Pharmacy Coverage Guidelines are subject to change as new information becomes available.

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1 PEDICULICIDE AND SCABICIDE AGENTS: ELIMITE (permethrin) 5% cream EURAX (crtamitn) 10% cream & ltin NATROBA (spinsad) 0.9% tpical suspensin OVIDE (malathin) 0.5% ltin SKLICE (ivermectin) 0.5% ltin SPINOSAD 0.9% tpical suspensin STROMECTOL (ivermectin) 3 mg tablet ULESFIA (benzyl alchl) 5% ltin Cverage fr services, prcedures, medical devices and drugs are dependent upn benefit eligibility as utlined in the member's specific benefit plan. This Pharmacy Cverage Guideline must be read in its entirety t determine cverage eligibility, if any. This Pharmacy Cverage Guideline prvides infrmatin related t cverage determinatins nly and des nt imply that a service r treatment is clinically apprpriate r inapprpriate. The prvider and the member are respnsible fr all decisins regarding the apprpriateness f care. Prviders shuld prvide BCBSAZ cmplete medical ratinale when requesting any exceptins t these guidelines. The sectin identified as Descriptin defines r describes a service, prcedure, medical device r drug and is in n way intended as a statement f medical necessity and/r cverage. The sectin identified as Criteria defines criteria t determine whether a service, prcedure, medical device r drug is cnsidered medically necessary r experimental r investigatinal. State r federal mandates, e.g., FEP prgram, may dictate that any drug, device r bilgical prduct apprved by the U.S. Fd and Drug Administratin (FDA) may nt be cnsidered experimental r investigatinal and thus the drug, device r bilgical prduct may be assessed nly n the basis f medical necessity. Pharmacy Cverage Guidelines are subject t change as new infrmatin becmes available. Fr purpses f this Pharmacy Cverage Guideline, the terms "experimental" and "investigatinal" are cnsidered t be interchangeable. BLUE CROSS, BLUE SHIELD and the Crss and Shield Symbls are registered service marks f the Blue Crss and Blue Shield Assciatin, an assciatin f independent Blue Crss and Blue Shield Plans. All ther trademarks and service marks cntained in this guideline are the prperty f their respective wners, which are nt affiliated with BCBSAZ. This Pharmacy Cverage Guideline des nt apply t FEP r ther states Blues Plans. Infrmatin abut medicatins that require precertificatin is available at Sme large (100+) benefit plan grups may custmize certain benefits, including adding r deleting precertificatin requirements. Page 1 f 7

2 PEDICULICIDE AND SCABICIDE AGENTS (cnt.) All applicable benefit plan prvisins apply, e.g., waiting perids, limitatins, exclusins, waivers and benefit maximums. Precertificatin fr medicatin(s) r prduct(s) indicated in this guideline requires cmpletin f the request frm in its entirety with the chart ntes as dcumentatin. All requested data must be prvided. Once cmpleted the frm must be signed by the prescribing prvider and faxed back t BCBSAZ Pharmacy Management at (602) r ed t Pharmacyprecert@azblue.cm. Incmplete frms r frms withut the chart ntes will be returned. Descriptin: Pediculsis (lice) and scabies are caused by ectparasites. Lice are small insects that live n the skin They are ften cnnected t hair n the scalp r in the pubic area Lice eggs (nits), are attached t the hair shaft next t the scalp, ften behind the ears r n the back f the neck Scabies is a cnditin caused by tiny mites insect-like parasites that dig under the skin Scabies mites usually dig int the skin between the fingers, r arund the ankles and wrists The areas where they dig may lk like wavy, red, raised lines n the skin Bth cnditins cause itching. With scabies the itching is ften wrse at night Pharmaclgic treatment f lice infestatin is fcused n use f tpical agents that wrk by a neurtxic actin in the parasite Agents include lindane, permethrin, pyrethrins/pipernyl butxide, crtamitn, and malathin Permethrin is recmmended as first-line treatment fr pediculsis Repeat treatment is typically required fr cmplete eradicatin and it is timed n the life cycle f the luse. Initial treatment is fllwed by a secnd treatment 7-10 days later t eradicate mst nnresistant lice Resistance t permethrin and pyrethrins/pipernyl butxide can be significant in varius cmmunities, necessitating the use f ther agents Scabies is treated with permethrin cream as a first line agent It shuld be applied t all areas f the bdy and reapplied in 1 week Itching may cntinue fr up t 2 weeks after apprpriate and effective treatment Off-label use f ral ivermectin may als be cnsidered if permethrin cannt be used r was unsuccessful Oral ivermectin is FDA-apprved fr treatment f nematde parasites strngylides stercralis and nchcera vlvulus There are n knwn differences in safety r efficacy fr all prducts except lindane Page 2 f 7

3 PEDICULICIDE AND SCABICIDE AGENTS (cnt.) Lindane may be assciated with higher rates f neurtxicity in infants, children, thse wh weigh less than 110 punds (50 kilgrams), individuals with ther skin cnditins, elderly patients r patients with uncntrlled seizure disrder r at increased risk fr seizures Pst-market cases f neurtxicity with lindane have been reprted The FDA released a drug safety cmmunicatin and revised the prescribing infrmatin Due t safety cncerns, guidelines recmmend that lindane nt be used fr head lice but may be used as an alternative agent fr scabies if treatment with permethrin r ral ivermectin are nt ptins Overall, mst prducts are well tlerated and have sufficient recrds f clinical experience All prducts are assciated with dermatlgic adverse events (such as skin irritatin, redness, and itching) Prducts used fr lice and scabies vary in their FDA-apprved age range. Sme prducts can be used in children as yung as 6 mnths f age Permethrin ltin (OTC) and cream (Rx nly) are the nly prducts FDA-apprved fr use in children 2 mnths f age and lder Definitins: Prducts used fr Pediculsis and Scabies: (listing des nt imply agent is n frmulary r withut need fr precertificatin) Active agent Benzyl alchl Crtamitn Gamma benzene hexachlride Malathin Permethrin Pyrethrin-pipernyl butxide (4%-0.33%) all OTC Spinsad Ivermectin Examples nt all inclusive Ulesfia 5% ltin Eurax 10% cream, ltin Lindane 1% ltin, shamp Ovide 0.5% ltin Elimite 5% cream Generic 5% cream OTC Nix 1% liquid OTC generic 1% liquid A-200 Lice killing max strength LiceMD Licide Prnt RID Natrba 0.9% suspensin Generic 0.9% suspensin OTC Strmectl 3 mg tab (ff-label) Generic 3 mg tab (ff-label) Sklice 0.5% ltin Page 3 f 7

4 PEDICULICIDE AND SCABICIDE AGENTS (cnt.) Criteria: Criteria fr initial therapy: Elimite, Eurax, Natrba, Ovide, Sklice, Spinsad, and Ulesfia is cnsidered medically necessary and will be apprved when ALL f the fllwing criteria are met: 1. Request will fllw FDA-apprve age limitatin 2. A cnfirmed diagnsis f ONE f the fllwing: Pediculsis Scabies 3. Individual has failure, cntraindicatin r intlerance t ALL f the fllwing: Fr Pediculsis: unable t use BOTH: Over-the-cunter permethrin 1% Over-the-cunter pyrethrin plus pipernyl butxide Fr Scabies: unable t use BOTH: Prescriptin permethrin 5% cream Generic ral ivermectin 3 mg 4. There are NO cntraindicatins: Cntraindicatin include: Hypersensitivity t any cmpnent f the prduct Fr Ovide: Use in nenates and infants Initial apprval duratin: 1 mnth Criteria fr initial therapy: Brand Strmectl (ivermectin) is cnsidered medically necessary and will be apprved when ALL f the fllwing criteria are met: 1. A cnfirmed diagnsis f ONE f the fllwing: Intestinal (i.e., nn-disseminated) strngylidiasis due t the nematde parasite Strngylides stercralis Onchcerciasis due t the nematde parasite Onchcerca vlvulus 2. Individual has failure, cntraindicatin r intlerance t generic ral ivermectin 3. Absence f ALL f the fllwing exclusins: Use in pediatric individuals weighing < 15 kg Wman f child bearing age wh is pregnant r nt currently using effective cntraceptin Initial apprval duratin: 1 mnth Criteria fr cntinuatin f cverage (renewal request): Elimite, Eurax, Natrba, Ovide, Sklice, Spinsad, Strmectl, and Ulesfia is cnsidered medically necessary with dcumentatin f ALL f the fllwing: 1. The individual has develped a recurrent infectin Page 4 f 7

5 PEDICULICIDE AND SCABICIDE AGENTS (cnt.) 2. Individual has nt develped any cntraindicatins r ther exclusins t its cntinued use Renewal duratin: 1 mnth Resurces: Elimite. Package Insert. Revised by manufacturer 07/2012. Accessed Elimite. Package Insert. Revised by manufacturer 08/2015. Accessed Eurax. Package Insert. Revised by manufacturer 03/2009. Accessed Eurax. Package Insert. Revised by manufacturer 09/2012. Accessed Natrba. Package Insert. Revised by manufacturer 12/2014. Accessed , Ovide. Package Insert. Revised by manufacturer 12/2011. Accessed , Sklice. Package Insert. Revised by manufacturer 02/2012. Accessed Sklice. Package Insert. Revised by manufacturer 01/2016. Accessed Spinsad. Package Insert. Revised by manufacturer 06/2015. Accessed Strmectl. Package Insert. Revised by manufacturer Accessed Strmectl. Package Insert. Revised by manufacturer 05/2010. Accessed Ulesfia. Package Insert. Revised by manufacturer 01/2014. Accessed Ulesfia. Package Insert. Revised by manufacturer 06/2015. Accessed Gunning K, Pippitt K, Kiraly B, and Sayler M: Pediculsis and Scabes: A treatment Update Indian J Clin Practice; Aug; 24(3), adapted frm Am Fam Physician 2012; 86(6): Wrkwski, KA, Blan, GA. Sexually transmitted diseases treatment guidelines, Centers fr Disease Cntrl and Preventin Sexually transmitted diseases treatment guidelines MMWR Recmm Rep. 2015;64:1-137 Devre CD, Schutze GE: Head lice. Clinical Reprt: Guidance fr the Clinician in Rendering Pediatric Care Pediatrics; 135(5): Errata 2015 Pediatrics; 136 (4): Salavastru CM, Chsidw O, Bffa MJ, Janier M, and Tiplica GS. Eurpean guideline fr the management f scabies. Eur Acad Dermatl Venerel 2017, 31: DOI: /jdv Page 5 f 7

6 Fax cmpleted prir authrizatin request frm t r t pharmacyprecert@azblue.cm. Call t check the status f a request. All requested data must be prvided. Incmplete frms r frms withut the chart ntes will be returned. Pharmacy Cverage Guidelines are available at Pharmacy Prir Authrizatin Request Frm D nt cpy fr future use. Frms are updated frequently. REQUIRED: Office ntes, labs, and medical testing relevant t the request that shw medical justificatin are required. Member Infrmatin Member Name (first & last): Date f Birth: Gender: BCBSAZ ID#: Address: City: State: Zip Cde: Prescribing Prvider Infrmatin Prvider Name (first & last): Specialty: NPI#: DEA#: Office Address: City: State: Zip Cde: Office Cntact: Office Phne: Office Fax: Dispensing Pharmacy Infrmatin Pharmacy Name: Pharmacy Phne: Pharmacy Fax: Requested Medicatin Infrmatin Medicatin Name: Strength: Dsage Frm: Directins fr Use: Quantity: Refills: Duratin f Therapy/Use: Check if requesting brand nly Check if requesting generic Check if requesting cntinuatin f therapy (prir authrizatin apprved by BCBSAZ expired) Turn-Arund Time Fr Review Standard Urgent. Sign here: Exigent (requires prescriber t include a written statement) Clinical Infrmatin 1. What is the diagnsis? Please specify belw. ICD-10 Cde: Diagnsis Descriptin: 2. Yes N Was this medicatin started n a recent hspital discharge r emergency rm visit? 3. Yes N There is absence f ALL cntraindicatins. 4. What medicatin(s) has the individual tried and failed fr this diagnsis? Please specify belw. Imprtant nte: Samples prvided by the prvider are nt accepted as cntinuatin f therapy r as an adequate trial and failure. Medicatin Name, Strength, Frequency Dates started and stpped r Apprximate Duratin Describe respnse, reasn fr failure, r allergy 5. Are there any supprting labs r test results? Please specify belw. Date Test Value Blue Crss Blue Shield f Arizna, Mail Stp A115, P.O. Bx 13466, Phenix, AZ Page 1 f 2

7 Pharmacy Prir Authrizatin Request Frm 6. Is there any additinal infrmatin the prescribing prvider feels is imprtant t this review? Please specify belw. Fr example, explain the negative impact n medical cnditin, safety issue, reasn frmulary agent is nt suitable t a specific medical cnditin, expected adverse clinical utcme frm use f frmulary agent, r reasn different dsage frm r dse is needed. Signature affirms that infrmatin given n this frm is true and accurate and reflects ffice ntes Prescribing Prvider s Signature: Date: Please nte: Sme medicatins may require cmpletin f a drug-specific request frm. Incmplete frms r frms withut the chart ntes will be returned. Office ntes, labs, and medical testing relevant t the request that shw medical justificatin are required. Blue Crss Blue Shield f Arizna, Mail Stp A115, P.O. Bx 13466, Phenix, AZ Page 2 f 2

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