Qutenza® (capsaicin) 8% patch is indicated for patients who meet the following criteria:

1. A documented diagnosis of neuropathic pain associated with postherpetic neuralgia. If eligible, coverage applies to a maximum of four patches every three months (no more frequently than every 12 weeks); and
2. The patient must have a contraindication to at least two other medications (e.g., amitriptyline, desipramine, gabapentin, Lyrica®  or Lidoderm®  patch) as indicated for the patient's condition; or
3. Failure of an adequate trial of one month each of two other medications (e.g., amitriptyline, desipramine, gabapentin, Lyrica®  or Lidoderm®  patch. 

The recommended dose of Qutenza is a single, 60-minute application of up to four patches. Treatment with Qutenza may be repeated every three months or as warranted by the return of pain (not more frequently than every three months).

Qutenza patch (J7335) contains 8% capsaicin (640 mcg/cm2). Each patch contains 179 mg of capsaicin. Do not dispense Qutenza to patients for self-administration. Only physicians or health care professionals under the close supervision of a physician are to administer Qutenza. Qutenza contains capsaicin capable of producing severe irritation of eyes, skin, respiratory tract and mucous membranes. It is critical that health care professionals who administer Qutenza have completely familiarized themselves with proper dosing, handling, and disposal procedures before handling Qutenza to avoid accidental or inadvertent capsaicin exposure to themselves or others.

The administration of Qutenza is considered part of an evaluation and management service (e.g., procedure code 99212-99215), It is not appropriate to report prolonged service codes for the administration of Qutenza (e.g., procedure codes 99354-99355) in addition to the evaluation and management visit, since the time involved in the administration is waiting and observation time not direct face-to-face time as defined in the prolonged services code description.

The use of Qutenza for any other indication is considered experimental/investigational, and therefore, not covered. A participating, preferred, or network provider can bill the member for the non-covered service.

NOTE:

Coverage for Qutenza is determined according to individual or group customer benefits.

Description

Qutenza® (capsaicin) 8% patch contains capsaicin in a localized dermal delivery system. Capsaicin, the primary pungent ingredient in hot chili peppers, is a transient receptor potential vanilloid 1 receptor (TRPV1) agonist. TRPV1 is an ion channel-receptor complex expressed on nociceptive nerve fibers in the skin. Topical administration of capsaicin causes an initial stimulation of the TRPV1-expressing cutaneous nociceptors, resulting in painful sensations. This is followed by pain relief thought to be mediated by a reduction in TRPV1-expressing nociceptor nerve endings. 

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition.

Dubinsky RM, Kabbani H, El-Chami Z, Bootwell C, Ali H. Practice parameter: Treatment of postherpetic neuralgia. An evidence-based report of the quality standards subcommittee of the American Academy of Neurology. Neurology. 2004;63:959-965.

McCleane G. Topical analgesics. Med Clin North Am. 2007;91(1):125-39.

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;7:1106-1112.

Qutenza® (capsaicin) 8% patch [package insert]. San Mateo, CA: NeurogesX, Inc;11/2009.

Irving GA, Backonja MM, Dunteman E, et al. A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. Pain Med. 2010. [Epub ahead of print].

Webster LR, Malan TP, Tuchman MM, Mollen MD, Tobias JK, Vanhove GF. A multicenter, randomized, double-blind, controlled dose finding study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. J Pain. 2010;11(10):972-982.

Webster LR, Tark M, Rauck R, Tobias JK, Vanhove GF. Effect of duration of postherpetic neuralgia on efficacy analyses in a multicenter, randomized, controlled study of NGX-4010, and 8% capsaicin patch evaluated for the treatment of postherpetic neuralgia. BMC Neurology. 2010;10:92-103.