LCD/NCD Portal

L31245

 

QUTENZA® (CAPSAICIN) 8% PATCH

 

01/01/2011

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Qutenza ® harnesses the power of capsaicin in a localized dermal delivery system and has the following characteristics:

• Qutenza ® is a single, 1 hour, localized treatment that can provide prolonged pain relief and should not be applied more frequently than every 12-week, as warranted by the return of pain.

• Qutenza ® is a non-narcotic therapy option that may be used alone or in combination with other PHN treatments.

• Qutenza ® contains high concentration capsaicin in a localized dermal delivery system that targets the nerve endings in the skin.

• Application of the patch can be quite painful, requiring use of a local topical anesthetic, as well as additional pain relief such as ice or use of opioid pain relievers.

• For safe and proper administration, only physicians or healthcare professionals under the close supervision of a physician are to administer Qutenza ®.

• The following warnings and precautions should be followed:

o Qutenza ® should not be applied to the face or scalp to avoid risk of exposure to the eyes or mucous membranes.

o The patient’s blood pressure should be monitored during and following treatment with Qutenza ®.

o Patients with unstable or poorly controlled hypertension, a recent history of cardiovascular or cerebrovascular events may be at an increased risk of adverse cardiovascular effects.

o Inhalation of airborne capsaicin can result in coughing or sneezing.

Indications

 

First Coast Service Options, Inc. (FCSO) Medicare will cover Qutenza ® (capsaicin) 8% patch for the FDA approved indication of neuropathic pain associated with PHN when all the following conditions are met:

• The patient has a diagnosis of painful PHN.

• The patient is having moderate to severe neuropathic pain below the head in one or more areas due to PHN.

• The patient has intact and unbroken skin with good perfusion over the painful area(s).

 

Limitations

 

FCSO Medicare WILL NOT COVER Qutenza ® (capsaicin) 8% patch for the FDA indication of neuropathic pain associated with PHN if any of the following conditions are present:

• The patient has hypertension that is not adequately controlled with medication.

• The patient has significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may put the patient at risk of adverse effects with treatment of Qutenza ® (capsaicin) 8% patch.

• The patient has hypersensitivity to capsaicin (i.e., chili peppers or over-the counter [OTC] capsaicin products), local anesthetics, or adhesives.

 

CPT/HCPCS Codes

 

 

J7335 CAPSAICIN 8% PATCH, PER 10 SQUARE CENTIMETERS

 

 

ICD-9 Codes that Support Medical Necessity

 

 

053.10 HERPES ZOSTER WITH UNSPECIFIED NERVOUS SYSTEM COMPLICATION

053.13 POSTHERPETIC POLYNEUROPATHY

053.19 HERPES ZOSTER WITH OTHER NERVOUS SYSTEM COMPLICATIONS

 

 

Documentation Requirements

• It is expected that this service is performed within the parameters of acceptable standards of medical practice as outlined in the FDA label for approved indication, application, and precautions.

• Medical record documentation must support the medical necessity for this service, the area(s) treated, as well as pre and post condition of the patient.

• This documentation must be made available to Medicare upon request.

 

Utilization Guidelines

• Distribution of Qutenza® is through a network of specialty pharmacies and specialty distributors to limit the possibility that this product would be dispensed to a patient for self-administration.

o Qutenza® will be sent directly to sites of care, such as physicians’ offices and hospital outpatient clinics, where it can be appropriately applied.

o Given its administration requirements, it is expected that Qutenza® would be administered by pain specialists in their offices.

o However, other qualified specialties who may be managing the patient’s pain may administer this treatment when all the criteria under the “Indications and Limitations of Coverage and/or Medical Necessity” section of this LCD are met.

• Qutenza® (capsaicin) 8% patch may not be applied more frequently than every 3 months, and only when warranted by the return of PHN pain as outlined under the “Indications and Limitations of Coverage and/or Medical Necessity” section of this LCD.

• Dosage and Administration

o Refer to the FDA label for Qutenza® (capsaicin) 8% patch for information on the administration of this drug.

• Dosage forms and strengths .

o Qutenza® patch contains 8% capsaicin (640 mcg/cm²). Each patch contains a total of 179 mg. of capsaicin.

 

Treatment Logic

• Shingles or herpes zoster rash is a painful viral infection caused by a reactivation of the varicella-zoster virus (human herpes virus, type 3) that causes chickenpox.

• Post herpetic neuralgia (PHN) is a rare, painful complication of shingles, a result of nerve damage caused by the shingles virus.

• The pain can persist long after the shingles rash clears up and can disrupt sleep, mood, work, and the person’s activities of daily living.

• Qutenza ® (capsaicin) 8% patch is a TRPV1 channel agonist approved by the Food and Drug Administration (FDA) for the management of neuropathic pain associated with PHN.

• The active ingredient in Qutenza ® is a synthetic form of capsaicin, the substance in chili peppers that gives them their heat sensation.

 

Sources of Information and Basis for Decision

 

ClinicalTrials.gov. (2008). NGX-4010 for the treatment of postherpetic neuralgia. Food and Drug Administration. (NCT00115310, NCT00061776, NCT00068081, & NCT00300222).

 

FCSO LCD 31245, Qutenza® (capsaicin) 8% patch, 01/01/2011. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Food and Drug Administration (FDA) prescribing information for Qutenza&® (capsaicin) 8% patch. (2009).

 

NeurogesX. (2010). Submission of evidenced-based clinical and economic data in support of formulary consideration: Qutenza®(capsaicin) 8% patch. Academy of Managed Care Pharmacy (AMCP) formulary submission.

 

Whitley, R., Volpi, A., McKendrick, M., van Wijck, A., & Oaklander, A. (2010). Management of herpes zoster and post-herpetic neuralgia now and in the future. Journal of clinical Virology 48 S1, S20-S28.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

CMS LCD L31245 Qutenza® (capsaicin) 8% patch