drug coverage criteria â new and therapeutic equivalent medications
drug coverage criteria â new and therapeutic equivalent medications
drug coverage criteria â new and therapeutic equivalent medications
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CLINICAL POLICYDRUG COVERAGE CRITERIA – NEW ANDTHERAPEUTIC EQUIVALENT MEDICATIONSPolicy Number: PHARMACY 179.44 T2Effective Date: April 1, 2013Table of ContentsCONDITIONS OF COVERAGE...................................COVERAGE RATIONALE………………………………DEFINITIONS…………………………………………….REFERENCES............................................................POLICY HISTORY/REVISION INFORMATION..........Policy History Revision InformationThe services described in Oxford policies are subject to the terms, conditions <strong>and</strong> limitations of theMember's contract or certificate. Unless otherwise stated, Oxford policies do not apply to MedicareAdvantage enrollees. Oxford reserves the right, in its sole discretion, to modify policies as necessary withoutprior written notice unless otherwise required by Oxford's administrative procedures or applicable state law.The term Oxford includes Oxford Health Plans, LLC <strong>and</strong> all of its subsidiaries as appropriate for thesepolicies.Certain policies may not be applicable to Self-Funded Members <strong>and</strong> certain insured products. Refer to theMember's plan of benefits or Certificate of Coverage to determine whether <strong>coverage</strong> is provided or if thereare any exclusions or benefit limitations applicable to any of these policies. If there is a difference betweenany policy <strong>and</strong> the Member’s plan of benefits or Certificate of Coverage, the plan of benefits or Certificate ofCoverage will governCOVERAGCONDITIONS OF COVERAGEEThis policy applies to Connecticut <strong>and</strong> New York Commercial plans.Exclusions:Page12667Related Policies:Prescription DrugQuantity Duration (QD)<strong>and</strong> Quantity LevelLimitations (QLL)This policy does not apply to New Jersey Commercial plans: Precertification is notrequired for the <strong>drug</strong>s listed in this policy <strong>and</strong> the <strong>coverage</strong> <strong>criteria</strong> does not apply. Referto the Member's certificate of <strong>coverage</strong> <strong>and</strong>/or health benefits plan documentation foradditional information.Note:Not all Oxford Members have a pharmacy benefit.For <strong>coverage</strong> of outpatient prescription <strong>drug</strong>s <strong>and</strong> specific exclusions, exceptions, <strong>and</strong>dispensing limitations, refer to the Member's pharmacy plan, if applicable.Oxford's Pharmacy Benefit Manager (PBM) provides a nationwide network ofparticipating pharmacies that dispense prescription <strong>medications</strong> on a retail level.Commercial groups with outpatient prescription <strong>drug</strong> <strong>coverage</strong> will have their pharmacybenefit administered by the PBM.For information regarding any quantity level limitations, refer to Prescription DrugQuantity Duration (QD) <strong>and</strong> Quantity Level Limitations (QLL). EDrug Coverage Criteria - New <strong>and</strong> Therapeutic Equivalent Medications: Clinical Policy (Effective 04/01/2013)©1996-2013, Oxford Health Plans, LLC1
COVERAGE RATIONALEThis policy provides information <strong>and</strong> <strong>criteria</strong> relevant to <strong>medications</strong> for which certain types ofprescription <strong>drug</strong> benefit exclusions may apply.In accordance with Oxford's prescription <strong>drug</strong> riders, certain <strong>medications</strong> are excluded from<strong>coverage</strong>. The rationale for such exclusions varies, <strong>and</strong> therefore <strong>coverage</strong> may be provided incertain clinical scenarios.There are two types of exclusions addressed in this policy:Exclude at Launch: In an effort to enhance the affordability <strong>and</strong> value of prescription<strong>drug</strong> riders, <strong>and</strong> as part of our Prescription Drug List (PDL) management, Oxford willproactively identify <strong>and</strong> help manage the cost of low value <strong>medications</strong> being introducedinto the market. The Exclude at Launch program delays <strong>coverage</strong> until a full evaluationcan be completed for <strong>new</strong> <strong>medications</strong> that may offer little to no additional health carevalue. Our PDL Management Committee will review each Exclude at Launch medicationto determine its tier placement or benefit <strong>coverage</strong>.Same Active Ingredient: Oxford may exclude <strong>coverage</strong> for a medication, unless it ismedically necessary for the member, if it includes the same active ingredient (or amodified version of an active ingredient) <strong>and</strong> is <strong>therapeutic</strong>ally <strong>equivalent</strong> to a coveredprescription medication. Oxford's definition of <strong>therapeutic</strong> equivalence refers to<strong>medications</strong> that produce the same <strong>therapeutic</strong> outcome <strong>and</strong> adverse event profile.The following table provides a list of prescription <strong>medications</strong> for which one or both of the aboveexclusions apply. Precertification through the Pharmacy Benefit Manager (PBM) is requiredfor all listed <strong>medications</strong>. Coverage will be provided only when Member has exhibitedintolerance (that is, sensitivity, <strong>drug</strong> allergy, adverse effect) to, or experienced a <strong>therapeutic</strong>failure with, the covered formulary alternative(s) noted below.Medication/DrugFormulary Alternative(s)Absoricaisotretinoin (generic Accutane), Amnesteem, Claravis,Myorisan, SotretAcuvailKetorolacAdoxa 150mg (Br<strong>and</strong>)Doxycycline 50 mg or 100mgAlsumasumatriptan injectionAltoprevLovastatin (generic Mevacor)AmrixCyclobenzaprine HCL(generic for Flexeril)AmturnideAmlodipine + Tekturna HCT (or individual components takenconcomitantly)Analpram Advanced KitHydrocortisone acetate/pramoxine HCl, Analpram HCAndrogelTestimAplenzinBuproprion XL (generic for Wellbutrin XL)Aqua Glycolilc HCHydrocortisone 2.5% (generic Hytone)Aricept (23 mg only)donepezil 10mg (generic for Aricept 10mg)Asacol HDAsacolAsmalPredPrednisolone sodium phosphate (generic Orapred)AsmalPred Plusprednisolone sodium phosphate (generic Orapred)Astelin (br<strong>and</strong> only)Azelastine nasal spray (generic Astelin), AsteproAtelviaActonelAugmentin XR / Amoxicillin-Clavulanate Amoxicillin/clavulanate potassium (generic for Augmentin)ERAuralgan 5.5%/1.4%Antipyrine/benzocaine solution – 5.4%/1.4% (genericAuralgan)Auvi-QEpiPen, EpiPen Jr.Drug Coverage Criteria - New <strong>and</strong> Therapeutic Equivalent Medications: Clinical Policy (Effective 04/01/2013)©1996-2013, Oxford Health Plans, LLC2
Medication/DrugFormulary Alternative(s)AxironTestimBenzaclin Kit (1%-5%)Clindamycin Phosphate + OTC Benzoyl PeroxideBenzefoam, Benzefoam Ultra OTC Benzoyl peroxideBepreveOTC ketotifen (Zaditor), azelastine (generic Optivar),LastacaftBeyazYaz + folic acidBinostoAlendronate (generic Fosamax), ib<strong>and</strong>ronate (genericBoniva), ActonelBromdayBromfenac (generic Xibrom), ketorolac (generic Acular)Caduet <strong>and</strong>Amlodipine (generic Norvasc) + Lipitor (atorvastatin)Generic Caduet(atorvastatin/amlodipine)Cambiadiclofenac potassium , diclofenac sodiumCentany AT Kitmupirocin ointmentCiclodan Combination Package Ciclopirox (generic Loprox)Ciclodan KitCiclopirox nail lacquerClarinexLevocetirizine (generic for Xyzal)Clarinex-DLevocetirizine (generic for Xyzal) + OTC pseudoephedrineClindacin PacClindamycin get, solution, lotion or swabsClindagelClindamycin gel 1% (generic Cleocin-T)Clindamycin/benzoyl peroxide (Duac,Duac CS, generic Duac)Clindamyciin/benzoyl peroxide (generic Benzaclin), Acanya,BenzaclinClobetaClobetasol 0.05% + OTC coal tarClobetasol shampoo (generic Clobex Clobetasol (generic Temovate)shampoo)Clobex shampooGeneric clobetasol propionate solution or foamCocet PlusAcetaminophen with codeineComfort Pac TizanadinetizanadineConZiptramadol immediate-release (generic Ultram), tramadolextended-release (generic Ultram ER)Coreg CRCarvedilol (generic for Coreg)Cosopt PFDorzolamide/timolol (generic Cosopt)Delos LotionOTC benzoyl peroxideDelos CleanserOTC benzoyl peroxideDesloratadine (generic Clarinex) Levocetirizine (generic Xyzal), OTC cetirizine (genericZyrtec), OTC fexofenadine (generic Allegra), OTC loratadine(generic Claritin)Desonil cream/ointment (Kit)Desonide 0.05% cream, ointmentDetrol LADetrol IRDoryx /doxycycline hyclate delayed Doxycycline (generic for Monodox, Vibramycin)release tabletDoxycycline monohydrate 150mg Doxycycline 50mg or 100mg(generic for Adoxa)DuexisIbuprofen (generic Motrin) plus OTC famotidine (genericPepcid AC)Dymistafluticasone (Flonase) + Astelin (azelastine) or Astepro(azelastine)Elestat/epinastineAzelastine, Bepreve, Optivar, OTC ketotifenEmadineAzelastine, Bepreve, Optivar, OTC ketotifenEpiduo Differin 0.1% gel (requires precertification after age 29) +OTC benzoyl peroxideExforgemlodipine (generic Norvasc) plus losartan (genericCozaar); amlodipine (generic Norvasc) plus Benicar orMicardis; amlodipine (generic Norvasc) plus DiovanExforge HCTamlodipine (generic Norvasc) plusDrug Coverage Criteria - New <strong>and</strong> Therapeutic Equivalent Medications: Clinical Policy (Effective 04/01/2013)©1996-2013, Oxford Health Plans, LLC3
Medication/DrugFormulary Alternative(s)losartan/hydrochlorothiazide (generic Hyzaar); amlodipine(generic Norvasc) plus Benicar HCT orMicardis HCT; amlodipine (generic Norvasc) plus DiovanHCTFenofibrate 48mg, 145mg (generic Fenofibrate 54mg, 160mg (generic Tricor, Antara, LipofenTricor)FlectorVoltaren GelFlo-PredPrednisolone (generic Prelone), Orapred, PediapredForfivo XLBupropion (generic Wellbutrin), bupropion SR (WellbutrinSR), buproprion XL (generic Wellbutrin XL)FortestaTestimGeneress FEGildess FE, Junel FE, Microgestin FE (generic for LoestrinFE),Giazobalsalazide (generic Colazal), sulfasalazine (genericAzulfidine), Apriso, LialdaGraliseGabapentin (generic Neurontin)HorizantGabapentin (generic Neurontin)IlevroDiclofenac ophthalmic solution (generic Voltaren), ketorolacophthalmic solution (Acular), NevanacIntermezzoZolpidem (generic Ambien), zaleplon (generic Sonata)Jalyn Avodart (requires precertification if
Medication/DrugFormulary Alternative(s)Otic CareAntipyrine/benzocaine solutionOxtellar XROxcarbazepine (generic Trileptal)Pacnex HPOTC benzoyl peroxidePacnex LPOTC benzoyl peroxidePatadayAzelastine, Bepreve, Optivar, OTC ketotifenPatanolAzelastine, Bepreve, Optivar, OTC ketotifenPediaderm AFnystatin creamPediaderm TAtriamcinolone 0.1% creamPedipirox-4Ciclopirox (generic Penlac)Pennsaid DropsVoltaren GelPertzye (lipase/protease/amylse) PancreazePramosone EHydrocortisone/pramoxine (generic Pramosone)Procort Hydrocortisone/pramoxine (generic Analpram E)Promiseb Complete KitPromisebQuillivant XRMethylphenidate solution (generic Methylin),methylphenidate extended-release (generic Ritalin LA),Adderall XR, VyvanseRayosprednisoneRequip XLRopinirole (Generic for Requip)Ropinirole extended release (Requip Ropinirole (generic Requip)XL)Rosadan Kit CreamMetronidazole cream (Metrocream)Rosadan Kit GelMetronidazole gel 0.75% (Metrogel)Rybix ODTtramadolRyzoltTramadol ER (generic for Ultram ER)SafyralYasmin + folic acidSancusoGranisetron (generic for Kytril)SilenordoxepinSkelaxin (br<strong>and</strong> only)chlorzoxazone (generic Parafon Forte DSC),cyclobenzaprine (generic Flexeril), metaxalone (genericSkelaxin), methocarbamol (generic Robaxin)SoltamoxTamoxifen (generic Nolvadex)Soma 250mg / carisoprodol 250mg Carisprodol 350mg (generic for Soma)Sorilux (calcipotriene)calcipotriene (Dovonex)SSS 10-4Sulfacetamide sodium/sulfurSubsysMorphine sulfate (generic MS IR), fentanyl citrate (genericActiq)SumadanSulfacetamide, sodium/sulfur (generic for Sulfatol)Sumaxin CPSulfacetamide sodium/sulfur (generic Sulfatol)Sumaxin TSsulfacetamide sodium/sulfurSuprax Chewable TabletsSuprax Oral SuspensionSynalarFluocinolone (generic Synalar)Synalar KitFluocinolone (generic Synalar)Synalar TSFluocinolone (generic Synalar)TekamloAmlodipine plus TekturnaTerbinexTerbinafine (generic for Lamisil)Tobradex STTobramycin/dexamethasone ophthalmic drops (generic forTobradex)Tramadol extended-release (generic Tramadol IR or Tramadol ERryzolt)TreximetSumatriptan plus naproxen.TrianexTriamcinolone ointment (generic Aristocort)Tribenzoramlodipine plus hydrochlorothiazide plus Benicar (or)Benicar HCT plus amlodipine (or) Azor plusDrug Coverage Criteria - New <strong>and</strong> Therapeutic Equivalent Medications: Clinical Policy (Effective 04/01/2013)©1996-2013, Oxford Health Plans, LLC5
Medication/DrugFormulary Alternative(s)hydrochlorothiazideTricor 48mg <strong>and</strong> 145mgFenofibrate, Antara, Fenoglide, Lipofen, TriglideTrilipixFenofibrate, Antara, Fenoglide, Lipofen, TriglideTwynstaMicardis + amlodipineUcerisBudesonide (generic Entocort EC)Ultravate X Combination Package Halobetasol (generic Ultravate) plus ammonium lactate (Lac-Hydrin)UltresaCreon, Zenpep, PancreazeUmecta emulsion, foam, suspension Urea 40%Umecta Kit (nail film pen/ filmsuspension)Urea 40% emulsion (Umecta) + hyaluronate gel 0.2%(Hylira)Umecta PD Urea 40%Uramaxin GT 45%Urea 40% emulsionUramaxin GT Kit Urea 40%Valturna 150-160mg, 300-320mg Tablet Diovan + TekturnaVeltinClindamycin gel + tretinoin gelVenlafaxine EREffexor XRViokaceCreon, Zenpep, PancreazeVimovoNaproxen sodium plus proton pump inhibitorXereseZovirax 5% cream + OTC hydrocortisone 1% creamXopenex NebulesAlbuterol nebulized solutionZetonna (ciclesonide)OmnarisZianaClindamycin gel + tretinoin gelZipsor 25mgDiclofenac potassium or diclofenac sodiumZolvitacetaminophen with hydrocodone solutionZonatussBenzonatateZuplenzondansetron tablet (generic for Zofran) , ondansetron ODT(generic for Zofran ODT)ZyclaraImiquimod 5% creamDEFINITIONSFor all of the definitions below, copayment/cost share will vary based on the members pl<strong>and</strong>esign. Refer to the Member's specific certificate of <strong>coverage</strong>, contract <strong>and</strong>/or prescription <strong>drug</strong>rider as applicable.Mail Order Pharmacy: A network pharmacy contracted to provide up to a 90-day supply ofcertain prescription <strong>medications</strong> (<strong>new</strong> or refill) by mail.Specialty Pharmacy: A network pharmacy contracted to provide <strong>coverage</strong> for specialty<strong>medications</strong> at an in network benefit level for members enrolled on NY <strong>and</strong> NJ LOBs.Retail Pharmacy: A network non-mail order pharmacy contracted to provide prescription<strong>medications</strong> (<strong>new</strong> or refill). NOTE: For members enrolled on NY LOBs <strong>new</strong> <strong>and</strong> re<strong>new</strong>ing on orafter 01/12/12, if a retail pharmacy has contracted with the PBM, in advance, for the same rates<strong>and</strong> terms <strong>and</strong> conditions as the mail order or specialty pharmacy, covered prescriptions will beavailable at the same co-payment or other reimbursement level that would apply to the mail-orderor non-retail specialty pharmacies (should any of these pharmacies be available in the servicearea).REFERENCESThe foregoing Oxford policy has been adapted from an existing UnitedHealthcare PharmacyClinical Pharmacy Program that was researched, developed <strong>and</strong> approved by the UnitedHealthGroup National Pharmacy & Therapeutics CommitteeDrug Coverage Criteria - New <strong>and</strong> Therapeutic Equivalent Medications: Clinical Policy (Effective 04/01/2013)©1996-2013, Oxford Health Plans, LLC6
1. Oxford Commercial Certificates of Coverage, Health Benefit Plans <strong>and</strong> Pharmacy BenefitRiders.2. Drug Facts <strong>and</strong> Comparisons. Lippincott Williams & Wilkins.3. All applicable pharmaceutical manufacturer package inserts <strong>and</strong> prescribing information.POLICY HISTORY/REVISION INFORMATIONDate04/01/2013Action/DescriptionRevised list of <strong>medications</strong> requiring precertification through thepharmacy benefit manager (PBM); added Absorica, Auvi-Q,Ilevro, Onmel, Oxtellar XR, Quillivant XR <strong>and</strong> UcerisArchived previous policy version PHARMACY 179.43 T2Drug Coverage Criteria - New <strong>and</strong> Therapeutic Equivalent Medications: Clinical Policy (Effective 04/01/2013)©1996-2013, Oxford Health Plans, LLC7
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