with unequivocal AMP victory
ALEXANDRIA, Va. — It’s a battle that raged for more than three years. But in mid-December, the retail pharmacy industry was able to declare a clear, unequivocal victory.
We’re talking, of course, about the struggle to head off what would have been a devastating change in the way Medicaid pays community pharmacies to dispense generic drugs to low-income patients. On Dec. 14, the chain and independent pharmacy lobbies announced they had reached a landmark agreement with the Centers for Medicare and Medicaid Services that effectively ends the threat.
In short, the National Association of Chain Drug Stores and the National Community Pharmacists Association refer to the proposed changes as AMP, which stands for average manufacturer price. CMS had proposed AMP as a new method for calculating the market price of generics as a new basis for establishing the federal upper limit of reimbursements to pharmacies for dispensing those generics to Medicaid patients.
CMS unveiled the new reimbursement guidelines as a way to cut Medicaid costs in line with the Deficit Reduction Act of 2006. But pharmacy leaders have long argued that it’s a flawed approach to cost-saving by the government. AMP doesn’t reflect the true acquisition cost of the generic for retail pharmacies, they argued, since it takes into account the lower costs paid by other types of purchasing entities, such as hospitals and institutions. What’s more, the feds’ definition of a multiple-source drug itself was flawed, pharmacy advocates asserted.
Together with the low rate of markups CMS was proposing for generic Medicaid payments, the new AMP rule drastically would have cut pharmacy reimbursements and made it all but impossible to dispense medicines to low-income patients without incurring a loss, pharmacy leaders have long argued. To head off the change, NACDS and NCPA filed a suit in federal district court in 2007 to halt the new AMP guidelines from taking effect.
The resulting court-imposed injunction has kept AMP from taking effect, and it has saved chain and independent pharmacies an estimated total of $5.5 million a day ever since. Now that CMS finally agreed to withdraw its reimbursement plan and go back to the drawing board, NACDS and NCPA, along with their members, are breathing a sigh of relief. The fact that they’ve also agreed to drop the suit signals the end of a long — and ultimately victorious — battle for respect, and a decent return on their business.
Travel clinics, immunizations take flight at Bartell Drugs
SEATTLE — You can say Bartell is getting into the travel business.
Bartell, which had an estimated $353.4 million in sales in 2009, began operating travel clinics eight years ago and now has them at 10 of its 59 stores. They were the brainchild of pharmacists Jolene Kalmbach and Sharon Woodward, who got the idea after noticing that patients’ doctors often lacked necessary expertise in travel medicine and that commercial travel clinics were overbooked.
Customers can pay $50 for a consultation with the pharmacist and then pay individually for immunizations. In particular, Bartell’s clinics benefit from a provision in Washington state’s pharmacy regulations that gives pharmacists limited power to prescribe medicines and vaccines under special agreements with physicians.
“Seattle has emerged as a business-and-leisure travel hub to Asia, Latin America and Europe,” said Bartell Drugs clinical care coordinator Rachel Allen. “The international travel clinics have become a signature service that not only supports awareness of our overall vaccination program but [also supports] sales of travel-related items throughout the entire store.”