Alpha-1 Antitrypsin (AAT) deficiency therapies prior authorization
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Defines prior authorization requirements for AAT augmentation products (ARALAST NP, GLASSIA, PROLASTIN-C, ZEMAIRA) including required clinical information, prescriber restrictions, and coverage duration for Health Alliance Plan members.
No material clinical or coverage changes in this revision.
Coverage Criteria and Product-Specific Prior Authorization
Initial authorization criteria
Covered when ALL of the following are met
Prescriber must be a pulmonologist; coverage duration 1 year
Akeega (selected criteria)
Covered when ALL of the following are met
ALK-positive tyrosine kinase inhibitors (class-level)
Covered when ALL of the following are met
Alunbrig
Covered when ALL of the following are met
Firdapse (amifampridine)
Covered when ALL of the following are met
Analeptic (armodafinil, modafinil)
Covered when ALL of the following are met
Antidepressants (selected)
Covered when ALL of the following are met
Antipsychotics (selected)
Covered when ALL of the following are met
Aprepitant
Covered when ALL of the following are met
When used for PONV provide rationale why preferred agent ondansetron not used
Arcalyst
Covered when ALL of the following are met
ARCALYST
ARCALYST — product-level PA summary
Exclusion Criteria: N/A; Required Medical Information: N/A
ARIKAYCE
ARIKAYCE — product-level PA criteria
Exclusion Criteria: N/A
ATTRUBY
ATTRUBY — product-level PA summary
Exclusion Criteria: N/A
AYVAKIT
AYVAKIT — product-level PA summary
Exclusion Criteria: N/A
Oncology agents
Selected oncology products — product-level PA summaries
Required Medical Information: Diagnosis
Required Medical Information: Diagnosis
BALVERSA (example)
Product-specific PA criteria examples (partial list from this document segment):
Exclusion criteria: N/A; Part B prerequisite: No
BENLYSTA SUBCUTANEOUS
Exclusions include severe active lupus nephritis and active central nervous system involvement; Part B prerequisite: No; Prerequisite Therapy: Yes
BOSULIF
Part B prerequisite: No; Exclusion criteria: N/A
BRAFTOVI
Part B prerequisite: No; Exclusion criteria: N/A
BRIVIACT
Part B prerequisite: No; Exclusion criteria: N/A
BONSITY
Exclusion: not approved in combination therapy with other osteoporosis agents
COBENFY — Initial coverage
COBENFY (and COBENFY STARTER PACK) coverage requires:
Coverage duration 5 years
COMETRIQ — Initial coverage
COMETRIQ coverage requires:
Coverage duration 5 years
COPIKTRA — Initial coverage
COPIKTRA coverage requires:
Coverage duration 5 years
CORLANOR — Initial coverage
CORLANOR coverage (for heart failure in adults) is provided when ALL of the following are met:
Prescribed by a cardiologist; coverage duration 12 months
COSENTYX — Initial coverage and step therapy
COSENTYX coverage requires:
Coverage duration 1 year; must not be used in combination with other biologic drugs or JAK inhibitors
Every two-week dosing requires failure of every four-week dosing
CRESEMBA — Initial coverage
CRESEMBA ORAL coverage requires:
Prior authorization required
CYCLOBENZAPRINE — Initial coverage
CYCLOBENZAPRINE coverage requires:
Coverage duration 1 year
cyclobenzaprine
coverage duration 1 year
Cystadrops
Daurismo
Coverage duration 5 years
Daybue
Demser (metyrosine)
Coverage duration 1 year
Diabetic supplies
Coverage duration 1 year
Diacomit
Fidaxomicin (Dificid)
Coverage duration 1 month
fidaxomicin
fidaxomicin
Exclusion criteria: N/A
DOPTELET
DOPTELET
Prescribed by appropriate specialist
DUPIXENT
DUPIXENT
Must not be used with other biologic drugs; prior therapy trials required per indication
DUVYZAT
DUVYZAT
Patient must be ambulatory upon initiation
Dronabinol
Dronabinol (oral capsule)
Not covered for treatment of pain
Product-specific PA / prerequisite criteria (multiple)
Per-product PA and prerequisite therapy requirements (examples captured below):
Coverage duration: 5 years; specific trials required by syndrome (Lennox‑Gastaut, Dravet).
Coverage duration 1 year
ERIVEDGE
ERIVEDGE (partial)
ERLEADA
ERLEADA (partial)
Erythropoiesis Stimulating Agents
Erythropoiesis Stimulating Agents (ARANESP, EPOGEN) (partial)
EXXUA
EXXUA (partial)
FASENRA
FASENRA (partial)
FILSUVEZ / FINTEPLA
FILSUVEZ / FINTEPLA (partial)
FORTEO
FORTEO (teriparatide) (partial)
FOTIVDA
FOTIVDA (partial)
Product-specific PA criteria (excerpt)
Coverage criteria and restrictions as listed per product
GILOTRIF (example product entry)
Coverage and PA elements for GILOTRIF as presented in the excerpt
Exclusion Criteria: N/A; Part B prerequisite: No; Prerequisite Therapy: No
TRULICITY (example product entry)
Coverage and PA elements for TRULICITY as presented
Indications: all medically-accepted indications
HADLIMA and other biologics (example biologic entry)
General biologic PA elements and prerequisites
Specific requirements vary by product and indication
This section summarizes the general coverage criteria applied across product entries in this segment. Where specified, prior authorization (PA) is required and approval is contingent on submission of documented diagnosis and supporting clinical information appropriate to the requested therapy (for example, phenotype and baseline A1‑PI level for AAT augmentation products). Prescriber restrictions apply when noted (e.g., pulmonologist for AAT augmentation products). Coverage durations are product-specific and commonly set at 1 year for many agents in this excerpt (some oncology and specialist agents list longer durations). Many entries explicitly state Exclusion Criteria: N/A, indicating no additional exclusions are documented in those product-level blocks, while select products list specific exclusions (see product-level entries).
Numerous product entries in this document excerpt explicitly show that off‑label uses or other exclusion lists are not applicable by marking related fields as N/A. Examples include oncology, neurologic, and behavioral health product entries where the 'Off‑Label Uses' or 'Exclusion Criteria' fields are recorded as N/A. Providers should therefore rely on the individual product PA criteria and required documentation fields when evaluating coverage rather than assuming additional off‑label restrictions unless a specific product entry states otherwise.
Multiple product entries within this segment explicitly state Exclusion Criteria: N/A, indicating there are no product‑specific exclusions documented in those blocks. This is visible for several agents (for example, ARCALYST, ARIKAYCE, ATTRUBY, AYVAKIT, BALVERSA) where the PA summary lists required medical information and prescriber or duration attributes but records no exclusions. Where exclusions are present for particular products elsewhere in the policy, those are captured in the individual product entries and should be followed; absence of exclusions here does not alter product‑specific exclusions found in other parts of the policy.
Actions Required by Prescribers / Denial Risks
Prior authorization required for AAT augmentation products
Prior authorization is required for ARALAST NP, GLASSIA, PROLASTIN‑C, and ZEMAIRA; the prescription must be written by a pulmonologist and include documentation of diagnosis of severe congenital A1‑PI deficiency with clinically evident emphysema, patient weight, A1‑PI phenotype, and baseline A1‑PI level. Coverage is authorized for 1 year.
- Prescriber must be a pulmonologist.
- Include diagnosis, weight, A1‑PI phenotype, and baseline A1‑PI level.
Prescriber must be a pulmonologist
The prescriber must be a pulmonologist for AAT augmentation product requests; prescriptions from other specialties risk denial for failure to meet the prescriber restriction.
Firdapse prior authorization and diagnostic confirmation
Firdapse (amifampridine) requires prior authorization and must be prescribed by a neurologist; submit electrodiagnostic testing (repetitive nerve stimulation) and anti‑P/Q‑type VGCC antibody testing to confirm Lambert‑Eaton diagnosis. Coverage is for 1 year.
- Prescriber must be a neurologist.
- Provide electrodiagnostic studies and anti‑P/Q‑type VGCC antibody testing.
ARIKAYCE — submit sputum culture and prior multidrug therapy documentation
For ARIKAYCE prior authorization, submit medical records including sputum culture confirming Mycobacterium avium complex (MAC) lung disease and documentation of failure to obtain negative sputum cultures after ≥6 months of a multidrug background regimen.
- Prescriber must be or consult with an infectious disease specialist or pulmonologist.
- Include sputum culture results and ≥6 months of prior multidrug therapy documentation.
ATTRUBY prescriber restriction and required diagnostic confirmation
ATTRUBY requires prior authorization and the prescription must be written by a cardiologist; include confirmation of diagnosis with appropriate testing. Coverage is for 1 year.
- Prescription must be written by a cardiologist.
- Provide diagnostic confirmation documentation.
Document prior therapy trials when prerequisite therapy is required
Some products in this document require documentation of prior therapy trials (Prerequisite Therapy: Yes); when indicated, prior therapy failure or intolerance must be documented before approval.
- When an entry lists Prerequisite Therapy: Yes, include clinical records showing trials and outcomes of specified prior agents.
Products that indicate no prerequisite therapy
Where the product entry indicates no prerequisite therapy, prior therapy trials are not required for approval but prior authorization criteria and required documentation still apply.
Antidepressant step‑therapy: document two prior antidepressant trials
For listed antidepressants used to treat major depressive disorder, the member must have tried two generic antidepressants from different classes (e.g., SSRIs, SNRIs, TCAs, bupropion) before certain agents will be approved; document the trials and outcomes.
- List the two different generic antidepressants tried and reason for failure/intolerance.
- Include dates and doses of prior trials.
Antipsychotic step‑therapy: document two atypical antipsychotic failures
For listed antipsychotics treating bipolar disorder or schizophrenia, prior authorization requires documentation of treatment failure with two atypical antipsychotics (or rationale why alternatives are unsuitable); include treatment history.
- Document the two atypical antipsychotics tried and reasons for failure.
- Provide diagnosis and treatment timeline.
Document trials of required alternatives per step‑therapy rules
When step therapy is specified, providers must document trial and failure (or contraindication) of the required alternative agents or formulations before requesting the listed product.
- Provide clinical notes showing trials, durations, and outcomes of alternative agents.
- If dosing frequency escalation is requested (e.g., Cosentyx every‑2‑week dosing), document failure of the lower‑frequency regimen.
Oncology products — PA, prescriber restrictions, and diagnostic testing
Prior authorization is required for many oncology agents in this section; prescriptions generally must be written by or in consultation with an oncologist and include diagnosis documentation and any diagnostic testing required (e.g., PDGFRA mutation for GIST, RET fusion testing). Coverage durations are listed per product (commonly 5 years).
- Ensure prescriber specialty matches the product's restriction (oncologist, hematologist, cardiologist, etc.).
- Include disease‑specific diagnostic testing when specified (e.g., PDGFRA D842V, RET fusions).
Examples: BALVERSA and BRAFTOVI — oncologist prescription and diagnosis documentation required
Examples: BALVERSA, BRAFTOVI and similar oncology agents require prior authorization with prescription by an oncologist and are typically authorized for up to 5 years; include documented diagnosis and any specified biomarker testing.
- Confirm prescriber is an oncologist.
- Attach diagnostic reports and biomarker test results.
BENLYSTA Subcutaneous — prescriber restriction and documentation
BENLYSTA Subcutaneous requires prior authorization; prescriber should be a rheumatologist or nephrologist and required documentation includes diagnosis, autoantibody testing, prior therapies and responses. Coverage duration is 3 years.
- Provide autoantibody test results and prior treatment history with outcomes.
- Confirm prescriber specialty (rheumatologist or nephrologist).
BRIVIACT — PA with prerequisite therapy noted
Brivaracetam (BRIVIACT) requires prior authorization with prerequisite therapy noted as 'Yes'; include age‑appropriate information per FDA labeling and documentation of prior therapy trials and response.
- Provide prior anticonvulsant trial history and response.
- Confirm beneficiary age per FDA labeling.
Targeted oncology agents — prescriber and baseline testing requirements
CABOMETYX, CALQUENCE, CAPRELSA and similar targeted agents require prior authorization; ensure the prescriber is or consults with an oncologist and submit required baseline testing where specified (e.g., ECG/electrolytes/TSH for CAPRELSA).
- Attach diagnostic and baseline monitoring tests as listed for each product.
- Confirm oncologist prescriber or consult note.
CINQAIR — prescriber restriction, baseline testing, and administration setting
CINQAIR (reslizumab) requires prior authorization with prescriber restricted to pulmonology or immunology, baseline testing including allergen test and FEV1 measures, and administration must occur in a setting prepared to manage anaphylaxis (self‑administration will not be approved).
- Do not request self‑administration; document plan for supervised administration.
- Provide allergen test, baseline FEV1 and post‑bronchodilator FEV1, asthma history, and baseline eosinophil count.
COBENFY — document diagnosis and treatment history
COBENFY (and COBENFY STARTER PACK) prior authorization requests must include documentation of diagnosis and treatment history; prerequisite therapy is required for some indications and coverage duration is commonly 5 years.
- Include treatment history demonstrating prior trials and outcomes.
- Document beneficiary age per FDA labeling.
Affected Products and Coding
| ARALAST NP | Product affected |
| GLASSIA | Product affected |
| PROLASTIN-C INTRAVENOUS SOLUTION | Product affected |
| ZEMAIRA | Product affected |
| BOSULIF ORAL CAPSULE 100 MG, 50 MG | Product presentation listed |
| BOSULIF ORAL TABLET 100 MG, 400 MG, 500 MG | Product presentation listed |
| brivaracetam oral solution | Product presentation listed |
| brivaracetam oral tablet | Product presentation listed |
| cyclobenzaprine oral tablet 10 mg, 5 mg | listed product |
| CYSTADROPS | listed product |
| DAURISMO ORAL TABLET 100 MG, 25 MG | listed product |
| DAYBUE | listed product |
| metyrosine | listed product (Demser) |
| alcohol pads | diabetic supply |
| GAUZE PADS 2 X 2 | diabetic supply |
| INSULIN PEN NEEDLE | diabetic supply |
| INSULIN SYRINGE (DISP) U-100 0.3 ML 29 GAUGE, 1 ML 29 GAUGE X 1/2", 1/2 ML 28 GAUGE | diabetic supply |
| NEEDLES, INSULIN DISP.,SAFETY | diabetic supply |
| DIACOMIT | listed product |
| fidaxomicin | listed product (Dificid) |
| FRUZAQLA ORAL CAPSULE 1 MG, 5 MG | Product listing as provided |
| FYCOMPA ORAL TABLET 10 MG, 12 MG, 2 MG, 4 MG, 6 MG, 8 MG | Product listing as provided |
| perampanel oral suspension | Product listing as provided |
| perampanel oral tablet 10 mg, 12 mg, 2 mg, 4 mg, 6 mg, 8 mg | Product listing as provided |
| GATTEX 30-VIAL | Product listing as provided |
| GATTEX ONE-VIAL | Product listing as provided |
| CERDELGA | Product listing as provided |
| miglustat | Product listing as provided |
| GABARONE | Product listing |
| GAVRETO | Product listing |
| GILOTRIF | Product listing |
| FOTIVDA | Product listing (mentioned) |
| IBRANCE ORAL CAPSULE 125 MG | Ibrance product listed |
| IBRANCE ORAL TABLET | Ibrance product listed |
| IMBRUVICA ORAL CAPSULE 140 MG | Imbruvica product listed |
| IMBRUVICA ORAL CAPSULE 70 MG | Imbruvica product listed |
| IMBRUVICA ORAL SUSPENSION | Imbruvica product listed |
| IMBRUVICA ORAL TABLET | Imbruvica product listed |
| INBRIJA INHALATION CAPSULE | product listed |
| TOBI PODHALER | product listed |
| INCRELEX | product listed |
| INREBIC | product listed |
| IMPAVIDO | product listed |
Definitions and Background
Alpha-1 proteinase inhibitor (A1-PI) deficiency is a congenital disorder that can result in early-onset emphysema. For members with severe congenital A1-PI deficiency who have clinically evident emphysema, augmentation therapy with plasma‑derived A1-PI products may be authorized when specific clinical documentation is provided. The PA submission must include the diagnosis, patient weight, the A1-PI genotype/phenotype characterization and measured baseline A1-PI level to document severity. Prescriptions for AAT augmentation products must be written by a pulmonologist, and authorized therapy is approved for a maximum duration of 1 year per the policy.
Policy Revision History
Prior authorization criteria for the listed products became effective; prerequisite therapy requirements are variably applied depending on product.
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