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   Generic drugs news

22.10.2011
Generics in the United Kingdom - Performance of the Market Is Forecast To Decelerate, With an Anticipated CAGR Of 7.9% for the Five-Year Period 2010... [reading]

22.10.2011
The US Generics Market Had Total Revenue of $71.4 Billion in 2010, Representing A CAGR Of 8.2% between 2006 and 2010 [reading]

21.10.2011
Antares Pharma Granted New U.S. Patent Covering VIBEX? Injector Technology [reading]

21.10.2011
Drugs giants probed by EU anti-trust authority [Deutsche Welle] [reading]

20.10.2011
CMS` Transparency Push Could Revolutionize Drug Pricing [reading]

19.10.2011
Perrigo confirms filing for generic version of PATANASE nasal spray [reading]

19.10.2011
Pharmacists to Federal Medicaid Officials: Revamp Proposed Generic Drug Federal Upper Limits to Preserve Pharmacy Access for Patients [reading]

19.10.2011
Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent Orders To Aid Public Comment [reading]

18.10.2011
Perrigo applies to FDA for generic nasal spray [reading]

18.10.2011
Watson confirms filing ANDA for generic version of Warner`s Atelvia [reading]

18.10.2011
Watson confirms filing ANDA with FDA for generic version of Noven`s Daytrana [reading]

17.10.2011
New NCPA Ads Feature Community Pharmacy Proposals to Reduce the Federal Deficit [reading]


 

Generic drugs news


Pharmacists to Federal Medicaid Officials: Revamp Proposed Generic Drug Federal Upper Limits to Preserve Pharmacy Access for Patients


19.10.2011

ALEXANDRIA, Va., Oct. 19 The National Community Pharmacists Association issued the following news release:

In an effort to preserve access to trusted, community pharmacists for millions of Americans, the National Community Pharmacists Association (http://www.ncpanet.org/) (NCPA) is offering federal Medicaid officials a number of suggestions to address flawed methodology that, if left in place, would result in potentially devastating cuts in Medicaid pharmacy reimbursement for a wide range of common, generic prescription drugs.

In a letter (http://www.ncpanet.org/pdf/leg/oct11/draft-amp-based-fuls.pdf) to the Centers for Medicare and Medicaid Services (CMS), NCPA details a number of shortcomings in the Average Manufacturer Price (AMP) data on which CMS is relying to calculate new caps on Medicaid pharmacy reimbursement, known as Federal Upper Limits (FULs), for multiple source, generic prescription drugs.

"Independent community pharmacies are the backbone of the Medicaid drug benefit," said NCPA CEO B. Douglas Hoey, RPh, MBA. "These small business pharmacists are often located in underserved rural and inner-city locations and care for twice as many Medicaid patients compared to national chain pharmacies. Community pharmacists reduce costs for Medicaid and taxpayers by maximizing the appropriate utilization of lower-price generic drugs and by providing face-to-face counseling to promote the proper use of medications as prescribed for patients. We have worked constructively with federal and state (http://www.ncpanet.org/pdf/leg/aug11/sebelius-re-medicaid-savings.pdf) officials to find Medicaid savings and will continue to do so.

"However, the newly proposed limits published by federal Medicaid officials would reimburse independent community pharmacies at rates that are below even the pharmacy`s acquisition costs for hundreds of products," Hoey noted. "The dispensing fees paid to pharmacies by Medicaid and virtually every health plan are already well below a pharmacy`s cost of dispensing. So it`s critical for pharmacies to be reimbursed fairly for the generic drugs they dispense, along with expert medication advice. If implemented as proposed, these caps would endanger patient access to care by forcing many independent community pharmacists to either curtail their participation in Medicaid or to leave the program altogether in order to avoid dramatic financial losses."

In the letter, NCPA explains the following concerns and recommendations:

* The AMP data on which CMS is relying does not accurately reflect acquisition costs for community pharmacies. Even at the reimbursement baseline established in the ACA, or Affordable Care Act (175 percent of the weighted average AMP), there are hundreds of products on CMS` proposed list with FULs that are below an independent community pharmacy`s acquisition costs. In addition, the ACA criteria requires FULs be set with AMPs of multiple source products that "are available for purchase by retail community pharmacies on a nationwide basis," which does not appear to be the case with the newly proposed CMS list.

* Inconsistency among drug manufacturer practices may contribute to the below-market FULs. The lack of guidance from CMS to manufacturers in terms of fully defining AMP has resulted in widely varying manufacturer practices in calculating AMP values. This, in turn, may contribute to the inadequate FULs proposed by CMS. Consequently, the new AMP regulation should be finalized before any AMP values are used to set FULs.

* Insufficient manufacturer data. The FULs are based on one month`s AMP data, without regard to the statutorily required "smoothing process" to help avoid wild fluctuations that could occur from month to month.

* CMS should recognize independent community pharmacies` higher drug acquisition costs. Despite aggressive efforts to negotiate lower prices, community pharmacies` acquisition costs are often 25-50 percent higher than those of publicly held chain pharmacies. The ACA granted CMS the flexibility and authority to set the FULs at a higher rate to account for that difference and to help preserve patient access in underserved rural and inner-city communities.

* CMS should fully resolve these and other issues before publishing its final, revised FULs. The publication by CMS of below-market reimbursement caps, such as those initially proposed, could result in additional health plans adopting a flawed reimbursement standard and further reducing the ability of independent community pharmacies to continue serving patients.

"The best way to lower health costs associated with prescription drugs is through the appropriate use of generic drugs and greater adherence, which helps prevent complications, "Hoey added. "Medicaid patients rely on clinically-trained pharmacists for counseling, which could be jeopardized if CMS doesn`t ultimately arrive at a more practical approach."

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What's the difference between generic drugs and brand-name drugs?
Actually, they both differ only in price and name, all the rest is the same. Generic drugs, as well as brand-name medications, have the same dosage, effects, including side effects, risks, strength and safety. They are like true copies of brand-name medications.

What makes generic drugs cheaper?
As a rule, in order to release and patent a certain drug the manufacturer should meet a range of requirements like developing, researching, marketing and promoting of a new medication. Overall, it is time- and money-consuming procedure, which leads to price growth. Speaking about generic drugs, they are usually brought unregistered onto the market, thus the manufacturer is exempt from paying taxes. However, the lower price here doesn't yield lower effectiveness. As a rule, the manufacturers of generic drugs are known reputable pharmaceutical companies.

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