What to do if insurance declines Jublia (efinaconazole) due to lack of testing for onychomycosis?

Insurance Denial for Jublia: Obtain Laboratory Confirmation First

Your insurance company is correct to require laboratory testing before approving Jublia (efinaconazole), and you should obtain mycological confirmation through microscopy and fungal culture before pursuing treatment. 1

Why Testing is Medically Necessary

The British Association of Dermatologists explicitly states that treatment should not be instituted on clinical grounds alone, as only 50% of nail dystrophies are actually fungal in origin. 1 The guidelines emphasize that the cost of diagnostic tests is always small relative to inappropriate and unnecessary treatment, particularly given that:

• Toenails require approximately 12 months to grow out completely 1
• Treatment failure without confirmed diagnosis makes it impossible to distinguish between incorrect diagnosis versus true treatment failure 1
• The most common cause of treatment failure in clinical practice is incorrect diagnosis made on clinical grounds alone 1

Specific Testing Required

Obtain proper nail specimens for both microscopy and culture: 1, 2

• For distal/lateral disease: Collect subungual debris from the most proximal part of the infection using a small dental scraper, cutting the nail back as far as possible through the entire thickness 1
• Laboratory processing: Material should undergo potassium hydroxide (KOH) preparation for direct microscopy AND culture on Saboraud's glucose agar with antibiotics, incubated at 28°C for at least 3 weeks 1, 2
• Submit as much material as possible, as fungal elements are often scanty in specimens 1

Steps to Take Now

1. Schedule laboratory testing immediately with a facility experienced in mycology specimens, as interpretation requires expertise to distinguish true pathogens from saprophytes and contaminants 1

2. Once positive results confirm fungal infection, resubmit to insurance with laboratory documentation showing:

   • Positive KOH microscopy demonstrating fungal elements 1, 2
   • Positive fungal culture identifying the specific organism 1

3. If testing is negative, you have avoided 12+ months of unnecessary treatment with a medication that costs significantly more than the diagnostic tests 1, 3

Important Clinical Context

Many conditions mimic onychomycosis including psoriasis, lichen planus, chronic trauma, bacterial infection (Pseudomonas causing green discoloration), and other nail dystrophies. 1, 2 Without laboratory confirmation, you risk treating a non-fungal condition with an antifungal medication.

Why Efinaconazole Specifically Requires Confirmation

Efinaconazole 10% solution is FDA-approved for mild-to-moderate distal and lateral subungual onychomycosis with specific efficacy against dermatophytes. 3, 4, 5 Complete cure rates are approximately 15-18%, with mycological cure rates around 54%. 4, 5 Given these modest success rates and the 48-52 week treatment duration required, confirming the correct diagnosis before initiating therapy is essential. 3, 6

The insurance requirement for testing protects you from unnecessary treatment and aligns with established dermatology guidelines. 1