Buyer Beware! Designer Name Private-Label Topicals?

A recent Workers Compensation Research Institute (WCRI) FlashReport[1] reviewed interstate variation and trends in workers’ compensation drug payments over three years for 28 states. A major finding was the share of prescription payments for dermatological agents have increased in many states, becoming a more prominent driver of drug payment.

Examples of dermatologic agents are those to be applied topically to the affected area, and include Lidoderm® patch (lidocaine), Pennsaid® (diclofenac sodium), and Flector® (diclofenac epolamine). WCRI also notes over-the-counter (OTC), including LidoPro®, Dendracin® and Terocin® patch. Importantly, the latter agents are examples of private-label topicals, which will be the focus of this discussion. Private-label (PL) topicals are independently manufactured over-the-counter products (OTC). They contain differing combination doses of salicylates, menthol, capsaicin, and/or lidocaine and are generally prescribed for minor pain conditions.

Official Disability Guidelines (ODG) Evidence Summary

These topicals products are marketed directly to physician offices for direct dispensing to patient. The ODG does not recommend PL topicals[2] and they don’t recommend physician-dispensing over pharmacy-dispensing due to higher costs and worse outcomes in workers compensation. They further state physician-dispensing may create financial incentives that affect the use of compound drugs and other medications, due primarily to fee schedule ambiguities. In addition, physician-dispensed drugs typically do not go through the pharmacy benefit management companies (PBMs) but are submitted directly to the payer. Physician dispensing has been found to be associated with higher costs and more lost time than pharmacy-dispensed medications.[3]

The prescribing and dispensing of PL agents is considered a profit-driven practice and excessively cost-restrictive. However, they provide little to no therapeutic benefit, and have markedly fiscally responsible comparable alternatives, as outlined in Table 1, which are widely commercially available. Importantly, the constituents in the PL topical often duplicates therapy with the currently prescribed regimen, either by therapeutic class or indication for treatment.

Table 1. Examples of PL topicals, approximate pricing based on a months’ supply, and of similar and cost-effective OTC alternatives.

Brand Name/Regulation Status~Price/quantity per month~AWP of OTC affordable alternative
Lidothol® patch – Rx$1,490$50
Terocin® patch – OTC$1,455$42
Dendracin® lotion – OTC$465$11
Lenzapro® – OTC$1507$56
LidoPro® ointment – OTC$486$11
LidoPro® patch – OTC$1,440$56
Venia® patch – OTC$1,263$56

Noteworthy, the majority of the PL products in the above table are OTC, thus they have not been reviewed or approved by the FDA, and as such they are not evaluated for safety and efficacy. Safety issues include reports of serious skin burns in products containing high doses of menthol and methyl salicylate.[4] Best practices call for medications should be dispensed at a pharmacy, not just for the purpose of cost-containment, but also in order for any potential drug-drug duplications, interactions or contraindications to therapy to be identified, and for allowing counseling and education to occur, thus providing an additional safety check for the patient.

PL claims require oversight based on their lofty price tag, lack of literature supporting safety and efficacy, and medical necessity, particularly as their use is trending upwards. ECS Doctors of Pharmacy (PharmDs) are here to assist as clinical experts in the area of optimization of drug regimens. Our goals are to improve clinical outcomes by assessing for safety and efficacy of the medication regimen; evaluating medical necessity of the medication(s) based on evidence-based clinical guidelines; all while reducing cost without compromising care and adhering to the high standards of care. The ECS Rx Program reviews medical records, prescription bills and prescription payment history for appropriateness of therapy based on authoritative-based guidelines.

For questions about medications or the ExamWorks Compliance Solutions Pharmacy programs, please contact Nahla D. Rizkallah, PharmD, MSCC, at 678.256.5086 or nahla.rizkallah@examworkscompliance.com

[1] WCRI FlashReport—Interstate Variation and Trends in Workers’ Compensation Drug Payments: 2016Q1 to 2019Q1. Vennela Thumula, Te-Chun Liu, and Dongchun Wang. June 2020. FR-20-01.

[2] ODG by MCG. Pain: Topicals, private-label. Available: http://odgbymcg.com. Accessed 7/9/2020

[3] ODG by MCG. Pain: Physician-dispensed drugs. Available: http://odgbymcg.com. Accessed 7/9/2020

[4] ODG by MCG. Pain: Topicals, private-label. Available: http://odgbymcg.com. Accessed 7/9/2020

Nahla Rizkallah, PharmD, MSCC

Nahla Rizkallah, PharmD, MSCC

Nahla D. Rizkallah, PharmD, MSCC, serves as the Senior Clinical Pharmacist at ExamWorks Compliance Solutions. In this capacity, she performs prescription analysis to optimize drug therapy using evidence-based guidelines and national guidelines, and participates in physician outreaches to implement the recommendations. She has 29 years of experience in various area of pharmacy practice including: review of Part D medications on Medicare Set-Aside Allocations, prior authorization reviews for the Florida Medicaid program as Senior Clinical Pharmacist, development of drug utilization criteria, academic detailing, Pharmacy and Therapeutics Committee, Pharmacy Manager for a closed mental health facility, Pharmacy Manager for the indigent, staff/clinical pharmacist for assisted- living facilities (ALFs), medication audits for ALFs, drug information center, clinical pathways, staff education, and surgical/medical pharmacy satellite at All Children’s Hospital. Dr. Rizkallah has the following certifications: Medicare Set-Aside Certified Consultant, Hypertension and Dyslipidemias, and Diabetes. Dr. Rizkallah received her Doctorate from the University of Florida in Gainesville followed by a one year American Society of Health-System Pharmacists accredited residency.

For questions about medications or the ExamWorks Compliance Solutions Pharmacy programs, please contact Nahla D. Rizkallah, PharmD at 678.256.5086 or nahla.rizkallah@examworkscompliance.com

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