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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsMESSA Prior Auth & Step Therapy Coverage | OpenPay…
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    ModifiedMESSAPolicy N/A

    Prior Authorization and Step Therapy Coverage Criteria

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    MESSA coverage requirements for prescription medications subject to prior authorization and/or step therapy, including clinical documentation, preferred-drug trials, approval durations, renewal requirements, and plan-specific coverage indicators.

    Policy Summary
    PayerMESSA
    PolicyPrior Authorization and Step Therapy Coverage Criteria
    Policy CodePolicy N/A
    Change TypeModified
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit documentation supporting medical necessity and showing that all medication-specific prior authorization and step-therapy criteria are satisfied.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    RequiredPrior authorization
    RequiredStep therapy
    200+ pagesDocument length
    Aug 6, 2026Current through
    NCNot covered indicator

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Medication Coverage Criteria

    Drug-specific coverage criteria

    Covered when the applicable diagnosis, age or weight, laboratory or diagnostic findings, prior-treatment requirements, safety restrictions, and benefit requirements are met.

    Iron, dermatology, sexual-health, and ADHD therapies: Accrufer: iron deficiency, age ≥10 years, and failure or intolerance to two over-the-counter iron products. Adbry: moderate-to-severe atopic dermatitis, age ≥12 years, failure of a listed high-potency topical or systemic therapy, and no same-indication biologic or targeted DMARD. Addyi: female age ≥18 and <65 with acquired generalized HSDD lasting >6 months after other causes are ruled out. Adzenys ER or amphetamine ER ODT: ADHD, age ≥6 years, failure or intolerance to generic methylphenidate and generic amphetamine therapy, or inability to swallow solid dosage forms with failure of a sprinkle-capable alternative.
    Hemophilia and hereditary angioedema pathways: Alhemo, Hemlibra, Hympavzi, or Qfitlia may be covered for the applicable congenital hemophilia A or B prophylaxis pathway with specialist and hemophilia-treatment-center care, factor VIII or IX deficiency or inhibitor documentation, bleeding history, and required prior therapy. Andembry, Haegarda, Orladeyo, Takhzyro, Dawnzera, Firazyr, or Ruconest require laboratory-confirmed HAE, qualifying attack frequency or severity, specialist prescribing where stated, and avoidance of duplicate HAE therapy; acute-attack products require the applicable acute-attack pathway.HAE generally requires ≥2 attacks/month or severe facial, throat, or gastrointestinal attacks; factor VIII or IX <1% indicates severe disease and 1%-5% moderate disease; inhibitor titer >5 BU/mL is high titer.
    Rare disease, metabolic, and hepatobiliary therapies: Aqneursa or Aqvesme: neurologic Niemann-Pick type C with specified genetic or biomarker confirmation and age or weight eligibility. Aqvesme thalassemia: genetically confirmed alpha- or beta-thalassemia with the applicable non-transfusion-dependent or transfusion-dependent pathway and hemoglobin or transfusion criteria. Arcalyst: CAPS, DIRA, or recurrent pericarditis pathway. Bylvay or Livmarli: PFIC or ALGS cholestatic pruritus pathway with transplant, cirrhosis, age, diagnostic, ursodiol, and, when applicable, Livmarli or Bylvay prerequisites. Cerdelga, Chenodal, Cholbam, Ctexli, Carbaglu, miglustat, Loargys, Galafold, Iqirvo, and related therapies require their disease-specific genetic, enzyme, biopsy, laboratory, specialist, and prior-treatment criteria.
    Pulmonary, respiratory, and cystic-fibrosis therapies: Alyftrek, Symdeko, Trikafta, Orkambi, Bronchitol, Cayston, Tobi Podhaler, Brinsupri, Glassia, Fasenra, Nucala, Dupixent, Tezspire, Ohtuvayre, nintedanib, Jascayd, and pulmonary-hypertension therapies are covered only for their listed CFTR-responsive cystic-fibrosis, bronchiectasis, alpha-1-antitrypsin deficiency, eosinophilic or type 2 airway disease, interstitial-lung-disease, or pulmonary-hypertension indications with the required age, laboratory, severity, controller-therapy, and step-therapy criteria.Examples include Alyftrek age ≥6 years; Bronchitol age ≥18 years with a passed tolerance test; Brinsupri age ≥12 years with ≥2 adult or ≥1 pediatric exacerbation in 12 months; Glassia FEV1 35%-60% predicted and low AAT; Dupixent eosinophilic asthma eosinophils ≥150/µL and COPD eosinophils ≥300/µL.
    Immunology and rheumatology therapies: Cibinqo, Cimzia, Cosentyx, Enbrel, Entyvio, Kevzara, Kineret, Nemluvio, Olumiant, Orencia SC, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Sotyktu, Taltz, Tremfya, Tyenne, adalimumab, Simponi, Skyrizi, tofacitinib, and related biologics or targeted therapies require a listed diagnosis, indication-specific age or weight, and the specified topical, DMARD, biologic, targeted-therapy, NSAID, corticosteroid, or other treatment failures. Same-indication biologic or targeted-DMARD combination therapy is excluded where stated.Some inflammatory-disease pathways require a DMARD trial of at least 3 months and failure of two to four listed advanced therapies.
    Neurologic, psychiatric, and seizure therapies: Austedo, Crexont, Daybue, Epidiolex, Evrysdi, Increlex, Imcivree, Nuedexta, Nuplazid, Onapgo, Nourianz, Oxervate, Qelbree, Qulipta, Quviviq, Rytary, topiramate products, Xcopri, Xywav, and related therapies require the stated neurologic or psychiatric diagnosis, age, genetic or diagnostic confirmation, step therapy, and safety criteria. SMA products require genetic confirmation and motor-function assessment; obesity products require genetic diagnosis or qualifying BMI and objective weight response when renewed.
    Cardiovascular, endocrine, oncology, and hematology therapies: Camzyos and Myqorzo require symptomatic obstructive HCM, NYHA class, LVEF, LVOT gradient, and failure or intolerance of a maximally tolerated beta blocker or calcium-channel blocker. Ibrance requires the applicable HR-positive breast-cancer indication and CDK4/6 step therapy. Dasatinib, nilotinib, and Tasigna require qualifying Ph-positive CML or ALL pathways and imatinib or dasatinib sequencing. Doptelet and eltrombopag require indication-specific thrombocytopenia, platelet counts, age, prior therapy, and dose limits. Rezdiffra requires noncirrhotic NASH/MASH with F2-F3 fibrosis, diet and exercise, and no alcohol use.Camzyos initial LVEF >55% and LVOT ≥50 mmHg; renewal LVEF ≥50%. Myqorzo initial LVEF ≥55% and LVOT ≥50 mmHg.
    Gastrointestinal, renal, reproductive, and weight-management therapies: Contrave, Qsymia, orlistat, Myfembree, Oriahnn, Orilissa, mirabegron, Gemtesa, Gattex, Viberzi, Viokace, Voquezna-like therapy, Tarpeyo, Filspari, Fabhalta, Voyxact, and infertility medications require the applicable diagnosis, age, BMI or weight, laboratory, benefit, prior-treatment, and combination restrictions. Fertility medications are covered only when medically appropriate and included in the member's fertility benefit.Weight-management examples: adult obesity BMI ≥30 kg/m² or BMI ≥27 kg/m² with a comorbidity; continued Contrave or orlistat coverage generally requires maintained 5% weight loss.
    Hepatitis C and infectious-disease therapies: Epclusa, sofosbuvir-containing therapy, Harvoni oral pellets, Sovaldi, and Vosevi require the applicable chronic hepatitis C genotype, age or weight, cirrhosis, prior-treatment, preferred-Epclusa, ribavirin, and case-by-case AASLD/FDA-label review. Livtencity requires post-transplant CMV infection or disease, age ≥12 years and weight ≥35 kg, and failure of a listed antiviral. Recurrent C. difficile prevention requires the stated recurrence, positive toxin-test, age, and nonduplication criteria.
    Osteoporosis, pulmonary hypertension, amyloidosis, and specialty therapies: Teriparatide, Forteo, and Tymlos require osteoporosis or fracture-risk criteria and the appropriate high-risk or very-high-risk bisphosphonate, zoledronate, or denosumab pathway. Uptravi or Ventavis requires pulmonary arterial hypertension with the specified sildenafil or tadalafil and ambrisentan or bosentan trials, or the PH-ILD pathway. Vyndamax or Vyndaqel requires confirmed wild-type or hereditary ATTR-CM, age ≥18 years, and NYHA class I-III disease. Wainua requires adult hATTR peripheral neuropathy with TTR mutation and staging criteria. Vyvgart Hytrulo requires either antibody-positive MG or diagnostic CIDP with prior standard-of-care failure and no prohibited combination therapy.Tymlos maximum duration is 2 years; Vyvgart Hytrulo MG generally requires ≥12 weeks of ineffective standard-of-care therapy.

    Combination restrictions: Adbry, Cibinqo, Dupixent, Ebglyss, Enbrel, Entyvio, Fasenra, Kevzara, Kineret, Litfulo, Nemluvio, Nucala, Olumiant, Orencia SC, Otezla, Otezla XR, Rinvoq, Rinvoq LQ, adalimumab, Simponi, Skyrizi, Sotyktu, Taltz, Tezspire, Tremfya, Tyenne, and Xeljanz products will not be used with another biologic, targeted DMARD, or other prohibited immunosuppressant for the same indication. Cibinqo, Olumiant, Litfulo, Rinvoq, Rinvoq LQ, and Xeljanz also include restrictions on specified potent immunosuppressants. Vyvgart Hytrulo is not covered with another biologic or immunoglobulin therapy for the applicable MG or CIDP indication.

    Therapy-specific exclusions: Alyftrek and Trikafta will not be used with another CFTR potentiator, including Orkambi, Kalydeco, or Symdeko. Andembry, Dawnzera, Haegarda, Orladeyo, and Takhzyro will not be used with another HAE prophylaxis product; acute HAE products such as Firazyr and Ruconest will not be combined with another acute-attack product. Alhemo and Hemlibra will not be used with immune tolerance induction. Empaveli and Fabhalta will not be used with Soliris, Ultomiris, or other PNH medications. Evrysdi will not be used with another SMN2-directed therapy or after SMA gene therapy. Galafold will not be used with another molecular chaperone or enzyme replacement therapy for Fabry disease; Loargys will not be used with another enzyme replacement therapy for ARG1 deficiency; Joenja will not be used with an immunosuppressive medication; Kygevvi will not be used with another TK2-deficiency medication; and Rivfloza will not be used with Oxlumo.

    Duplicate, interaction, and safety restrictions: Belsomra, Dayvigo, Lumryz, and sodium oxybate/Xyrem are excluded with other sedative-hypnotics, specified CNS depressants, or alcohol. Belbuca, hydrocodone products, Opana ER, and Nucynta ER are not covered with more than one long-acting opioid concurrently. Emgality, Nurtec ODT, and other specified migraine-prevention therapies will not be combined with another CGRP antagonist. Diclofenac 2% and Flector are excluded with concurrent oral NSAID therapy. Orlistat and phentermine/topiramate ER are excluded with other weight-loss products; Ozempic and Trulicity are excluded with another GLP-1 agonist-containing product; and Repatha is excluded with another PCSK9 inhibitor. Iqirvo and Livdelzi are excluded with additional second-line PBC therapy, including another PPAR agonist. Filspari is excluded with a RAS inhibitor or an endothelin receptor antagonist such as Vanrafia. Vyndamax, Vyndaqel, and Wainua are excluded with another transthyretin-amyloidosis therapy.

    Indication and benefit exclusions: Certain infertility products, including cetrorelix, Crinone, and ganirelix acetate, are not covered when used for assisted reproductive treatment unless the applicable fertility benefit supports coverage. Selected hepatobiliary therapies require no liver-transplant history or planned transplant and no decompensated cirrhosis; Livmarli specifically requires these conditions. Rezdiffra is not continued after progression to cirrhosis. Imcivree continuation requires at least a 5% reduction in baseline body weight or BMI. Therapy for epidermolysis bullosa wounds is excluded with current or historical malignancy in the treatment area, active infection, prior stem-cell transplant, or prior gene therapy. Recurrent C. difficile prevention therapy is not combined with Zinplava, Rebyota, or another CDI-prevention product. Wainua is excluded when ocular or cerebral manifestations predominate, after liver transplant, or with NYHA heart-failure classification above II. Xolair is not covered with another food-allergy desensitization therapy or another same-indication biologic/targeted DMARD and, for food allergy, requires epinephrine access and an allergen-avoidant diet. Vardenafil and other erectile-dysfunction products are subject to the member's benefit and quantity limits.

    Initial Authorization Criteria

    Initial therapy criteria

    Initial authorization requires one complete product-specific pathway; when a pathway lists alternatives, the alternatives are separated by OR and all criteria within the selected branch must be met.

    General initial authorization: Document the requested drug's covered diagnosis, age or weight, disease severity, laboratory or genetic confirmation, specialist or treatment-center requirements, required prior-treatment failures or intolerances, dose or duration limits, and absence of prohibited concomitant therapy.
    Preferred and generic sequencing: Complete the applicable step therapy before coverage. Examples include Novolog before Afrezza; two preferred triptans before almotriptan; Xenazine before Austedo for Huntington chorea; imatinib before dasatinib or nilotinib and imatinib plus dasatinib before Tasigna; preferred Epclusa before specified hepatitis C therapy; generic alternatives before specialty ADHD, seizure, opioid, dermatologic, pulmonary, gastrointestinal, and migraine products.
    Product-specific branches: The initial pathways include the listed products from Afrezza through Brivaracetam; Bylvay, Camzyos, Cibinqo, Cimzia, Cosentyx, and Dupixent; Enbumyst, Empaveli, Emgality, Enbrel, Entyvio, Eohilia, Epidiolex, Evrysdi, Fabhalta, Fasenra, Filspari, Furoscix, Gattex, Gemtesa, Glassia, growth hormone, Haegarda, hepatitis C therapies, Hemlibra, Hympavzi, Ibrance, Imcivree, Imiquimod, Increlex, Iqirvo, Kevzara, Kineret, Livmarli, Livtencity, Loargys, Lupkynis, and narcolepsy therapies; and the O-to-X pathways listed in the policy.

    Renewal and Continued Coverage

    General and medication-specific continuation criteria

    Continuation coverage is authorized when the applicable initial criteria remain met and the medication demonstrates the required clinical benefit or objective response.

    General renewal: Current indication, age, diagnostic, laboratory, prior-treatment, safety, and concomitant-therapy criteria remain satisfied, and the medication is providing clinical benefit.
    Medication-specific response: Alhemo: decreased bleeding. Andembry, Haegarda, Dawnzera, Orladeyo, or Takhzyro: at least 50% reduction in HAE attack number or severity. Camzyos: clinical benefit with LVEF ≥50%. Contrave or orlistat: maintained ≥5% baseline weight loss, current weight, continued lifestyle modification, and BMI ≥18.5 kg/m². Evrysdi: clinically significant motor-function improvement, stabilization, or reduced decline. Gattex: ≥20% reduction in weekly parenteral nutrition or IV-fluid volume. Hemlibra or Qfitlia: decreased bleeds, with Hemlibra also requiring no anti-drug antibodies impairing efficacy. Imcivree: annual review with maintained ≥5% weight or BMI reduction. Lupkynis: clinical benefit such as stabilized or improved GFR or ≥50% proteinuria reduction. Nuplazid: clinically significant psychosis improvement. Qsymia: adult ≥5% weight loss or pediatric ≥1% BMI reduction with the applicable BMI threshold. Pyrukynd: improvement in hemoglobin, hemolysis markers, or transfusion needs. Rezdiffra: no cirrhosis progression plus a specified NASH/MASH or fibrosis benefit. Ruconest or Firazyr: objective acute-attack improvement. Voxzogo: open epiphyses with maintained or increased growth. Wayrilz: stable platelet count ≥50,000/mcL.

    Preferred-Drug and Prerequisite Therapy

    Requested medicationRequired preferred or generic therapyFailure, intolerance, or exceptionIndication-specific sequencing
    AfrezzaNovologTreatment failure or intolerance to NovologInsulin therapy
    Aimovig or AjovyTwo migraine-preventive medications from different classesFailure or intolerance to the required preventive therapiesMigraine prevention
    Chemotherapy-induced nausea/vomiting therapyGeneric 5-HT3 antagonist and preferred NK1 antagonistTrial and failure of both required classesCINV prevention
    AlmotriptanTwo generic triptans: Imitrex, Maxalt, Amerge, or Zomig/ZMTTrial of two generic triptansAcute migraine
    Austedo for Huntington disease choreaGeneric Xenazine (tetrabenazine)Failure, contraindication, or intolerance to XenazineHuntington disease chorea; tardive dyskinesia does not require this step
    FleqsuvyBaclofen tabletsFailure or intolerance, unless the member cannot swallow tabletsSpasticity
    Beconase AQTwo listed intranasal steroids: fluticasone, flunisolide, or triamcinoloneFailure or intolerance to two listed steroidsAllergic rhinitis
    BelsomraOne of immediate-release zolpidem, eszopiclone, zaleplon, trazodone, or doxepinTreatment failure with one listed medicationInsomnia; do not combine with another sedative hypnotic
    BonjestaGeneric DiclegisFailure or intolerance to DiclegisNausea and vomiting of pregnancy
    Tracleer suspensionSildenafil or tadalafil, plus ambrisentan or bosentan tabletsFailure of both pulmonary-hypertension treatment componentsWHO Group 1 pulmonary arterial hypertension
    BosulifImatinib and dasatinibFailure, contraindication, or intolerance to bothPh-positive CML
    BrivaracetamThree generic preferred antiseizure alternativesFailure or intolerance to three alternativesSeizure disorder or epilepsy
    BelbucaTwo long-acting opioids, including a buprenorphine transdermal patchFailure or intolerance to both; concurrent use of more than one long-acting opioid is not coveredModerate-to-severe chronic pain requiring around-the-clock opioid therapy
    BronchitolNebulized hypertonic salineFailure, contraindication, or intoleranceCystic fibrosis pulmonary maintenance therapy
    BylvayGeneric ursodiol; Livmarli for ALGSFailure, contraindication, or intolerance to required therapyPFIC: ursodiol; ALGS: ursodiol followed by Livmarli
    BynfeziaGeneric octreotide acetateTreatment failureAcromegaly, metastatic carcinoid tumor, or VIPoma
    CamzyosNon-vasodilating beta blocker or nondihydropyridine calcium-channel blockerFailure, contraindication, or intolerance at the maximally tolerated doseSymptomatic obstructive HCM
    CibinqoHigh-potency topical corticosteroid or specified systemic immunomodulatorTreatment failure of one listed therapyAtopic dermatitis; age-specific requirements apply
    CimziaPreferred biologics/biosimilars, DMARDs, Orencia, Taltz, or other listed agentsFailure, contraindication, or intolerance as specifiedCrohn disease: four agents; RA: DMARD plus three advanced therapies and Orencia; other indications vary
    CladribineOne generic or preferred multiple-sclerosis therapyFailure or intoleranceMultiple sclerosis
    Contraceptives with $0 copaymentAt least three generic contraceptivesFailure or intolerance to three generic contraceptivesPregnancy prevention
    CosentyxTopical steroids and specified biologic, targeted, conventional, or NSAID therapiesFailure or intolerance to the indication-specific alternativesPsoriasis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, hidradenitis suppurativa, or enthesitis-related arthritis
    CrexontGeneric Sinemet CRTreatment failureParkinson disease
    Ctexli for gallstonesActigall or ursodiolFailure or intoleranceGallstones in a member ineligible for surgery
    DasatinibImatinibFailure, contraindication, or intoleranceQualifying adult or pediatric Ph-positive CML or ALL pathway
    DawnzeraHaegarda, Takhzyro, Orladeyo, and AndembryFailure of all four listed HAE prophylaxis productsHAE with qualifying laboratory findings and attack burden
    DayvigoThree of zolpidem, eszopiclone, zaleplon, trazodone, or doxepin, followed by BelsomraFailure, contraindication, or intoleranceInsomnia; no concurrent sedative hypnotic
    Deferiprone tabletsGeneric Jadenu or generic ExjadeFailure or intoleranceTransfusional iron overload due to thalassemia
    Deflazacort productsAdequate-dose generic prednisone or prednisoloneFailure, contraindication, or intoleranceDuchenne muscular dystrophy
    Desvenlafaxine ERAt least three antidepressantsFailure of at least three agentsDepressive disorder
    DexilantFour generic proton-pump inhibitorsFailure or intolerance to four listed agentsAcid-related disorder
    DiacomitTwo of generic valproic acid, clobazam, or topiramateFailure, contraindication, or intoleranceDravet syndrome; use with clobazam
    DichlorphenamideLifestyle modification and acetazolamideFailure, contraindication, or intolerance to acetazolamidePrimary hyperkalemic or hypokalemic periodic paralysis
    Diclofenac 2%Generic oral diclofenac, two other traditional oral NSAIDs, and generic PennsaidTrial, failure, or intolerance as specifiedKnee osteoarthritis; no concurrent oral NSAID therapy
    Diclofenac potassium (Zipsor)Oral diclofenac and two other preferred oral NSAIDsFailure of all listed alternativesAcute pain
    Diclofenac sodium 3% gelCryotherapy or phototherapy, topical fluorouracil, and generic imiquimod 5%Failure or intolerance to each prerequisiteActinic keratosis
    DojolviMedium-chain triglycerides at maximally tolerated doseTrial and failureLong-chain fatty-acid oxidation disorder
    Doryx, Doryx MPC, and doxycycline formulationsGeneric doxycycline monohydrate and generic immediate-release doxycycline hyclateFailure or intolerance to bothIndication-specific doxycycline therapy
    Doxepin topicalTwo topical steroids plus a preferred topical calcineurin inhibitor; or two OTC topical analgesics plus a preferred topical NSAIDTreatment failure to the applicable sequenceAtopic pruritus, lichen simplex chronicus, or peripheral neuropathic pain
    DupixentIndication-specific topical, systemic, inhaled, antihistamine, or standard-of-care therapyFailure or inadequate control after required therapy; contraindication or intolerance where allowedAtopic dermatitis, asthma, CRSwNP, COPD, EoE, prurigo nodularis, urticaria, bullous pemphigoid, or AFRS
    ADHD products in this sectionGeneric methylphenidate and generic amphetamine product, one long-actingFailure or intolerance; sprinkle-capable alternative may apply if unable to swallowADHD
    EbglyssSpecified high-potency topical or systemic therapyTreatment failureModerate-to-severe atopic dermatitis
    EcozaTwo OTC topical antifungals and two oral generic antifungalsTreatment failureTinea pedis
    EdarbyclorTwo generic ARBsFailure or intoleranceHypertension
    Elepsia XRThree generic or preferred antiseizure alternatives, including generic KeppraFailure or intoleranceSeizure disorder or epilepsy
    EmgalityTwo migraine-preventive medications from different classesFailure of two preventive medicationsMigraine prevention
    Empaveli for C3G or IC-MPGNMaximally tolerated ACE inhibitor, ARB, or SGLT2 inhibitorRequired background therapy must be ineffective or otherwise meet the stated pathwayComplement-mediated kidney disease
    EnbrelOne DMARD for RA or pJIA; topical steroid for psoriasisFailure after the applicable minimum trialRA, pJIA, psoriasis, psoriatic arthritis, or ankylosing spondylitis
    EntyvioTwo preferred or listed biologic/targeted therapies; established Entyvio IVTreatment failure of two alternativesUlcerative colitis or Crohn disease
    EohiliaProton-pump inhibitor or swallowed topical glucocorticoidFailure, contraindication, or intoleranceEosinophilic esophagitis
    EpidiolexGeneric seizure alternatives; number varies by syndromeFailure, contraindication, or intolerance to the specified alternativesLennox-Gastaut, Dravet, or tuberous-sclerosis-complex seizures
    GelniqueAt least two generic overactive-bladder therapiesFailure or intoleranceOveractive bladder
    GemtesaTwo preferred overactive-bladder therapiesFailure or intolerance to bothOveractive bladder
    RavictiBuphenyl (sodium phenylbutyrate)Treatment failureUrea-cycle disorder with dietary management
    GrastekOne intranasal corticosteroid and one oral or intranasal antihistamineTrial of one agent from each classGrass-pollen allergic rhinitis
    Non-preferred growth hormone productsAll preferred products: Genotropin and NorditropinFailure of all preferred productsAdult or pediatric growth hormone indications
    Sofosbuvir-containing therapy or Harvoni oral pelletsPreferred EpclusaFailure of Epclusa in adults where specifiedQualifying chronic hepatitis C
    Hetlioz LQ for Smith-Magenis syndromeOTC melatonin and acebutololFailure, contraindication, or intoleranceSmith-Magenis syndrome with nighttime sleep disturbance
    Hetlioz LQ for restless legs syndromeTwo of pramipexole, ropinirole, gabapentin, or pregabalinFailure, contraindication, or intoleranceRestless legs syndrome
    Hetlioz LQ for post-herpetic neuralgiaGeneric gabapentin; generic tricyclic antidepressant if under 65Failure, contraindication, or intolerancePost-herpetic neuralgia
    Hydrocodone bitartrate, hydrocodone, and ExalgoThree generic long-acting opioidsFailure or intolerance; concurrent use of more than one long-acting opioid is not coveredModerate-to-severe chronic pain
    Hympavzi for hemophilia AHemlibraFailure or intoleranceHemophilia A without factor VIII inhibitors
    IbranceKisqali and VerzenioFailure, contraindication, or intolerance to bothHR-positive breast cancer primary pathway
    IbsrelaLactulose or polyethylene glycol, and LinzessFailure or intolerance to both stepsConstipation
    Imiquimod for actinic keratosisCryotherapy or phototherapy, topical fluorouracil, and generic imiquimod 5%Failure or intolerance to each prerequisiteActinic keratosis; wart pathway has no listed step
    Non-preferred subcutaneous immunoglobulinsGammagard and HizentraFailure or intolerance to all preferred productsDiagnosis requiring subcutaneous immunoglobulin
    IyuzehOne generic or preferred ophthalmic prostaglandin analogTrial of one productGlaucoma
    JatenzoOne generic or preferred testosterone product, followed by KyzatrexFailure, contraindication, or intoleranceMale hypogonadism
    Jornay PMOne generic stimulantFailure or intoleranceADHD
    Karbinal ERGeneric carbinoxamine and two other generic antihistaminesTreatment failureAllergic condition
    Kevzara or Kineret specified rheumatology pathwaysOne DMARD, three biologic/targeted therapies, and OrenciaFailure or intolerance; other Kineret pathways use steroids, NSAIDs, or colchicineRA and selected inflammatory conditions
    L-glutamineHydroxyurea and OTC L-glutamineFailure, contraindication, or intolerance; hydroxyurea step is generally at least six monthsSickle cell disease
    Kyzatrex before JatenzoKyzatrexFailure or intolerance to the required testosterone pathwayMale hypogonadism
    LivmarliGeneric ursodiol; Bylvay additionally for PFICFailure, contraindication, or intoleranceALGS: ursodiol; PFIC: ursodiol followed by Bylvay
    LivtencityGanciclovir, valganciclovir, cidofovir, or foscarnetTreatment failurePost-transplant CMV infection or disease
    Narcolepsy therapiesWakix; generic or preferred stimulant; adult pathways also use modafinil/armodafinil and SunosiFailure, contraindication, or intolerance as applicable by age and indicationCataplexy: Wakix; excessive daytime sleepiness: stimulant plus Wakix, then adult-specific agents
    LupkynisCyclophosphamide plus glucocorticoids or mycophenolate mofetil plus glucocorticoids; Benlysta and GazyvaFailure, contraindication, or intoleranceActive lupus nephritis
    LyvispahBaclofen tabletsFailure, unless unable to swallow tabletsSpasticity
    NemluvioIndication-specific conventional therapy; Dupixent additionally for prurigo nodularisFailure, contraindication, or intoleranceAtopic dermatitis or prurigo nodularis
    Nexletol or NexlizetHigh-intensity statin, two generic statins for intolerance, or one statin if rhabdomyolysis occurredThe applicable statin-intolerance or rhabdomyolysis pathway may substitute for maximum-dose statin trialCardiovascular risk, hypercholesterolemia, or HeFH
    NilotinibImatinibFailure, contraindication, or intolerancePh-positive CML
    NoctivaOne generic OAB medication and generic oral desmopressin after lifestyle changesFailure or intolerance to OAB medication; trial of desmopressinNocturnal polyuria
    NourianzDopamine agonist or COMT inhibitor added to levodopaFailure or intoleranceParkinson disease with intermittent off episodes
    Nurtec ODT for acute migraineTwo generic triptansFailure or contraindicationAcute migraine
    Nurtec ODT for migraine preventionTwo medications from different preventive classesFailure or intolerance to bothMigraine prevention; no concurrent CGRP antagonist
    NyvepriaNeulasta and ZiextenzoFailure or intolerance to bothPegfilgrastim support
    Odactra or RagwitekOne intranasal corticosteroid and one oral or intranasal antihistamineTrial of one agent from each classAllergic rhinitis; product-specific allergen applies
    OhtuvayreDual LABA/LAMA therapyFailure of dual therapyCOPD
    Olpruva or PheburaneBuphenyl (sodium phenylbutyrate)Treatment failureUrea-cycle disorder with dietary management
    Olumiant or Orencia SCDMARD and specified advanced biologic or targeted therapiesFailure or intolerance; required number varies by indication and ageRA, pJIA, psoriatic arthritis, psoriasis, or severe alopecia areata
    OmnarisTwo of generic fluticasone, generic flunisolide, or OTC NasacortFailure or intoleranceAllergic rhinitis
    OnapgoLevodopa plus at least one adjunctive Parkinson therapyInadequate control despite current regimenAdvanced Parkinson disease motor fluctuations
    Onzetra XsailGeneric sumatriptan nasal spray plus another generic triptan; adolescents may use generic rizatriptanFailure or intoleranceAcute migraine
    OpsynviSildenafil or tadalafil plus ambrisentan and bosentanFailure, intolerance, or contraindication; exception if stable on individual componentsWHO Group I PAH, functional class II–III
    OraceaGeneric doxycycline monohydrate and generic immediate-release doxycycline hyclateFailure or intolerance to bothRosacea
    OrgovyxFirmagonFailure, contraindication, or intoleranceAdvanced prostate cancer
    Oriahnn or OrilissaTwo hormone-related therapies; Oriahnn also requires MyfembreeTrial of required therapiesFibroid-related bleeding or endometriosis pain
    Otezla or Otezla XROne topical steroid for psoriasis or Behcet-related oral ulcersTreatment failure; no step listed for psoriatic arthritis alonePsoriatic arthritis, psoriasis, or Behcet oral ulcers
    OtrexupOral methotrexate followed by injectable methotrexateTreatment failure of both formulationsRA, pJIA, or psoriasis
    Oxcarbazepine extended-releaseAt least three generic alternatives, including generic oxcarbazepineFailure or intoleranceEpilepsy with seizures
    Opana ERThree generic long-acting opioidsFailure or intolerance; concurrent use of more than one long-acting opioid is not coveredModerate-to-severe chronic pain
    OzempicOne generic or preferred type 2 diabetes medication when applicableTrial may be bypassed when coverage is requested directly for type 2 diabetes treatmentType 2 diabetes; no concurrent GLP-1 agonist-containing product
    PalsonifyOne of generic octreotide, Sandostatin LAR, Somatuline Depot, Mycapssa, or Signifor LARFailure of at least one listed therapyAcromegaly
    Pancreatic enzyme productsCreon and ZenpepTreatment failure of bothPancreatic enzyme insufficiency
    QsymiaLifestyle modification programPhysician attestation required; pediatric BMI pathway differs from adult BMI pathwayAdult obesity/overweight or pediatric obesity
    PhenoxybenzaminePreferred alpha1 blocker plus calcium-channel blocker; non-preoperative pathway requires two alpha1 blockersFailure or intolerancePheochromocytoma-related hypertension or sweating
    PitavastatinAt least two generic statinsFailure or intoleranceHyperlipidemia
    PrucaloprideLactulose or polyethylene glycol and LinzessFailure or intolerance to both stepsChronic constipation
    QnaslTwo intranasal steroids: fluticasone, flunisolide, or OTC NasacortFailure or intoleranceAllergic rhinitis
    Qelbree or Quillichew ERGeneric or preferred ADHD products, including methylphenidate and amphetamine productsFailure or intolerance; formulation exception may apply if unable to swallowADHD
    QuliptaTwo medications from different migraine-preventive classesFailure or intolerance; no concurrent CGRP antagonist for preventionMigraine prevention
    QuviviqThree listed sedative-hypnotics followed by BelsomraFailure, contraindication, or intoleranceInsomnia
    RagwitekOne intranasal corticosteroid and one oral or intranasal antihistamineTrial of one agent from each classShort-ragweed allergic rhinitis
    RasuvoInjectable methotrexate; oral methotrexate may also be requiredTreatment failure or intoleranceRA, pJIA, or psoriasis
    RebifTwo generic or preferred multiple-sclerosis medicationsFailure or intoleranceMultiple sclerosis
    RecorlevKetoconazole, mitotane, or cabergolineFailure, contraindication, or intoleranceEndogenous hypercortisolemia in Cushing syndrome
    RepathaOne high-intensity statin; two generic statins for intolerance; or one statin after rhabdomyolysisStatin intolerance or rhabdomyolysis pathway may apply; no concurrent PCSK9 inhibitorPrimary hyperlipidemia, cardiovascular-risk reduction, or familial hypercholesterolemia
    Rexulti or SecuadoTwo preferred second-generation antipsychoticsFailure, contraindication, or intoleranceSchizophrenia, adjunctive MDD, or related psychiatric indication
    Rinvoq or Rinvoq LQDMARD and/or TNF inhibitor, depending on indicationFailure, contraindication, or intolerance; minimum three months where specifiedRA, PsA, pJIA, AD, UC, Crohn disease, AS, nr-axSpA, or GCA
    RivflozaHigh-dose vitamin B6Failure, contraindication, or intolerance after at least three months; no concurrent OxlumoPrimary hyperoxaluria type 1
    RolvedonNeulasta and ZiextenzoFailure or intolerance to bothPegfilgrastim support
    RuconestGeneric FirazyrTreatment failure; no concurrent acute HAE productAcute HAE attacks
    Lennox-Gastaut seizure therapyAt least three generic seizure alternativesFailure, contraindication, or intoleranceLennox-Gastaut syndrome
    RytaryGeneric Sinemet CRTreatment failureParkinson disease
    SancusoGeneric ondansetron/ODT and generic granisetronTreatment failureChemotherapy- or radiation-related nausea/vomiting
    SephienceGeneric sapropterinFailure or intoleranceSepiapterin-responsive PKU/HPA
    SotyktuOne topical steroid and two listed systemic or biologic alternativesFailure or intolerance to the pathway-specific agentsAdult psoriasis or psoriatic arthritis
    SovaldiPreferred EpclusaFailure of Epclusa; pediatric genotype 2/3 pathway uses ribavirinQualifying chronic hepatitis C
    SpevigoAcitretin, methotrexate, cyclosporine, or infliximabContinued GPP flares during or after therapy; contraindication or intolerance may applyPrevention of GPP flares
    StimufendNeulasta and ZiextenzoFailure or intolerance to bothGranulocyte colony-stimulating-factor support
    Sumatriptan/naproxen combinationGeneric sumatriptan plus naproxen and a second generic triptan; ages 12–17 may use generic MaxaltFailure or intoleranceAcute migraine
    Tadalafil suspensionGeneric sildenafil suspensionFailure, intolerance, or contraindication; inability to swallow tablets requiredWHO Group 1 PAH
    TaltzIndication-specific topical steroid and biologic/targeted therapiesFailure, contraindication, or intolerance as specifiedPsoriasis, PsA, nr-axSpA, or ankylosing spondylitis
    Tapentadol immediate-releaseThree generic immediate-release opioidsFailure or intoleranceAcute pain
    Nucynta ERThree generic long-acting opioids and Xtampza ER where applicableFailure or intolerance; age-specific neuropathic-pain steps may applyChronic pain or diabetic peripheral neuropathy; no concurrent long-acting opioid
    TarpeyoMaximally tolerated ACE inhibitor or ARB, generic corticosteroid, and SGLT2 inhibitorContraindication or intolerance may substitute where specified; ACEi/ARB may be omitted if contraindicatedPrimary IgA nephropathy at risk of progression
    TasignaImatinib and dasatinibFailure, contraindication, or intolerancePh-positive CML
    TasimelteonOTC melatonin and Rozerem; SMS also requires acebutololFailure, contraindication, or intoleranceNon-24-hour sleep-wake disorder or Smith-Magenis syndrome
    Teriparatide, Forteo, or TymlosVery high risk: zoledronate, or preferred denosumab if zoledronate is contraindicated; high risk: oral/IV bisphosphonate and preferred denosumabFailure, contraindication, or intolerance according to risk pathwayOsteoporosis with high- or very-high-fracture risk
    TezspireDaily oral corticosteroid or high-dose inhaled corticosteroid plus LABA, leukotriene modifier, or LAMAInadequate control after at least three months; required standard-of-care therapy continuesEosinophilic, allergic, oral-corticosteroid-dependent, or severe asthma; CRSwNP pathway
    Teglutik or TiglutikGeneric riluzole tabletsDifficulty swallowing tablets may substitute for the trialALS
    Tobi PodhalerGeneric Tobi tobramycin inhalation nebulization solutionFailureCystic fibrosis with Pseudomonas aeruginosa
    Tofacitinib formulationsFormulation-specific DMARD and TNF-inhibitor therapyFailure or intolerance; DMARD trial generally at least three months where statedRA, PsA, UC, pJIA, or ankylosing spondylitis
    Eprontia, topiramate ER, or Trokendi XRAt least three generic alternatives, including generic topiramate where specifiedFailure or intoleranceEpilepsy, Lennox-Gastaut syndrome, or migraine prevention
    Tremfya for psoriasisOne topical steroidFailurePsoriasis
    TrulicityOne generic or preferred type 2 diabetes medication when coverage is not requested directly for diabetesTrial may be bypassed for direct type 2 diabetes treatmentType 2 diabetes; no concurrent GLP-1 agonist-containing product
    TyenneIndication-specific DMARD, glucocorticoid, NSAID, mycophenolate mofetil, or cyclophosphamide therapyFailure, intolerance, contraindication, or lack of candidacy as specifiedRA, pJIA, Still disease, GCA, or SSc-ILD
    UbrelvyTwo generic triptansFailure or contraindicationAcute migraine in adults
    Uptravi or VentavisSildenafil or tadalafil plus ambrisentan or bosentanTreatment failure of required pulmonary-hypertension componentsWHO Group 1 PAH; PH-ILD pathway may not require the same steps
    VarubiAll generic 5-HT3 antagonists and a preferred NK1 antagonistFailure of all required antiemetic classesChemotherapy-induced nausea/vomiting prevention
    Vernal keratoconjunctivitis therapyDual-acting topical antihistamine/mast-cell stabilizer, ophthalmic corticosteroid, and generic Restasis; compromised-cornea pathway requires RestasisFailure or intolerance to required topical therapiesVernal keratoconjunctivitis
    Vesicare LSTwo anticholinergic drugsTreatment failure; formulation exception may apply if unable to swallow and solution has failedNeurogenic detrusor overactivity
    Vigabatrin powderThree generic seizure alternatives and Sabril powder for epilepsy pathwayFailure, contraindication, or intoleranceInfantile spasms or adjunctive epilepsy treatment
    ViokaceCreon and ZenpepTreatment failure of bothExocrine pancreatic insufficiency
    Voquezna-like therapyGeneric first-line H. pylori regimen or three generic/OTC PPIsTrial and failure, contraindication, or intolerance as applicableH. pylori, erosive esophagitis, or non-erosive GERD
    VoseviPrior NS5A regimen; applicable sofosbuvir regimen; preferred EpclusaPrior regimen failure and treatment-experience documentation requiredTreatment-experienced chronic hepatitis C
    VoydeyaEmpaveli and FabhaltaFailure, contraindication, or intolerance; must be added to Soliris or UltomirisPNH with clinically significant extravascular hemolysis
    VoyxactMaximally tolerated ACE inhibitor or ARB, SGLT2 inhibitor, Tarpeyo, and preferred endothelin receptor antagonistFailure, contraindication, or intolerance; exceptions applyPrimary IgA nephropathy at risk of progression
    VtamaAny generic topical therapyTreatment failureDermatologic indication
    Vyvgart Hytrulo for MGOne listed standard-of-care immunosuppressant for at least 12 weeksIneffective treatment; all options may be excepted if contraindicated or not toleratedAChR-antibody-positive myasthenia gravis
    Vyvgart Hytrulo for CIDPGeneric corticosteroids or immunoglobulin therapyFailure, contraindication, or intoleranceCIDP
    VyzultaThree generic preferred prostaglandin medicationsFailure, contraindication, or intoleranceElevated intraocular pressure/glaucoma
    Wakix for narcolepsy with cataplexyWakix when age appropriateFailure, contraindication, or intoleranceNarcolepsy with cataplexy
    Wakix for narcolepsy with excessive daytime sleepinessGeneric or preferred stimulant plus Wakix; adults also modafinil or armodafinil and SunosiFailure, contraindication, or intoleranceNarcolepsy with excessive daytime sleepiness
    WayrilzGeneric eltrombopagFailure or non-candidacy for corticosteroids, immunoglobulins, or splenectomy; current severe thrombocytopenia or bleedingChronic immune thrombocytopenia
    WinleviOne oral acne agent and three topical acne agentsFailure, contraindication, or intoleranceAcne
    WinrevairGeneric sildenafil or tadalafil and generic or preferred endothelin-receptor antagonistFailure, intolerance, or contraindicationWHO Group 1 PAH
    XcopriAt least three generic seizure-treatment alternativesFailure or intoleranceEpilepsy with seizures
    XelprosTwo preferred glaucoma medications, such as Xalatan, Lumigan, or Travatan ZTreatment failureElevated intraocular pressure
    XepiGeneric BactrobanTrial requiredImpetigo
    550-mg product for IBS-DTricyclic antidepressantFailure, contraindication, or intoleranceIBS-D
    550-mg product for SIBOTwo generic antibioticsFailureSIBO confirmed by breath test
    550-mg product for IMONeomycinUse unless contraindicatedIMO confirmed by breath test
    550-mg product for hepatic encephalopathyLactuloseFailure, contraindication, or intoleranceHepatic encephalopathy
    Xolair for allergic asthmaDaily oral or high-dose inhaled corticosteroid plus appropriate controllerInadequate control after at least three monthsUncontrolled moderate-to-severe allergic asthma
    Xolair for chronic spontaneous urticariaMaximal-dose second-generation antihistamine plus one additional listed therapyFailure after the required therapy durationChronic spontaneous urticaria
    XyostedGeneric Depo-testosterone or generic DelatestrylFailure, contraindication, or intoleranceMale hypogonadism
    Xywav for narcolepsy with cataplexyWakix when age appropriateFailure, contraindication, or intoleranceAge ≥7; narcolepsy with cataplexy
    Xywav for narcolepsy with excessive daytime sleepinessGeneric or preferred stimulant and Wakix; adults also modafinil or armodafinil and SunosiFailure, contraindication, or intoleranceNarcolepsy with excessive daytime sleepiness
    Xywav for idiopathic hypersomniaNo specific prior therapy listed in the rendered pathwayAge ≥18 and qualifying diagnosis requiredIdiopathic hypersomnia
    Step Therapy

    Complete step therapy before submission

    Complete the required preferred-drug trial before requesting a nonpreferred medication. Document treatment failure, contraindication, or intolerance when the applicable criterion allows it, and submit the sequence and outcome with the authorization request.

    • Confirm the required alternative and order of therapy for the specific drug and indication.
    • Record the trial duration, treatment outcome, contraindication, or intolerance.
    • Examples include preferred Epclusa before specified hepatitis C therapies, generic Sinemet CR before Crexont or Rytary, and two generic triptans before Ubrelvy.

    Prior Authorization and Submission Requirements

    Prior Authorization

    Secure authorization and support the request

    Obtain prior authorization before prescribing a medication subject to this policy and submit documentation supporting medical necessity. Coverage may be denied when required documentation, step therapy, clinical criteria, or plan benefits are not satisfied.

    • Submit the diagnosis, age or weight, disease severity, laboratory or diagnostic confirmation, prior-treatment history, and applicable specialist information.
    • Confirm that required alternatives have been tried and failed, or that contraindication or intolerance is documented where permitted.
    • Verify the member’s prescription drug benefit; medications excluded from the plan may be denied or may fall under the medical benefit.
    Prior Authorization

    Match the request to medication-specific criteria

    For each requested medication, submit the drug-specific indication and all applicable age, diagnostic, laboratory, prior-treatment, dosing, safety, specialist, and renewal requirements. The policy includes medication-specific criteria ranging from Accrufer after two over-the-counter iron-product failures to specialty therapies requiring genetic confirmation, specialist care, or multiple preferred-drug failures.

    Approval Durations and Quantity Restrictions

    Quantity limits and approval periods
    Erectile dysfunction and infertility productsCaverject, Muse, sildenafil (Viagra), Staxyn, Stendra, and vardenafil (Levitra) may be subject to plan-specific quantity limits; infertility products remain subject to the member’s fertility benefit.
    Gallstone therapyCoverage for Chenodal and Ctexli used for gallstones is limited to 24 months.
    Eltrombopag (Promacta) maximum dosesMaximum daily doses are 75 mg for chronic ITP, 100 mg for thrombocytopenia associated with chronic hepatitis C, and 150 mg for severe aplastic anemia.
    Short approval periodsDrug-specific initial approval periods include 60 days, 90 days, 3 months, 6 months, 12 weeks, and 1 year.
    Imcivree approval periodsInitial approval is 4 months for POMC, PCSK1, or LEPR deficiency and 1 year for Bardet-Biedl syndrome.
    Longer approval limits

    Administration and Dispensing Location

    Billing Rule

    Verify site-of-care requirements

    Confirm the required administration setting before dispensing. Some medications excluded from the prescription benefit may be covered under the medical benefit when administered in a physician’s office or another approved site of care; other therapies require outpatient stability, home administration, specialist dispensing, or hospital initiation.

    • Hemophilia products including Alhemo, Hemlibra, Hympavzi, and Qfitlia must be prescribed and dispensed through a specialist or treatment center associated with a hemophilia treatment center.
    • Samsca must be initiated or re-initiated in a hospital.
    • Winrevair is self-administered unless the member is clinically unable to do so; applicable immunoglobulin criteria require subcutaneous administration.
    • Xolair prefilled-syringe self-administration requires the first three doses under health-care-provider guidance.

    Clinical Thresholds and Eligibility Values

    Age, laboratory, weight, severity, response, and clinical thresholds
    Age thresholdsExamples include Accrufer ≥10 years, Adbry ≥12 years, Alyftrek ≥6 years, Alhemo ≥12 years, Loargys ≥2 years, Livtencity ≥12 years, Lupkynis ≥18 years, Spevigo ≥12 years, Tascenso ODT ≥10 years, and adult pathways generally ≥18 years.
    Hemophilia laboratory thresholdsHigh factor VIII or IX inhibitor titer is >5 BU/mL; severe hemophilia has factor VIII or IX levels <1%; moderate hemophilia has levels of 1%–5%.
    Hereditary angioedema laboratory thresholdsQualifying HAE findings include C4 below the laboratory normal range, stated as 16–58 mg/dL, and C1 inhibitor antigenic or functional level below normal, with normal function stated as ≥41%.
    Platelet and hematologic thresholdsChronic or persistent ITP requires platelets <100,000/mcL for at least 3 months; qualifying current counts include <20,000/mcL or <30,000/mcL with active bleeding. Eltrombopag also uses hepatitis C platelets <75,000/mcL and severe aplastic anemia platelets ≤30,000/mcL.
    Cardiac thresholdsCamzyos initial LVEF must be >55% and renewal LVEF ≥50%, with LVOT peak gradient ≥50 mmHg. Myqorzo requires LVEF ≥55% and LVOT gradient ≥50 mmHg; Verquvo requires LVEF <45%.

    Policy Terms and Abbreviations

    Definitions and abbreviations
    Prior authorizationA utilization-management process requiring the physician to submit documentation supporting the need for a medication before MESSA will cover it.
    Step therapyA utilization-management process requiring previous treatment with one or more preferred drugs before coverage of the requested medication is approved.
    NCNot covered; the member may be responsible for the full cost of the medication.
    DMARD and targeted DMARDDMARD means disease-modifying antirheumatic drug; targeted DMARD means targeted disease-modifying antirheumatic drug.
    HAE and related laboratory termsHAE means hereditary angioedema. Qualifying laboratory confirmation uses C4 and C1 esterase inhibitor values below the laboratory reference range.
    Cardiac and pulmonary abbreviationsLVEF means left ventricular ejection fraction; LVOT gradient means left ventricular outflow tract peak gradient; PAH means pulmonary arterial hypertension, classified as WHO Group 1; PH-ILD means pulmonary hypertension associated with interstitial lung disease.

    Policy Background

    MESSA uses prior authorization to confirm that selected medications are prescribed consistently with FDA-approved safe-prescribing requirements and that the request is supported by documented medical necessity. The review may require diagnosis and severity information, laboratory or genetic confirmation, prior-treatment history, and evidence that medication-specific criteria are satisfied before coverage is approved.

    Step therapy directs members to try preferred or lower-cost alternatives before a nonpreferred medication is covered. The policy applies this review across common and specialty conditions, including dermatologic disease, pulmonary hypertension, hemophilia, cystic fibrosis, hereditary angioedema, rare metabolic disease, hematologic disease, neurologic disease, and psychiatric conditions.

    Preferred Biosimilar and Biologic Options

    Billing Rule

    Use the preferred biosimilar pathway

    Use the preferred biosimilar or biologic options identified for the specific indication when completing step therapy. The required product varies by diagnosis and may include a preferred adalimumab biosimilar, preferred ustekinumab biosimilar, or preferred tocilizumab biosimilar.

    • Cimzia and Cosentyx pathways may require preferred adalimumab, ustekinumab, or tocilizumab biosimilar trials, depending on indication.
    • Entyvio pathways list preferred adalimumab and ustekinumab biosimilars among alternatives.
    • Kevzara, Kineret, Olumiant, Orencia SC, and Sotyktu pathways may require preferred adalimumab, tocilizumab, or ustekinumab biosimilar options.
    • Tavneos may be initiated with cyclophosphamide plus glucocorticoids or rituximab/rituximab biosimilar plus glucocorticoids.
    Policy Summary
    PayerMESSA
    PolicyPrior Authorization and Step Therapy Coverage Criteria
    Policy CodePolicy N/A
    Change TypeModified
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit documentation supporting medical necessity and showing that all medication-specific prior authorization and step-therapy criteria are satisfied.
    SourceLink
    On This Page
    Medication Coverage CriteriaInitial Authorization CriteriaRenewal and Continued CoveragePreferred-Drug and Prerequisite TherapyPrior Authorization and Submission RequirementsApproval Durations and Quantity RestrictionsAdministration and Dispensing LocationClinical Thresholds and Eligibility ValuesPolicy Terms and AbbreviationsPolicy BackgroundPreferred Biosimilar and Biologic Options
    Higher-complexity specialty pathways: For hemophilia products, include factor level or inhibitor titer, bleeding history, specialist and hemophilia-treatment-center dispensing, and required factor or Hemlibra failure. For immune and inflammatory products, include diagnosis-specific DMARD, biologic, targeted therapy, steroid, NSAID, or topical failures. For rare disease products, include required genetic, biopsy, enzyme, flow-cytometric, or disease-specific laboratory confirmation.
    Growth, metabolic, and weight pathways: Adult or pediatric growth hormone products require the applicable pituitary, HIV-wasting, short-bowel, deficiency, growth, skeletal-maturity, or associated-disease pathway; non-preferred products require failure of Genotropin and Norditropin. Imcivree requires a qualifying genetic deficiency or Bardet-Biedl syndrome with obesity. Qsymia requires adult or pediatric BMI criteria, baseline weight, lifestyle-modification attestation, and no other weight-loss product. Osteoporosis anabolic therapy requires the appropriate fracture-risk and antiresorptive step pathway.
    Narcolepsy and sleep-wake pathways: Narcolepsy with cataplexy requires age ≥7 years and Wakix failure, contraindication, or intolerance when age appropriate. Narcolepsy with excessive daytime sleepiness requires age ≥7 years plus failure or intolerance to a generic or preferred stimulant and Wakix; adults additionally require modafinil or armodafinil and Sunosi failure or intolerance. The adult idiopathic-hypersomnia pathway requires age ≥18 years and the applicable prior-treatment history.Age ≥7 years for the clearly rendered narcolepsy pathways; age ≥18 years for idiopathic hypersomnia.

    Continuation and renewal criteria

    Renewal requires that current indication and safety criteria remain satisfied and that the medication continues to provide clinical benefit. Product-specific response thresholds and fixed durations also apply.

    General continuation requirement: Current drug-specific criteria remain met, the requested medication is being used for the covered indication, and documented clinical benefit supports continued treatment.
    Objective response requirements: Hemophilia continuation requires fewer bleeds or successful treatment response. HAE prophylaxis generally requires a 50% reduction in attack number or severity; acute HAE therapy requires at least 50% improvement in time to symptom relief with maintained improvement. SMA therapy requires repeat motor assessment showing improvement, stabilization, or reduced decline. Obesity therapy requires maintained weight or BMI reduction. Other products may require objective laboratory, symptom, lesion, growth, cardiac, renal, or disease-stability benefit.
    Safety and monitoring: Submit current laboratory or clinical monitoring when required, including platelet counts and dose adjustment for thrombocytopenia therapies, LVEF for Camzyos or Myqorzo, current weight or BMI for weight-management therapies, growth and open epiphyses for growth therapies, and absence of prohibited combination therapy or serious adverse events when specified.
    Fixed-duration limits: Chenodal or Ctexli gallstone treatment is limited to 24 months; Tymlos is limited to 2 years; Oriahnn is limited to 2 years; Orilissa is limited to 2 years at 150 mg or 6 months at 200 mg; and the 550-mg product allows a maximum of two IBS-D renewals after recurrent symptoms, subject to the applicable course limits.

    Product-specific renewal thresholds and outcomes

    Renewal requests must include the product-specific outcome, safety, laboratory, or duration evidence required for the requested therapy.

    Cardiac and metabolic thresholds: Camzyos renewal requires clinical benefit and LVEF ≥50%. Myqorzo renewal requires clinical benefit and LVEF ≥40%. Contrave and orlistat require maintained ≥5% weight loss, current weight, lifestyle participation, and BMI ≥18.5 kg/m². Qsymia requires adult maintenance of ≥5% weight loss or pediatric maintenance of a 1% BMI reduction with the applicable BMI-for-age threshold.Camzyos LVEF ≥50%; Myqorzo LVEF ≥40%; weight-management response ≥5% for adults where stated.
    HAE renewal thresholds: Andembry, Dawnzera, Haegarda, Orladeyo, and Takhzyro require a 50% or greater reduction in attack number or attack severity. Firazyr and Ruconest require at least 50% improvement in time to symptom relief with maintained improvement.≥50% reduction or improvement
    Hematologic, neurologic, and growth outcomes: Thrombocytopenia renewal requires recent platelet assessment, generally 50,000-200,000/mcL or dose adjustment under FDA labeling, with reduced bleeding when counts are 20,000-50,000/mcL. Evrysdi requires repeat motor assessment and meaningful motor benefit. Hemlibra and Qfitlia require decreased bleeding. Voxzogo requires open epiphyses and maintained or increased growth. Wayrilz requires stable platelets ≥50,000/mcL.
    Disease-specific limits and exclusions: Rezdiffra is not continued after progression to cirrhosis and requires a specified NASH/MASH or fibrosis benefit. Tymlos is limited to a maximum of 2 years. The 550-mg product requires recurrent symptoms for IBS-D or SIBO/IMO renewal, permits no more than two IBS-D renewals, and otherwise requires current criteria and clinical benefit for hepatic encephalopathy.
    • Accrufer: iron deficiency, age at least 10 years, and failure or intolerance to two over-the-counter iron products.
    • Alhemo, Hemlibra, Hympavzi, and Qfitlia: provide factor or inhibitor findings, bleeding history, treatment-center involvement, and required prior prophylaxis history.
    • Specialty products may require genetic or molecular confirmation, biopsy or laboratory evidence, specialist prescribing, and documented response or intolerance to required alternatives.
    • Review the applicable product criteria and approval duration before submission; renewal generally requires current criteria and clinical benefit.
    Documentation Required

    Submit the supporting clinical record

    Assemble a complete clinical record before submitting the request. Documentation should establish the diagnosis and severity, objective laboratory or genetic evidence, specialist involvement, prior-treatment history and outcomes, concomitant therapies, and—when renewing—current clinical benefit.

    • Diagnostic confirmation: include relevant biopsy, flow cytometry, genetic testing, molecular testing, ECG or electrographic records, and disease-specific laboratory results.
    • Step-therapy history: list each required generic, preferred, or standard therapy with dates, duration, response, failure, contraindication, or intolerance.
    • Specialty care: identify the prescribing specialist and treatment center when required, including hemophilia treatment-center involvement.
    • Renewals: submit current assessments and objective response measures such as reduced bleeding, HAE attack reduction, motor-function response, weight loss, platelet response, or preserved cardiac function.
    Denial Risk

    Prevent denial before prescribing or renewal

    Review the request for exclusion and renewal risks before submission. Coverage may be denied for prohibited combinations, missing clinical or step-therapy criteria, plan exclusions, absent diagnostic evidence, or failure to demonstrate ongoing benefit.

    • Do not combine applicable biologics or targeted DMARDs for the same indication, or use prohibited duplicate therapies such as multiple long-acting opioids, CGRP antagonists for prevention, or HAE prophylaxis products.
    • Check safety exclusions, including sedative hypnotics, other CNS depressants, alcohol, concurrent CFTR potentiators, and prohibited PNH or enzyme-replacement therapies.
    • For renewal, document current eligibility and clinical benefit; product-specific requirements may include no cirrhosis progression, a 50% reduction in HAE attacks, maintained weight loss, or a stable platelet response.
    • Verify plan status: “NC” means not covered and the member may be responsible for the full cost.
    Oriahnn and Orilissa 150 mg may be approved for up to 2 years; Orilissa 200 mg is approved for 6 months; teriparatide, Forteo, and Tymlos have a maximum treatment or approval period of 2 years.
    Selected drug-specific periods and renewalsLivmarli: 6 months; Livtencity: 3 months; Samsca: 60 days; Veozah, Vyalev, Vyvgart Hytrulo, Winlevi, and Xelpros: 1 year; Vyleesi and Xepi: 60 days; Wayrilz: 3 months; the 550-mg IBS-D course allows a maximum of 2 renewals.
    Weight, obesity, and response thresholdsContrave requires BMI ≥30 kg/m², or ≥27 kg/m² with a weight-related comorbidity, and continuation requires maintained 5% weight loss with BMI ≥18.5 kg/m². Imcivree requires adult BMI ≥30 kg/m² or pediatric BMI ≥95th percentile and at least 5% reduction in baseline weight or BMI for continuation.
    Disease-severity, laboratory, and response thresholdsExamples include problematic hypoglycemia glucose <54 mg/dL; PNH high activity LDH ≥1.5 times ULN with a qualifying symptom or event; Glassia FEV1 35%–60% predicted; Nucala asthma eosinophils ≥150 cells/µL and HES eosinophils ≥1,000 cells/µL with at least 2 HES flares; osteoporosis T-score ≤−2.5 or FRAX risk ≥20% major fracture/≥3% hip fracture; Voydeya hemoglobin ≤9.5 g/dL with absolute reticulocytes ≥120 × 10^9/L; and Xolair indication-specific IgE ranges.
    Disease and specialty abbreviationsPSVT means paroxysmal supraventricular tachycardia; PNH means paroxysmal nocturnal hemoglobinuria; SMA means spinal muscular atrophy; CRSwNP means chronic rhinosinusitis with nasal polyposis; EoE means eosinophilic esophagitis; CIDP means chronic idiopathic demyelinating polyneuropathy; hATTR means hereditary transthyretin amyloidosis with peripheral neuropathy; and ADPKD means autosomal dominant polycystic kidney disease.