Neighborhood Health Plan RI Prior Auth Coverage | OpenPayer
CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A
Prior Authorization Criteria for Specialty and Oncology Drugs — Coverage Criteria
Lists prior authorization groups, covered drugs and indications (FDA-approved and some medically-accepted), required documentation, restrictions, and duration requirements for PA requests for Neighborhood Health Plan of Rhode Island members and providers.
Policy Summary
PayerNeighborhood Health Plan of Rhode Island
PolicyPrior Authorization Criteria for Specialty and Oncology Drugs — Coverage Criteria
Policy CodePolicy N/A
Change TypeNo material changes
Effective DateN/A
Next Review DateN/A
Key ActionSubmit prior authorization with indication-specific documentation (e.g., biomarker test results or right heart catheterization data) to support approval.
No material clinical or coverage changes in this revision.
20+drug groups shown
manyentries with diagnostic or prior-therapy steps
examplesoncology agents w/ biomarker criteria
Plan Yeartypical coverage duration
Coverage Criteria by Drug / Indication
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.
PAH agent coverage criteria
Covered when ALL of the following are met for PAH agents (example language shown):
PAH new start hemodynamics: Right heart catheterization confirms pulmonary arterial hypertension (WHO Group 1) AND pretreatment mean pulmonary arterial pressure (mPAP) > 20 mmHg AND pretreatment pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg AND pretreatment pulmonary vascular resistance (PVR) meets agent-specific threshold (e.g., ≥3 Wood units for treprostinil).mPAP >20 mmHg; PCWP ≤15 mmHg; PVR (agent-specific, e.g., ≥3 WU)
Applies to WHO Group 1 PAH new starts; supporting right heart catheterization report required.
BALVERSA coverage criteria
Covered when ALL of the following are met for BALVERSA (erdafitinib):
BALVERSA urothelial carcinoma: Tumor has susceptible FGFR3 genetic alterations AND requested as subsequent therapy for locally advanced, recurrent, or metastatic urothelial carcinoma (or stage II–IV recurrent/persistent bladder urothelial carcinoma).presence of FGFR3 alteration
Covered when ALL of the following are met for BRAFTOVI (encorafenib) in colorectal cancer and melanoma (examples):
BRAF V600E colorectal cancer: Tumor is positive for BRAF V600E mutation AND disease is advanced or metastatic or unresectable metachronous metastases, AND use per indication (often combined with other agents as specified).BRAF V600E mutation
Documentation of tumor BRAF V600E required.
BRAF V600 activating mutation — melanoma: Tumor is positive for a BRAF V600 activating mutation (e.g., V600E or V600K) AND requested as single agent or in combination with a MEK inhibitor (e.g., binimetinib) for unresectable, limited resectable, metastatic disease or adjuvant systemic therapy.BRAF V600 mutation
Covered when ALL of the following are met for AYVAKIT:
AYVAKIT molecular requirement: Disease is FIP1L1–PDGFRA rearrangement–positive AND harbors PDGFRA D842V mutation AND disease is resistant to imatinib (for myeloid/lymphoid neoplasms with eosinophilia indication).FIP1L1–PDGFRA rearrangement and PDGFRA D842V mutation
Molecular testing documentation required.
ALVAIZ (romiplostim-like) ITP/AA criteria
Covered when criteria for chronic or severe ITP or severe aplastic anemia are met (ALVAIZ example):
ITP — new start: Patient had inadequate response or intolerance to prior therapy (e.g., corticosteroids or IVIG) AND an untransfused platelet count prior to initiation <30,000/mcL OR 30,000–50,000/mcL with symptomatic bleeding or bleeding risk factors (e.g., planned procedure, anticoagulation, comorbidity).platelet counts as specified (<30,000 or 30,000–50,000 with risk)
Baseline platelet laboratory report required.
ITP — continuation: Platelet response on therapy: current platelet count ≤200,000/mcL OR >200,000 to ≤400,000/mcL with dose adjusted to maintain a platelet count sufficient to avoid clinically important bleeding.platelet ranges as specified
Current platelet count and dosing notes required.
Severe aplastic anemia (AA): For severe AA continuation/maintenance: current platelet count 50,000–200,000/mcL OR <50,000/mcL without appropriately titrated therapy ≥16 weeks OR <50,000/mcL and transfusion-independent OR >200,000 to ≤400,000/mcL with dosing adjustment per response definitions.
Opioid continuation and specialty use
Opioid prior authorization — covered when ALL of the following are met:
Opioid PA criteria: 1) Drug is prescribed for cancer-, sickle cell–, terminal–, or palliative–related pain OR patient meets opioid-use history criteria (≥30 days on extended‑release opioid or ≥1 week on immediate‑release opioid); AND 2) Patient can safely take the requested dose based on opioid history; AND 3) Prescriber is experienced in potent opioid management; AND 4) Patient will be monitored for opioid use disorder; AND 5) Request is for continuation after the specified minimum prior exposure period.prior opioid exposure duration as specified
Document prior opioid use and monitoring plan.
Tumor type and prior therapy requirements
Covered when specific disease-stage and prior therapy conditions are met for tumor‑type–directed agents (examples):
Tumor type and prior therapy — oncology examples: Coverage requires indication‑specific conditions such as disease stage (e.g., advanced/relapsed/Stage IV for RCC), specified biomarker positivity where required (e.g., RET‑fusion for NSCLC), and prior therapy history when applicable (e.g., progressed after ≥2 FDA‑approved therapies for GIST).disease stage and prior therapy as specified per agent
Tumor staging, prior treatment records, and molecular testing reports required.
Diagnostic confirmation
Agents requiring disease confirmation by laboratory or genetic testing — covered when diagnostic confirmation is provided:
Diagnostic confirmations — selected examples: For Gaucher disease: diagnosis confirmed by deficient beta‑glucocerebrosidase enzyme assay or genetic testing. For NAGS deficiency: diagnosis confirmed by enzymatic, biochemical, or genetic testing. For cystinosis: diagnosis confirmed by increased leukocyte cystine concentration, genetic testing, or demonstration of corneal cystine crystals by slit‑lamp exam.specific laboratory/genetic test results per disease
Attach laboratory or genetic test reports to the PA request.
Cystinosis and MS walking impairment
Covered when ALL of the following are met for cystinosis agents and for dalfampridine in MS walking impairment:
Cystinosis confirmation: Diagnosis confirmed by increased leukocyte cystine concentration OR genetic testing OR slit‑lamp demonstration of corneal cystine crystals, AND corneal cystine crystal accumulation present when required by product labeling.diagnostic test evidence
Provide laboratory/genetic report or ophthalmology slit‑lamp findings.
Dalfampridine — MS walking impairment: For new starts: patient demonstrates sustained walking impairment prior to initiation. For continuation: objective evidence of improved walking speed or other objective measure since starting therapy.documented objective walking impairment and follow‑up measure
Timed walking test or similar objective measurement recommended.
TKI and AML combination criteria
Tyrosine kinase inhibitor (TKI) and AML combination criteria — covered when the following are met:
CML/Ph+ ALL TKI requirements: Diagnosis confirmed by Philadelphia chromosome / BCR‑ABL gene for CML or Ph+ ALL; if resistant to prior TKI therapy, documentation of required mutation testing (e.g., T315I and other listed mutations) per agent is provided.cytogenetic/mutation testing
Provide cytogenetics and kinase‑domain mutation test results.
AML — Daurismo/DAURISMO use: When used for AML, the TKI must be administered in combination with cytarabine and patient selection meets agent‑specific criteria (e.g., age ≥75 or comorbidities precluding intensive chemo for induction; used for induction, consolidation, or relapsed/refractory settings as labeled).combination with cytarabine and patient eligibility
Treatment plan and chemotherapy regimen documentation required.
DOPTELET platelet thresholds and prior therapy
Covered when ALL of the following are met for DOPTELET (avatrombopag):
DOPTELET indications and thresholds: For thrombocytopenia in chronic liver disease: untransfused platelet count prior to a scheduled procedure <50,000/mcL. For chronic ITP (new starts): prior inadequate response or intolerance to therapies (e.g., corticosteroids, IVIG) AND untransfused platelet count <30,000/mcL OR 30,000–50,000/mcL with symptomatic bleeding or bleeding risk factors. For continuation: platelet response criteria must be met (current platelet ≤200,000/mcL, or >200k to ≤400k with dose adjustment). Age ≥18 years applies.platelet counts as specified; age ≥18 years
Baseline and current platelet counts and prior therapy history required.
Drizalma step therapy: Patient has tried duloxetine capsules prior to Drizalma OR is unable to take duloxetine capsules (e.g., difficulty swallowing, need for nasogastric administration).trial of duloxetine or documented inability to take duloxetine capsules
Document prior trial or swallowing/administration limitation.
Atopic dermatitis — initial therapy: Patient has moderate‑to‑severe atopic dermatitis AND inadequate response to topical corticosteroid or topical calcineurin inhibitor OR these are not advisable; continuation requires maintained clinical benefit.clinical severity and prior topical therapy failure
Document prior topical therapy and clinical severity.
Asthma — initial therapy: For oral corticosteroid–dependent asthma: inadequate control despite high‑dose inhaled corticosteroid plus an additional controller. For moderate‑to‑severe asthma: baseline blood eosinophils ≥150 cells/µL and inadequate control despite medium‑to‑high‑dose inhaled corticosteroid plus additional controller.>=150 cells/µL for moderate‑to‑severe asthma
Provide blood eosinophil count and prior controller therapy history.
Eosinophilic esophagitis (EoE) — initial therapy:
Eosinophilic Esophagitis (EoE)
Covered when ALL of the following are met for initial EoE therapy:
EoE initial therapy: 1) Esophageal biopsy showing ≥15 intraepithelial esophageal eosinophils per high power field; AND 2) Clinical manifestations of EoE (e.g., dysphagia); AND 3) Patient weighs ≥15 kg; AND 4) Inadequate response, intolerance, or contraindication to topical corticosteroid.>=15 eosinophils/HPF; weight ≥15 kg
Biopsy report and prior therapy documentation required.
EoE continuation: Patient achieved or maintained a positive clinical response on therapy.
Objective or documented symptom improvement required.
Chronic Obstructive Pulmonary Disease (COPD)
Covered when ALL of the following are met for COPD initial therapy:
COPD concomitant therapy: Patient is either receiving standard inhaled triple therapy (ICS + LAMA + LABA) OR receiving LAMA+LABA with contraindication to inhaled glucocorticoid.
Document current inhaled therapy and contraindications if applicable.
COPD eosinophil: Absolute blood eosinophil count ≥300 cells per microliter prior to initiating therapy.>=300 cells/microliter
Provide recent CBC with differential.
COPD continuation: Patient achieved or maintained a positive clinical response while on therapy.
Document symptom or exacerbation improvement.
Chronic Spontaneous Urticaria (CSU)
Covered when ALL of the following are met for CSU initial therapy:
CSU evaluation: Patient evaluated for other causes of urticaria (including bradykinin‑related angioedema and IL‑1–associated syndromes).
Documentation of evaluation required.
CSU duration: Spontaneous wheals, angioedema, or both for at least 6 weeks.>=6 weeks
Covered when ALL of the following are met for BP initial therapy:
BP diagnostic confirmation: Diagnosis confirmed by direct immunofluorescence OR immune serological test(s).
Attach pathology/immunofluorescence or serology reports.
BP clinical manifestations: Patient exhibits clinical features consistent with BP (e.g., bullae, excoriations, eczematous or urticarial erythematous lesions).
Clinical exam documentation required.
BP prior therapy: Prior inadequate response to a high‑potency topical corticosteroid OR systemic corticosteroid OR topical/systemic corticosteroids are not advisable for the patient.
Prior treatment history required.
BP continuation: Patient achieved or maintained a positive clinical response on therapy.
Severe Asthma and Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Covered when ALL of the following are met for severe asthma or EGPA initial therapy:
Asthma eosinophil or steroid dependence: Either baseline blood eosinophils ≥150 cells/µL OR patient is systemic corticosteroid–dependent.>=150 cells/µL
Provide baseline eosinophil count or steroid dependence documentation.
Asthma controller failure: History of severe asthma despite medium‑to‑high‑dose inhaled corticosteroid plus an additional controller (LABA, LAMA, leukotriene modifier, or sustained‑release theophylline), unless intolerant/contraindicated.
Document prior controller regimens and response.
Asthma continuation: Asthma control has improved on treatment (reduction in symptoms/exacerbations or reduced oral corticosteroid dose).
Covered when ALL of the following are met for prophylaxis with FULPHILA (pegfilgrastim biosimilar):
FULPHILA cancer type: Patient has a solid tumor or non‑myeloid cancer.
Diagnosis documentation required.
FULPHILA chemotherapy: Patient is currently receiving or will be receiving myelosuppressive anti‑cancer therapy.
Treatment plan showing myelosuppressive regimen required.
FULPHILA timing: When used with chemotherapy, administer at least 24 hours after chemotherapy; for prophylaxis of febrile neutropenia ensure timing and cancer type criteria are met.24 hours post‑chemotherapy
Schedule documentation required.
GATTEX — Short Bowel Syndrome (SBS)
Covered when ANY of the following are met for GATTEX initial therapy in short bowel syndrome (SBS):
GATTEX adult dependence: Adult patient dependent on parenteral support for ≥12 months.>=12 months
Parenteral support history required.
GATTEX pediatric dependence: Pediatric patient is dependent on parenteral support.
GATTEX continuation: Requirement for parenteral support has decreased from baseline while on therapy.documented reduction in parenteral support
Objective documentation of decreased dependence required.
Growth Hormone (pediatric and adult GHD, TS, SGA)
Covered when diagnostic and testing criteria for pediatric or adult growth hormone deficiency, Turner syndrome, or SGA are met:
Pediatric GHD: Neonate diagnosis OR age <2.5 years with pre‑treatment height >2 SD below mean and slow growth velocity OR ≥2.5 years with specified height velocity/height deficits AND failed two GH stimulation tests (peak <10 ng/mL) OR pituitary/CNS disorder with IGF‑1 >2 SD below mean.GH stimulation peak <10 ng/mL
Provide GH stimulation test results, IGF‑1, and growth charts.
Turner syndrome: Confirmed by karyotype AND pre‑treatment height <5th percentile for age.
Attach karyotype and growth data.
SGA: Birth weight <2500 g at GA >37 weeks OR birth weight/length <3rd percentile or ≥2 SD below mean and failure to catch up by age 2.
Provide birth records and growth follow‑up.
Pediatric growth hormone (GHD, TS, SGA)
Covered when pediatric growth hormone criteria are met:
Pediatric GHD entry: Patient is neonate or meets pediatric growth velocity/height deficit criteria AND meets diagnostic testing criteria (failed GH stimulation tests or pituitary/CNS disorder with low IGF‑1).GH stimulation peak <10 ng/mL
Provide GH stimulation test results and growth data.
Adult GHD
Adult growth hormone deficiency — Covered when ANY of the following are met:
Adult GHD entry: Failed two GH stimulation tests OR pre‑treatment IGF‑1 >2 SD below mean plus failed one GH stimulation test OR organic hypothalamic–pituitary disease with ≥3 pituitary hormone deficiencies and low IGF‑1 OR genetic/structural defects OR childhood‑onset GHD with congenital abnormality.GH stimulation and IGF‑1 criteria
Provide endocrine testing and clinical history.
HER2 agents (e.g., Herceptin, Herzuma)
HER2-targeted agents — Covered for specified HER2‑positive/overexpressing tumor types with additional conditions:
HER2 monoclonal antibodies/agents: Indications include neoadjuvant and metastatic HER2‑positive breast cancer and selected other tumors (e.g., HER2‑amplified colorectal cancer requiring RAS and BRAF wild‑type and specific combination regimens); some indications require prior intolerance to specific agents and combination therapy as specified.HER2 amplification/overexpression (per testing)
Provide HER2 testing and prior therapy/intolerance documentation where required.
HCV therapy (Harvoni)
Hepatitis C antiviral coverage (Harvoni and others) — covered when documentation is provided:
HCV antiviral prerequisites: Infection confirmed by HCV RNA in serum prior to treatment AND planned regimen, genotype, prior treatment history, cirrhosis status (compensated vs decompensated), HIV coinfection status, and resistance‑associated substitutions when applicable; durations per current AASLD‑IDSA guidance.HCV RNA positive prior to treatment
Attach HCV RNA result, genotype, and treatment plan.
Hereditary angioedema (e.g., Haegarda, icatibant)
Covered when disease‑specific criteria are met for hereditary angioedema (HAE) therapies:
HAE prophylaxis/acute therapy: For prophylaxis: HAE with C1 inhibitor deficiency/dysfunction confirmed by laboratory testing OR HAE with normal C1 inhibitor plus confirmed mutation (F12, PLG, KNG1, HS3ST6, MYOF) or family history with refractory angioedema after high‑dose antihistamine trial. For acute attacks: similar laboratory confirmation or mutation/family history criteria apply.laboratory confirmation or specified mutation
Specialist prescriber or consultation recommended; age limits per agent.
ICLUSIG (ponatinib) criteria
ICLUSIG (ponatinib) — covered when ANY of the following are met:
ICLUSIG uses in CML/ALL/GIST: For CML: accelerated/blast phase with no other kinase inhibitor indicated OR chronic phase with resistance/intolerance to ≥2 prior kinase inhibitors (including imatinib, dasatinib, or nilotinib) OR T315I mutation positive. For ALL: Philadelphia chromosome/BCR‑ABL positive. For GIST: residual/unresectable/recurrent/metastatic disease progressed after ≥2 FDA‑approved therapies.diagnosis confirmation and prior therapy history or mutation status
Provide cytogenetics, mutation testing, and prior TKI treatment history.
TNF inhibitors (Humira, Idacio)
TNF inhibitors and biosimilars (e.g., Humira, Idacio) — covered when criteria for indicated rheumatologic and dermatologic conditions are met:
TNF inhibitors new start criteria: For moderately to severely active rheumatoid arthritis (new starts): inadequate response/intolerance/contraindication to methotrexate OR prior biologic/targeted synthetic DMARD; for ankylosing spondylitis: inadequate response/intolerance to NSAIDs or contraindication; for plaque psoriasis: ≥3% BSA or crucial areas affected with prior therapy failure/intolerance to systemic agents unless severe disease warrants biologic first‑line.BSA ≥3% or crucial area involvement
Document prior therapy trials and disease severity.
CML / Ph+ ALL / GIST indications
Covered when ANY of the following are met for use in CML, Ph+ ALL, or GIST:
CML accelerated/blast phase: Patient has accelerated or blast phase CML and no other kinase inhibitor is indicated.
Diagnosis documentation required.
CML chronic phase after ≥2 TKIs: Chronic phase CML with resistance or intolerance to at least two prior kinase inhibitors AND at least one was imatinib, dasatinib, or nilotinib.prior TKI history
Provide prior TKI treatment history and response.
T315I mutation positive: Patient is positive for the T315I mutation.mutation testing
Attach mutation assay result.
Imatinib-group required criteria
IMATINIB / IMKELDI and related products — covered when specific disease and prior therapy criteria are met:
Diagnosis confirmation (CML/Ph+ ALL): Diagnosis confirmed by detection of the Philadelphia chromosome or BCR‑ABL gene for CML or Ph+ ALL.cytogenetic/molecular confirmation
Provide diagnostic testing reports.
Prior TKI failure or specified use: For CML: prior TKI failure/intolerance as specified per entry; for cutaneous melanoma: indicated for metastatic/unresectable disease positive for c‑KIT activating mutations and used as subsequent therapy after progression/intolerance to BRAF‑targeted therapy where applicable.prior therapy history and mutation testing
Provide mutation assays and prior treatment documentation.
IVIG clinical criteria
IVIG clinical criteria — covered when ANY of the following disease‑specific criteria are met:
CLL: For B‑cell chronic lymphocytic leukemia (CLL): serum IgG <500 mg/dL OR history of recurrent bacterial infections.IgG <500 mg/dL
Provide serum IgG and infection history.
BMT/HSCT: For bone marrow/hematopoietic stem cell transplant: IVIG requested within first 100 days post‑transplant OR serum IgG <400 mg/dL.IgG <400 mg/dL or within 100 days post‑transplant
Provide transplant date and IgG levels.
Pediatric HIV: For pediatric HIV: serum IgG <400 mg/dL OR history of recurrent bacterial infections.IgG <400 mg/dL
Gefitinib (IRESSA) criteria
Gefitinib (IRESSA) — covered when ALL of the following are met:
NSCLC EGFR mutation: Non‑small cell lung cancer that is recurrent, advanced, or metastatic AND tumor positive for a sensitizing EGFR mutation.sensitizing EGFR mutation
Provide molecular testing documenting EGFR sensitizing mutation.
LAZCLUZE coverage criteria
Covered when ALL of the following are met for LAZCLUZE (examples for breast and colorectal cancer):
LAZCLUZE — breast cancer: Disease is recurrent, advanced, or metastatic (including brain metastases) AND disease is HER2‑positive AND requested drug will be used in combination with an aromatase inhibitor, capecitabine, or trastuzumab.HER2‑positive
Provide HER2 testing and treatment plan showing combination therapy.
LAZCLUZE — colorectal cancer: Requested drug used in combination with trastuzumab AND patient has not had previous treatment with a HER2 inhibitor.no prior HER2 inhibitor exposure; HER2 testing
Document prior HER2 inhibitor history and molecular testing.
LENVIMA coverage criteria
LENVIMA — covered when indication‑specific criteria are met (examples):
LENVIMA indications: Indications include medullary thyroid carcinoma, recurrent endometrial carcinoma (in combination with pembrolizumab after prior systemic therapy), thymic carcinoma, unresectable/metastatic cutaneous melanoma, differentiated thyroid cancer not amenable to RAI, unresectable/inoperable HCC with extensive tumor burden, advanced/relapsed RCC, and others per labeling.disease staging and prior therapy per indication
Provide disease status and prior therapy history as applicable.
LONSURF / LORBRENA criteria
Covered when ALL of the following are met for LONSURF or LORBRENA (examples):
LONSURF — GI cancers: Disease is unresectable locally advanced, recurrent, or metastatic esophageal/gastric/GEJ cancer AND patient previously treated with at least two prior lines of chemotherapy.≥2 prior lines of chemotherapy
Document prior chemotherapy regimens and timing.
LORBRENA — NSCLC: Disease is ALK‑positive AND patient had inadequate response/intolerance/contraindication to Alecensa (alectinib) or Alunbrig (brigatinib) OR for ROS1‑positive disease used following progression on crizotinib, entrectinib, or ceritinib.ALK or ROS1 positivity and prior therapy history
Provide molecular testing and prior therapy details.
MAVYRET (HCV) criteria
MAVYRET (HCV) coverage conditions — covered when ALL of the following are met:
HCV therapy prerequisites: Infection confirmed by HCV RNA prior to starting treatment AND planned regimen, genotype, prior treatment history, cirrhosis status, HIV coinfection status, resistance‑associated substitutions where applicable, and transplantation status; therapy durations follow current AASLD‑IDSA guidance.HCV RNA positive
Attach HCV RNA and relevant clinical documentation.
Melanoma BRAF criteria: Tumor positive for BRAF V600 activating mutation (e.g., V600E or V600K) AND requested drug used as single agent or in combination with a BRAF inhibitor per disease setting (unresectable, resectable limited, metastatic, or adjuvant systemic therapy).BRAF V600 mutation
Provide tumor molecular testing report.
Thyroid BRAF criteria: Papillary/follicular/oncocytic thyroid carcinoma positive for BRAF V600E AND disease not amenable to radioactive iodine AND use in combination with dabrafenib as specified.BRAF V600E mutation
Provide molecular testing and RAI ineligibility documentation.
NEXAVAR coverage
NEXAVAR (sorafenib) oncology criteria — covered when indication‑specific requirements are met:
NEXAVAR covered indications: Indications include specified AML settings (FLT3‑ITD positive under defined uses), selected sarcoma and bone tumor subtypes, GIST after progression on ≥2 FDA‑approved therapies, medullary thyroid carcinoma, and other listed malignancies per entry.biomarker or prior therapy per indication
Provide mutation testing and prior therapy documentation as applicable.
OGIVRI general HER2 criteria: Indications include neoadjuvant and recurrent/advanced HER2‑positive breast cancer (including CNS/leptomeningeal metastases) and selected HER2‑positive GI, uterine serous, hepatobiliary, and colorectal HER2‑amplified/RAS and BRAF wild‑type disease with specific combination requirements; for some indications prior intolerance to Trazimera must be documented.HER2 amplification/overexpression and RAS/BRAF status where specified
Provide HER2, RAS, BRAF testing and prior agent intolerance documentation.
OGIVRI colorectal specifics: Disease is HER2‑amplified AND RAS and BRAF wild‑type AND requested drug will be used in combination with pertuzumab, tucatinib, or lapatinib AND patient has not had prior HER2 inhibitor therapy.molecular testing confirming HER2‑amplified and RAS/BRAF wild‑type
Document molecular testing and prior HER2 inhibitor exposure.
Acromegaly — Initial and Continuation
Acromegaly — Initial and continuation coverage criteria:
Acromegaly initial therapy: 1) High pretreatment IGF‑1 level for age/gender based on lab reference range AND 2) Inadequate or partial response to surgery or radiotherapy OR documentation of a clinical reason why surgery/radiotherapy was not performed.elevated IGF‑1 for age/gender
Provide IGF‑1 result and surgical/radiation history or rationale.
Acromegaly continuation: Patient's IGF‑1 level has decreased or normalized since initiation of therapy (documented therapeutic response).decrease or normalization of IGF‑1
Provide follow‑up IGF‑1 measurements.
Severe hypertriglyceridemia
Covered when ALL of the following are met for severe hypertriglyceridemia therapy (omega‑3‑acid ethyl esters):
Severe hypertriglyceridemia — initial: Patient has pretreatment triglyceride level ≥500 mg/dL prior to starting therapy.>= 500 mg/dL
Covered when ANY of the following are met for relapsed/refractory pediatric low‑grade glioma (OJEMDA):
Pediatric LGG — BRAF alterations: Tumor positive for either a BRAF fusion/rearrangement OR a BRAF V600 mutation.presence of BRAF fusion/rearrangement or V600 mutation
Provide tumor molecular testing confirming BRAF alteration.
HER2-targeted therapy conditional coverage
HER2‑targeted therapy conditional coverage (multiple HER2 agents) — covered when ALL of the following are met for colorectal and hepatobiliary indications:
Colorectal cancer HER2‑amplified: 1) Disease is HER2‑amplified AND RAS and BRAF wild‑type; AND 2) Requested drug will be used in combination with pertuzumab, tucatinib, or lapatinib; AND 3) Patient has not had prior HER2 inhibitor therapy.HER2‑amplified and RAS/BRAF wild‑type
Provide molecular testing and prior therapy history.
Hepatobiliary HER2 condition: 1) Disease is HER2‑positive AND 2) Requested drug will be used in combination with pertuzumab.HER2‑positive
Provide HER2 testing and planned regimen.
ESAs — Initial and Reauthorization
Covered when ALL of the following are met for erythropoiesis‑stimulating agents (ESAs, e.g., Procrit):
ESA initial approval general criteria: 1) Adequate iron stores (e.g., transferrin saturation ≥20%) for uses except chemotherapy or surgery; AND 2) Pretreatment hemoglobin (Hgb) <10 g/dL for all uses except surgery; AND 3) For MDS: pretreatment serum erythropoietin ≤500 IU/L.Hgb <10 g/dL; TSAT ≥20%; EPO ≤500 IU/L
Provide pretreatment Hgb, iron studies, and EPO when applicable.
ESA reauthorization: 1) Patient received at least 12 weeks of ESA therapy AND 2) Patient responded to ESA therapy AND 3) Current Hgb <12 g/dL AND 4) For uses except chemotherapy or MDS: adequate iron stores (TSAT ≥20%).Hgb <12 g/dL
Provide treatment duration, response documentation, and current labs.
PAH diagnostic confirmation
Pulmonary arterial hypertension (PAH) diagnostic confirmation — covered when ALL of the following are met:
PAH hemodynamic criteria: Right heart catheterization confirms PAH AND pretreatment mean pulmonary arterial pressure >20 mmHg AND pulmonary capillary wedge pressure ≤15 mmHg AND pulmonary vascular resistance ≥3 Wood units for new starts (agent‑specific thresholds may vary).mPAP >20 mmHg; PCWP ≤15 mmHg; PVR ≥3 WU
Right heart catheterization report and hemodynamic values required prior to PAH agent initiation.
Psoriasis biologic initiation
Covered when ALL of the following are met for initiation of biologic therapy for moderate‑to‑severe plaque psoriasis:
Psoriasis biologic initiation: 1) At least 3% body surface area affected OR crucial body areas involved OR severe disease (≥10% BSA) warranting biologic as first‑line; AND 2) Inadequate response, intolerance, or contraindication to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) unless biologic first‑line is justified.>=3% BSA (or >=10% for severe first‑line biologic)
Document BSA, prior therapies tried, or rationale for first‑line biologic.
Phenylbutyrate — opioid-induced constipation
Phenylbutyrate for opioid‑induced constipation — covered when ALL of the following are met:
Phenylbutyrate coverage: Indication: opioid‑induced constipation in chronic non‑cancer pain in a patient who does not require frequent opioid dose escalation AND one of: (A) patient unable to tolerate oral medications, OR (B) inadequate response or intolerance to an oral agent indicated for opioid‑induced constipation (e.g., Movantik), OR (C) contraindication to trial of an oral agent; coverage limited to 4 months.coverage duration: 4 months
Provide prior oral agent trial or documentation of intolerance/administration limitation.
Biologic initiation criteria for rheumatologic and dermatologic indications — covered when prior therapy or disease severity requirements are met:
Rheumatologic biologic initiation: For moderately to severely active rheumatoid arthritis (new starts): patient has inadequate response/intolerance/contraindication to methotrexate OR prior biologic/targeted synthetic DMARD as specified; for ankylosing spondylitis and psoriatic arthritis similar step requirements apply (e.g., inadequate response to NSAIDs or TNF inhibitors where specified).prior therapy failures as specified
Document prior conventional and biologic DMARD trials and responses.
Plaque psoriasis biologic initiation: At least 3% BSA affected or crucial body areas involved AND inadequate response/intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) OR contraindication OR severe disease warranting biologic first‑line (≥10% BSA or crucial areas).BSA thresholds as noted
Document BSA and prior therapy history.
Molecular marker-dependent coverage
Molecular marker–dependent coverage — targeted oncology agents covered when molecular and disease‑stage criteria are met:
RETEVMO (RET) — NSCLC and solid tumors: For NSCLC: disease is recurrent, advanced, or metastatic AND tumor is RET fusion‑positive. For other solid tumors: disease is recurrent/persistent/progressive/unresectable/locally advanced/metastatic AND tumor is RET fusion‑positive and prior systemic therapy or lack of satisfactory alternatives documented.RET fusion‑positive
Provide molecular testing and disease stage/prior therapy documentation.
ROZLYTREK — ROS1/NTRK: For ROS1‑positive NSCLC: recurrent, advanced, or metastatic disease. For NTRK fusion‑positive solid tumors: tumor harbors NTRK gene fusion without a known acquired resistance mutation.ROS1 or NTRK fusion positivity and absence of known resistance mutation for NTRK
Attach molecular testing and resistance mutation assessment where applicable.
RUBRACA indications
Rucaparib (RUBRACA) — covered when indication‑specific criteria are met:
mCRPC with BRCA: Metastatic castration‑resistant prostate cancer with a deleterious BRCA mutation (germline and/or somatic) AND prior androgen receptor‑directed therapy AND prior taxane chemotherapy (or unfit for chemotherapy) AND will be used with GnRH analog or after bilateral orchiectomy.deleterious BRCA mutation
Provide BRCA testing and prior therapy history.
Maintenance ovarian cancer: For maintenance of BRCA‑mutated ovarian/fallopian tube/primary peritoneal cancer: patient in complete or partial response to primary therapy OR recurrent disease in response to platinum‑based chemotherapy.BRCA mutation and response to prior therapy
Document BRCA status and response to prior therapy.
Hematology targeted therapy criteria
Hematology targeted therapy criteria — covered when biomarker and prior therapy criteria are met:
FLT3‑ITD AML uses: For AML: agent‑specific biomarker positivity (e.g., FLT3‑ITD) and use in defined treatment settings (maintenance after transplant, low‑intensity induction, consolidation, or relapsed/refractory) per product labeling.FLT3‑ITD where specified
Provide mutation testing and intended treatment setting.
CML chronic phase — targeted agents: For CML chronic phase: diagnosis confirmed by Philadelphia chromosome/BCR‑ABL AND required prior TKI history or mutation status per agent (e.g., resistance/intolerance to imatinib/dasatinib/nilotinib, or T315I mutation positivity where indicated).BCR‑ABL/Ph confirmation and prior TKI history/mutation testing
Provide cytogenetics, mutation testing, and prior treatment records.
Central Precocious Puberty (CPP) initial therapy
Central precocious puberty (CPP) — covered when ALL of the following are met:
CPP diagnostic criteria: Diagnosis confirmed by pubertal response to a GnRH agonist test OR pubertal level on third‑generation LH assay AND bone age assessment supports CPP AND onset of secondary sexual characteristics before age 8 in females or before age 9 in males; age limits apply (female <12 years, male <13 years).diagnostic hormone testing and bone age assessment
Attach endocrine test results and bone age study.
Teriparatide initial and continuation
Teriparatide (parathyroid hormone analog) — initial and continuation criteria:
Postmenopausal osteoporosis entry: One of: history of fragility fracture OR pre‑treatment T‑score ≤ −2.5 OR T‑score > −2.5 and < −1 with high FRAX probability; AND patient has indicators for high fracture risk OR failed/intolerant to prior injectable osteoporosis therapy OR completed ≥1 year oral bisphosphonate trial or clinical reason to avoid oral bisphosphonate. Initial coverage limited to 24 months.Initial: 24 months
Provide T‑score, FRAX, fracture history, and prior therapy documentation.
Continuation criteria: If patient received ≥24 months of therapy: patient remains at or has returned to high fracture risk and benefit outweighs risks (high FRAX thresholds defined in policy).continuation assessed per high FRAX or clinical criteria
Provide ongoing risk assessment and justification for continuation.
MET exon 14-mutant NSCLC
Covered when ALL of the following are met for MET exon 14‑skipping mutant NSCLC targeted therapy:
MET exon 14 requirement: Tumor is positive for MET exon 14 skipping mutation and disease is recurrent, advanced, or metastatic as specified for listed agents (e.g., TABRECTA, TEPMETKO).MET exon 14 skipping mutation
Provide molecular testing confirming MET exon 14 skipping mutation.
BRAF V600–positive indications for TAFINLAR
Covered when ALL of the following are met for TAFINLAR (dabrafenib) BRAF V600–positive indications:
BRAF V600 requirement for TAFINLAR: Tumor positive for BRAF V600 activating mutation (e.g., V600E or V600K) for indicated malignancies (melanoma, NSCLC BRAF V600E, thyroid carcinoma not amenable to RAI, LCH/Erdheim‑Chester, or other solid tumors); requested drug to be used as single agent or in combination with trametinib as specified per indication.BRAF V600 mutation
Provide tumor BRAF testing and planned regimen.
PAH hemodynamic confirmation
PAH hemodynamic confirmation — entry criteria for PAH agents:
PAH hemodynamic criteria: Right heart catheterization confirms PAH (WHO Group 1); pretreatment mean pulmonary arterial pressure >20 mmHg; pulmonary capillary wedge pressure ≤15 mmHg; and pulmonary vascular resistance meets agent‑specific threshold (e.g., ≥3 Wood units for treprostinil; some agents list ≥2 WU).mPAP >20 mmHg; PCWP ≤15 mmHg; PVR agent‑specific (e.g., ≥3 WU)
Attach right heart catheterization hemodynamic report for new starts.
Topical tacrolimus criteria
Topical tacrolimus for atopic dermatitis — covered when ANY of the following are met:
Atopic dermatitis criteria: For moderate to severe atopic dermatitis: disease affects sensitive areas (face/genitals/skin folds) OR inadequate response/intolerance/contraindication to at least one first‑line topical corticosteroid; for all indications prescribe short‑term or non‑continuous chronic use. Age limits: tacrolimus 0.03% ≥2 years; tacrolimus 0.1% ≥16 years.age limits as specified
Document prior topical therapy and area involvement.
TRAZIMERA HER2 indications and combinations
TRAZIMERA (trastuzumab biosimilar) — HER2‑targeted indications and combinations:
Colorectal HER2‑amplified: For colorectal cancer: disease is HER2‑amplified and RAS and BRAF wild‑type AND requested drug used in combination with pertuzumab, tucatinib, or lapatinib AND patient has not had prior HER2 inhibitor therapy.HER2‑amplified and RAS/BRAF wild‑type
Provide molecular testing and prior HER2 therapy documentation.
Hepatobiliary HER2+: For hepatobiliary carcinoma: disease is HER2‑positive AND requested drug used with pertuzumab.HER2‑positive
Provide HER2 testing and planned regimen.
Endometrial cancer HER2: For endometrial cancer: requested drug used with carboplatin and paclitaxel then continued as single‑agent maintenance per regimen guidance.
PAH agent coverage criteria
Covered when ALL of the following are met for PAH agents (treprostinil example):
PAH confirmation: Right heart catheterization confirms PAH (attach report).
Required for agent initiation.
Mean PAP: Pretreatment mean pulmonary arterial pressure >20 mmHg.>20 mmHg
Covered when ANY of the following AML conditions are met for Venetoclax (VENCLEXTA):
Newly diagnosed AML — elderly/comorbid: Newly diagnosed AML in patients aged ≥75 years OR with comorbidities that preclude intensive induction chemotherapy.age ≥75 or comorbidity preventing intensive chemo
Provide age and comorbidity documentation.
Poor/adverse risk AML: Patient has poor/adverse risk disease and is a candidate for intensive induction therapy as specified.risk classification per AML prognostics
Provide cytogenetic/molecular risk data.
Relapsed/refractory AML: Relapsed or refractory AML per treating clinician and documentation of prior therapy history.prior therapy history for relapse/refractory status
CSF1R mutation-required indications
Covered when ANY of the following are met for CSF1R‑directed agents (example: TURALIO):
LCH with CSF1R mutation: For Langerhans cell histiocytosis: disease harbors a CSF1R mutation.CSF1R mutation
Provide molecular testing confirming CSF1R mutation.
Erdheim‑/Rosai‑Dorfman with CSF1R mutation: For Erdheim‑Chester disease or Rosai‑Dorfman disease: disease harbors CSF1R mutation AND patient has symptomatic or relapsed/refractory disease warranting therapy.CSF1R mutation and symptomatic/relapsed disease
Provide mutation testing and clinical history.
Biomarker-driven coverage
Biomarker‑driven oncology coverage — covered when the indicated molecular biomarker and disease requirements are met:
EGFR/ALK/ROS1/MET biomarker requirements: For agents targeting EGFR, ALK, ROS1, MET alterations: tumor must be positive for the specified sensitizing alteration (e.g., sensitizing EGFR mutation, ALK or ROS1 fusion, MET exon 14 skipping) and disease stage must match labeled indication (e.g., recurrent/advanced/metastatic NSCLC).specified molecular alteration per agent
Provide molecular testing report and disease stage documentation.
NTRK fusion tumors: For TRK inhibitors (e.g., VITRAKVI): tumor is NTRK gene fusion‑positive and without a known acquired resistance mutation.NTRK fusion positive and absence of known acquired resistance mutation
Provide molecular testing and resistance mutation assessment.
Step therapy — non-oncology examples
Step therapy — non‑oncology examples (rheumatologic and psychiatric):
Psychiatric step therapy example: For MDD (TRINTELLIX example): inadequate response, intolerance, or contraindication to one of: SNRIs, SSRIs, mirtazapine, or bupropion prior to approval of requested agent.prior antidepressant trial
Document prior antidepressant trials and responses.
Rheumatologic biologic step: For agents such as XELJANZ (some indications): new starts must have inadequate response/intolerance/contraindication to at least one TNF inhibitor (additional combination requirements may apply per indication).prior TNF inhibitor trial or contraindication
Provide prior biologic treatment history.
Testosterone cypionate — IBS-D, SIBO, HE recurrence
Testosterone cypionate — covered when the specified indication‑ and duration‑specific conditions are met:
IBS‑D initial or repeat use: Covered when patient is treatment‑naïve to the requested drug OR for recurrence provided the patient has not already completed an initial 14‑day course plus two additional 14‑day courses; coverage duration for IBS‑D: 14 days.course limits
Document prior use history and dates of prior courses.
SIBO: Covered when patient has recurrence after a successful course OR diagnosis is confirmed by quantitative culture of upper gut aspirate or breath testing (lactulose or glucose hydrogen breath test); coverage duration: 14 days.diagnostic confirmation required
Attach breath test or culture results.
Reduction in overt HE recurrence: Covered for reduction in risk of overt hepatic encephalopathy recurrence for a duration of up to 6 months as specified.
CNS cancers and pediatric high‑grade glioma: Tumor positive for BRAF V600E mutation AND requested drug used in combination with cobimetinib OR used for pediatric diffuse high‑grade glioma per labeled indication.BRAF V600E mutation
Provide tumor molecular testing and treatment plan.
Melanoma indications: Tumor positive for BRAF V600 activating mutation (V600E or V600K) AND requested as single agent or with cobimetinib for unresectable, limited resectable, metastatic, or adjuvant systemic therapy.BRAF V600 mutation
Provide molecular testing and intended regimen.
NSCLC BRAF V600E: Tumor positive for BRAF V600E mutation AND disease is recurrent, advanced, or metastatic per indication.
XPOVIO prior therapy requirements
XPOVIO (selinexor) — prior therapy requirements:
Multiple myeloma prior therapy: Patient must have been treated with at least one prior therapy for multiple myeloma when requesting XPOVIO as indicated.prior therapy required
Provide prior therapy records.
B‑cell lymphoma prior lines: For indicated high‑grade B‑cell lymphomas, patient must have been treated with at least two lines of systemic therapy prior to XPOVIO use.≥2 prior systemic therapies
Provide prior systemic therapy history.
Yutrepia and Zarxio required information
Required diagnostic and administration information for Yutrepia and Zarxio:
Yutrepia (PAH/PH): Diagnosis confirmed by right heart catheterization with pretreatment hemodynamic thresholds documented (mean PAP >20 mmHg, PCWP ≤15 mmHg, PVR ≥3 Wood units) for new starts.hemodynamic thresholds
Attach right heart catheterization report.
Zarxio (G‑CSF) with chemotherapy: If used with chemotherapy administer at least 24 hours after chemotherapy; for prophylaxis or treatment of chemotherapy‑induced febrile neutropenia patient must have solid tumor or non‑myeloid cancer and be receiving myelosuppressive anti‑cancer therapy.timing and cancer type requirements
Provide chemotherapy schedule and cancer diagnosis.
Zonisade coverage criteria
Zonisade (seizure adjunct) — covered when ANY of the following are met:
Adjunctive partial‑onset seizures: Patient has inadequate response/intolerance/contraindication to a generic anticonvulsant AND to agents listed (e.g., Aptiom, Xcopri, Spritam), OR patient has difficulty swallowing solid oral dosage forms; age restriction: ≥16 years.age ≥16 years; prior therapy trials or swallowing difficulty
Provide prior anticonvulsant trial history or documentation of swallowing impairment.
Drug Lists and Key Clinical Thresholds
Listed drug names (partial extract)mixed
N/A
Extensive list of drug names potentially covered (see chunks 10-11)
Drugs listed in this segmentmixed
LAZCLUZE
Drug name listed as prior authorization group
LENVIMA
Drug name listed
LEUPROLIDE ACETATE
Drug name listed
LIDOCAINE PATCHES
Drug name listed
LIVTENCITY
Drug name listed
LONSURF
Drug name listed
LORBRENA
Drug name listed
LUMAKRAS
Drug name listed
LUMIZYME
Drug name listed
LUPRON DEPOT-PED
Drug name listed
1–10 of 41
1/5
Drug list in section (no billing codes provided)mixed
Continuation requirementContinuation beyond 24 months requires continued high fracture risk and favorable benefit-risk assessment
FRAX adjustment noteHigh FRAX fracture probability definitions apply to continuation criteria
Prior Authorization, Documentation, and Step Therapy
Prior Authorization
Prior Authorization Required
Prior authorization required. Providers must submit documentation confirming biomarker status (e.g., RET, NTRK, BRAF, MET, EGFR, ALK, ROS1, PDGFRA, IDH2, BRCA/PALB2) or prior-line therapy where indicated. Requests for oncology and targeted agents will be reviewed only when molecular testing demonstrating the actionable alteration is provided and the disease stage/setting matches the drug’s required indication (for example: RETEVMO (RETEVMO) — RET fusion-positive tumors for solid tumor use; ROZLYTREK/entrectinib/larotrectinib — documented NTRK fusion for NTRK-fusion positive tumors and stage-specific requirements such as recurrent/advanced/metastatic disease as noted). For pediatric low-grade glioma (LGG) targeted with BRAF agents, provide documented BRAF testing results showing V600 mutation when required.
Biomarker or prior-therapy confirmation required for biomarker-linked indications (e.g., RET, NTRK, BRAF, MET exon14, ALK, ROS1, PDGFRA).
Provide prior-line therapy documentation when policy requires progression on or intolerance to specified agents or number of prior systemic therapies.
Pediatric BRAF testing required for LGG when BRAF-targeted therapy is requested.
Denial Risk
Drug Interaction Exclusions / Denial Risk
Drug interactions and exclusion conditions that will cause denial: • DHE nasal sprays (and similar formulations) will be denied if concurrent potent CYP3A4 inhibitors are present due to significant interaction risk. • Ergotamine and ergot-derivative products are excluded when used concomitantly with potent CYP3A4 inhibitors — coverage will be denied. Providers should document absence of contraindicated interacting medications or submit a management plan.
DHE nasal/CYP3A4 interaction — deny if potent CYP3A4 inhibitor co-prescribed.
Ergotamine products — coverage denied when used with potent CYP3A4 inhibitors (e.g., ritonavir, certain macrolides).
Billing Rule
Medicare Part A / B vs Part D — Denial Risk
Medicare Part D billing/coverage limits — many infused or physician‑administered products are covered under Part A or Part B; if the medication is furnished and billed under Part A/B or is administered in a physician setting where Part A/B coverage applies, Part D coverage will be denied. Examples: IVIG, erythropoiesis-stimulating agents when administered as part of dialysis or physician-supplied anemia care, certain chemotherapy-administered supportive agents. When a Part A or Part B benefit is available for the specific service or administration, submit documentation if you believe Part D should apply; otherwise expect a Part D denial.
Coverage under Part D will be denied if coverage is available under Part A or Part B for the medication as prescribed and administered for the individual (e.g., IVIG, drugs furnished incident to a physician service).
If drug is furnished/dispensed or administered under Part A/B, include justification and billing context if requesting Part D coverage.
Documentation Required
Required Diagnostic, Laboratory, and Disease-Stage Documentation
Specific disease-stage, diagnostic, and laboratory documentation expectations (examples consolidated): provide diagnostic confirmation and relevant labs or hemodynamics as noted below. Failure to supply required documentation will result in denial. • Hepatitis C (HCV): HCV RNA positive prior to treatment; include genotype, treatment history, cirrhosis status, HIV coinfection status, transplant status, and resistance-associated substitutions when applicable. • HT-1 (hereditary tyrosinemia type 1): confirm by succinylacetone detection or DNA testing. • Acromegaly: pre-treatment IGF-1 elevated for age/gender per lab reference and documentation of inadequate/partial response to or contraindication for surgery/radiotherapy. • Hypertriglyceridemia: provide appropriate fasting triglyceride level as required by the agent’s criteria. • Pulmonary arterial hypertension (PAH): submit hemodynamic data from right heart catheterization consistent with PAH (including WHO group/status where required). • NSCLC (including RET, ROS1, ALK, BRAF, EGFR contexts): document tumor molecular status (e.g., RET fusion-positive for RET-directed agents), disease stage (recurrent/advanced/metastatic) and prior systemic therapy history when required (e.g., Zykadia/ceritinib requests — provide prior ALK testing and prior therapy history). • Multiple myeloma and select hematologic agents: document disease status and required transferrals or cytogenetic markers (example: multiple myeloma — document relapsed/progressive disease and required combinational or genetic criteria).
HT-1: Biochemical (succinylacetone) or DNA confirmation required.
Acromegaly: baseline IGF-1 and prior surgery/radiation response documented.
PAH: right heart catheterization hemodynamic data required.
Note
Agent-specific Documentation Examples
Examples of agent‑specific documentation/requirements to include with PA requests: • RETEVMO (RETEVMO): tumor RET fusion-positive confirmation and for NSCLC the disease must be recurrent, advanced, or metastatic. • ROZLYTREK / NTRK-directed agents: documented NTRK fusion and specification of tumor type and stage; for certain indications first- or later-line use must match policy language. • IDHIFA, IMATINIB and other targeted agents: include mutation testing (e.g., IDH2 for IDHIFA) and prior-therapy context (newly-diagnosed AML not candidate for intensive induction, or relapsed/refractory as specified). • Zykadia (ceritinib) or other NSCLC ALK agents: include prior ALK testing and prior treatment history/sequence when policy requires prior kinase inhibitor trials. • For teriparatide and postmenopausal osteoporosis agents: include fracture history or pre-treatment T-score, FRAX probability, and documentation of prior bisphosphonate or injectable therapy failure/intolerance when required.
RETEVMO: RET fusion-positive proof and NSCLC disease stage.
ROZLYTREK / NTRK: fusion testing and disease-stage documentation.
IDHIFA/IMATINIB: mutation testing and prior-therapy documentation for AML/CML indications.
Teriparatide/postmenopausal osteoporosis: T-score/FRAX or fragility fracture history and prior therapy attempts.
Molecular and Genetic Test Requirements
inv-244: FGFR3
BiomarkerFGFR3 susceptible genetic alterations
IndicationRequired for BALVERSA in urothelial carcinoma (susceptible FGFR3 alterations)
Testing requirementMolecular testing must document presence of FGFR3 alteration
IndicationsRequired for HER2-targeted therapies across breast, colorectal (HER2-amplified), hepatobiliary, endometrial, gastric and other cancers
Combination constraintsSome HER2 indications require combination with pertuzumab, tucatinib, lapatinib, or paclitaxel and RAS/BRAF wild-type status for colorectal disease
inv-254: RAS and BRAF
MarkersRAS and BRAF wild-type status (when required)
ContextRequired for HER2-amplified colorectal cancer to qualify for combination HER2-targeted regimens
DocumentationMolecular testing confirming RAS and BRAF wild-type and HER2 amplification required
RAS/BRAF contextColorectal HER2 regimens require RAS and BRAF wild-type status
Combination constraintsMany HER2 entries require combination with pertuzumab, tucatinib, lapatinib, or specific chemotherapies
Permitted Regimens and Combinations
Regimen
Indication / Notes
Coverage Status
BRAFTOVI (encorafenib) as single agent or in combination with binimetinib
Melanoma: tumor positive for BRAF V600 activating mutation (e.g., V600E or V600K); used as single agent or with binimetinib for unresectable, limited resectable, metastatic disease or adjuvant systemic therapy
Covered
Regimen
Indication / Notes
Coverage Status
BRAFTOVI (encorafenib)
Colorectal cancer (including appendiceal adenocarcinoma): tumor positive for BRAF V600E mutation with advanced or metastatic disease or unresectable metachronous metastases
covered_with_criteria
Regimen
Indication / Notes
Coverage Status
Cotellic (cobimetinib) in combination with vemurafenib
For CNS tumors (glioma/glioblastoma) or melanoma: tumor positive for BRAF V600 activating mutation; used in combination with vemurafenib for unresectable, limited resectable, metastatic disease or adjuvant systemic therapy
Covered
Regimen
Indication / Notes
Coverage Status
Erlotinib (ERLOTINIB)
Recurrent/advanced/metastatic non-small cell lung cancer: patient has sensitizing EGFR mutation-positive disease (includes brain metastases from NSCLC)
Covered
Regimen
Indication / Notes
Coverage Status
GAVRETO (selpercatinib)
Non-small cell lung cancer: tumor is RET fusion/rearrangement–positive; used in recurrent/advanced/metastatic disease as specified
Covered
Regimen
Indication / Notes
Coverage Status
Everolimus (EVEROLIMUS)
Covered for specified previously treated malignancies and select histiocytic neoplasms per indication-specific prior therapy and mutation requirements (see individual disease entries)
Covered
Regimen
Indication / Notes
Coverage Status
HER2-targeted agent in combination with pertuzumab, tucatinib, or lapatinib
For HER2-amplified colorectal cancer: disease must be HER2-amplified and RAS and BRAF wild-type; requested drug used in combination with pertuzumab, tucatinib or lapatinib; patient must not have had prior HER2 inhibitor therapy
Covered
Regimen
Indication / Notes
Coverage Status
HER2-targeted agent used in combination with pertuzumab
For hepatobiliary carcinoma: disease is HER2-positive and the HER2 agent is used in combination with pertuzumab
Covered
Regimen
Indication / Notes
Coverage Status
HER2-targeted agent given with paclitaxel then continued as single-agent maintenance
For HER2-positive endometrial cancer: administered in combination with paclitaxel and continued as single-agent maintenance
Covered
Regimen
Indication / Notes
Coverage Status
Kanjinti (trastuzumab biosimilar) in combination regimens
Used with pertuzumab for HER2-amplified colorectal cancer; with paclitaxel for endometrial cancer; subject to restrictions regarding prior HER2 inhibitor exposure and intolerance criteria
Covered
Regimen
Indication / Notes
Coverage Status
Combination with trastuzumab and related HER2 combinations (pertuzumab, tucatinib, lapatinib)
For colorectal cancer: requested agent used in combination with trastuzumab (or with pertuzumab/tucatinib/lapatinib as specified) and patient must be HER2-amplified and RAS and BRAF wild-type; prior HER2 inhibitor exposure restrictions apply
Indicated for tumors positive for BRAF V600 activating mutation (e.g., melanoma, select solid tumors); use per disease setting (unresectable/metastatic or adjuvant) and per pairing guidance
Covered
Regimen
Indication / Notes
Coverage Status
Requested HER2-targeted drug used in combination with pertuzumab, tucatinib, or lapatinib
For HER2-amplified colorectal cancer: disease must be HER2-amplified and RAS and BRAF wild-type; patient must not have had prior HER2 inhibitor therapy
covered_with_criteria
Regimen
Indication / Notes
Coverage Status
Pomalyst (pomalidomide)
For multiple myeloma: used after at least two prior therapies including an immunomodulatory agent (IMiD) and a proteasome inhibitor (relapsed/refractory indications)
covered_with_criteria
Regimen
Indication / Notes
Coverage Status
Rucaparib (RUBRACA) maintenance
Maintenance treatment for BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to primary therapy, or after platinum-based chemotherapy for recurrent disease
Covered
Regimen
Indication / Notes
Coverage Status
Dasatinib for GIST with PDGFRA exon 18 mutation
For gastrointestinal stromal tumor (GIST): patient is positive for PDGFRA exon 18 mutation and has received prior therapy with avapritinib
Covered
Regimen
Indication / Notes
Coverage Status
TRAZIMERA (trastuzumab biosimilar) combinations
For colorectal cancer: disease is HER2-amplified and RAS and BRAF wild-type; requested drug used in combination with pertuzumab, tucatinib, or lapatinib; patient must not have had prior HER2 inhibitor therapy
Covered
Regimen
Indication / Notes
Coverage Status
TAFINLAR (dabrafenib) as single agent or with trametinib
For tumors positive for BRAF V600 activating mutation (e.g., melanoma, NSCLC BRAF V600E, thyroid carcinoma not amenable to RAI, LCH/Erdheim-Chester disease, other solid tumors); used as single agent or combined with trametinib per indication
Covered
Regimen
Indication / Notes
Coverage Status
Tukysa (tucatinib) in combination with trastuzumab
For HER2-positive colorectal cancer: patient must be HER2-positive and RAS wild-type and not previously treated with a HER2 inhibitor; used in combination with trastuzumab
Covered
Regimen
Indication / Notes
Coverage Status
Venetoclax (VENCLEXTA) in combination with dexamethasone
For multiple myeloma: used in combination with dexamethasone for patients with t(11;14) translocation or related indicated uses per entry
Covered
Regimen
Indication / Notes
Coverage Status
Vemurafenib (ZELBORAF) as single agent or with cobimetinib
For tumors positive for BRAF V600 activating mutation (e.g., melanoma, CNS tumors, NSCLC BRAF V600E): used as single agent or in combination with cobimetinib per specific indication and disease setting
Covered
Regimen
Indication / Notes
Coverage Status
Selinexor (XPOVIO)
Covered per labeled indications after required prior therapies: e.g., multiple myeloma requires at least one prior therapy; B-cell lymphomas require at least two lines of systemic therapy as specified
covered_with_criteria
Line-of-Therapy Designations
Policy Background
This document defines the prior authorization (PA) requirements for a broad set of specialty and oncology medications covered by Neighborhood Health Plan of Rhode Island. It summarizes indication‑specific entry and continuation criteria that providers must document when requesting PA, including diagnostic confirmation (for example, right heart catheterization with pretreatment hemodynamics for pulmonary arterial hypertension), molecular or biomarker testing (for targeted oncology therapies such as RET, BRAF, FGFR3, MET, NTRK, etc.), and prior therapy or step‑therapy requirements where applicable.
Providers should expect that many listed drugs require submission of supporting clinical information specific to the indication (e.g., HCV RNA and genotype for hepatitis C agents; pretreatment IGF‑1 and prior surgery/radiotherapy for acromegaly; documented platelet counts and prior ITP therapy for thrombocytopenia agents). The PA rules also include age or prescriber restrictions, administration/timing rules (for example, G‑CSF agents given at least 24 hours after chemotherapy), coverage durations, and explicit exclusions (for example, exclusion of contemporaneous use of ivacaftor‑containing CFTR modulators).
Decisions may be denied if required documentation or criteria are missing — common denial risks include absence of required right heart catheterization values for PAH agents, missing tumor molecular test results for biomarker‑driven oncology agents, or when a drug is more appropriately billed under Medicare Part A/B rather than Part D. Providers should submit the specific laboratory, pathology, imaging, mutation testing, and prior therapy history cited in the applicable PA entry to support medical necessity.
SGA definition for GH indicationBirth weight <2500 g at GA >37 weeks OR birth weight/length <3rd percentile or >=2 SD below mean for GA with failure to catch-up growth by age 2
Age requirementSGA entry applies to children >=2 years of age for GH therapy
DocumentationBirth metrics and growth history required for PA
inv-210: Turner syndrome (TS) requirement
Turner syndrome confirmationConfirmed by karyotyping AND pre-treatment height <5th percentile for age
GH documentationKaryotype required as part of growth hormone PA documentation
Indication contextUsed to establish eligibility for pediatric growth hormone therapy
inv-211: T315I mutation
T315I mutation roleBCR-ABL T315I mutation confers resistance to many TKIs and is an indication for certain therapies (e.g., ponatinib/ICLUSIG)
TestingMutation testing required to document T315I positivity for PA
Clinical implicationPresence may alter recommended TKI selection and prior-therapy requirements
NSCLC contextDisease must be recurrent, advanced, or metastatic with documented sensitizing EGFR mutation
DocumentationMolecular testing result required with PA request
inv-213: HER2-positive / HER2-amplified
HER2-positive / HER2-amplifiedTumor overexpressing or amplified for HER2 (ERBB2) required for HER2-targeted therapy coverage
Tumor typesBreast, colorectal (HER2-amplified with RAS/BRAF wild-type), hepatobiliary, endometrial, gastric and others listed
Combination/previous therapy noteSome indications require combination regimens or absence of prior HER2 inhibitor exposure
inv-214: BRAF V600 activating mutation
BRAF V600 activating mutationBRAF V600E or V600K required for BRAF-targeted agents (MEK/BRAF combinations) in melanoma, thyroid carcinoma, and other tumors
Combination useOften paired with MEK inhibitors (dabrafenib, encorafenib, binimetinib) per indication
NTRK gene fusion-positiveTumor harboring NTRK gene fusion without a known acquired resistance mutation
IndicationEligible for TRK inhibitor therapy (VITRAKVI/ROZLYTREK) per entries
DocumentationMolecular testing and documentation of absence of acquired resistance mutation required
inv-221: FLT3-ITD-positive AML
FLT3-ITD-positive AMLFLT3-ITD mutation required to qualify for certain AML-targeted therapies (e.g., specific NEXAVAR/venetoclax contexts)
Clinical settingsUsed in maintenance, induction, consolidation, or relapsed/refractory AML settings per agent-specific criteria
TestingMolecular FLT3-ITD testing required for PA documentation
inv-222: SIBO confirmation methods
SIBO confirmation methodsQuantitative culture of upper gut aspirate OR breath testing (lactulose or glucose hydrogen breath test)
ContextRequired for SIBO diagnosis when seeking PA for related therapies (e.g., testosterone cypionate SIBO indication)
AlternativeClinical recurrence after prior successful course may also qualify per entry
Policy Summary
PayerNeighborhood Health Plan of Rhode Island
PolicyPrior Authorization Criteria for Specialty and Oncology Drugs — Coverage Criteria
Policy CodePolicy N/A
Change TypeNo material changes
Effective DateN/A
Next Review DateN/A
Key ActionSubmit prior authorization with indication-specific documentation (e.g., biomarker test results or right heart catheterization data) to support approval.
Clinical history and platelet trend data required; APR/IPR definitions apply.
Diagnosis confirmed by esophageal biopsy with ≥15 intraepithelial eosinophils per high power field AND clinical manifestations (e.g., dysphagia) AND patient weighs ≥15 kg AND inadequate response/intolerance/contraindication to topical corticosteroid; continuation requires maintained clinical response.
>=15 eosinophils/HPF; weight ≥15 kg
Attach esophageal biopsy report and clinical history.
COPD — initial therapy: Patient is either receiving standard inhaled triple therapy (ICS + LAMA + LABA) OR receiving LAMA+LABA with contraindication to inhaled glucocorticoid AND has absolute blood eosinophil count ≥300 cells/µL prior to initiating therapy; continuation requires clinical benefit.>=300 cells/µL
Document inhaled therapy regimen and eosinophil count.
CSU — initial therapy: Patient evaluated for other causes of urticaria, has spontaneous wheals/angioedema for ≥6 weeks, and remains symptomatic despite H1 antihistamine therapy; continuation requires demonstrated benefit.>=6 weeks duration
Clinical evaluation and treatment history required.
Patient has experienced clinical benefit since initiation of therapy.
Documented improvement required.
Documented clinical benefit required.
EGPA initial: For EGPA: history or presence of eosinophil count >1000 cells/µL or blood eosinophils >10%.>1000 cells/µL or >10%
Provide eosinophil counts and clinical correlation.
EGPA continuation: Beneficial response demonstrated by reduced relapses, reduced daily oral corticosteroid dose, or absence of active vasculitis.
Documented clinical benefit required.
Adult GHD: Failed two GH stimulation tests OR pre‑treatment IGF‑1 >2 SD below mean plus failed one stimulation test OR organic hypothalamic–pituitary disease with ≥3 pituitary hormone deficiencies and low IGF‑1, OR genetic/structural defects OR childhood‑onset GHD with congenital abnormality.GH stimulation/IGF‑1 criteria
Provide endocrine testing and relevant imaging.
GH continuation: Patient is experiencing improvement on therapy.
Documented clinical/growth response required.
Ph+ ALL: Diagnosis of acute lymphoblastic leukemia confirmed by detection of the Philadelphia chromosome or BCR‑ABL gene.cytogenetic confirmation
Provide diagnostic cytogenetics or molecular testing.
GIST coverage: Disease is residual, unresectable, recurrent, or metastatic/tumor rupture AND progressed after at least two FDA‑approved therapies.prior therapy progression
Document prior therapies and progression timeline.
Provide pediatric HIV status and IgG.
Dermatomyositis/polymyositis: At least one standard first‑line treatment tried and unsuccessful or intolerant OR inability to receive standard therapy due to contraindication.prior therapy attempts documented
Provide treatment history and rationale for IVIG.
Pure red cell aplasia: PRCA secondary to parvovirus B19 infection.etiology documentation
Provide virology and hematology reports.
Provide treatment plan and HER2 testing.
PVR:
Pretreatment pulmonary vascular resistance meets agent‑specific threshold (e.g., ≥3 Wood units for treprostinil; ≥2 WU for some agents such as selexipag/uptravi).
see agent thresholds
Provide measured PVR in hemodynamic report.
Provide prior treatment records.
6 months duration
Provide indication documentation and treatment plan.
BRAF V600E mutation
Provide molecular testing and disease stage documentation.
NSCLC targeted therapies: molecular testing and disease-stage/prior therapy documentation required.