Tocilizumab (Actemra) and selected specialty injectable medication coverage
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Clinical prior authorization and coverage criteria for Actemra (intravenous and subcutaneous formulations) and summary entries for other specialty products listed in this section; governs CareSource members in North Carolina and providers seeking prior authorization for these products.
No material clinical or coverage changes in this revision.
Coverage Criteria by Product
Actemra; ARIKAYCE
Coverage criteria below are organized by product. Each criteria group lists initial and continuation requirements, exclusions, age/prescriber restrictions, coverage duration, and other operational notes.
ALL of the following
- Actemra (tocilizumab) - Exclusion: concurrent use with a Biologic DMARD or Targeted Synthetic DMARD is not allowed.
- Initial therapy: Indication-specific criteria (e.g., RA, GCA, SJIA, PJIA) - age limits apply (GCA/RA ≥18; PJIA/SJIA ≥2 for initial). Prescriber restriction: rheumatologist or in consultation with one for RA, GCA, PJIA, SJIA initial therapy.
- RA initial: patient has tried ONE of Enbrel, a preferred adalimumab product, Rinvoq, or Xeljanz/XR (or prior trials with Cimzia, Kevzara, infliximab, golimumab SC/IV, Orencia, or a non-preferred adalimumab can count); OR patient has heart failure or prior lymphoproliferative disorder.
- PJIA initial: tried ONE of Enbrel, Rinvoq, Xeljanz, preferred adalimumab product (or prior trials with Kevzara, infliximab, Orencia, or non-preferred adalimumab count); OR heart failure or prior lymphoproliferative disorder. SJIA/systemic-onset JIA: approve for initial therapy.
- Giant Cell Arteritis initial: patient has tried or is currently taking systemic corticosteroid or corticosteroid is contraindicated.
- Interstitial lung disease indication: age ≥18 for initial and continuation; diagnosis confirmed by HRCT and elevated acute phase reactants as required per indication-specific rules.
- Continuation therapy (all indications): prescriber documents patient response to therapy. Coverage duration: approve through end of plan year for most Actemra indications.
ALL of the following
- ARIKAYCE (amikacin liposome inhalation) - Initial therapy: Mycobacterium avium complex (MAC) lung disease in adults - ALL of the following must be met:
ALL of the following
- A) Positive sputum culture for MAC (any positive culture after completion of a background multidrug regimen also meets criterion).
- B) MAC isolate susceptible to amikacin.
- C) ARIKAYCE will be used in combination with a background multidrug regimen (example regimen: macrolide [azithromycin or clarithromycin], ethambutol, and a rifamycin [rifampin or rifabutin]).
- Prescriber restriction: pulmonologist, infectious disease physician, or physician specializing in MAC lung infections. Age restriction: ≥18 (initial). Coverage duration: 1 year.
- Continuation therapy: ARIKAYCE prescribed with background multidrug regimen AND patient either (a) has not achieved negative sputum cultures for MAC or (b) has achieved negative sputum cultures for less than 12 months.
Additional Products and Consolidated Oncology / Specialty Biologic Criteria
ALL of the following
- ARCALYST (rilonacept) - Exclusion: concurrent biologic therapy.
- Initial therapy age restriction: CAPS/pericarditis ≥12 years. Prescriber restrictions: CAPS - rheumatologist, geneticist, allergist/immunologist, or dermatologist; DIRA initial - rheumatologist/geneticist/dermatologist/physician specializing in autoinflammatory disorders; Pericarditis - cardiologist or rheumatologist.
- Initial therapy DIRA: patient weighs ≥10 kg, genetic test confirming bi-allelic pathogenic IL1RN variants, and prior clinical benefit with anakinra SC injection.
- Pericarditis: recurrent pericarditis required for initial approval.
- Continuation: patient demonstrated response to therapy for all indications. Coverage durations: CAPS 3 months initial/1 year continuation; DIRA 6 months initial/1 year continuation; Pericarditis 3 months initial/1 year continuation.
ALL of the following
- Benlysta (belimumab) - Exclusion: concurrent use with other biologics or with Lupkynis per product policies where applicable.
- Indications: SLE and lupus nephritis per FDA labeling. Age restriction: ≥5 years (initial). Prescriber: SLE - rheumatologist, clinical immunologist, nephrologist, neurologist or dermatologist for initial and continuation; lupus nephritis - nephrologist or rheumatologist.
- SLE initial: autoantibody-positive SLE (ANA and/or anti-dsDNA) AND Benlysta used concurrently with at least one other standard therapy (antimalarials, systemic corticosteroid, and/or other immunosuppressants) unless intolerant to standard therapy.
- Lupus nephritis initial: biopsy-confirmed lupus nephritis (eg WHO class III, IV, V) AND Benlysta used with an immunosuppressive regimen (eg azathioprine, cyclophosphamide, leflunomide, methotrexate, mycophenolate mofetil and/or systemic corticosteroid).
- Continuation: Benlysta used concurrently with at least one other standard therapy (unless intolerant) AND patient has responded to therapy (subcutaneous or IV) as documented by prescriber. Coverage duration: SLE initial 4 months/cont 1 year; lupus nephritis initial 6 months/cont 1 year.
ALL of the following
- Blenrep (belantamab mafodotin) - Approve according to FDA-approved indications and standard oncology criteria; prescriber restriction: oncologist; coverage duration: 1 year. Approve in relapsed/refractory multiple myeloma per product labeling and oncology practice standards (e.g., prior lines of therapy as required).
ALL of the following
- Ibandronate IV - Indications: Treatment of postmenopausal osteoporosis. Exclusion: concurrent use with other osteoporosis medications as specified.
- Coverage duration: authorization for 12 months.
- Initial authorization requires ONE of the following: 1) T-score ≤ -2.5 at lumbar spine, femoral neck, or total hip (current or prior); 2) History of osteoporotic or fragility fracture; 3) T-score between -1.0 and -2.5 and physician determines patient at high risk for fracture AND inadequate response to oral bisphosphonate therapy after a 12-month trial or intolerability to oral bisphosphonate (eg severe GI adverse effects), inability to swallow or remain upright, pre-existing GI condition; OR prior trial of IV bisphosphonate (ibandronate or zoledronic acid); OR patient has osteoporotic/fragility fracture.
ALL of the following
- Ambrisentan / Bosentan (endothelin receptor antagonists) - Indications: Pulmonary arterial hypertension (PAH) WHO Group 1; bosentan may also be used for chronic thromboembolic pulmonary hypertension (CTEPH) in selected cases per policy.
- Required: Right-heart catheterization results confirming PAH for WHO Group 1 indications. Prescriber restriction: cardiology or pulmonology consultation required for PAH; CTEPH - cardiologist or pulmonologist.
- Other criteria for CTEPH with bosentan: patient must have tried Adempas, have a contraindication to Adempas, or be currently receiving bosentan for CTEPH. Coverage duration: 1 year.
ALL of the following
- Braftovi (encorafenib) - Approval requires diagnosis and documented BRAF V600 mutation (or BRAF V600E) status as applicable.
- Melanoma: unresectable, advanced or metastatic melanoma with BRAF V600 mutation. Colon/rectal cancer: BRAF V600E mutation-positive disease and use in combination with anti-EGFR therapy (cetuximab/panitumumab) and chemotherapy per regimens described (e.g., FOLFOX) or in previously treated disease with EGFR combination. NSCLC: BRAF V600E mutation-positive recurrent/advanced/metastatic disease when used in combination with MEK inhibitor Mektovi (binimetinib). Appendiceal adenocarcinoma: BRAF V600E positive advanced/metastatic disease in combination with cetuximab or panitumumab. Coverage duration: 1 year; age ≥18 for listed oncology uses.
ALL of the following
- CIMZIA (certolizumab pegol) - Exclusion: concurrent use with a Biologic DMARD or Targeted Synthetic DMARD.
- Required medical information: diagnosis, concurrent medications, previous therapies tried. Age restrictions: generally ≥18 for AS, nr-axSpA, PsA, RA, CD, and PP initial therapy; JIA ≥2 years initial.
- Prescriber restrictions: RA/AS/JIA initial - rheumatologist; Crohn’s disease - gastroenterologist; PsA - rheumatologist or dermatologist; Plaque Psoriasis - dermatologist; nr-axSpA - rheumatologist.
- Initial therapy rules: indication-specific step-therapy requirements (examples): AS initial - tried TWO of Enbrel, preferred adalimumab, Xeljanz/XR, Cosentyx (non-preferred adalimumab counts if needed); PsA initial - tried TWO of Enbrel, preferred adalimumab, Cosentyx, Tremfya, preferred ustekinumab, Otezla, Rinvoq, Skyrizi, Xeljanz/XR; RA initial - tried two of Enbrel, preferred adalimumab, Rinvoq, or Xeljanz/XR (alternate biologic trials may count); CD initial - tried ONE prior (preferred adalimumab, preferred infliximab, preferred ustekinumab, Skyrizi, Rinvoq, or Tremfya).
- Continuation: approval if documentation of response to therapy as determined by prescriber. Coverage duration: approve through end of plan year. Part B prerequisite therapy required: Yes where specified.
ALL of the following
- Camzyos (mavacamten) - Obstructive hypertrophic cardiomyopathy (oHCM) criteria.
- Initial approval requires all of the following: (i) at least one symptom associated with oHCM (eg dyspnea, chest pain, syncope, fatigue, reduced exercise tolerance) AND New York Heart Association (NYHA) Class II or III symptoms; (ii) left ventricular hypertrophy and either maximal wall thickness ≥15 mm OR familial HCM with maximal wall thickness ≥13 mm; (iii) peak LVOT gradient ≥50 mmHg at rest or with provocation (Valsalva or post-exercise). Prescriber: cardiologist. Age: ≥18. Initial coverage duration: 8 months; continuation: 1 year with response documented and treatment established ≥8 months for continuation criteria.
- Continuation criteria: patient established on therapy ≥8 months; evidence of beneficial clinical response by objective measures or symptom stabilization/improvement; LVEF ≥50% required for continuation.
ALL of the following
- Chemet (dimercaptosuccinic acid) - Initial authorization for acute lead poisoning in pediatric patients 12 months to 18 years: approve if blood lead level >45 mcg/dL prior to starting Chemet. Prescriber should be experienced in chelation therapy (eg medical toxicologist or poison control specialist). Coverage duration: 2 months.
ALL of the following
- Cinacalcet - Indication-specific coverage. Required medical information: diagnosis and relevant labs. Prescriber restrictions: hypercalcemia due to parathyroid carcinoma - oncologist or endocrinologist consultation; primary hyperparathyroidism-related hypercalcemia - nephrologist or endocrinologist consultation; hyperparathyroidism in post-renal transplant - transplant physician/nephrologist/endocrinologist consultation.
- Coverage duration: 12 months. Other criteria: hypercalcemia due to parathyroid carcinoma - approve. Primary hyperparathyroidism - approve if failed or unable to undergo parathyroidectomy. Secondary hyperparathyroidism in CKD on dialysis - deny under Medicare Part D (submit under ESRD bundle). Hyperparathyroidism in post-renal transplant - baseline calcium and iPTH above normal prior to starting cinacalcet.
ALL of the following
- Clobazam (Sympazan) - Exclusion: N/A. Initial therapy age restriction: ≥2 years and older. Prescriber: neurologist or in consultation with one for initial therapy.
- Lennox-Gastaut initial: patient has tried and/or is concomitantly receiving one of lamotrigine, topiramate, rufinamide, felbamate, Fintepla, Epidiolex or valproic acid. Treatment-refractory seizures initial: tried/concomitantly receiving at least two other antiepileptic drugs. Continuation: prescriber confirms patient is responding to therapy. Coverage duration: 1 year.
ALL of the following
- CRYSVITA (burosumab) - Indications: X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO). Exclusion: CKD severe/ESRD.
- XLH initial: baseline serum phosphorus below normal for age AND (a) baseline TmP/GFR below normal for age and gender OR (b) genetic test confirming PHEX pathogenic variant. For patients ≥18, require current signs/symptoms of XLH. Continuation: patient deriving clinical benefit as determined by prescriber. Coverage duration: XLH initial/continuation - 1 year.
- TIO initial: mesenchymal tumor that cannot be curatively resected or identified/localized AND baseline serum phosphorus below normal for age AND baseline TmP/GFR below normal for age and gender AND current signs/symptoms of TIO. Initial 6 months; continuation 1 year if responding.
ALL of the following
- Cystagon (cysteamine) - Cystinosis (nephropathic): Prescriber/consult with nephrologist or metabolic disease specialist. Diagnosis confirmed by genetic testing showing biallelic pathogenic/likely pathogenic CTNS variants OR white blood cell cystine concentration above upper limit of normal. Coverage duration: 1 year.
ALL of the following
- Dalfampridine - Multiple sclerosis ambulatory therapy. Age ≥18. Prescriber: neurologist or MS specialist. Initial: patient ambulatory, drug intended to improve or maintain mobility, and impaired ambulation documented by objective measure (eg timed 25-foot walk, MSWS-12). Continuation: patient ambulatory and demonstrating benefit or response to therapy per prescriber. Coverage duration: 1 year.
ALL of the following
- Deferasirox - Chronic/transfusion-related iron overload. Required: serum ferritin level prior to initiation. Prescriber: hematologist. Transfusion-related chronic iron overload initial: receiving regular blood transfusions AND serum ferritin >1000 mcg/L prior to starting. Non-transfusion-dependent thalassemia syndromes initial: serum ferritin >300 mcg/L prior to starting. Continuation: patient benefiting from therapy as confirmed by prescriber. Coverage duration: 1 year.
ALL of the following
- Daurismo (glasdegib) - Acute myeloid leukemia (AML): approve when used in combination with cytarabine per labeling. Prescriber: oncologist. Coverage duration: 1 year.
ALL of the following
- Emgality (galcanezumab) - Migraine prevention and episodic cluster headache. Exclusion: concurrent combination therapy with another CGRP inhibitor for migraine prevention. Age ≥18. Required medical info: diagnosis and headache frequency. Initial migraine prevention: ≥4 migraine days per month prior to initiating; if currently on Emgality, must demonstrate significant clinical benefit (eg reduction in monthly migraine days or severe migraine days). Episodic cluster headache: 1 headache every other day to 8 headaches per day. Coverage duration: 1 year.
ALL of the following
- Enbrel (etanercept) - Exclusion: concurrent use with biologic therapy or targeted synthetic DMARD. Required: diagnosis, concurrent meds, previous therapies tried. Age restrictions vary by indication (initial RA/AS ≥18; JIA/PsA/Behcet's ≥2; GVHD ≥6; PP ≥4). Prescriber restrictions for initial therapy: RA/AS/JIA - rheumatologist; PsA - rheumatologist; PP - dermatologist; GVHD - oncologist/hematologist/ transplant-affiliated physician.
- Initial therapy step: RA/JIA/AS/PP/PsA initial require prior trials of preferred adalimumab or other specified agents per indication (eg try one preferred adalimumab). Continuation: approve if patient had response to therapy. Coverage duration: approve through end of plan year.
ALL of the following
- Diacomit (stiripentol) - Dravet Syndrome: age ≥6 months and older initial. Prescriber: neurologist. Initial approve if patient is concomitantly receiving clobazam or is unable to take clobazam due to adverse events. Continuation: approve if patient responds to therapy. Coverage duration: 1 year.
ALL of the following
- Epidiolex (cannabidiol) - Seizure indications (Dravet, Lennox-Gastaut, TSC, refractory epilepsy). Age ≥1 year for initial. Prescriber: neurologist. Initial for Dravet: tried or concomitantly receiving at least two other antiseizure drugs or has tried/receiving Diacomit, clobazam, or Fintepla. Lennox-Gastaut/TSC/refractory epilepsy: tried or concomitantly receiving at least two other antiseizure drugs. Continuation across indications: patient responding to therapy. Coverage duration: 1 year.
ALL of the following
- Ensacove (ALK inhibitor) - NSCLC with ALK rearrangement: For new starts, use preferred ALK products (Alecensa or Lorbrena) unless prescriber documents inappropriate. Approve for FDA-approved ALK-positive NSCLC indications. Coverage duration: 1 year; age ≥18.
ALL of the following
- Epkinly (epcoritamab) - Lymphoma indications: Approve for diffuse large B-cell lymphoma, follicular lymphoma, HIV-related B-cell lymphoma, post-transplant lymphoproliferative disorders per product labeling when prior systemic therapy requirements are met. Prescriber: oncologist. Coverage duration: 1 year.
ALL of the following
- Fasenra (benralizumab) - Initial asthma criteria: Age ≥6 years initial. Exclusion: concurrent use with another monoclonal antibody therapy. Prescriber: allergist, immunologist, or pulmonologist. Initial asthma: ALL of A) blood eosinophils ≥150 cells/µL within 6 weeks prior to treatment, B) patient used an inhaled corticosteroid with at least one additional controller medication, and C) uncontrolled asthma defined by one of exacerbation/system measures (systemic CS in past year, ED/hospital visit, FEV1 <80% predicted [<90% for <18], FEV1/FVC <0.80, or worsened asthma with systemic CS taper). Coverage duration: initial 6 months, continuation 12 months.
- Fasenra EGPA criteria: Age ≥18 initial; prescriber and lab/eosinophil thresholds per policy; initial EGPA requires active non-severe disease, on systemic corticosteroid ≥4 weeks, and blood eosinophils ≥150 cells/µL within prior 4 weeks or prior to any monoclonal antibody that may alter eosinophils. Continuation: documented response to therapy. Coverage durations: EGPA initial 8 months, continuation 12 months.
ALL of the following
- Fintepla (fenfluramine) - Dravet Syndrome criteria: initial approve if patient has tried or is concomitantly receiving at least two other antiepileptic drugs or has tried/concomitantly receiving Epidiolex, Clobazam or Diacomit. Continuation: responding to therapy. Age per product labeling; prescriber: neurologist. Coverage duration: 1 year.
ALL of the following
- Epk-inly / EPKINLY Dravet criteria - EPKINLY (if referencing for B-cell lymphoma or Dravet options): follow product-specific criteria - for Dravet, ensure prior antiseizure trials and neurologist involvement. For lymphoma uses, require prior lines of systemic therapy as specified and oncology prescriber.
ALL of the following
- Fabrazyme (agalsidase beta) - Fabry disease: Exclusion concurrent use with Galafold or Elfabrio. Required: diagnosis, genetic and lab test results demonstrating deficient alpha-galactosidase A activity or pathogenic GLA variant. Prescriber: geneticist, endocrinologist, metabolic disorder specialist or lysosomal storage disorder specialist. Coverage duration: 1 year.
ALL of the following
- ESA (erythropoiesis-stimulating agents) indication-specific criteria (eg Procrit/Retacrit) - Required: diagnosis and Hb thresholds per indication. Prescriber restrictions for MDS anemia/myelofibrosis: hematologist/oncologist. Coverage durations vary by indication (chemo 6 months, transfusion 1 month, CKD 1 year, etc.). Other criteria: specific Hb thresholds and prior therapy rules per indication (eg Hb <10 g/dL for certain initial therapies).
ALL of the following
- RET-targeted therapies (eg selpercatinib, pralsetinib, others) - Indications: RET fusion-positive or RET mutation-positive tumors (NSCLC, thyroid cancer, medullary/anaplastic thyroid cancer) confirmed by an FDA-approved test. Approve when disease is advanced/recurrent/metastatic and requires systemic therapy; prescriber: oncologist. Coverage duration: 1 year.
ALL of the following
- EGFR-targeted therapies (eg afatinib/Gilotrif, gefitinib) - NSCLC with sensitizing EGFR mutations (exon 19 deletion, L858R exon 21, L861Q, G719X, S768I) confirmed by approved test. Prescriber: oncologist. Coverage duration: 1 year. For squamous NSCLC: progression after platinum-based chemo for some agents as specified.
ALL of the following
- HERNEXEOS - HER2 (ERBB2) mutation-positive NSCLC: Approve for unresectable/metastatic NSCLC with activating HER2/ERBB2 mutation detected by approved test and after at least one prior systemic therapy. Coverage duration: 1 year.
ALL of the following
- Gomekli (for neurofibromatosis type 1) - Prescriber: geneticist or specialist; approve for symptomatic plexiform neurofibromas not amenable to complete resection. Coverage duration: 1 year.
ALL of the following
- Icatibant for Hereditary Angioedema (HAE) - Prescriber: allergist/immunologist or HAE specialist. Indications: treatment of acute attacks in HAE due to C1-INH deficiency (Type I/II) with diagnostic labs (low functional C1-INH <50% and low C4 at baseline). Prior icatibant responders: approve when prior favorable response documented.
ALL of the following
- ICLUSIG (ponatinib) - Indications: CML/ALL and related neoplasms per labeling. Required: Philadelphia chromosome/BCR-ABL status and T315I mutation status where applicable. Approve for T315I-positive disease or after trial of other TKIs as specified. Coverage duration: 1 year.
ALL of the following
- Growth hormone (somatropin) - Indications and testing: pediatric and adult GHD requirements include stimulation testing thresholds, IGF-1 criteria, and diagnosis-specific rules (ISS, SHOX, SGA, Noonan, Prader-Willi, CKD) with prescriber endocrinologist involvement. Coverage durations per indication (eg ISS 6 months initial, 12 months continuation). Continuation requires documented response.
ALL of the following
- HAE (C1-INH deficiency) initial therapy criteria - Diagnosis confirmed by low functional C1-INH and low C4 at baseline. Prescriber: allergist/immunologist or HAE specialist. Coverage duration: 1 year; initial therapy rules apply for on-demand and prophylactic agents per product.
ALL of the following
- Ilaris (canakinumab) - Exclusion: concurrent biologic therapy (TNF antagonists, etanercept, adalimumab, certolizumab, golimumab, infliximab), anakinra, or rilonacept. Age restrictions per indication (CAPS ≥4 yrs, SJIA/HIDS/MKD/FMF/TRAPS ≥2 yrs; Still's disease ≥18). Prescriber restrictions by indication (rheumatologist, geneticist, allergist/immunologist, dermatologist). Initial and renewal criteria per indication (eg CAPS/SJIA initial approvals; renewal requires documented response). Acute gout flare: intolerance/contraindication to NSAIDs and colchicine and receiving concomitant urate-lowering therapy unless contraindicated. FMF/HIDS/TRAPS initial: CRP ≥10 mg/L or ≥2x ULN and specified flare frequency or hospitalization history; FMF requires trial of colchicine unless contraindicated.
ALL of the following
- Imkeldi (imatinib for pediatric oral powder formulation) - Approve per product labeling; for Ph+ ALL/CML require Philadelphia chromosome/BCR-ABL status. Coverage duration: 1 year.
ALL of the following
- Inbrija (levodopa inhalation) - Indication: Parkinson's disease acute OFF episodes. Exclusion: asthma, COPD or other chronic lung disease. Required: patient is currently taking carbidopa-levodopa and experiencing OFF episodes. Prescriber: neurologist. Coverage duration: 1 year.
ALL of the following
- Testosterone therapies - Coverage criteria for hypogonadism (primary or secondary) in males: persistent signs/symptoms of androgen deficiency, two morning pre-treatment serum testosterone measurements on separate days both low per lab reference, prescriber restrictions (endocrinologist for gender-affirming care), continuing therapy requires persistent signs/symptoms and at least one pre-treatment low testosterone. Age and duration limits per indication (eg delayed puberty approvals). Coverage durations: generally 12 months; initial shorter durations for pubertal induction.
ALL of the following
- Itovebi (alpelisib) - PIK3CA-mutated breast cancer: Approve for locally advanced or metastatic HR-positive, HER2-negative, PIK3CA-mutated disease per approved test when used in combination with endocrine therapy (e.g., fulvestrant) and meeting postmenopausal or appropriate ovarian suppression criteria. Prescriber: oncology; coverage duration: 1 year.
- Itovebi (oral) initial/renewal: initial requires documented PIK3CA mutation; renewal requires clinical benefit and tolerability per prescriber.
ALL of the following
- Ivermectin - Indications: pediculosis (head/body/pubic lice) and scabies (classic, treatment-resistant, crusted, or when topical not tolerated). Coverage duration: 30 days. Off-label uses listed (eg ascariasis, enterobiasis) per policy. Prescriber: N/A. Age per labeling.
ALL of the following
- IWILFIN - Neuroblastoma: Approve for high-risk disease to reduce relapse risk when used after multiagent multimodality therapy including anti-GD2 immunotherapy AND patient has at least partial response to prior therapy. Prescriber: oncologist. Coverage duration: 1 year.
ALL of the following
- JAKAFI (ruxolitinib) - Multiple hematologic/oncologic indications: age and indication-specific rules (eg ALL 1-21 yrs, GVHD ≥12, MF/PV/accelerated/blast phase ≥18). Prescriber restrictions vary. Coverage duration: 1 year. Other criteria: PV requires prior hydroxyurea or peginterferon/ropeginterferon trial; GVHD requires prior conventional systemic treatment; other indication-specific mutation or prior therapy criteria apply.
ALL of the following
- JAYPIRCA (pirtobrutinib) / JEMPERLI (dostarlimab) - Indication-specific oncology criteria apply: JAYPIRCA for mantle cell lymphoma, CLL/SLL, Richter's transformation, MCL post-BTK trials as specified; JEMPERLI for dMMR/MSI-H solid tumors including endometrial cancer and other listed indications per product labeling. Prescriber: oncologist. Coverage duration: 1 year.
ALL of the following
- Tolvaptan (polycystic kidney disease) - Approve per product labeling for autosomal dominant polycystic kidney disease (ADPKD) with appropriate risk criteria; prescriber: nephrologist; coverage duration: as specified by policy.
Prior Authorization, Documentation, and Denial Risks
Prior authorization: Actemra and related biologics
Prior authorization is required and requests must include diagnosis, concurrent medications, previous drugs tried, age eligibility, and prescriber specialty or consultation as specified for initial therapy (e.g., rheumatologist for RA/PJIA/SJIA/GCA).
- Approve through end of plan year for most indications; RA initial requires trial of ONE of: Enbrel, a preferred adalimumab product, Rinvoq, or Xeljanz/XR (alternative agents may count as noted).
- PJIA initial requires trial of ONE of: Enbrel, Rinvoq, Xeljanz, or a preferred adalimumab product.
- GCA initial requires trial of or current use of systemic corticosteroid unless contraindicated.
Prior authorization and coverage durations vary by product
Prior authorization is required for the listed specialty products and coverage durations vary by product (examples: 3 months for certain IV anti-infectives; 1 year is typical for many specialty agents).
- Some products (e.g., IV anti-infectives like tobramycin, voriconazole) have 3-month authorizations.
- Many products (oncology, orphan, chronic specialty agents) are authorized for 1 year unless otherwise specified.
Step therapy required before Actemra for RA/PJIA
Initial RA and PJIA authorization for tocilizumab (Actemra) requires prior trial of at least one preferred alternative unless an exception applies; RA initial specifically requires trial of one of Enbrel, a preferred adalimumab product, Rinvoq, or Xeljanz/XR (alternative trials may count).
- If the patient lacks those trials, prior trials with Cimzia, Kevzara, infliximab, golimumab SC/IV, Orencia, or a non-preferred adalimumab product may be accepted.
- GCA requires trial of or current systemic corticosteroid unless contraindicated.
Infliximab/Remicade prior authorization requirements
Prior authorization for infliximab (Remicade) requires documentation of the diagnosis, concurrent medications, and prior medications tried; many indications require trial of specified conventional therapies or immunosuppressants prior to approval.
- Continuation authorizations require documented response to therapy.
- Concurrent use with another biologic DMARD or targeted synthetic DMARD is excluded.
Authorization duration — typical 12 months
Authorization durations are product-specific but will generally be for 12 months for many specialty agents unless otherwise stated in the individual product entry.
- Certain products have shorter initial authorizations (examples: 3 months for some IV anti-infectives; LIVTENCITY initial 2 months).
- Continuation periods commonly extend to 1 year or through the end of the plan year.
Required clinical documentation for Actemra PA
Prior authorization for Actemra must include required clinical documentation: diagnosis, concurrent medications, prior therapies tried, and prescriber specialty/consultation when applicable.
- For RA/PJIA/SJIA/GCA initial therapy, document the prior therapy trials used to meet step requirements (examples specified in the RA/PJIA rules).
- Continuation requests must include prescriber assessment that the patient had a clinical response.
HAE diagnostic documentation required for icatibant PA
For icatibant (HAE) initial therapy, prior authorization requires diagnostic laboratory documentation of HAE: baseline functional C1‑INH level <50% of normal and low baseline serum C4 per laboratory reference values; prior responders may submit prescriber documentation of favorable clinical response to icatibant.
- Authorization will be for 1 year when diagnostic criteria or prior favorable response are documented.
- Prescriber should be an allergist/immunologist or clinician specializing in HAE.
Right‑heart catheterization required for PAH agent PA
Prior authorization for PAH agents requires right‑heart catheterization results to confirm WHO Group 1 pulmonary arterial hypertension as part of the required documentation.
- Prescriber must be a cardiologist or pulmonologist or document consultation.
- Requests lacking right‑heart catheterization confirmation will not meet the PAH diagnostic requirement.
Concurrent biologic/tsDMARD use is excluded
Concurrent use with another biologic DMARD or targeted synthetic DMARD is an exclusion; requests for Actemra will be denied if the patient is concurrently receiving another biologic or targeted synthetic DMARD.
- The policy explicitly excludes concurrent biologic/tsDMARD therapy for Actemra and multiple other biologics.
- Providers must document that no excluded concurrent biologic/tsDMARD is being used.
Denial risk: missing documentation or prescriber restrictions
Missing required documentation (e.g., diagnosis, prior therapy trials) or failure to meet prescriber specialty requirements may lead to denial of the prior authorization request.
- Product entries list 'Required Medical Information: Diagnosis, concurrent medications, previous drugs tried' — absence of these items risks denial.
- Prescriber restrictions (e.g., specialist consultation for initial therapy) must be met and documented.
CIMZIA concurrent DMARD exclusion and PA implications
CIMZIA requests require prior therapy trial documentation and exclude concurrent use with another biologic DMARD or targeted synthetic DMARD; lack of required prior‑therapy documentation or evidence of concurrent biologic use may trigger denial.
- Initial therapy approvals are granted through the end of the plan year when documentation of required trials (counts and acceptable alternatives) is provided.
- Concurrent biologic/tsDMARD use is an explicit exclusion for CIMZIA.
Prior systemic therapy must be documented for some oncology agents
Certain oncology targeted therapies require prior systemic therapy before approval; lack of documented prior systemic therapy (as specified) can trigger non‑approval.
- HER2‑mutant NSCLC approvals require the patient to have received at least one prior systemic therapy.
- Providers must submit prior therapy history to support oncology targeted therapy requests.
KINERET: prior trials and concurrent biologic exclusion
KINERET prior authorization for RA requires documentation that the patient has tried TWO specified agents (Enbrel, a preferred adalimumab product, Rinvoq, Xeljanz/XR, or a preferred tocilizumab product); concurrent use with another biologic DMARD or targeted synthetic DMARD is excluded.
- If the patient has not tried the two preferred agents, prior trials of listed alternative biologics/non‑preferred agents may count as noted in the policy.
- Prescriber must be a rheumatologist or document specialty consultation for initial therapy.
GIST: prior‑therapy requirements can trigger denial
For GIST and related agents, failure to document the required prior trials of two agents from the specified list (imatinib, avapritinib, sunitinib, dasatinib, regorafenib, ripretinib) may result in denial.
- Policy requires prior trials per NCCN‑aligned sequence — providers must supply medication history.
- Absence of the required prior‑therapy trials is a common denial trigger for GIST approvals.
Infliximab/Remicade PA: documentation, prior therapy, and concurrent‑use exclusion
Infliximab/Remicade prior authorization excludes concurrent use with another biologic DMARD or targeted synthetic DMARD and requires documentation of diagnosis, concurrent medications, and prior medications tried; many indications require trials of specified conventional therapies prior to approval.
- Continuation approvals require documented response to therapy.
- Providers must document prior conventional therapy trials (e.g., csDMARD ≥3 months for RA) when applicable.
Product Codes, Durations, and Key Thresholds
Key Definitions and Terms
Detailed Code Tables and Identifiers
| Hadlima, Simlandi | Preferred adalimumab products (examples listed) |
| Actemra, Tyenne | Preferred tocilizumab products (examples listed) |
| 200 mg/day, 400 mg/day, 600 mg/day | KISQALI dosing strengths listed |
| 10 mg/day - 24 mg/day | LENVIMA dosing strengths listed |
| MEKTOVI | Binimetinib (MEKTOVI) - product-specific criteria |
| MELANOMA BRAF | BRAF V600 mutation or BRAF fusion-positive requirement (indication-specific) |
| NEMLUVIO | Nemluvio product-specific criteria |
| MONJUVI | Monjuvi prior therapy and prescriber requirements |
| MYFEMBREE | Myfembree uterine fibroids/endometriosis criteria |
| NAGLAZYME | Enzyme assay/genetic testing required (Naglazyme) |
| NERLYNX | Nerlynx oncology criteria including HER2 status |
| NEXLETOL | Hyperlipidemia criteria including LDL-C thresholds and prior statin/ezetimibe |
| NEXLIZET | Hyperlipidemia criteria mirroring Nexletol |
| NINLARO | Ninlaro product entry |
| sildenafil (PAH) 20 mg | oral tablet for pulmonary arterial hypertension |
| tadalafil (PAH) 20 mg | oral tablet for pulmonary arterial hypertension |
| pirfenidone 267 mg / 801 mg | oral formulations for idiopathic pulmonary fibrosis |
| Polivy | polatuzumab vedotin |
| Product list | Multiple product names listed across chunks (e.g., Polivy, Pomalyst, posaconazole DR, Poteligeo, Prevymis IV/oral, eltrombopag, pyrimethamine, Qinlock, Qulipta, Radicava ORS, zoledronic acid-mannitol IV, Releuko, Infliximab/Remicade, treprostinil, Repatha) |
Background and Scope
Tocilizumab (Actemra) is included for all FDA‑approved indications such as rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic and polyarticular juvenile idiopathic arthritis (SJIA/PJIA), and cytokine release syndrome related to CAR T‑cell therapy. Initial therapy for rheumatologic indications requires specialist involvement (rheumatologist) and documentation of prior therapy trials as specified by indication; continuation is allowed when the prescriber documents clinical response and is typically approved through the end of the plan year. Prior authorization requests must include diagnosis, concurrent medications, and previous medications tried.
Policy Revision History
Policy H6396 (Actemra and selected specialty products) becomes effective; coverage criteria and prior authorization rules apply as of this date.
Document prepared (version V.4) with effective date 2026-03-01; updates include Actemra formulations and criteria clarifications.
Previous document version noted in source archive (part of multi-part policy set); historical entries retained for audit trail.
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