Claritin® OTC Status Triggers Series of Changes
By Carl Reed

The nonsedating antihistamine (NSAH) therapeutic class is effective and popular for the treatment of allergic rhinitis and common histamine-related hypersensitivity reactions. This is an important class because NSAH drugs are important for companies whose employees' alertness is critical to performing job duties such as manufacturing facilities, airlines, or hospitals.

The American Academy of Allergy Asthma and Immunology (AAAAI) suggests that either an NSAH or an inhaled steroid can be used for persistent mild to moderate allergic rhinitis. In most cases, the NSAH is the drug chosen. The AAAAI also suggests that both should be used together as the appropriate first-line therapy for severe allergic rhinitis.

Until it recently became available over-the-counter (OTC), Claritin® (generic name loratidine) was the most widely used prescription NSAH. However, Claritin's® new OTC status is causing plan sponsors to change how the class is managed. Simplifying the issue, there are four major strategies for managing the NSAH class:

1. Exclude all NSAH drugs because there is now an OTC alternative.
2. For plans with a three-tier copayment scheme, move prescription NSAH products to the highest tier copayment (or nonpreferred status) while excluding any Claritin® OTC product. In many cases, OTC Claritin® and OTC Alavert®, an equivalent product, are less expensive for a course of treatment than the copayment for the covered prescription product.
3. The third approach is to exclude OTC Claritin® from plan coverage while not changing the copayments and formulary status for the remaining prescription agents in the class (Allegra®, Clarinex®, and Zyrtec®).
4. The fourth approach is to cover OTC loratidine in either the first or the second tier as the preferred NSAH agent and move all others to the highest copayment available.

The AWP for the daily dosage of these drugs are listed in 
Figure 1: Comparison of Prescription Alternatives to Claritin®.

In strictly financial terms, excluding all NSAH drugs (Option 1) will save the most money. However, many employers will not find this an acceptable benefit design because they need fully alert employees. These employers believe that some product should be available to these individuals under the covered benefit.

Assuming that some of the remaining NSAH are on a preferred status, Option 3 will not save much money because the former prescription Claritin utilization will shift to the remaining products. Some savings may occur based on lower drug costs as Claritin was the most expensive drug in the category. However, any potential savings will be affected by the copayment amount for these drugs.

Option 2 appears to make the most sense for many plans. At normal third-tier copay levels, OTC loratidine is less expensive than the copay amount and patients will have a financial incentive to use the OTC product rather than the prescription products. For those that do not find loratidine to be effective, they will still have the option of using a prescription NSAH.

Option 4 makes sense for those plans that can cover OTC products and want to continue to have this class available. Because the cost of the OTC loratidine is less than the prescription alternative, plans that make the OTC the preferred alternative would reap significant savings. This option might be problematic for those groups that exclude OTCs from coverage in their certificates of insurance.

Based on PBMI's research, by virtue of not having made a decision about what to do, most plan sponsors have chosen Option 3 for the moment. Most plans typically exclude OTC products. Unless the plans want to make an exception for Claritin®, they must now decide what to do with the other NSAHs.

Changes in the coverage and availability of NSAH drugs may result in the increased use of other types of prescription agents. For example, leukotriene modifiers (LTMs) are drugs traditionally used for asthma. Singulair®, one of the leading drugs in this class, was recently approved by the U.S. Food and Drug Administration (FDA) for the relief of the symptoms of seasonal allergic rhinitis. Singulair® is currently the only LTM that has this indication. It also is likely to be the only one prescribed for this indication because Accolate® and Zyflo® are twice daily and four times daily medications, respectively. The class should be carefully monitored to ensure proper use of Singulair®, and other costly brand-name agents including Accolate® and Zyflo®. Figure 1 lists the cost of LTMs.

Step therapy is the most effective tool for limiting access to LTMs to those members with allergic rhinitis who have failed to respond to NSAH drugs and other agents in prior courses of therapy. Plan sponsors should work with their clinical staff and or pharmacy benefits managers to ensure members with asthma continue to have access to LTMs when medically appropriate.

Monitoring LTMs is recommended because it is expected that the AAAAI standard might change as physicians get more experience with LTMs. However, it is my opinion that these products should only be used by those that fail other therapies.

It also is expected that the use of nasal steroids may increase with the changes to the NSAH class but this will be mitigated by the reluctance of some people to use nasal sprays. Figure 1 also lists the cost of steroidal nasal sprays.

Reed is Director of Pharmacy for Preferred Care, a New York HMO with more than 200,000 lives. He is also a member of the New York State Medicaid Pharmacy & Therapeutics Committee.

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