Actimmune (interferon gamma-1b) prior authorization
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Prior authorization criteria and coverage details for Actimmune and related specialty products for Simply Healthcare Plans members.
No material clinical or coverage changes in this revision.
Coverage Criteria (Product-specific)
PROLASTIN-C Initial Therapy
PROLASTIN-C covered when documentation meets initial-use criteria
References ATS/ERS 2003; required medical information: method and numeric value
PROLASTIN-C Continuation Therapy
PROLASTIN-C continuation criteria
Required for continued coverage; coverage duration 1 year
ALUNBRIG Initial Therapy
ALUNBRIG coverage criteria for NSCLC
Coverage duration 1 year
AUGTYRO Initial Therapy
AUGTYRO coverage criteria for oncology indications
Coverage duration 1 year
AUSTEDO Initial and Continuation Therapy
AUSTEDO criteria summarized
Continuation requires clinically significant improvement or stabilization on AIMS
Continuation requires improvement or stabilization in chorea score
Apokyn Initial Therapy
Apomorphine (Apokyn) initiation criteria
Erectile dysfunction use excluded; coverage duration 1 year
Arcalyst Initial and Continuation Therapy
Arcalyst criteria highlights
Prerequisite therapy required for some uses; continuation requires maintenance on stable dose with clinical benefit
Continuation requires stable dose and clinical improvement
AUVELITY Initial Therapy
AUVELITY criteria highlights
Prior authorization required; coverage duration 1 year
AUVELITY - Initial
AUVELITY
Prerequisite therapy: No
AVMAPKI FAKZYNJA - Initial
AVMAPKI FAKZYNJA CO-PACK
Coverage duration 1 year
AYVAKIT - Initial
AYVAKIT
Prior authorization required; coverage duration 1 year
BALVERSA - Initial
BALVERSA
Prior authorization required; coverage duration 1 year
Banzel - Initial
Banzel (rufinamide)
Prior authorization required; coverage duration 1 year
Bempedoic acid - Initial/Continuation
Bempedoic acid agents
Prior authorization required; continuation requires LDL-C reduction or positive clinical response; coverage duration 1 year
Benlysta - Initial
Benlysta (belimumab) IV or SC
Initial authorization 6 months; continuation 1 year; detailed renal criteria apply for lupus nephritis
Besremi - Initial
BESREMI
Coverage duration 1 year
Bimzelx - Initial
BIMZELX (guselkumab) subcutaneous
Prior authorization required; coverage duration 1 year
Initial therapy (bimekizumab - psoriasis)
Covered when ALL of the following are met
Applies to psoriasis; other indications have analogous prerequisite therapy requirements
Continuation therapy
Covered for continuation when ALL of the following are met
Carglumic acid criteria
Carglumic acid — Initial and continuation criteria
Required documentation: diagnosis of NAGS deficiency; coverage duration 1 year
Required for continued coverage
Cosentyx criteria
Cosentyx — Initial and continuation criteria by indication
Prior authorization required; coverage duration 1 year
Tadalafil (BPH) criteria
Tadalafil for BPH — prior therapy requirement
Prior authorization required; coverage duration 1 year
Corlanor criteria
Corlanor — adult and pediatric criteria
Coverage duration 1 year
Cresemba criteria
Cresemba — antifungal criteria
Prior authorization required; coverage duration 1 year
Cresemba — Initial/Continuing Therapy
Covered when coverage criteria and prerequisites are met for isavuconazonium (Cresemba):
Prerequisite therapy required in some indications; coverage duration 1 year
Cystagon
Covered when documentation supports medically-accepted indications:
Coverage duration 1 year
Danziten
Covered when documentation supports medically-accepted indications and required testing:
Prior authorization required; coverage duration 1 year
Daraprim (pyrimethamine)
Covered when used for specified infectious indications with required combination therapy:
Prior authorization required; coverage duration 1 year
Darzalex Faspro
Covered when prior exposure to excluded agents is absent:
Prior authorization required; coverage duration 1 year
Daurismo
Covered when medically-accepted indications met with age/comorbidity considerations:
Prior authorization required; coverage duration 1 year
DHE Nasal Agents
Covered when migraine treatment sequencing or contraindications documented:
Prior authorization required; coverage duration 1 year
Diacomit
Covered when used for Dravet Syndrome with combination therapy and prior response details:
Prior authorization required; coverage duration 1 year
Diazepam (High-Risk Medication)
Covered when prescriber documents high-risk medication rationale or alternatives:
Prior authorization required; coverage duration 1 year
Dificid (fidaxomicin)
Covered when used for medically-accepted indications with short duration:
Coverage duration 30 days
Dimethyl fumarate - Initial therapy
Covered when ALL of the following are met
Prior authorization required; coverage duration 1 year
Dupixent - Initial therapy criteria (selected indications)
Covered when indication-specific criteria are met
Dupixent initial 6 months; continuation 1 year
Initial coverage 6 months; continuation 1 year
Duragesic (fentanyl) - Initial and continuation use
Covered when ALL of the following are met
Provide diagnosis; age ≥2 years for fentanyl patch
Initial 3 months; maintenance 6 months; cancer/terminal/palliative 1 year
Documentation required for continuation
Elidel (pimecrolimus) - Use criteria
Covered when ALL of the following are met
Prior authorization required; coverage duration 1 year
Eligard - Use criteria (prostate cancer)
Covered when appropriate for medically-accepted indications
Prior authorization required; coverage duration 1 year
EMSAM - Use criteria
Covered when ALL of the following are met
Prior authorization required; coverage duration 1 year
EMSAM (selegiline transdermal) — Initial Coverage Criteria
Covered when ALL of the following are met:
Age restriction: individual is 18 years of age or older; prior authorization required
ENBREL — Initial and Continuation Criteria
Initial use covered when specified indication-specific severity and prior therapy conditions are met; continuation when improvement or stabilization is documented and member is maintained on a stable dose.
Prior authorization required; continuation requires clinical improvement/stabilization; coverage duration 1 year
Coverage duration 1 year
ENDARI (l-glutamine) — Initial and Continuation Criteria
Covered when ALL of the following are met for initial use:
Member ≥5 years of age; prior authorization required; coverage duration 1 year
ENSACOVE — Coverage Criteria
Covered when ALL of the following are met:
Prior authorization required; coverage duration 1 year
EPCLUSA (sofosbuvir-velpatasvir) — Coverage Criteria
Covered when ALL of the following are met:
Prior authorization required; applied consistent with AASLD/IDSA guidance
EPIDIOLEX — Coverage Criteria
Covered when ALL of the following are met for seizure indications:
Prior authorization required; coverage duration 1 year
EPO Agents (EPOGEN/PROCRIT/RETACRIT) — Initial and Continuation Criteria
Initial use covered when ALL of the following are met:
Indication‑specific requirements apply; prior authorization required
Not for use beyond 6 weeks after chemo completion for myelosuppressive chemo‑induced anemia
ESA perioperative initial criteria
ESA use for elective, non-cardiac, non-vascular surgery is covered when ALL of the following are met
Prior authorization required
Eraxis indications
Eraxis (anidulafungin) covered when ANY of the following indications are present
Prior authorization required; coverage duration 1 year
Esbriet (pirfenidone) criteria
Pirfenidone (Esbriet) initial use covered when ALL of the following are met
Prior authorization required; coverage duration 1 year; continuation requires clinical improvement or stabilization
External insulin pumps
External insulin pump coverage when ALL of the following are met
Age requirements apply (≥2 years for type 1; ≥18 years for type 2); prior authorization required; coverage duration 1 year
Fasenra (benralizumab) criteria
Fasenra coverage per indication-specific criteria
Age ≥18 for EGPA; prior authorization required
Age ≥12 for HES; prior authorization required
Age ≥6 for severe eosinophilic asthma; prior authorization required
Initial Therapy
Covered when ALL of the following are met for each indication:
Initial approval 6 months; continuation 1 year
References Wechsler 2024
Continuation Therapy
Covered for continuation when therapy has demonstrated clinical benefit:
Continuation approval duration: 1 year
FRUZAQLA - Coverage
Covered with prior authorization when criteria are met
Exclusion criteria and prescriber restrictions apply as listed
GALAFOLD - Initial use
Covered when ALL of the following are met
Prior authorization required; coverage duration 1 year
GATTEX - Initial use
Covered when ALL of the following are met
Initial coverage listed as 7 months; continuation 1 year; prior authorization required
GAVRETO - Coverage
Covered when ALL of the following are met
Prior authorization required; coverage duration 1 year
GILENYA (fingolimod) - Coverage
Covered when ALL of the following are met
Prior authorization required; coverage duration 1 year
GILOTRIF - Coverage
Covered when ALL of the following are met
Prior authorization required; coverage duration 1 year
Glatiramer agents - Coverage
Covered when ALL of the following are met
Prior authorization required; coverage duration 1 year
GLEEVEc (imatinib) - Coverage
Covered when ALL of the following are met
Prior authorization required; coverage duration 1 year
Gleostine (lomustine) - Coverage
Covered with prior authorization
Coverage duration 1 year
GLP-1 agents (liraglutide, semaglutide, dulaglutide, etc.) - Coverage for Type 2 Diabetes
Covered when ALL of the following are met
Prior authorization required; exclusion for weight‑loss indications; coverage duration 1 year
GLP agents — Type 2 Diabetes coverage criteria
Covered when ALL of the following are met
Exclusion: use for weight loss is not covered; prior authorization required
Gomekli for NF1
Covered when ALL of the following are met
Prior authorization required; coverage duration 1 year
Hadlima (adalimumab biosimilar) inflammatory indications
Initial and continuation therapy covered when indication-specific prerequisites are met
Age restrictions apply per indication; prior authorization required
Coverage duration 1 year
Hepsera (adefovir) coverage
Covered when ALL of the following are met
Age restriction: ≥12 years; prior authorization required; coverage duration 1 year
Hernexeos oncology coverage
Covered when ALL of the following are met
Prior authorization required; coverage duration 1 year
High Risk Medications (HRM) prior authorization
PA required for listed HRM when ALL of the following are met
Coverage duration typically 1 year
Human Growth Hormone (HGH) coverage criteria
Covered when ALL applicable, indication-specific criteria are met
Prior authorization required; coverage duration 1 year
Coverage duration 1 year
Human Growth Hormone — Initial and Continuation Criteria
Covered when specified diagnostic and clinical criteria are met for pediatric, adolescent transition, and adult GHD
Adalimumab (Humira) — Indication-specific criteria
Covered when indication-specific prior therapy and disease severity criteria are met
Age requirements vary by indication; prior authorization required
Prerequisite therapy required
Continuation requires clinical improvement/stabilization
Coverage duration 1 year
Oncology and other specialty agents — biomarker and prior therapy-based coverage
Covered when specified biomarker/mutation testing and prior therapy criteria are satisfied
Prior authorization required; coverage duration commonly 1 year
imkeldi - Initial Coverage
Covered when ALL of the following are met (imkeldi):
Coverage duration 1 year
INCRELEX - Initial Therapy
Covered when ALL of the following are met (INCRELEX):
Prior authorization required; coverage duration 1 year
Ingrezza - Initial and Continued Use
Covered when ALL of the following are met (Ingrezza for tardive dyskinesia):
For continued use, clinical improvement or AIMS stabilization required; prior authorization required; coverage duration 1 year
Iressa - NSCLC
Covered when ALL of the following are met (Iressa/gefitinib):
Prior authorization required; coverage duration 1 year
Itovebi - Breast Cancer
Covered when ALL of the following are met (Itovebi):
Prior authorization required; coverage duration 1 year
Itovebi criteria
Itovebi (oral tablets 3 mg, 9 mg) covered when specified biomarker and timing criteria documented
Prior authorization required; coverage duration 1 year
Itraconazole criteria
Itraconazole covered for medically-accepted indications with indication-specific duration and prerequisite therapy for some tinea infections
Prior authorization required for specified indications
IVIG criteria
IVIG covered for multiple immunologic, autoimmune, hematologic, infectious, neurologic, and transplant-related indications when indication-specific diagnostic and treatment-failure criteria are met.
Prior authorization required; continuation requires objective clinical improvement; typical coverage 1 year
Continuation requires objective clinical improvement
Prior authorization required; continuation requires demonstrated clinical benefit
Other specialty drug criteria
These products require prior authorization with age or diagnosis-specific documentation; coverage durations commonly set to 1 year.
Specific clinical criteria referenced in product block
Specific clinical criteria referenced in product block
Age ≥18 required; prior authorization required; coverage duration 1 year
This policy explicitly lists an exclusion for the use of tadalafil‑PAH formulations when prescribed for erectile dysfunction. Prior authorization for tadalafil in the PAH indication still requires documentation of WHO Group 1 pulmonary arterial hypertension with right‑heart catheterization showing: mPAP ≥ 25 mm Hg, PCWP/PAWP/LVEDP ≤ 15 mm Hg, and PVR > 3 Wood units, and WHO functional class II–IV symptoms; however, prescribing the PAH formulation to treat erectile dysfunction is not covered. Coverage duration for approved PAH use is typically 1 year.
Apomorphine (Apokyn) is excluded from coverage when used for erectile dysfunction. For covered use in Parkinson disease, initial administration must be started in conjunction with an antiemetic (excluding 5‑HT3 antagonist agents) and prior authorization is required; approved treatment durations are generally set to 1 year. The exclusion for ED indicates apomorphine will not be authorized when the indication provided is erectile dysfunction.
Provider Actions, Prior Authorization & Required Documentation
Actimmune — prior authorization required
Prior authorization is required for ACTIMMUNE. Initial approvals are issued with a coverage duration of 1 year and the product is listed for all medically-accepted indications.
ALECENSA — prior authorization
ALECENSA requests require prior authorization; coverage duration is listed as 1 year and the product is included under the plan's prior authorization program.
PROLASTIN‑C — document low A1AT and emphysema/COPD
PROLASTIN-C prior authorization requires a verified alpha‑1 antitrypsin level ≤ 11 micromol/L (approx. 80 mg/dL by radial immunodiffusion or 57 mg/dL by nephelometry) and documentation of clinically evident emphysema or COPD; continuation requires clinically significant improvement or stabilization.
ALUNBRIG — provide ALK mutation status
ALUNBRIG prior authorization for NSCLC requires documentation of ALK mutation status; coverage duration is 1 year.
Amphetamine salts — prior authorization (1 year)
Amphetamine‑dextroamphetamine products require prior authorization and are assigned a coverage duration of 1 year; age and prescriber restrictions are referenced in the product entry.
Ampyra — improvement in ambulation required for renewal
Dalfampridine (Ampyra) prior authorization requires documentation that the member achieved and sustained improvement in ambulation for renewal; coverage duration is 1 year.
Apokyn — initiate with antiemetic (no 5‑HT3 antagonists)
Apomorphine (Apokyn) prior authorization requires that initial use for Parkinson disease be initiated in conjunction with an antiemetic (excluding 5‑HT3 antagonists); erectile dysfunction use is excluded and coverage duration is 1 year.
Arcalyst — document IL1RN mutation status
Arcalyst prior authorization for DIRA requires documentation of IL1RN mutation status and that disease is in remission from prior anakinra; continuation requires maintenance on a stable dose with clinical improvement or stabilization.
Augtyro — provide ROS1 or NTRK molecular testing
AUGTYRO prior authorization requires molecular testing documentation: ROS1 mutation status for NSCLC and NTRK gene fusion status for solid tumors; coverage duration is 1 year.
Austedo — DSM‑5 confirmation and stable exposure required
AUSTEDO prior authorization requires diagnosis‑specific documentation: for tardive dyskinesia a DSM‑5 confirmation, at least 30 days of stable exposure to offending medications, and presence of involuntary movements; continuation requires clinically significant improvement or stabilization on the appropriate scales.
Auvelity — age ≥18 for MDD; PA required
AUVELITY prior authorization requires that for major depressive disorder the individual be 18 years of age or older; PA criteria apply and coverage duration is 1 year.
AUVELITY — prior authorization and 1‑year duration
AUVELITY prior authorization: initial approval requires meeting the product's PA criteria including the age restriction (MDD ≥18 years); coverage duration is 1 year.
AVMAPKI FAKZYNJA — KRAS and ECOG 0–1 required
AVMAPKI FAKZYNJA co‑pack prior authorization requires documentation of KRAS mutation status and ECOG performance status 0–1 for the ovarian cancer indication; coverage duration is 1 year.
AYVAKIT — platelet threshold and PDGFRA mutation required
AYVAKIT prior authorization requires a platelet count ≥50 x 10^9/L for AdvSM/ISM indications and PDGFRA exon 18 mutation status (including D842V) for GIST indications; coverage duration is 1 year.
Balversa — attestation of FGFR3 mutation required
BALVERSA prior authorization for metastatic urothelial carcinoma requires a written or verbal attestation confirming FGFR3 mutation; coverage duration is 1 year.
Banzel — trial of one preferred agent required
Banzel (rufinamide) prior authorization requires diagnosis documentation, age ≥1 year, and a trial with inadequate response or intolerance to ONE preferred agent (e.g., carbamazepine) prior to approval; coverage duration is 1 year.
Bempedoic acid agents — lipid‑lowering prerequisites
NEXLETOL/NEXLIZET (bempedoic acid) prior authorization requires documentation of high ASCVD risk or HeFH/primary hyperlipidemia and suboptimal LDL‑C response to therapy; continuation requires LDL‑C reduction or positive clinical response and coverage is typically 1 year.
Benlysta — strict SLE diagnostic, lab, and activity documentation
BENLYSTA prior authorization (IV or SC) requires SLE diagnosis per ACR criteria with lab verification (positive ANA ≥1:80 or anti‑dsDNA ≥30 IU/mL), active disease demonstrated by SELENA‑SLEDAI ≥6 while on current therapy, ≥30 days of standard therapy, and use in combination with standard therapy; initial authorization 6 months, continuation 1 year.
Besremi — prior authorization (1 year)
BESREMI requires prior authorization and is assigned a coverage duration of 1 year.
Bimzelx — AAD 2019 criteria and age ≥18
BIMZELX (guselkumab) prior authorization requires confirmation of chronic moderate to severe plaque psoriasis per AAD 2019 (BSA ≥3% or <3% with sensitive/impact areas) and the individual must be ≥18 years old; coverage duration is 1 year.
Bimzelx — PA and 1‑year coverage; age restriction 18+
BIMZELX prior authorization: approvals are for individuals aged 18 years or older with documentation meeting the AAD 2019 psoriasis criteria; coverage duration is 1 year.
Other listed specialty products — PA required (typical 1 year)
Prior authorization is required for the many specialty products listed in this segment; the typical coverage duration is 1 year and product‑specific required information (age, diagnostics, biomarkers, prior therapy) is noted per product.
PA required for listed specialty products — prescriber restrictions may apply
Prior authorization is required for the specialty products listed; coverage duration is commonly 1 year and prescriber or other restrictions may apply per product entry.
Carglumic acid — diagnostic criteria and continuation monitoring
Carglumic acid prior authorization requires documentation of N‑acetylglutamate synthase (NAGS) deficiency for initial use (acute or chronic) or use as adjunctive therapy for PA/MA; continuation requires clinically significant improvement or stabilization in plasma ammonia.
Cosentyx — indication‑specific prior therapy documentation required
Cosentyx prior authorization requires indication‑specific diagnostic documentation and prior‑therapy trials (e.g., phototherapy or systemic therapy for plaque psoriasis); continuation requires clinical improvement or stabilization.
Cresemba — inpatient initiation then outpatient continuation; prerequisite antifungal therapy required
Cresemba (isavuconazonium) prior authorization requires documentation that therapy was initiated inpatient and is being continued outpatient when applicable, and documentation of prior antifungal therapy failure/intolerance or contraindication for specified indications; coverage duration is 1 year.
Cresemba — document prior antifungal therapy or contraindication
Cresemba prior authorization: document prior antifungal therapy or contraindication (e.g., voriconazole, amphotericin B) as required for the indication; PA and 1‑year duration apply.
Cystagon — prior authorization (1 year)
Cystagon requires prior authorization; coverage duration is 1 year.
Danziten — molecular testing (Ph and listed mutations) required
Danziten prior authorization requires documentation of Philadelphia chromosome status and specific mutation testing (e.g., T315I, Y253H, E255K/V, F359V/C/I, G250E); coverage duration is 1 year.
Daraprim — leucovorin combination and indication documentation
Daraprim (pyrimethamine) prior authorization requires use in combination with leucovorin and documentation of the treated indication (e.g., toxoplasmosis); coverage duration is 1 year.
Darzalex FASPRO — exclusion if prior anti‑CD38 therapy received
Darzalex FASPRO prior authorization requires that the member has not received prior treatment with daratumumab or another anti‑CD38 agent (an exclusion); coverage duration is 1 year.
Coding & Code Lists
| BIMZELX SUBCUTANEOUS SOLUTION AUTO-INJECTOR 160 MG/ML, 320 MG/2ML | Product descriptor as listed |
| BIMZELX SUBCUTANEOUS SOLUTION PREFILLED SYRINGE 160 MG/ML, 320 MG/2ML | Product descriptor as listed |
| SOLUTION PREFILLED SYRINGE 160 MG/ML, 320 MG/2ML | Product descriptor as listed |
| bosutinib | ORAL TABLET 100 MG, 400 MG, 500 MG |
| BRAFTOVI ORAL CAPSULE 75 MG | Product descriptor as listed |
| BRUKINSA ORAL CAPSULE / TABLET | Product descriptor as listed |
| sodium phenylbutyrate oral powder 3 gm/tsp | Buphenyl product descriptor |
| sodium phenylbutyrate oral tablet | Buphenyl product descriptor |
| BYSANTI | Product and titration packs |
| CABOMETYX | Product descriptor |
| CALQUENCE ORAL TABLET | Product descriptor |
| CAPRELSA ORAL TABLET 100 MG, 300 MG | Product descriptor |
| CAPRELSA ORAL TABLET 100 MG, 300 MG | Product listed |
| carglumic acid oral tablet soluble | Carglumic acid |
| COSENTYX (300 MG DOSE) | Cosentyx product |
| COSENTYX SENSOREADY (300 MG) | Cosentyx presentation |
| COSENTYX SENSOREADY PEN | Cosentyx pen |
| COSENTYX SUBCUTANEOUS | Cosentyx SC |
| CRESEMBA ORAL | Isavuconazonium oral |
| CRESEMBA ORAL | Cresemba oral |
| CYSTAGON | Cystagon |
| DANZITEN | Danziten |
| pyrimethamine | Daraprim (pyrimethamine) oral |
| DARZALEX FASPRO | Darzalex Faspro |
| DAURISMO ORAL TABLET 100 MG | Daurismo 100 mg |
| DAURISMO ORAL TABLET 25 MG | Daurismo 25 mg |
| dihydroergotamine mesylate nasal | DHE nasal |
| DIACOMIT ORAL CAPSULE 250 MG | Diacomit 250 mg capsule |
| DIACOMIT ORAL CAPSULE 500 MG | Diacomit 500 mg capsule |
| DIACOMIT ORAL PACKET 250 MG | Diacomit 250 mg packet |
| DIACOMIT ORAL PACKET 500 MG | Diacomit 500 mg packet |
| DIAZEPAM INTENSOL | Diazepam Intensol |
| diazepam oral concentrate | Diazepam oral concentrate |
| diazepam oral solution 5 mg/5ml | Diazepam oral solution 5 mg/5ml |
| diazepam oral tablet 10 mg, 2 mg, 5 mg | Diazepam oral tablets 10/2/5 mg |
| DIFICID | Dificid |
| fidaxomicin | fidaxomicin |
| DIFICID | fidaxomicin |
| dimethyl fumarate 120 mg | delayed release oral capsule 120 mg |
| dimethyl fumarate 240 mg | delayed release oral capsule 240 mg |
| DUPIXENT 200 mg/1.14 mL | subcutaneous solution auto-injector / prefilled syringe 200 mg |
| DUPIXENT 300 mg/2 mL | subcutaneous solution auto-injector / prefilled syringe 300 mg |
| fentanyl (Duragesic) | transdermal patch |
| pimecrolimus (Elidel) | topical cream |
| ELIGARD | leuprolide acetate depot |
| EMSAM | selegiline transdermal system |
| FASENRA PEN | Product affected (benralizumab) |
| FASENRA SUBCUTANEOUS SOLUTION PREFILLED SYRINGE 10 MG/0.5ML, 30 MG/ML | Product affected (benralizumab formulations) |
| FRUZAQLA ORAL CAPSULE 1 MG, 5 MG | Product affected listing (no formal billing codes provided) |
| GALAFOLD | Product affected listing (diagnostic criteria required) |
| GATTEX | Product affected listing (SBS indication) |
| GAVRETO | Product affected listing (RET fusion positive tumors) |
| fingolimod hcl | Gilenya product listing |
| GILOTRIF | Product listing (EGFR mutation status required for NSCLC) |
| glatiramer acetate subcutaneous solution prefilled syringe 20 mg/ml, 40 mg/ml | Glatiramer product listings |
| GLATOPA SUBCUTANEOUS SOLUTION PREFILLED SYRINGE 20 | Glatopa product listing |
| imatinib mesylate oral tablet 100 mg, 400 mg | Gleevec product listing |
| lomustine | Gleostine product listing |
| liraglutide; OZEMPIC; RYBELSUS; TRULICITY | GLP-1 agents product listings (multiple formulations and strengths listed) |
| OZEMPIC (0.25 OR 0.5 MG/DOSE) SUBCUTANEOUS SOLUTION PENINJECTOR 2 MG/3ML | listed product |
| OZEMPIC (1 MG/DOSE) SUBCUTANEOUS SOLUTION PENINJECTOR 4 MG/3ML | listed product |
| OZEMPIC (2 MG/DOSE) | listed product |
| OZEMPIC ORAL TABLET 1.5 MG, 4 MG, 9 MG | listed product |
| RYBELSUS ORAL TABLET 14 MG, 3 MG, 7 MG | listed product |
| TRULICITY SUBCUTANEOUS SOLUTION AUTO-INJECTOR | listed product |
| liraglutide | listed product |
| GOMEKLI ORAL CAPSULE 1 MG, 2 MG | listed product |
| GOMEKLI ORAL TABLET SOLUBLE | listed product |
| HADLIMA PUSHTOUCH SUBCUTANEOUS SOLUTION AUTOINJECTOR 40 MG/0.4ML, 40 MG/0.8ML | listed product |
| HADLIMA SUBCUTANEOUS SOLUTION PREFILLED SYRINGE 40 MG/0.4ML, 40 MG/0.8ML | listed product |
| adefovir dipivoxil | listed product |
| HERNEXEOS | listed product |
| No codes listed |
| NORDITROPIN FLEXPRO | human growth hormone product listed |
| OMNITROPE | human growth hormone product listed |
| ≥ 50 x 10^9/L | Platelet count threshold for AYVAKIT as listed |
Definitions & Key Clinical Thresholds
Step Therapy Requirements
| Step therapy requirement | Details |
|---|---|
| Required prior to coverage of listed AED agents | |
| Trial and inadequate response or intolerance to ONE listed preferred antiepileptic agent (e.g., carbamazepine, levetiracetam IR, lamotrigine IR, valproate, topiramate, etc.) or documentation that the preferred agent is not FDA‑approved for the prescribed indication |
| Step therapy requirement | Details |
|---|---|
| Prerequisite therapy required for some Arcalyst indications | |
| For initial DIRA use: documentation of IL1RN mutation status and disease in remission from prior anakinra treatment; prerequisite therapy indicated for specified Arcalyst indications |
| Step therapy requirement | Details |
|---|---|
| Trial of one preferred agent required before authorization | |
| Individual must have had a trial and inadequate response or intolerance to ONE preferred agent (examples listed per product entry) prior to authorization (e.g., rufinamide requires failure of one preferred AED) |
| Step therapy requirement | Details |
|---|---|
| Trial and failure/intolerance of specified conventional therapies required prior to biologic approval unless contraindicated | |
| For biologic agents (examples: psoriasis, AS, nr-axSpA, HS), member must have had inadequate response or intolerance to listed conventional therapies (phototherapy or systemic agents for psoriasis; NSAIDs or nonbiologic DMARDs for AS/nr-axSpA; oral antibiotics for HS) unless there is documented contraindication |
| Step therapy requirement | Details |
|---|---|
| Required prior to tadalafil (5 mg) for BPH | |
| Member must have trialed and had an inadequate response or intolerance to TWO of the following: alfuzosin, doxazosin, silodosin prior to approval of tadalafil 5 mg for BPH |
| Step therapy requirement | Details |
|---|---|
| Required prior to Cosentyx for plaque psoriasis | |
| For plaque psoriasis initial use, member must have inadequate response or intolerance to phototherapy or other systemic therapy (e.g., acitretin, cyclosporine, methotrexate) or documented contraindication to these therapies |
| Step therapy requirement | Details |
|---|---|
| Trial of up to two oral triptans required prior to DHE nasal unless contraindicated | |
| Member must have trialed and had inadequate response or intolerance to up to TWO oral triptan agents (almotriptan, eletriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan) unless oral triptans are unacceptable for documented clinical reasons (unable to take oral meds, rapid onset required, unable to tolerate oral triptans, or vascular risk factors) |
| Step therapy requirement | Details |
|---|---|
| Trial documented prior therapy failure or intolerance before approval | |
| For indication-specific agents (example Dupixent), initial use requires documented failure or intolerance to specified prior therapies (e.g., 3-month trial of combination controller therapy for severe eosinophilic asthma or prior topical/systemic therapies for dermatologic indications) as outlined in product criteria |
| Step therapy requirement | Details |
|---|---|
| Required prior/concurrent trials of conventional therapies or documented contraindication | |
| ENBREL initial use requires failure or intolerance to one or more conventional therapies (e.g., methotrexate titrated to maximally tolerated dose for RA; phototherapy or one systemic agent for plaque psoriasis) or documented contraindication to those therapies |
| Step therapy requirement | Details |
|---|---|
| Documentation of trials for at least two antiepileptic drugs | |
| EPIDIOLEX initial therapy for Lennox-Gastaut or Dravet syndrome requires inadequate response to two prior antiepileptic drugs documented in the medical record prior to authorization |
| Step therapy requirement | Details |
|---|---|
| Prior therapy required before Fasenra for HES | |
| For HES initial use, member must have had a trial and inadequate response to oral corticosteroids and have experienced two or more HES flares in the past 12 months requiring escalation of therapy; eosinophil thresholds and age requirements apply |
| Step therapy requirement | Details |
|---|---|
| Trial of high-dose ICS+LABA prior to benralizumab for asthma | |
| For severe eosinophilic asthma, initial approval requires a 3-month trial with inadequate response or intolerance to high‑dose inhaled corticosteroid plus long‑acting beta2‑agonist (or other listed controller therapies such as leukotriene modifiers, theophylline or oral corticosteroids) and documented exacerbation history; blood eosinophil threshold applies |
| Step therapy requirement | Details |
|---|---|
| Documentation of prior inadequate response or intolerance — recurring step requirement | |
| Many biologic and specialty agents require documented inadequate response or intolerance to specified conventional therapies (examples include MTX for RA, phototherapy/systemic agents for psoriasis, NSAIDs/DMARDs for AS) or documentation of contraindication prior to approval |
| Step therapy requirement | Details |
|---|---|
| Failure or intolerance to specified conventional therapy required before approval | |
| For Humira (adalimumab) indications (RA, PsA, AS, psoriasis, PJIA, UC, uveitis, HS, CD), prerequisite therapy requirements include failure or intolerance to specified conventional therapies (e.g., methotrexate for RA; phototherapy or one systemic therapy for psoriasis; NSAIDs or nonbiologic DMARDs for AS) unless contraindicated |
| Step therapy requirement | Details |
|---|---|
| No prerequisite therapy required for INCRELEX | |
| INCRELEX (mecasermin) initial use: no prerequisite therapy required; eligibility is based on primary IGF‑1 deficiency diagnostic criteria documented in the record |
| Step therapy requirement | Details |
|---|---|
| No prerequisite therapy required for Ingrezza | |
| Ingrezza initial use for tardive dyskinesia does not require prior pharmacologic step therapies; approval requires DSM‑5 confirmation of TD, documented stable offending medication exposure, presence of involuntary movements, and age ≥18 |
| Step therapy requirement | Details |
|---|---|
| Required for certain tinea indications before itraconazole approval | |
| For second‑line non‑onychomycosis tinea infections, itraconazole requires prior trial and inadequate response or intolerance to at least one topical therapy (e.g., ciclopirox, clotrimazole, ketoconazole, econazole, or nystatin) before authorization; onychomycosis duration limits also apply |
| Step therapy requirement | Details |
|---|---|
| Required prior therapies before IVIG initiation for many autoimmune/neurologic indications | |
| Initial IVIG for specified autoimmune and neurologic diagnoses typically requires prior inadequate response, intolerance, or contraindication to specified alternative therapies (number and type vary by indication) before IVIG initiation; continuation requires objective clinical benefit |
Quantity & Duration Limits
Site of Care Notes
Infusion center — not specified
The document does not specify infusion center site‑of‑care details in this excerpt.
Hospital outpatient — inpatient initiation then outpatient continuation for select antifungals
For certain infections treated with inpatient initiation (e.g., isavuconazonium/Cresemba), the policy requires initial inpatient start with documented reason and allows outpatient continuation under PA.
Dupixent — no explicit office/home restriction stated
No explicit site‑of‑care restriction is stated for Dupixent in this excerpt; subcutaneous administration may occur in office or at home per product labeling.
Background
This policy segment provides concise prior authorization (PA) criteria across multiple specialty therapies, emphasizing required diagnostic documentation, biomarker/mutation testing where relevant, and indication‑specific prerequisites. Common elements include: (1) PA required for listed agents with initial approvals commonly issued for 1 year and continuation requiring evidence of clinical benefit; (2) targeted oncology and precision therapies require written or lab verification of tumor biomarkers (examples: ALK, ROS1, NTRK, PDGFRA exon 18, FGFR3, RET) before authorization; (3) biologic and immunomodulatory agents require indication‑appropriate disease severity measures and prior therapy trials or documented contraindications (examples: BSA ≥3% or involvement of sensitive areas for psoriasis; SELENA‑SLEDAI ≥6 for SLE; blood eosinophils ≥150 cells/µL for severe eosinophilic asthma); (4) some metabolic, genetic, and rare disease therapies require enzyme assay or genetic confirmation (examples: alpha‑1 antitrypsin level ≤11 micromol/L for PROLASTIN‑C; alpha‑galactosidase A activity <5% or GLA mutation for GALAFOLD); and (5) several agents specify step‑therapy or prerequisite trials (e.g., trial of up to two oral triptans before DHE nasal agents, trials of conventional systemic or phototherapy prior to certain biologics). The background excerpt summarizes these themes to guide providers on the typical documentation and testing needed to support PA requests across the specialty drug portfolio.
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