Multiple drug prior authorization criteria (CareSource formulary segment) - OpenPayer

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Multiple drug prior authorization criteria (CareSource formulary segment) - OpenPayer

Initial Therapy Criteria (per product)

ARIKAYCE (amikacin liposome inhalation) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of Mycobacterium avium complex (MAC) lung disease confirmed by positive culture or molecular testing and clinical/radiographic findings consistent with MAC lung disease.
Patient is refractory to, intolerant of, or has contraindication to guideline-recommended multidrug oral therapy for MAC (eg, macrolide-based regimen) OR has severe disease where inhaled therapy is clinically indicated.
Prescription is for amikacin liposome inhalation suspension (ARIKAYCE) at FDA‑approved dosing and route (inhalation).
Prescriber is a pulmonologist or infectious disease specialist, or therapy is initiated in consultation with one of these specialists.
Operationally, chart documentation of consult is required.
For initial therapy only: patient is 18 years of age or older (unless FDA labeling indicates otherwise).

ARCALYST (rilonacept) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of an autoinflammatory condition for which rilonacept (ARCALYST) is indicated (eg, cryopyrin-associated periodic syndromes including neonatal-onset multisystem inflammatory disease, Muckle-Wells syndrome, familial cold autoinflammatory syndrome) or other FDA‑approved indication.
Clinical documentation supports active disease (eg, recurrent inflammatory episodes, elevated acute phase reactants) and rilonacept is prescribed at FDA‑approved dosing and route (subcutaneous).
Patient has tried and had inadequate response or intolerance to first‑line/conventional therapies when such therapies are standard for the condition (eg, corticosteroids, NSAIDs, other disease‑specific agents), unless contraindicated or not clinically appropriate.
Prescriber is a specialist experienced in managing autoinflammatory diseases (eg, rheumatologist, immunologist).

Various IV/injectable antimicrobials and other drugs - Initial Therapy (bulk listing)

Covered when ALL of the following are met:

ALL of the following

Requested product is an IV or injectable antimicrobial or related agent listed in the formulary bulk group and is being used for an indication supported by FDA labeling or strong medical evidence.
For IV/injectable antimicrobials: documentation includes diagnosis, culture/susceptibility results when available, site of infection, prior antibiotic therapy tried and reason for change (resistance, intolerance, clinical failure), and planned duration of therapy.
For specialty injectables (non-antimicrobial) included in the bulk listing: documentation includes diagnosis, rationale for agent selection, prior therapies tried (if applicable), and dose/route consistent with prescribing information.
Prescriber is appropriate for the condition (eg, infectious disease specialist for complex infections, oncologist for antineoplastics).

COSENTYX (syringes, pens, SC and IV) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis for which secukinumab (COSENTYX) is FDA‑approved (eg, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis) or other accepted indication; therapy consistent with labeled dosing for SC or IV formulations where applicable.
Requested formulation and device (syringe, autoinjector/pen, prefilled syringe, or IV where indicated) is specified and is appropriate for the patient and indication.
Documentation of prior therapies when required by indication-specific step therapy (eg, failure/intolerance to conventional systemic therapies for psoriasis) or other clinical requirements per indication.
Prescriber is a specialist appropriate to the condition (eg, dermatologist, rheumatologist, or gastroenterologist as applicable).

CRYSVITA (burosumab) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of X-linked hypophosphatemia (XLH) or other FDA‑approved indication for burosumab (CRYSVITA).
Clinical and laboratory evidence of hypophosphatemia due to XLH (eg, low fasting serum phosphorus) and documentation that alternative therapies have been considered or tried per standard of care where applicable (eg, oral phosphate and active vitamin D analogs), unless contraindicated.
Prescriber is an endocrinologist, metabolic specialist, or clinician experienced in managing metabolic bone disorders.
Request is for burosumab at FDA‑approved dosing and route (subcutaneous) for initial therapy and patient meets age requirements per labeling.

DAURISMO (glasdegib) oral - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of acute or chronic myeloid/hematologic malignancy for which glasdegib (DAURISMO) is indicated (eg, newly diagnosed acute myeloid leukemia in combination with low‑dose cytarabine) consistent with FDA labeling.
Patient meets label-specified eligibility criteria (eg, age, performance status, inability to tolerate intensive induction therapy) and glasdegib is prescribed at FDA‑approved dosing and oral route.
Documentation of prior therapies where applicable and rationale for using glasdegib (eg, combination with low‑dose cytarabine).
Prescriber is an oncologist or hematologist experienced in treating the indicated malignancy.

Medical supplies for insulin delivery - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Requested item(s) are medical supplies for insulin delivery (eg, alcohol prep pads, sterile gauze pads, pen needles for insulin pens, insulin syringes) intended for subcutaneous insulin administration.
Documentation supports a diagnosis requiring insulin therapy and that supplies requested are reasonable for home insulin administration (eg, frequency of use consistent with prescribed insulin regimen).
Quantity requested is consistent with usual clinical need (eg, pen needles and syringes in amounts aligned with prescribed injection frequency); overuse will be subject to quantity limits per benefit plan.
Supplies are furnished or prescribed by a clinician managing the patient's diabetes (eg, primary care, endocrinologist) and documentation may be required at prior authorization review.

DIACOMIT (stiripentol) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of a condition for which stiripentol (DIACOMIT) is FDA‑approved (eg, Dravet syndrome) and prescribing is consistent with labeled dosing and concomitant therapy requirements.
Patient is receiving or will receive stiripentol in combination with appropriate concomitant antiepileptic drugs per labeling (eg, clobazam) unless contraindicated, with documentation of rationale if used as monotherapy.
Prescriber is a neurologist or specialist experienced in managing pediatric epilepsy or Dravet syndrome.

dimethyl fumarate (delayed release) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis for which delayed‑release dimethyl fumarate (e.g., Tecfidera or generic equivalents) is indicated (eg, relapsing forms of multiple sclerosis) and request is for appropriate oral formulation and dosing.
Patient has documented prior therapies where required by step‑therapy rules (eg, failure, intolerance, or contraindication to alternative disease‑modifying therapies) as applicable per formulary rules.
Prescriber is a neurologist or clinician experienced in managing MS.

DOPTELET (avatrombopag) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of thrombocytopenia associated with chronic liver disease in patients scheduled to undergo a procedure, or other FDA‑approved indication for avatrombopag (DOPTELET).
Baseline platelet count and planned procedure documentation provided when applicable; avatrombopag dosing and timing consistent with FDA labeling for the indication.
Patient has no contraindications to avatrombopag and prescriber is appropriate (eg, hematologist, proceduralist, or treating physician).

DUPIXENT (pen/syringe) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis for which dupilumab (DUPIXENT) is FDA‑approved (eg, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis) and request is for an approved formulation/device (pen or prefilled syringe) and dosing.
For atopic dermatitis initial therapy: patient is 12 years of age or older (or per current labeling) and has at least moderate disease (eg, BSA ≥10% or as clinically documented) with inadequate response to topical therapies including at least one adequate trial of medium‑ to high‑potency topical corticosteroids unless contraindicated.
For asthma or other indications, documentation of prior controller therapies and indication‑specific requirements per labeling or guideline‑based criteria as applicable.
Prescriber is an appropriate specialist (eg, allergist, immunologist, dermatologist, pulmonologist) or consulted with such specialist for initiation.

Continuation Therapy Criteria

Continuation — product-specific and general continuation rules

Continuation therapy / ongoing use rules

Continuation — ACTEMRA SUBCUTANEOUS / ACTPEN: Criteria: Diagnosis provided; No concurrent use with another Biologic DMARD or Targeted Synthetic DMARD; Continuation requires patient had a response to therapy as determined by the prescriber; Indication-specific continuation rules (eg interstitial lung disease, GCA) and prescriber restrictions apply

See ACTEMRA SUBCUTANEOUS entry for full continuation and age/prescriber rules

Continuation — ARIKAYCE: Continuation criteria: Arikayce prescribed in combination with background multidrug regimen AND patient has not achieved negative sputum cultures for MAC OR has achieved negative sputum cultures for <12 months; Coverage duration: 1 year

Initial requirements include positive sputum culture and amikacin susceptibility

Continuation — BENLYSTA: Continuation requires Benlysta is being used concurrently with at least one other standard therapy unless intolerant AND the patient has responded to Benlysta subcutaneous or intravenous; Coverage durations vary by indication (SLE cont 1 year; lupus nephritis cont 1 year)

Initial lupus nephritis has biopsy confirmation requirement

Continuation — DUPIXENT: Continuation: many indications require the patient has received at least 6 months of therapy and demonstrated benefit (examples: asthma, CRSwNP, EoE, prurigo nodularis, CSU, bullous pemphigoid); Exclusion: concurrent monoclonal antibody or JAK inhibitor use; Age and prescriber restrictions apply

See indication-specific continuation A/B criteria in source

General Continuation Therapy: For many products continuation requires the patient had a response to therapy as determined by the prescriber; coverage durations commonly 1 year (some initial shorter)

See product-specific continuation nodes for details

Exclusions & Not Covered Concurrent Therapies

Concurrent-use and exclusion branches (per-product)

Per-product exclusion or 'no concurrent use' branches

ACTEMRA exclusions: No concurrent use with a Biologic DMARD or Targeted Synthetic DMARD; Not for COVID-19 hospitalized patients

Applies to IV and SC formulations

Actimmune exclusions: No specific concurrent biologic exclusion listed for Actimmune; prescriber and genetic/test confirmation requirements apply

Actimmune has prescriber specialty and genetic confirmation requirements

ADBRY / DUPIXENT / ADBRY exclusions: No concurrent use with another monoclonal antibody therapy or with JAK inhibitors (oral or topical); for Dupixent specifically exclude concurrent monoclonal antibody or JAKi use

Applies across atopic dermatitis and other indications

Emgality / Aimovig / Qulipta exclusions: Exclude combination therapy with another CGRP inhibitor for migraine prevention (Emgality, Aimovig); Qulipta excludes concurrent CGRP inhibitor for prevention

Prevents overlapping CGRP preventive agents

Arikayce concurrent regimen requirement: Arikayce must be used in combination with a background multidrug regimen (eg macrolide + ethambutol + rifamycin); continuation requires combination use and sputum culture status

Not an exclusion but a concurrent-therapy requirement

Benlysta concurrent therapy exclusion: Exclude concurrent use with other biologics or with Lupkynis; lupus indications require use concurrently with standard therapies unless intolerant

Specifically prohibits other biologics/Lupkynis concurrent use

Cosentyx / Enbrel / Hadlima / Simlandi exclusions: Exclude concurrent use with other biologic DMARDs or targeted synthetic DMARDs for inflammatory indications; applies to initial therapy rules as well

Repeated across multiple TNF/IL/IL-17 products

Infliximab / Zymfentra concurrent use exclusions: Concurrent use with Biologic DMARD or Targeted Synthetic DMARD is excluded for infliximab products; Zymfentra excludes concurrent biologic or targeted synthetic DMARD for inflammatory conditions

Infliximab family explicit exclusion

PAH prostacyclin exclusions (treprostinil, opsynvi, opsumit, uptravi): Exclude concurrent use with other oral or inhaled prostacyclin agents or with guanylate cyclase stimulators as specified; right-heart catheterization and specialist prescriber required

Products specify no concurrent prostacyclin or sGC use

Nucala / Fasenra / Mepolizumab class exclusions: Concurrent use with another monoclonal antibody therapy is excluded (e.g., other anti-eosinophil biologics); induction/continuation require eosinophil thresholds and concurrent controllers per indication

Applies to anti-IL-5/anti-IL-5R agents

General concurrent-use exclusions: Many specialty products explicitly deny coverage for concurrent use with specified therapies (examples include CFTR modulators combinations, concurrent biologic DMARDs/JAK inhibitors, combination CGRP inhibitors, guanylate cyclase stimulators with some PAH agents, ganciclovir/valganciclovir with Livtencity) — refer to product entry for exact prohibited agents

Per-product precise exclusions in source

Anemia management in dialysis patients: ESA treatment for anemia in patients with chronic renal failure on dialysis is denied under Medicare Part D and should be submitted under the ESRD bundled payment benefit. Part B vs Part D coverage determinations for medical‑benefit agents will be made at prior authorization review per CMS guidance where noted.

Provider Actions — Prior Authorization, Documentation, & Billing

Prior Authorization

Prior authorization required

Prior authorization required for listed products; submit diagnosis, required lab/genetic tests, prior therapy history, and prescriber specialty/consultation evidence as specified per product.

Submit diagnosis, concurrent medications, prior drug trials, and required test results per product (e.g., genetic/mutation tests for targeted oncology agents).
Prescriber specialty/consultation required for many agents (examples: rheumatologist for Actemra/Benlysta; pulmonologist for Arikayce; oncologist for most oncology agents).
Part B vs Part D determinations will be made at time of prior authorization review for specified products (e.g., certain oncology and infusion agents).
ESA use for anemia in dialysis patients is denied under Medicare Part D and should be submitted under the ESRD bundled payment benefit.

Documentation Required

Documentation required

Documentation must include required mutation/biomarker tests, lab thresholds, imaging, and prior therapy trials as specified by product criteria.

Examples — oncology: provide approved-test results for mutations/biomarkers when required (BRAF V600, RET, ROS1, EGFR, KRAS G12C, IDH1/2, FLT3, HER2 IHC3+, PIK3CA, MET exon 14, BRCA/HRR).
Examples — specialty agents: CFTR genotype/evidence of abnormal CFTR function for CF modulators (sweat chloride, two CF-causing mutations, or nasal potential difference).
Lab thresholds: LDL thresholds for lipid agents (e.g., Repatha/Nexletol requirements), hemoglobin and erythropoietin thresholds for ESAs (eg Hb, serum erythropoietin ≤500 mU/mL), serum ferritin cutoffs for iron chelation (>1000 mcg/L transfusion-related; >300 mcg/L non‑transfusion).
Pulmonary/respiratory: HRCT or biopsy confirmation and FVC ≥40% predicted for antifibrotics (e.g., Ofev/pirfenidone); right‑heart catheterization results for PAH agents.
Imaging examples: HRCT for interstitial lung disease; sinus CT/endoscopy for CRSwNP; biopsy confirmation for lupus nephritis, etc.
Examples of prior therapy trials: oncology — prior lines of systemic therapy required per agent (document regimens tried); rheumatology — prior trials of specified DMARDs or TNF inhibitors as listed (examples: Enbrel, preferred adalimumab products, Rinvoq, Xeljanz).
Other labs: eosinophil thresholds (eg Dupixent, Nucala, Fasenra), platelet counts for thrombopoietin agents, ferritin for chelation, IGF-1 for acromegaly.

Denial Risk

Common denial risks / exclusions

Claims may be denied for uses or combinations that are explicitly excluded or outside policy-specified conditions.

Concurrent use of another biologic DMARD or targeted synthetic DMARD where excluded (examples: many autoimmune biologics — Actemra, infliximab/Remicade, ustekinumab, etc.).
Concurrent use exclusions for specific classes (e.g., concurrent monoclonal antibodies or JAK inhibitors with Dupixent; concurrent cGRP inhibitors with Emgality/Qulipta where prohibited).
Billing exclusion: ESA therapy for anemia in chronic renal failure on dialysis denied under Medicare Part D (submit under ESRD bundled payment).
Use for cosmetic or non-covered indications will be denied (examples: weight gain for cosmetic reasons).
Specific code_group ‘Concurrent use exclusions’ entries (e.g., Fabrazyme concurrent with migalastat or pegunigalsidase alfa) result in denial when present.

Billing Rule

Coverage durations & reauthorization

Authorizations typically granted for 1 year unless product-specific initial shorter durations apply; continuation requires documentation of benefit.

Notable initial-duration exceptions: Benlysta (SLE initial 4 months; lupus nephritis initial 6 months), Arcalyst (CAPS initial 3 months; DIRA initial 6 months; Pericarditis initial 3 months), Dupixent initial durations for many indications (often 6 months initial for non‑AD indications).
Many products authorize through end of plan year or for 1 year on continuation.
Part B vs Part D determinations are made at prior authorization review for specified products (CMS guidance applies).

Background & Definitions

This is the V–Z (later alphabetical) segment (Part V–Z) of a multi-part prior authorization/formulary policy. It covers many specialty and oncology products and provides indication‑specific initial and continuation criteria, prescriber‑of‑record or consultation requirements, and biomarker/genetic testing prerequisites where applicable.

Term	Definition
Part B vs Part D determination	Coverage under Medicare Part B or Part D will be determined at time of prior authorization review per CMS guidance.
HRM (High‑Risk Medication)	Medications requiring a prescriber risk/benefit assessment, often with age‑related restrictions and documentation prior to approval.
Male / Female / Postmenopausal / Premenopausal definitions	When used in criteria, 'woman'/'female' and 'man'/'male' are defined by biological traits regardless of gender identity or expression.
Systemic regimen	A regimen containing one or more listed systemic anticancer agents (examples provided in policy).
BTK inhibitor	Bruton tyrosine kinase inhibitors such as Brukinsa (zanubrutinib), Calquence (acalabrutinib), Imbruvica (ibrutinib).
High‑intensity statin	Atorvastatin ≥40 mg daily or rosuvastatin ≥20 mg daily.
Statin intolerance	Experiencing statin‑related rhabdomyolysis or muscle symptoms during separate trials of atorvastatin and rosuvastatin with symptom resolution upon discontinuation in both trials.
PAH WHO Group 1	Pulmonary arterial hypertension WHO Group 1 requiring right‑heart catheterization to confirm diagnosis prior to some PAH therapies.
ALSFRS‑R	Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised; used for eligibility/continuation in ALS therapy criteria.
Transfusion‑dependent anemia (Rytelo)	Requiring transfusion of ≥4 red blood cell units over an 8‑week period.