FDA approves generic versions of Zyprexa
SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic versions of two drugs made by Eli Lilly for treating schizophrenia and bipolar disorder, the agency said Monday.
The FDA announced the approval of generic olanzapine tablets and olanzapine orally disintegrating tablets, respectively generic versions of Lilly’s Zyprexa and Zyprexa Zydus. Dr. Reddy’s Labs and Teva Pharmaceuticals USA will manufacture olanzapine tablets, while Dr. Reddy’s, Apotex and Par Pharmaceuticals will manufacture the orally disintegrating version.
"The approval of generic olanzapine offers greater access to a widely used treatment for mental illness," FDA Office of Pharmaceutical Science deputy director Keith Webber said. "Having affordable treatment options is good for patients with long-term illnesses that must be carefully managed."
On Thursday, Prasco Labs announced that it would partner with Lilly to make authorized generic versions of Zyprexa and Zyprexa Zydus, scheduled to launch at the same time as the generic versions. An authorized generic drug is the branded drug marketed under its generic name at a reduced price.
CMS needs fair definition of AMP
WHAT IT MEANS AND WHY IT’S IMPORTANT — When CMS withdrew its proposed AMP rule about a year ago, it should have included the sections pertaining to how federal upper limits were calculated — that is, assuming you are using AMP to come up with those FULs. That’s a pretty good argument for throwing out the draft FULs CMS published last week. How can you solve X plus no less than 175% if you’re not really settled on what X equals?
(THE NEWS: NACDS expresses concerns with new FUL list for pharmacy Medicaid reimbursement. For the full story, click here)
That’s a problem because smaller, independent pharmacies could be facing reimbursement cuts of up to 38% to 44%, according to the National Community Pharmacists Association. And its not just mom and pop shops that lack the buying power of a big chain — according to NCPA, the typical independent’s average acquisition costs are about 25% to 50% higher than the average publicly held pharmacy chain — that would get hurt by all this. "After a comprehensive analysis, one [National Association of Chain Drug Stores] member company found that more than half of the draft FULs were below the pharmacy’s cost to acquire these products from a wholesaler," NACDS noted in a Oct. 21 letter to CMS.
First, CMS needs to settle on a fair definition of AMP is before it can determine the minimum amount it will pay pharmacies to dispense drugs to Medicaid patients. According to analysis conducted by Pembroke Consulting, nearly two-thirds of the drugs published in the original AMP data, were being sold by their manufacturers for less than 25 cents a pill — 175% up 25 cents or less doesn’t add up to what a pharmacy will pay for that pill.
Walgreens pharmacists to provide resources to Medicare Part D beneficiaries
DEERFIELD, Ill. — Walgreens is continuing to provide resources to Medicare Part D beneficiaries in order to help them better understand their healthcare options.
Walgreens pharmacists this year are offering a free plan comparison report generated from Medicare’s online plan finder at any of its more than 7,700 locations. The report, Walgreens said, is based on the patient’s current medications, so that patients can choose a plan for the first time or determine if their current plan is still the best fit for their needs. What’s more, the report details each plan’s estimated annual costs, including monthly premiums, branded and generic co-pays and coverage through the coverage gap. Medicare beneficiaries also should ensure their pharmacy of choice is in their plan’s network, the drug store chain said.
Patients interested in receiving a report now can schedule appointments for a Medicare Part D plan review at their local pharmacy or at Walgreens.com/medicare. Pharmacists also are available to review plans on a walk-in basis and nearly 4,000 Walgreens stores nationwide will host representatives from Medicare Part D plans, who will provide information and can help people enroll in plans that best fit their needs.
“There are substantial savings available to Medicare Part D beneficiaries this year, so it’s important they know their options to realize these benefits,” Walgreens group VP pharmacy operations Suzanne Hansen said. “Our pharmacists are among the most trusted and accessible sources for help with making an informed plan choice. They can’t decide for you, but they can certainly be a resource to help you understand your options.”
Medicare enrollees have until Dec. 7 to review their coverage options for 2012, Walgreens noted.