PHARMACY

Worksite clinics emerge as healthcare-reform player

BY Antoinette Alexander

WHAT IT MEANS AND WHY IT’S IMPORTANT News that Take Care Health Systems has opened a second on-site pharmacy at an Electric Boat shipyard is further testament to the value of such on-site facilities at employer locations.

(THE NEWS: Walgreens adds Take Care pharmacy at Electric Boat’s Groton shipyard. For the full story, click here)

As the article states, Take Care pharmacists at the newly-opened site will provide prescriptions and pharmacy services to some 14,000 Electric Boat employees, retirees and their dependents enrolled in the company’s health plan.

Take Care Health Systems, which is owned by Walgreens, is the largest operator of worksite clinics, operating well over 300 worksite clinics.

Employer-based pharmacies benefit employees by offering them a convenient, accessible and cost-effective vehicle for the delivery of services. It has been proven that by proactively managing the pharmaceutical needs of employees, these on-site programs help to mitigate the trend of escalating healthcare costs while also improving medication adherence.

In general, on-site health clinics differ depending on the employer’s level of investment and employee population size and may comprise of a full primary care center with a fitness facility, a pharmacy or an on-site health coach.

Because no two clinics are alike and there are a lot of variables to consider, such as scope of services, the number of employees and general age of employees, it is difficult to specify cost savings; however, it has been estimated that savings are generally $2 to $4 for every $1 invested.

It is clear that the worksite clinic model, which is an ideal fit for an employer with 1,000 or more employees at a site, is evolving and emerging as a critical player in healthcare reform.

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PHARMACY

Roxane gets nod for generic herpes treatment

BY Alaric DeArment

COLUMBUS, Ohio The Food and Drug Administration has approved a generic version of a drug for herpes made by Roxane Labs, Roxane said Wednesday.

The FDA approved Roxane’s valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths. The drug, which is a version of GlaxoSmithKline’s Valtrex, is used to treat genital herpes, cold sores and herpes zoster.

Valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths had sales of $2.13 billion in 2009, according to IMS Health.

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GPhA responds to FTC’s attempt to quash ‘pay-for-delay’ deals

BY Alaric DeArment

WASHINGTON The Federal Trade Commission again is going after settlements between branded and generic drug companies that it calls anticompetitive, the agency said.

In testimony Wednesday before the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, FTC chairman Jon Leibowitz spoke of the FTC’s goal of eliminating the patent settlements, which it derides as “pay-for-delay” deals. “Years of experience have proven that competitive markets work better than anything else to bring consumers lower prices, greater innovation and more choices among products and services,” Leibowitz said.

In a typical patent settlement scenario, a generic drug company will challenge a brand company’s patent on a drug by filing a regulatory approval application for a generic version with the Food and Drug Administration containing a Paragraph IV certification. Provided for under the Hatch-Waxman Act of 1984, the law that created an abbreviated approval pathway for generic drugs, a Paragraph IV certification is a legal assertion that the patent is invalid, unenforceable or won’t be infringed by a generic version of the drug.

The brand drug company typically will respond with a patent infringement suit, and often, rather than going to trial, the two companies will reach a settlement whereby the generic drug company agrees to hold off launching its version in exchange for the brand company paying money or agreeing not to launch an “authorized generic,” essentially the branded drug sold under its generic name at a discount. But in most cases, the settlements allow the generic company to launch its version months, or even years, ahead of the patent expiration.

The Generic Pharmaceutical Association, an industry lobbying group that has long criticized the FTC on the issue of patent settlements, lashed out at Leibowitz’s testimony. “Following the testimony today by commissioner Leibowitz before a Senate judiciary subcommittee, GPhA feels compelled to set the record straight,” GPhA president and CEO Kathleen Jaeger said. “The fact is that it is patents, not settlements, that protect the brands from generic competition. Despite claims to the contrary, settlements actually help bring affordable generic medicines to market sooner, to the benefit of consumers and the healthcare system.”

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