Lidocaine Transdermal (Lidoderm, ZTlido) Form

Lidocaine (Lidoderm®, ZTlido™) is an amide-type local anesthetic agent.
FDA Approved Indication(s) Lidoderm is indicated for relief of pain associated with post-herpetic neuralgia. ZTlido is indicated for relief of pain associated with post-herpetic neuralgia in adults. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Lidoderm and ZTlido are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Post-herpetic Neuralgia Secondary to Herpes Zoster (must meet all):

1. Diagnosis of post-herpetic neuralgia secondary to herpes zoster;
2. Age ≥ 18 years;
3. For requests exceeding a 30 day supply (> 90 patches), member must meet both of the following (a and b):
   a. Failure of a ≥ 30 day trial of gabapentin at doses ≥ 1,800 mg/day, unless contraindicated or clinically significant adverse effects are experienced;
   b. If member is ≤ 64 years of age: Failure of a ≥ 30 day trial of one tricyclic antidepressant (TCA) (e.g., amitriptyline, nortriptyline, desipramine), unless contraindicated or clinically significant adverse effects are experienced;
   4. Member must use generic lidocaine transdermal patch, unless contraindicated or clinically significant adverse effects are experienced;
   5. Request does not exceed 3 patches per day. Approval duration: 6 months B. Diabetic Neuropathy (off-label) (must meet all):
   6. Diagnosis of diabetic neuropathy;
4. Age ≥ 18 years;
5. Request is for Lidoderm;

6. Member must use generic lidocaine transdermal patch, unless contraindicated or clinically significant adverse effects are experienced; Page 1 of 8

   CLINICAL POLICY Lidocaine Transdermal

   5. For requests exceeding a 30 day supply (> 90 patches), member must meet all of the following (a, b, and c):
      a. Failure of a ≥ 30 day trial of gabapentin at doses ≥ 1,800 mg/day, unless contraindicated or clinically significant adverse effects are experienced; b. If member is ≤ 64 years of age: Failure of a ≥ 30 day trial of one TCA (amitriptyline, nortriptyline, desipramine, imipramine) at up to maximally indicated doses, unless all are contraindicated or clinically significant adverse effects are experienced; c. Failure of a ≥ 30 day trial of a serotonin-norepinephrine reuptake inhibitor (duloxetine, extended-release venlafaxine) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
   6. Request does not exceed 3 patches per day. Approval duration: 6 months C. Other diagnoses/indications (must meet 1 or 2):
   7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. All Indications in Section I (must meet all):
   9. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
7. Member is responding positively to therapy;

8. If request is for a dose increase, new dose does not exceed 3 patches per day. Approval duration: 12 months Page 2 of 8

   CLINICAL POLICY Lidocaine Transdermal B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
      IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration TCA: tricyclic antidepressant Appendix B: Therapeutic Alternatives
      This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
      Dosing Regimen Drug Name Generic lidocaine transdermal patch 5% (Lidoderm) TCAs amitriptyline (Elavil®)
      Dose Limit/ Maximum Dose 3 patches/day for a maximum of 12 hours Apply up to 3 patches to intact skin to cover the most painful area for up to 12 hours in a 24-hour period. Diabetic Peripheral Neuropathy* 25 mg to 100 mg PO QD 150 mg/day† Post-herpetic Neuralgia** 25 mg to 137.5 mg (median: 75 mg) PO QHS
      Page 3 of 8

   CLINICAL POLICY Lidocaine Transdermal Drug Name Dosing Regimen desipramine (Norpramin®) imipramine (Tofranil®, Tofranil PM®) nortriptyline (Pamelor®) Diabetic Peripheral Neuropathy Initially 25 mg PO QHS, then titrate as tolerated to efficacy (usual range: 75 mg to 150 mg PO QHS) Post-herpetic Neuralgia 10 to 25 mg PO QHS and titrate to pain relief as tolerated (in one study, mean dose was 167 mg/day) Diabetic Peripheral Neuropathy 50 mg to 150 mg PO QHS Diabetic Peripheral Neuropathy 50 mg to 75 mg PO daily Post-herpetic Neuralgia 75 mg to 150 mg PO daily Serotonin/Norepinephrine Reuptake Inhibitors duloxetine (Cymbalta®) Diabetic Peripheral Neuropathy 60 mg PO QD venlafaxine (extended- release) (Effexor XR®) Miscellaneous gabapentin (immediate- release: Neurontin®; extended-release: Horizant®, Gralise®) Diabetic Peripheral Neuropathy 75 mg to 225 mg PO QD Diabetic Peripheral Neuropathy** Immediate-release: 300 mg PO TID titrated based on clinical response Post-herpetic Neuralgia Immediate-release: 300 mg PO QD on day 1, 300 mg PO BID on day 2, 300 mg PO TID on day 3, then titrate as needed to 1,800 mg/day Extended-release (Gralise): 300 mg PO on day 1, 600 mg on day 2, 900 mg on days 3-6, 1,200 mg on days 7-10, 1,500 mg on days 11-14, and 1,800 mg on day 15 and thereafter Extended-release (Horizant): 600 mg/day PO for 3 days, 600 mg PO BID on day 4 and thereafter Dose Limit/ Maximum Dose 200 mg/day† 150 mg/day 150 mg/day 60 mg/day 225 mg/day Immediate release: 3600 mg/day† Gralise: 1,800 mg/day† Horizant: 1,200 mg/day† Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Page 4 of 8

   CLINICAL POLICY Lidocaine Transdermal Agents not included in this list may not have evidence supporting their use in the indications covered by this policy *Off-label use †Maximum dose for drug, not necessarily indication Appendix C: Contraindications/Boxed Warnings • Contraindication(s): history of sensitivity to local anesthetics of the amide type, or to any other component of the product • Boxed warning(s): none reported V. Dosage and Administration
   Indication Post-herpetic neuralgia Diabetic neuropathy† (Lidoderm only) Dosing Regimen Apply up to 3 patches at once to intact skin to cover the most painful area for up to 12 hours in a 24-hour period. Apply up to 4 patches topically to the most painful area (Max recommended by manufacturer: 3 patches to the most painful area). Wear for up to 12 hours within a 24-hour period; however, some studies allowed patches to remain in place for up to 18 hours. Maximum Dose 3 patches/day for a maximum of 12 hours Optimal dosage has not been determined (max recommended by manufacturer: 3 patches/day for a maximum of 12 hours) †Off-label indication VI. Product Availability
   Drug Name lidocaine patch (Lidoderm) lidocaine topical system (ZTlido) Availability Transdermal patch: 5% Topical system: 1.8% VII.