CurrentBaylor Scott & White Health PlanPolicy N/A

Prior authorization criteria for multiple drugs (Part 1)

This document is the first part of a multi-part prior authorization manual listing PA groups, drugs, indications, required medical information, approval/renewal criteria, prescriber restrictions, exclusions, and coverage durations for Baylor Scott & White Health Plan (Part 1 of 9).

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyPrior authorization criteria for multiple drugs (Part 1)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPA is required for all listed agents/groups in Part 1 per their specified criteria; approvals are time-limited as specified (commonly 12 months).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update (has_material_change=false).

~40Drugs/groups listed in Part 1 (approx.)

12 monthsCommon approval duration

90/180Lookback for current therapy evidence (days)

noHas material change

~40Distinct PA groups in this part

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Coverage Summary

• Part 1 covers many drug‑specific prior authorization (PA) groups for Baylor Scott & White Health Plan senior and commercial products, including biologics, specialty agents, inhaled/injectable therapies, topical products, supplies and more. (See Part 1 drug list.)

• Overall coverage stance: covered_with_criteria — agents are coverable when the specific PA criteria are met (FDA‑labeled indications or CMS‑supported compendia, required labs/assessments, prior therapy trials or current‑therapy evidence).

• Common PA features: initial approvals are time‑limited and require meeting the listed criteria; most renewals require documentation of prior plan approval and clinical benefit (examples provided per drug group).

• Common approval durations: approvals are typically for 12 months (many biologics, specialty, and chronic therapies); some groups have shorter or indication‑specific durations (e.g., colony stimulating factors and certain antifungals often 6 months; some initial uses 1–3 months).

• Common lookback windows for evidence of ongoing therapy: 90 or 180 days (used as alternatives to prescriber attestation for current therapy across multiple PA groups).

• Approvals are explicitly time‑limited and contingent on meeting the listed initial or renewal criteria in each PA group (diagnostic confirmation, prior trials/intolerances, prescriber specialty, dosing within FDA or CMS compendia).

Initial Therapy Criteria (selected groups)

Render of selected initial approval criteria groups (consolidated). Each criteria group preserves the original nested AND/OR logic for initial-therapy decisions.

ALL of the following

Alosetron (Initial approval): Patient has a diagnosis of irritable bowel syndrome with severe diarrhea (IBS-D).
ALL of the following
- Patient is female.
- At least ONE of the following:
  - Frequent and severe abdominal pain/discomfort.
  - Frequent bowel urgency or fecal incontinence.
  - Disability or restriction of daily activities due to IBS.

Continuation / Renewal Criteria

Renewal / continuation criteria trees

Renewal / continuation logic trees labeled 'Renewal approval' or 'Renewal criteria' across groups; preserves requirement patterns: prior approval, diagnosis, documented clinical benefit, dose within labeling, and no combination biologic/agent.

Aimovig PA - Renewal approval: Patient has been previously approved for the requested agent through the plan's Prior Authorization criteria; patient has a diagnosis of migraine; agent used for migraine prophylaxis; patient has had clinical benefit

Arikayce PA - Renewal approval: Patient previously approved through plan PA criteria; has diagnosis of MAC lung disease; has had clinical benefit; will continue combination antibiotic therapy with requested agent

Benlysta SC PA - Renewal approval: Previously approved through plan PA criteria; will continue standard SLE therapy or LN therapy as applicable; patient has had clinical benefit; will NOT be using in combination with another biologic agent; dose within FDA labeled dosing

Exclusions / Combination and Other Not Covered Uses

Exclusions, combination prohibitions, and age/cosmetic exclusions

Explicit exclusions, combination prohibitions, age-based PA non-applicability and cosmetic exclusions rendered as NOT/Prohibited branches.

Prohibition: concurrent biologic immunomodulators: Patient will NOT be using the requested agent in combination with another biologic immunomodulator

Applied across Actemra, Benlysta, general biologic immunomodulators, Stelara, Humira, Enbrel, Cosentyx, etc.

Prohibition: PCSK9 combination: Patient will NOT be using the requested agent in combination with another PCSK9 agent

Repatha / PCSK9 agents prohibition

Prohibition: Palynziq / Sapropterin combination in PKU: Palynziq initial/renewal: patient will NOT be using the requested agent in combination with sapropterin; Sapropterin initial/renewal: patient will NOT be using in combination with Palynziq

Applicable Codes

Provider Actions & Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the agents/groups listed in Part 1. Approvals are time-limited (commonly 12 months unless the group specifies otherwise). Requests must meet the specific PA group criteria and membership in the PA group for the requested agent is required for review/approval.

Approvals are time-limited (commonly 12 months unless otherwise specified).
Requests must meet the specific PA group criteria for the listed agent/group.

Documentation Required

Document clinical benefit for renewals

For renewals the provider must document prior approval through the plan and demonstrate clinical benefit. Examples called out include Aimovig, Arikayce, and Benlysta. Where evidence-of-current-therapy is required, submit a claim within the specified lookback window (commonly 90 or 180 days) or provide prescriber attestation with clinical justification.

Clinical Evidence & Decision Thresholds

The policy relies on FDA‑labeled indications and, where permitted, CMS‑approved compendia to support non‑FDA (compendia‑supported) uses and dosing. Across PA groups the policy specifies measurable clinical thresholds for approval and for renewal — examples include: a documented decrease in monthly migraine days for CGRP agents, improved or stabilized timed 25‑foot walk for dalfampridine renewal, laboratory or imaging improvements such as decreased alkaline phosphatase or total bilirubin ≤ ULN for Ocaliva renewal, reductions in blood phenylalanine for Palynziq, and improvements/stabilization in hemoglobin, platelet count, liver or spleen volumes for Gaucher enzyme replacement. The policy lists numeric thresholds where applicable (e.g., hemoglobin or lab cutoffs, Phe > 600 micromol/L, pulmonary hemodynamic cutoffs) which are used to evaluate coverage decisions.

Background

This file is Part 1 of a multi‑part formulary/prior authorization manual for Baylor Scott & White Health Plan covering senior and commercial products. It enumerates multiple drug‑specific PA groups included in Part 1 and, for each group, provides detailed initial and renewal clinical criteria, exclusions, prescriber or specialty requirements, and specified approval durations.

Applicability: these PA groups apply to the plan’s senior and commercial products listed by Baylor Scott & White. In this Part 1 the PA groups are organized by drug or drug group (each PA group lists the named agent(s) and the specific criteria that must be met for coverage).

Definitions

Definitions (term: definition):

• PA: Prior Authorization.

• CMS compendia: Compendia approved by the Centers for Medicare & Medicaid Services used to support off‑label indications or dosing.

• Preferred agent: formulary‑designated biologic or conventional agent that may be required to be tried prior to non‑preferred agents.

• Formulary conventional prerequisite agent: a non‑biologic therapy (topical or systemic) the plan may require trial of before biologic approval.

• FDA labeled dosing: dosing within the FDA product label for the requested indication.

• FDA labeled contraindications: contraindications as listed in the FDA‑approved prescribing information.

• Pt: Patient.

• C1‑INH: C1 esterase inhibitor (antigenic and functional levels) used to confirm HAE.

• IGF‑1: Insulin‑like growth factor‑1 (used in growth hormone assessment).

Revision History

N/AImported fragmentLatest

Part 1 of multi-part PA manual; no explicit revision dates in source fragment.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyPrior authorization criteria for multiple drugs (Part 1)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPA is required for all listed agents/groups in Part 1 per their specified criteria; approvals are time-limited as specified (commonly 12 months).

SourceLink

On This Page

Prescriber has ruled out anatomic or biochemical abnormalities of the gastrointestinal tract.

Contraindications per FDA labeling must be checked; approval duration: 12 months.

ALL of the following

Androgen Injectable (Testosterone Enanthate) - Initial approval: Patient has documented indication for testosterone replacement therapy as defined by primary hypogonadism or other FDA-approved indications.
Baseline serum total testosterone measured on at least two separate mornings and found to be below the laboratory reference range for young adult males.
Documentation of signs and symptoms consistent with testosterone deficiency (e.g., decreased libido, fatigue, loss of muscle mass).
Prescriber restrictions and age rules apply per group-specific requirements; duration per plan rules.

ALL of the following

Apomorphine Injectable (Apokyn) - Initial approval: Patient has diagnosis of Parkinson disease with OFF episodes.
Documentation of inadequate control of OFF episodes with optimized oral dopaminergic therapy or intolerance/contraindication to alternatives.
Prescriber is a neurologist or specialist experienced in management of Parkinson disease (preferred).
Coverage duration and quantity limits per product labeling; ensure rescue/emergency use instructions provided.

ALL of the following

Atopic Dermatitis (Tacrolimus) - Initial approval: Patient has a diagnosis of atopic dermatitis requiring topical calcineurin inhibitor therapy.
One of the following prerequisites:
- Inadequate response, contraindication, or intolerance to medium/high-potency topical corticosteroids when appropriate for site/age.
- Need for steroid-sparing therapy due to risk of skin atrophy or long-term topical steroid adverse effects.
Age restrictions per tacrolimus labeling; duration typically 12 months.

ALL of the following

Apokyn (Apomorphine) - duplicate group consolidated with Apomorphine Injectable above; initial criteria as listed.

ALL of the following

Atovaquone - Initial approval: Patient has diagnosis and indication consistent with FDA-approved uses (e.g., Pneumocystis jirovecii pneumonia prophylaxis/treatment) or supported compendia.
Dose requested is within FDA- or compendia-supported dosing for the indication.
Approval duration typically 12 months; prescriber documentation of indication required.

ALL of the following

Acyclovir Topical - Initial approval: Patient has an FDA-labeled indication or compendia-supported indication for topical acyclovir.
Approval duration: 12 months.

ALL of the following

Actemra - Initial approval: Patient has an FDA-approved indication for the requested route/formulation (e.g., rheumatoid arthritis, systemic juvenile idiopathic arthritis, etc.).
Patient has an inadequate response, intolerance, or contraindication to conventional therapy when required by indication-specific guidelines (where applicable).
Initial approvals per indication; review Actemra renewal criteria separately. Coverage duration and dosing per labeling.

ALL of the following

Actemra - Renewal approval: Patient previously approved through plan criteria, and documentation of clinical benefit on therapy (reduced disease activity, symptom improvement).
No evidence of unacceptable toxicity or adverse effects that would require discontinuation.

ALL of the following

Aimovig - Initial approval: Patient has diagnosis of migraine.
Patient experiences 4 or more migraine headache days per month.
Agent is being used for migraine prophylaxis.
Patient will NOT be using the requested agent in combination with another CGRP antagonist for migraine prophylaxis.
Approval duration: 12 months; renewal requires evidence of clinical benefit and prior approval through plan criteria.

ALL of the following

Benign Prostatic Hyperplasia (Tadalafil 2.5 mg, 5 mg) - Initial approval: Patient has diagnosis of benign prostatic hyperplasia and tadalafil is prescribed at an appropriate dose (2.5 or 5 mg) for daily use.
Documentation of symptoms consistent with BPH and assessment using accepted symptom scores (e.g., AUA-SI) as available.
Approval duration per plan (commonly 12 months); prescriber and age restrictions per product labeling.

ALL of the following

Carglumic Acid - Initial approval: Patient has diagnosis consistent with N-acetylglutamate synthase deficiency or other FDA-approved indication.
Documentation of diagnostic testing or specialist confirmation supporting indication.
Coverage duration and dosing per labeling; prescriber specialty often required.

ALL of the following

Cayston (aztreonam inhalation) - Initial approval: Patient has cystic fibrosis with documented Pseudomonas aeruginosa airway infection or other FDA-approved indication.
Prescriber is pulmonologist or CF specialist (preferred).
Duration and cycle limits per labeling.

ALL of the following

Crysvita (burosumab) - Initial approval: Patient has one of the FDA-approved indications (e.g., X-linked hypophosphatemia [XLH] with radiographic and biochemical evidence of disease in pediatric/adult patients or tumor-induced osteomalacia per labeling).
ALL of the following
- Baseline serum phosphate and other relevant labs consistent with hypophosphatemia due to XLH or TIO.
- Documentation of previous management attempts as applicable (e.g., conventional therapy) and specialist confirmation (endocrinology/ metabolic bone disease).
Approval duration and dosing per indication/age; prescriber restriction to appropriate specialist.

ALL of the following

Dalfampridine - Initial approval: Patient has diagnosis of multiple sclerosis with walking impairment.
Prescriber documents baseline walking speed or functional assessment and intent to monitor benefit.
Prescriber restriction: neurologist preferred; coverage duration per plan and product labeling; contraindicated in patients with history of seizures or moderate/severe renal impairment.

ALL of the following

Dupixent - Initial approval (fragment consolidated): Patient has an FDA-approved indication for dupilumab (e.g., atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis) and meets indication-specific prerequisites per labeling or compendia (e.g., prior use of topical therapies for atopic dermatitis or high-dose inhaled corticosteroids for asthma when applicable).
Dose requested is within FDA- or compendia-supported dosing.
Approval duration typically 12 months; prescriber specialty and baseline labs as required by indication.

ALL of the following

Epidiolex - Initial approval: Patient has diagnosis of an FDA-approved seizure disorder (e.g., Lennox-Gastaut syndrome, Dravet syndrome, tuberous sclerosis complex) or compendia-supported indication.
Documentation of prior antiepileptic therapy trials as appropriate and baseline liver function tests per labeling.
Renewal requires evidence of clinical benefit; coverage duration per plan.

ALL of the following

Erythropoietin Stimulating Agents (Aranesp/Procrit/Retacrit) - Initial approval (selected elements): Patient has diagnosis of anemia due to chronic kidney disease, chemotherapy-induced anemia, or other covered indication per labeling/compendia.
ANY of the following
- Baseline hemoglobin and iron status documented; iron deficiency corrected if present.
- For chemo-induced anemia, documentation that anemia is due to chemotherapy and anticipated clinical benefit outweighs risks.
Dose and hemoglobin targets per guideline; monitoring and hematocrit/hemoglobin checks required during therapy.

ALL of the following

Fasenra - Initial approval: Patient has diagnosis of severe eosinophilic asthma or other FDA-approved indication and meets criteria (e.g., inadequate control on high-dose inhaled corticosteroids plus additional controller).
Documentation of eosinophil counts if required by indication-specific criteria.
Approval duration per plan; prescriber specialty preferred: pulmonology or allergy/immunology.

ALL of the following

Fentanyl Oral (lozenge) - Initial approval: Patient has documentation of opioid-tolerant status and indication appropriate for fentanyl transmucosal formulations (e.g., management of breakthrough cancer pain) per labeling.
Not for opioid-naive patients; quantity limits and documentation of opioid tolerance required; prescriber and payer safeguards apply.

ALL of the following

Fintepla - Initial approval: Patient has diagnosis of Dravet syndrome or other FDA-approved indication and meets specialty-specific prerequisites.
Documentation of prior antiepileptic therapies as appropriate and baseline labs per labeling.
Approval duration per plan; prescriber specialty recommended (neurology/epilepsy).

ALL of the following

Gammagard/Gamunex-C/Gammaplex (IVIG) - Initial approval (consolidated approval criteria): Patient has an FDA-approved indication for IVIG (e.g., primary immunodeficiency, immune thrombocytopenia where indicated, chronic inflammatory demyelinating polyneuropathy per guidelines) or a compendia-supported indication with specialist documentation.
ALL of the following
- Documentation of diagnosis, baseline severity measures, and prior therapies tried and failed when relevant.
- Dose requested and dosing interval consistent with FDA labeling or evidence-based guidelines for the indication.
Coverage duration and frequency vary by indication; Gammaplex coverage duration to be set per indication-specific rules. Prescriber specialty (immunology, neurology, hematology) preferred.

ALL of the following

Gaucher Enzyme Replacement (Cerezyme/Elelyso/Vpriv) - Initial approval: Patient has confirmed diagnosis of Gaucher disease and meets diagnostic and baseline criteria per specialty guidelines and FDA labeling.
Diagnosis confirmed by enzyme assay and/or genetic testing; specialist (metabolic/lysosomal storage disease) documentation required.
Dose and duration per labeling; prior authorization required for enzyme replacement therapies.

ALL of the following

Growth Hormone (Omnitrope) - Initial approval (children): Patient has FDA-approved pediatric indication (e.g., growth hormone deficiency, Turner syndrome, chronic renal insufficiency) with appropriate baseline auxologic measurements and endocrine evaluation.
Adults - Growth Hormone (Initial approval): Patient has FDA-approved adult indication (e.g., adult growth hormone deficiency) with documented biochemical testing and specialist endorsement (endocrinology).
Coverage duration and monitoring per labeling; prior therapy and height/IGF-1 criteria applied for pediatric approvals.

ALL of the following

HAE agents (Cinryze, Haegarda, Icatibant) - Initial approval: Patient has diagnosis of hereditary angioedema with documented C1-INH deficiency or functional deficiency as applicable and specialist confirmation (allergy/immunology).
Documentation of attack frequency/severity or need for prophylaxis per agent-specific labeling.
Prescriber specialty required; approval duration per agent labeling.

ALL of the following

High Risk Medications - Initial approval: Agents flagged as high-risk require prescriber justification, monitoring plan, and documentation of necessity consistent with the plan's high-risk medication management program.
Specific product-level rules apply (e.g., REMS, baseline labs).

ALL of the following

Imiquimod - Initial approval: Patient has an FDA-approved indication for topical imiquimod (e.g., superficial basal cell carcinoma, actinic keratosis, external genital warts) or compendia-supported use with documentation.
Approval duration typically 12 months; document site and prior therapies as applicable.

ALL of the following

Inbrija - Initial approval: Patient has diagnosis of Parkinson disease and levodopa-responsive motor fluctuations; Inbrija intended for intermittent treatment of OFF episodes as adjunctive therapy.
Prescriber documents prior management and that patient is on appropriate oral levodopa regimen.
Prescriber specialty preferred; duration per labeling.

ALL of the following

Ingrezza - Initial approval: Patient has diagnosis of tardive dyskinesia and meets criteria for treatment with valbenazine per labeling (e.g., documentation of moderate to severe TD and failed/intolerant to alternatives).
Prescriber specialty and baseline assessments required; duration per plan.

ALL of the following

Injectable Oncology (biosimilars listed) - Initial approval: Patient has cancer diagnosis appropriate for the requested biologic; indication and dosing match FDA labeling or compendia-supported regimens; biosimilar substitution per plan policy.
Oncology agents often require specialist prescriber and documentation of prior lines of therapy where applicable; coverage duration per regimen.

ALL of the following

Insulin Pen/Syringe Needle - Initial approval: Product will be used for insulin delivery and patient has used insulin within past 180 days (or documentation supports current need).
Approval duration: 12 months; this aligns with Alcohol Swabs PA logic for supplies used in insulin delivery.

ALL of the following

Deferasirox (Exjade/Jadenu) - Initial approval: Patient has transfusional hemosiderosis or other FDA-approved indication with documented iron overload and baseline labs (ferritin, liver/renal function).
Dose within labeling; prescriber specialty hematology recommended; monitoring per labeling.

ALL of the following

Ivermectin (cream/tablet) - Initial approval: Patient has FDA-approved indication (e.g., scabies for cream; strongyloidiasis or onchocerciasis for oral where indicated) or compendia-supported use with documentation.
Approval duration per indication; contraindications and age restrictions per labeling.

ALL of the following

Leuprolide - Initial approval: Patient has an FDA-approved indication (e.g., prostate cancer, central precocious puberty, endometriosis) with documentation of diagnosis and appropriate specialist prescriber.
Formulation-specific dosing and duration required; prior authorization per plan.

ALL of the following

Lidocaine topical products (ointment, patch, solution, cream, ZTlido) - Initial approval: Indication consistent with labeling (e.g., postherpetic neuralgia for patch) or compendia-supported use; documentation of diagnosis and prior therapies as applicable.
Duration and quantity limits per product; ZTlido may have distinct criteria.

ALL of the following

Lumryz - Initial approval: Patient has diagnosis of narcolepsy with cataplexy or idiopathic hypersomnia per product labeling and meets prerequisites for product use.
Specialty prescriber recommended; dosing per labeling; monitoring for adverse events required.

ALL of the following

Mavyret - Initial approval: Patient has chronic hepatitis C infection with genotype and disease stage appropriate for Mavyret per labeling or compendia; dosing within labeling.
Baseline HCV genotype, viral load, and liver staging documentation preferred; prescriber specialty hepatology/infectious disease recommended.

ALL of the following

Mifepristone - Initial approval: Indication and prescriber requirements per FDA labeling and plan policy; documentation of indication and adherence to REMS or risk mitigation if applicable.

ALL of the following

Migranal (dihydroergotamine) - Initial approval: Patient has diagnosis of migraine and appropriate acute therapy indications; contraindications (e.g., vasospastic disease, concomitant triptans) have been reviewed.
Route-specific criteria and quantity limits apply.

ALL of the following

Modafinil - Initial approval: Patient has diagnosis supporting use (e.g., narcolepsy, shift work sleep disorder, obstructive sleep apnea with residual excessive sleepiness) and meets labeling criteria including prescriber documentation.
Quantity limits and prior therapy documentation may be required.

ALL of the following

Ocaliva (obeticholic acid) for PBC - Initial approval: Patient has primary biliary cholangitis and documentation of inadequate response or intolerance to ursodeoxycholic acid (UDCA) unless UDCA contraindicated; baseline liver tests and monitoring plan per labeling.
Ocaliva has boxed warning and dose adjustments for advanced liver disease; prescriber specialty hepatology required.

ALL of the following

Ofev (nintedanib) - Initial approval: Patient has an FDA-approved fibrotic interstitial lung disease indication (e.g., idiopathic pulmonary fibrosis) or systemic sclerosis-associated ILD per labeling/compendia; documentation of baseline pulmonary function tests.
Coverage duration and monitoring per labeling; prescriber specialty pulmonology recommended.

ALL of the following

Otezla (apremilast) - Initial approval: Patient has an FDA-approved indication (psoriatic arthritis, plaque psoriasis) and meets prior-therapy requirements where applicable (e.g., response to topical or systemic agents per indication).
Dose within labeling; duration per plan.

ALL of the following

Palynziq, Panretin, Pegylated Interferon, Pirfenidone, Posaconazole, and Opioid ER agents - Initial approval: Follow indication-specific rules: document diagnosis, prior therapies, and specialist involvement where required; adhere to class-level patterns for prior authorization (e.g., specialty prescriber, monitoring plans, contraindications).

ALL of the following

Pirfenidone - Initial approval: Patient has idiopathic pulmonary fibrosis per labeling with baseline pulmonary function testing and specialist confirmation; prescriber documents intent to monitor for adverse effects.
Prescriber restriction and duration: pulmonology preferred; coverage duration per plan and labeling.

ALL of the following

Posaconazole - Initial approval: Patient has indication supported by FDA labeling (e.g., antifungal prophylaxis in high-risk patients) or compendia; documentation of indication and dosing requested.
Coverage duration: set per indication (e.g., prophylaxis duration tied to neutropenia period).

ALL of the following

Prolia - Initial approval: Patient has diagnosis of osteoporosis with documentation of fracture risk or prior fracture, bone mineral density T-score consistent with indication, and meets baseline requirements including calcium/vitamin D repletion as appropriate.
Additional baseline requirements: document prior use of or contraindication to alternative therapies if required by policy; prescriber specialty (endocrinology/osteoporosis) recommended.
Initial coverage duration per dosing schedule; follow coverage durations and re-dosing intervals per plan.

ALL of the following

Promacta (eltrombopag) - Initial approval: Indications include immune thrombocytopenia (ITP) and other FDA-approved uses; initial approval requires documentation of diagnosis, baseline platelet counts, and prior therapies as applicable (e.g., corticosteroids, IVIG) or rationale for use in other indications per compendia.
Other initial indications: document indication-specific prerequisites and prescriber specialty (hematology).
Coverage durations vary by indication; ensure duration matches policy guidance.

ALL of the following

Pulmonary Hypertension agents (Adempas, Ambrisentan, Bosentan, Opsumit [macitentan], Sildenafil, Tadalafil, Ventavis) - Initial approval general themes: Patient has documented pulmonary arterial hypertension or other FDA-supported pulmonary hypertension subgroup per WHO group classification; prescriber is a pulmonologist or cardiologist with pulmonary hypertension expertise; baseline hemodynamic testing and functional class documentation where appropriate.
Coverage duration per agent and indication; monitoring and REMS (for endothelin receptor antagonists) apply.

ALL of the following

Pyrukynd - Initial approval: Patient has Huntington disease with chorea and meets labeling criteria; prescriber specialty neurology; documentation of baseline disease severity.
Prescriber restriction and duration per product labeling and plan policy.

ALL of the following

Quinine - Initial approval: Patient has an FDA or compendia-supported diagnosis for quinine use (e.g., severe nocturnal leg cramps where covered by policy) with documentation and review of alternatives; contraindications reviewed.
Coverage duration specified per diagnosis in policy; ensure documentation of benefit if renewal requested.

ALL of the following

Regranex - Initial approval: Patient has diabetic neuropathic foot ulcer meeting size/depth criteria, and standard wound care has been attempted or is being provided; documentation from wound care specialist preferred.
Duration per course as defined by product labeling and policy.

ALL of the following

Repatha (evolocumab) - Initial approval: Patient meets one of the LDL-lowering or cardiovascular indications consistent with FDA labeling or compendia: heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, clinical ASCVD requiring additional LDL lowering, primary hyperlipidemia, or compendia-supported uses.
ALL of the following
- Documentation of baseline lipid panel and statin/intolerance history as applicable (e.g., maximally tolerated statin therapy tried and documented).
- Prescriber restriction: lipid specialist or cardiologist preferred for primary/complex indications; coverage duration per plan (often 12 months).
PCSK9 agent general initial approval fragments and renewal criteria apply; renewal requires LDL response or ongoing clinical justification.

ALL of the following

Rezurock - Initial approval: Patient has indication supported by FDA labeling (e.g., chronic graft-versus-host disease) with specialist documentation and prior therapy history per label.
Renewal criteria exist separately; prescriber specialty required.

ALL of the following

Sapropterin - Renewal criteria: Ensure continued benefit for phenylketonuria management; initial approval criteria are separate (not fully enumerated here).

ALL of the following

Self-Administered Oncology (general criteria) - Initial approval: Patient has cancer diagnosis appropriate for the requested self-administered oncology agent; regimen, dosing, and indication consistent with FDA labeling or compendia; prescriber documentation of plan for administration/monitoring at home.
Large list of self-administered oncology drugs follow this pattern; specialist prescriber required and supportive documentation necessary.

ALL of the following

Sivextro (tedizolid) - Initial approval: Patient has indication supported by FDA labeling (e.g., acute bacterial skin and skin structure infections) with documentation of diagnosis and prior antimicrobial therapy where applicable.

ALL of the following

Somatostatin Analogs - Lanreotide (Somatuline Depot) and Octreotide (Octreotide Acetate) - Initial approval: Patient has an FDA-approved indication (e.g., neuroendocrine tumors, acromegaly where applicable) with specialist documentation and relevant baseline studies.
Dosing and coverage duration per indication and product labeling.

ALL of the following

Somavert (pegvisomant) - Initial approval: Patient has acromegaly with inadequate control on or intolerance to other therapies; endocrine specialist documentation and baseline IGF-1 evaluations required.

ALL of the following

Yargesa (miglustat) - Initial approval: Patient has a substrate reduction therapy indication per labeling (e.g., Niemann-Pick Type C) with specialist documentation and genetic/diagnostic confirmation required.

ALL of the following

Teriparatide and Tymlos (abaloparatide) - Initial approval: Patient has osteoporosis meeting criteria for anabolic therapy (e.g., very high fracture risk, failure of or intolerance to antiresorptive therapy) with BMD, fracture history, and prior therapy documentation as required.
Coverage duration and prior use rules: teriparatide coverage duration limits and prior use requirements apply; follow policy for cumulative anabolic therapy duration limits.

ALL of the following

Trelstar (leuprolide) - Initial approval: Patient has an FDA-approved indication with documentation; prescriber specialty and dosing per labeling.

ALL of the following

Sodium Phenylbutyrate - Initial approval: Patient has urea cycle disorder indication with specialist documentation; prescriber restriction applies.

ALL of the following

Viberzi - Initial approval: Patient has diagnosis of irritable bowel syndrome with diarrhea (IBS-D) and meets plan-specific prerequisites and contraindication screening (e.g., not used in patients without gallbladder).

ALL of the following

Vowst - Initial approval: Patient meets criteria for fecal microbiota, live-jslm (recurrent C. difficile) per labeling and prescriber restriction; documentation of recurrent C. difficile episodes and prior therapies required.
Prescriber restriction and coverage duration apply.

ALL of the following

Xdemvy - Coverage duration: initial coverage durations specified per indication; initial approval requires indication documentation per labeling (e.g., atopic dermatitis).

ALL of the following

Xifaxan - Initial approval: Patient has an FDA-approved indication (e.g., hepatic encephalopathy, IBS-D, traveler’s diarrhea) with documentation of diagnosis and prior therapies as applicable.

ALL of the following

Ztalmy - Initial approval: Patient has trigeminal neuralgia or other approved indication per labeling and meets prescribing prerequisites; documentation of diagnosis and prior therapies as applicable.

General Biologic Immunomodulators - Renewal approval (common): Patient has been previously approved through PA criteria; has an FDA labeled indication; has had clinical improvement (slowing of disease progression or decrease in symptom severity/frequency); will NOT be using in combination with another biologic immunomodulator; dose within FDA labeled dosing

Biologic Immunomodulators PA - Renewal approval (Stelara / Rinvoq / Humira examples): Patient was previously approved; has FDA labeled indication; has had clinical improvement; will not be used in combination with another biologic immunomodulator; dose within labeled dosing

Emgality - Renewal approval: Patient previously approved; if migraine ensure not using in combination with another CGRP agent for prophylaxis; if episodic cluster headache patient has had clinical benefit

Cayston / Tobramycin Neb - Renewal approval: Previously approved through PA criteria; diagnosis of cystic fibrosis; had clinical benefit; will NOT be using in combination with another inhaled antibiotic unless prescriber documents switching or justification for concurrent/alternating therapy

Arcalyst - Renewal pattern: For agents with initial 'will NOT be used in combination with another biologic agent' the renewal requires prior approval, same diagnosis, clinical benefit, and continued absence of combination biologic use

IVIG / Gammaplex - Renewal approval: Previously approved through PA criteria; meets one of listed diagnosis categories; patient has had clinical benefit where required; duration rules apply per indication (some 6 months)

Pulmonary Hypertension agents - Renewal approval common requirements: Previously approved through PA criteria; has FDA labeled indication (or compendia-supported where stated); patient has had clinical benefit with the requested agent

Dupixent - Renewal approval: Previously approved through PA criteria; meets one of the labeled diagnoses; not using in combination with another biologic or JAK inhibitor for the indication; had clinical benefit; dose within FDA labeled dosing

Fasenra - Renewal approval: Previously approved; diagnosis (severe asthma with eosinophilic phenotype or EGPA) with continuing asthma or maintenance therapy or intolerance branch; patient had clinical benefit; not used in combination with Xolair/Dupixent/another IL-5 inhibitor; dose within labeling

Dalfampridine - Renewal criteria: Previously approved through PA criteria; diagnosis MS; continued use with disease modifying agent or intolerance/contraindication to DMT; patient has had improvement or stabilization in timed walking speed (timed 25-foot walk)timed 25-foot walk improvement

Palynziq / Sapropterin - Renewal criteria: Previously approved through PA criteria; PKU diagnosis; blood Phe levels maintained or decreased from baseline; will NOT be used in combination with the other PKU agent; dose within labelingblood Phe improvements

Gaucher enzyme replacement - Renewal approval: Previously approved; diagnosis of GD1; improvement and/or stabilization in at least one of hemoglobin, platelet count, liver volume, spleen volume, growth velocity, bone pain/disease; dose within FDA labeled dosingimprovement/stabilization evidence

Crysvita - Renewal criteria: Previously approved through PA criteria; diagnosis XLH or TIO and demonstrates improvement in listed clinical or radiographic outcomes; dose within FDA labelingclinical/radiographic improvement

Ofev / Pirfenidone - Renewal criteria: Previously approved; diagnosis of IPF or specified ILD; patient has had clinical benefit with the requested agentclinical benefit

Trikafta - Renewal criteria: Previously approved through PA criteria; diagnosis of cystic fibrosis; patient has had improvement or stabilization (FEV1, weight/BMI, CFQ-R, reduced exacerbations); will NOT be using in combination with another CFTR modulatorclinical benefit/stabilization

IV antifungals (Cresemba/Posaconazole/ Voriconazole) - Renewal criteria pattern: Previously approved through PA criteria; continued indicators of active disease (radiologic findings, cultures, serum biomarkers) or continued severe immunocompromise for prophylaxis; patient has had clinical benefit where applicablecontinued indicators of active disease

Biologic immunomodulators (Riabni/Ruxience/etc.) - Renewal: Previously approved; FDA labeled indication or compendia-supported indication; evidence of current treatment OR prescriber attestation; patient has had clinical improvement; will NOT be used in combination with another biologic immunomodulator; dose within labeling; additional safety screening (HBsAg/anti-HBc) where specifiedHBsAg/anti-HBc screening where specified

Xolair - Renewal approval (detailed): Previously approved through PA criteria; clinical benefit per indication branch (asthma, chronic idiopathic urticaria, nasal polyps, IgE-mediated food allergy); will NOT be used in combination with Dupixent or injectable IL-5 inhibitor; dose within labelingclinical benefit

Vyndamax/Vyndaqel - Renewal criteria: Previously approved through PA criteria; diagnosis ATTR-CM; used to reduce CV mortality/hospitalization; patient has had clinical benefit; will NOT be using another tafamidis formulation in combinationclinical benefit

General renewal requirements (common pattern summary): For most agents renewal requires: prior plan approval; FDA labeled indication (or compendia-supported); documentation of clinical benefit (improvement/stabilization or continued indicators of disease activity as appropriate); no prohibited combinations; dose within FDA labeled dosing

Mutual exclusion for PKU agents

Prohibition: topical retinoids cosmetic exclusion: Requested topical retinoid (tazarotene, tretinoin) will NOT be used for cosmetic purposes; if cosmetic use, PA excluded/denied

Cosmetic use exclusion

Age-based PA non-applicability: Benzodiazepines and High Risk Medications: PA does NOT apply to patients less than 65 years of age for many benzodiazepine groups and high-risk medication PA does NOT apply to patients less than 65 years of age<65 years

Benzodiazepines groups (Clobazam, Clorazepate, Diazepam, Lorazepam, Oxazepam, Sympazan) and High Risk Medications

Age-based PA non-applicability: Memantine PA: PA does NOT apply to patients greater than or equal to 30 years of age (memantine ER and memantine) - policy applies to patients younger than 30>=30 years excluded

Memantine PA age rule

Prohibition: Combination of Linezolid and Sivextro (tedizolid): Patient will NOT be using Linezolid in combination with Sivextro (tedizolid) for the same infection

Infectious agents combination prohibition

Prohibition: Sivextro and Linezolid concurrent use: Sivextro: Patient will NOT be using the requested agent in combination with linezolid for the same infection

Mutual prohibition

Prohibition: Fentanyl (lozenge/patch/other) concurrent fentanyl agents: Patient will NOT be using the requested agent in combination with any other oral or nasal fentanyl agent

Opioid ER combination prohibition

Prohibition: Teriparatide / Tymlos / other PTH analog combinations: Patient will NOT be using teriparatide or Tymlos in combination with a bisphosphonate, denosumab (Prolia/Xgeva), romosozumab, or another parathyroid hormone analog for the requested indication

Bone agent combination prohibition

Prohibition: CFTR modulators combination: CFTR modulator agents (Kalydeco, Orkambi, Trikafta, others) — patient will NOT be using the requested agent in combination with another CFTR modulator agent for the requested indication

CFTR modulator combination prohibition

Prohibition: iron chelator combination: Deferasirox (Exjade/Jadenu): patient will NOT be using the requested agent in combination with another iron chelating agent (e.g., deferiprone) for the requested indication

Prohibition: erythropoietin Part B vs Part D and concomitant restrictions: Some agents are subject to Part B vs Part D review; concurrent therapy restrictions per agent apply and documented in agent-specific criteria

Billing/coverage note rather than clinical combination

Prohibition: HAE agents combination: HAE agents: for acute treatment or prophylaxis, patient will NOT be using the requested agent in combination with another HAE agent indicated for the same treatment intent

Cinryze, Haegarda, Icatibant clauses

Prohibition: Iron chelators, PCSK9, biologic immunomodulators, HAE agents - summary: Across multiple groups the policy explicitly prohibits use of the requested agent in combination with another agent of the same class or specific named agents as noted in each group's criteria

Aggregate prohibition node

Common denial‑risk conditions and exclusions the provider should note include: use in disallowed combinations (e.g., dual biologic immunomodulators, CGRP combination for migraine, concomitant PCSK9 with another PCSK9, HAE agents used together), requests for cosmetic use of topical retinoids, and explicit FDA‑labeled contraindications. Other frequent denial drivers are missing required objective data (e.g., baseline labs, genetic testing, hemodynamic confirmation for PAH), failure to show required prior therapy trials or intolerance to preferred/prerequisite agents, and age exclusions where the PA does not apply (examples: benzodiazepine PAs often do not apply under 65).

Aimovig: renewal requires prior approval and documentation that the patient has had clinical benefit (see Aimovig PA).

Arikayce: renewal requires prior approval and documentation of clinical benefit (see Arikayce PA).

Benlysta: renewal requires prior approval, ongoing standard therapy, and documentation of clinical benefit (see Benlysta SC PA).

If no recent claim, prescriber attestation with clinical justification may be accepted per the PA group's alternative pathways.

Documentation Required

Specialist prescriber requirement for select agents

Certain agents require that the prescriber be a relevant specialist or that the prescriber documents a specialist consultation. Examples: Arikayce requires an infectious disease/pulmonology/thoracic specialist (or consult); Apokyn (apomorphine) requires a neurologist or specialist consultation; many biologic immunomodulators require a specialist or documentation that the prescriber consulted a specialist.

Arikayce — infectious disease, pulmonology, or thoracic specialist (or consult).
Apokyn (apomorphine injection) — neurologist or specialist consultation required.
Many biologic immunomodulators (e.g., Actemra/Cosentyx/Enbrel/etc.) require specialist prescribers or documentation that the prescriber consulted a specialist.

Documentation Required

Baseline and monitoring data required (agent-specific)

Many agents require baseline tests or monitoring data as part of initial approval and renewals. Attach lab results and dates with the PA request. Examples and agent-specific requirements are listed below.

Androgen therapies — document pretreatment or current testosterone levels as specified (total serum testosterone <300 ng/dL or below lab lower limit where applicable).
Growth hormone — submit IGF-1 and results of GH stimulation tests (failure definitions noted) and growth metrics for children.
HBV screening — selected biologics (e.g., Riabni/Ruxience) require HBsAg and anti-HBc screening prior to therapy and management where indicated.
Cystagon — baseline white blood cell (WBC) cystine level required prior to initiation.
Fintepla — echocardiogram assessment required before and during treatment.
Prolia/Xgeva — pretreatment or current calcium level required (must be within lab normal range or corrected prior to use).
Palynziq — baseline blood phenylalanine (Phe) level required prior to initiation.

Denial Risk

Combination therapy prohibitions (denial risk)

The policy explicitly prohibits certain concurrent combinations — requests for such combinations will be denied.

No concurrent biologic immunomodulators (many biologic PA groups require the agent NOT be used in combination with another biologic).
No concurrent PCSK9 agents (e.g., Repatha/X other PCSK9) — PCSK9 class prohibition.
Sapropterin must NOT be used in combination with Palynziq for PKU therapy.
Linezolid must NOT be used in combination with Sivextro (tedizolid) for the same infection.
Teriparatide must NOT be used in combination with denosumab (Prolia/Xgeva), romosozumab, or other PTH analogs for the same indication.

Billing Rule

Coverage duration & billing notes

Approvals have defined durations and billing notes. Common rules: most approvals are for 12 months; some agents or indications have shorter initial durations or different renewal windows. Part B vs Part D billing may apply for selected agents (e.g., IVIG products). Requested doses must be within FDA labeling or supported by CMS compendia.

Common coverage duration: 12 months for many agents (explicit in many PA groups).
Exceptions: some initial approvals are shorter (examples: colony stimulating factors — 6 months; Dalfampridine initial 3 months; Palynziq initial 9 months per its PA).
IVIG/selected agents (e.g., Gammaplex/Gammagard) are subject to Part B versus Part D review — bill accordingly.
Requested dose must be within FDA labeled dosing for the requested indication or supported in CMS approved compendia.

Documentation Required

Evidence of ongoing therapy or prescriber justification

Provide evidence that the patient is currently on therapy or, if no recent claim exists, provide a prescriber attestation including clinical justification. Evidence pathways commonly accept a claim within 90 or 180 days or a signed prescriber attestation.

Acceptable evidence: a claim showing treatment within past 90 days (many biologics) or 180 days where specified.
If no claim, prescriber attestation that the patient is currently treated plus clinical justification that changing therapy would risk the patient is accepted.
This requirement applies to initial approval pathways and renewals for many PA groups.

Documentation Required

Opioid ER & Controlled Substance checks

Opioid ER and other controlled substance ER agents require additional documentation: PDMP review and formal pain management documentation. These agents are not intended for PRN use and require consultative evaluation and a patient-specific pain management plan.

State PDMP review is required and prescriber must determine opioid/controlled substance history does not indicate high overdose risk.
A formal consultative evaluation (diagnosis and full medication history) and a patient-specific pain management plan must be on file.
Requests for opioid ER agents should not be for PRN (as-needed) use; evidence of current treatment (claim within lookback window) or prescriber attestation is required.