Prior authorization criteria for Qutenza (capsaicin) topical patch
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Prior authorization criteria for Qutenza (capsaicin) patches for treatment of neuropathic pain (PHN or DPN of the feet) for Alaska Medicaid members; describes approval, denial, cautions, duration, and quantity limits.
No material clinical or coverage changes in this revision.
Coverage Criteria for Qutenza (capsaicin) Patch
Initial approval
Covered when ALL of the following are met
Approval criteria
All alternatives (member must have failed or be contraindicated to each of the following)
- a: Gabapentin or pregabalin
- b: Any tricyclic antidepressant
- c: Topical diclofenac
- d: Lidocaine 5% patch
Include safety cautions and applicability: Qutenza patches must be applied by a licensed health care professional and are not appropriate for self-administration. Do not apply on or near the eyes or on mucous membranes because unintended capsaicin exposure can cause severe irritation. Be aware that application can cause transient increases in blood pressure, substantial burning or pain, and reductions in sensory function; these risks inform patient selection and monitoring during and immediately after application.
If the request does not meet the listed approval criteria (for example, the member is under the age threshold, does not have an eligible diagnosis, lacks required prior trials or documented contraindications, or the product will not be applied by a licensed health care professional), the service is considered not medically necessary and the prior authorization request will be denied.
Provider Requirements, Authorization, and Documentation
Prior authorization, duration, and quantity limits
Prior authorization is required. Initial approvals are for 1 month; reauthorization may be approved for up to 12 months. Quantity is limited to up to 4 patches per application, and the dose may be repeated up to once every 90 days.
Required prior medication trials (step therapy)
Patient must have tried and failed for a minimum of four weeks at a recognized therapeutic dose or have a documented contraindication to ALL of the following: gabapentin or pregabalin; any tricyclic antidepressant; topical diclofenac; lidocaine 5% patch.
- Minimum trial duration: 4 weeks
- Required agents: gabapentin or pregabalin; any tricyclic antidepressant; topical diclofenac; lidocaine 5% patch
Required documentation to support authorization
Document that the patient is ≥ 18 years of age, has a diagnosis of neuropathic pain due to postherpetic neuralgia (PHN) or diabetic peripheral neuropathy (DPN) of the feet, and has completed the required prior trials or has documented contraindications to all listed therapies. Also document that application will be performed by a licensed health care professional.
- Age ≥ 18 years
- Diagnosis: PHN OR DPN of the feet
- Records of prior trials (duration and dose) or documented contraindications to each required agent
- Confirmation that a licensed health care professional will perform the application
Denial for unmet approval criteria
Requests that do not meet the approval criteria (age, diagnosis, required prior trials or documented contraindications, or professional application) will be denied.
Required Conservative Therapies Before Approval
Trials of gabapentin or pregabalin; any tricyclic antidepressant; topical diclofenac; lidocaine 5% patch — 4 week trial requirements
Minimum trial requirements before approval
Trials should be at recognized therapeutic doses and documented in the record.
Application Frequency and Quantity Limits
Definitions
Background
Qutenza is a high‑concentration topical capsaicin patch (a TRPV1 agonist) used for localized neuropathic pain. It is indicated for neuropathic pain associated with postherpetic neuralgia and for diabetic peripheral neuropathy of the feet. Because of its potency, application is performed by a licensed health care professional; unintended exposure may cause severe irritation and other transient adverse effects such as increased blood pressure, substantial burning/pain, and sensory changes.
Not Covered
Not covered: Self-administration of Qutenza patches is not appropriate and therefore is not covered. Do not use the product on or near the eyes or on mucous membranes due to the risk of severe irritation from unintended capsaicin exposure.
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