Subject: Dermatologic Anesthetics

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	anestacon (lidocaine gel 2%)
C	lidocaine solution/gel
C	lidocaine viscous soln
C	lidocaine ointment 5%
C	lidocaine/prilocaine
C	lidomar (lidocaine viscous soln)
C	Lidoderm disc®  (lidocaine patch)
CS	LidoSite®  (lidocaine/epinephrine iontophoretic patch)	X	X	X		X	X
NC	EMLA cream ®  (lidocaine/prilocaine)						X
NC	Synera®  (lidocaine/tetracaine patch)		X			X	X
NC	Xylocaine®  (lidocaine viscous solution)						X

Policy:

1. Precertification Criteria

Medicare Part B vs. Part D Review Criteria

Under Medicare prescription drug benefit plans, including plans that use an open or closed formulary, LidoSite is subject to review because they may be considered to be either a Medicare Part B drug or a Medicare Part D drug.  

Medicare Part B Criteria:

LidoSite will be considered to be a Medicare Part B drug and medically necessary for those members who meet the following precertification criteria:

A. The indication for which the drug is being prescribed is covered under Part B as determined by 
the physician's local carrier.

Medicare Part D Criteria:

LidoSite will be considered to be Medicare Part D drugs and medically necessary for those members who meet the following precertification criteria:

A. The indication for which the drug is being prescribed is an approved indication in the drug 
labeling or CMS approved compendia and is not being covered by the physician's local carrier.


Additional Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Lidosite and Synera is subject to precertification.   If precertification requirements apply Aetna considers Lidosite and Synera to be medically necessary for those members who meet the following precertification criteria:
 
For LidoSite (A and B) and Synera (A ONLY)

A.  A documented diagnosis where a member requires a superficial dermatological procedure such as venipuncture (blood test), intravenous cannulation, excision, electrodesiccation, or laser ablation of superficial skin lesions and local analgesia is needed.

AND

B.  Quantity limits: According to the manufacturer, LidoSite can be dosed up to a maximum daily dose at the interval(s) as indicated in the table below.  A quantity of this drug will be considered medically necessary as indicated in the table below:


Drug	Maximum Daily Dose/ Dosing Interval	Dosage Strength	Quantity Limits
LidoSite	1 patch/ Prior to superficial dermatological procedures such as venipuncture, intravenous cannulation, and laser ablation of superficial skin lesions; Current delivery lasts for 10 minutes following actuation of the LidoSite Controller- In clinical studies the medical procedure was initiated within 10 minutes of patch removal.(A new patch may be applied to a different skin site after 30 minutes)	10% lidocaine/ 0.1% epinephrine	Up to 25 patches in 30 days





For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of LidoSite will be considered medically necessary for those members who meet the following criteria:

• Member is undergoing more than 25 procedures requiring dermal analgesia in a 30-day period
  OR 
• Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.
  



2. Step Therapy Criteria

Under some plans, including plans that use an open or closed formulary, Lidosite and Synera  is subject to step-therapy.  Aetna considers Synera to be medically necessary for those members who meet the following step-therapy criteria:

A documented trial of lidocaine/prilocaine - a generic alternative on the Aetna Medicare Preferred Drug List.

If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below.)


3. Medical Exception Criteria

EMLA, Lidosite, Synera and Xylocaine are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.*  Therefore, they are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers EMLA, Lidosite, Synera and Xylocaine to be medically necessary for those members who meet the following criteria:

For  EMLA and Xylocaine

A. A documented

• Contraindication to one preferred dermal anesthetic alternative  OR
• Intolerance to one preferred dermal anesthetic alternative OR
• Allergy to one preferred dermal anesthetic alternative OR
• Failure of an adequate trial of one month of one preferred dermal anesthetic alternative

For LidoSite and Synera

A.  A documented diagnosis where a member requires a superficial dermatological procedure such as venipuncture (blood test), intravenous cannulation, excision, electrodesiccation, or laser ablation of superficial skin lesions and local analgesia is needed.

AND

B.  A documented:

• Contraindication to the preferred generic alternative, lidocaine/prilocaine OR
• Intolerance to the preferred generic alternative, lidocaine/prilocaine OR
• Allergy to the preferred generic alternative, lidocaine/prilocaine OR
• Failure of an adequate trial of one use of the preferred generic alternative, lidocaine/prilocaine
  

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
7. Fick DM, Cooper JW, Wade WE, et al.  Updating the Beers criteria for potentially inappropriate medication use in older adults.  Arch Intern Med. 2003;163:2716-24.
8. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.

Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 30, 2009