Subject:
Capsaicin 8% patch (Qutenza)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Capsaicin 8% patch (Qutenza) was FDA approved in November 2009 for the management of neuropathic pain associated with postherpetic neuralgia (PHN). Capsaicin 8% patch is an agonist for the transient receptor potential vanilloid-1 receptor (TRPV1), which is an ion channel-receptor complex expressed on nociceptive nerve fibers in the skin. Topical administration stimulates and desensitizes the TRPV1 channel and also causes local depletion of substance P, an endogenous neuropeptide involved in sensory perception and pain transmission.
A randomized, double-blind Phase III study was conducted in 418 patients to assess the safety and efficacy of capsaicin 8% patch in percent change in the mean Numeric Pain Rating Scale (NPRS) scores (0=no pain, 10= worst pain possible). Patients had an average NPRS score from 3-9 secondary to PHN with a combined surface area of ≤ 1000 cm2 with at least 6 months since shingles vesicle crusting. Patients were excluded if they had used any topical pain medication in the painful area within 21 days of the study patch application, uncontrolled diabetes, hypertension, class 1 anti-arrhythmic drug, painful PHN located on the face above the hairline of the scalp and/or in proximity to mucous membranes or hypersensitivity to capsaicin. Patients were randomized to receive either capsaicin patch 0.04% as placebo or 8% as the active arm once every 3 months. The primary endpoint is percent change in the mean NPRS scores for average pain for the past 24 hours from baseline during weeks 2 to 8. Patients were pretreated with lidocaine 4% for 60 minutes and then treated with capsaicin patch for 60 minutes. At baseline, the mean pain scores for the capsaicin 8% patch (5.7; 95% CI, 5.46 to 5.89) were similar to the control group (5.8; 95% CI, 5.54-5.99). The results showed that capsaicin 8% patch had a 32% reduction vs. the controlled group of 24.4% (p=0.0108) in the mean NPRS scores for average pain for the past 24 hours from baseline during weeks 2 to 8. Another randomized, double-blind, phase III study was conducted in 402 patients to assess efficacy and safety of capsaicin 8% patch. At baseline, the mean pain scores for the capsaicin 8% patch (6.0; 95% CI, 5.73 to 6.18) were similar to the control group (5.8; 95% CI, 5.63 to 6.05). The results showed that the capsaicin 8% patch group had a reduction of -29.6% in NPRS score compared the -19.9% reduction shown by the control group (p=0.0010). The most common adverse reactions (≥5% and greater than control) are application site erythema, application site pain, application site pruritis, and application site papules. Transient changes in blood pressure were seen on the day of treatment, and they were associated with pain after patch was applied.
In July 2020, Capsaicin 8% patch (Qutenza) was FDA approved for the treatment of adult patients with neuropathic pain associated with diabetic peripheral neuropathy of the feet.
The efficacy was established in one 12-week, double-blind, randomized, placebo-controlled, multicenter study. This study enrolled patients with neuropathic pain associated with diabetic peripheral neuropathy (DPN) diagnosed at least 1 year prior to screening and an average pain score of ≥ 4 over the baseline period on an 11-point Numerical Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (worst possible pain). QUTENZA and placebo were each applied as a single, 30-minute application. The baseline mean pain score in this study was 6.51 (SD 1.45) and was similar in both groups. Patients who entered the study on stable doses of pain-control medications were required to keep dosing stable throughout the duration of the study. Use of opioid medication other than short-acting rescue medication was not allowed during the study. Concomitant medications for neuropathic pain associated with DPN were taken during the study by 47.2% of the patients and included anticonvulsants and non-SSRI antidepressants. Prior to study patch application, a topical anesthetic was applied to the treatment area for 30 minutes. Patients were permitted to use local cooling and additional analgesic medications for treatment-related discomfort as needed through Day 5. Patients recorded their pain daily. In this 12-week study, the percent change in average pain from baseline to Week 12 was higher in the QUTENZA group compared to the placebo group. The percent change in average pain from baseline to Week 12 was -22% (±3%) for placebo and -30% (±3%) for QUTENZA. The least-squares mean change was -1.92 on the 11-point NPRS scale for QUTENZA, vs -1.37 for placebo, a least-squares mean difference of -0.56 (95% CI -0.98, -0.14).
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
1. Qutenza (capsaicin 8%) patch should be administered by a healthcare professional.
2. Qutenza (capsaicin 8%) patch is considered medically necessary when ALL of the following are met:
- Patient is 18 years or older; AND
- Patient has a diagnosis of neuropathic pain associated with postherpetic neuralgia; OR
- Patient has a diagnosis of neuropathic pain associated with diabetic peripheral neuropathy of the feet; AND
- Patient has failed or is contraindicated to two drugs from anticonvulsant and/or tri-cyclic antidepressant class (e.g. amitriptyline, desipramine, gabapentin, lyrica); AND
- Patient does not have uncontrolled diabetes (defined by A1C ≥9%) or uncontrolled hypertension, a recent history of cardiovascular or cerebrovasacular events, hypersensitivity to capsaicin, current use of class 1 anti-arrhythmic medications, or painful postherpetic neuralgia on the face above the hairline of the scalp and/or in proximity to mucous membranes
[INFORMATIONAL NOTE:
- The manufacturer recommends not breast-feeding on the day of treatment after the patch has been applied to reduce any potential infant exposure.
- Guidelines from American Academy of Neurology: Tricyclic antidepressants, the antiepileptic drug gabapentin, the lidocaine skin patch, and opioids were found to be effective in reducing pain. Aspirin cream and capsaicin were found to be below the level of benefit that is considered clinically important in treatment of chronic pain.
- Based on safety labeling in the prescribing information, transient increases in blood pressure may occur during and shortly after the Qutenza™ treatment. Blood pressure changes were associated with treatment-related increases in pain. Monitor blood pressure and provide adequate support for treatment-related pain. Patients with unstable or poorly controlled hypertension or a recent history of cardiovascular or cerebrovascular events may be at an increased risk of adverse cardiovascular events. Qutenza™ should not be used on face or scalp.]
3. When Qutenza (capsaicin 8%) patch is considered medically necessary, initial therapy will be eligible at the FDA approved dose of up to 4 patches every 3 months for an initial approval for 6 months.
[INFORMATIONAL NOTE: Based on the FDA approved package insert, Qutenza™ may be applied to the most painful skin areas, using up to four patches, for 60 minutes. Do not use Qutenza™ on broken skin. Application of Qutenza™ may be repeated not more frequently than every three months.]
4. Continued therapy will be considered annually if the member has improvement in symptoms.
5. Other uses of Qutenza (capsaicin 8%) patch are considered investigational including, but not limited to, generalized pain (non-neuropathic pain), HIV-associated neuropathic pain, psoriasis, vitiligo, intractable pruritus, phantom limb syndrome, vulvar vestibulitis, apocrine chromhidrosis, reflex sympathetic dystrophy, treprostinil (Remodulin) infusion site pain, critical ischemia in end stage renal failure, painful arteriovenous fistulae, and spinal cord injury neuropathic pain.
[INFORMATIONAL NOTE: The STEP trial (NCT01533428) recruited 369 patients to assess the safety and efficacy of a single treatment of capsaicin 8% transdermal delivery system versus placebo in reducing neuropathic pain caused by diabetes over a period approximately 12 weeks following administration. Publication is not yet available. Clinical trial NCT02171182 has finished recruiting 319 patients in the Czech Republic to assess the efficacy of capsaicin 8% patch in clinical practice for treatment of post-operative neuropathic pain.]
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL specifically for this drug. Per Local Coverage Article A53127 Self-Administered Drug Exclusion List, Medicare covers drugs that are furnished “incident to” a physician’s service provided that the drugs are medically reasonable and necessary, approved by the Food and Drug Administration (FDA) and are not usually administered by the patients who take them. Therefore, Medicare Advantage Products will cover when the Horizon BCBSNJ Medical Policy criteria are met AND the drug is furnished and administered by a licensed medical provider as part of a physician service.
For members with a Medicare drug plan (Part D) Capsaicin 8% patch (Qutenza) may be covered under that plan.
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Capsaicin 8% Patch (Qutenza)
Qutenza (Capsaicin 8% Patch)
Neuropathic Pain
Postherpetic Neuralgia
Diabetic peripheral neuropathy
References:
1. Qutenza® (Capsaicin 8% patch) Prescribing Information. NeurgesX, Inc. San Mateo, CA. July 2020.
2. Qutenza® (Capsaicin 8% patch) AMCP-Format Dossier. NeurgesX, Inc. San Mateo, CA. April 2010.
3. Backonja M et al. One 60-minute application of a high-concentration capsaicin patch (NGX-4010) significantly reduced pain for up to 3 months in patients with postherpetic neuralgia: results from a randomized, double-blind, controlled Phase 3 study. Presented at the Annual Meeting of the American Academy of Neurology (AAN) 2008.
4. Backonja M et al. One-Hour Application of NGX-4010, a High-Concentration Capsaicin Patch, in Postherpetic Neuralgia. Presented at the Annual Meeting of the American Academy of Pain Management 2008.
5. Irving G et al. An efficacy and safety analysis of a single one-hour application of NGX-4010 in patients with postherpetic neuralgia: results of a randomized, double-blind, 12-week, controlled study. Presented at the World Congress on Pain 2008.
6. 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;47(12):1106-12.
7. ClinicalTrials.gov. Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy. Available from: http://clinicaltrials.gov/ct2/show/NCT00233155?term=NGX-4010&rank=5
8. ClinicalTrials.gov. Efficacy and safety study of Topical Capsaicin in Painful Diabetic Neuropathy. Available from: http://clinicaltrials.gov/ct2/show/NCT00993070?term=qutenza&rank=6
9. ClinicalTrials.gov. Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis. Available from: http://clinicaltrials.gov/ct2/show/NCT00004316?term=qutenza&rank=24
10. ClinicalTrials.gov. Effects of Capsaicin on the Structure, Distribution, and Function of Cutaneous Small Nerve Fibers in Psoriatic Skin. Available from: http://clinicaltrials.gov/ct2/show/NCT00697034?term=qutenza&rank=3
11. Libri V, Gibbs JS, Pinato DJ, et al. Capsaicin 8% patch for treprostinil subcutaneous infusion site pain in pulmonary hypertension patients. Br J Anaesth. 2013 Sep 26. [Epub ahead of print].
12. ClinicalTrials.gov. A Phase III, Double-bblind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of Qutenza in Subjects with Painful Diabetic Peripheral Neuropathy. Available from: https://clinicaltrials.gov/ct2/show/NCT01533428?term=qutenza&rank=10
13. ClinicalTrials.gov. A Non-interventional Post-registration Clinical Study of Efficacy and Safety of Qutenza in Patients with Post-operative Peripheral Neuropathic Pain. Available at: https://clinicaltrials.gov/ct2/show/NCT02171182?term=qutenza&rank=4
14. ClinicalTrials.gov. Qutenza for Critical Ischaemia in End Stage Renal Failure. Available from https://clinicaltrials.gov/ct2/show/NCT01704339?term=qutenza&rank=5
15. ClinicalTrials.gov. Qutenza (topical capsaicin 8%) for Painful Arteriovenous Fistulae. Available from https://clinicaltrials.gov/ct2/show/NCT01748422?term=qutenza&rank=6
16. ClinicalTrials.gov. Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain (Capsaicin). Available from https://clinicaltrials.gov/ct2/show/NCT02441660?term=qutenza&rank=7
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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