PHARMACY

Preserve pharmacy choice for military, leaders of NACDS, NCPA urge Congress

BY Jim Frederick

ALEXANDRIA, Va. With Congress mulling a massive defense spending package for fiscal year 2010, chain and independent pharmacy leaders are urgently asking lawmakers to preserve patient choice and a level playing field for community pharmacies in the TRICARE military health program.

On Friday, the National Association of Chain Drug Stores and the National Community Pharmacists Association sent letters to four leaders of the Senate and House with broad influence in matters of military spending. Among them: Senators Ben Nelson, D-Neb., and Lindsey Graham, R-S.C.; and Reps. Susan Davis, D-Calif., and Joe Wilson, Republican of South Carolina.

The purpose: to urge them to include provisions in the National Defense Authorization Act that will continue to enable TRICARE beneficiaries to access prescription drugs and services at retail pharmacies without financial penalties.

“Retail pharmacies dispense more TRICARE prescriptions than any other pharmacy practice setting,” noted NACDS president and CEO Steve Anderson and NCPA EVP and CEO Bruce Roberts in their appeal. “In order to continue to give TRICARE beneficiaries choice, provide savings to the Department of Defense, and allow retail pharmacies to provide prescription drugs and services to our nation’s military personnel, we believe provisions regarding retail pharmacy co-payments and medication therapy management programs must be included in the FY 2010 Defense Authorization.”

At this point, the only reason the TRICARE program doesn’t penalize military members and their families for choosing local community pharmacies to fill their prescriptions — rather than mail-order or military base pharmacies — is because of a freeze on higher retail pharmacy co-payments imposed by Congress over each of the last two years. In their letter, Anderson and Roberts asked Congressional leaders to extend the freeze to maintain freedom of choice for the roughly 9 million military members and their families who depend on TRICARE for their health and pharmacy services.

“Until an improved co-payment structure can be identified and implemented, we urge you to extend the current freeze on increases to retail pharmacy co-payments,” they wrote. “A temporary extension of this freeze is necessary to ensure TRICARE beneficiaries will continue to have access to the pharmacy provider of their choice.”

Lending urgency to the appeal from NACDS and NCPA are two factors: the looming budget negotiations over military spending, and a final rule from the Dept. of Defense, published March 17, that could open the door to a permanent change in the way co-payments are imposed on TRICARE beneficiaries. That change could eliminate, once and for all, the barriers that stand in the way of a level playing field for retail pharmacies that compete against military-post pharmacies and mail order for military prescription business.

“The rule presents an opportunity for the restructuring of beneficiary cost sharing in the TRICARE pharmacy program,” Anderson and Roberts reminded lawmakers. “Rather than using co-payments to drive TRICARE beneficiaries to a particular pharmacy practice setting, cost sharing should encourage use of the most cost effective, therapeutically appropriate medication.”

In addition, the two noted, “The TRICARE pharmacy benefit should also include programs, such as medication therapy management, that enhance patient adherence to medication therapies, improve health outcomes and reduce overall healthcare costs.

“We are committed to working with Congress and the Department on these important revisions,” added the chain and independent pharmacy advocates.

The two also praised the new Defense Department rule for clarifying that TRICARE could negotiate with drug suppliers for the same federal pricing discounts for prescriptions dispensed by retail pharmacies that they get for mail-order and military-base outlets. That provision also helps maintain a level playing field and freedom of choice for military beneficiaries, said Anderson and Roberts, and “brings to fruition a sensible policy that the federal government has pursued for years.”

Federal budget planners estimate the discounts obtained through direct negotiations with drug companies for the TRICARE Retail Pharmacy network would yield approximately $12.7 billion in savings by 2015.

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New Democrat Coalition supports H.R. 1548

BY Alaric DeArment

WASHINGTON Leaders of the New Democrat Coalition voted Thursday to endorse a biosimilars bill introduced as an alternative to a bill that would use the Hatch-Waxman Act of 1984 as a model.

H.R. 1548, the Pathway for Biosimilars Act, introduced by fellow New Democrat Reps. Anna Eshoo of California and Jay Inslee of Washington, would allow a regulatory pathway for biosimilars but allow 14 years of market exclusivity, compared with the five-year period allowed by a bill introduced earlier by Rep. Henry Waxman, D-Calif.

“America’s patients want new cures, and they deserve access to cheaper medicines,” New Democrat chairwoman Rep. Ellen Tauscher of California said. “That’s why the Food and Drug Administration needs the authority to approve follow-on biologics.”

The bill, introduced on March 17, competes with Waxman’s Promoting Innovation and Access to Life-Saving Medicine Act, introduced on March 11, along with a companion bill introduced in the Senate on March 26. The Generic Pharmaceutical Association supports the Waxman bill, while the Biotechnology Industry Organization supports the Eshoo bill.

In other news, Sen. Orrin Hatch, R-Utah, who co-sponsored the Hatch-Waxman Act that made generic pharmaceutical drugs possible, broke with Waxman in telling reporters at drug regulation conference that he and Sen. Ted Kennedy, D-Mass., support longer exclusivity periods for biosimilars, according to published reports.

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FDA approves Johnson & Johnson’s Simponi to treat arthritis

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating three types of arthritis.

The agency announced Friday that it had approved Johnson & Johnson’s Simponi (golimumab), a once-monthly injection for treating moderate-to-severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis, an arthritis of the spine.

“[Today’s] approval provides another treatment option for patients with these three debilitating disorders,” FDA Center for Drug Evaluation and Research Division of Anesthesia, Analgesia and Rheumatology Products director Bob Rappaport said. “And the steps we’re taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class.”

Simponi, a monoclonal antibody made by J&J biologics division Centocor Ortho Biotech, is designed for use in combination with Barr Labs’ immunosuppressant drug Trexall (methotrexate) when treating rheumatoid arthritis, with or without Trexall when treating psoriatic arthritis and alone when treating ankylosing spondylitis.

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