Download MDWISE PRIOR AUTHORIZATION CRITERIA

MDWISE STEP THERAPY CRITERIA
SCABICIDES AND PEDICULICIDES
FORMULARY STATUS Preferred, Pays at Point of Sale
PERMETHRIN OTC Lotion / cream rinse and liquid: 1% (Quantity Limit 120ml)
PYRETHRINS/PIPERONYL BUTOXIDE OTC Shampoo: 0.33%/4% (Quantity Limit 120ml)
FORMULARY STATUS Preferred, Requires Step Therapy (Second-Line)
LINDANE Shampoo: 1% (Quantity Limit 60ml)
OVIDE® (malathion) Lotion: 0.5% (Quantity Limit 60ml)
ULESFIA™ (benzyl alcohol) Lotion: 5% (Quantity Limit 48oz)
NOTE: Patient must meet criteria #1 for initial approval of PA request.
PA CRITERIA FOR APPROVAL:
1. Diagnosis of pediculus capitus (head lice and its eggs).
AND
2. Documented trial and failure of a first line agent (permethrin or pyrethrin/piperonyl butoxide) within the
previous 45 days, but no earlier than 21 days after the original fill.
If the above conditions are met, the request will be approved. If the above conditions are not met, the
request will be referred to a Medical Director for medical necessity review.
PA CRITERIA FOR RENEWAL:
1. Ovide and Ulesfia can be approved for a second treatment if live lice are present 7-9 days after the
initial treatment.
If the above condition is met, the request will be approved for a maximum of 2 treatments in a 30 day period.
If the above conditions are not met, the request will be referred to a Medical Director for medical necessity
review.
FDA INDICATIONS
Permethrin (lotion /cream rinse and liquid): Treatment of head lice (Pediculus humanus capitus) and its nits
(eggs).
Pyrethrins/piperonyl butoxide (shampoo): Treatment of infestations of head lice, body lice, and pubic (crab)
lice and their eggs.
Lindane (shampoo): Treatment of head lice (Pediculosis humanus capitis), crab lice (Pthirus pubis), and
their ova only in patients who have failed or cannot tolerate other approved therapies. The CDC
recommends this agent not be used in infants and children less than 2 years old.
Ovide (lotion): Indicated for patients infested with Pediculus humanus capitus (head lice and their ova) of the
scalp hair in patients ≥ 6 years old.
Ulesfia (lotion): Indicated for the topical treatment of head lice infestation in patients 6 months of age and
older. Ulesfia does not have ovicidal activity.
DOSAGE AND ADMINISTRATION
Permethrin (lotion /cream rinse and liquid): About 30-60ml of the cream rinse should be applied to washed
and towel dried hair and allowed to remain for 10 minutes, and then rinsed with water. Repeat application if
lice are still present after 7-10 days.
Pyrethrins with piperonyl butoxide: Apply shampoo to dry hair and leave on for 10 minutes, then shampoo.
Second treatment is recommended 7 days after initial treatment.
Lindane (shampoo): Shampoo should be applied to hair that is clean and completely dry without adding
water. The shampoo should be worked into the hair and allowed to remain in place for 4 minutes only and
then rinse. No more than 2 ounces (60ml) should be dispensed for larger adults. DO NOT REPEAT.
Ovide (lotion): Apply to dry hair until the scalp and hair are thoroughly coated, allow hair to naturally dry for
8-12 hours then thoroughly wash hair. If lice are present after 7-9 days repeat application.
Ulesfia (lotion): Using the guidelines below, apply sufficient Ulesfia lotion to dry hair to completely saturate
the scalp and hair. Leave on for 10 minutes then thoroughly rinse off with water. Repeat treatment after 7
days to get rid of lice that hatched from eggs.
Hair Length (inches)
0-2
Short
2-4
4-8
Medium
8-16
16-22
Long
Over 22
Amount of Ulesfia Lotion Per Treatment
4-6 oz (1/2-3/4 bottle)
6-8 oz (3/4-1 bottle)
8-12 oz (1-1.5 bottles)
12-24 oz (1.5-3 bottles)
24-32 oz (3-4 bottles)
32-48 oz (4-6 bottles)
BOXED WARNING:
Seizures and deaths have been reported following Lindane (shampoo) use with repeat or prolonged
application, but also in rare cases following a single application according to directions. Lindane shampoo
should be used with caution in infants, children, the elderly, and individuals with other skin conditions, and
those who weigh <110 lbs (50 kg) as they may be at risk of serious neurotoxicity. It is contraindicated in
premature infants and individuals with known uncontrolled seizure disorders.
REFERENCES
1. McEvoy GK, editor. Scabicies and Pediculicides. American Society of Health System Pharmacists
(AHFS) Drug Information 2006. 84:04.12: 3438-3450.
2. Clark, L et al. Therapy for Head Lice Based on Life Cycle, Resistance, and Safety Considerations.
Pediactrics 2007. 119; 965-974.
3. Ross K. Head Lice, Resistance, and Malathion. Pediactrics 2008; 121;222.
4. Eyerdam, DH et al. A Randomized, Investigator-Blinded Time Ranging Study of Comparative Efficacy of
0.5% Malathione Gel Versus Ovide Lotion (0.5% Malathion) of Nix Crème Tinse (1% Permethrin) Use
as Labeled, for the Treatment of Head Lice. Pediactric Dermatology 2007; 405-411.
5. Facts and Comparisons, St. Louis, eFacts 2010 CliniSphere Version ISBN 1-57439-036-8.
6. Drugdex In: Micromedex Healthcare Series. 2010. Available from: http://www.thomsonhc.com.
Accessed July 2010.
7. Ovide Prescribing Information. Taro Pharmaceuticals USA. July 2005. Lindane Prescribing Information.
Morton Grove Pharmaceuticals Inc. June 2005.
8. Ulesfia Prescribing Information. Sciele Pharma, Inc. April 2009.
Revision/Review Date: MAC 10/12/2011
Associated Policy: Prior Authorization of Medications 236.200