PHARMACY

Indies, PBMs renew clash over transparency

BY Jim Frederick

ALEXANDRIA, Va., and WASHINGTON — The war of words between independent pharmacies and the pharmacy benefit management industry again is heating up. And again, the two groups are at odds over the question of how transparent — or opaque — the PBM industry’s business dealings with its clients are, and whether those business practices demand reform.

The newest spat over the issue came Tuesday after the National Community Pharmacists Association testified during a federal public hearing on labor practices affecting welfare benefit plans. At that hearing, NCPA’s VP PBM transparency Zachary French urged the U.S. Department of Labor to impose new disclosure standards on PBMs as the government mulls new rules for employee benefit providers for pension and health plans.

French told Labor Department officials that independent pharmacies struggle against an “extremely concentrated PBM marketplace” with “minimal … state and federal regulation” and an opaque business model that fosters “fraudulent and deceptive conduct.”

What’s more, he asserted, “one of the PBM’s primary profit streams is derived from rebates provided by drug manufacturers for driving [branded] drug market share on drugs purchased on behalf of PBM clients. PBMs retain all or a very large percentage of these rebates, even though they are generated by the welfare benefit plans’ pharmacy ‘spend.’”

French argued that the practice is “a clear conflict of interest on the part of the PBM serving in its role as a service provider to a welfare benefit plan.”

The NCPA executive told the agency that the recently enacted healthcare-reform legislation “now mandates a certain degree of PBM transparency in the form of aggregated required disclosures of all of the PBMs that will serve any of the state insurance exchange health plans, as well as in Medicare Part D.”

In equally harsh language, the Pharmaceutical Care Management Association was quick to respond. “The independent drug store lobby continues its ‘disclosure double standard’ campaign of opposing pricing transparency for themselves in Medicaid while demanding more transparency for pharmacy benefit managers,” the group said. “This campaign puts its congressional and retail pharmacy allies in the embarrassing role of attacking and defending the same policy, depending on whether it applies to them or other members of the pharmacy supply chain.”

The PCMA was referring to a new effort by the NCPA to exempt independent pharmacies from antitrust laws so they can fully collaborate in accountable care organizations and other new healthcare provider teams envisioned by the health-reform law.

“While the federal ‘transparency’ provision in the healthcare law already applies to PBMs — but not independent retailers — an interesting irony remains: independent drug stores are themselves the least ‘transparent’ part of today’s pharmacy supply chain,” PCMA asserted. “PBMs support policies that empower payers to make informed healthcare purchasing decisions. However, so-called ‘transparency’ proposals that would give drug stores and drug makers access to competitive information would undermine these efforts and only increase prices.”

What’s more, the group argued, “the [Federal Trade Commission] has explored this issue and concluded that the PBM market is extremely competitive and that this kind of ‘transparency’ would increase, not decrease, costs for consumers.”

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Momenta, Sandoz file patent suit against Teva over generic Lovenox

BY Alaric DeArment

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Momenta said Teva infringed two patents covering analysis processes for the drug enoxaparin sodium. Momenta co-developed and marketed enoxaparin under a partnership with Sandoz, the generic drug division of Novartis. The drug is a generic version of Sanofi-Aventis’ Lovenox.

Teva, whose application for its own generic version of Lovenox is under review by the Food and Drug Administration, denied that it infringed the two patents and said the lawsuit was “without merit.”

The marketing of generic Lovenox by Momenta and Sandoz became a hot topic because of its potential implications for the implementation of the regulatory approval pathway for biosimilars provided by the healthcare-reform law. Though the FDA classifies Lovenox as a pharmaceutical drug, its chemical complexity and manufacturing process mean it has more in common with biologics than with traditional pharmaceuticals, and experts said the FDA’s approval of the generic version could influence its approach to biosimilars in the future.

 

 

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Nonprofits urge for more means of addressing obesity epidemic

BY Alaric DeArment

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The Obesity Society and the Obesity Action Coalition said Monday that they were urging the FDA Endocrine and Metabolic Drugs Advisory Committee to consider the need for more measures against obesity as the committee reviewed an application for Orexigen Therapeutics’ anti-obesity drug Contrave (naltrexone and bupropion), with the review scheduled for Tuesday.

Obesity affects some 93 million Americans, but the FDA has turned down approval applications for two obesity drugs, including Vivus’ Qnexa (phentermine and topiramate) and Arena Pharmaceuticals’ Lorquess (lorcaserin), while requesting that Abbott’s weight-loss drug Meridia (sibutramine) be removed from the market due to safety concerns.

“We are deeply concerned about the effect that the FDA’s recent decisions will have for ongoing and future research into desperately needed new obesity treatments,” Obesity Society president Jennifer Lovejoy stated. “As the FDA’s advisers consider the application before them, we hope that the agency will assure a balanced process, taking into account the urgent medical need.”

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