Background

Qutenza™ (capsaicin) is the only prescription capsaicin product currently available and it is FDA- approved for the management of neuropathic pain associated with postherpetic neuralgia (PHN). Qutenza™ works by targeting certain pain nerves in the area of skin where pain is being experienced. It selectively binds to a transient receptor potential vanilloid 1 (TRPV1), a protein that resides on the membranes of pain and heat sensing neurons.

The capsaicin in Qutenza™ is a synthetic equivalent of the naturally occurring compound found in chili peppers. There are a variety of over the counter (OTC) topical capsaicin products available in lower strengths (0.025% up to 0.25%). These OTC formulations are used in the treatment of pain associated with arthritis and musculoskeletal conditions. Qutenza™ is available as an 8% topical patch. It must be used under the supervision of a healthcare professional, and the recommended dose is one 60- minute application of up to 4 patches which may be repeated no sooner than every 3 months. Qutenza™ represents another option in the treatment of PHN.

Pain relief occurs during the first week after the application and may last up to 3 months or more. Immediately after the application, the patient is sensitive to heat and should avoid hot showers, sun, and extreme exercise. Over the course of several months, there may be a gradual re-emergence of painful neuropathy thought to be due to TRPV1 nerve fiber reinnervation of the treated area Commonly utilized agents in the treatment of PHN include analgesics, anesthetics, anticonvulsants, antivirals, corticosteroids, and tricyclic antidepressants. Lyrica^® (pregabalin), Lidoderm® (lidocaine) and gabapentin are FDAapproved for the treatment of PHN. Qutenza™ was approved based on the results of two 12- week, doubleblind, randomized, dose-controlled multicenter studies. Qutenza™ 8% was more effective than the capsaicin 0.04% comparator in both studies. There are currently no clinical trials directly comparing Qutenza™ to gabapentin, Lyrica^® (pregabalin), or Lidoderm^®.

Policy

Qutenza^® (capsaicin 8%) may be considered MEDICALLY NECESSARY when the following criteria has been:

• Patient is at least 18 years of age; AND
• Patient has a documented baseline Numerical Pain Rating Scale (NPRS) score; AND

Management of neuropathic pain associated with postherpetic neuralgia (PHN)

• Patient has postherpetic neuralgia that has persisted for at least 6 months following healing of herpes zoster rash (i.e., crusting of the skin vesicles); AND
• Painful areas to be treated are not located on the face, above the hairline of the scalp, and/or in proximity to mucous membranes; AND
• Patient had an inadequate response (or contraindication) to ALL of the following:
  • Tricyclic antidepressant (e.g., amitriptyline, nortriptyline, maprotiline, desipramine, etc.)
  • A gabapentinoid (e.g., pregabalin or gabapentin)

Treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet:

• Patient has painful, distal, symmetrical, sensorimotor polyneuropathy due to diabetes that has persisted for at least 1 year prior to screening; AND
• All other causes of pain in the feet have been ruled out; AND
• Patient had an inadequate response (or contraindication) to ALL of the following:
  • An antidepressant (e.g., duloxetine, venlafaxine, amitriptyline, nortriptyline, maprotiline, desipramine, etc.)
  • A gabapentinoid (e.g., pregabalin or gabapentin)

Renewal Criteria

Authorizations can be renewed based on the following criteria:

• Patient continues to meet the initial criteria AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: severe application site pain and burning, hypertension, decrease in sensory function, etc.; AND
• Patient has experienced an improvement in pain based on the Numerical Pain Rating Scale (NPRS) compared to baseline.

References

1. Qutenza Patch (capsaicin 8%) [prescribing information]. Morristown, NJ: Averitas Pharma, Inc; February 2023.
2. Backonja M, Wallace MS, Blonsky ER, et al. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol 2008; 7: 1106–12.
3. R. M. Dubinsky, H. Kabbani, Z. El-Chami, C. Boutwell, H. Ali, Practice Parameter: Treatment of postherpetic neuralgia. An evidence-based report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2004 September 28;63(6) 959-965.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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