CurrentPacificSource Health PlansPolicy N/A

2026 PacificSource Health Plans Prior Authorization Criteria

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Prior authorization criteria for a broad range of pharmacy and specialty drugs, biologics, gene and cell therapies, infusions, and related services submitted by providers.

Policy Summary

PayerPacificSource Health Plans

Policy2026 PacificSource Health Plans Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with the applicable clinical documentation, laboratory results, treatment history, and specialist information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsDefault initial authorization

24 monthsDefault renewal authorization

AnnualMinimum review frequency

1–2 monthsTypical update frequency

451 pages

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CurrentPacificSource Health PlansPolicy N/A

2026 PacificSource Health Plans Prior Authorization Criteria

Customize your policy alerts

Sign up for all pacificsource policy alerts

Know when pacificsource releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Prior authorization criteria for a broad range of pharmacy and specialty drugs, biologics, gene and cell therapies, infusions, and related services submitted by providers.

Policy Summary

PayerPacificSource Health Plans

Policy2026 PacificSource Health Plans Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with the applicable clinical documentation, laboratory results, treatment history, and specialist information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsDefault initial authorization

24 monthsDefault renewal authorization

AnnualMinimum review frequency

1–2 monthsTypical update frequency

451 pages

Covered Uses and Medical Necessity

Actimmune

Covered when the applicable indication and all indication-specific requirements are met.

Covered indication: FDA-approved indication not excluded by plan design; chronic granulomatous disease; severe malignant osteopetrosis; or NCCN indication with evidence level 2A or higher.

Required documentation and regimen: Document BSA and prescribed dose; for pediatric patients with BSA less than 0.5 m², document weight and dose; use disease-specific diagnostic confirmation and specialist oversight; for CGD, use antibacterial and antifungal prophylaxis; and round to the nearest vial within 10% of the prescribed dose.

Addyi and Vyleesi

Covered when all HSDD criteria are met.

HSDD diagnosis: Patient has acquired, generalized HSDD with clinically significant distress or interpersonal difficulty for at least 6 months; at least 3 sexual-interest/arousal domains are absent or significantly reduced; and symptoms are not attributable to another medical or psychiatric condition, relationship distress, medication, substance use, or other significant stressor.At least 3 domains; at least 6 months

Administrative requirements: Treatment is not for a male patient or to enhance sexual performance, and prescribing is by or in consultation with a mental health provider.

Vyleesi is limited to premenopausal women; Addyi is for women younger than 65 years.

Revcovi for ADA-SCID

Covered when all ADA-SCID requirements are met.

Diagnosis and laboratory confirmation: ADA-SCID is confirmed by biallelic pathogenic ADA variants and at least one qualifying laboratory abnormality involving ADA, dATP, ATP, S-adenosylhomocysteine hydrolase, or 2′-deoxyadenosine.

Treatment alternatives: Gene therapy and matched sibling or family-donor hematopoietic cell transplantation are unavailable, or gene therapy or transplantation was unsuccessful.

Adzynma for congenital TTP

Covered for severe congenital TTP when all diagnostic and regimen requirements are met.

Diagnosis: Severe congenital TTP is confirmed by homozygous or compound heterozygous ADAMTS13 variants and ADAMTS13 activity below 10% of normal.ADAMTS13 activity <10% of normal

Treatment type: For on-demand treatment, document a current or past acute event with platelet reduction of at least 50% or platelet count below 100,000/microliter and LDH above twice baseline or the upper limit of normal; OR for prophylaxis, document at least one prior TTP event.

Scenesse for EPP

Covered when all EPP requirements are met.

EPP diagnosis and severity: Patient is at least 18 years old; EPP is confirmed by biallelic FECH loss-of-function mutations; total erythrocyte protoporphyrin is elevated with at least 85% metal-free protoporphyrin; and phototoxic reactions cause functional dysfunction and significant impact on activities of daily living.Age ≥18 years; ≥85% metal-free protoporphyrin

Afinitor and everolimus

Covered when the applicable FDA-approved, NCCN, or TSC criteria are met.

Covered indication: FDA-approved indication not excluded by plan design; NCCN indication with evidence level 2A or higher; or TSC with treatment-resistant epilepsy or symptomatic SGCT/SEGA in a patient who is not a good surgical candidate.

Indication-specific requirements: For TSC treatment-resistant epilepsy, document failure of two antiepileptic regimens, failure of adjunct Epidiolex, and use of Afinitor Disperz as adjunct therapy; oncology requests require performance status, prior therapies, and treatment regimen.

Lemtrada for relapsing MS

Covered when all relapsing-MS requirements are met.

Diagnosis and prior therapy: Relapsing-remitting MS or active secondary progressive MS is diagnosed under revised McDonald criteria with MRI evidence, and the patient has failed or not tolerated rituximab or established Ocrevus treatment.

Safety and continuation: HIV infection, active infection, and concurrent MS disease-modifying medication are absent. Reauthorization requires provider attestation of treatment success.

Lumizyme for Pompe disease

Covered when all Pompe disease requirements are met.

Diagnosis and clinical manifestations: Pompe disease is confirmed by deficient acid alpha-glucosidase activity or GAA mutation testing, and the patient has at least one clinical sign or symptom.At least 1 clinical sign or symptom

Administration: Emergency medical support for anaphylaxis, severe allergic reaction, or acute cardiorespiratory failure is available; concurrent enzyme-replacement therapy is avoided; and dose rounding is within 10% of the prescribed dose.

Pompe disease

Covered when all applicable requirements are met.

Alglucosidase alfa: Confirmed Pompe disease; one or more clinical signs or symptoms; emergency medical support available during administration; and prescribing by or consultation with a qualified metabolic or endocrine specialist.Dose rounding to nearest vial within 10%

Severe diarrhea-predominant IBS

Covered when all applicable requirements are met.

Alosetron: Woman aged 18 years or older with chronic diarrhea-predominant IBS for at least 6 months; severe abdominal symptoms, urgency, fecal incontinence, or activity-limiting disability; other gastrointestinal causes excluded; inadequate response to loperamide, dicyclomine, hyoscyamine, and amitriptyline or nortriptyline; and gastroenterologist involvement.Age ≥18 years; symptoms ≥6 months

AAT deficiency augmentation

Covered when all applicable requirements are met.

Alpha-1 proteinase inhibitor augmentation: Adult has severe congenital AAT deficiency with a qualifying high-risk phenotype, clinically evident emphysema or COPD, qualifying FEV1, documented nonsmoking status, and pulmonologist involvement.AAT ≤11 mmol/L; FEV1 30%-65% predicted, or 66%-80% predicted with decline ≥100 mL/year

Dose is 60 mg/kg intravenously once weekly.

Lambert-Eaton myasthenic syndrome

Covered when all applicable requirements are met.

Amifampridine: Patient is at least 6 years old with confirmed LEMS, compatible proximal muscle weakness with or without autonomic features and areflexia, inadequate response or intolerance to a specified prior regimen unless active SCLC-LEMS, and neurologist or oncologist involvement.Age ≥6 years; CMAP increase ≥60% after maximum voluntary contraction or at 50 Hz

Systemic lupus erythematosus

Covered when all applicable requirements are met.

Anifrolumab: Adult has moderate-to-severe autoantibody-positive SLE, has failed at least 12 weeks of hydroxychloroquine or chloroquine combined with cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil, has failed at least 12 weeks of subcutaneous Benlysta, and is managed by a rheumatologist or experienced SLE specialist.Each required prior treatment ≥12 weeks

Chemotherapy-induced nausea and vomiting prophylaxis

Covered when all applicable requirements are met.

Rolapitant prophylaxis: Adult is receiving an initial or repeat course of highly or moderately emetogenic chemotherapy; the planned regimen is documented; and treatment failure with a 5-HT3 antagonist plus dexamethasone during the current regimen is documented.1 dose per 14 days; age ≥18 years

Coverage is for prophylaxis, not acute or breakthrough nausea and vomiting.

Hemophilia and von Willebrand disease

Covered for qualifying hemophilia A, hemophilia B, or VWD indications when product-specific requirements are met.

Diagnosis and indication: Document qualifying hemophilia A, hemophilia B, or VWD; factor level or activity; current weight; dose rationale; baseline and current laboratory information; Bethesda titer and recent bleeding history; and an acute bleeding, perioperative, or routine prophylaxis indication.

Product requirements: Meet product-specific preferred-product, contraindication, severity, FDA-label, and specialist requirements.

Antihemophilic factor coverage

Antihemophilic factors are covered when the applicable indication, product-specific clinical criteria, documentation, and restrictions are met.

General criteria: The requested product is medically necessary for the applicable hemophilia or VWD indication, supported by laboratory titer levels, dose and bleed history, and consistent with the FDA label.

Non-preferred product qualification: Document intolerable adverse events to all preferred products, with the event not attributable to an expected active-ingredient effect; OR document current treatment with the non-preferred product outside samples or manufacturer assistance programs.

Antithymocyte globulin coverage

Antithymocyte globulins are covered when the applicable indication and required medical information are documented.

General requirements: Use is an FDA-approved indication, an NCCN indication with evidence level 2A or better, or a specified compendia-supported use; submit a complete treatment plan, current weight, dose, frequency, and duration.NCCN evidence level 2A or better; vial rounding within 10%

Covered clinical use: Covered use includes transplant rejection treatment or prophylaxis, qualifying aplastic anemia, graft-versus-host disease prophylaxis, or qualifying oncology use.

Antithrombin III coverage

Antithrombin III is covered when the laboratory diagnosis and indication-specific criteria are met.

Laboratory confirmation: Document hereditary antithrombin deficiency confirmed by antithrombin activity below 70% on a functional assay; testing must not occur during acute illness, surgery, or an acute thromboembolic event.AT activity <70%

Covered indication: Treatment is for perioperative thromboprophylaxis with heparin, peripartum thromboembolism prevention, or prevention or treatment of thromboembolism meeting the applicable alternative-anticoagulant criteria.

All-indication diagnostic criteria

Covered when the patient has documented hereditary antithrombin deficiency.

Diagnostic confirmation: Document hereditary antithrombin deficiency confirmed by antithrombin activity below 70% on a functional assay obtained outside acute illness, surgery, or a thromboembolic event.AT activity <70%

Perioperative thromboembolism prevention

For prevention of perioperative thromboembolism:

Perioperative prevention: Use antithrombin III first-line for perioperative thromboprophylaxis in combination with heparin, with or without intent to bridge to warfarin.

Peripartum thromboembolism prevention

For prevention of peripartum thromboembolism, document at least one qualifying pathway.

Peripartum pathway: Personal or family history of thrombosis.

Alternative pathway: Insufficient response to heparin and intolerance to direct oral anticoagulants.

Initial therapy and covered indications

Covered when all of the following are met.

Laboratory confirmation: Document hereditary antithrombin deficiency with antithrombin activity below 70% on a functional assay obtained outside acute illness, surgery, or a thromboembolic event.AT activity <70%

Covered indication

Perioperative: Use first-line with heparin, with or without planned bridging to warfarin.
Peripartum: Document personal or family thrombosis history, or insufficient response to heparin with DOAC intolerance.

Perioperative thromboembolism prevention

Covered for prevention of perioperative thromboembolism when the treatment regimen is appropriate.

Perioperative regimen: Use antithrombin III first-line in combination with heparin, with or without intent to bridge to warfarin.

Peripartum thromboembolism prevention

Covered when one qualifying pathway is documented.

Peripartum pathway: Personal or family history of thrombosis.

Alternative pathway: Insufficient response to heparin and intolerance to direct oral anticoagulants.

Hereditary antithrombin deficiency confirmation

When hereditary antithrombin deficiency is the basis for treatment, all laboratory confirmation conditions must be met.

Confirmed deficiency: Document hereditary antithrombin deficiency confirmed by antithrombin activity below 70% on a functional assay obtained outside acute illness, surgery, or a thromboembolic event.<70%

Perioperative thromboprophylaxis

For perioperative thromboprophylaxis:

Perioperative regimen: Use antithrombin III first-line with heparin, with or without intent to bridge to warfarin.

Peripartum thromboprophylaxis

For peripartum thromboembolism prevention:

Qualifying pathway: Personal or family history of thrombosis.

Alternative pathway: Insufficient response to heparin and intolerance to direct oral anticoagulants.

Diagnostic confirmation

Covered when the diagnosis is confirmed.

Confirmed deficiency: Document hereditary antithrombin deficiency with activity below 70% on a functional assay; testing must not occur during acute illness, surgery, or a thromboembolic event.<70%

Perioperative thromboembolism prevention

For prevention of perioperative thromboembolism:

Perioperative prophylaxis: Use antithrombin III first-line with heparin, with or without intent to bridge to warfarin.

Peripartum thromboembolism prevention

For prevention of peripartum thromboembolism:

Qualifying pathway: Personal or family history of thrombosis.

Alternative pathway: Insufficient response to heparin and intolerance to direct oral anticoagulants.

Prevention of thromboembolism

Covered when diagnosis and laboratory confirmation are documented.

Diagnosis and confirmation: Document hereditary antithrombin deficiency confirmed by antithrombin activity below 70% on a functional assay obtained outside acute illness, surgery, or a thromboembolic event.<70%

Prevention of perioperative thromboembolism

Covered for perioperative thromboprophylaxis when the regimen is appropriate.

Perioperative regimen: Use antithrombin III first-line in combination with heparin, with or without intent to bridge to warfarin.

Prevention of peripartum thromboembolism

Covered when at least one peripartum pathway is documented.

Peripartum pathway: Personal or family history of thrombosis.

Alternative pathway: Insufficient response to heparin and intolerance to direct oral anticoagulants.

Perioperative prevention

Covered for perioperative thromboembolism prevention.

Perioperative prophylaxis: Use antithrombin III first-line with heparin, with or without intent to bridge to warfarin.

Peripartum prevention

Covered when at least one pathway is documented.

Peripartum pathway: Personal or family history of thrombosis.

Alternative pathway: Insufficient response to heparin and intolerance to direct oral anticoagulants.

Confirmed hereditary antithrombin deficiency

Covered when the diagnosis is confirmed.

Confirmed hereditary deficiency: Document hereditary antithrombin deficiency confirmed by activity below 70% on a functional assay obtained outside acute illness, surgery, or an acute thromboembolic event.<70%

Prevention of thromboembolism

Covered for prevention of thromboembolism when the documentation is met.

Deficiency and alternative therapy: Document hereditary antithrombin deficiency with activity below 70% on a qualifying functional assay and inadequate response, intolerance, or contraindication to DOACs.<70%

Perioperative thromboembolism prevention

Covered as an approved first-line regimen.

Perioperative prophylaxis: Use antithrombin III with heparin for perioperative thromboprophylaxis, with or without intent to bridge to warfarin.

Peripartum thromboembolism prevention

Covered when one pathway is documented.

Peripartum pathway: Personal or family history of thrombosis.

Alternative pathway: Insufficient response to heparin and intolerance to direct oral anticoagulants.

Perioperative prophylaxis

Approved first-line for perioperative thromboprophylaxis.

Perioperative use: Use antithrombin III in combination with heparin, with or without intent to bridge to warfarin.

Peripartum prophylaxis

Covered when one pathway is documented.

Peripartum pathway: Personal or family history of thrombosis.

Alternative pathway: Insufficient response to heparin and intolerance to direct oral anticoagulants.

General thromboembolism prevention

Coverage requires documentation of inadequate response, intolerance, or contraindication to DOACs.

Need for antithrombin III: Inadequate clinical response to DOACs.

Need for antithrombin III: Intolerance to DOACs.

Need for antithrombin III: Contraindication to DOACs.

Prevention of Perioperative Thromboembolism

Covered for prevention of perioperative thromboembolism.

Perioperative regimen: Use antithrombin III first-line with heparin, with or without intent to bridge to warfarin.

Prevention of Peripartum Thromboembolism

Covered when at least one documentation pathway is met.

Peripartum pathway: Personal or family history of thrombosis.

Alternative pathway: Insufficient response to heparin and intolerance to DOACs.

Prevention of Thromboembolism

Covered when inadequate response, intolerance, or contraindication to alternative anticoagulants is documented.

Alternative anticoagulant requirement: Document inadequate clinical response, intolerance, or contraindication to heparin and DOACs.

Antithrombin III prevention of thromboembolism

Covered when the applicable indication and clinical requirements are met.

Laboratory support: Functional antithrombin assay is 70% or greater and was not obtained during acute illness, surgery, or an active thromboembolic event.>=70%

Covered indication: General thromboembolism prevention, perioperative prevention, or peripartum prevention is requested and the applicable indication-specific criteria are met.

Authorization, Documentation, and Denial Risks

Prior Authorization

Default Authorization Periods

Use the default authorization periods unless the criteria below specify a different duration.

Initial authorization: 6 months
Renewal: 24 months

Documentation Required

Actimmune Authorization

Submit Actimmune clinical documentation supporting the diagnosis, dose, relevant treatment regimen, and indication.

Document BSA and prescribed dose; document weight and dose for pediatric patients with BSA <0.5 m²
For CGD, provide molecular confirmation and antibacterial and antifungal prophylaxis
For severe malignant osteopetrosis, provide radiographic or molecular confirmation
For oncology use, provide performance status, staging, prior therapies, and anticipated treatment course

Initial Authorization Criteria

Actimmune initial therapy

Initial therapy requires indication-specific diagnostic and clinical documentation.

Initial Actimmune request: Provide diagnostic confirmation, disease-specific clinical information, prescribed dose, BSA or pediatric weight as applicable, and specialist oversight.

Adzynma initial therapy

Initial therapy requires severe congenital TTP confirmation and an appropriate regimen.

Initial Adzynma request: Confirm severe cTTP with ADAMTS13 genetic and activity testing and document the prophylactic or on-demand treatment basis.ADAMTS13 activity <10% of normal

Afinitor initial therapy

Initial therapy requires qualifying oncology or TSC criteria.

Renewal and Reauthorization Criteria

Actimmune continuation

Reauthorization requires documentation of disease responsiveness.

Continuation: Document disease responsiveness to therapy.

Addyi and Vyleesi continuation

Reauthorization requires treatment success and continued eligibility.

Continuation: Document treatment success and confirm that the patient remains premenopausal where applicable.

Revcovi continuation

Reauthorization requires treatment success.

Treatment success:

Required Prior Treatments and Preferred Products

Step	Required therapy or pathway	Requirement before coverage	Duration
1	Rituximab, preferably Riabni or Ruxience; or Ocrevus if previously established on treatment	Document treatment failure or intolerance; Ocrevus must not have been obtained through samples or a manufacturer assistance program	Not specified

Step	Required therapy or pathway	Requirement before coverage	Duration
1	Afinitor Disperz as adjunct seizure therapy	For treatment-resistant TSC epilepsy, document failure of two antiepileptic regimens and failure of adjunct Epidiolex	Not specified

Step	Required therapy or pathway	Requirement before coverage	Duration
1	Loperamide; dicyclomine; hyoscyamine; and amitriptyline or nortriptyline	Document inadequate response to all four listed therapies	Not specified

Step	Required therapy or pathway	Requirement before coverage	Duration
1	Oral prednisone plus azathioprine; or IV immunoglobulin plus oral prednisone or azathioprine	Document inadequate clinical response or intolerance; exception applies in active SCLC-LEMS	Not specified

Step	Required therapy or pathway	Requirement before coverage	Duration
1	Hydroxychloroquine or chloroquine combined with cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil	Document treatment failure	At least 12 weeks

Step	Required therapy or pathway	Requirement before coverage	Duration
2	Subcutaneous Benlysta	Document treatment failure	At least 12 weeks

Step	Required therapy or pathway	Requirement before coverage	Duration
1	5-HT3 receptor antagonist, such as ondansetron or granisetron, combined with dexamethasone	Document treatment failure during the current chemotherapy regimen	Not specified

Step	Preferred products	Requirement before coverage	Applies before
1	Kogenate FS, Kovaltry, Novoeight, Jivi, and Adynovate	Document inadequate response or an intolerable adverse event with all preferred products	Eloctate or Nuwiq

Step	Product sequence	Requirement before coverage	Indication or exception
1	Kogenate FS → Helixate FS	Helixate FS requires Kogenate FS failure due to an intolerable adverse event and a compelling rationale that the same event is not expected with Helixate FS	Factor VIII products
1	Rixubis → Benefix, Idelvion, or Rebinyn	Document treatment failure or contraindication to Rixubis	Hemophilia B
1	Rixubis → Alprolix	Document contraindication to Rixubis	Perioperative management
1	Humate P and Alphanate → Vonvendi	Document treatment failure or contraindication to both products	Perioperative prophylaxis or acute moderate-to-severe bleeding
1	Wilate → Vonvendi	Document treatment failure or contraindication to Wilate	Routine prophylaxis

Step	Requirement	Failure or exception documentation	Coverage target
1	Try or document inability to use applicable preferred products	Document inadequate response, treatment failure, contraindication, or intolerable adverse event as required for the product; an adverse event must be intolerable and not an expected active-ingredient effect	Non-preferred antihemophilic factor

Step	Alternative therapy	Requirement before coverage	Requested use
1	Basiliximab	For acute transplant-rejection prophylaxis, document treatment failure, an intolerable adverse event, or a contraindication to basiliximab	Antithymocyte globulin for transplant rejection prophylaxis
1	Thymoglobulin	For Atgam requests for renal allograft rejection, document treatment failure or a rationale for avoiding Thymoglobulin	Atgam for renal allograft rejection

Step	Treatment setting	Required regimen or pathway	Requirement
1	Perioperative prophylaxis	Antithrombin III first-line in combination with heparin, with or without intent to bridge to warfarin	Use the stated first-line regimen
1	Peripartum prophylaxis	Personal or family history of thrombosis; OR insufficient response to heparin and intolerance to DOACs	Document one qualifying pathway

Step	Required therapy or pathway	Requirement before coverage	Duration
1	Heparin, followed by consideration of antithrombin III when applicable	Document insufficient response to heparin and intolerance to direct oral anticoagulants	Not specified

Step	Treatment setting	Required regimen	Requirement
1	Perioperative prophylaxis	Antithrombin III in combination with heparin	Approved first-line therapy

Step	Required therapy or pathway	Requirement before coverage	Duration
1	Heparin and direct oral anticoagulants	For the alternative peripartum pathway, document inadequate response to heparin and intolerance to direct oral anticoagulants	Not specified

Step	Treatment setting	Required regimen	Requirement
1	Perioperative thromboprophylaxis	Antithrombin III in combination with heparin	Approved first-line regimen; may include intent to bridge to warfarin

Step	Required therapy or pathway	Requirement before coverage	Exception
1	Heparin and direct oral anticoagulants	Document insufficient response to heparin together with intolerance to direct oral anticoagulants	Not required when the alternative personal or family thrombosis-history pathway is met

Step	Treatment setting	Required regimen	Bridging option
1	Perioperative thromboprophylaxis	Use antithrombin III first-line in combination with heparin	With or without intended bridging to warfarin

Step	Required therapy or pathway	Requirement before coverage	Duration
2	Heparin and direct oral anticoagulants	For the alternative peripartum pathway, document insufficient response to heparin and intolerance to direct oral anticoagulants	Not specified

Step	Alternative therapy	Requirement before coverage	Requested use
1	Direct oral anticoagulants	Document inadequate clinical response, intolerance, or contraindication	Prevention of thromboembolism

Step	Alternative therapy	Requirement before coverage	Requested use
1	Direct oral anticoagulants	Document inadequate clinical response, intolerance, or contraindication before antithrombin III coverage	Prevention of thromboembolism

Step	Required therapy or pathway	Requirement before coverage	Exception
2	Heparin and direct oral anticoagulants	For peripartum prevention, document insufficient response to heparin together with intolerance to direct oral anticoagulants	Not required when a personal or family history of thrombosis is documented

Step	Alternative therapies	Requirement before coverage	Requested use
1	Heparin and direct oral anticoagulants	Document failure or inability to use heparin and DOACs, including inadequate response, intolerance, or contraindication	Prevention of thromboembolism

Step	Treatment history	Requirement before coverage	Requested use
1	Prior or current heparin and/or DOAC therapy	Document applicable treatment history, including inadequate response, intolerance, or contraindication to alternative anticoagulant therapy	Prevention of thromboembolism

Quantity and Dose Limits

Lemtrada quantity limit

Initial authorization5 doses for 5 days

Reauthorization3 doses for 3 days

Renewal timingEligible for renewal 12 months after administration of the last dose

Varubi (rolapitant) quantity limit

Quantity limit1 dose per 14 days

Eligible useProphylaxis of chemotherapy-induced nausea and vomiting associated with an eligible chemotherapy regimen

Age restriction18 years of age and older

Site-of-Care Requirements

Billing Rule

Use the most cost-effective site of care

All approvals are subject to utilization of the most cost-effective site of care.

Billing Rule

Infusion center and emergency support

Use the most cost-effective site of care, and ensure appropriate emergency medical support is readily available during administration.

Billing Rule

Alosetron site of care

All alosetron approvals are subject to use of the most cost-effective site of care.

Preferred Biosimilar Products

Step Therapy

Rituximab preferred biosimilars

For the required prior MS therapy before Lemtrada, rituximab biosimilars Riabni and Ruxience are identified as preferred products.

Policy Summary

PayerPacificSource Health Plans

Policy2026 PacificSource Health Plans Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with the applicable clinical documentation, laboratory results, treatment history, and specialist information.

SourceLink

On This Page

Document disease responsiveness for reauthorization

Documentation Required

Addyi and Vyleesi HSDD Authorization

Submit documentation that the patient meets the Addyi or Vyleesi HSDD criteria.

Document acquired, generalized HSDD meeting DSM-5 criteria, including at least 3 symptoms, persistence for at least 6 months, and clinically significant distress
Document that symptoms are not caused by a medical or psychiatric condition, relationship distress, medication, or substance use
For reauthorization, document treatment success and confirm the patient remains premenopausal

Documentation Required

ADA-SCID Authorization

Submit diagnostic and treatment-pathway documentation for Revcovi in ADA-SCID.

Confirm ADA-SCID with biallelic pathogenic ADA variants and qualifying laboratory findings
Document that gene therapy and matched-sibling or family-donor HCT are unavailable or unsuccessful
For reauthorization, document disease stability or improvement and treatment success

Documentation Required

Congenital TTP Authorization

Submit Adzynma documentation establishing severe congenital TTP and the requested treatment pathway.

Provide ADAMTS13 molecular testing showing homozygous or compound heterozygous variants and activity <10% of normal
For on-demand treatment, document the acute event and platelet or LDH findings
For prophylaxis, document at least one prior TTP event
For reauthorization, document improved TTP events, platelet counts, symptoms, or acute-event laboratory response

Documentation Required

EPP Authorization

Submit Scenesse documentation establishing EPP and clinically significant phototoxic disease.

Provide biallelic FECH loss-of-function confirmation and elevated total erythrocyte protoporphyrin with at least 85% metal-free protoporphyrin
Document phototoxic reactions that impair activities of daily living
For reauthorization, document response and continued sun and light protection

Documentation Required

Afinitor Authorization

Submit Afinitor documentation supporting the oncology or TSC indication and prescribed regimen.

For oncology use, document performance status and all prior therapies
For TSC epilepsy, document treatment resistance, Epidiolex failure, and appropriate Afinitor Disperz adjunct use, or symptomatic SGCT/SEGA unsuitable for surgery
For reauthorization, document disease responsiveness

Documentation Required

Lemtrada Authorization

Submit Lemtrada documentation confirming relapsing MS and the required prior therapy.

Provide MRI or clinical documentation consistent with revised McDonald MS criteria
Document failure or intolerance of rituximab or established Ocrevus therapy
For renewal, provide provider attestation of treatment success

Documentation Required

Pompe Disease Authorization

Submit Lumizyme documentation confirming Pompe disease and the planned treatment regimen.

Confirm GAA deficiency by enzyme assay or GAA molecular testing
Provide current weight and planned regimen
Document clinical signs or symptoms and availability of emergency medical support
For reauthorization, document clinically significant response

Documentation Required

Pompe Disease Documentation

Lumizyme and other Pompe enzyme-replacement requests must include complete Pompe disease documentation and avoid duplicate enzyme-replacement therapy.

Document the diagnosis, weight, regimen, clinical manifestations, and response
Do not use concurrently with Nexviazyme, Pombiliti, or Opfolda

Documentation Required

Severe Diarrhea-Predominant IBS

Submit Alosetron documentation showing severe diarrhea-predominant IBS and failure of required therapies.

Document female sex, symptoms for at least 6 months, diarrhea, qualifying severity, and exclusion of other gastrointestinal causes
Document inadequate response to loperamide, dicyclomine, hyoscyamine, and amitriptyline or nortriptyline
For reauthorization, document treatment success

Documentation Required

AAT Deficiency Augmentation Therapy

Submit Alpha-1 proteinase inhibitor documentation establishing severe congenital AAT deficiency with clinically evident emphysema or COPD.

Provide AAT serum concentration ≤11 mmol/L and a qualifying high-risk phenotype or mutation
Document FEV1 30–65% predicted, or FEV1 66–80% with decline ≥100 mL/year
Document nonsmoking status for at least 6 months before initiation and continued abstinence
Use 60 mg/kg IV weekly and document response for renewal

Documentation Required

Lambert-Eaton Syndrome

Submit Amifampridine documentation confirming LEMS and the required prior treatment history.

Provide positive P/Q-type VGCC antibodies or qualifying RNS findings and compatible clinical signs
Document inadequate response or intolerance to required prednisone/azathioprine or IVIG-based therapy, except in active SCLC-LEMS
For reauthorization, document improved or sustained muscle strength

Documentation Required

Systemic Lupus Erythematosus

Submit Saphnelo documentation confirming moderate-to-severe autoantibody-positive SLE and prior therapies.

Document non-organ-threatening moderate-to-severe SLE and positive ANA and/or anti-dsDNA
Document at least 12 weeks of hydroxychloroquine or chloroquine plus a conventional immunosuppressant
Document at least 12 weeks of subcutaneous Benlysta failure
For renewal, document treatment success or clinically significant response

Documentation Required

Chemotherapy Nausea Prophylaxis

Submit oncology documentation supporting chemotherapy-induced nausea and vomiting prophylaxis.

Provide the planned chemotherapy regimen and document that it is highly or moderately emetogenic
Document failure of a 5-HT3 antagonist with dexamethasone during the current regimen
Observe the quantity limit of 1 dose per 14 days
For renewal, document treatment success and continued eligibility

Documentation Required

Hemophilia and VWD Factor Products

Submit complete hemophilia and VWD documentation, including diagnosis, laboratory results, dose, bleeding history, and indication.

For hemophilia, provide factor level and severity; for VWD, provide VWF antigen, VWF activity, and factor VIII activity
Provide current weight, baseline factor activity, Bethesda titer, recent bleeds with severity and cause, and rationale
Identify acute bleeding, perioperative, or routine prophylaxis use
For reauthorization, provide dose, interval bleeds, treatment history, and inhibitor titers

Documentation Required

Antihemophilic Factor Authorization

Submit antihemophilic factor clinical documentation supporting the requested product and dose.

Document the diagnosis, factor activity, current weight, planned dose, product labeling, and clinical rationale
Document treatment goals and recent bleeding history
Use the product-specific age, indication, and laboratory requirements

Documentation Required

Antithymocyte Globulin Authorization

Submit a complete antithymocyte globulin treatment plan.

Provide planned dose, frequency, duration, and current weight
For transplant prophylaxis, document donor/recipient risk factors and failure, intolerance, or contraindication to basiliximab when applicable
For renal allograft rejection, document failure or rationale for avoiding Thymoglobulin when requesting Atgam
For oncology use, provide performance status, staging, prior therapies, and anticipated course

Documentation Required

Oncology Documentation

Oncology requests for covered products must include disease-specific oncology documentation.

Document diagnosis, staging, performance status, all prior therapies, prescribed regimen, and anticipated treatment course
Requests with Karnofsky ≤50% or ECOG ≥3 may be excluded

Documentation Required

Confirm Hereditary Antithrombin Deficiency

Confirm hereditary antithrombin deficiency before requesting antithrombin III.

Document antithrombin activity <70% on a functional assay
The assay must not be obtained during acute illness, surgery, or a thromboembolic event that could falsely lower the result

Documentation Required

Perioperative Use With Heparin

For perioperative thromboprophylaxis, document clinical and laboratory eligibility and the planned regimen.

Antithrombin III is first-line in combination with heparin, with or without planned bridging to warfarin
Provide the procedure, timing, dose, and heparin plan

Documentation Required

Peripartum Eligibility

Peripartum requests require documentation of hereditary antithrombin deficiency and qualifying thrombotic risk.

Provide a personal or family history of thrombosis, or document insufficient response to heparin and intolerance to DOACs
Include the pregnancy-related indication, planned regimen, and timing

Documentation Required

Laboratory Confirmation of hATd

Document the laboratory diagnosis and indication before antithrombin III authorization.

Provide a functional antithrombin activity result <70% obtained outside acute illness, surgery, or an acute thromboembolic event
Identify prevention or treatment of thromboembolism, perioperative prophylaxis, or peripartum prophylaxis

Documentation Required

Antithrombin Functional Assay

Use an antithrombin functional assay to establish hereditary antithrombin deficiency.

Result must be <70% of normal
Do not rely on a result obtained during acute illness, surgery, or an acute thromboembolic event

Documentation Required

Prior Anticoagulant History

Document prior anticoagulant history when antithrombin III is requested for prevention or treatment of thromboembolism.

Provide inadequate clinical response, intolerance, or contraindication to prior therapy when required
For peripartum use, document insufficient heparin response and DOAC intolerance when that pathway is used

Documentation Required

Alternative Anticoagulant History

Document alternative anticoagulant history when antithrombin III is requested outside approved perioperative first-line use.

Provide the clinical response, intolerance, or contraindication to alternative anticoagulants, including DOACs
Include dates, agents, outcomes, and supporting clinical records

Denial Risk

Actimmune Denial Risks

Actimmune is not approvable for poor performance status or incomplete oncology documentation.

Do not approve with Karnofsky ≤50% or ECOG ≥3
Oncology requests lacking performance status, staging, prior therapies, or anticipated treatment course are incomplete

Denial Risk

Nonqualifying HSDD or Excluded Use

Deny Addyi or Vyleesi when HSDD criteria are not met or use is excluded.

Nonqualifying HSDD, male treatment, or use to enhance sexual performance is not covered
Do not approve when symptoms are attributable to another condition, relationship distress, medication, substance use, or other stressor

Denial Risk

ADA-SCID Denial Risks

Deny Revcovi when ADA-SCID is not confirmed or the required treatment-pathway documentation is unavailable.

Other autosomal-recessive SCIDs are excluded
Missing genetic, laboratory, gene-therapy, or HCT documentation does not support approval

Denial Risk

Non-Congenital TTP Diagnosis

Adzynma is not covered for acquired or immune-mediated TTP or another non-congenital TTP-like disorder.

Require ADAMTS13 genetic and activity confirmation of cTTP

Denial Risk

Cosmetic Use

Scenesse is not covered for cosmetic indications.

Cosmetic use, including treatment of vitiligo, is excluded

Denial Risk

Afinitor Criteria Failure

Afinitor may be denied for inadequate performance status or failure to meet TSC epilepsy criteria.

Oncology requests with Karnofsky ≤50% or ECOG ≥3 are excluded
TSC epilepsy requests must document treatment resistance, Epidiolex failure, and the approved Afinitor Disperz adjunct pathway, or qualifying symptomatic SGCT/SEGA

Denial Risk

Lemtrada Exclusions

Lemtrada is not approvable when contraindicating conditions or concurrent MS disease-modifying therapy are present.

Exclude active infection, HIV infection, and concurrent MS disease-modifying medications
Require prior rituximab failure or intolerance, or established Ocrevus failure or intolerance

Denial Risk

Concurrent Enzyme-Replacement Therapy

Do not approve Lumizyme with concurrent enzyme-replacement therapy.

Exclude concurrent Nexviazyme, Pombiliti, or Opfolda

Denial Risk

Concurrent Enzyme Replacement Therapy

Pompe disease requests must not include concurrent enzyme-replacement therapy.

Review for concurrent Nexviazyme, Pombiliti, or Opfolda before approval

Denial Risk

Alosetron Contraindications

Alosetron is contraindicated for specified gastrointestinal, hepatic, thrombotic, inflammatory, or medication-related conditions.

Exclude chronic or severe constipation, obstruction, stricture, toxic megacolon, perforation, adhesions, ischemic colitis, impaired intestinal circulation, thrombophlebitis, hypercoagulable state, Crohn disease, ulcerative colitis, diverticulitis, or severe hepatic impairment
Exclude concomitant fluvoxamine

Denial Risk

Alpha-1 Proteinase Inhibitor Exclusions

Alpha-1 proteinase inhibitors are not covered when severe AAT deficiency has not been established or an exclusion applies.

Exclude unestablished severe AAT deficiency, IgA deficiency or IgA antibodies, prior liver transplant, and ongoing smoking

Denial Risk

Amifampridine Exclusions

Amifampridine is excluded for seizure disorder, active brain metastases, or significant cardiac risk.

Exclude clinically significant prolonged QTc or additional torsades risk factors
Require age ≥6 years

Denial Risk

Anifrolumab Exclusions

Anifrolumab is not covered with other biologic therapies or for severe active CNS lupus.

Exclude combination biologic use
Exclude severe active central nervous system lupus

Denial Risk

Prophylaxis-Only Use

Chemotherapy nausea products are for prophylaxis associated with qualifying emetogenic chemotherapy, not acute or breakthrough treatment.

Do not approve treatment of acute or breakthrough nausea and vomiting
Require a planned highly or moderately emetogenic regimen

Denial Risk

Product-Specific Factor Exclusions

Factor-product approval is subject to product-specific indication, laboratory, age, and severity restrictions.

Review FDA labeling and the requested product's approved disease and age range
Exclude products for noncovered diseases or indications

Denial Risk

Insufficient Factor Documentation

Deny factor-product requests when the indication, bleeding history, laboratory results, dose, or treatment rationale is not adequately documented.

Approval requires necessity and laboratory titer support
Reauthorization requires planned dose, interval bleeds, past treatment history, and appropriate inhibitor titers

Denial Risk

Antihemophilic Factor Exclusions

Antihemophilic factors are excluded for acute thrombosis, embolism, or disseminated intravascular coagulation symptoms and other listed noncovered uses.

Review the requested product against its FDA label and policy-specific exclusions

Denial Risk

Age and Label Restrictions

Apply product-specific age and label restrictions to factor products.

Jivi: age ≥7 years; Adynovate: age ≥12 years; Vonvendi: age ≥18 years
Wilate routine prophylaxis for VWD: age ≥6 years

Denial Risk

Immunosuppression-Related Exclusion

Antithymocyte globulin is not appropriate when additional immunosuppression is contraindicated by active infection or the oncology criteria are not met.

Exclude active acute or chronic infections contraindicating immunosuppression
Oncology use with Karnofsky ≤50% or ECOG ≥3 is excluded

Denial Risk

Required Alternative Therapy History

For transplant induction, require the documented alternative-therapy history.

Document failure, intolerance, or contraindication to basiliximab for prophylaxis
For Atgam treatment of renal allograft rejection, document failure or rationale for avoiding Thymoglobulin

Denial Risk

Insufficient Diagnostic Confirmation

Deny antithrombin III when hereditary deficiency is not confirmed by a reliable functional assay.

Require activity <70% outside acute illness, surgery, or an acute thromboembolic event
A nonspecific or unreliable laboratory result is insufficient

Denial Risk

Peripartum Criteria Not Met

Peripartum antithrombin III requests require qualifying thrombotic risk and anticoagulant history.

Deny when there is no personal or family thrombosis history and no documented insufficient heparin response with DOAC intolerance

Denial Risk

Unconfirmed Antithrombin Deficiency

Deny antithrombin III when hereditary deficiency is unconfirmed or the laboratory result is unreliable.

Do not use activity results obtained during acute illness, surgery, or acute thrombosis as definitive confirmation

Denial Risk

Peripartum Criteria Not Met

Peripartum authorization is not supported without the required risk history and treatment documentation.

Require personal or family thrombosis history, or insufficient heparin response plus DOAC intolerance

Prior Authorization

Prior Authorization Required

Prior authorization requires a confirmed indication and reliable laboratory support.

Require documented hATd with functional antithrombin activity <70% and indication-specific clinical records

Prior Authorization

Antithrombin III Prior Authorization

Antithrombin III prior authorization requires laboratory confirmation and indication-specific documentation.

Provide functional antithrombin activity <70% obtained outside confounding acute conditions
Identify perioperative, peripartum, or thromboembolism treatment/prevention use

Denial Risk

Unconfirmed Hereditary Antithrombin Deficiency

Deny when hereditary antithrombin deficiency is not confirmed by a valid functional assay.

Require activity <70% and a test obtained outside acute illness, surgery, or acute thromboembolism

Prior Authorization

Perioperative Prophylaxis With Heparin

Perioperative prophylaxis requires the approved first-line regimen with heparin.

Document combination with heparin, with or without intent to bridge to warfarin
A regimen inconsistent with this pathway requires clinical justification

Prior Authorization

Peripartum Prevention Pathway

Peripartum prevention requires documentation of the qualifying risk pathway.

Provide personal or family thrombosis history, or insufficient heparin response with DOAC intolerance
Include the planned peripartum regimen

Documentation Required

Confirm Hereditary Antithrombin Deficiency

Confirm hereditary antithrombin deficiency before authorizing treatment or prophylaxis.

Functional antithrombin activity must be <70% and obtained outside confounding acute conditions

Prior Authorization

Perioperative Use With Heparin

Perioperative antithrombin III use requires documentation of combination therapy with heparin.

Antithrombin III is approved first-line for perioperative thromboprophylaxis with heparin
Document whether warfarin bridging is intended

Prior Authorization

Indication-Specific Prior Authorization

Requests lacking indication-specific clinical or laboratory documentation require prior authorization review.

Provide diagnosis, functional antithrombin activity, indication, planned dose, and treatment history

Documentation Required

Alternative Anticoagulant Pathway

For thromboembolism treatment or prevention, document inadequate response, intolerance, or contraindication to alternative anticoagulants when required.

Provide agent, dates, response, adverse effects or contraindication, and supporting records

Denial Risk

Failure to Meet Indication Criteria

Deny when the requested indication is not established by the required clinical and laboratory documentation.

Require a qualifying diagnosis, functional assay result, and indication-specific treatment plan

Denial Risk

Missing Laboratory Confirmation

Deny when laboratory confirmation is missing, unreliable, or obtained during a confounding event.

Require documented hATd and antithrombin activity <70% on a valid functional assay

Denial Risk

Alternative Anticoagulant Requirement

For thromboembolism treatment or prevention, the required alternative anticoagulant history must be documented.

Deny when inadequate response, intolerance, or contraindication to the required alternative therapy is not established

Denial Risk

Failure to Establish Need After DOAC Therapy

Deny when the record does not establish medical need after appropriate DOAC therapy.

Require documented DOAC intolerance or inadequate response when that pathway is required
Include agent, duration, outcome, and supporting clinical records

Denial Risk

Peripartum Criteria Not Met

Peripartum authorization is not supported without the required thrombotic risk and anticoagulant history.

Require personal or family thrombosis history, or insufficient heparin response with DOAC intolerance

Denial Risk

Missing Clinical or Laboratory Support

Deny when clinical or laboratory support for hereditary antithrombin deficiency or the requested indication is missing.

Require a valid functional assay <70%, indication-specific records, and a treatment plan

Denial Risk

Inappropriate Perioperative Regimen

Deny perioperative requests using a regimen inconsistent with the approved first-line pathway.

Perioperative prophylaxis requires antithrombin III in combination with heparin
Document dose, timing, procedure, and any planned warfarin bridge

Documentation Required

Actimmune Oncology Documentation

Actimmune oncology documentation must be complete and must support an acceptable performance status.

Document performance status, staging, all prior therapies, and anticipated treatment course
Do not approve with Karnofsky ≤50% or ECOG ≥3

Documentation Required

HSDD Documentation and Exclusions

HSDD documentation must establish the DSM-5 diagnosis and exclude nonqualifying causes or uses.

Document at least 3 affected domains, symptoms for at least 6 months, and clinically significant distress
Exclude male treatment, sexual-performance enhancement, and symptoms caused by another condition or substance

Documentation Required

Revcovi Treatment-Pathway Documentation

Revcovi requires diagnostic confirmation and documentation that definitive treatment pathways are unavailable or unsuccessful.

Provide biallelic ADA variants and qualifying laboratory findings
Document unavailable or unsuccessful gene therapy or HCT

Documentation Required

Adzynma cTTP Documentation

Adzynma requires molecular and functional confirmation of congenital TTP.

Provide ADAMTS13 variants and activity <10%
Document an acute event for on-demand treatment or a prior TTP event for prophylaxis

Documentation Required

Scenesse EPP Documentation

Scenesse requires genetic, biochemical, and clinical documentation of EPP.

Provide FECH mutation, metal-free protoporphyrin ≥85%, and functionally significant phototoxic reactions

Documentation Required

Afinitor Documentation

Afinitor requests require documentation specific to oncology or TSC use.

Provide prior therapies and performance status for oncology
For TSC epilepsy, document required prior therapy failures or qualifying SGCT/SEGA

Documentation Required

Lemtrada Documentation

Lemtrada requests require MS diagnostic evidence and required prior treatment history.

Document MRI or clinical evidence consistent with MS
Document rituximab or established Ocrevus failure or intolerance

Documentation Required

Lumizyme Documentation

Lumizyme requires diagnostic confirmation, clinical manifestations, dosing information, and response documentation.

Provide GAA enzyme or molecular testing, weight, planned regimen, signs or symptoms, and emergency-support capability

Documentation Required

Alosetron Documentation

Alosetron requires documentation of severe diarrhea-predominant IBS and failure of all required medications.

Document chronicity, diarrhea, severity, exclusion of other causes, and inadequate response to loperamide, dicyclomine, hyoscyamine, and a tricyclic antidepressant

Documentation Required

Alpha-1 Proteinase Inhibitor Documentation

Alpha-1 proteinase inhibitor requests require laboratory, phenotype, pulmonary-function, and smoking-status documentation.

Provide AAT concentration, qualifying phenotype, emphysema/COPD evidence, FEV1 criteria, and nonsmoking status

Documentation Required

LEMS Documentation

LEMS requests require confirmatory testing, compatible symptoms, and required prior therapy documentation.

Provide VGCC antibody or RNS evidence, proximal weakness, and inadequate response or intolerance to the required regimen

Documentation Required

Anifrolumab Documentation

Anifrolumab requires documentation of moderate-to-severe autoantibody-positive SLE and prior conventional and biologic therapy.

Provide disease manifestations, ANA and/or anti-dsDNA positivity, 12 weeks of combination therapy, and 12 weeks of subcutaneous Benlysta failure

Documentation Required

Chemotherapy Nausea Documentation

Chemotherapy nausea prophylaxis requires oncology documentation of the regimen, emetogenic risk, and step therapy.

Provide the current chemotherapy regimen, moderate or high emetogenic classification, and failure of a 5-HT3 antagonist plus dexamethasone

Documentation Required

Hemophilia and VWD Documentation

Factor-product requests require complete hemophilia or VWD clinical and laboratory documentation.

Provide diagnosis, factor or VWF results, weight, dose, Bethesda titer, recent bleeding history, and indication

Documentation Required

Antihemophilic Factor Clinical Documentation

Antihemophilic factor requests require documentation supporting medical necessity and product selection.

Provide factor activity, dose rationale, bleeding history, prior treatment, and product-specific requirements

Documentation Required

Antithymocyte Globulin Treatment Plan

Antithymocyte globulin requests require a complete treatment plan and indication-specific risk documentation.

Provide dose, frequency, duration, weight, and transplant risk factors or oncology treatment details
Document alternative therapy failure, intolerance, or contraindication when required

Documentation Required

Antithrombin III Clinical and Laboratory Documentation

Antithrombin III requests require laboratory confirmation of deficiency and an indication-specific treatment plan.

Provide functional antithrombin activity <70% outside confounding acute conditions
Document perioperative, peripartum, or thromboembolism indication and planned regimen

Documentation Required

Prior Anticoagulant History

Document prior anticoagulant exposure and response for antithrombin III requests requiring alternative-therapy review.

Include agent, dates, response, intolerance, contraindication, and relevant laboratory or clinical records

Documentation Required

Alternative Anticoagulant History

Document alternative anticoagulant history when the requested antithrombin III use is not the approved perioperative first-line pathway.

Provide evidence of inadequate response, intolerance, or contraindication to heparin, DOACs, or other required alternatives

Initial Afinitor indication: Document a qualifying FDA-approved or NCCN indication, or TSC-associated treatment-resistant epilepsy or symptomatic SGCT/SEGA meeting policy criteria.

Alglucosidase alfa initial therapy

Initial therapy requires all applicable criteria.

Initial Pompe therapy: Confirm GAA deficiency or GAA mutation, document clinical signs or symptoms, ensure emergency support is available, and provide specialist prescribing or consultation.Dose rounding within 10%

Alpha-1 proteinase inhibitor initial therapy

Initial therapy requires all applicable criteria.

Initial AAT augmentation: Document severe congenital AAT deficiency, qualifying phenotype, emphysema or COPD, qualifying FEV1, nonsmoking status, and pulmonologist involvement.AAT ≤11 mmol/L; FEV1 30%-65% or 66%-80% with decline ≥100 mL/year

Amifampridine initial therapy

Initial therapy requires all applicable criteria.

Initial LEMS therapy: Confirm LEMS with compatible proximal weakness; document inadequate response or intolerance to a specified prior regimen unless active SCLC-LEMS; and confirm age at least 6 years.Age ≥6 years

Anifrolumab initial therapy

Initial therapy requires all applicable criteria.

Initial SLE biologic therapy: Document moderate-to-severe autoantibody-positive SLE, failure of qualifying combination conventional therapy for at least 12 weeks, failure of subcutaneous Benlysta for at least 12 weeks, and specialist involvement.Each prior treatment ≥12 weeks

Rolapitant initial therapy

Initial therapy requires all applicable criteria.

Initial chemotherapy prophylaxis: Document planned highly or moderately emetogenic chemotherapy, failure of a 5-HT3 antagonist plus dexamethasone during the current regimen, and adult age.1 dose per 14 days; age ≥18 years

Antihemophilic-factor initial therapy

Initial therapy requires all applicable criteria.

Initial factor therapy: Document a qualifying hemophilia A, hemophilia B, or VWD diagnosis and indication, dose and laboratory information, and required preferred-product sequencing or non-preferred-product exception.

Antihemophilic factor initial therapy

Initial therapy must meet product-specific requirements.

Initial antihemophilic factor request: Document the hemophilia or VWD indication, laboratory titer levels, planned dose, preferred-product failure, contraindication, or intolerable adverse-event history, and hematologist involvement.

Antithymocyte globulin initial therapy

Initial therapy requires a covered indication and complete treatment plan.

Initial antithymocyte globulin request: Document a covered FDA-approved, NCCN-supported, or compendia-supported use; planned dose, frequency, duration, current weight, and applicable transplant, oncology, or aplastic-anemia criteria.NCCN evidence level 2A or better where applicable

Antithrombin III initial therapy

Initial therapy requires laboratory confirmation and an eligible indication.

Initial antithrombin III request: Document hereditary antithrombin deficiency with functional activity below 70% and satisfy the applicable perioperative, peripartum, prevention, or treatment criterion.AT activity <70%

Initial antithrombin III authorization

Initial coverage requires diagnostic confirmation and indication-specific documentation.

Diagnostic confirmation: Document hereditary antithrombin deficiency with activity below 70% on a functional assay obtained outside acute illness, surgery, or a thromboembolic event.<70%

Initial antithrombin III authorization

Covered for documented hereditary antithrombin deficiency when the applicable indication criteria are met.

Deficiency confirmation: Document activity below 70% on a valid functional assay and ensure testing was not performed during acute illness, surgery, or a thromboembolic event.<70%

Indication: Meet perioperative or peripartum thromboembolism-prevention criteria.

Perioperative initial therapy

Initial therapy is covered for perioperative thromboembolism prevention when the regimen criteria are met.

Perioperative regimen: Use antithrombin III first-line with heparin, with or without intent to bridge to warfarin.

Peripartum initial therapy

Initial therapy is covered when one qualifying pathway is met.

Peripartum pathway: Personal or family history of thrombosis.

Alternative pathway: Insufficient response to heparin and intolerance to DOACs.

Initial diagnostic criteria

Initial authorization requires laboratory confirmation.

Diagnostic confirmation: Document hereditary antithrombin deficiency with activity below 70% on a functional assay obtained outside acute illness, surgery, or a thromboembolic event.<70%

Perioperative therapy

For perioperative thromboprophylaxis:

Perioperative regimen: Use antithrombin III first-line with heparin, with or without intent to bridge to warfarin.

Peripartum therapy

For peripartum thromboembolism prevention:

Qualifying pathway: Personal or family history of thrombosis.

Alternative pathway: Insufficient response to heparin and intolerance to DOACs.

Initial antithrombin III authorization

Initial authorization requires laboratory confirmation.

Initial confirmation: Document hereditary antithrombin deficiency with activity below 70% on a functional assay not obtained during acute illness, surgery, or a thromboembolic event.<70%

Initial antithrombin III authorization

Initial therapy requires deficiency confirmation and an approved prevention indication.

Initial authorization: Document hereditary antithrombin deficiency, activity below 70% on a valid functional assay, and an approved perioperative, peripartum, or other thromboembolism-prevention indication.<70%

Initial antithrombin III authorization

Initial coverage requires the applicable indication and supporting clinical information.

Initial authorization: Provide the thromboembolism-prevention indication and supporting clinical information, including functional activity below 70% when diagnosing hereditary deficiency and the required peripartum history or treatment-response documentation.

Initial antithrombin III therapy

Initial therapy is covered when an applicable indication-specific criterion is met.

Covered indication: Perioperative thromboprophylaxis with heparin; peripartum prevention meeting the stated pathway; or prevention of thromboembolism with inadequate response, intolerance, or contraindication to DOACs.

Perioperative initial therapy

Approved first-line for perioperative thromboprophylaxis.

Perioperative use: Use antithrombin III with heparin, with or without intent to bridge to warfarin.

Peripartum initial therapy

For peripartum prevention, document one qualifying pathway.

Peripartum pathway: Personal or family history of thrombosis.

Alternative pathway: Insufficient response to heparin and intolerance to DOACs.

Initial Antithrombin III Therapy

Initial coverage requires the indication-specific criteria for the requested use.

Approved use: Perioperative prevention, peripartum prevention, or prevention of thromboembolism with documented inability to use alternative anticoagulants.

Initial antithrombin III authorization

Initial therapy is covered when the laboratory requirement and a covered indication are met.

Laboratory support: Functional antithrombin assay is at least 70% and was not obtained during acute illness, surgery, or an active thromboembolic event.>=70%

Indication: Meet general, perioperative, or peripartum thromboembolism-prevention criteria.

Show disease stability or improvement through increased plasma ADA activity, decreased red-cell dATP/dAXP, or improved immune function with fewer or less severe infections.

Adzynma continuation

Reauthorization depends on treatment type.

Prophylactic response: Improvement in the number or severity of TTP events, platelet counts, or clinical symptoms.

On-demand response: Platelet count reaches at least 150,000/microliter or returns to within 25% of baseline.≥150,000/microliter or within 25% of baseline

Scenesse continuation

Reauthorization requires clinically significant response and continued protective measures.

Continuation: Document fewer or less severe phototoxic reactions, longer sun-exposure duration, improved quality of life, or another clinically significant response, and continued sun and light protection.

Afinitor continuation

Reauthorization requires disease responsiveness.

Continuation: Document that disease remains responsive to everolimus therapy.

Lemtrada continuation

Reauthorization requires provider attestation of treatment success.

Continuation: Attest to treatment success; renewal is eligible 12 months after the last dose.12 months after last dose

Lumizyme continuation

Reauthorization requires treatment success and clinically significant response.

Continuation: Document clinically significant response to Lumizyme therapy.

Pompe disease continuation

Reauthorization requires treatment success and clinically significant response.

Continuation: Document treatment success and clinically significant response to alglucosidase alfa.

Alosetron continuation

Reauthorization requires treatment success and clinically significant response.

Continuation: Document treatment success and clinically significant response to alosetron.

LEMS continuation

Reauthorization requires improved or sustained muscle strength.

Continuation: Document improved or sustained muscle strength on clinical assessments.

SLE continuation

Reauthorization requires treatment success or clinically significant response.

Continuation: Document treatment success or clinically significant response.

Antiemetic continuation

Reauthorization requires treatment success and continued eligibility.

Continuation: Document treatment success and that the initial chemotherapy-prophylaxis criteria remain met.

Hemophilia and VWD continuation

Reauthorization requires complete dosing, bleeding, treatment, and inhibitor documentation.

Continuation: Submit planned dose, number and severity of acute bleeds since the last approval with cause, treatment history, and factor VIII or IX inhibitor titer as appropriate.

Antihemophilic factor reauthorization

Reauthorization requires updated clinical and treatment information.

Continuation: Submit planned treatment dose, acute bleeds since the last approval with severity and cause, past treatment history, and factor VIII or IX inhibitor titer as appropriate.

Billing Rule

AAT therapy site of care

All alpha-1 proteinase inhibitor approvals are subject to use of the most cost-effective site of care.

Billing Rule

Amifampridine site of care

All amifampridine approvals are subject to use of the most cost-effective site of care.

Billing Rule

Rolapitant site of care

All rolapitant approvals are subject to use of the most cost-effective site of care.

Billing Rule

Antihemophilic factor site of care

All antihemophilic factor approvals are subject to use of the most cost-effective site of care.

Billing Rule

Antithymocyte globulin site of care

All antithymocyte globulin approvals are subject to use of the most cost-effective site of care.