PHARMACY

NACDS, NCPA call pharmacy ‘backbone of Medicaid’s drug benefit’

BY Allison Cerra

ALEXANDRIA, Va. — The National Association of Chain Drug Stores and the National Community Pharmacists Association on Friday sent a joint letter to every governor and state Medicaid director on the importance of pharmacies in Medicaid and the industry’s interest in working with state governments to cut costs.

“Community pharmacies play a vital role in the Medicaid program as the backbone of its drug benefit,” wrote Steven Anderson, NACDS president and CEO, and Kathleen Jaeger, NCPA EVP and CEO. “Local pharmacists can provide expert medication counseling and other cost-saving services that help mitigate the $290 billion that is estimated to be spent on an annual basis as the result of patients who do not adhere properly to their medication regimen.”

The recommendations propositioned in the letter include:

  • Advocating dispensing of generic medicines. Community pharmacy has a higher rate of generic dispensing (71%) than any other practice setting, including mail-order pharmacy, the letter stated;
  • Incorporating medication therapy management services provided by pharmacists. The community pharmacist can provide critical advice and guidance to patients with chronic conditions, who very often need instruction and re-enforcement of optimal medication use, the letter suggested;
  • For states considering adjustments to beneficiary cost sharing, NACDS and NCPA urged those governments to make co-payments mandatory as permitted under federal law. Requiring pharmacies to bear the costs of uncollected co-payments — which in some states is as high as 50% — is unfair, the associations argued, particularly at a time when there already have been significant reductions in pharmacy Medicaid reimbursement; and
  • For states considering an average-acquisition-cost-based pharmacy reimbursement formula, NACDS and NCPA suggested undertaking comprehensive cost-of-dispensing studies and adjusting state dispensing fees, recognizing the importance of reimbursing pharmacies accurately for all aspects of providing prescriptions to Medicaid patients.

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PHARMACY

Impax granted FDA approval for generic Adoxa

BY Allison Cerra

HAYWARD, Calif. — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

The drug maker on Friday said it received final approval of its abbreviated new drug application for doxycyline monohydrate capsules in the 150-mg strength. The drug, which is a tetracycline antibiotic used to treat bacterial infections, is a generic version of Adoxa. Adoxa is manufactured by PharmDerm, a Nycomed subsidiary.

Impax said its generic division, Global Pharmaceuticals, will launch the product.

U.S. sales of Adoxa in the 150-mg strength were approximately $25 million in the 12 months ended in December 2010, according to Wolters Kluwer.

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Anticipating regulations, biosimilars move through pipeline

BY Alaric DeArment

Though efforts to repeal the Patient Protection and Affordable Care Act via the court system remain under way — with recent victories for opponents in Virginia and Florida — the attempt to repeal the healthcare-reform bill in Congress failed, thus leaving the bill and, most importantly, the regulatory approval pathway for follow-on biologics intact.


Whatever the outcome, progress on follow-on biologics — also called biosimilars or biogenerics — has hummed along over the past several months. Sandoz, the generics arm of Swiss drug maker Novartis and a key biosimilars manufacturer for the European market, has as many as 10 biosimilar compounds under development, according to reports published in early February.


Meanwhile, Momenta Pharmaceuticals announced that it received a patent from the U.S. Patent and Trademark Office that included a way of preparing glatiramer acetate. Momenta is hoping to market a generic version of the drug, which Teva Pharmaceutical Industries, together with Sandoz, markets as a multiple sclerosis treatment under the brand name Copaxone. Though the Food and Drug Administration approved Copaxone as a pharmaceutical drug, its chemical complexity places it in league with biotech drugs, similar to Sanofi-Aventis’ blood thinner Lovenox (enoxaparin sodium), for which Teva recently began marketing a generic version.


In the meantime, Teva — which also makes biosimilars for the European market — has sought to use the existing approval process for biologics to win approval for follow-on biologics in the United States, meaning that it still must subject the drugs to clinical trials. In addition to its generic version of Lovenox, Teva sought approval from the FDA for a biosimilar of Amgen’s Neupogen (filgrastim), which it already markets in Europe and hoped to launch in the United States under the name Neutroval, though the FDA declined to approve it. 


In January, Spectrum Pharmaceuticals and Viropro announced plans to develop a biosimilar of Rituxan (rituximab), a Genentech drug used to treat cancer.


Formal regulations still could be years away, even if guidance for draft regulations appear this year, industry experts have told Drug Store News. In November 2010, the FDA brought together representatives of the generic drug, branded drug and biotechnology lobbies to offer input about what form regulations for follow-on biologics should take.


When those regulations finally do appear, they’ll be somewhat more complex than the ones for generic pharmaceutical drugs. For one, biosimilar manufacturers still will have to conduct clinical trials. Unlike pharmaceuticals, the molecular complexity of biologics and the fact that they come from specially grown cell lines make it more difficult to create exact replicas of the originals, so the trials would have to demonstrate that the follow-on biologics work as well and as safely as the drugs on which they’re based.


On top of that, the number of companies manufacturing follow-on biologics will be much smaller due to the higher costs involved, including constructing factories, developing the drugs and conducting the trials. This probably will limit the number of manufacturers to those companies that already make follow-on biologics — including Teva, Sandoz and Hospira — and to companies with enough cash on hand to get into the business, like Mylan, which has expressed interest in biosimilars, and such branded drug companies as Merck and Pfizer.

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