Coverage Policy Manual
Policy #: 2010000
Category: Medicine
Initiated: June 2010
Last Review: October 2018
  Capsaicin (Qutenza) for the Treatment of Post-Herpetic Neuralgia

Description:
Varicella zoster virus (VZV) is an exclusively human virus, affecting approximately 1,000,000 individuals in the U.S. per year (Gilden, 2009).  An acute infection with VZV causes chicken pox.   After an acute infection, the virus becomes dormant in cranial, dorsal root and autonomic ganglia. With advancing age or immunosuppression, the virus reactivates causing herpes zoster (shingles) rash.  Herpes zoster usually begins with pain, itching, burning or tingling sensation followed by an eruption of a rash.  The rash normally heals within 4-6 weeks followed by complete resolution of pain.  However, about 10-20% of herpes zoster (shingles) patients will experience postherpetic neuralgia (PHN) which is characterized by constant, severe pain despite healing of the rash.  PHN can last for at least three months and sometimes even years.
 
Management of PHN is difficult. Treatment strategies are aimed at limiting viral replication and pain control.  Capsaicin cream has been used for the treatment of pain related to PHN. Capsaicin is an agonist for the Transient Receptor Potential Vanilloid 1 receptor (TRPV1), which is an ion channel-receptor complex selectively expressed on nociceptive nerve fibers in the skin.  Topical administration of capsaicin causes an initial enhanced stimulation of the tRPV-1-expressing cutaneous nociceptors that may be associated with painful sensations.  This is followed by pain relief thought to be mediated by a reduction in TRPV-1-expressing nociceptor nerve endings.  
 
Qutenza ® (capsaicin) 8% patch contains a synthetic equivalent of the naturally occurring compound found in chili peppers.  Qutenza must be administered by or under the close supervision of a physician.   Application of the patch can cause a large degree of discomfort and may cause an increase in blood pressure.  The patch may be administered every 3 months, but not more frequently than every 3 months.
 
Qutenza® received approval from the U.S. Food and Drug Administration (FDA) on November 16, 2010 for the management of neuropathic pain associated with postherpetic neuralgia.  The patch is manufactured by Lohmann Therapie-Systems AD of Andernach, Germany and is distributed by NeurogesX Inc. of San Mateo, CA.
 
There is not a specific CPT or HCPCS code for the application of the Qutenza® patch.  Application of the patch would be billed with an E/M code that should reflect the level of complexity of the visit.
  

Policy/
Coverage:
The use of the Qutenza® (capsaicin) 8% patch meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the management of pain associated with postherpetic neuralgia in patients who meet ALL of the following criteria:
 
    • Aged 18 years or older
    • PHN persisting for at least 6 months
    • Healed herpes zoster rash
 
(Note: The patch may not be administered more frequently than every 3 months)
 
The use of the Qutenza® (capsaicin) patch for all other indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria, the use of the Qutenza® (capsaicin) patch for all other indications is considered investigational.  Investigational services are contract exclusions in most member benefit certificates of coverage.
 

Rationale:
This policy is based on the FDA approval of the Qutenza® (capsaicin) 8% patch.  According to the prescribing information provided by Neurogesx, Inc., the effectiveness of the patch was established in two double-blind, randomized, placebo-controlled trials.  Patients (N=401 and N=416) over the age of 18 with postherpetic neuralgia were randomized to receive either a Qutenza® patch or a low-dose capsaicin control patch.  According to the manufacturer, in both trials, the group receiving Qutenza® demonstrated a greater reduction in pain compared to the control group for the primary assessment at week 8 as measured by the percent change in average pain from baseline.
 
Backonja and colleagues published results of one study in which a total of 402 patients were randomized. Patients who were randomized to the Qutenza® patch had a significantly larger reduction in pain during weeks 2 through 8 than did patients in the control group. Eighty-seven patients (42%) had a >30% reduction in mean numeric pain rating scale (NPRS). Transient blood pressure changes and erythema and pain at the application site were reported.
 
The Qutenza® patch has also been studied for the treatment of patients with painful HIV-associated neuropathy (Simpson, 2008). In a double-blind multicenter study, 307 patients with painful HIV-associated distal sensory polyneuropathy were randomized to receive either application of capsaicin dermal patch or a low-concentration control patch. The primary efficacy endpoint was percent change in NPRS from baseline in mean “average pain for past 24 hours” scores from weeks 2 to 12. Patients that received a single application of capsaicin dermal patch had a mean pain reduction of 22.8% compared to a 10.7% reduction in the control group.  Although results of this study are promising, at this time, the Qutenza® (capsaicin) 8% patch is FDA approved only for the treatment of the management of pain associated with postherpetic neuralgia.
 
2014 Update
A literature search conducted through August 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
One double-blind study by Martini and colleagues was identified (Martini, 2013). Data from four double-blind, randomized controlled trials on the efficacy of topical capsaicin 8% (Qutenza) versus an active control (capsaicin 0.04%) in patients with postherpetic neuropathic pain were combined. Longitudinal pharmacodynamic, mixture and covariate analyses were performed on the pooled dataset. Data from 1248 patients treated with Qutenza (n = 722) or topical low-dose capsaicin 0.04% (n = 526) were successfully analysed. Five distinct response subgroups were detected with different treatment efficacies, including a group of non-responders, a group showing partial analgesic effect and a group showing full analgesic effect. Active control and Qutenza had similar response profiles, but the proportional distribution of patients among the five response groups was in favour of Qutenza, with 40% less non-responders and 25% more patients showing a full analgesic response. For Qutenza, important predictors of efficacy were efficacy of lidocaine pretreatment and greater pretreatment pain score variability.
 
The analyses indicate the existence of different response groups to treatment with Qutenza and an active control patch that may possibly be related to different pain mechanisms among these groups, despite a presumed common underlying disease process, and that require different treatment approaches among subgroups.
 
2015 Update
A literature search conducted through August 2015 did not reveal any new information that would prompt a change in the coverage statement.  
 
2016 Update
A literature search conducted through August 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Katz and colleagues conducted a meta-analysis of 6 completed randomized and controlled Qutenza studies by pooling individual patient data. Sustained response was defined as>50% decrease in the mean pain intensity from baseline to weeks 2 to 12, and Complete Response as an average pain intensity score≤1 during weeks 2 to 12. Logistic regression was used to identify predictors of response and Complete Response, and subgroups of patients who respond best to the capsaicin patch (Katz, 2015). Baseline pain intensity score (BPIS)≤4 was a predictor of Sustained and Complete Response in PHN and HIV-AN patients; absence of allodynia and presence of hypoesthesia, and a McGill Pain Questionnaire (MPQ) sensory score <22 were predictors of Sustained Response in PHN patients; female sex was a predictor of Sustained and Complete Response in HIV-AN patients. Thus, characteristics associated with the highest chance of responding to the capsaicin patch were, for PHN, BPIS≤4, MPQ sensory score≤22, absence of allodynia, and presence of hypoesthesia; for HIV-AN, they were female sex and BPIS≤4. Patients with these characteristics had a statistically significantly greater chance of responding to the capsaicin patch than other patients.
 
2017 Update
A literature search conducted through August 2017 did not reveal any new information that would prompt a change in the coverage statement.  
 
2018 Update
A literature search conducted through September 2018 did not reveal any new information that would prompt a change in the coverage statement.

CPT/HCPCS:
J7336Capsaicin 8% patch, per sq cm

References: Backonja M, Wallace MS, Blonsky ER, et al.(2008) NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol. 2008 Dec;7(12):1106-12. Epub 2008 Oct 30.

Gilden D, Nagel MA, Mahalingam R, et al.(2009) Clinical and molecular aspects of varicella zoster virus infection. Futue Neurol. 2009 January 1; 4(1):103-117.

Katz NP, Mou J, Paillard FC, et al.(2015) Predictors of Response in Patients With Postherpetic Neuralgia and HIV-Associated Neuropathy Treated With the 8% Capsaicin Patch (Qutenza). Clin J Pain. 2015 Oct;31(10):859-66.

Martini CH1, Yassen A, Krebs-Brown A, et al.(2013) A novel approach to identify responder subgroups and predictors of response to low- and high-dose capsaicin patches in postherpetic neuralgia. Eur J Pain. 2013 Nov;17(10):1491-501. doi: 10.1002/j.1532-2149.2013.00329.x. Epub 2013 May 6.

Qutenza Prescribing Information. http://www.qutenza.com/_docs/qutenza_full_PI_.pdf. Last accessed June 2010.

Simpson DM, Brown S, Tobias J: NGX-4010 Study Group.(2008) Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. Neurology. 2008 Jun 10;70(24):2305-13.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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