What is a Fungal Nail Cure Worth? Ask Jublia

Would you pay $11,260 for a safe topical medication to treat fungal toenail infection that has a 15% chance of  complete cure?  It seems this is unlikely but that’s what the Jublia® folks at Valient are trying to sell.  If it seems like there must be some mistake here is the math:

  • Cost of one 4 ml bottle of Jublia® at the lowest cost local pharmacies per GoodRx.com: $470 using a “free” coupon available online from the manufacturer.
  • There are about 20 drops in one ml, so that means about 80 drops per bottle.
  • Treatment requires two drops per affected great toenail daily, and one drop per each other nail affected. For this example I assume 2 great toenails and 2 other nails affected, so a  use of 6 drops daily meaning a bottle would last 80/6= about 14 days.
  • For a 48 week course of therapy this would require 24 bottles of Jublia at $470 / bottle, or a total cost of $11,260. If only one great nail were affected the cost would be $3948 and if all 10 nails were affected it would be $22,560.

This is incredible when the low success rates of Jublia, a 15 – 17% complete success rate means that per complete cure (no fungus on testing and normal appearing nails after treatment) the cost per complete cure would range from $26320 for the single great toenail patient to $150,400 for the patient with all 10 toenails affected.

Compare this to the cost of $12 for a 90 day course of generic terbenafine with a 38% complete success rate making it cost about $32 per complete cure using this oral medication.

About the same time that I started seeing TV ads for Jublia® I began to have patients asking me if I recommended Jublia® for their fungal toenail infections.  Fungal toenails are both common and difficult to treat.  I was skeptical when I first heard of Jublia because up to this time topical therapy has been generally ineffective.  Oral treatment has been somewhat more effective, but modest cure rates and high recurrence rates combined with potential serious side effects have kept me from encouraging patients to undertake oral therapy.  Unless their nails are bothering them enough to make the low success rate worth a try many patients shy away from treatment and put up with their fungal nails. Looking at the details of Jublia success rates as presented in the prescribing information available from Valeant Pharmaceuticals does little to make me excited about prescribing Jublia.  Here are some of the data from the clinical trials used to gain FDA approval:

  • Jublia needs to be applied to the whole of all affected toenails daily for up to 48 weeks. It should be applied to the surface of the nail as well as the underside of the nail, and the skin immediately adjacent to the nail.
  • A complete cure, i.e. a normal appearing nail and no evidence of the fungus on follow up testing was achieved in only 15.2% and 17.8% of study participants (vs. 3.3% and 5.5% with placebo vehicle use)
  • 26.4% and 23.4% of participants in the two studies had either complete or almost complete improvement in the nail appearance and no fungus found on follow up testing.
  • The prescribing information does not discuss recurrence rates, but with oral treatment of fungal nails recurrence rates at 1 year after successful treatment are approximately 15%. It seems unrealistic to expect lower recurrence rates with Jublia.
  • Jublia seems to be quite safe with about 1-2% or patients having annoying topical irritation or ingrown toenail as side effects but no systemic ill effects reported.

I understand that insurance companies negotiate discounts on medications from the drug companies, and that only insured patients are likely to consider Jublia given its extraordinary price tag.  Still I don’t see myself prescribing a tedious, 48 week course of daily topical therapy that costs the health care system several years of health insurance premiums for most families for fungal nail infections. I tend to discuss the risks of oral terbenafine with patients and many choose not to take the potential risk of liver inflammation associated with this drug given the relatively low success rates and high recurrence rates.  Somewhat incredibly Jublia has priced itself in the range of new therapies like the new Hepatitis C drugs we use for life threatening diseases and yet wonder if the extraordinary costs are viable for a much more serious disease. .

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