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Health Plans Initiating Coverage Of Claritin, Prilosec OTC – Survey

This article was originally published in The Pink Sheet Daily

Executive Summary

Rx-to-OTC switches are leading the trend of increasing coverage of over-the-counter products, in part because follow-ons have not been proven significantly more effective, a survey by the Pharmacy Benefit Management Institute finds.

Schering-Plough's non-sedating antihistamine Claritin is being covered by 10% of employers, according to a survey by the Pharmacy Benefit Management Institute.

"The availability of a non-sedating antihistamine in an OTC form is important because it provides plan sponsors with coverage options for the other non-sedating antihistamines," the survey notes.

Some plans choose to exclude all other Rx second-generation antihistamines, PBMI says, adding that 12% of plans have chosen this option.

Among plans with three-tier schemes, 30% relegated other prescription non-sedating antihistamines to third-tier status. Because an over-the-counter product generally costs less than a third-tier co-pay, many beneficiaries opt for the former, PBMI notes.

The 2004 survey marks the first time since the Prescription Drug Benefit Cost & Plan Design Survey Report was first conducted in 1995 that the evaluation has included OTCs.

Data was collected during the fall of 2003; Takeda Pharmaceuticals North America provided funding for the survey. In addition to OTC use, the survey found that employers are increasingly moving to fixed rebate payments in their contracts with pharmacy benefit managers (1 (Also see "Employers Moving To Fixed Rebate Payments In PBM Contracts – Survey" - Pink Sheet, 25 Oct, 2004.)).

More than 400 surveys representing roughly 11 mil. beneficiaries were collected. Eighteen percent of respondents had roughly 2,000 or fewer members, while 12% had more than 50,000.

"Respondents were asked to specify who has primary responsibility for defining the drug benefit: the employer or another entity such as a managed care organization, health care administrator or insurer," the survey says.

"This information allows evaluation of the differences among benefit designs based on whether the employer or a third party is responsible for defining the drug benefit," PBMI explains.

PBMI credits Claritin and Prilosec OTC (omeprazole magnesium) for the shift towards OTC coverage. The nonprescription version of the proton pump inhibitor is marketed by Procter & Gamble.

Only 4% of employers currently cover Prilosec OTC, most likely because the PPI is available as a prescription drug, as well as in generic form, the survey notes.

The survey maintains that Prilosec's mechanism of action, which works over a two-week period for frequent heartburn sufferers, contributes to fewer plans covering the drug.

"Because the OTC formulation…is indicated for 14 days of treatment, only 32% exclude the prescription formulation," PBMI adds.

Prilosec's follow-on Nexium (esomeprazole) is excluded from 9% of plans "in part because of published concerns that this new product is only slightly more effective than the previous generation of products," according to the survey. "Plan sponsors are weighing in with their opinions of these drugs by modifying their PBM's classification of these drugs in formulary and cost-sharing categories."

In this vein, 16% of plans require step therapy or prior authorization before filling prescriptions for Nexium "to encourage patients to use the older, less expensive products first." Other PPIs, such as TAP's Prevacid (lansoprazole) and Wyeth's Protonix (pantoprazole sodium) are excluded from only 4% of plans.

"Plans tend to treat both Prilosec and Nexium in the same manner with either placed in the third tier or both in the second tier," the survey says. The designation "is most likely because of the formulary design of the PBMs administering the plan sponsors' benefits."

Historically, OTC coverage was only viewed as an option by managed care organizations, which had group model HMOs distributing Rx drugs from their own pharmacies, the survey claims. Therefore, the pharmacies could hand out nonprescription drugs while allowing pharmacists to monitor who purchased them as a covered benefit.

Presently, employers are encouraging the purchase of OTCs by eliminating co-pays for short periods of time, offering coupons and including the drugs in the lowest-cost tier of their plans. Coverage and incentives likely will increase in 2005, PBMI predicts.

Despite this trend, there are still barriers to nonprescription drug coverage. Plan sponsors are concerned beneficiaries will unnecessarily take OTCs or self-diagnose and medicate inaccurately.

- Lauren Schwartz

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