On December 26, 2008, Allergan received approval from the U.S. Food and Drug Administration for Latisse™ (bimatoprost ophthalmic solution) 0.03% as a treatment for hypotrichosis (madarosis) of the eyelashes, the condition of having inadequate or not enough eyelashes. [2009 ICD-9-CM Diagnosis 374.55]. Available only through a doctor, Latisse™ is a once-daily prescription treatment applied to the base of the upper eyelashes with a sterile, single-use-per-eye disposable applicator. More information about Latisse™ is available on the product web site at www.Latisse.com, including the following useful documents:
Patient Information http://www.Latisse.com/pdf/LatisseProductInformation.pdf
Prescribing Information http://www.allergan.com/assets/pdf/Latisse_pi.pdf
On March 2, 2009, Allergan launched Latisse™ through both their Dermatology and Eyecare Divisions. Because Latisse™ has cosmetic indications, Allergan’s principal strategy for this product will emanate from its Dermatology Division, but the Eyecare Division will market Latisse™ and detail optometrists and ophthalmologists, while the Dermatology Division will detail all other physicians who are potential prescribers.
Regulatory Issues Affecting Optometry
While Latisse™ offers optometrists a new treatment modality and a probable new patient base, the regulatory issues regarding prescribing or dispensing the drug for a fee vary from state to state. Optometrists should contact their state board of optometry to learn if prescribing this drug for therapeutic or cosmetic purposes is within the scope of practice. In some states it may be advisable to consult your association Executive Director for guidance before contacting the optometry board seeking an opinion. It should also be noted that the authority to prescribe a medication does not necessarily allow providers to dispense drugs for a fee in every state.
Apply Professional Judgment When Prescribing This Medication
1. Latisse™ may be prescribed for either therapeutic or cosmetic purposes. By definition, “hypotrichosis” is a relative term. While there are cases in which therapeutic use is justified, billing a third party payer for a use that is purely cosmetic is subject to insurance contract coverage issues.
2. Some patients may be aware that the active ingredient in Latisse™ is the same as that in Lumigan®. They may also be aware that Lumigan® is less expensive, so may ask their optometrist to prescribe the lower cost solution, and offer to apply it with a Q-tip®. The Latisse™ applicators are FDA approved and designed to ensure that the correct dosage is applied, maximizing effectiveness and safety. Optometrists should be aware of the potential consequences of off-label use of medication.
New Patients Can Find You
Interested patients may search for prescribing doctors with the “Find A Doctor” tool on the Latisse™ Web site. The current listing of physicians includes only those who participated in the Food and Drug Administration studies for Latisse™. When Allergan refreshes this list in April 2009, additional doctors who have signed up on the site will receive an e-mail asking to confirm their desire to be listed. To be added to this list, at least one unit purchase or one prescription for Latisse™ must be associated with the doctor's name.
PROBLEM OR ISSUE TO BE ADDRESSED:
It is likely that many patients will be asking about this medication.
Please make this information available to your membership. Watch for updates on the AOA Web site at www.aoa.org.