Prior authorization criteria for TYENNE and selected medications
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Prior authorization criteria for TYENNE (162 mg/0.9 mL syringe and autoinjector) and examples of other medications; covers requirements, prescriber and age restrictions, required documentation, exclusions, and prerequisite therapy for Care Continuum members.
No material clinical or coverage changes in this revision.
Coverage Criteria by Indication and Agent
Indication-specific initial and continuation criteria
Covered when the following indication-specific criteria are met
Pulmonary arterial hypertension (PAH) WHO Group 1
Approve when ALL of the following are met (1, 2, 3 and 4):
Chronic thromboembolic pulmonary hypertension (CTEPH)
Patient meets the following (a, b, c, and d):
Gaucher Disease, Type 1
Approve if the following is met:
Phenylbutyrate products: Initial and continuation criteria
Urea cycle disorders —
Aimovig initial therapy
Aimovig —
Document dose and frequency within FDA-approved dosing; reauthorization requires documentation of positive clinical response.
Alosetron Coverage Criteria
Alosetron (Severe diarrhea-predominant IBS)
Initial approval duration: 6 months.
Continuation approval duration: 1 year.
Alpha-1 Proteinase Inhibitors Coverage Criteria
Alpha-1 proteinase inhibitors (listed brands)
Required medical information: diagnosis.
Age restriction: 18 years and older.
Initial approval criteria for AAT augmentation
Alpha1‑Antitrypsin (AAT) Deficiency with Emphysema (or COPD) — approve if the patient meets BOTH of the following (a and b):
Both conditions (a and b) required; record assay method and result.
Ambrisentan PAH coverage criteria
Pulmonary arterial hypertension (PAH) WHO Group 1: Patient meets the following (1 and 2):
Right heart catheterization report and WHO functional class documentation required.
Anticonvulsant therapy coverage criteria
Covered when ALL of the following are met
Prerequisite therapy required; documentation required.
IV antifungal (voriconazole) coverage criteria
Covered when BOTH of the following are met
Prior authorization required; coverage duration: 3 months if criteria met.
Chemotherapy-induced anemia (initial)
Covered when ALL of the following are met for chemotherapy-induced anemia
Part B vs Part D determined at prior authorization review per CMS guidance.
Chronic renal failure anemia
Covered when ALL of the following are met for chronic renal failure (non-dialysis)
MDS anemia
Covered when ALL of the following are met for Myelodysplastic Syndrome (MDS) anemia
Applies to MDS patients not candidates for active leukemia treatment.
Agent-specific: Arcalyst
Covered indications by agent
PA indicator: All FDA‑Approved Indications.
CAPS (Cryopyrin-Associated Periodic Syndrome) - Initial and Continuation
Covered when ALL of the following are met
Initial approval duration: 6 months; continuation approval: 1 year.
DIRA (Deficiency of the Interleukin-1 Receptor Antagonist) - Initial and Continuation
Covered when ALL of the following are met
Initial approval duration: 6 months.
Continuation approval duration: 1 year.
Pericarditis - Initial and Continuation
Covered when ALL of the following are met
Initial approval duration: 3 months.
Continuation approval duration: 1 year.
MAC Lung Disease - Arikayce Initial and Continuation
Covered when ALL of the following are met
Initial coverage duration: up to 1 year.
Continuation approval: 1 year.
Atypical Antipsychotics — Coverage Criteria
Covered when specific conditions and step therapy/exceptions are met for atypical antipsychotics
Coverage duration: 3 years; prerequisite therapy required as specified per agent.
Requests for Rexulti, quetiapine ER and fluoxetine‑olanzapine may be authorized for MDD or bipolar depression without preferred trials as noted.
IV Antifungals — Coverage Notes
IV antifungals
Coverage duration for IV voriconazole: 3 months when criteria met.
Basal Insulin — Coverage Criteria
Basal insulin
Age restrictions and specific step criteria vary by agent; see individual agent sections.
Basaglar / Basaglar Tempo / Rezvoglar approval
Approve when ANY one of the following is met:
Insulin glargine U300 / Tresiba approval
Approve when ANY one of the following is met:
Benlysta - Lupus Nephritis Initial approval
Approve when ALL of the following are met:
Benlysta - Lupus Nephritis Continuation
Approve when ALL of the following are met:
Benlysta - SLE Initial approval
Approve when ALL of the following are met:
Benlysta - SLE Continuation
Approve when ALL of the following are met:
Pulmonary arterial hypertension (PAH) — WHO Group 1
Covered when ALL of the following are met
Prescriber must be or consult with a cardiologist or pulmonologist.
Chronic thromboembolic pulmonary hypertension (CTEPH)
Covered when ALL of the following are met
CTEPH is listed as an off‑label use for some agents in this extract.
NAGS deficiency and PA/MMA acute treatment
Covered when specific diagnostic proof and laboratory thresholds are met:
Coverage duration: 12 months if genetic test available; 3 months if criteria met without genetic test.
Document concurrent ammonia‑lowering measures.
Mantle Cell / CLL / SLL indications with formulary preference
Covered when ONE of the following is met:
Applies to mantle cell lymphoma, chronic lymphocytic leukemia, and small lymphocytic lymphoma.
Cystic fibrosis indication
Covered when ALL of the following are met for the cystic fibrosis indication:
Coverage duration: 1 year.
Chenodal initial therapy
Chenodal is covered for radiolucent gallstones when ALL of the following initial-therapy conditions are met:
Prerequisite (step) therapy required.
Chenodal continuation therapy
For continuation of Chenodal:
Continuation coverage duration: 1 year.
Tadalafil coverage (BPH)
Covered when ALL of the following are met:
Initial approval duration: 6 months; if symptoms improve, continuation may be approved long term.
Cobenfy coverage
Covered when ALL of the following are met:
Basal insulin — Initial coverage criteria
Basal insulin — Covered when ALL of the following are met:
Coverage duration examples: 3 years for some basal insulin entries; prior authorization required.
Cosentyx — Initial coverage criteria
Cosentyx — Covered when ALL of the following are met for specified invasive fungal indications:
Coverage duration: 1 year; prior authorization and prerequisite therapy required.
Coverage duration: 1 year; prior authorization and prerequisite therapy required.
Concurrent administration of this agent with a Biologic DMARD or a Targeted Synthetic DMARD is an informational exclusion. Requests documenting simultaneous use of another biologic or targeted synthetic immunomodulator should be identified and may be denied; providers must discontinue the concomitant biologic/targeted synthetic therapy prior to approval or provide documentation that concurrent use is clinically necessary and supported by guideline-based rationale.
For ADEMPAS specifically, concurrent use with phosphodiesterase inhibitors used for pulmonary hypertension (for example, sildenafil, tadalafil) or with other soluble guanylate cyclase stimulators is excluded. Prior authorization requests should document that the patient is not receiving these agents concurrently; absence of such documentation or evidence of concurrent use may result in denial.
Coverage excludes concurrent therapy with more than one phenylbutyrate product. Only a single phenylbutyrate formulation may be active on a patient’s regimen at one time; prior authorization will be denied or returned for clarification if two or more phenylbutyrate products are documented as being used concurrently.
Combination use of this agent with a calcitonin gene-related peptide (CGRP) antagonist is excluded when the CGRP antagonist is being used for migraine prophylaxis; requests showing concurrent prophylactic CGRP antagonist therapy will be denied. Separately, where the policy or specific criterion lists a biological‑sex restriction, patients who are biologically male are excluded from coverage; prior authorization requests must document the patient’s sex and eligibility per the stated criterion.
Where specified in the criteria, members who are biologically male are excluded from approval. Providers must document the patient’s biological sex in the prior authorization submission; absence of documentation or submission for a biologically male patient when the criterion excludes that sex will be a basis for denial.
Coding and Clinical Thresholds
| N/A | List of anticonvulsant products named in document |
| BRIVARACETAM 100 MG TABLET | listed anticonvulsant medication |
| BRIVARACETAM 10 MG/ML ORAL SOL | listed anticonvulsant medication |
| BRIVARACETAM 10 MG TABLET | listed anticonvulsant medication |
| BRIVARACETAM 25 MG TABLET | listed anticonvulsant medication |
| BRIVARACETAM 50 MG TABLET | listed anticonvulsant medication |
| BRIVARACETAM 75 MG TABLET | listed anticonvulsant medication |
| DIACOMIT | listed anticonvulsant medication |
| DILANTIN 30 MG CAPSULE | listed anticonvulsant medication |
| ESLICARBAZEPINE ACETATE | listed anticonvulsant medication |
| METHSUXIMIDE | listed anticonvulsant medication |
| VORICONAZOLE 200 MG VIAL | IV antifungal product |
| VORICONAZOLE (HPBCD) | IV antifungal product |
| preferred product list | Carbamazepine, Epitol, Divalproex, ethosuximide, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine (IR or suspension), phenytoin, primidone, Roweepra, tiagabine, topiramate (capsule/sprinkle/tablet), valproic acid, zonisamide capsule |
| ARANESP 100 MCG/0.5 ML SYRINGE | listed formulation |
| ARANESP 100 MCG/ML VIAL | listed formulation |
| ARANESP 10 MCG/0.4 ML SYRINGE | listed formulation |
| ARANESP 150 MCG/0.3 ML SYRINGE | listed formulation |
| ARANESP 200 MCG/0.4 ML SYRINGE | listed formulation |
| ARANESP 200 MCG/ML VIAL | listed formulation |
| ARANESP 25 MCG/0.42 ML SYRING | listed formulation |
| ARANESP 25 MCG/ML VIAL | listed formulation |
| ARANESP 300 MCG/0.6 ML SYRINGE | listed formulation |
| ARANESP 40 MCG/0.4 ML SYRINGE | listed formulation |
| ARCALYST | listed medication |
| ARIKAYCE | Arikayce (amikacin liposome inhalation suspension) |
| BASAGLAR KWIKPEN U-100 | Basal insulin product listed |
| BASAGLAR TEMPO PEN U-100 | Basal insulin product listed |
| INSULIN GLARGINE MAX SOLOSTAR | Basal insulin product listed |
| INSULIN GLARGINE SOLOSTAR U300 | Basal insulin product listed |
| REZVOGLAR KWIKPEN | Basal insulin product listed |
| TRESIBA | Basal insulin product listed |
| TRESIBA FLEXTOUCH U-100 | Basal insulin product listed |
| TRESIBA FLEXTOUCH U-200 | Basal insulin product listed |
| ASENAPINE MALEATE | Atypical antipsychotic listed |
| CAPLYTA | Atypical antipsychotic listed |
| CLOZAPINE ODT | Atypical antipsychotic listed |
| FANAPT | Atypical antipsychotic listed |
| OLANZAPINE-FLUOXETINE HCL | Atypical antipsychotic combination listed |
| OPIPZA | Atypical antipsychotic listed |
| PALIPERIDONE ER | Atypical antipsychotic listed |
| PERSERIS | Atypical antipsychotic listed |
| QUETIAPINE FUMARATE ER | Atypical antipsychotic listed |
| REXULTI (multiple tablet strengths listed) | Atypical antipsychotic listed |
| ANTIFUNGALS (IV) | Class listed (Part B prerequisite: N/A) |
| BENLYSTA 200 MG/ML AUTOINJECT | Benlysta 200 mg/mL autoinject |
| BENLYSTA 200 MG/ML SYRINGE | Benlysta 200 mg/mL syringe |
| BOSENTAN 125 MG TABLET | Bosentan 125 mg tablet |
| BOSENTAN 62.5 MG TABLET | Bosentan 62.5 mg tablet |
| BOSENTAN 125 MG TABLET | Bosentan 125 mg tablet |
| BOSENTAN 62.5 MG TABLET | Bosentan 62.5 mg tablet |
| BRUKINSA | Brukinsa (zanubrutinib) |
| CARGLUMIC ACID | Medication name as listed |
| CAYSTON | Medication name as listed |
| TADALAFIL 2.5 MG TABLET | Tadalafil 2.5 mg tablet |
| TADALAFIL 5 MG TABLET | Tadalafil 5 mg tablet |
| COBENFY | Cobenfy |
| COBENFY STARTER PACK | Cobenfy Starter Pack |
| COSENTYX (2 SYRINGES) | Cosentyx presentation listed in policy |
| COSENTYX SENSOREADY (2 PENS) | Cosentyx presentation listed in policy |
| COSENTYX SENSOREADY PEN | Cosentyx presentation listed in policy |
| COSENTYX SYRINGE | Cosentyx presentation listed in policy |
| COSENTYX UNOREADY PEN | Cosentyx presentation listed in policy |
| CRESEMBA 186 MG CAPSULE | Medication listed under Cosentyx section |
| CRESEMBA 74.5 MG CAPSULE | Medication listed under Cosentyx section |
Prior Authorization, Documentation, Step Therapy, and Denial Risks
PA required for all FDA‑approved indications
Prior authorization is required for all FDA‑approved indications.
Coverage duration: initial 6 months; continuation lifetime
Initial prior authorizations are approved for 6 months; continuation approvals are lifetime, subject to meeting continuation criteria.
PA required for listed medications (examples)
Prior authorization is required for the listed medications (examples include CERDELGA, CEREZYME, ELELYSO, MIGLUSTAT, VPRIV, YARGESA).
PA required for FDA‑approved indications
Prior authorization is required for all FDA‑approved indications for the listed medications; the PA indicator for these agents is 'All FDA‑Approved Indications'.
AIMOVIG AUTOINJECTOR requires prior authorization
AIMOVIG AUTOINJECTOR is listed in the policy and requires prior authorization.
PA and prerequisite therapy for alpha‑1 proteinase inhibitors
Alpha‑1 proteinase inhibitors require prior authorization and the policy notes that prerequisite therapy is required for these agents.
AAT augmentation: baseline AAT and smoking status required
Prior authorization for AAT augmentation requires documentation of diagnosis and a baseline (pretreatment) AAT serum concentration below specified thresholds, and that the patient is a current non‑smoker.
- Baseline AAT <11 µmol/L (or <80 mg/dL by radial immunodiffusion or <57 mg/dL by nephelometry)
- Documented non‑smoker status
Ambrisentan PAH: RHC hemodynamics and WHO FC required
Prior authorization for ambrisentan requires diagnosis of PAH confirmed by pretreatment right heart catheterization with mPAP ≥25 mm Hg, PCWP/PAWP/LVEDP ≤15 mm Hg, PVR >3 Wood units, and documentation of WHO functional class II–IV.
PA applies to listed products for all FDA‑approved indications
Prior authorization applies to the listed products and is indicated for all FDA‑approved indications (PA indicator = 1 for these entries).
Coverage duration examples: anticonvulsants 3 years; IV antifungals 3 months
Examples of approved coverage durations in the policy: anticonvulsant therapy — 3 years; IV antifungals (voriconazole) — 3 months.
PA indicator varies by agent
Prior authorization is required and the PA indicator varies by agent (e.g., values of '4' or '1' are used to denote scope of PA).
PA and prerequisite therapy for IV antifungals/anti‑infectives
IV antifungal and other anti‑infective entries require prior authorization and, where noted, prerequisite therapy is required.
PA and prerequisite therapy for atypical antipsychotics
Atypical antipsychotic requests require prior authorization and prerequisite therapy (preferred trials) unless an exception applies.
Prerequisite/step failure requirement for PA
Prior authorization requires that the member has failed, is intolerant to, has a contraindication to, or would be expected to have an adverse reaction to preferred products before approval when prerequisite therapy is specified.
PA indicator = 1 (all FDA‑approved indications) for some agents
For some agents the PA indicator denotes coverage of all FDA‑approved indications (PA indicator = 1).
Bosentan requires PA and specialty prescriber
Bosentan requires prior authorization and prescriber restriction—must be prescribed by or in consultation with a cardiologist or pulmonologist per policy.
Brukinsa requires PA; coverage limited to 1 year
Brukinsa is subject to prior authorization for its medically‑accepted indications and coverage duration is limited to 1 year per the policy section.
PA indication categories used in policy
The policy uses categorical PA indication indicators (e.g., '4' or '1') to specify the scope of prior authorization for each agent.
PA applies to FDA‑approved indications per indicator
Prior authorization applies to and is used to manage coverage for FDA‑approved indications as indicated by the PA indication indicator values.
Prerequisite therapy must be documented
Several entries require prerequisite therapy; prior treatments must be documented before approval when prerequisite therapy is indicated.
- Document prior medication trials with dates and reasons for failure/intolerance when requested
PA required for listed products (all FDA‑approved indications)
Prior authorization is required for all FDA‑approved indications for the listed products (reiteration of PA scope).
Document prior treatments before approval
When prerequisite therapy is required, providers must document prior treatments (trial dates and reasons for failure/intolerance) before approval.
- Include dates of trials and reason for failure/intolerance when documenting prior therapy
PA required for basal insulin and Cosentyx
Basal insulin and Cosentyx require prior authorization; Cosentyx coverage applies to all FDA‑approved indications (PA indicator = 1).
Prerequisite therapies required for RA and pJIA
RA and pJIA initial approvals require trials and failures of two of: Enbrel, a preferred adalimumab product (Simlandi or Hadlima), Rinvoq, or Xeljanz/XR.
SSc‑ILD diagnostic and prerequisite requirements
SSc‑ILD initial approval requires exclusion of other causes and HRCT or surgical lung biopsy patterns consistent with SSc‑ILD.
Step therapy: trial/failure of preferred PAH agents required
For PAH/CTEPH, step therapy requires trial and failure (or documented contraindication/intolerance) to preferred endothelin receptor antagonists (ambrisentan or bosentan) and preferred PDE‑5 inhibitors (sildenafil or tadalafil), with documentation of dates and reasons.
No prerequisite therapy required where noted
Some entries explicitly list 'N/A' for prerequisite therapy—no prerequisite therapy is required for those agents.
Alosetron step therapy: antidiarrheal and antispasmodic trials required
Alosetron requires prior trials of one antidiarrheal (e.g., loperamide) and one antispasmodic (e.g., dicyclomine) before approval.
Step therapy not specified (N/A) for some agents
For some agents the policy lists 'N/A' for step therapy—no step edits are specified in the extract.
Non‑preferred anticonvulsants: document preferred trials
Non‑preferred anticonvulsant requests require documentation that preferred formulary alternatives were tried and failed (including trial dates and reasons) before approval.
- Provide preferred drug name(s), dates of trial, and reason for failure/intolerance
No prerequisite therapy or Part B prerequisites where listed N/A
Certain entries list no prerequisite therapy or Part B prerequisites (noted as N/A) in the policy.
Arikayce: prior multidrug failure and MIC required
Arikayce requires failure to achieve negative sputum cultures on a prior multidrug regimen and documentation of an amikacin MIC ≤64 µg/mL; Arikayce is to be used with background multidrug therapy.
- Document prior multidrug regimen and sputum culture history
- Provide amikacin MIC ≤ 64 µg/mL
Atypical antipsychotics: preferred trial requirements
Atypical antipsychotics generally require trials of preferred formulary alternatives (one or two failures depending on drug) unless an exception applies.
Basaglar/Rezvoglar step criteria: trial of preferred glargine required
Basaglar and Rezvoglar approvals require failure, intolerance, or contraindication to preferred products (Lantus or insulin glargine‑YFGN) unless exceptions apply.
Insulin glargine U300/Tresiba step criteria
Insulin glargine U300 and Tresiba approvals require failure, intolerance, or contraindication to preferred products (Lantus, insulin glargine‑YFGN or Toujeo) unless exceptions apply.
Basal insulin: prerequisite therapy flagged as required
The basal insulin section header flags prerequisite therapy is required, though specific prior therapy details may be absent in parts of the extract.
Document prior therapies and reasons for failure/intolerance
Providers must document prior treatments and reasons for failure or intolerance when prerequisite therapy is required.
- Include medication names, trial dates, and reasons for discontinuation or failure
Chenodal step therapy: ursodiol trial/failure required
For Chenodal initial therapy the patient must have tried and failed ursodiol or have a contraindication/intolerance to it before approval.
Tadalafil step therapy and AUA‑SI requirement
Tadalafil for BPH requires prior trials and failure or intolerance/contraindication to two drugs from different classes and documentation of an AUA‑SI score ≥8.
- Trials must include alpha‑1 blocker (≥1 month at max tolerated dose) and 5‑alpha reductase inhibitor (≥4 months at max tolerated dose) or combination therapy (≥4 months)
- Document AUA‑SI ≥ 8
Step therapy required for basal insulin and Cosentyx (exceptions apply)
Step therapy rules require prior trials of listed agents for basal insulin and Cosentyx in many scenarios; exceptions allowed for intolerance/contraindication.
Document dosing and objective baseline/continuation measures
For all diagnoses document dose and frequency within FDA‑approved dosing; provide objective baseline and continuation disease activity measures (examples: CDAI, DAS28, PAS, RAPID3, SDAI, sJADAS, ACR pedi).
Policy Background and Scope
This policy governs prior authorization requirements for TYENNE (162 mg/0.9 mL syringe and autoinjector) and provides example criteria for other agents. Prior authorization is required for covered indications, with documentation including diagnosis, objective baseline and follow-up disease activity measures (examples: CDAI, DAS28, sJADAS, ACR pedi), and dose/frequency consistent with FDA labeling. Initial approvals are typically for 6 months and continuation approvals are generally lifetime when continuation criteria are met; some agents have indication-specific durations. Prescriber specialty requirements and age restrictions apply where noted (e.g., metabolic disease specialist for certain metabolic therapies). Providers should include all required diagnostic data and prior therapy documentation at submission to avoid delays or denials.
Clinical Definitions and Measurement Thresholds
Policy Revision History
Prior Authorization Criteria document last updated (header shows 'Prior Authorization Criteria Last Updated 8 /202 6'), indicating a revision in August 2026.
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