Prior authorization requirements for specialty drugs
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Defines prior authorization requirements, clinical prerequisites, prescriber restrictions, coverage durations, and other PA criteria for multiple specialty pharmacy products for Denver-Health-Medical-Plan Medicare products (Elevate Medicare Choice HMO D‑SNP and Elevate Medicare Select HMO). Affects providers requesting coverage for listed drugs.
No material clinical or coverage changes in this revision.
Coverage Criteria by Product / Indication
TYMLOS — Initial coverage
Covered when ALL of the following are met for TYMLOS:
Document that patient has not received a total of 24 months cumulative parathyroid hormone therapy.
Humira-family and related biologics — Initial and renewal
Covered when ALL of the following are met for Humira and many related biologics:
Prescribed by or in consultation with a rheumatologist for specified diagnoses
Prescriber specialty restrictions apply
Specific renewal criteria vary by indication
ARIKAYCE — Initial and renewal
ARIKAYCE coverage and renewal:
All FDA‑approved indications
Documentation of cultures and clinical improvement required
Oncology targeted agents — Coverage
Selected oncology agents:
All FDA‑approved indications
Movement disorder agents — Coverage
Neurology and movement disorders:
All FDA‑approved indications
All FDA‑approved indications
Initial Therapy (FASENRA — Asthma initial)
FASENRA — Asthma (initial): Covered when ALL of the following are met
Continuation Therapy (FASENRA — Asthma renewal)
FASENRA — Asthma (renewal): Covered when ALL of the following are met
Psoriasis / PSA Initial Therapy
Psoriasis / Psoriatic Arthritis: Initial coverage requirements
Document BSA/SPGA/PASI where applicable
Prescriber specialty consultation recommended
HAE Initial Therapy (HAEGARDA)
HAEGARDA — Hereditary angioedema (initial): Covered when ALL of the following are met
Prescriber must be or consult hematologist, immunologist, allergist, or pulmonologist
Initial/renewal coverage 12 months; renewal requires reduction in attack frequency/severity
CML Mutation-guided Therapy (SCEMBLIX / BOSULIF)
SCEMBLIX / BOSULIF for Ph+ CML: Pre-initiation requirements
Appropriate mutation testing must be documented
PAH Initial Therapy (Bosentan)
Bosentan — PAH initial: Covered when ALL of the following are met
Coverage duration initial/renewal 12 months
General and product-specific PA criteria
Coverage is generally provided when the product is used for FDA‑approved indications and when drug-specific clinical prerequisites are met:
Present for most listed products
Typical duration noted across products
Prescriber specialty required for some agents
See product‑specific step requirements
Document required tests/results
Payment determination may be required for certain agents
Dupilumab Initial and Renewal Criteria
Covered when ALL of the following indication-specific requirements are met for dupilumab:
Prescriber must be specialist or in consultation per indication
No concurrent use with certain other biologics or targeted small molecules as specified
Coverage durations vary by indication (initial/renewal 6–12/12 months per indication)
Droxidopa (NOH) Criteria
Covered when ALL of the following are met for NOH:
Initial coverage 3 months; renewal 12 months with continued benefit documented
Eltrombopag / Alvaiz Criteria
Covered when ALL of the following are met for persistent or chronic immune thrombocytopenia (ITP):
Initial coverage 6 months; renewal 12 months with improvement in platelet count or reduced bleeding events
Applies to all indications
Elagolix (Orilissa) Criteria
Covered when ALL of the following are met for moderate-to-severe pain associated with endometriosis:
Initial duration 6 months; renewal 12 months with improvement in pain
Retacrit (EPO) Criteria
Covered when hemoglobin thresholds appropriate to indication are met:
Initial/renewal durations vary by indication
Diclofenac Topical Criteria
Covered when ALL of the following are met for osteoarthritis of the knee:
Coverage duration 6 months
Rozlytrek oral pellets Criteria
Covered when BOTH of the following are met for Rozlytrek oral pellets:
Coverage duration 12 months
Xtandi Criteria
Covered when ALL of the following are met for prostate cancer indications:
All FDA‑approved indications considered
Balversa — Initial Therapy
Balversa
Prescriber and other product‑specific requirements per labeling
Aimovig/Ajovy — Initial and Renewal Criteria (CGRP inhibitors)
CGRP inhibitors for migraine prevention
Renewal 12 months with documented reduction in migraine/headache frequency, severity, or duration
Prescriber specialty as appropriate
VOWST — Initial and Repeat Course Criteria
VOWST for recurrent C. difficile infection
Coverage duration 30 days
Repeat‑course limits and timing apply
Kerendia — Initial Criteria
Kerendia (finerenone) criteria
Coverage durations generally 12 months
Biologics — Initial and Renewal Criteria
Biologic therapy requirements for psoriasis, psoriatic arthritis, RA, AS, UC, CD
Initial coverage commonly 6 months; renewal 12 months with continued benefit required
Initial commonly 6 months; renewal 12 months
Fintepla — Initial and Renewal Criteria
Fintepla (fenfluramine) criteria for LGS/Dravet
Applies per product labeling
Morphine concentrate — Criteria
Morphine concentrate criteria
Coverage duration 12 months for opioid‑tolerant; lifetime for hospice/palliative care
Imatinib/Imkeldi — Duration and Special Criteria
Imatinib / Imkeldi duration rules
For Ph+ CML ensure patient has not received prior TKI therapy
Icatibant — Criteria
Icatibant for hereditary angioedema (HAE)
Coverage duration 12 months
HAE — Initial/renewal criteria (general HAE products)
Covered when ALL of the following are met for HAE products:
Document complement testing results
Imatinib / IMKELDI — Initial/renewal
Covered when ALL of the following are met for imatinib/IMKELDI:
Document indication and prior TKI exposure
Biologics (infliximab and others) — Initial/renewal
Covered when ALL of the following are met for infliximab and similar biologics:
Document prior trials and BSA/clinical measures as applicable
Insulin administration supplies coverage limitation
General coverage notes for insulin-related supplies
Coverage duration LIFETIME for these supplies when applicable
Actimmune initial and renewal criteria
Actimmune (interferon gamma‑1b) coverage criteria
Specialist prescriber required
Kalydeco initial and renewal criteria
Kalydeco (ivacaftor) coverage criteria
Initial coverage 12 months; renewal lifetime contingent on clinical improvement
Lanreotide / Somatuline criteria
Lanreotide / Somatuline coverage criteria
Initial coverage acromegaly 3 months; renewal 12 months with IGF‑1/symptom improvement
Yervoy durations and renewal condition
Yervoy (ipilimumab) coverage durations
Payment determination may apply
Cystic fibrosis (CF) products coverage criteria
Cystic fibrosis (CF) products (e.g., ORKAMBI and other CF modulators) are covered when ALL of the following are met
Initial duration 6–12 months depending on product; renewal requires clinical improvement
NUCALA (mepolizumab) criteria
NUCALA coverage criteria differ by indication and require ALL of the following for initial approval
Initial duration 12 months for asthma; CRSwNP initial 6 months; renewal requires clinical benefit
Initial 6 months; renewal requires clinical benefit
Renewal requires clinical response (reduced exacerbations or ≥5% increase in FEV1)
OPSUMIT (PAH) criteria
OPSUMIT (macitentan) for pulmonary arterial hypertension is covered when ALL of the following are met
Initial and renewal duration 12 months
Somatostatin analogs for acromegaly
Lanreotide/Somatuline for acromegaly is covered when ALL of the following are met
Initial coverage 3 months; renewal 12 months based on IGF‑1 normalization/clinical improvement
Endometriosis (GnRH agents)
GnRH‑modulating agents for endometriosis are covered when ALL of the following are met
Initial/renewal duration 6 months; renewal requires pain improvement and add‑back therapy
CPP (pediatric leuprolide) criteria
Central precocious puberty (CPP) coverage criteria for pediatric leuprolide products
Initial/renewal coverage 12 months; renewal requires Tanner staging stabilization/regression
Glutamine (sickle cell) criteria
Glutamine for sickle cell disease (SCD)
Initial 12 months; renewal requires maintained or reduced acute complications
OFEV coverage criteria
OFEV (nintedanib) coverage rules — initial and renewal criteria by indication
Initial coverage IPF 12 months; renewal requires meaningful improvement or maintenance in annual rate of decline
Initial coverage SSC‑ILD 6 months; prescriber pulmonologist or rheumatologist
Initial coverage PF‑ILD 12 months; renewal requires clinical benefit
XOLAIR coverage criteria
XOLAIR coverage rules by indication
Initial coverage typically 6 months; renewal 12 months
Initial coverage 6 months; renewal requires clinical benefit
Initial coverage 12 months
Initial coverage 12 months; renewal 24 months for food allergy
Orfadin coverage criteria
ORFADIN (nitisinone) hereditary tyrosinemia type 1 rules
Initial coverage 6 months; renewal requires decreased succinylacetone from baseline
Renewal coverage 12 months
PARP inhibitor constraints (LYNPARZA, ZEJULA)
LYNPARZA and ZEJULA noted usage constraints
Coverage durations generally 12 months
Prescriber and trial requirements (general)
Drugs with prescriber specialty or trial requirements
Prescriber restrictions per product
Coverage duration 12 months
Hypocalcemia secondary to hypoparathyroidism criteria
Hyopcalcemia secondary to hypoparathyroidism — covered when ALL of the following are met
Coverage duration 12 months
Cushing disease (SIGNIFOR) initial approval criteria
Cushing disease (SIGNIFOR) — initial approval criteria
Initial coverage 6 months; renewal 12 months with evidence of continued improvement and tolerability
Asthma (CINQAIR) criteria
Asthma (CINQAIR) — covered when ALL of the following are met
Initial/renewal 12 months; renewal requires continued ICS+maintenance and clinical response
Idiopathic pulmonary fibrosis (pirfenidone)
Idiopathic pulmonary fibrosis (pirfenidone) — covered when ALL of the following are met
Initial/renewal 12 months; renewal requires clinical meaningful improvement or maintenance in annual rate of decline
PAH / CTEPH (ADEMPAS)
Pulmonary arterial hypertension / CTEPH (ADEMPAS) — covered when ALL of the following are met
Initial/renewal 12 months; strict concurrent therapy exclusions
Penicillamine—Cystinuria / Wilson disease / RA
Penicillamine — covered when criteria vary by indication
Coverage initial 12 months; renewal varies by indication
PAH initial coverage criteria
Covered when ALL of the following are met for PAH (initial):
Document RHC values
Specialist involvement required
Concurrent therapy exclusions must be documented
CTEPH initial coverage criteria
Covered when ALL of the following are met for CTEPH (initial):
Not a candidate for surgery or inoperable/persistent/recurrent disease after surgery
Document surgical evaluation
Concurrent therapy exclusions apply
Uptravi initial criteria
Initial coverage for Uptravi requires:
Step‑therapy requirement documented
Plaque psoriasis initial criteria
Covered when ALL of the following are met for plaque psoriasis initial therapy:
Also require no concurrent systemic biologic/targeted small molecule
Document absence of concurrent biologic/TSM
HCV direct-acting antivirals criteria
Covered when ALL of the following are met for HCV agents:
Apply AASLD/IDSA guidance
Document regimen and contraindicated interactions checked
Document medication reconciliation and hepatic function where applicable
VOSEVI — Initial Therapy
VOSEVI coverage when ALL of the following are met
Follow AASLD/IDSA guidance
NORDITROPIN FLEXPRO — Initial Therapy (HCV RNA requirement noted)
NORDITROPIN FLEXPRO coverage when ALL of the following are met
Prescribed by or in consultation with an endocrinologist for most indications
Growth hormone products — Initial and Renewal
Growth hormone products coverage when ALL of the following are met
Renewal requires evidence of improvement and open epiphyses for pediatric indications
PAH agents — Initial Therapy
Pulmonary arterial hypertension (PAH) agent coverage when ALL of the following are met
Coverage duration typically 12 months
Actemra — Initial and Renewal
Actemra coverage when ALL of the following are met
Initial durations vary by indication (initial often 6 months; renewal 12 months)
Testosterone products — Initial and Renewal
Testosterone therapies coverage when ALL of the following are met
Renewal requires improved symptoms and tolerance
ACTEMRA / TYENNE Coverage
ACTEMRA / TYENNE (tocilizumab and biosimilars) — covered when meeting indication‑ and prescriber‑specific requirements
See indication‑specific durations (initial often 6 months)
Renewal requires continued benefit
Explicit exclusion applies
XELJANZ Coverage
XELJANZ / XELJANZ XR — covered when indication‑specific prerequisites and step therapy are met
Initial authorization 6 months; renewal 12 months
Document DMARD trial or contraindication
UBRELVY Coverage
UBRELVY (ubrogepant) — acute migraine agent with triptan trial requirement and renewal PRO measures
Initial 6 months; renewal 12 months with patient‑reported improvement or consistent efficacy
Document PROs or consistent effectiveness
RINVOQ Coverage
RINVOQ (upadacitinib) — covered when indication‑specific clinical criteria, specialist prescribing, and step therapy are satisfied
Prescriber: rheumatologist
Prescriber dermatologist/allergist/immunologist
Initial 6 months; renewal 12 months with continued benefit
Document steroid taper
tolvaptan (ADPKD) Coverage
Tolcapts/ tolvaptan for ADPKD — covered when diagnostic and specialist prerequisites met
Initial 6 months; renewal 12 months; renewal requires not progressed to ESRD/dialysis
General initial and renewal criteria (multiple products)
Covered when the indication‑specific prerequisites and discontinuation/renewal conditions below are met
Applies to many product entries
Applies to PSO entries
Applies to RA entries
Applies to AD entries
GCA prerequisite
Applies to many products
Product-specific criteria
Product-specific requirements
Document BSA or sensitive site involvement
Specialist consultation required for some products
Applies to CF entries
E.g., Rozlytrek pellet/capsule rules
Product-specific coverage summary
Coverage determinations for listed products follow the stated coverage durations and indications
See specific product entry for details
Short course duration as listed
Kineret (anakinra) is expressly excluded for the indication of COVID‑19 in hospitalized adults. Requests for Kineret to treat COVID‑19 in an inpatient setting will not meet coverage criteria and should be denied.
CGRP inhibitor class policy: concurrent use of QULIPTA (and other CGRP inhibitors) with another CGRP inhibitor for migraine prevention is not permitted. For Aimovig and Ajovy the policy specifies prior authorization with an initial authorization typically 6 months and renewal 12 months, and renewal requires documented clinical benefit (reduction in migraine/headache frequency, severity, or duration). Any request proposing simultaneous preventive CGRP therapy will be considered non‑compliant with the concurrent‑use restriction and may be denied.
Bosentan for pulmonary arterial hypertension is excluded from concurrent use with cyclosporine A or glyburide. In addition, initiation is contraindicated when liver transaminases (ALT/AST) are > 3× upper limit of normal or when bilirubin has increased by ≥ 2× ULN. Requests that show concurrent therapy with cyclosporine A or glyburide, or that document hepatic enzyme elevations above these thresholds, do not meet coverage criteria.
Prior Authorization, Documentation & Denial Risks
TYMLOS — prior authorization; 24-month limit
Prior authorization is required for TYMLOS. Coverage is limited to 24 months and the request must document that the patient has not received a total of 24 months cumulative parathyroid hormone therapy for osteoporosis.
HUMIRA family — PA with initial 6‑month (HS 12‑month) and 12‑month renewal
Humira family products require prior authorization; initial authorizations are typically 6 months for most listed indications (12 months for hidradenitis suppurativa), and renewals are 12 months with documentation that the patient continues to benefit and no prohibited concurrent biologic/targeted small molecule use.
PA required for listed specialty drugs
Prior authorization is required for the specialty products listed in this section (examples include Humira, Xeljanz, Orencia); coverage durations and product-specific clinical prerequisites are specified per product.
FASENRA — eosinophil ≥150 cells/mcL and PA
Fasenra requires prior authorization for asthma and an initial blood eosinophil count ≥150 cells/mcL within the past 12 months; prescriber specialty and concurrent-therapy restrictions apply per indication.
General PA requirement — typical 12‑month duration
Most specialty pharmacy products in this document require prior authorization; the common coverage duration is 12 months unless a product-specific exception is noted.
Mavenclad — limited-course authorization (48 weeks; cumulative limit)
Mavenclad (cladribine) has a distinct authorization approach: initial coverage described as a 48‑week course with treatment limited by cumulative exposure (not to exceed two years total across courses).
Specialist prescriber requirement and coverage durations
Some products require prescription by or consultation with a specified specialist (examples: Huntington disease and tardive dyskinesia formulations), and those entries commonly set coverage durations (often 12 months; some 6 months) tied to specialist prescribing.
Dupilumab — indication‑specific PA and documentation
Dupilumab prior authorization requires indication‑specific documentation (e.g., blood eosinophil 150–1500 cells/mcL for eosinophilic asthma, EoE confirmed by EGD with biopsy, AD extent ≥10% BSA or special‑site involvement) and appropriate specialist prescribing; renewal requires evidence of clinical improvement.
Balversa — PA; 12‑month coverage
Balversa (erdafitinib) oral tablets require prior authorization; coverage duration is specified as 12 months and approvals apply to FDA‑approved indications.
CGRP inhibitors (Aimovig/Ajovy) — PA; initial 6‑month, renewal 12‑month
Aimovig and Ajovy (CGRP inhibitors) require prior authorization: initial authorization typically 6 months with renewal at 12 months; concurrent use with other CGRP inhibitors for migraine prevention is not allowed and renewal requires documented reduction in migraine frequency/severity/duration.
VOWST — PA; 30‑day course and prior‑treatment rules
VOWST requires prior authorization with a coverage period of 30 days; initial use requires prior antibiotic treatment for recurrent C. difficile infection or, if previously treated with VOWST, documentation of treatment failure and limits on prior courses.
Kerendia — PA; HF criteria and cardiology consult
Kerendia (finerenone) prior authorization for heart‑failure indication requires NYHA class II–IV and LVEF ≥40% (not due to specified causes), prescriber by or in consultation with a cardiologist, and no concurrent mineralocorticoid receptor antagonist use.
HAE agents — PA; complement testing and specialty prescriber
HAE agents require prior authorization with confirmatory complement testing to establish hereditary angioedema, prescription by or in consultation with an allergist/immunologist/hematologist, a 12‑month coverage period, and no concurrent use with medications for acute HAE attacks.
Imatinib / IMKELDI — PA; adjuvant GIST 36‑month duration; prior TKI exclusion
Imatinib (and IMKELDI when used for patients unable to swallow generic tablets) requires prior authorization; adjuvant GIST treatment coverage is 36 months while other indications are 12 months, and Philadelphia chromosome‑positive CML coverage requires that the patient has not received prior TKI therapy.
Biologics (e.g., infliximab) — PA; step and concurrent‑use restrictions
Infliximab and similar biologics require prior authorization with indication‑specific initial periods (typically 6 months) and 12‑month renewals, prescriber specialty restrictions, required prior trials of preferred agents for certain diagnoses, and prohibition on concurrent systemic biologic or targeted small‑molecule therapy.
PA required for insulin supplies and select DME‑like items
Prior authorization is required for the listed durable medical supplies (insulin syringes, pen needles, alcohol prep pads, sharps containers) and related injectables/pen kits; some items are covered under Part D only when used concurrently with insulin and have specific coverage durations.
CFTR modulators — PA; confirmed CFTR mutation and specialist prescriber
Cystic fibrosis modulators require prior authorization with documentation of a confirmed CFTR mutation acceptable for the therapy, prescription by or in consultation with a pulmonologist or CF specialist, and initial coverage periods (commonly 6–12 months) with renewal based on clinical improvement.
NUCALA — PA; blood eosinophils ≥150 cells/mcL and specialist prescriber
NUCALA (mepolizumab) prior authorization requires evidence of an eosinophilic phenotype (blood eosinophils ≥150 cells/mcL within the past 12 months for asthma), specialist prescriber, required background controller therapy, and renewal contingent on clinical response; concurrent anti‑IL‑5 biologics are not allowed.
Leuprolide — prescriber/duration notes; prostate cancer 12‑month
Leuprolide products require indication‑consistent prior authorization; prostate cancer indications typically have 12‑month coverage and some formulations require payment‑determination notes.
Topical lidocaine — indication alignment and PA
Topical lidocaine products require prior authorization and the indication must match listed pain conditions (post‑herpetic neuralgia, diabetic neuropathy, chronic back pain, osteoarthritis of knee/hip); billing/payment determination may vary with setting (Part B vs Part D).
Prior authorization — typical 12‑month coverage
Prior authorization is required for many products and the common coverage duration for listed specialty agents is 12 months unless a product‑specific exception is specified.
OFEV — PA durations vary by ILD indication (SSC‑ILD 6 mo; IPF/PF‑ILD 12 mo)
OFEV authorizations vary by indication: initial SSC‑ILD requests are typically 6 months while IPF and PF‑ILD initial requests are typically 12 months; renewal requests require documentation of clinical benefit and are usually 12 months.
Hypocalcemia/hypoparathyroidism — PA; endocrinology consult and calcitriol trial
Hypocalcemia secondary to hypoparathyroidism requires prior authorization with prescriber being or consulting an endocrinologist, trial of or contraindication to calcitriol, exclusion for CSR‑mutation or acute post‑surgical hypoparathyroidism, and coverage duration of 12 months.
SIGNIFOR — PA; endocrinology prescriber; 6‑month initial
SIGNIFOR for Cushing disease requires prior authorization with prescription by or in consultation with an endocrinologist; initial coverage is 6 months and renewal 12 months with evidence of continued improvement and tolerability.
CINQAIR — PA; eosinophils ≥150 cells/mcL and step trials
CINQAIR for severe eosinophilic asthma requires prior authorization: blood eosinophils ≥150 cells/mcL within past 12 months, prescribed by or in consultation with allergy/pulmonary specialist, concurrent ICS plus another maintenance med, trial of or contraindication to two preferred agents (Fasenra, Nucala, Dupixent), no concurrent disallowed biologics, and renewal requires clinical response.
NURTEC — PA; triptan trial and CGRP concurrent‑use prohibition
NURTEC ODT requires prior authorization: initial 6 months (renewal 12 months), documentation of trial of or contraindication to one triptan for acute migraine, no concurrent use with other CGRP inhibitors for acute or preventive migraine, and renewal requires patient‑reported improvement or consistent effectiveness.
Pirfenidone (IPF) — PA; UIP on HRCT and FVC ≥50%
Pirfenidone for IPF requires prior authorization with HRCT demonstrating a UIP pattern (or surgical lung biopsy plus HRCT), baseline predicted FVC ≥50%, pulmonologist prescribing or consultation, and renewal contingent on meaningful improvement or maintenance in annual rate of decline.
ADEMPAS — PA; RHC confirmation and concurrent‑use exclusions
Adempas (riociguat) for PAH requires prior authorization with diagnosis confirmed by right‑heart catheterization (mean PAP >20 mmHg, PCWP ≤15 mmHg, PVR >2 Wood units), prescriber specialty (cardiology or pulmonology), 12‑month initial/renewal coverage, and strict concurrent‑therapy exclusions (nitrates, nitric oxide donors, PDE inhibitors).
Penicillamine — PA; indication‑specific trials and diagnostics
Penicillamine prior authorization varies by indication: Wilson disease requires a Leipzig score ≥4 with hepatology/gastroenterology prescriber; RA requires trial of or contraindication to 3 months of one DMARD (methotrexate ≥20 mg/week if tried); cystinuria and other indications have specified diagnostic requirements and specialist prescribers.
PEGASYS — PA; specialist prescriber and 48‑week duration for hepatitis
PEGASYS (interferon) for hepatitis B/C requires prior authorization with prescription by or in consultation with a gastroenterologist, infectious disease specialist, or hepatologist; coverage for hepatitis B/C listed as 48 weeks.
PAH/CTEPH agents — PA; RHC confirmation and specialist consult
Initial and renewal authorizations for PAH and CTEPH agents require right‑heart catheterization confirmation with specified hemodynamics, prescriber being or consulting a cardiologist or pulmonologist, coverage typically 12 months, and concurrent‑therapy exclusions as listed.
Biologics (dermatology/rheumatology) — PA with step‑therapy and specialist prescriber
For dermatology/rheumatology biologics, prior authorization requires prior trials of specified therapies or contraindications (step therapy), prescriber specialty consultation, and limits on concurrent systemic biologic or targeted small‑molecule use; initial durations commonly 6 months with renewals at 12 months.
HCV agents — PA; HCV RNA within 6 months and drug‑interaction check
HCV direct‑acting antivirals require prior authorization with documentation of HCV RNA within the prior 6 months and application of AASLD/IDSA‑aligned guidance; screening for listed drug interactions and hepatic impairment exclusions is required.
VOSEVI — PA; HCV RNA within 6 months and interaction exclusions
VOSEVI prior authorization requires HCV RNA documentation within the past 6 months, verification that the patient is not taking listed interacting medications, and adherence to AASLD/IDSA guidance; decompensated cirrhosis may require concurrent ribavirin unless ineligible.
NORDITROPIN FLEXPRO — PA; HCV RNA and endocrinology consult
NORDITROPIN FLEXPRO prior authorization requires indication‑appropriate documentation and includes an HCV RNA requirement within the prior 6 months for certain product‑affected entries; prescriber is or consults an endocrinologist for growth‑hormone indications.
Growth hormone products — PA; endocrinology prescriber and indication documentation
Growth‑hormone products require prior authorization with indication‑specific documentation (e.g., pediatric GHD, ISS, SGA, Turner, Prader‑Willi), specialist (endocrinologist) prescribing or consultation, and renewal evidence of improvement.
Actemra — PA; step trials and rheumatology prescriber requirement
Actemra prior authorization requires specialist prescriber (rheumatologist) for RA/PJIA and relevant specialists for other indications; RA initial approval requires trial of or contraindication to two preferred agents and initial periods are typically 6 months with 12‑month renewals.
ACTEMRA — prescriber specialty and initial durations
ACTEMRA entries require that initial prescriptions for RA/PJIA be by or in consultation with a rheumatologist and that initial coverage durations vary by indication (e.g., 6 months for RA/PJIA/SJIA/GCA).
XELJANZ — PA; specialist prescriber and 6‑month initial
Xeljanz/Xeljanz XR requires prior authorization with initial prescriptions by or in consultation with the appropriate specialist depending on indication (e.g., rheumatologist for RA, gastroenterologist for UC); initial authorization is 6 months with renewal at 12 months.
RINVOQ — PA; specialist prescriber, objective criteria, 6‑month initial
RINVOQ (upadacitinib) prior authorization requires specialist prescribing or consultation appropriate to indication, an initial 6‑month authorization, and indication‑specific objective criteria (e.g., NR‑axSpA requires elevated CRP or sacroiliitis on MRI; AD requires ≥10% BSA or special‑site involvement).
Initial DMARD trial requirement — 3 months (methotrexate ≥20 mg/wk if tried)
Initial authorization for many biologics in RA requires documentation of trial of or contraindication to a 3‑month course of one DMARD (if methotrexate tried, dose ≥20 mg/week or maximally tolerated), and this must be documented in the PA request.
Coverage duration — common initial 6‑month then 12‑month renewal pattern
Initial coverage durations are commonly 6 months for many biologics (examples listed) with renewals typically 12 months; exceptions and product‑specific durations are noted per drug entry.
Payment determination (Part B vs Part D) may be required
Payment determination may be required to establish whether a product is covered under Medicare Part B versus Part D for certain listed drugs (verify Part B vs Part D applicability when submitting PA).
Prior authorization and coverage durations — follow product‑specific limits
Prior authorization is required for the listed specialty products; coverage durations are specified per product (commonly 12 months; some exceptions such as Zurzuvae 14 days) and must not be exceeded without authorization change.
Product Codes, Strengths and Identifiers
| ALUNBRIG ORAL TABLET 180 MG, 30 MG, 90 MG | ALUNBRIG ORAL TABLET 180 MG, 30 MG, 90 MG |
| ALUNBRIG ORAL TABLETS,DOSE PACK | ALUNBRIG ORAL TABLETS,DOSE PACK |
| HAEGARDA SUBCUTANEOUS RECON SOLN 2,000 UNIT, 3,000 UNIT | HAEGARDA SUBCUTANEOUS RECON SOLN 2,000 UNIT, 3,000 UNIT |
| dimethyl fumarate oral capsule,delayed release(dr/ec) 120 mg, 240 mg | dimethyl fumarate oral capsule,delayed release(dr/ec) 120 mg, 240 mg |
| VUMERITY | VUMERITY |
| MODEYSO | MODEYSO |
| JEMPERLI | JEMPERLI |
| ALVAIZ | ALVAIZ (product listing) |
| ELREXFIO (strengths noted in product entry) | ELREXFIO vial/solution strengths referenced in product entry |
| ROZLYTREK CAPSULES / ORAL SUSPENSION / ORAL PELLETS | Rozlytrek capsule and pellet formulations and oral suspension option referenced (capsule-to-suspension trial required before pellets) |
| XTANDI ORAL CAPSULE / ORAL TABLET 40 MG, 80 MG | XTANDI listed as oral capsule/tablet strengths 40 mg, 80 mg |
| HEMOGLOBIN THRESHOLD CATEGORIES | Retacrit hemoglobin-based indication thresholds referenced (e.g., <10 g/dL; surgery <13 g/dL) |
| MONOJECT INSUL SYR U100 | MONOJECT INSUL SYR U100 (example syringe SKUs listed) |
| LITE TOUCH PEN NEEDLE 31G | LITE TOUCH pen needles and multiple syringe SKUs listed |
| NOVOFINE / NANO PEN NEEDLES | NOVOFINE, NANO and other pen needle product SKUs listed |
| ASSORTED INSULIN SYRINGES AND ALCOHOL PREP PADS | Extensive list of insulin syringes, pen needles, alcohol prep pads, and related items |
| UPTRAVI ORAL TABLET 200 MCG, 400 MCG, 600 MCG, 800 MCG, 1000 MCG, 1200 MCG, 1400 MCG, 1600 MCG | UPTRAVI oral tablet strengths listed |
| UPTRAVI INTRAVENOUS | UPTRAVI intravenous formulation listed |
| EPCLUSA ORAL TABLET / ORAL PELLETS | EPCLUSA (sofosbuvir/velpatasvir) oral tablet / oral pellets formulation |
| VOSEVI | VOSEVI (sofosbuvir/velpatasvir/voxilaprevir) |
| No codes listed |
| XELJANZ | XELJANZ (tofacitinib) |
| XELJANZ XR | XELJANZ XR |
| RINVOQ | RINVOQ (upadacitinib) |
| RINVOQ LQ | RINVOQ LQ |
| ACTEMRA | ACTEMRA (tocilizumab) including ACTPEN |
| TYENNE | TYENNE (tocilizumab biosimilar) including autoinjector |
| STELARA | STELARA (ustekinumab) |
| LOQTORZI | LOQTORZI |
| OJEMDA | OJEMDA (oral formulations) |
| MEKINIST | MEKINIST (trametinib) oral |
| OGIVRI | OGIVRI (biosimilar trastuzumab) |
Clinical Thresholds & Quick Values
Initial Therapy / Medical Necessity Requirements
Renewal / Continuation Requirements
Step Therapy & Required Trials
| Requirement | Notes / Evidence |
|---|---|
| Trial of or contraindication to preferred agents (e.g., 3-month trial of one DMARD for RA) prior to approval of biologic/targeted agents | |
| Documentation must be provided (trial details or contraindication) and prescriber specialty requirements apply as indicated |
| Requirement | Notes / Evidence |
|---|---|
| Trial of conventional systemic or topical therapies or phototherapy (e.g., methotrexate, cyclosporine, PUVA/UVB, topical corticosteroids) prior to biologic/targeted agent for psoriasis | |
| For moderate–severe plaque psoriasis: ≥3-month trial of an oral immunosuppressant or PUVA, or documented intolerance/contraindication; no concurrent use with another systemic biologic/targeted small molecule |
| Requirement | Notes / Evidence |
|---|---|
| Trial of two preferred agents (exceptions: one preferred agent required for Crohn's disease) prior to many biologic approvals | |
| Exceptions: step-agent requirement may be waived for pregnancy, breastfeeding, or attempting pregnancy; documentation of trials or contraindications required |
| Requirement | Notes / Evidence |
|---|---|
| Document trial of required prior therapy or provide documentation of contraindication | |
| Example: Acthar initial (except infantile spasms/MS) requires trial of IV corticosteroids or documentation of contraindication |
| Requirement | Notes / Evidence |
|---|---|
| Trial of or contraindication to formulary alternatives is required for some products (e.g., formulary diclofenac products before certain topical solutions) | |
| Examples: eltrombopag oral suspension packets require prior trial of tablet formulation; elagolix requires trial of NSAID and progestin for endometriosis |
| Requirement | Notes / Evidence |
|---|---|
| Trial of or contraindication to specified prior therapies required before biologic initiation for certain indications (e.g., IPF: trial of pirfenidone before OFEV; SSC-ILD: trial of or contraindication to Actemra SQ) | |
| Documentation of trial or contraindication must be included with PA request |
| Requirement | Notes / Evidence |
|---|---|
| Must trial or have contraindication to two preferred agents before coverage for many rheumatologic indications (e.g., RA, PsA) prior to Actemra and similar biologics | |
| If methotrexate was tried, documentation should show dose ≥20 mg/week or maximally tolerated dose when applicable |
| Requirement | Notes / Evidence |
|---|---|
| Trial of or contraindication to one generic octreotide injection required before initial approval of lanreotide (Somatuline) for acromegaly | |
| Prescriber must be or consult with an endocrinologist; initial coverage duration noted (acromegaly initial 3 months) |
| Requirement | Notes / Evidence |
|---|---|
| Actimmune initial therapy must be prescribed by or in consultation with a specialist (e.g., hematologist, infectious disease specialist, immunologist for CGD) | |
| Initial coverage duration 6 months; renewal 12 months with demonstrated clinical benefit |
| Requirement | Notes / Evidence |
|---|---|
| Attempt octreotide (generic) prior to lanreotide initiation for acromegaly unless contraindicated | |
| Documentation of trial or contraindication required; prescriber specialty: endocrinologist |
| Requirement | Notes / Evidence |
|---|---|
| Use VITRAKVI capsule formulation prior to oral solution unless patient is unable to take capsules | |
| VITRAKVI oral solution approval requires trial of capsules or documentation of inability to swallow capsules |
| Requirement | Notes / Evidence |
|---|---|
| Non-response or contraindication to first-line agents (NSAID and progestin-containing preparation) is required before initiation of GnRH agents (e.g., elagolix) for endometriosis | |
| Diagnosis confirmation (surgical/direct visualization or histopathology within 10 years) and OB/GYN prescriber requirements apply |
| Requirement | Notes / Evidence |
|---|---|
| Document trial of or contraindication to preferred agent(s) where specified (e.g., OFEV IPF: trial of pirfenidone; Orfadin suspension: trial of preferred nitisinone tablets/capsules) | |
| Documentation must be included with PA requests; coverage durations and prescriber requirements vary by product |
| Requirement | Notes / Evidence |
|---|---|
| CINQAIR initial requires trial of or contraindication to two preferred agents (FASENRA, NUCALA, DUPIXENT) before approval | |
| For ARCALYST (DIRA indication), trial of preferred agent KINERET is required in some cases |
| Requirement | Notes / Evidence |
|---|---|
| Prior trials of specified formulary agents or classes required before approval (examples: oral ERAs, PDE‑5 inhibitors, phototherapy, DMARDs per indication) | |
| Step therapy specifics depend on indication; documentation of trials or contraindications required |
| Requirement | Notes / Evidence |
|---|---|
| Trial of or contraindication to two preferred agents is required for RA prior to Actemra coverage | |
| Preferred agents include ENBREL, HUMIRA/CYLTEZO/YUFLYMA, XELJANZ, RINVOQ, ORENCIA; documentation required |
| Requirement | Notes / Evidence |
|---|---|
| For certain PAH agents, patient must be on background PAH therapy for at least 3 months with at least two agents from different classes (oral ERA, PDE‑5 inhibitor, or oral sGC stimulator) or have documented contraindication/intolerance | |
| Diagnosis must be confirmed by right heart catheterization with specified hemodynamics; prescriber specialty required |
| Requirement | Notes / Evidence |
|---|---|
| Prior trials or documented contraindications to specified prior therapies are required before approval for many products (examples: DMARDs, NSAIDs, oral immunosuppressants, phototherapy) | |
| Provider must supply documentation of trials, doses (e.g., methotrexate ≥20 mg/week if used), and prescriber specialty where indicated |
| Requirement | Notes / Evidence |
|---|---|
| Trials of specified agents (oral immunosuppressants, DMARDs, NSAIDs) are required for psoriasis, psoriatic arthritis and related indications prior to biologic initiation | |
| Example: psoriasis requires ≥3-month trial of an oral immunosuppressant or PUVA or documented intolerance/contraindication; HF agents may require trial of preferred SGLT2 before Verquvo per product notes |
Quantity Limits & Course Restrictions
Site of Care & Payment Determination
Infusion center — payment determination may be required (Part B vs Part D)
Infusion‑center administered drugs may require payment determination to establish Medicare Part B versus Part D coverage; confirm site‑of‑care billing rules when submitting PA for infusion products.
Mixed Part B/Part D designation — verify per product
Some products have mixed Part B/Part D designation notes — confirm drug‑and‑use specific Part B prerequisite flags and include payment‑determination documentation when required.
Biosimilar References & Requirements
HERCEPTIN HYLECTA — trial of preferred biosimilars required
For HERCEPTIN HYLECTA (trastuzumab reference products), PA may require trial of or contraindication to one of the preferred biosimilars (HERZUMA, OGIVRI, ONTRUZANT, TRAZIMERA) for adjuvant or metastatic breast cancer prior to approval.
Policy Background
This document provides prior authorization requirements and clinical prerequisites for a broad set of specialty pharmacy products used across oncology, rheumatology, dermatology, gastroenterology, pulmonary, and neurologic indications. Coverage is tied to FDA‑approved indications and typically requires documentation of indication‑specific diagnostics or biomarkers (for example, HCV RNA within the prior 6 months for HCV direct‑acting antivirals, right‑heart catheterization hemodynamics for pulmonary arterial hypertension, and complement testing to confirm hereditary angioedema).
Common administrative expectations include specialist prescribing or consultation when specified, evidence of prior trials or contraindications to preferred or conventional therapies (step‑therapy), and demonstration of clinical benefit at renewal. Typical initial authorization periods are 6 months for many biologics and select agents, with renewals commonly set to 12 months, unless a drug‑specific duration is noted (for example, TYMLOS initial coverage is limited to 24 months).
The policy emphasizes concurrent‑therapy exclusions and safety‑related contraindications that affect coverage decisions (examples: no concurrent use of multiple systemic biologics or targeted small molecules for the same indication; for PAH agents, no concurrent nitrates/PDE inhibitors and hemodynamic confirmation by right‑heart catheterization with mean PAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units).
Providers should submit prior authorization requests with the required objective documentation (laboratory results, imaging, specialist consultation notes, and prior‑therapy trial documentation) as specified for each product to avoid delays or denials.
Definitions and Abbreviations
Policy Revision History
Policy becomes effective for Elevate Medicare Choice (HMO D‑SNP) and Elevate Medicare Select (HMO); TYMLOS coverage duration specified as 24 months and prior‑therapy limit noted
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