CurrentBaylor Scott & White Health PlanPolicy N/A

Prior authorization rules for specialty and pharmacy drugs (partial list)

This document defines prior authorization groups, indications, required information, restrictions, and coverage durations for multiple pharmacy/specialty drugs under Baylor Scott & White Health Plan; it affects providers seeking drug coverage for plan members.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyPrior authorization rules for specialty and pharmacy drugs (partial list)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of FDA-labeled indication or CMS-compendia support and required treatment history or test results.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>50drugs listed (partial)

12 monthstypical approval duration

180 daysinsulin lookback (alcohol swabs)

AAT <11AAT threshold (Prolastin‑C)

FDA contraindicationsexplicit exclusions

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Coverage Criteria by Drug / Group

Aimovig - Initial and Renewal

Aimovig covered when ALL of the following are met

Aimovig Initial Approval: 1. Patient has a diagnosis of migraine; 2. Patient has 4 or more migraine headache days per month; 3. The requested agent is being used for migraine prophylaxis; 4. Patient will NOT be using the requested agent in combination with another calcitonin gene-related peptide (CGRP) agent for migraine prophylaxis.

Approval duration: 12 months

Aimovig Renewal Approval: 1. Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria; 2. Patient has a diagnosis of migraine; 3. The requested agent is being used for migraine prophylaxis; 4. Patient has had clinical benefit with the requested agent; 5. Patient will NOT be using the requested agent in combination with another calcitonin gene-related peptide (CGRP) agent for migraine prophylaxis.

Approval duration: 12 months

Actimmune

Actimmune covered when ALL of the following are met

Actimmune Approval: 1. Patient has an FDA labeled indication or an indication supported in CMS-approved compendia for the requested agent; 2. The requested dose is within FDA labeled dosing or supported in CMS-approved compendia dosing for the requested indication.

Approval duration: 12 months

Acyclovir (topical)

Acyclovir topical covered when ALL of the following are met

Acyclovir Topical Approval: 1. Patient has an FDA labeled indication or an indication supported in CMS-approved compendia for the requested agent.

Approval duration: 12 months

Alcohol Swabs Initial Approval

Covered when BOTH of the following are met

Alcohol Swabs PA criteria: 1) The requested medical supply product will be used in the delivery of insulin to the body; 2) Patient's medication history includes use of insulin within the past 180 days.

Approval duration: 12 months

Alosetron Initial Approval

Covered when ALL of the following are met

Alosetron PA criteria: 1) Patient has a diagnosis of irritable bowel syndrome with severe diarrhea (IBS-D); 2) Patient's sex is female; 3) Patient exhibits at least one qualifying symptom: frequent and severe abdominal pain/discomfort OR frequent bowel urgency or fecal incontinence OR disability/restriction of daily activities due to IBS; 4) Prescriber has ruled out anatomic or biochemical abnormalities of the gastrointestinal tract.

Exclude if FDA-labeled contraindications present; Approval duration: 12 months

Prolastin-C Initial and Renewal Approval

Initial approval requires ALL of the following; renewal requires ALL of the following

Prolastin-C initial approval: 1) Patient has alpha-1 antitrypsin deficiency (AATD) with clinically evident emphysema; 2) Pre-treatment serum AAT level < 11 micromol/L (80 mg/dL by immunodiffusion or 57 mg/dL by nephelometry); 3) Requested dose is within FDA labeled dosing for the requested indication.

Approval duration: 12 months

Prolastin-C renewal approval: 1) Patient has been previously approved through the plan's Prior Authorization criteria; 2) Patient has AATD with clinically evident emphysema; 3) Patient has had clinical benefit with the requested agent; 4) Requested dose is within FDA labeled dosing for the requested indication.

Approval duration: 12 months

Danazol - General required information

Criteria for approval require BOTH of the following:

Danazol approval: 1) Patient has ONE of: (A) an FDA labeled indication for the requested agent OR (B) an indication supported in CMS-approved compendia; AND 2) ONE of: (A) patient will NOT be using the requested agent in combination with another androgen or anabolic steroid OR (B) prescriber has provided information in support of therapy with more than one agent.

From policy Danazol required information.

Testosterone injectables (cypionate, enanthate) - Required criteria

Criteria for approval require ALL of the following (logical structure preserved from document):

Testosterone approval structure: A. Diagnosis-specific requirements based on indication (e.g., AIDS/HIV-associated wasting; metastatic/inoperable breast cancer in females; primary or secondary hypogonadism in males; delayed puberty in adolescent males); AND B. For males, pretreatment or current total or free serum testosterone levels consistent with policy (total serum testosterone below laboratory lower limit of normal or <300 ng/dL, or free serum testosterone below lab lower limit) as applicable; AND C. Patient will NOT be using the requested agent in combination with another androgen or anabolic steroid unless prescriber justifies combination therapy.

Policy lists multiple diagnosis-specific branches and laboratory thresholds.

Antipsychotics: Approval Criteria

Approval criteria require BOTH of the following:

Antipsychotics PA: 1. Patient has an FDA labeled indication or an indication supported in CMS-approved compendia for the requested agent; AND 2. ONE of: (a) evidence of a claim that the patient was treated with the requested agent within the past 180 days; OR (b) prescriber states the patient is currently being treated with the requested agent; OR (c) patient has dementia-related psychosis or dementia-related behavioral symptoms and dementia-specific safeguards are met (diagnosis other than dementia-related psychosis or behavioral symptoms, severe behavior endangering patient/others, and prescriber discussion of increased mortality risk).

PA does not apply to patients <65 years; approval duration: 12 months

Apomorphine: Approval Criteria

Criteria for approval require BOTH of the following:

Apomorphine PA: 1. The requested agent will be used to treat acute, intermittent hypomobility ("off" episodes) associated with advanced Parkinson's disease; AND 2. The agent will be used in combination with other Parkinson's disease therapies (e.g., levodopa, dopamine agonist, MAO-B inhibitor).

Prescriber should be a neurologist or specialist or have consulted one.

Arcalyst: Approval Criteria

Criteria for approval require BOTH of the following (one of multiple diagnosis paths):

Arcalyst diagnosis paths: A. Diagnosis of CAPS including FCAS or MWS (patient >=12 years) OR B. Deficiency of interleukin-1 receptor antagonist with agent used for maintenance of remission OR C. Recurrent pericarditis with agent used to reduce risk of recurrence.

Patient must NOT be using the requested agent in combination with another biologic when prohibited.

Arikayce: Initial and Renewal Criteria

Criteria for initial approval require ALL of the following:

Arikayce initial approval: 1. Patient has a diagnosis of Mycobacterium avium complex (MAC) lung disease; AND 2. Patient has not achieved negative sputum cultures despite at least 6 consecutive months of standard combination antibiotic therapy for MAC lung disease; AND 3. Patient will continue treatment with combination antibiotic therapy that includes the requested agent.

Prescriber should be an appropriate specialist; Approval duration: 12 months

Arikayce renewal approval: 1. Patient has been previously approved through the plan's PA criteria; AND 2. Patient has a diagnosis of MAC lung disease; AND 3. Patient has had clinical benefit with the requested agent; AND 4. Patient will continue combination antibiotic therapy with the requested agent.

Approval duration: 12 months

Eucrisa (crisaborole) — Initial Approval

Covered when ALL of the following are met:

Eucrisa initial approval: 1. Patient has a diagnosis of atopic dermatitis; AND 2. ONE of: (A) patient tried and had inadequate response to a topical corticosteroid or topical corticosteroid combination; OR (B) patient has intolerance or hypersensitivity to a topical corticosteroid or topical corticosteroid combination; OR (C) patient has an FDA labeled contraindication to a topical corticosteroid or topical corticosteroid combination.

Approval duration: 12 months

Topical Tacrolimus — Initial Approval

Covered when ONE of the following is met:

Tacrolimus initial approval: 1. Patient has a diagnosis of atopic dermatitis AND ONE of: (A) tried and had inadequate response to a topical corticosteroid or topical corticosteroid combination; OR (B) intolerance or hypersensitivity to a topical corticosteroid or topical corticosteroid combination; OR (C) FDA labeled contraindication to a topical corticosteroid or topical corticosteroid combination; OR 2. Patient has an indication supported in CMS-approved compendia for tacrolimus.

Approval duration: 12 months

Atovaquone — Initial Approval

Covered when BOTH of the following are met:

Atovaquone initial approval: A. ONE of: (i) patient has a diagnosis of mild-to-moderate Pneumocystis jirovecii pneumonia (PJP); OR (ii) patient is using the agent for prevention of PJP; AND B. ONE of: (1) patient has intolerance or hypersensitivity to trimethoprim/sulfamethoxazole (TMP/SMX); OR (2) patient has an FDA labeled contraindication to TMP/SMX; OR C. patient has an indication supported in CMS-approved compendia for the requested agent.

Approval duration: 12 months

Attruby (for ATTR-CM) — Initial and Renewal Criteria

Initial approval requires ALL of the following; renewal requires ALL of the following:

Attruby initial approval: Initial: 1. Patient has a diagnosis of cardiomyopathy of wild type or variant transthyretin-mediated amyloidosis (ATTR-CM); AND 2. Diagnosis has been confirmed by testing (e.g., PYP scan, monoclonal antibody studies, biopsy, scintigraphy, genetic testing/TTR genotyping); AND 3. Patient has clinical manifestations of cardiomyopathy (e.g., dyspnea, fatigue, orthostatic hypotension, syncope, peripheral edema); AND 4. Hospitalization is indicated per text; AND 5. Patient will NOT use the requested agent in combination with Amvuttra or a tafamidis agent for the requested indication.

Approval duration: 12 months; prescriber should be a specialist or consult a specialist

Attruby renewal approval: Renewal: 1. Patient has been previously approved through the plan's PA criteria; AND 2. Patient has a diagnosis of ATTR-CM; AND 3. The requested agent will be used to reduce cardiovascular death and cardiovascular-related hospitalization; AND 4. Patient has NYHA Functional Class I, II, or III heart failure; AND 5. Patient has had clinical benefit with the requested agent; AND 6. Patient will NOT use the requested agent in combination with Amvuttra or a tafamidis agent for the requested indication.

Approval duration: 12 months; prescriber specialty/consult required

Austedo (deutetrabenazine) medical necessity

Covered when ALL of the following are met

Austedo approval: 1. ONE of: A) Patient has a diagnosis of chorea associated with Huntington's disease AND BOTH: (i) either patient does not have current diagnosis of depression OR patient has depression and is treated for it; and (ii) either patient does not have passive suicidal ideation/behavior OR if present patient is not actively suicidal; OR B) Patient has a diagnosis of tardive dyskinesia AND ONE of: prescriber has reduced dose or discontinued causative medications OR prescriber provides clinical rationale why reduction/discontinuation is not appropriate. 2. Patient will NOT be using the requested agent in combination with a monoamine oxidase inhibitor (MAOI). 3. Patient will NOT be using the requested agent in combination with reserpine.

Prescriber specialty requirement applies; Approval duration: 12 months

Tadalafil (2.5 mg, 5 mg) medical necessity

Covered when ALL of the following are met

Tadalafil for BPH: 1. Patient has a diagnosis of benign prostatic hyperplasia (BPH); AND 2. Patient has tried and had an insufficient response, intolerance/hypersensitivity, or FDA labeled contraindication to TWO alpha blocker agents (e.g., terazosin, doxazosin, tamsulosin).

Not covered if used to treat erectile dysfunction only; exclude FDA labeled contraindications.

Belsomra and Benlysta SC medical necessity

Covered when criteria per prior auth group are met

Belsomra: Patient has an FDA labeled indication for the requested agent.

Approval duration: 12 months

Benlysta SC: Criteria per Benlysta SC PA group apply; CMS review pending for required medical information.

Approval duration: 12 months where applicable

Clobazam medical necessity

Covered when medically-accepted indications are met

Clobazam: Patient has a medically-accepted indication (FDA labeled or supported in CMS compendia) for the requested agent; follow Benzodiazepines PA group required medical information and exclusions.

Part of Benzodiazepines PA group

General agent-specific PA criteria

Approval is granted when the following grouped criteria are met for each agent (examples below reflect the document's nested logic):

Top-level: A. BOTH of the following: (1) ONE of: evidence of a claim that the patient is currently being treated with the requested agent within the past 180 days OR prescriber states the patient is currently being treated with the requested agent; AND (2) ONE of: patient has an FDA labeled indication OR an indication supported in CMS-approved compendia for the requested agent; AND (3) patient diagnosis meets agent-specific requirements (e.g., seizure disorder, anxiety disorder with required SSRI/SNRI trial/intolerance/contraindication, skeletal muscle spasms, alcohol withdrawal) AND patient does NOT have any FDA-labeled contraindications to the requested agent.

PA does not apply to patients <65 years where specified

Agent prior authorization criteria (lorazepam, oxazepam, Sympazan)

Covered when ALL of the following are met (agent-specific shared structure):

Overall PA requirements: 1. PA does not apply to patients less than 65 years of age (where specified); for patients subject to PA, there must be evidence of current treatment or prescriber attestation (claim within past 180 days) AND patient has an FDA labeled indication or an indication supported in CMS compendia; AND diagnosis-specific requirements apply (for anxiety: trial and inadequate response to a formulary SSRI or SNRI OR intolerance/hypersensitivity OR FDA labeled contraindication to SSRI/SNRI).180 days

Applies to lorazepam, oxazepam, Sympazan and related benzodiazepine group

Bexarotene gel — Initial Approval

Criteria for initial approval require BOTH of the following:

Bexarotene initial: 1) Patient has an FDA labeled indication or an indication supported in CMS compendia for the requested agent; AND 2) ONE of: (A) evidence of a claim that the patient is currently being treated with the requested agent within the past 180 days; OR (B) prescriber states the patient is currently being treated with the requested agent; OR (C) ALL of: (i) patient has stage IA or IB cutaneous T-cell lymphoma with cutaneous lesions AND refractory/persistent disease despite prior skin-directed therapy OR intolerance/hypersensitivity to prior skin-directed therapy OR FDA labeled contraindication to prior skin-directed therapy; AND prescriber is a specialist or consulted a specialist; AND patient does NOT have any FDA labeled contraindications to the requested agent.

Initial approval logical structure preserved

Bexarotene gel — Renewal

Criteria for renewal approval require ALL of the following:

Bexarotene renewal: 1) Patient has been previously approved through the plan's PA criteria; AND 2) Patient has an FDA labeled indication or an indication supported in CMS compendia for the requested agent; AND 3) ONE of: (A) evidence of a claim that the patient is currently being treated with the requested agent within the past 180 days; OR (B) prescriber states the patient is currently being treated with the requested agent; OR (C) ALL of: (i) patient has had clinical benefit with the requested agent; AND (ii) prescriber is a specialist or has consulted a specialist; AND (iii) patient does NOT have any FDA labeled contraindications to the requested agent.

Renewal requires demonstration of benefit or continued treatment plus specialist involvement

Actemra — Initial Approval

Criteria for initial approval require ALL of the following:

Actemra initial: 1) Patient has an FDA labeled indication for the requested agent; AND 2) ONE of: (A) evidence of a claim that the patient is currently being treated with the requested agent within the past 90 days; OR (B) prescriber states the patient is currently being treated with the requested agent and provides clinical justification that the patient is at risk if therapy is changed; OR (C) patient's diagnosis is indicated for preferred biologic immunomodulator agent(s) AND ONE of: medication history shows use of preferred biologic(s) OR intolerance/hypersensitivity to preferred biologic(s) OR FDA labeled contraindication to preferred biologic(s); OR the request is for an FDA labeled indication not covered by preferred biologic(s); AND 3) Patient will NOT be using the requested agent in combination with another biologic immunomodulator.

Includes prohibition on combination biologics; approval duration: 12 months

Actemra — Renewal

Criteria for renewal approval require ALL of the following:

Actemra renewal: 1) Patient has been previously approved through the plan's PA criteria; AND 2) Patient has an FDA labeled indication for the requested agent; AND 3) Patient has had clinical improvement (slowing of disease progression or decrease in symptom severity/frequency); AND 4) Patient will NOT be using the requested agent in combination with another biologic immunomodulator.

Renewal requires documented clinical improvement and no combination biologics

Cosentyx — Initial and Renewal

Initial criteria require ALL of the following:

Cosentyx initial: 1) Patient has an FDA labeled indication for the requested agent; AND 2) ONE of: (A) evidence of a claim that the patient is currently being treated with the requested agent within the past 90 days; OR (B) prescriber states the patient is currently being treated and provides clinical justification; OR (C) patient's medication history indicates use of another biologic for the same FDA labeled indication; OR (D) patient's diagnosis does not require a conventional prerequisite agent; OR (E) patient's medication history indicates use of ONE formulary conventional prerequisite agent; OR (F) intolerance to at least one formulary conventional prerequisite; OR (G) FDA labeled contraindication to at least one formulary conventional prerequisite; AND 3) Patient will NOT be using the requested agent in combination with another biologic immunomodulator.

Formulary conventional agents listed for plaque psoriasis; approval duration: 12 months

Cosentyx renewal: 1) Patient has been previously approved through the plan's PA criteria; AND 2) Patient has an FDA labeled indication for the requested agent; AND 3) Patient has had clinical improvement; AND 4) Patient will NOT be using the requested agent in combination with another biologic immunomodulator.

Renewal mirrors other biologics with requirement for improvement

Agent-specific prerequisite use guidance

Preferred/prerequisite requirements: Use of TWO preferred agents (Hadlima, Rinvoq tablets/solution, or Simlandi) is required for polyarticular juvenile idiopathic arthritis/rheumatoid arthritis; use of ONE preferred agent (Rinvoq tablets) is required for giant cell arteritis; NO preferred agent required for certain diagnoses (SSc-ILD, cytokine release syndrome, systemic juvenile idiopathic arthritis). For Cosentyx, one conventional prerequisite agent is required for plaque psoriasis; no prerequisites for several other listed indications.

Specifies where step therapy applies and where it does not

Enbrel — Initial and Renewal (partial)

Documented criteria (partial) follow the standard biologic pattern:

Enbrel initial (partial): Agent lists FDA-approved indications; exclusion includes FDA labeled contraindications. Detailed initial/renewal criteria not included in this excerpt but follow the biologic immunomodulator pattern.

Partial section

Initial and Renewal Criteria (general)

Covered when ALL of the following are met

Initial approval general: 1. Patient has an FDA labeled indication for the requested agent; AND 2. ONE of: evidence of a claim showing the patient was treated with the requested agent within the past 90 days; OR prescriber attests patient is currently treated and provides clinical justification if therapy is changed; OR patient's medication history indicates prior use of preferred biologic(s) or intolerance/contraindication to preferred agents or the request is for an FDA indication not covered by preferred agents; AND 3. Patient will NOT be using the requested agent in combination with another biologic immunomodulator.

Applies across multiple biologic immunomodulator PA groups

Renewal approval general: 1. Patient has been previously approved through the plan's PA criteria; AND 2. Patient has an FDA labeled indication; AND 3. Patient has had clinical improvement (slowing of progression or decrease in symptom severity/frequency); AND 4. Patient will NOT be using the requested agent in combination with another biologic immunomodulator.

Standard renewal pattern

Initial and Renewal Criteria (general)

Covered when ALL of the following are met

Initial approval criteria: 1) Patient has an FDA labeled indication for the requested agent; AND 2) ONE of: evidence of a claim showing the patient was treated with the requested agent within the past 90 days; OR prescriber attests current treatment and provides clinical justification if therapy is changed; OR patient's medication history indicates use of another biologic for the same indication; OR patient's diagnosis does not require a conventional prerequisite; OR patient's medication history indicates use of ONE formulary conventional prerequisite agent; OR intolerance/hypersensitivity or FDA labeled contraindication to at least one conventional prerequisite agent; AND 3) Patient will NOT be using the requested agent in combination with another biologic immunomodulator.

Exact ordering varies by drug section

Initial and Renewal Criteria (general)

Covered when ALL of the following are met

Renewal approval criteria: 1) Patient has been previously approved through the plan's PA criteria; AND 2) Patient has an FDA labeled indication for the requested agent; AND 3) Patient has had clinical improvement (slowing of disease progression or decrease in symptom severity/frequency); AND 4) Patient will NOT be using the requested agent in combination with another biologic immunomodulator.

Standard across listed biologic agents

Biologic immunomodulator PA criteria

Biologic immunomodulator (continuation/initial) — Covered when ALL of the following are met

Biologic immunomodulator initial: 1) Patient has an FDA labeled indication for the requested agent; AND 2) ONE of: evidence of a claim showing current treatment within the past 90 days; OR prescriber states patient is currently treated and provides clinical justification if therapy is changed; OR patient's diagnosis is indicated for preferred biologic(s) and ONE of: prior use of preferred biologic(s), intolerance/hypersensitivity to preferred biologic(s), or FDA labeled contraindication to preferred biologic(s); OR the request is for an FDA labeled indication not covered by preferred agents; AND 3) Patient will NOT be using the requested agent in combination with another biologic immunomodulator.

Follow preferred-agent step rules

Biologic immunomodulator renewal: 1) Patient has been previously approved through the plan's PA criteria; AND 2) Patient has an FDA labeled indication; AND 3) Patient has had clinical improvement; AND 4) Patient will NOT be using the requested agent in combination with another biologic immunomodulator.

Continuation criteria mirror initial pattern

Carglumic acid criteria

Carglumic acid — Covered when BOTH of the following are met

Carglumic approval: 1) Acute hyperammonemia due to deficiency of hepatic enzyme N-acetylglutamate synthase (NAGS), OR chronic hyperammonemia due to NAGS deficiency, OR acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA); AND 2) Requested dose is within FDA labeled dosing for the requested indication.

Cayston criteria

Cayston (aztreonam for inhalation) — Covered when ALL of the following are met

Cayston approval: 1) Patient has a diagnosis of cystic fibrosis; AND 2) Documentation of Pseudomonas aeruginosa respiratory infection; AND 3) ONE of: (a) patient is not currently (within past 60 days) being treated with another inhaled antibiotic; OR (b) patient is currently being treated with another inhaled antibiotic within past 60 days AND either prescriber confirms the other inhaled antibiotic will be discontinued or provides information supporting concurrent or alternating therapy.

Chenodal criteria

Chenodal (chenodeoxycholic acid) — Covered when BOTH of the following are met

Chenodal approval: 1) Patient has a diagnosis of radiolucent stones in a well-opacifying gallbladder; AND 2) Requested dose is within FDA labeled dosing for the requested indication.

Chorionic gonadotropin criteria

Chorionic gonadotropin (Pregnyl) — Covered for medically accepted indications

Chorionic gonadotropin: Patient has a medically-accepted indication (FDA labeled or supported in CMS-approved compendia) for chorionic gonadotropin.

Follow PA group requirements and exclusions

Hormonal indications (cryptorchidism / hypogonadotropic hypogonadism)

Approval for hormonal indications requires ONE of the following scenario sets:

Hormonal indication scenarios: A. Diagnosis of prepubertal cryptorchidism not due to anatomic obstruction; OR B. Male with hypogonadotropic hypogonadism AND measured LH and FSH at low-normal or below lab normal range; OR C. Indication supported in CMS-approved compendia.

Testosterone laboratory criteria

Additional laboratory requirement applicable to hormonal approvals:

Testosterone laboratory requirement: Patient has a measured current or pretreatment total serum testosterone below the testing laboratory's lower limit of normal or <300 ng/dL OR free serum testosterone below the testing laboratory's lower limit of normal.

Applies where testosterone measurement is required

Cinacalcet (hypercalcemia / hyperparathyroidism)

Cinacalcet group criteria — ONE of the following:

Cinacalcet indications: A. Diagnosis of hypercalcemia due to parathyroid carcinoma with pretreatment serum calcium above lab upper limit; OR B. Diagnosis of primary hyperparathyroidism and patient is unable to undergo parathyroidectomy; OR C. Another FDA-approved or CMS compendia-supported indication (e.g., secondary hyperparathyroidism in ESRD on dialysis).

Pretreatment serum calcium requirement applies where noted

Colony stimulating factors (Fulphila)

Fulphila (colony stimulating factor) criteria:

Fulphila approval: Patient has an FDA labeled indication or an indication supported in CMS-approved compendia for the requested agent; AND prescriber is a specialist in the area of the patient's diagnosis or has consulted with such a specialist.

Approval duration: 6 months where specified

Cobenfy (initial and renewal criteria)

Cobenfy initial and renewal criteria:

Cobenfy initial approval: 1) Patient has an FDA labeled indication; AND 2) ONE of: evidence of current treatment within the past 180 days OR prescriber states current treatment. Additionally, prescriber must assess baseline liver enzymes, bilirubin, and heart rate prior to starting therapy; and there must be prior trials (trial and inadequate response to two antipsychotics OR intolerance/hypersensitivity to two antipsychotics OR FDA contraindication to two antipsychotics) as applicable.

Cobenfy renewal approval: 1) Patient has been previously approved through plan's PA criteria; AND 2) Patient has an FDA labeled indication; AND 3) Evidence of current treatment within past 180 days or prescriber statement and appropriate clinical monitoring (heart rate, liver enzymes/bilirubin) as indicated; AND 4) Patient has had clinical benefit with the agent.

General approval criteria

Covered when ALL of the following are met

General approval criteria: 1. Patient has an FDA labeled indication or an indication supported in CMS-approved compendia for the requested agent; AND 2. Prescriber is a specialist in the area of the patient's diagnosis or has consulted with such a specialist.

Required for approval

Ziextenzo - Initial Therapy

Ziextenzo initial approval requires:

Ziextenzo approval: Patient has an FDA labeled indication or an indication supported in CMS-approved compendia for the requested agent.

Prescriber must be a specialist or have consulted a specialist; approval duration: 6 months

Corlanor - Initial Therapy

Corlanor approval criteria (patient must meet either A or B):

Corlanor pediatric pathway: ALL of the following: patient has stable, symptomatic heart failure due to dilated cardiomyopathy; agent is for a pediatric patient >=6 months; patient is in sinus rhythm with an elevated heart rate.

Approval duration: 12 months

Corlanor adult pathway: ALL of the following: patient has stable, symptomatic chronic heart failure; agent is for an adult patient; baseline or current left ventricular ejection fraction (LVEF) <=35%; patient is in sinus rhythm with resting heart rate >=70 bpm prior to initiation; and patient is on a maximally tolerated beta blocker OR has intolerance/contraindication to beta blocker.

Approval duration: 12 months

Cresemba - Initial and Renewal Therapy

Cresemba initial approval requires ONE of the following:

Cresemba indications: A. Diagnosis of invasive aspergillosis; OR B. Diagnosis of invasive mucormycosis; OR C. Another indication supported in CMS-approved compendia for the requested agent.

Renewal requires prior approval plus continued indicators of active disease or clinical benefit; approval duration: 6 months

What Providers Must Do / Authorizations & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required.

PA groups apply across the plan's pharmacy and medical benefit where applicable.
Requests lacking required documentation or with FDA-labeled contraindications may be denied.

Prior Authorization

Acyclovir Topical PA

Acyclovir topical (and other listed topical antivirals) require prior authorization. Approval is contingent on an FDA‑labeled indication or a CMS‑compendia supported indication and dosing within FDA or CMS compendia limits.

Approval duration is typically 12 months unless otherwise specified.
Documentation must show indication and that requested dose is supported by FDA labeling or CMS compendia.

Prior Authorization

Initial Therapy: Medically Necessary Conditions

Aimovig Initial Therapy

Aimovig initial therapy criteria

Aimovig Initial: Diagnosis of migraine; >=4 migraine headache days per month; agent used for migraine prophylaxis; patient will NOT use the agent in combination with another CGRP agent for migraine prophylaxis.

Actimmune Initial Therapy

Actimmune initial therapy criteria

Actimmune Initial: Patient has an FDA labeled indication or an indication supported in CMS-approved compendia; dosing is within FDA-labeled or compendia-supported ranges.

Initial Therapy Criteria (misc aggregated)

Continuation / Renewal Requirements

Prolastin-C Renewal

Prolastin-C renewal: 1) Patient has been previously approved through the plan's PA criteria; 2) Patient has AATD with clinically evident emphysema; 3) Patient has had clinical benefit with the requested agent; 4) Requested dose is within FDA labeled dosing.

Approval duration: 12 months

Arikayce continuation therapy

Arikayce renewal criteria

Arikayce continuation: Patient has been previously approved; continued diagnosis of MAC lung disease; patient has had clinical benefit with the requested agent; and will continue combination antibiotic therapy with the requested agent.

Approval duration: 12 months

Attruby continuation

Attruby renewal requirements

Step Therapy / Trial Requirements

Coverage requirement
Do not use in combination with another CGRP agent for migraine prophylaxis (concurrent CGRP therapy prohibited).

Coverage requirement
Patient will NOT be using the requested agent in combination with another androgen or anabolic steroid OR prescriber provides supporting information for combination therapy.

Coverage requirement
Demonstrate prior treatment or meet dementia-specific conditions (evidence of current treatment within past 180 days, prescriber attestation, or dementia-related safeguards) before approval for antipsychotic use in dementia-related indications.

Coverage requirement
Atopic dermatitis agents: trial and inadequate response to a topical corticosteroid (or intolerance/hypersensitivity or FDA-labeled contraindication) required prior to approval.
Topical tacrolimus: trial/failure or intolerance/contraindication to topical corticosteroid OR CMS-compendia-supported indication required prior to approval.
Atovaquone (PJP): intolerance/hypersensitivity or FDA-labeled contraindication to trimethoprim/sulfamethoxazole (TMP/SMX) required for treatment or prophylaxis unless CMS compendia support exists.

Coverage requirement
For BPH indication, patient must have tried and had insufficient response, intolerance, or FDA-labeled contraindication to TWO alpha blocker agents prior to tadalafil approval.

Coverage requirement
For anxiety disorder indications, documentation of prior trial and inadequate response to a formulary SSRI or SNRI, or documented intolerance/hypersensitivity or FDA-labeled contraindication to an SSRI/SNRI, is required prior to benzodiazepine approval.

Coverage requirement
For anxiety disorder indications, patient must have tried and had an inadequate response to a formulary SSRI or SNRI, or have intolerance/hypersensitivity or an FDA-labeled contraindication to a formulary SSRI/SNRI, prior to approval.

Coverage requirement
Certain diagnoses require prior use of specified preferred agents or one conventional prerequisite agent before approval; details vary by diagnosis and agent (see preferred-agent and conventional-prerequisite rules).

Coverage requirement
Specified preferred-agent trials required for select diagnoses: examples include one preferred agent (Hadlima or Simlandi) required for certain adult indications and two preferred agents required for juvenile idiopathic arthritis/rheumatoid arthritis per age-specific rules.

Coverage requirement
Use of ONE conventional prerequisite agent is required for plaque psoriasis and Crohn's disease prior to certain biologic approvals; no conventional prerequisite is required for psoriatic arthritis or specified ulcerative colitis indications.

Diagnosis	Preferred-agent trials required
Polyarticular juvenile idiopathic arthritis / Rheumatoid arthritis
Two preferred agents (e.g., Hadlima, Rinvoq tablets/solution, or Simlandi) required prior to non-preferred biologic approval.

Coverage requirement
Document prior trials or intolerance/contraindications to required agents (e.g., for Cobenfy: trial and inadequate response or intolerance/contraindication to two antipsychotics) as part of PA documentation.

Laboratory, Lookbacks, and Key Clinical Thresholds

Pre-treatment serum AAT level

Threshold valuePre-treatment serum AAT level < 11 micromol/L (80 mg/dL by immunodiffusion or 57 mg/dL by nephelometry)

Indication linkedRequired for Prolastin-C initial approval in patients with AATD and clinically evident emphysema

Dose requirementRequested dose must be within FDA‑labeled dosing for the indication

Insulin use lookback

Lookback periodUse of insulin within the past 180 days

Use caseDocumentation required for alcohol swabs PA to show product used in insulin delivery

Policy Background and Scope

This document provides Baylor Scott & White Health Plan prior authorization rules for a large set of pharmacy and specialty agents. It organizes medications into PA groups and, for each group or agent, lists the required clinical information, step or prerequisite therapy expectations, exclusions (notably FDA‑labeled contraindications), prescriber requirements, and typical approval durations (commonly 12 months, with some agents/indications at 6 months or other specified periods).

Policy sections include: drug/group descriptions and covered indications (FDA‑labeled or supported by CMS‑approved compendia), explicit initial and renewal criteria (often requiring evidence of current treatment within a specified lookback window or prescriber attestation), documentation and monitoring requirements (laboratory or functional assessments where applicable), step‑therapy or preferred‑agent routes (trials of formulary or preferred biologics or conventional agents when required), and exclusions/denial triggers (for example, using an agent solely for an excluded purpose or presence of FDA contraindications).

Providers seeking coverage should follow the agent‑specific criteria exactly: include the diagnosis, any required laboratory values or confirmatory testing, evidence of prior trials or current therapy within the stated lookback period, and documentation of clinical benefit for renewals. Requests that do not meet the listed criteria, lack required documentation, propose forbidden combinations (for example, concurrent biologic immunomodulators or combination CGRP agents), or fall under an explicit exclusion risk denial.

Key Definitions and Terms

Medically-Accepted Indications

DefinitionMedically-accepted indications = indications that are FDA labeled or supported in CMS‑approved compendia for the requested agent

Where usedThis definition is applied across PA criteria to determine eligible diagnoses

Denial riskRequests lacking an FDA‑labeled or compendia‑supported indication may be denied

AATD with clinically evident emphysema

DefinitionAATD with clinically evident emphysema: alpha‑1 antitrypsin deficiency with clinical emphysema

PA implicationRequired diagnosis for Prolastin‑C initial and renewal approvals

Biosimilar / Preferred Biologic Requirements

Billing Rule

Preferred agent requirement (Hadlima/Simlandi example)

Use of one preferred biosimilar agent (Hadlima or Simlandi) is required for certain rheumatologic diagnoses before coverage of non‑preferred biologics; for other diagnoses, two preferred agents may be required per policy.

Billing Rule

Preferred agent numbers for JIA (Hadlima/Rinvoq/Simlandi example)

Preferred agent counts and specific requirements apply to juvenile idiopathic arthritis and related diagnoses (examples: Hadlima, Rinvoq, Simlandi lists); confirm the required number of preferred agents per diagnosis before requesting non‑preferred therapy.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyPrior authorization rules for specialty and pharmacy drugs (partial list)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of FDA-labeled indication or CMS-compendia support and required treatment history or test results.

SourceLink

On This Page

Aimovig (erenumab) prior authorization requires documentation of migraine diagnosis, frequency, and that the agent is being used for prophylaxis. Concomitant use with another CGRP antagonist is not allowed.

Initial approval criteria include: diagnosis of migraine, ≥4 migraine headache days per month, and use for prophylaxis.
Renewal requires prior approval through plan criteria, continued diagnosis of migraine, continued prophylactic use, and documented clinical benefit.
Approval duration: 12 months.

Prior Authorization

Alcohol Swabs PA

Alcohol swabs and certain insulin delivery supplies require documentation of recent insulin use and that the product will be used in insulin delivery.

Documentation must show insulin use within the past 180 days.
The supply must be intended for use in the delivery of insulin.

Prior Authorization

Alosetron PA

Alosetron is subject to PA with indication, severity, and prescriber evaluation documented; exclusion for FDA‑labeled contraindications applies.

Applicable only for eligible diagnoses (IBS‑D in females with severe symptoms).
Prescriber must have ruled out anatomic or biochemical GI abnormalities.

Prior Authorization

Alpha-1-Proteinase Inhibitor (Prolastin-C) PA

Alpha‑1‑proteinase inhibitor therapies (e.g., Prolastin‑C) require demonstration of alpha‑1 antitrypsin deficiency with emphysema and a qualifying pre‑treatment serum AAT level; dosing must be within FDA‑labeled range.

Initial criteria include AATD diagnosis with clinically evident emphysema and pre‑treatment AAT level below defined thresholds.
Renewal requires prior approval, continued diagnosis, clinical benefit, and dosing within labeled range.

Prior Authorization

Prior authorization required (androgen products)

Prior authorization is required for androgen products (injectable and topical). Demonstrate diagnosis, relevant laboratory values, and that the patient will not receive concurrent androgen/anabolic steroid therapy unless prescriber justifies combination therapy.

Indications include hypogonadism with documented low serum testosterone or specific wasting/malignancy indications as defined per product.
Pretreatment and/or current total or free testosterone levels must be documented when required.
If multiple androgen/anabolic agents are requested, prescriber justification is required; otherwise concurrent use is disallowed.

Prior Authorization

Antipsychotics PA

Antipsychotics PA: prior authorization does not apply to patients under 65. Approval requires FDA indication (or CMS compendia supported) and evidence of current treatment or prescriber attestation; dementia‑related uses have special documentation requirements including discussion of mortality risk.

Evidence of a claim for current treatment within past 180 days OR prescriber statement that patient is currently treated with the agent.
For dementia‑related psychosis, document severity or danger and that prescriber discussed increased mortality risk with patient or surrogate.
Approvals apply to the requested medication only and are typically for 12 months.

Prior Authorization

Apomorphine PA

Apomorphine injectables require documentation that the agent is for acute, intermittent 'off' episodes in advanced Parkinson's disease and is being used in combination with standard Parkinson's therapies.

Must document diagnosis of advanced Parkinson's disease with motor fluctuations.
Confirm concomitant use with levodopa or other Parkinson's agents.

Prior Authorization

Arcalyst PA

Arcalyst (rilonacept) PA requires diagnostic confirmation of CAPS or recurrent pericarditis where applicable, age restrictions, and that the agent will not be used concurrently with another biologic.

For CAPS, patient age must meet minimums (e.g., ≥12 years where specified).
Prescriber must confirm maintenance use or reduction in recurrence risk as appropriate.

Prior Authorization

Arikayce PA

Arikayce prior authorization requires documented MAC lung disease, failure to achieve negative sputum cultures after ≥6 months of standard combination therapy, and continuation of combination antibiotic therapy with the requested agent; specialist prescriber preferred.

Document prior standard combination therapy (macrolide + rifamycin + ethambutol) and persistent positive cultures.
Prescriber should be an infectious disease or pulmonary specialist or have consulted one.
Approval duration: 12 months.

Prior Authorization

Armodafinil PA

Armodafinil PA follows standard PA rules for high‑risk wakefulness agents; provide evidence of current therapy or indication supported by FDA or CMS compendia.

Documentation may include prior claims or prescriber attestation of current treatment within the look‑back period.

Prior Authorization

Eucrisa (Crisaborole) PA

Eucrisa (crisaborole) for atopic dermatitis requires prior trial and inadequate response or intolerance to a topical corticosteroid unless contraindicated.

Document trial and inadequate response to a topical corticosteroid OR documented intolerance/hypersensitivity/contraindication to topical corticosteroids.
Approval duration: 12 months.

Prior Authorization

Tacrolimus PA

Topical tacrolimus prior authorization requires documentation of atopic dermatitis and either prior topical steroid failure, intolerance, or contraindication, or a CMS‑compendia supported indication.

Document prior trial with topical corticosteroid and inadequate response OR intolerance/hypersensitivity/contraindication.
Approval duration: 12 months.

Prior Authorization

Atovaquone PA

Atovaquone PA requires documentation of diagnosis (mild‑to‑moderate PJP or prophylaxis) and TMP/SMX intolerance, hypersensitivity, or FDA contraindication unless the use is supported in CMS compendia.

Document intolerance/hypersensitivity or FDA contraindication to TMP/SMX when used for PJP prevention or treatment.
Approval duration: 12 months.

Prior Authorization

Attruby PA

Attruby prior authorization requires confirmatory diagnostic testing for transthyretin‑mediated amyloid cardiomyopathy and that the agent will not be used with competing therapies (Amvuttra or tafamidis); specialist prescriber required.

Provide test confirmation (PYP scan, monoclonal antibody studies, biopsy, scintigraphy, or TTR genotyping).
Document NYHA class and clinical manifestations when applicable.
Do not combine with Amvuttra or tafamidis for the same indication.

Prior Authorization

Prior authorization groups

Prior authorization groups are organized to require indication‑specific documentation, to enforce exclusion for FDA‑labeled contraindications, and to require evidence of current treatment or prescriber attestation where applicable.

Common requirement: FDA‑labeled indication or CMS‑compendia supported indication and dosing within labeled or compendia limits.
Requests may be denied for missing or outdated documentation, lack of indication, presence of FDA contraindications, or failure to show required prior trials or clinical benefit.

Prior Authorization

Clobazam PA requirements

Clobazam and other benzodiazepine PA rules: prescriber attestation or claims evidence of current treatment and absence of FDA contraindications must be provided; PA may not apply to patients under specified ages per group.

Provide evidence of current treatment within the look‑back period or prescriber statement.
Document diagnosis (seizure disorder, anxiety disorder as applicable) and intolerance or contraindication to formulary alternatives when required.

Prior Authorization

Clorazepate/Diazepam PA requirements

Clorazepate, diazepam and other benzodiazepines follow similar documentation expectations: current therapy evidence or prescriber attestation, FDA‑labeled indication or CMS compendia support, and absence of contraindications.

For anxiety disorder indications, document prior trials of formulary SSRIs/SNRIs or intolerance/contraindication when required.
PA may be exempt for patients under certain age thresholds per group guidance.

Prior Authorization

Prior authorization requirements

For listed selected agents and biologic immunomodulators, documentation must include clinical rationale, prior agent trials or reasons for exemption (intolerance, contraindication, prior use), and confirmation that the requested agent will not be used in combination with another biologic immunomodulator.

Initial approval commonly requires: FDA‑labeled indication or CMS compendia support AND evidence of current therapy or prior use of preferred/conventional agents OR prescriber justification for exemption.
Renewal requires prior approval, continued FDA indication, clinical improvement/benefit, and no concurrent biologic immunomodulator therapy.

Documentation Required

Required documentation for approval

Provider must supply required documentation for approval — missing items are frequent denial triggers. Documentation must be current and clearly show diagnosis, prior treatments, laboratory values, and clinical benefit when applicable.

Required documentation varies by agent but commonly includes: diagnosis, relevant labs (e.g., testosterone, AAT, calcium, ejection fraction), prior therapy history with dates, medication claims history when available, specialist consultation when required, and objective evidence of clinical benefit for renewals.
Documentation must show either a claim for current treatment within the plan’s look‑back period (commonly 60–180 days depending on agent) or a prescriber attestation that the patient is currently being treated along with supporting clinical justification.
For initial approval provide evidence of: diagnosis, prior requisite therapies (or documented intolerance/contraindication), dosing within FDA or compendia ranges, and any required diagnostic testing (e.g., PYP scan, genetic testing, sputum cultures).

Documentation Required

Documentation must show either a claim for current treatment or prescriber attestation

Documentation must show either a claim for current treatment within the required look‑back period or a prescriber attestation that the patient is currently being treated, with clinical justification if no claim is present.

Typical look‑back windows are 60, 90, or 180 days depending on the PA group — check the group‑specific criteria.
Prescriber attestation should include start date, dose, and reason for absence of pharmacy claim if applicable.

Documentation Required

Required evidence of current treatment and diagnosis

Required evidence of current treatment and diagnosis must be recent and specific: diagnosis codes, clinical notes, labs, imaging, or culture results as appropriate to the drug and indication.

Examples: positive Pseudomonas culture for Cayston; pre‑treatment AAT level for alpha‑1 therapies; sputum cultures and prior MAC therapy history for Arikayce; PYP scan or TTR genotyping for ATTR‑CM agents.
Clinical notes should document treatment response or rationale for continuation at renewal.

Documentation Required

For initial approval provide evidence of

For initial approvals provide specific evidence depending on the agent: diagnosis confirmation, prior therapeutic trials (or documented intolerance/contraindication), required laboratory or diagnostic test results, and dosing information within approved or compendia ranges.

Biologic immunomodulators: show prior use of preferred or conventional agents when required, or provide justification for exemption.
Carglumic acid, Chenodal, and other specialty agents: include diagnosis, biochemical markers, and any genetic testing or enzyme assays required by the PA group.

Documentation Required

Required medical information (general biologic immunomodulators)

Required medical information for general biologic immunomodulators includes FDA‑labeled indication, evidence of prior preferred/conventional agent use or reason for exemption (intolerance, contraindication, prior use), prescriber specialty when required, and assurance that the agent will not be used in combination with another biologic immunomodulator.

Initial approval commonly requires a claim of current treatment within past 90 days or prescriber justification if not present.
Renewal requires documentation of clinical improvement (slowing of disease progression or reduction in symptom severity/frequency).
Formulary preferred agents and conventional prerequisite agents lists (by diagnosis) must be checked and documented when applicable.

Documentation Required

Cayston required documentation

Cayston (aztreonam for inhalation) required documentation must confirm cystic fibrosis diagnosis, evidence of Pseudomonas aeruginosa respiratory infection, and details about current or recent inhaled antibiotic use. Denials are commonly issued when culture documentation is missing or when criteria for concurrent inhaled antibiotic use are not met.

Provide documentation confirming P. aeruginosa respiratory infection (culture or other microbiologic evidence).
If patient has been on another inhaled antibiotic within the past 60 days, include prescriber confirmation that the other inhaled antibiotic will be discontinued or clinical justification to support concurrent/alternating therapy.
Cayston‑specific denial risk: requests lacking microbiologic confirmation of Pseudomonas or without clear plan for discontinuation/justification of concurrent inhaled antibiotics are likely to be denied.

Documentation Required

Carglumic acid required documentation

Carglumic acid required documentation: include diagnosis, relevant metabolic labs, and any genetic testing or specialist consultation notes that support use.

Document hyperammonemia etiology and evidence that carglumic acid is indicated per labeling or compendia.
Provide recent laboratory values showing need (e.g., elevated ammonia levels) and supporting metabolic specialist input when available.

Documentation Required

Chenodal required documentation

Chenodal required documentation: include diagnosis of cerebrotendinous xanthomatosis or other FDA‑labeled indication, relevant biochemical or genetic testing, and prior therapy history.

Provide diagnostic test results (e.g., genetic testing) or specialist documentation supporting Chenodal use.
Document prior treatments and clinical rationale for Chenodal.

Documentation Required

Required documentation and assessments

Required documentation and assessments at renewal: demonstrate prior plan approval, ongoing diagnosis, objective evidence of clinical benefit or disease stabilization, and absence of combination therapy with contraindicated agents.

Include objective measures of improvement where applicable (labs, imaging, symptom frequency/severity scores).
If renewal lacks documentation of clinical benefit or shows contraindications or prohibited combinations, request will be denied.

Step Therapy

For selected diagnoses, trial(s) of specified agents required

For selected diagnoses, trials of specified preferred or conventional agents are required prior to approval unless there is documented intolerance, hypersensitivity, FDA contraindication, or clinical justification.

Examples: two alpha‑blocker failures required for benign prostatic hyperplasia prior to tadalafil approval; preferred biologic or conventional agent trials required for many biologic immunomodulator indications per the policy.
Document prior agent names, dates, and reasons for discontinuation (inefficacy, intolerance, contraindication).

Step Therapy

Preferred-agent step requirements

Preferred‑agent step requirements: where the policy specifies preferred biologic or conventional agents, evidence of prior use or documented intolerance/contraindication is required before non‑preferred agents will be approved.

Examples: Use of specified preferred agents (Hadlima, Rinvoq tablets/solution, Simlandi, etc.) is required for certain diagnoses as listed in the policy.
Document medication history showing use of preferred agents or provide justification for exemption.

Step Therapy

Step or prior trials for Cobenfy

Step or prior trials for Cobenfy: document required prior therapies or clinical justification as specified by the Cobenfy PA group before approval will be granted.

Follow the Cobenfy group‑specific criteria for prerequisite agents or exemptions.
Provide medication history, intolerance/contraindication evidence, or prescriber justification if preferred steps are bypassed.

Denial Risk

Contraindication exclusions

Contraindication exclusions: any request with an FDA‑labeled contraindication to the requested agent should be excluded and may be denied.

Verify current FDA labeling for contraindications before submission.
If an FDA‑labeled contraindication exists, provide documentation if seeking exception — such requests are subject to denial.

Denial Risk

Requests may be denied if the patient does not meet criteria

Requests may be denied if the patient does not meet the PA group's specified indication, lacks required documentation, has an FDA‑labeled contraindication, or fails to meet step‑therapy or prior trial requirements.

Common denial triggers include missing microbiology or diagnostic testing, absent lab values, no evidence of prior requisite therapies, and concurrent use of disallowed combinations (e.g., multiple biologics or CGRP agents).
Documentation that is not current (outside the policy's look‑back windows) may result in denial.

Denial Risk

Exclusion and trigger conditions

Exclusion and trigger conditions: FDA‑labeled contraindications are exclusions; certain clinical scenarios (e.g., fertility use for chorionic gonadotropin, erectile dysfunction only) explicitly trigger exclusion and denial.

Review the policy's product‑specific exclusion list prior to submission.
Requests for excluded uses will be denied.

Prior Authorization

Indication requirement

Indication requirement: approvals require an FDA‑labeled indication or an indication supported by CMS‑approved compendia. Where compendia support is required, include citation or supporting documentation.

If the requested use is off‑label, provide CMS compendia support documentation; otherwise the request will be denied as not meeting indication criteria.
Dosing must align with FDA labeling or compendia recommendations for the requested indication.

Denial Risk

Contraindications trigger denial

Contraindications trigger denial: any FDA‑labeled contraindication to the requested agent is a basis for denial unless a documented exception is justified and approved.

Ensure screening for contraindications before submitting a PA request.
Provide clinical rationale and supporting documentation if requesting an exception; exceptions are not guaranteed.

Documentation Required

Required medical information

Required medical information (general): include patient identifiers, diagnosis with supporting documentation, relevant laboratory or diagnostic test results, prior and current medication history with dates, prescriber specialty or consultation when required, dosing and route, and objective measures of benefit for renewals.

Attach copies of labs, imaging, culture results, genetic testing, or specialist notes as applicable to the request.
Include dates for prior therapy trials and reasons for discontinuation (inefficacy, intolerance, contraindication).
Renewal requests must document prior plan approval and clinical benefit.

Alcohol Swabs initial:

Requested product will be used in insulin delivery; AND patient has used insulin within the past 180 days.

Approval duration: 12 months

Alosetron initial: IBS-D diagnosis; female sex; at least one qualifying symptom (severe abdominal pain/discomfort OR frequent bowel urgency/fecal incontinence OR disability/restriction of daily activities); AND prescriber has ruled out anatomic or biochemical GI abnormalities.

Approval duration: 12 months

Prolastin-C initial: AATD with clinically evident emphysema; pre-treatment serum AAT level <11 micromol/L (80 mg/dL by immunodiffusion or 57 mg/dL by nephelometry); requested dose within FDA labeled dosing.

Approval duration: 12 months

Danazol initial therapy

Danazol initial: Patient has an FDA labeled indication OR an indication supported in CMS compendia; AND patient will NOT be using the agent in combination with another androgen/anabolic steroid OR prescriber provides justification for combination therapy.

Testosterone initial therapy

Testosterone initial: Diagnosis-specific indications (AIDS/HIV wasting; metastatic/inoperable breast cancer in females; primary/secondary hypogonadism in males; delayed puberty in adolescent males) AND for males, pretreatment or current total/free testosterone levels consistent with policy (total < lab lower limit or <300 ng/dL) as applicable; AND no concurrent use with another androgen/anabolic steroid unless justified.

Coverage durations vary (delayed puberty 6 months); lab thresholds specified in policy.

Initial therapy requirements (selected drugs)

Initial therapy criteria for selected drugs

Apomorphine initial: Used for acute, intermittent "off" episodes AND used in combination with Parkinson's agents (e.g., levodopa); prescriber should be a specialist.

Arikayce initial: Diagnosis of MAC lung disease; failure to achieve negative sputum after >=6 consecutive months of standard combination therapy; will continue combination therapy including Arikayce.

Prescriber specialist required; Approval duration: 12 months

Eucrisa initial

Eucrisa initial therapy criteria

Eucrisa initial: Diagnosis of atopic dermatitis AND trial and inadequate response to a topical corticosteroid or intolerance/hypersensitivity or FDA labeled contraindication to topical corticosteroids.

Tacrolimus initial

Tacrolimus initial therapy criteria

Tacrolimus initial: Diagnosis of atopic dermatitis AND either trial/failure to topical corticosteroid OR intolerance/hypersensitivity OR FDA labeled contraindication to topical corticosteroid; OR indication supported in CMS compendia.

Atovaquone initial

Atovaquone initial therapy criteria

Atovaquone initial: Diagnosis of mild-to-moderate PJP or use for PJP prevention AND intolerance/hypersensitivity to TMP/SMX OR FDA labeled contraindication to TMP/SMX; OR indication supported in CMS compendia.

Attruby initial

Attruby initial therapy criteria

Attruby initial: Confirmed ATTR-CM by testing (e.g., PYP scan, biopsy, genetic testing/TTR genotyping); diagnosis of ATTR-CM with clinical manifestations of cardiomyopathy; hospitalization (per policy text); and not used with Amvuttra or tafamidis for the requested indication.

Austedo initial therapy

Austedo initial therapy criteria

Austedo initial: Meets diagnostic and safety criteria for chorea (Huntington's disease) OR for tardive dyskinesia (including attempt to reduce/discontinue causative agents or clinical rationale why not appropriate); AND not using MAOI or reserpine concomitantly.

Prescriber specialist or consult required; Approval duration: 12 months

Initial therapy requirements

Initial authorization requirements mirror the general criteria below.

Initial authorization general: Documentation of current treatment (claim within 180 days or prescriber attestation) AND FDA labeled indication or CMS compendia-supported indication AND absence of FDA labeled contraindications; for anxiety indications additional SSRI/SNRI trial or intolerance/contraindication documentation is required.

Initial therapy criteria

Initial approval criteria for listed agents

Initial PA nodes: PA requires (1) evidence of current treatment or prescriber attestation (claim within past 180 days), (2) FDA labeled indication or CMS compendia-supported indication, and (3) absence of FDA labeled contraindications; for anxiety, evidence of prior SSRI/SNRI trial or intolerance/contraindication is required.

Initial therapy

Initial approval rules require documented indication and evidence of recent use or justification plus agent-specific prerequisites.

Initial therapy general: Patient has an FDA labeled indication (or CMS compendia support where specified) AND one of: evidence of recent claim within specified timeframe (90–180 days), prescriber attestation of current treatment, or meeting nested alternative prerequisites (treatment history, intolerance, contraindication, or specialist involvement).

Agent-specific variants present in respective sections

Initial therapy

Initial therapy general biologic: FDA labeled indication AND evidence of current treatment or prescriber attestation/justification OR meeting preferred-agent pathway AND not used in combination with another biologic immunomodulator.

Applies to biologic immunomodulators

Initial approval

Initial therapy requirements common across many biologics

Initial therapy common biologics: Patient has an FDA labeled indication AND meets one of the medication-history/current-treatment conditions (recent claim within 90 days, prescriber attestation with justification, prior use of preferred agents, intolerance/contraindication to preferred or conventional prerequisite agents) AND will not use the agent in combination with another biologic immunomodulator.

Some agents reference preferred biologic or formulary conventional prerequisite agents depending on indication

Biologic initial therapy

Initial approval conditions for biologic immunomodulators

Biologic initial: Patient has an FDA labeled indication AND one of: recent claim within 90 days; prescriber attests current treatment and provides clinical justification if changing therapy; OR diagnosis appropriate for preferred agents with prior use, intolerance, or contraindication; OR request for FDA indication not covered by preferred agents; AND patient will not be on combination biologic immunomodulators.

Cobenfy initial therapy

Cobenfy initial approval requirements

Initial Cobenfy: Patient has an FDA labeled indication AND evidence of current treatment within past 180 days OR prescriber statement; prescriber performed baseline assessments (liver enzymes, bilirubin, heart rate) and prior trials/intolerance/contraindications to two antipsychotics as applicable.

Coverage duration

Coverage duration for approval

Duration: Approval duration as stated in sections (commonly 6 months for colony stimulating factors; 12 months for many agents).6 months

See agent-specific sections for exact duration

Ziextenzo initial

Ziextenzo initial therapy requirement

Ziextenzo initial: Patient has an FDA labeled indication or an indication supported in CMS-approved compendia for the requested agent.

Prescriber must be a specialist or have consulted a specialist; approval duration: 6 months

Cresemba initial

Cresemba initial therapy requirement

Cresemba initial: Diagnosis of invasive aspergillosis OR invasive mucormycosis OR another CMS compendia-supported indication.

Approval duration: 6 months; renewal requires continued active disease or clinical benefit

Attruby continuation: Renewal requires prior approval, continued ATTR-CM diagnosis, use to reduce cardiovascular death and CV-related hospitalization, NYHA Functional Class I-III, documented clinical benefit with the requested agent, and not using the agent in combination with Amvuttra or a tafamidis agent.

Approval duration: 12 months; prescriber specialty/consult required

Continuation therapy

Renewal/continuation requires prior approval, continued indication, and evidence of clinical benefit and prohibits combination biologic use.

Continuation general: 1) Patient has been previously approved through the plan's PA criteria; AND 2) Patient has an FDA labeled indication for the requested agent; AND 3) Patient has had clinical improvement (or evidence of ongoing treatment); AND 4) Patient will NOT be using the requested agent in combination with another biologic immunomodulator.

Applies across multiple biologic agents

Renewal criteria (continuation)

Renewal: Previously approved through plan PA; FDA-labeled indication; clinical improvement; no concurrent biologic immunomodulator use.

Applies to biologic immunomodulators

Renewal criteria

Continuation (renewal) therapy requirements

Continuation: Patient previously approved; patient has FDA labeled indication; evidence of clinical improvement; patient will not use the agent in combination with another biologic immunomodulator.

Standard approval duration often 12 months

Biologic continuation therapy

Continuation/renewal criteria for biologic immunomodulators

Biologic continuation: Patient previously approved through plan's PA criteria; has an FDA labeled indication; demonstrates clinical improvement; patient will not be using the requested agent in combination with another biologic immunomodulator.

Cresemba continuation

Cresemba renewal requirements

Cresemba renewal: Patient previously approved through plan PA criteria AND (patient has invasive aspergillosis or invasive mucormycosis with continued indicators of active disease OR patient has another compendia-supported indication and has had clinical benefit).

Approval duration: 6 months

Approval duration (context)

Approval will be for 12 months

Total serum testosterone level

Testosterone thresholdTotal serum testosterone below the testing laboratory's lower limit of normal or < 300 ng/dL

Also acceptableFree serum testosterone below the testing laboratory's lower limit of normal

Context of useRequired for male hypogonadism / hormonal approvals and for delayed puberty pathway

Unexplained involuntary weight loss

Weight‑loss definition>10% baseline body weight within 12 months or >7.5% within 6 months

Assessment requirementAll other causes of weight loss must be ruled out

Clinical contextUsed in criteria for male AIDS/HIV-associated wasting syndrome and testosterone product approvals

Body mass index

BMI thresholdBody mass index (BMI) < 20 kg/m2 (or <27 kg/m2 with total body cell mass <35%)

Alternative metricAt least 5% total body cell mass (BCM) loss within 6 months can meet criteria

Clinical useApplies to testosterone product approval for wasting syndromes

recent treatment lookback

Recent treatment lookback (general)Past 180 days (evidence of claim or prescriber attestation commonly accepted)

Biologics variantSome biologics use a 90‑day recent treatment lookback instead (see agent-specific criteria)

PurposeUsed to document current treatment for PA or to support continuation/renewal

prior antibiotic therapy duration

Minimum duration>= 6 consecutive months

Regimen describedStandard combination therapy for MAC: macrolide + rifamycin + ethambutol

RelevanceRequired prior antibiotic therapy duration for Arikayce initial approval

Current-treatment claim lookback

Claim lookback window180 days (evidence of a claim within past 180 days or prescriber attestation fulfills current‑treatment requirement)

Applies toCommonly applied to benzodiazepine PA groups and other non‑biologic agents for patients >=65 years

Alternate acceptancePrescriber attestation may substitute when no claim is present

recent treatment look-back

Recent treatment lookback (biologics)Within past 90 days (commonly required for biologic immunomodulators to demonstrate current treatment)

AlternativePrescriber attestation with clinical justification acceptable when claim absent

ContextUsed in initial approval pathways for many biologics to show ongoing therapy

inhaled antibiotic look-back

Inhaled antibiotic look-back windowWithin past 60 days

Clinical requirementPatient must not currently (within past 60 days) be treated with another inhaled antibiotic, or prescriber must document discontinuation or provide rationale for concurrent/alternating therapy

Applies toCayston (aztreonam for inhalation) prior authorization

Total serum testosterone

Total testosterone thresholdTotal serum testosterone below the testing laboratory's lower limit of normal or < 300 ng/dL

Free testosteroneFree serum testosterone below laboratory lower limit also acceptable

Use caseRequired for hormonal indications including hypogonadotropic hypogonadism and delayed puberty pathways

Pretreatment serum calcium

Pretreatment serum calciumPretreatment serum calcium above the testing laboratory's upper limit of normal

Indication linkRequired for hypercalcemia due to parathyroid carcinoma pathway under cinacalcet criteria

Alternative usesAlso relevant where inability to undergo surgery is documented for primary HPT

Resting heart rate

Resting heart rate threshold>= 70 beats per minute (resting) prior to initiation

Clinical contextRequired baseline for Corlanor (ivabradine) adult pathway

Associated requirementsPatient must be in sinus rhythm and on maximally tolerated beta blocker or have intolerance/contraindication to beta blocker

Left ventricular ejection fraction (LVEF)

LVEF thresholdLeft ventricular ejection fraction (LVEF) <= 35%

Applies toCorlanor adult pathway for stable, symptomatic chronic heart failure

DocumentationBaseline or current LVEF may be required during PA review

Pediatric age for Corlanor

Pediatric minimum age>= 6 months

PathwayApplies to Corlanor pediatric pathway for stable symptomatic heart failure due to dilated cardiomyopathy

Additional requirementsPatient must be in sinus rhythm with elevated heart rate per criteria

Associated lab requirementPre‑treatment serum AAT level < 11 micromol/L (see Prolastin‑C criteria)

IBS-D

DefinitionIBS‑D = irritable bowel syndrome with severe diarrhea

PA requirementAlosetron PA requires female sex, qualifying symptoms, and exclusion of anatomic/biochemical GI abnormalities

Approval durationApproval will be for 12 months when criteria met

Delayed puberty (male)

DefinitionDelayed puberty (male): adolescent males with delayed sexual maturation considered under testosterone criteria

Coverage durationApproval duration for delayed puberty pathway is shorter (6 months noted elsewhere in policy excerpts)

Required evaluationsClinical and laboratory evaluation including testosterone levels per policy

acute, intermittent hypomobility ('off' episodes)

DefinitionAcute, intermittent hypomobility ('off' episodes) = advanced Parkinson's disease 'off' episodes

PA requirementApomorphine PA requires use for acute 'off' episodes and concurrent Parkinson's agents

PrescriberSpecialist prescriber (e.g., neurologist) or specialist consultation recommended

macrolide + rifamycin + ethambutol for >=6 months

Definitionmacrolide + rifamycin + ethambutol for >=6 months = standard combination therapy for MAC lung disease

UsageRequired prior regimen for Arikayce initial approval when sputum remains positive

Minimum duration>= 6 consecutive months

ATTR-CM

DefinitionATTR‑CM = cardiomyopathy of wild type or variant transthyretin‑mediated amyloidosis confirmed by testing (e.g., PYP scan, biopsy, TTR genotyping)

PA implicationRequired confirmatory testing and clinical manifestations for Attruby initial approval

Renewal criteriaRenewal requires NYHA class I–III and documented clinical benefit

Topical corticosteroid trial

DefinitionTopical corticosteroid trial = documented trial and inadequate response to a topical corticosteroid (or intolerance/contraindication)

Applies toRequired before Eucrisa or topical tacrolimus approval unless contraindicated or compendia-supported indication exists

ExamplesIncludes agents such as hydrocortisone or triamcinolone

Chorea (Huntington's disease)

DefinitionChorea (Huntington's disease) = involuntary movements associated with Huntington's disease

PA considerationsAustedo PA includes mental health and suicide‑risk assessments for chorea pathway

Concomitant medication restrictionsProhibits concurrent MAOI or reserpine use with Austedo

Tardive dyskinesia

DefinitionTardive dyskinesia = movement disorder often related to dopamine receptor blocking agents

PA requirementAustedo PA requires attempt to reduce/discontinue offending agents or clinical rationale if not appropriate

Medication exclusionsConcomitant MAOI or reserpine use prohibited

Current treatment

DefinitionCurrent treatment = evidence of a claim within past 180 days or prescriber statement that patient is currently being treated

UseUsed to satisfy PA evidence-of-current-treatment requirements for many agents

Age noteSome PA groups exclude patients <65 from PA requirement (clauses vary by group)

Current treatment evidence

DefinitionCurrent treatment evidence = pharmacy claim within past 180 days OR prescriber attestation that patient is currently being treated

ApplicationCommonly accepted in benzodiazepine and other PA groups to demonstrate ongoing therapy

SubstitutePrescriber attestation may be accepted when claim unavailable

Recent treatment evidence

DefinitionRecent treatment evidence = claim showing treatment within past 90–180 days (90 days for many biologics; 180 days for others)

PurposeUsed in initial approval logic to show recent use or support prescriber attestation justification

ContextSpecific window depends on agent class (biologic vs non‑biologic)

Conventional prerequisite agent

DefinitionConventional prerequisite agent = formulary conventional systemic or topical agents (e.g., methotrexate, acitretin, topical corticosteroids) required before certain biologics

Applies toPlaque psoriasis and Crohn's disease often require one conventional prerequisite agent before biologic use

ExceptionSome indications (psoriatic arthritis) have no conventional prerequisite requirement

Current treatment evidence (90 days)

DefinitionCurrent treatment evidence (biologics) = claim within past 90 days or prescriber attestation with clinical justification

PurposeUsed to support continuation or initiation of biologic immunomodulators

Renewal implicationRenewal also requires documented clinical improvement and no concurrent biologic use

NAGS deficiency

DefinitionNAGS deficiency = deficiency of hepatic enzyme N‑acetylglutamate synthase

PA implicationCarglumic acid PA requires diagnosis of NAGS deficiency or related acute hyperammonemia

Dose requirementRequested dose must be within FDA‑labeled dosing

Hypogonadotropic hypogonadism

DefinitionHypogonadotropic hypogonadism = hypogonadism secondary to pituitary deficiency with low or low‑normal LH and FSH

PA requirementApproval pathway requires measured LH and FSH at low‑normal or below lab normal range

Associated labTotal/free serum testosterone measurement required per hormonal criteria

Colony Stimulating Factors

DefinitionColony stimulating factors = listed CSF agents requiring PA under Colony Stimulating Factors PA groups (e.g., Fulphila, Granix, Nivestym, Udenyca, Ziextenzo)

PrescriberPrescriber should be a specialist in the diagnosis area or have consulted one

Approval durationMany CSF approvals are for 6 months (Ziextenzo/others) per group

NYHA class, LVEF

DefinitionNYHA class and LVEF thresholds referenced for Corlanor: NYHA functional class and LVEF ≤35% are part of criteria

UseApplied to determine eligibility and renewal for Corlanor (adult pathway requires LVEF ≤35% and NYHA symptomatic heart failure)

Associated HRResting HR ≥70 bpm required prior to initiation in adults