Prior Authorization Criteria — A1-PI Augmentation Products and Selected Specialty Agents
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Prior authorization and coverage guidance for A1-PI augmentation products (ARALAST NP, GLASSIA, PROLASTIN-C, ZEMAIRA) including required documentation, prescriber restrictions, and coverage duration for Health Alliance Plan members.
No material clinical or coverage changes in this revision.
Coverage Criteria and Product-Specific Authorization Rules
inv-01: Initial coverage criteria
Covered when ALL of the following are met
Coverage duration limited to 1 year
inv-02: AKEEGA — Initial Authorization
AKEEGA — Approve when ALL of the following are met:
Coverage duration: 5 years
inv-03: ALK TKIs — Initial Authorization
ALK-positive tyrosine kinase inhibitors — Approve when ALL of the following are met:
Coverage duration: 5 years
inv-04: ALUNBRIG — Initial/Continuation Therapy
ALUNBRIG — Approve when ALL of the following are met:
Coverage duration: 5 years; may approve continuation of prior therapy
inv-05: FIRDAPSE — Initial Authorization
FIRDAPSE (amifampridine) — Approve when ALL of the following are met:
Coverage duration: 1 year
inv-06: Aprepitant — Initial Authorization
Aprepitant — Approve when ALL of the following are met:
Coverage duration: 6 months
inv-07: Antidepressants — Initial Authorization
Selected Antidepressants — Approve when ALL of the following are met:
Coverage duration: 5 years
inv-08: Antipsychotics — Initial Authorization
Selected Antipsychotics — Approve when ALL of the following are met:
Coverage duration: 3 years
inv-09: Sample: BALVERSA
Examples of product-specific PA requirements (selection from this section):
Coverage duration: 5 years; exclusion criteria: N/A
inv-10: BENLYSTA SUBCUTANEOUS - Initial Therapy
Covered when ALL of the following are met:
Coverage duration: 3 years; exclusions include severe active lupus nephritis, active CNS lupus, and concomitant use with other biologic drugs
inv-11: BONSITY - Initial Therapy
Covered when ALL of the following are met:
Coverage duration: 2 years; not approved in combination with other osteoporosis agents (PTH/PTHrP analogs)
inv-12: BOSULIF - Initial and Continuation
Covered when the following documented:
inv-13: CORLANOR - Heart failure coverage criteria
Covered when ALL of the following are met for CORLANOR heart failure indication
Coverage duration: 12 months
inv-14: COSENTYX - Indication-specific coverage criteria
Covered when ALL of the following are met for COSENTYX (disease-specific requirements summarized)
Coverage duration: 1 year; must not be used in combination with other biologic drugs or JAK inhibitors
Patients who have already tried a biologic are not required to 'step back'
Every two‑week dosing requires demonstration of failure of every four‑week dosing
inv-15: Cyclobenzaprine — Covered with criteria
Cyclobenzaprine
Coverage duration: 1 year
inv-16: CYSTADROPS — Covered with criteria
CYSTADROPS
Coverage duration not specified in excerpt
inv-17: DAURISMO — Covered with criteria
DAURISMO
Coverage duration: up to 5 years
inv-18: Demser — Covered with criteria
Demser (metyrosine)
Coverage duration: 1 year
inv-19: Diabetic supplies — Covered with criteria
Diabetic supplies
Coverage duration: 1 year; applies to listed supply items
inv-20: Diacomit — Covered with criteria (with noted exclusion)
Diacomit
inv-21: Fidaxomicin — Initial Authorization
Fidaxomicin (DIFICID) coverage when the following are met:
Coverage duration: 1 month
inv-22: DOPTELET — Initial Authorization
DOPTELET coverage when the following are met:
Coverage duration: 1 month for chronic liver disease; 6 months for chronic immune thrombocytopenia; CLD-associated use requires scheduled pre-planned procedure documentation
inv-23: DUVYZAT — Initial Authorization
DUVYZAT coverage when the following are met:
Patient ambulatory at initiation; coverage duration: 1 year
inv-24: Dronabinol — Initial Authorization
Dronabinol coverage when the following are met:
Coverage duration: 1 year; not covered for treatment of pain
inv-25: Dupixent — Indication-specific Criteria
Dupixent coverage when ALL of the following are met:
Coverage duration: 1 year; must not be used in combination with other biologic drugs
inv-26: Enbrel — Indication-specific Criteria
Enbrel coverage when ALL of the following are met:
Must not be used in combination with other biologic drugs or JAK inhibitors; coverage generally 1 year; prerequisite therapy required for many indications
inv-27: General PA and coverage criteria
Covered when ALL of the following are met (as applicable per product):
See product-specific entries for exact agents, tests, and durations
Exceptions may apply for pediatric patients as noted
Requests that violate exclusions should be denied
inv-28: Epidiolex prior therapy requirements
Covered for specific seizure syndromes when evidence of prior trials is provided:
Epidiolex coverage
Epidiolex coverage
Epidiolex coverage
inv-29: Ergotamine derivatives coverage criteria
Covered for migraine when ALL of the following are met:
Coverage duration: 1 year
inv-30: Dihydroergotamine nasal (for migraine)
Covered when ALL of the following are met
Coverage duration: 1 year
inv-31: ERIVEDGE
Covered when ALL of the following are met
Coverage duration: 5 years
inv-32: ERLEADA (enzalutamide) oral tablets
Covered when ALL of the following are met
Coverage duration: 1 year; for certain prostate cancer indications require failure/intolerance/contraindication to abiraterone
inv-33: Erythropoiesis Stimulating Agents (Aranesp, Epogen)
Covered when ALL of the following are met
Exclusions: uncontrolled hypertension; pure red cell aplasia that begins after ESA treatment; coverage duration: 1 year
inv-34: EXXUA (vilazodone ER) for MDD
Covered when ALL of the following are met
Coverage duration: 5 years
inv-35: FASENRA (benralizumab)
Covered when ALL of the following are met
Must not be used in combination with other biologic drugs; coverage duration: 1 year
inv-36: FILSUVEZ and FINTEPLA
Covered when ALL of the following are met
Coverage/other criteria not specified in excerpt
inv-37: FORTEO (teriparatide)
Covered when ALL of the following are met
Coverage duration: 2 years; requires trial and failure on an oral bisphosphonate (or parenteral if GI intolerant) AND trial and failure on denosumab; not to be combined with other PTH/PTHrP analogs
inv-38: Forteo Initial Therapy
Forteo (teriparatide) covered when ALL of the following are met:
Coverage duration: 2 years; failure defined as intolerance, decreased BMD vs prior DEXA, or new fracture
inv-39: Fotivda Criteria
Fotivda (tivozanib) covered when ALL of the following are met:
Prescriber and coverage details per PA
inv-40: Fruzaqla Initial Therapy
Fruzaqla covered when ALL of the following are met:
Coverage duration: 5 years
inv-41: Fycompa Criteria
Fycompa (perampanel) covered when ALL of the following are met:
Coverage duration: 5 years
inv-42: Gabarone Criteria
Gabarone covered when ALL of the following are met:
Indications limited to some FDA‑approved uses
inv-43: GATTEX Criteria
GATTEX covered when ALL of the following are met:
Discontinue therapy if intestinal malignancy occurs; coverage duration: 3 years
inv-44: Gaucher's Disease Treatment Criteria
Gaucher's disease treatments covered when ALL of the following are met:
Not approved for Type II or Type III Gaucher's disease; coverage duration: 3 years
inv-45: Gavreto Criteria
Gavreto covered when ALL of the following are met:
Coverage duration: 5 years
inv-46: GAVRETO
GAVRETO
Coverage duration: 5 years
inv-47: GILOTRIF
GILOTRIF
Coverage duration: 5 years
inv-48: GLEOSTINE
GLEOSTINE
Coverage duration: 5 years
inv-49: TRULICITY
TRULICITY
Coverage duration: 1 year; prerequisite therapy required as specified
inv-50: GOMEKLI
GOMEKLI
Coverage duration: 5 years
inv-51: Growth hormone
Growth hormone (Norditropin Flexpro)
Coverage duration: 3 years; exclusion: presence of contraindications to therapy
inv-52: General PA and prerequisite therapy criteria (excerpt)
Covered when ALL of the following are met (product-specific):
See specific product nodes for exact requirements
Prerequisite therapy applies when specified per product
See product-specific exclusion fields
inv-53: HUMULIN R U-500 authorization
General PA attributes for HUMULIN R U-500
Coverage duration per product entry
inv-54: HYRNUO authorization
General PA attributes for HYRNUO
Coverage duration per product entry
inv-55: Ibrance authorization
Ibrance prior authorization criteria
Coverage duration: 1 year; trial of Kisqali or Verzenio required prior to approval unless specified exceptions (PIK3CA‑mutated cases)
inv-56: Idhifa authorization
Idhifa prior authorization criteria
Coverage duration: 5 years
inv-57: Imbruvica authorization
Imbruvica prior authorization criteria
Coverage duration: 1 year
inv-58: Product-specific PA criteria
Each product is subject to its own PA criteria; common elements include required medical information, prescriber restrictions, coverage duration, indications, and prerequisite therapy.
Coverage duration commonly 5 years where specified
Prescriber specialist required as noted
Coverage duration: 3 years
Coverage duration: 1 year
This portion of the policy does not list any explicit exclusion conditions for the A1‑PI augmentation products (ARALAST NP, GLASSIA, PROLASTIN‑C, ZEMAIRA). The product entries show required documentation — including diagnosis of severe congenital A1‑PI deficiency with clinically evident emphysema, patient weight, A1‑PI phenotype, and baseline A1‑PI level — plus a prescriber restriction that the prescription must be written by a pulmonologist and a coverage duration of 1 year, but no additional exclusion criteria are specified in this excerpt.
The excerpts in this segment commonly show product-level entries where the field for exclusion criteria is recorded as N/A. For example, the AKEEGA entry explicitly lists Exclusion Criteria: N/A while specifying required diagnosis, prescriber specialty, age appropriateness, and a coverage duration of 5 years.
Multiple product entries in this segment either leave the Exclusion Criteria field blank or mark it as N/A. Examples include ARCALYST, ARIKAYCE, ATTRUBY, AUGTYRO, AVMAPKI‑FAKZYNJA, AYVAKIT, and BALVERSA — each lists required documentation, prescriber restrictions, and coverage duration but shows no additional exclusion conditions in the provided excerpts.
Coding for Affected Products
| ARALAST NP | Product affected |
| GLASSIA | Product affected |
| PROLASTIN-C INTRAVENOUS SOLUTION | Product affected |
| ZEMAIRA | Product affected |
| No codes listed |
| ALECENSA | product name listed |
| XALKORI | product name listed (oral capsule/pellet) |
| ZYKADIA | product name listed |
| ALUNBRIG ORAL TABLET 180 MG, 30 MG, 90 MG | product and strengths listed |
| ALUNBRIG ORAL TABLETS,DOSE PACK | product listing |
| FIRDAPSE | amifampridine product listed |
| AKEEGA | product listed |
| aprepitant | product listed |
| armodafinil | product listed |
| modafinil 100 mg, 200 mg | product and strengths listed |
| AUVELITY | product listed |
| FETZIMA | product listed |
| TRINTELLIX | product listed |
| vilazodone | product listed |
| asenapine maleate | product listed |
| CAPLYTA | product listed |
| REXULTI | product listed |
| cyclobenzaprine oral tablet 10 mg | product listing from policy |
| cyclobenzaprine oral tablet 5 mg | product listing from policy |
| CYSTADROPS | product listing from policy |
| DAURISMO ORAL TABLET 100 MG | product listing from policy |
| DAURISMO ORAL TABLET 25 MG | product listing from policy |
| metyrosine | Demser product listing from policy |
| alcohol pads | diabetic supply product |
| GAUZE PADS 2 X 2 | diabetic supply product |
| INSULIN PEN NEEDLE | diabetic supply product |
| INSULIN SYRINGE (DISP) U-100 0.3 ML 29 GAUGE | diabetic supply product |
| INSULIN SYRINGE (DISP) 1 ML 29 GAUGE X 1/2" | diabetic supply product |
| INSULIN SYRINGE (DISP) 1/2 ML 28 GAUGE | diabetic supply product |
| NEEDLES, INSULIN DISP.,SAFETY | diabetic supply product |
| DIACOMIT | product listing from policy |
| HUMULIN R U-500 (CONC) INSULIN | Product affected |
| HUMULIN R U-500 (CONC) KWIKPEN | Product affected |
| HYRNUO | Product affected |
| IBRANCE ORAL CAPSULE 125 MG | Product affected |
| IBRANCE ORAL TABLET | Product affected |
| IBTROZI | Product affected |
| ICLUSIG | Product affected |
| IDHIFA | Product affected |
| IMBRUVICA ORAL CAPSULE 140 MG | Product affected |
| IMBRUVICA ORAL SUSPENSION | Product affected |
| IMBRUVICA ORAL TABLET | Product affected |
| IMKELDI | Product affected |
Prior Authorization Actions, Documentation, and Denial Risks
PA required for A1-PI augmentation products
Prior authorization is required for the listed A1-PI augmentation products; submit required medical information including diagnosis of severe congenital A1-PI deficiency with clinically evident emphysema, patient weight, A1-PI phenotype, and baseline A1-PI level. Prescription must be written by a pulmonologist; coverage duration is 1 year.
- Required medical information: diagnosis, weight, phenotype, baseline A1-PI level
- Prescriber restriction: pulmonologist
- Coverage duration: 1 year
AKEEGA — prior authorization and prescriber requirement
AKEEGA requires prior authorization with documentation of diagnosis (metastatic castration‑resistant prostate cancer with deleterious or suspected deleterious BRCA mutation) and that the prescriber is an oncologist or urologist; beneficiary age must be appropriate per FDA labeling. Coverage duration: 5 years.
- Diagnosis: metastatic castration‑resistant prostate cancer with deleterious or suspected deleterious BRCA mutation
- Prescriber restriction: oncologist or urologist
- Coverage duration: 5 years
ALK TKIs — PA and prescriber restriction
ALK tyrosine kinase inhibitors require prior authorization; submit diagnosis and ensure the prescription is written by an oncologist. Coverage duration is 5 years.
- Products: ALECENSA, XALKORI, ZYKADIA
- Prescriber restriction: oncologist
- Coverage duration: 5 years
ALUNBRIG — ALK confirmation and PA
ALUNBRIG requires prior authorization with documentation that metastatic NSCLC is ALK‑positive as detected by an approved test; prescription must be by or in consultation with an oncologist. Coverage duration: 5 years; continuation of prior therapy may be approved.
- Required: ALK‑positive NSCLC confirmed by an approved test
- Prescriber restriction: oncologist (or consult)
- Coverage duration: 5 years; continuation may be approved
FIRDAPSE — diagnostic confirmation and PA
For FIRDAPSE (amifampridine) prior authorization is required; submit electrodiagnostic studies (including repetitive nerve stimulation) and anti‑P/Q‑type VGCC antibody testing to confirm Lambert‑Eaton diagnosis. Prescription must be written by a neurologist. Coverage duration: 1 year.
- Diagnostic confirmation: electrodiagnostic studies and anti‑P/Q‑type VGCC antibody testing
- Prescriber restriction: neurologist
- Coverage duration: 1 year
Aprepitant — chemotherapy regimen documentation required
Aprepitant requires prior authorization when used with highly or moderately emetogenic chemotherapy; submit the chemotherapy regimen (drug, dose, frequency). For PONV use, provide rationale why preferred agents (e.g., ondansetron) are not appropriate. Coverage duration: 6 months.
- Required documentation: chemotherapy regimen (drug, dose, frequency)
- For PONV: rationale why preferred agents are not appropriate
- Coverage duration: 6 months
Antipsychotics — PA and prior treatment documentation
Selected antipsychotics require prior authorization with documentation of diagnosis and treatment history; for bipolar disorder or schizophrenia, document failure of two atypical antipsychotics or provide rationale. Coverage duration: 3 years.
- Required: diagnosis and treatment history
- Schizophrenia/bipolar: failure of two atypical antipsychotics (or rationale)
- Coverage duration: 3 years
ARIKAYCE — required documentation and PA
ARIKAYCE prior authorization requires medical records supporting the request including sputum culture confirming MAC lung disease; prescriber must be or consult with an infectious disease specialist or pulmonologist. For initial review provide documentation of failure to obtain negative sputum cultures after ≥6 months of multidrug background regimen therapy. Coverage duration: 1 year.
- Required documentation: sputum culture supporting MAC lung disease
- Prior therapy documentation: failure to clear sputum after ≥6 months of multidrug regimen for initial review
- Prescriber restriction: infectious disease specialist or pulmonologist
- Coverage duration: 1 year
ATTRUBY — diagnostic confirmation and PA
ATTRUBY requires prior authorization with confirmation of diagnosis via appropriate testing; prescription must be written by a cardiologist. Coverage duration: 1 year.
- Required documentation: confirmation of diagnosis with appropriate testing
- Prescriber restriction: cardiologist
- Coverage duration: 1 year
AUGTYRO — prior authorization
Prior authorization is required for AUGTYRO (oral capsules); beneficiary age must be appropriate per FDA labeling and other criteria in the product entry must be met.
- Beneficiary age per FDA labeling
- PA required before dispensing
AVMAPKI‑FAKZYNJA — PA and prescriber restriction
AVMAPKI‑FAKZYNJA requires prior authorization; the prescription must be written by an oncologist and coverage duration is 5 years.
- Prescriber restriction: oncologist
- Coverage duration: 5 years
BENLYSTA SC — PA and required documentation
BENLYSTA SUBCUTANEOUS requires prior authorization; submit diagnosis, autoantibody testing, and prior treatments with responses. Prescription must be written by a rheumatologist or nephrologist. Coverage duration: 3 years.
- Required documentation: diagnosis, autoantibody testing, prior treatments and responses
- Prescriber restriction: rheumatologist or nephrologist
- Coverage duration: 3 years
BRIVIACT — PA and prerequisite therapy
BRIVIACT (brivaracetam) requires prior authorization; prerequisite therapy is noted as required and prescriber/age must align with FDA labeling.
- Required: documentation of response to brivaracetam and prerequisite therapy
- Prescriber/age per FDA labeling
BRUKINSA — prior authorization
BRUKINSA oral tablet requires prior authorization; no prerequisite therapy is listed and prescriber/use must follow FDA labeling.
- PA required; Prerequisite Therapy: No
- Prescriber/age per FDA labeling
COBENFY — PA and step therapy requirement
COBENFY requires prior authorization; submit diagnosis and treatment history. For schizophrenia, document failure with two atypical antipsychotics. Coverage duration: 5 years.
- Required documentation: diagnosis and treatment history
- Schizophrenia: failure of two atypical antipsychotics required
- Coverage duration: 5 years
COMETRIQ — PA and prescriber restriction
COMETRIQ requires prior authorization; prescription must be written by an oncologist. Coverage duration: 5 years.
- Prescriber restriction: oncologist
- Coverage duration: 5 years
COPIKTRA — PA and prescriber restriction
COPIKTRA requires prior authorization; prescription must be written by an oncologist or hematologist. Coverage duration: 5 years.
- Prescriber restriction: oncologist or hematologist
- Coverage duration: 5 years
CORLANOR — PA and required clinical documentation
CORLANOR prior authorization requires documentation supporting heart failure in adults: left ventricular ejection fraction ≤35%, heart rate ≥70 bpm in sinus rhythm, and that the patient is on a maximally tolerated beta‑blocker or has a contraindication to beta‑blocker. Prescription should be by a cardiologist; coverage duration: 12 months.
- EF ≤ 35% and HR ≥ 70 bpm in sinus rhythm
- On maximally tolerated beta‑blocker OR contraindication to beta‑blocker
- Prescriber restriction: cardiologist
- Coverage duration: 12 months
COSENTYX — PA, documentation, and combination exclusion
COSENTYX requires prior authorization; prescriber must be a rheumatologist or dermatologist. Submit diagnosis, prior treatments and reasons for failure, and baseline/ongoing TB monitoring. Coverage duration: 1 year; must not be used in combination with other biologic drugs or JAK inhibitors.
- Prescriber restriction: rheumatologist or dermatologist
- Required documentation: diagnosis, prior treatments and failures, TB monitoring
- Coverage duration: 1 year
- Combination therapy exclusion: not used with other biologics or JAK inhibitors
CRESEMBA — prior authorization and prerequisite therapy
CRESEMBA (oral) requires prior authorization; beneficiary age must be appropriate per FDA labeling and prerequisite therapy is noted as required.
- PA required; prerequisite therapy: Yes
- Age per FDA labeling
Cyclobenzaprine — PA, documentation, and age notes
Cyclobenzaprine oral tablets (5 mg, 10 mg) require prior authorization with medical records documenting the diagnosis. Patients under age 65 are approved; patients aged 65 and older must meet additional age‑specific criteria. Coverage duration: 1 year.
- Required documentation: medical records documenting diagnosis
- Patients <65: approved; patients ≥65: additional criteria apply
- Coverage duration: 1 year
CYSTADROPS — prescriber restriction and diagnostic documentation
CYSTADROPS requires prior authorization; prescribing is limited to an ophthalmologist or corneal specialist and documentation of corneal cystine crystals is required before initiation.
- Prescriber restriction: ophthalmologist or corneal specialist
- Required clinical finding: documentation of corneal cystine crystal
GATTEX — PA and required documentation
GATTEX prior authorization requires documentation of diagnosis and prior therapies and responses; for adult patients submit colonoscopy of entire colon with polyp removal before initiation. Prescriber must be a gastroenterologist; discontinue therapy if intestinal malignancy is present. Coverage duration: 3 years.
- Required documentation: diagnosis, prior therapies and responses; adults: colonoscopy with polyp removal documented
- Prescriber restriction: gastroenterologist
- Exclusion: discontinue if intestinal malignancy
- Coverage duration: 3 years
Demser (metyrosine) — PA and surgical candidacy documentation
Demser (metyrosine) prior authorization requires documentation of diagnosis and whether the patient is a candidate for surgery. Coverage duration: 1 year.
- Required documentation: diagnosis and surgical candidacy
- Coverage duration: 1 year
Diabetic supplies — PA and purpose confirmation
Diabetic supplies require prior authorization for a 1‑year duration; prescriber must confirm that the supply is requested for use directly associated with delivering insulin to the patient.
- Prescriber confirmation required: supply is for insulin delivery
- Coverage duration: 1 year
Fidaxomicin — PA and prescriber restriction
Fidaxomicin (DIFICID) requires prior authorization for Clostridium difficile infection and must be prescribed by or in consultation with an infectious disease specialist. Coverage duration: 1 month.
- Required documentation: diagnosis of C. difficile
- Prescriber restriction: infectious disease specialist (or consult)
- Coverage duration: 1 month
DOPTELET — PA, documentation, and prescriber restriction
DOPTELET requires prior authorization with documentation of diagnosis and platelet count; prescribing is limited to an appropriate specialist (e.g., hematologist, oncologist, gastroenterologist). Coverage duration varies by indication (1 month for chronic liver disease; 6 months for chronic immune thrombocytopenia).
- Required medical information: diagnosis and platelet count
- Prescriber restriction: appropriate specialist (hematologist/oncologist/gastroenterologist)
- Coverage duration: indication-specific (1 month CLD; 6 months ITP)
Dronabinol — PA, documentation, and indication limits
Dronabinol requires prior authorization with documentation of diagnosis, previous treatments and outcomes; for cancer‑related weight loss, document failure or intolerance to megestrol. Dronabinol is not covered for treatment of pain. Coverage duration: 1 year.
- Required documentation: diagnosis, prior treatments and outcomes
- Cancer cachexia: failure/intolerance to megestrol required
- Not covered for pain
- Coverage duration: 1 year
Dupixent — PA, documentation, and prescriber restriction
Dupixent requires prior authorization with indication‑specific documentation (e.g., baseline eosinophil count for asthma, mucin/culture for AFRS). Prescribing is limited to specified specialties (allergist, immunologist, pulmonologist, otolaryngologist, dermatologist, gastroenterologist). Coverage duration: 1 year; many indications require prerequisite therapy trials.
- Required: diagnosis and indication‑specific documentation (e.g., eosinophil ≥150 cells/mcL for asthma)
- Prescriber restriction: specified specialties (allergist, immunologist, pulmonologist, otolaryngologist, dermatologist, gastroenterologist)
- Coverage duration: 1 year
- Prerequisite therapy: Yes for many indications
Epidiolex — required prior therapy documentation
Epidiolex prior authorization requires documentation of prior anticonvulsant trials per indication (valproate and lamotrigine for Lennox‑Gastaut; valproate and topiramate for Dravet; two different anticonvulsants from different classes for refractory seizures). Submit diagnosis, prior therapies and outcomes; prescriber must be or consult with a neurologist.
- Lennox‑Gastaut: documentation of valproate and lamotrigine trial/outcomes
- Dravet: documentation of valproate and topiramate trial/outcomes
- Refractory seizures: documentation of two different anticonvulsant trials/outcomes
- Prescriber restriction: neurologist (or consult)
Dihydroergotamine nasal — PA and triptan trial requirement
Dihydroergotamine nasal requires prior authorization; prescriber must be a headache specialist, pain management specialist, or neurologist. For migraine, document trial and failure of two different triptans (one oral tablet and one other formulation) unless contraindicated. Coverage duration: 1 year.
- Required documentation: diagnosis, prior treatments and responses
- Triptan trial: failure of two different triptans (one oral, one other formulation) unless contraindicated
- Prescriber restriction: headache specialist, pain management specialist, or neurologist
- Coverage duration: 1 year
FILSUVEZ — PA and age requirement
FILSUVEZ requires prior authorization; beneficiary must be of appropriate age per FDA labeling and applicable product criteria must be met as listed in the product entry.
- PA required; age per FDA labeling
- Follow product‑specific criteria in PA entry
FINTEPLA — prior authorization
FINTEPLA requires prior authorization; beneficiary must be of appropriate age per FDA labeling and applicable product criteria must be met as listed in the product entry.
- PA required; age per FDA labeling
- Follow product‑specific criteria in PA entry
FORTEO — PA, pretreatment testing and step therapy
FORTEO (teriparatide) prior authorization requires documentation of diagnosis, fracture history, prior therapy and response, and required pretreatment testing (DXA if not in past 2 years; serum calcium, phosphorus, creatinine, alkaline phosphatase, albumin, 25‑OH vitamin D; 24‑hour urine calcium/creatinine or fasting specimen). Prescriber must be an endocrinologist. Prior trials and failure of an oral bisphosphonate (or parenteral if GI intolerant) AND denosumab are required. Coverage duration: 2 years.
- Required pretreatment testing: DXA, serum calcium, phosphorus, creatinine, alkaline phosphatase, albumin, 25‑OH D, 24‑hour urine calcium/creatinine (or fasting specimen)
- Prior therapy: trial/failure of oral bisphosphonate (or parenteral if intolerant) AND trial/failure of denosumab
- Prescriber restriction: endocrinologist
- Coverage duration: 2 years
Fruzaqla — PA and prior therapy documentation
Fruzaqla requires prior authorization with documentation of prior therapies and treatment history consistent with metastatic colorectal cancer previously treated with specified regimens; prescriber must be or consult with a hematologist/oncologist. Coverage duration: 5 years.
- Required documentation: prior chemotherapy regimens and treatment history
- Prescriber restriction: hematologist/oncologist
- Coverage duration: 5 years
GAVRETO — PA and diagnostic confirmation
GAVRETO requires prior authorization; submit diagnosis and verification of RET fusion mutation by an FDA‑approved diagnostic test for NSCLC or thyroid cancer. Prescription must be written by an oncologist or pulmonologist. Coverage duration: 5 years.
- Required documentation: diagnosis and FDA‑approved diagnostic test confirming RET fusion mutation
- Prescriber restriction: oncologist or pulmonologist
- Coverage duration: 5 years
GILOTRIF — PA and prescriber restriction
GILOTRIF requires prior authorization with documented diagnosis; prescription must be written by an oncologist. Coverage duration: 5 years.
- Required documentation: diagnosis
- Prescriber restriction: oncologist
- Coverage duration: 5 years
Ibrance — PA, documentation and step therapy
Ibrance prior authorization requires documentation of diagnosis and previous therapies tried; prescription must be written by an oncologist. A trial of Kisqali or Verzenio is required prior to approval unless the beneficiary has PIK3CA‑mutated HR‑positive, HER2‑negative locally advanced or metastatic breast cancer. Coverage duration: 1 year.
- Required documentation: diagnosis and previous therapies
- Prescriber restriction: oncologist
- Step therapy: trial of Kisqali or Verzenio required unless PIK3CA‑mutated exception
- Coverage duration: 1 year
Idhifa — PA and prescriber restriction
Idhifa requires prior authorization with documentation of diagnosis; prescription must be by or in consultation with a hematologist/oncologist. Coverage duration: 5 years.
- Required documentation: diagnosis
- Prescriber restriction: hematologist/oncologist
- Coverage duration: 5 years
Imbruvica — PA and prescriber restriction
Imbruvica requires prior authorization with documentation of diagnosis; prescription must be written by an oncologist, hematologist, or transplant specialist. Coverage duration: 1 year.
- Required documentation: diagnosis
- Prescriber restriction: oncologist, hematologist, or transplant specialist
- Coverage duration: 1 year
BONSITY — required documentation and exclusion
For BONSITY prior authorization submit diagnosis, fracture history, prior therapy and response, and required pretreatment testing (DXA and labs). Prescriber must be an endocrinologist; BONSITY is not approved for combination therapy with other osteoporosis agents.
- Required: diagnosis, fracture history, prior therapy and response
- Pretreatment testing: DXA (if not in 2 years), serum calcium, phosphorus, creatinine, alkaline phosphatase, albumin, 25‑OH D, 24‑hour urine calcium/creatinine or fasting ratio
- Prescriber restriction: endocrinologist
- Combination therapy exclusion applies
Diacomit — PA and exclusion note
Diacomit requires prior authorization; note that the policy states there is no clinical data to support use of Diacomit alone to treat Dravet syndrome (exclusion noted).
- PA required
- Exclusion note: Diacomit alone for Dravet syndrome lacks supporting clinical data
Background — Condition and Therapy Context
Alpha‑1 antitrypsin (A1‑PI) deficiency is a hereditary condition that can result in early‑onset emphysema. The policy supports augmentation therapy with plasma‑derived A1‑PI products for members who have a documented diagnosis of severe congenital A1‑PI deficiency with clinically evident emphysema. Prior authorization is required and the request must include documentation of the patient’s A1‑PI phenotype and baseline A1‑PI level, current weight, and be prescribed by a pulmonologist. Coverage authorizations are limited to 1 year per the terms shown in the policy excerpt.
Key Definitions and Required Clinical Data
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