Topical Lidocaine - NC Standard

Restricted Product(s)

• Lidocaine 5% ointment 
• Lidocaine-Prilocaine 2.5-2.5% cream 
• Lidoderm® (lidocaine patch 5%) 
• Pliaglis® (Lidocaine-tetracaine cream 7%/7%) 
• Synera® (lidocaine-tetracaine) patch 
• ZTLido™ (lidocaine topical system) 1.8% 

FDA Approved Use

• Lidocaine 5% ointment 
  • Anesthesia of accessible mucous membranes of the oropharynx o Anesthetic lubricant for intubation 
  • Temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites 
• Lidocaine-Prilocaine 2.5-2.5% cream 
  • For use on normal intact skin to provide local analgesia, for use on genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia
• Pliaglis (Lidocaine-tetracaine cream 7%/7%) 
  • Use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal. 
• Lidoderm and ZTLido 
  • for the relief of pain associated with post-herpetic neuralgia 
• Synera (lidocaine-tetracaine) patch 
  • For use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions

Criteria for Approval of Restricted Product(s)

1. The request is for lidocaine 5% patch, Lidoderm or ZTLido; AND 
   1. The patient is using for pain associated with post-herpetic neuralgia; OR 
2. The request is for lidocaine 5% ointment; AND
   1. The patient will use the ointment for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites; AND i. The patient has tried and failed over-the-counter lidocaine; OR 
   2. The patient will use the ointment for anesthesia of accessible mucous membranes of the oropharynx; OR 
   3. The patient will use the ointment for anesthetic lubricant for intubation; OR 
3. The request is for Pliaglis; AND 
   1. The patient will use the product for analgesia during a non-cosmetic, superficial, dermatological procedure(s); OR 
4. The request is for Synera; AND 
   1. The patient will use the product for local dermal analgesia for superficial venous access; OR 
   2. The patient will use the product for superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions; OR 
5. The request is for lidocaine-prilocaine cream 2.5%-2.5%; AND 
   1. The patient will use on genital mucous membranes for superficial minor surgery; OR 
   2. The patient will use as pretreatment for infiltration anesthesia; OR 
   3. The patient will use on normal intact skin for local analgesia; AND 
      1. The patient has tried and failed over-the-counter lidocaine; AND 
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval:

• Lidoderm/ ZTlido: 365 days (1 year)
• Lidocaine 5% ointment: 90 days 
• Pliaglis: 90 days 
• Synera: 90 days 
• Lidocaine-Prilocaine 2.5%-2.5%: 90 days

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Jul 2021: Criteria update: Annual criteria review. Addition of Lidocaine 2.5-2.5% cream to policy. Lidoderm and ZTLido duration of approval decreased to 365 days.
Jul 2019: Criteria Change: Lidocaine 5% ointment, Pliaglis, and Synera added to criteria
Sep 2018: New to market Ztlido added to the criteria.
Jan 2017: Added quantity limit exception criteria
Jul 2011: Original utilization management criteria issued.

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