CurrentHealthPartnersPolicy N/A

Medicare Part D Prior Authorization Requirements — Selected Part

Part of HealthPartners' 2026 Medicare Part D prior authorization requirements listing drugs, coverage criteria, exclusions, prerequisite therapies, prescriber restrictions, and authorization durations for Part D‑covered medications; affects providers and pharmacies submitting Part D prior authorizations.

Policy Summary

PayerHealthPartners

PolicyMedicare Part D Prior Authorization Requirements — Selected Part

Policy CodePolicy N/A

Change TypeRoutine update (no material changes)

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required diagnostic documentation and evidence of prior therapy trials or specialist consultation as specified for the requested drug.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

manydrugs listed with PA requirements in this section

6-12 monthstypical initial coverage duration cited

Yesprerequisite therapy required for several products

FDA-approvedIndications listed for many drugs

Part Dformulary referenced

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Coverage Criteria (Initial, Indications, Exclusions)

Stimulant / Wakefulness Agent — Initial Criteria (example)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of an FDA-approved indication for the requested stimulant/awakefulness agent (e.g., modafinil, armodafinil, armodafinil alternative) not otherwise excluded from Part D.
Patient does not use the requested agent concurrently with another wakefulness/targeted agent (e.g., modafinil) or other contraindicated targeted agent as listed in the product-specific exclusions.
For obstructive sleep apnea (OSA): documentation of OSA defined by either (A) >=15 obstructive respiratory events per hour on a sleep study, unless prescriber documents that a sleep study is not feasible, OR (B) >=5 obstructive respiratory events per hour on a sleep study plus at least one symptom (daytime sleepiness, unintentional sleep episodes while awake, unrefreshing sleep, fatigue, insomnia, gasping/choking, loud snoring or breathing interruptions).
For narcolepsy: diagnosis confirmed with polysomnography and multiple sleep latency test (MSLT) unless prescriber documents a sleep study is not feasible; if required, documentation of diagnostic testing must be provided.
For shift work disorder (SWD): documentation supporting disturbed chronobiologic rhythmicity (sleep study or clinical documentation) and exclusion of other medical causes or medications causing symptoms.
For other FDA-approved indications (e.g., idiopathic hypersomnia, adjunctive therapy for treatment-resistant depression where applicable): documentation meeting FDA-labeled diagnostic and prior therapy requirements, including trial and inadequate response to standard therapies when specified.
Prescriber attestation that patient does not have an FDA-labeled contraindication to the requested agent and that genetic or other testing has been completed if required for the agent.
Initial approval duration per product labeling; renewal requires documentation of positive response to therapy (symptom improvement, decreased excessive sleepiness days, improved functioning) and absence of intolerable adverse effects.

ATTRUBY (tafamidis) — ATTR‑CM Coverage Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of wild-type or hereditary transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).
Diagnosis confirmed by either (A) cardiac biopsy with positive Congo red staining and ATTR confirmation by mass spectrometry or immunofluorescence, OR (B) noninvasive workup showing: (i) serum kappa/lambda free light chain ratio within 0.26–1.65, AND (ii) absence of monoclonal protein on serum immunofixation, AND (iii) absence of monoclonal protein on urine immunofixation, AND (iv) myocardial uptake on 99mTc-PYP with heart-to-contralateral ratio >1.5 or visual grade ≥2.
Clinical history consistent with heart failure: documentation of at least one prior hospitalization for heart failure OR signs/symptoms of cardiomyopathy/heart failure (e.g., dyspnea, fatigue, orthostatic hypotension, syncope, peripheral edema).
Patient is negative for light-chain (AL) amyloidosis per criteria above.

Oncology Targeted Agents — General Initial Criteria

Covered when ALL of the following are met:

ALL of the following

Patient has a diagnosis of cancer matching an FDA-approved indication for the requested targeted oncology agent, not otherwise excluded from Part D.
If the agent’s use requires genetic or biomarker testing (e.g., ALK, ROS1, BRAF, EGFR, BRCA, etc.), appropriate testing has been completed and results indicate the requested agent is appropriate for the patient’s tumor profile; documentation of test type, date, and result required.
Patient does not have an FDA-labeled contraindication or limitation of use that is not otherwise supported by NCCN or other accepted compendia; any off-label use must be supported by compendia evidence where applicable.
Agent is being used as first-line therapy when FDA-labeled or compendia-supported as first-line, OR patient has experienced inadequate response or medical contraindication to first-line therapy for the requested indication; documentation of prior therapies and response required.

Inbrija (inhaled levodopa) — Initial and Renewal Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of Parkinson’s disease with OFF episodes while on carbidopa/levodopa therapy.
Prescriber attestation that the patient (or caregiver) has received education on proper inhaler technique for INBRIJA (inhaled levodopa).
Patient is currently taking carbidopa/levodopa and has tried and failed at least one adjunctive agent for OFF episodes (trial of rasagiline, ropinirole, entacapone, pramipexole, rotigotine, or selegiline) for at least 4 weeks unless clinically contraindicated; documentation of prior agents, durations, and reasons for inadequacy or intolerance required.
Patient does not have underlying lung disease OR, if patient has limited pulmonary function (FEV1 <50%), prescriber documents that INBRIJA has not been studied and the provider attests benefits outweigh risks and documents monitoring plan.

Kalydeco (ivacaftor) — Initial and Renewal Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of cystic fibrosis (CF).
Patient has at least one CFTR mutation that is responsive to ivacaftor per FDA labeling or in vitro data supporting responsiveness; documentation of mutation(s) must be provided.
Patient is not receiving another CFTR modulator concurrently for the same indication (CFTR modulators must not be used together unless product labeling allows).
Prescribed by or in consultation with a pulmonologist or specialist from a CF treatment center.
Renewal criteria: patient has been seen within the last 12 months and prescriber documents a positive clinical response to therapy (examples: improvement or stabilization in FEV1, reduction in pulmonary exacerbations, improvement in weight or other approved clinical markers).

Kerendia (finerenone) — Initial and Renewal Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis consistent with an FDA-approved indication for finerenone (Kerendia), such as CKD with type 2 diabetes per label, not otherwise excluded from Part D.
Urine albumin-to-creatinine ratio (UACR) is ≥30 mg/g at baseline.
Estimated glomerular filtration rate (eGFR) is ≥25 mL/min/1.73 m^2 at baseline.
Serum potassium is ≤5.0 mEq/L prior to initiation of therapy.
Patient has trialed and will continue, or has medical contraindication or intolerance to, an ACE inhibitor or an angiotensin II receptor blocker (ARB) as appropriate for the indication, unless contraindicated.

ORKAMBI (lumacaftor/ivacaftor) — Initial and Renewal Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of cystic fibrosis and homozygosity for the F508del mutation in the CFTR gene (as specified for ORKAMBI), not otherwise excluded from Part D.
Patient is not receiving another CFTR modulator concurrently for the requested indication (CFTR modulators should not be used together unless specifically allowed by labeling).
Prescribed by or in consultation with a pulmonologist or CF treatment center specialist.
Renewal criteria: patient has been seen within the last 12 months and prescriber documents positive response to therapy (e.g., stabilization or improvement in pulmonary function, reduction in exacerbations) and continued tolerability.

Eltrombopag — Indications and Criteria

Covered when ANY of the following FDA indications and specific criteria are met (select applicable indication):

ANY of the following

Chronic or persistent immune thrombocytopenia (ITP): baseline platelet count <50,000/mm3 AND inadequate response or contraindication to corticosteroids, IVIG, or splenectomy; renewal requires positive clinical response in platelet counts and bleeding risk reduction.
Severe aplastic anemia: baseline platelet count <50,000/mm3 AND inadequate response or contraindication to standard therapies or intended concurrent use with cyclosporine or glucocorticoids; renewal requires clinical response evidence.
Chronic hepatitis C thrombocytopenia: baseline platelet count <75,000/mm3 with contraindication to interferon-based therapy or as specified in labeling; renewal per clinical response and therapy plan.
Dose and monitoring per product labeling; prescriber should be a hematologist or specialist where applicable and patient must not have labeled contraindications.

Repatha (evolocumab) — Prior Authorization Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of an FDA-approved indication for evolocumab (Repatha), not otherwise excluded from Part D.
For HeFH or ASCVD with LDL remaining above threshold despite therapy: trial of a high-intensity statin plus ezetimibe for at least 8 weeks with LDL remaining above goal, OR documented statin intolerance (rhabdomyolysis to one statin or intolerance to both atorvastatin and rosuvastatin) preventing adequate statin therapy.
For homozygous familial hypercholesterolemia (HoFH): patient age >10 years and trial of high-intensity statin for minimum of 8 weeks with LDL above goal, or documented statin intolerance as above.
Patient must not be receiving concurrent PCSK9-directed therapy that is explicitly excluded (Repatha may not be used concurrently with PRALUENT or LEQVIO).

PEGASYS (peginterferon alfa-2a) — Criteria for HCV

Covered when ALL of the following are met:

ALL of the following

Diagnosis of chronic hepatitis C infection consistent with an FDA-approved indication for peginterferon alfa-2a (PEGASYS) therapy, including genotype-specific recommendations per labeling and current AASLD/IDSA guidance.
Documentation of HCV genotype, baseline viral load (HCV RNA) within the past 6 months, and relevant liver function tests prior to initiation.
Patient is not concurrently taking contraindicated medications and does not have moderate or severe hepatic impairment (Child-Pugh B or C) unless labeling supports use.
Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious disease specialist, or other clinicians experienced in HCV management; coverage duration per FDA labeling and genotype-specific recommended durations (12–48 weeks as applicable).

Pulmonary Arterial Hypertension (PAH) Agents — Initial Approval Criteria

Covered when ALL specific diagnostic criteria for Group 1 pulmonary arterial hypertension (PAH) are met:

ALL of the following

Diagnosis of Group 1 PAH confirmed by right heart catheterization demonstrating: mean pulmonary artery pressure (mPAP) ≥20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤15 mmHg, and pulmonary vascular resistance (PVR) >2 Wood units.
Clinical documentation of WHO/NYHA functional class and relevant symptoms; selection of pulmonary hypertension agent is appropriate to WHO Group 1 PAH and consistent with FDA labeling or guideline recommendations.
Exclusion of contraindicated concomitant medications per product labeling (for certain agents: no concurrent use with nitrates, nitric oxide donors, PDE inhibitors/non-specific PDE inhibitors, or other specified contraindicated agents).
Prescribed by or in consultation with a cardiologist or pulmonologist experienced in PAH management; prior trials of oral therapies and rationale for escalation to the requested agent documented when required (e.g., inadequate response or contraindication to PDE5 inhibitors, ERA, or riociguat where applicable).

ZEJULA (niraparib) — Coverage Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of an FDA-approved indication for ZEJULA (niraparib) consistent with product labeling, not otherwise excluded from Part D.
For maintenance therapy settings: used for indicated ovarian, fallopian tube, or primary peritoneal cancer patients in complete or partial response to platinum-based chemotherapy when specified by labeling (first-line maintenance or recurrent maintenance per FDA indications).
For BRCA-mutated indications: documentation of deleterious or suspected deleterious germline and/or somatic BRCA mutation when required by indication; provide genetic test results.
Patient must not have an FDA-labeled contraindication to therapy and dosing limited to FDA-labeled dosing guidelines.

Coding, Thresholds, and Key Values

Listed drugs without codesmixed

NDC/HCPCS not listed

abiraterone oral tablet 250 mg, 500 mg (drug product listed without codes in this segment)

(placeholder) Additional listed products without codesmixed

NDC/HCPCS not listed

Various other drugs referenced in the formulary index are listed without explicit NDC or HCPCS codes in this excerpt (see formulary index pages).

Part B/Part D potential overlapmixed

NDC/HCPCS not listed

ARANESP (various strengths) — note may be covered under Part B or Part D depending on setting; documentation of use/setting may be required to determine coverage

Formulary identifiermixed

FID: 26132

HealthPartners Part D Formulary identifier

Formulary products listed (no codes provided)mixed

NDC/HCPCS not listed

Document lists product names and formulations but does not provide explicit NDC or HCPCS codes in this section (examples include ORKAMBI, OTEZLA, posaconazole, REPATHA, RETACRIT and others).

Formulary product listingsNDC

NDCs and strength listings (multiple entries)

Drug list includes many specific product strengths and formulations (examples: acetylcysteine solution 100 mg/ml, albuterol nebulization strengths, aprepitant capsules 125/80/40 mg, etc.)

Right heart catheterization thresholds — PAH

mean pulmonary artery pressure (mPAP)>= 20 mmHg

pulmonary capillary wedge pressure (PCWP)<= 15 mmHg

pulmonary vascular resistance (PVR)> 2 Wood units

Alpha‑1 antitrypsin level thresholds

AAT level (micromoles/L)< 11 micromoles/L

AAT radial immunodiffusion (mg/dL)< 80 mg/dL

Prior Authorization, Documentation, Step Therapy, and Denial Risks

Prior Authorization

Actemra — prior authorization and step therapy

Prior authorization required. Actemra may not be used concurrently with other biologic therapies. Initial approval requires a diagnosis consistent with an FDA‑approved indication and documentation of inadequate response or medical contraindication to required step-therapy: rheumatoid arthritis or polyarticular juvenile idiopathic arthritis—failure or contraindication to at least two preferred drugs (examples: Hadlima, Simlandi, Rinvoq); giant cell arteritis—failure or contraindication to at least one preferred drug (example: Rinvoq); systemic sclerosis–associated ILD—failure or contraindication to mycophenolate. Prescriber must be a rheumatologist or pulmonologist (or consult). Coverage duration: 12 months.

Do not combine with other biologic therapies (concurrent biologic exclusion).
Step therapy: inadequate response to at least two preferred drugs for most inflammatory indications.
Prescriber restriction: prescribed by or in consultation with a rheumatologist or pulmonologist.
Coverage duration: 12 months.

Step Therapy Tables and Requirements

Requirement	Details
Step therapy requirement
Actemra initial approval requires documentation of inadequate response or medical contraindication to at least two preferred drugs (preferred alternatives include Hadlima, Simlandi, Rinvoq) prior to approval; prescriber must be or consult a rheumatologist or pulmonologist.
Concurrent therapy exclusion
Actemra may not be used concurrently with other biologic therapies (requests may be denied if used concurrently).

Requirement	Details
Prior antiseizure trials
For selected neurology/antiseizure products, initial approval requires documentation of inadequate response or medical contraindication to two prior anti-seizure medications before approval; prescriber must be or consult neurology.

Requirement	Details
Prerequisite therapy required
Certain agents require documented trial and inadequate response or intolerance to specified alternative therapies (examples: oncology/targeted agents require prior first‑line therapy failure or genetic testing where indicated).

Requirement	Details
Documentation of prior therapy and reason for change
For later‑line or targeted agents, requests must include documentation of prior therapy (which agents, durations) and clinical reason for switching (inadequate response, intolerance, or contraindication); genetic testing when required must be provided and support the request.

Requirement	Details
Trial and failure/contraindication documentation required
Many therapies require documentation of prior trial and inadequate response or medical contraindication to specified alternatives (examples include acute migraine agents and dupilumab topical prerequisites).

Requirement	Details
Triptan trials required
Dihydroergotamine for acute migraine requires inadequate response or contraindication to two triptan medications (examples: sumatriptan, naratriptan, rizatriptan) prior to approval; prescriber specialty and positive response on renewal required.

Requirement	Details
Prior trials required before coverage
Several agents (examples EMSAM, Fintepla) require documented inadequate response or contraindication to two prior agents from specified classes before initial approval; documentation of trials must be supplied.

Requirement	Details
Prior or prerequisite therapies required
Several specialty and oncology agents require prerequisite therapies (examples: Jaypirca requires prior BTK and BCL‑2 inhibitors for CLL; Inqovi may require prior azacitidine for MDS); requests must document prior regimens and reasons for progression/change.

Requirement	Details
Preferred agent trial required
Kineret (anakinra) and similar agents require prior inadequate response or contraindication to preferred alternatives (examples Hadlima, Simlandi, Rinvoq) before approval; concurrent biologic use is prohibited.

Requirement	Details
Lipid‑lowering prerequisite
For PCSK9 and other lipid‑lowering agents, trial of a high‑intensity statin plus ezetimibe concomitantly for a minimum of 8 weeks is required unless documented statin intolerance; LDL thresholds and specialist involvement apply.

Requirement	Details
Statin + ezetimibe trial
Before approving certain non‑statin lipid therapies, documentation of at least an 8‑week trial of a high‑intensity statin plus ezetimibe (concomitant use) is required, or documentation of statin intolerance (e.g., rhabdomyolysis or intolerance to both atorvastatin and rosuvastatin).

Requirement	Details
Acute migraine/prior therapies
For acute migraine agents and migraine prevention: acute agents require failure/intolerance to two triptans before approving alternatives; prevention agents require ≥4 migraine days/month for initial authorization and prohibition of concurrent CGRP antagonists. Documentation of trials or contraindications required.

Requirement	Details
Statin + ezetimibe (duplicate)
Trial of one high‑intensity statin plus ezetimibe for a minimum of 8 weeks required, or documented statin intolerance, before coverage of selected lipid agents; specialist consultation recommended.

Requirement	Details
Conservative/systemic therapy before Otezla
Otezla initial approval requires prior conservative or systemic therapies attempted per criteria (e.g., topical corticosteroids trial for psoriasis or appropriate systemic agents) with documentation of inadequate response or contraindication before initiation.

Requirement	Details
Prior DMARD/biologic trials required
For agents like RINVOQ, initial approval requires prior trials of specified conventional DMARDs (methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) and one or more biologics (Hadlima, Enbrel, Simlandi) depending on indication; document trials and responses.

Requirement	Details
Vigabatrin prior AED trials
Vigabatrin for complex partial seizures requires documented failure on two other formulary antiepileptic drugs or documented contraindications to their use prior to approval; prescriber neurology consultation expected.

Requirement	Details
Tyenne prior trials
Tyenne initial criteria require trial and inadequate response or contraindication to preferred drugs (examples listed such as Hadlima, Simlandi, Rinvoq) prior to approval; documentation required of prior agents and reasons for change.

Requirement	Details
Molecular criteria and diagnosis
For some targeted oncology agents, diagnosis plus required molecular/genetic testing results must be submitted prior to approval (document genetic test and result supporting therapy selection).

Requirement	Details
Xeljanz prior trials
Xeljanz initial approval requires prior inadequate response or contraindication to at least two preferred drugs (lists provided per indication such as Hadlima, Simlandi, Selarsdi, Yesintek, Rinvoq, Skyrizi, Otezla); concurrent biologic use is prohibited.

Requirement	Details
Vumerity prior therapy
Vumerity requires documented inadequate response or medical contraindication to at least one of specified disease‑modifying therapies (teriflunomide, dimethyl fumarate, fingolimod, or glatiramer acetate) prior to approval; documentation required.

Requirement	Details
XIFAXAN travelers' diarrhea prerequisites
For travelers' diarrhea indication, XIFAXAN requires trial and failure or documented contraindication/resistance to listed antibiotics (ciprofloxacin, levofloxacin, ofloxacin, azithromycin) before approval; documentation of antibiotic trials or resistance required.

Quantity and Dose Limits

Actimmune quantity (example dosing)

Actimmune example quantity/dose50 mcg per square meter (three times weekly) — maximum dose referenced in policy

ContextCoverage duration 12 months; dose limited to FDA labeling

Multiple listed — dose limitation

Dose limits generalLimited to doses within FDA‑labeled dosing guidelines (applies across multiple products)

Examples where quantity limitedValchlor approvals limited to two 60 g tubes per month; ZURZUVAE limited to FDA labeled 14‑day course

Renewal implicationRenewal typically requires evidence of positive response and adherence to labeled dosing

Setting-Dependent Coverage (Part B vs Part D)

Documentation Required

Site‑of‑care documentation for Part B vs Part D

When determining Part B vs Part D coverage, submit information describing the drug use and dispensing setting (e.g., hospital outpatient, infusion center, office, or pharmacy) as requested; some immunoglobulin and infusion products may be covered under Part B depending on setting.

Provide details on drug use and where it will be dispensed/administered
Some immunoglobulin products and certain drugs may be Part B in specific settings

Note

Definitions, Background, and Scope

This document lists HealthPartners’ Medicare Part D prior authorization rules for selected drugs, focusing on clinical verification, prerequisite therapies, prescriber requirements, quantity limits, and exclusions that affect coverage decisions. The Part D prior authorization process described here requires providers to document an FDA‑approved indication not excluded from Part D, submit any required diagnostic testing (for example, genetic tests or laboratory values), and attest that the patient does not have an FDA‑labeled limitation of use or contraindication when that is listed as an exclusion. Prior authorization decisions commonly authorize therapy for an initial period of 6 months for select initial approvals or 12 months for standard renewals, and many biologic or specialty agents are restricted to dosing within FDA‑labeled guidelines.

Right heart catheterization criteria for PAH (definition)

Right heart catheterization confirmationDiagnosis confirmed by mPAP >=20 mmHg, PCWP <=15 mmHg, and PVR >2 Wood units

PrescriberPrescribed by or in consultation with a cardiologist or pulmonologist

Prior therapy requirementOften requires inadequate response or contraindication to oral PAH therapies before inhaled/prostacyclin agents

Policy Summary

PayerHealthPartners

PolicyMedicare Part D Prior Authorization Requirements — Selected Part

Policy CodePolicy N/A

Change TypeRoutine update (no material changes)

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required diagnostic documentation and evidence of prior therapy trials or specialist consultation as specified for the requested drug.

SourceLink

On This Page

Patient has New York Heart Association (NYHA) class I, II, or III heart failure at the time of initiation.

Patient is not receiving concomitant therapies excluded by product labeling; ATTRUBY may not be used concurrently with ONPATTRO or TEGSEDI.

Prescribed by or in consultation with a cardiologist; prescriber documentation of baseline assessments per labeling and plan for monitoring.

Renewal criteria: patient has been evaluated by the prescriber within the past 12 months and the medication has demonstrated efficacy (stabilization or improvement in functional class, biomarkers, imaging or other clinical parameters as documented by the prescriber).

For combination regimens with specific companion agents (e.g., BRAFTOVI+MEKTOVI, TAFINLAR+MEKINIST), documentation supports use per FDA labeling or compendia for the listed indication.

Prescriber attestation of intent to monitor and manage therapy per oncology standards; initial approvals typically limited to six months with renewal contingent on documented clinical benefit (tumor response, disease stabilization, symptom improvement) and tolerable safety profile.

Prescribed by or in consultation with a neurologist; renewal requires documentation of positive response to therapy (reduction in OFF time or improved motor function) and assessment of inhaler technique and pulmonary safety within the prior 12 months.

For the indication to reduce risk of cardiovascular death, hospitalization for heart failure and urgent HF visits, documentation supports appropriate clinical risk (e.g., HF with LVEF ≥40% where applicable).

Renewal criteria: positive response to therapy and continued need; documentation that patient remains on an ACE inhibitor or ARB, or has documented contraindication/intolerance to both, if required by indication; monitoring of serum potassium and renal function per labeling.

Prescribed by or in consultation with a cardiologist, endocrinologist, or clinician focusing on lipid management; provide baseline LDL and documentation of prior lipid-lowering therapies and response.

Renewal requires documentation of LDL reduction or clinical benefit and continued need for therapy per guideline-based targets.

Renewal criteria: virologic response per treatment milestones (e.g., end-of-treatment response and sustained virologic response as applicable) and tolerability.

Renewal requires documentation of clinical benefit (improvement or stabilization in functional class, exercise capacity, hospitalization reduction, or other objective measures) and monitoring per labeling; coverage duration typically 12 months.

Initial approvals limited to six months; renewal contingent on demonstrated clinical benefit and tolerability as documented by prescriber.

AAT nephelometry (mg/dL)< 57 mg/dL

Coverage duration examples

Example short initial duration6 months (examples: abiraterone initial; CGRP antagonist initial for migraine prevention)

Typical renewal/continuation duration12 months (common renewal duration for many products)

Other short example durations3 months (episodic cluster headache initial for EMGALITY); 10 days (fidaxomicin)

OSA respiratory events/hour diagnostic thresholds

OSA diagnostic threshold — events/hour>= 15 obstructive respiratory events per hour on sleep study

OSA diagnostic alternative>= 5 events/hour on sleep study PLUS at least one associated symptom (daytime sleepiness, unintentional sleep episodes, unrefreshing sleep, fatigue, insomnia, gasping/choking, loud snoring, breathing interruptions)

When sleep study not feasiblePrescriber may confirm sleep study not feasible (policy allows attestation)

PAH hemodynamic thresholds

mean pulmonary artery pressure (mean PAP)>= 20 mmHg

pulmonary capillary wedge pressure (PCWP)<= 15 mmHg

pulmonary vascular resistance (PVR)> 2 Wood units (some entries cite >=3 WU for specific agents)

99mTc‑PYP uptake criteria for ATTR diagnosis

99mTc‑PYP heart-to-contralateral (H/CL) ratio> 1.5

Visual planar gradingGrade >= 2 (visual myocardial uptake)

Eosinophil count threshold

Pre-treatment peripheral blood eosinophil count>= 150 cells/mcL

Timing of eosinophil resultMeasured within prior 12 months (policy examples for biologic asthma agents)

Use caseRequired to support eligibility for eosinophilic asthma biologics (e.g., Nucala)

Walking ability requirement for dalfampridine

Walking ability requirementPatient currently able to walk 25 feet

Physician attestationPhysician must attest patient has difficulty walking (per policy)

Deferasirox LIC threshold

Liver iron concentration (LIC)>= 5 mg Fe per gram dry weight

ContextRequired for deferasirox in non‑transfusion dependent iron overload eligibility

Serum ferritin thresholds for deferasirox

Serum ferritin — non‑transfusion dependent> 300 mcg/L

Serum ferritin — transfusion dependent> 1000 mcg/L prior to starting therapy

Absolute neutrophil count threshold for deferiprone

Absolute neutrophil count (ANC)> 1.5 x 10^9/L

ContextRequired for deferiprone initiation in transfusion‑induced iron overload

Migraine days per month threshold

Minimum migraine days per month for prevention>= 4 migraine days/month

Age requirementPatients age 18 and older (per policy examples)

Parenteral nutrition dependence duration for GATTEX

Parenteral nutrition dependence duration>= 1 year

Additional requirementInability to taper parenteral requirements

UACR threshold

Urine albumin-to-creatinine ratio (UACR)>= 30 mg/g

ContextRequired baseline parameter for Kerendia initiation

eGFR threshold

Estimated glomerular filtration rate (eGFR)>= 25 mL/min/1.73m2

ContextRequired baseline parameter for Kerendia initiation

Serum potassium threshold

Serum potassium<= 5.0 mEq/L before starting therapy

ContextRequired baseline parameter for Kerendia initiation

Inbrija FEV1 consideration

FEV1 consideration for InbrijaIf FEV1 <50%, provider attestation required acknowledging limited data and benefits vs risks

Inhaler educationProvider must attest patient has or will receive inhaler technique education

OSA sleep study events — diagnostic thresholds

OSA sleep study diagnostic threshold (short)15 or more obstructive respiratory events per hour, or >=5 with symptoms

Symptom examplesDaytime sleepiness, unrefreshing sleep, gasping/choking, loud snoring

Severe primary IGF-1 deficiency thresholds for Increlex

Severe primary IGF-1 deficiency — height SDSHeight SDS <= -3.0

Severe primary IGF-1 deficiency — basal IGF-1 SDSBasal IGF-1 SDS <= -3.0

Documentation Required

General prior authorization and coverage duration (example guidance)

Prior authorization is required for specialty and oncology agents; where used as an example in the formulary, initial approvals are typically limited-term with renewal based on positive response documentation. Typical initial coverage durations are six months for many oral oncology agents and six to twelve months for chronic specialty therapies; renewals require documentation of clinical benefit (positive response) and adherence to FDA‑labeled dosing.

Example coverage durations: Oncology targeted oral agents — 6 months initial; many chronic specialty biologics — 12 months initial.
Renewal generally requires documentation of positive response and continuing indication.
Initial documentation frequently required: diagnosis, prior therapies, relevant genetic testing when indicated, and absence of FDA‑labeled contraindications.

Prior Authorization

BRUKINSA — oncology prior authorization and line-of-therapy requirements

Prior authorization required. BRUKINSA initial approval requires diagnosis per FDA‑approved indication and line-of-therapy documentation: mantle cell lymphoma (adult) requires at least one prior therapy; relapsed/refractory marginal zone lymphoma requires prior anti‑CD20 regimen; relapsed/refractory follicular lymphoma approval when used in combination with obinutuzumab after two or more systemic therapy lines. Requests must not conflict with FDA contraindications. Coverage duration: six months; renewal requires evidence of positive response.

Provide indication and prior therapy history (lines of therapy, prior anti‑CD20 where required).
Limit approvals to FDA‑labeled dosing.
Coverage duration: 6 months initial; renewal contingent on positive response.

Prior Authorization

CABOMETYX — prior authorization and regimen documentation

Prior authorization required. CABOMETYX initial approval requires diagnosis consistent with FDA‑approved indications and documentation of the specific indication and prior treatment when applicable (e.g., hepatocellular carcinoma after sorafenib; advanced RCC in combination with nivolumab for frontline advanced RCC). Coverage duration: six months; renewal requires positive response. Do not exceed FDA dosing.

Indication-specific documentation required (e.g., prior sorafenib for HCC).
Combination/regimen notes: approvals are indication- and regimen-specific (e.g., CABOMETYX + nivolumab for first‑line advanced RCC).
Coverage duration: 6 months initial; renewal requires evidence of benefit.

Prior Authorization

Fidaxomicin (Dificid) — prior authorization and 10‑day coverage

Prior authorization required for fidaxomicin (Dificid). Approve when diagnosis of Clostridioides difficile infection is documented. Coverage duration limited to a 10‑day course. Dose must be within FDA‑labeled dosing guidelines.

Indication required: C. difficile infection.
Coverage duration: 10 days.
No Part B prerequisite; prescriber/age restrictions: none specified.

Prior Authorization

Glutamine — sickle cell disease prior authorization criteria

Prior authorization required. Glutamine (for sickle cell disease) initial approval requires documented diagnosis of sickle cell disease and history of at least two or more painful crises in the prior 12 months despite hydroxyurea unless hydroxyurea is contraindicated. Prescriber should be a hematologist/oncologist. Coverage duration: 12 months; renewal requires positive response.

Age restriction: patients age 5 and older.
Prescriber restriction: hematologist/oncologist or consult.
Coverage duration: 12 months; limited to FDA dosing guidelines.

Prior Authorization

Epidiolex — seizure disorder prior authorization criteria

Prior authorization required. Epidiolex initial approval for Lennox‑Gastaut syndrome, Dravet syndrome, or seizures associated with tuberous sclerosis complex requires diagnosis and documentation of inadequate response or contraindication to two anti‑seizure medications. Prescriber must be neurology or in consultation with neurology. Coverage duration: 12 months.

Require prior trial and failure or contraindication to two antiseizure agents (examples listed in source).
Prescriber restriction: neurology or neurology consult.
Coverage duration: 12 months; dosing limited to FDA labeling.

Prior Authorization

ERLEADA — prostate cancer prior authorization criteria

Prior authorization required. ERLEADA initial criteria differentiate non‑metastatic castration‑resistant prostate cancer (NMCRPC) and metastatic castration‑sensitive prostate cancer (MCSPC). For NMCRPC, documentation of high‑risk disease (rapidly rising PSA) is required. For MCSPC require castrate testosterone (<50 ng/dL), or bilateral orchiectomy, or concurrent use of a GnRH analog. Coverage duration: six months; renewal requires meeting continuing castrate criteria or orchiectomy.

Document castrate testosterone level (<50 ng/dL) or bilateral orchiectomy or concurrent GnRH analog.
Coverage duration: 6 months initial; renewal per criteria.
Dose limited to FDA‑labeled dosing.

Prior Authorization

Fintepla — seizure disorder prior authorization criteria

Prior authorization required. Fintepla initial approval for indicated seizure disorders requires diagnosis and documentation of inadequate response or contraindication to two antiseizure medications; renewal requires evidence of clinical benefit. Coverage duration: align with seizure specialty drugs (commonly 12 months).

Prescriber guidance: specialist consultation appropriate (neurology).
Coverage duration: typically 12 months; adhere to FDA dosing.

Prior Authorization

HAEGARDA and HAE prophylaxis — diagnostic and prior authorization requirements

Prior authorization required for HAEGARDA and other HAE prophylactic agents. Initial approval for prophylaxis requires confirmatory testing for hereditary angioedema (C1‑INH antigenic level, C1‑INH functional level, and C4 level) consistent with type I or II HAE or known pathogenic mutation, and evaluation/removal of medications that can cause angioedema. Prescriber should be a hematologist, allergist, or immunologist. Coverage duration: six months; renewal requires clinic visit within past 12 months and documented positive response (reduced attack frequency/severity). Concurrency: do not use another HAE prophylactic agent concurrently.

Confirmatory diagnostic testing required (C1‑INH antigenic, functional, C4) or known HAE mutation.
Prescriber restriction: hematologist, allergist, or immunologist.
Coverage duration: 6 months initial; renewal requires visit within 12 months and response.
Concurrency exclusion: no concurrent HAE prophylaxis agents.

Prior Authorization

Icatibant — acute HAE attack prior authorization and documentation

Prior authorization required for icatibant for acute HAE attacks. Initial approval requires confirmatory HAE diagnostic testing (see prophylaxis) and documentation that the treated event is an acute moderate‑to‑severe attack (airway involvement, severe abdominal pain with vomiting, facial swelling, or painful facial distortion). Do not use concurrently with other HAE agents indicated for acute attacks.

Confirmatory testing of C1‑INH and C4 levels or known pathogenic mutation.
Must document acute attack severity signs (airway compromise, severe abdominal symptoms, facial swelling).
Concurrency exclusion: no concurrent acute‑attack HAE agent use.

Prior Authorization

Kineret — prior authorization, prescriber restriction, and concurrency exclusion

Prior authorization required. Kineret may not be used concurrently with other biologic therapies. Initial approval requires diagnosis consistent with labeled indications (CAPS, rheumatoid arthritis with inadequate response/contraindication to two preferred drugs, or DIRA with genetic confirmation). Prescriber restriction: rheumatologist, genetics, dermatology, or specialists experienced in autoinflammatory diseases. Coverage duration: 12 months; renewal requires achievement of treatment goals and adherence to dosing limits.

Genetic testing required for DIRA (mutation in IL1RN gene) where applicable.
Concurrency exclusion: no concurrent biologic therapies.
Prescriber restriction: specialist consultation (rheumatology/genetics/dermatology).
Coverage duration: 12 months.

Prior Authorization

Nucala — prior authorization and required pre‑treatment eosinophil documentation

Prior authorization required. Nucala may not be used concurrently with another monoclonal antibody therapy. For severe asthma, initial criteria include a pre‑treatment blood eosinophil count ≥150 cells/µL (within prior 12 months) and inadequate control despite medium/high‑dose inhaled corticosteroid plus another maintenance agent. Renewal requires evidence of benefit (reduced exacerbations or hospitalizations).

Concurrency exclusion: no concurrent monoclonal antibody therapy.
Document baseline eosinophil count ≥150 cells/µL within 12 months.
Prescriber/consult: specialty as indicated; coverage duration: 12 months.

Prior Authorization

Nexletol — prior authorization and lipid‑lowering step requirement

Prior authorization required. Nexletol (bempedoic acid) initial approval for hyperlipidemia with HeFH or ASCVD requires prior trial of a high‑intensity statin plus ezetimibe concurrently for at least 8 weeks with LDL remaining above goal, or documentation of true statin intolerance (rhabdomyolysis or intolerance to both atorvastatin and rosuvastatin). Prescriber specialty recommended (cardiology/endocrinology). Coverage duration: 12 months.

Require documentation of prior high‑intensity statin + ezetimibe trial of ≥8 weeks or documented statin intolerance.
Prescriber restriction: cardiologist/endocrinologist or lipid specialist.
Coverage duration: 12 months.

Prior Authorization

OFEV — ILD/IPF prior authorization and diagnostic requirements

Prior authorization required. OFEV (nintedanib) initial approval requires diagnosis confirmation of IPF or other progressive fibrosing ILD per HRCT and/or histopathology, exclusion of other causes of ILD, baseline lung function thresholds (FVC ≥50% for IPF; DLCO and other thresholds as specified), and prior trial or contraindication to pirfenidone where indicated. Coverage duration: typically 12 months; do not use with underlying liver disease.

Diagnostic confirmation: HRCT pattern of UIP or compatible histopathology; exclude environmental or connective tissue causes.
Baseline FVC and DLCO thresholds required.
Contraindication/exclusion: underlying liver disease.

Prior Authorization

REVCOVI — SCID (ADA) prior authorization and diagnostic documentation

Prior authorization required. REVCOVI for ADA‑deficient SCID requires diagnostic confirmation of ADA deficiency by decreased ATP in erythrocytes, biallelic ADA1 mutations, absence of ADA in relevant tissues, or positive TRECs screening, and documentation that the patient is not a candidate for or has failed hematopoietic stem cell transplant. Initial coverage: 6 months then 12 months if renewal criteria met; annual reauthorization requires a visit within the past 12 months and attestation of transplant ineligibility or failure.

Document ADA deficiency via one of the listed laboratory/genetic tests.
Confirm failed or unsuitable for HSCT.
Coverage duration: 6 months initial, then 12 months on renewal.

Prior Authorization

REZDIFFRA — MASH/NASH prior authorization, fibrosis staging and counseling documentation

Prior authorization required. REZDIFFRA for MASH/NASH requires diagnostic confirmation prior to initiation (liver biopsy showing NAFLD activity score ≥4 with requisite component scores, or elastography/MRI/CT demonstrating fibrosis) and staging of fibrosis (F2 or F3). Prescriber should provide documentation that therapy will be used with diet/exercise counseling. Renewal after ≥1 year requires absence of fibrosis progression and continued counseling documentation. Coverage duration: 12 months.

Require pre‑treatment liver biopsy or elastography/imaging evidence and fibrosis stage F2–F3.
Prescriber restriction: endocrinologist, gastroenterologist, or hepatologist.
Require documentation that counseling on diet and exercise was provided and will continue.

Step Therapy

RINVOQ — step therapy and prior authorization requirements

Prior authorization required. RINVOQ initial approval for inflammatory and autoimmune indications requires diagnosis consistent with an FDA indication and prior therapy trials where applicable (many indications require inadequate response/contraindication to one or more preferred biologic or DMARD therapies). Renewal requires documentation that treatment goals have been met. Concurrency exclusions apply per class (no concurrent biologic use where noted).

Step/prerequisite therapy: prior failure or contraindication to listed preferred agents (examples in source).
Concurrency exclusion: do not combine with other biologic therapies when specified.
Coverage duration: typically 12 months.

Prior Authorization

RUBRACA — oncologic prior authorization and prior therapy requirements

Prior authorization required. RUBRACA oncology approvals require diagnosis of an FDA‑approved indication and prior therapy history: e.g., BRCA‑mutated MCRPC requires prior AR‑directed therapy and a taxane; maintenance for recurrent ovarian cancer requires response to platinum chemotherapy. Coverage duration: six months; renewal requires evidence of positive response.

Document germline/somatic BRCA mutation where indicated (genetic testing requirement).
Provide prior therapy history (AR‑directed therapy, taxane, platinum response as applicable).
Coverage duration: 6 months initial.

Prior Authorization

Sapropterin — PKU diagnostic prior authorization and monitoring

Prior authorization required. Sapropterin for PKU requires baseline blood phenylalanine (PHE) level measurement prior to initiation and ongoing monitoring; initial approvals require elevated baseline PHE above recommended levels for age/condition and specialist prescriber; renewal requires maintenance of acceptable PHE levels or clinical benefit. Coverage duration per policy (e.g., 3 months initial then 12 months on renewal in some metabolic agents).

Require baseline blood PHE prior to initiation and periodic monitoring.
Prescriber: specialists in genetics/metabolism recommended.
Coverage durations and renewal thresholds based on response and lab monitoring.

Prior Authorization

PAH agents (including Sildenafil/Tadalafil/uptravi) — hemodynamic diagnostic and concurrency requirements

Prior authorization required. Sildenafil/Tadalafil for PAH and other PAH agents: diagnosis must be Group 1 PAH confirmed by right heart catheterization with hemodynamics (mean PAP ≥20 mmHg, PCWP ≤15 mmHg, PVR threshold as specified). For prostacyclin/inhaled agents, confirm Group 1 PAH hemodynamics and document inadequate response or contraindication to prior oral therapy. Concurrency exclusions: no concurrent use with other inhaled/parenteral prostacyclin agents where specified; prior trial/failure of oral therapies (PDE5 inhibitors, ERAs, or ADEMPAS) is often required.

Right heart catheterization documentation required: mean PAP ≥20 mmHg, PCWP ≤15 mmHg, PVR thresholds per policy.
Prior trial/failure of oral PAH therapies required for escalation to prostacyclin/inhaled agents.
Concurrency exclusion: no concurrent inhaled/parenteral prostacyclin use.

Prior Authorization

SIRTURO — MDR‑TB prior authorization and regimen documentation

Prior authorization required. SIRTURO (bedaquiline) for MDR‑TB requires use as part of a combination anti‑tuberculosis regimen with documentation of resistance or adverse reactions to standard agents and infectious disease specialist involvement. Coverage duration: 24 weeks.

Prescriber: infectious disease specialist consultation required.
Used as part of combination MDR‑TB regimen; document resistance/adverse reactions to standard drugs.
Coverage duration: 24 weeks.

Prior Authorization

Sodium oxybate — narcolepsy prior authorization and exclusions

Prior authorization required. Sodium oxybate for narcolepsy requires diagnostic confirmation by PSG/MSLT or CSF analysis supporting narcolepsy with cataplexy or excessive daytime sleepiness, and documentation of inadequate response to or contraindication to one sleep disorder agent (e.g., modafinil/armodafinil) for at least one month. Prescriber must be experienced in narcolepsy management. Concurrency exclusion: do not use with sedative hypnotics. Coverage duration: 12 months with renewal requiring clinical benefit and follow‑up within 12 months.

Require documented diagnostic testing (PSG/MSLT or CSF analysis).
Prescriber experienced with narcolepsy (neurologist/sleep specialist).
Concurrency exclusion: no concurrent sedative hypnotics.
Coverage duration: 12 months; renewal requires visit within past 12 months and evidence of benefit.

Prior Authorization

Skyrizi — prior authorization, prescriber restriction, and concurrent biologic exclusion

Prior authorization required. Skyrizi and other biologics: may not be used concurrently with other biologic therapies. Prescriber restriction: prescribe by or in consultation with appropriate specialists (dermatology, rheumatology, gastroenterology). Coverage duration: 12 months; renewal requires evidence of continued benefit.

Concurrency exclusion: no concurrent biologic/monoclonal antibody therapy.
Prescriber restriction: specialist consultation.
Coverage duration: 12 months; limited to FDA dosing.

Prior Authorization

Trikafta — CFTR modulator prior authorization and genetic testing requirement

Prior authorization required. Trikafta (CFTR modulator) requires diagnostic confirmation of cystic fibrosis and documentation of at least one F508del mutation or an in‑vitro responsive CFTR mutation; concurrent use with other CFTR modulators is prohibited (must discontinue other CFTR modulators prior to initiation). Prescriber should be a pulmonologist or CF center specialist. Coverage duration: 12 months; renewal requires provider attestation of ongoing clinical benefit.

Genetic testing requirement: documentation of CFTR mutation (F508del or in‑vitro responsive mutation).
Concurrency exclusion: no concurrent CFTR modulator therapy; existing modulators must be stopped prior to Trikafta.
Prescriber restriction: pulmonologist or CF specialist; coverage duration: 12 months.

Prior Authorization

Uptravi — PAH prior authorization, hemodynamic confirmation, and prostacyclin concurrency exclusion

Prior authorization required. Uptravi and other prostacyclin pathway agents for PAH require right heart catheterization confirmation of Group 1 PAH hemodynamics and prior inadequate response or contraindication to oral therapies. Do not combine with other prostacyclin inhaled or parenteral agents unless specifically indicated. Prescriber should be a cardiologist or pulmonologist. Coverage duration: 12 months.

Hemodynamic confirmation via right heart cath required.
Concurrency exclusion: no concurrent inhaled/parenteral prostacyclin agents.
Prescriber restriction: cardiologist or pulmonologist; coverage duration: 12 months.

Prior Authorization

Valchlor — prior therapy requirement and prior authorization

Prior authorization required. Valchlor initial approval requires a diagnosis consistent with FDA indication and documentation of at least one prior skin‑directed therapy (topical corticosteroids, bexarotene topical gel, etc.). Renewal: no disease progression. Coverage duration: six months initial, then 12 months if renewal criteria met. Approvals limited to product quantity limits per policy.

Require prior trial of at least one skin‑directed therapy.
Coverage duration: 6 months initial, then 12 months on renewal.
Quantity limits: approvals limited to two 60‑gram tubes per month as noted.

Prior Authorization

Venclexta — oncology prior authorization and prior therapy documentation

Prior authorization required. Venclexta (venetoclax) oncology use requires diagnosis of an FDA‑approved indication and documentation of prior therapies where applicable (e.g., for CLL/ SLL or AML settings). Coverage duration: six months initial; renewal requires evidence of response. Limit dosing to FDA labeling.

Provide prior therapy history relevant to indication.
Coverage duration: 6 months initial; renewal contingent on positive response.
Dose and administration per FDA labeling.

Prior Authorization

Verquvo — heart failure prior authorization and criteria

Prior authorization required. Verquvo for heart failure requires documented EF <45%, NYHA class II–IV symptoms, and either recent HF hospitalization within 6 months or outpatient IV diuretic use within 3 months. Require trial or inadequate response/contraindication to at least two guideline‑directed therapies (ACE/ARB/ARNI, beta‑blocker, aldosterone antagonist or SGLT2). Prescriber: cardiology consult recommended. Coverage duration: 12 months; renewal requires documented benefit.

Document EF and NYHA class, recent hospitalization or IV diuretic use.
Document prior or concurrent guideline therapies and rationale for Verquvo use.
Prescriber: cardiologist or consult; coverage: 12 months.

Prior Authorization

Voriconazole — invasive fungal infection prior authorization and specialist prescriber

Prior authorization required. Voriconazole initial approval requires diagnosis of invasive aspergillosis, serious Scedosporium/Fusarium infection, or esophageal candidiasis in non‑neutropenic patients with contraindication/inadequate response to fluconazole or alternatives. Prescriber should be an infectious disease, transplant, hematology/oncology specialist. Coverage duration varies by indication (one month for esophageal candidiasis; six months for other indications).

Specialist prescriber recommended (ID, transplant, hematology/oncology).
Coverage duration: 1 month for esophageal candidiasis; 6 months for invasive infections.
Prior therapy failure or contraindication documentation required.

Prior Authorization

Vosevi — HCV prior authorization, drug interaction exclusions, and hepatic impairment contraindication

Prior authorization required. Vosevi for HCV requires diagnostic documentation consistent with AASLD/IDSA guidance including recent HCV RNA within 6 months, and avoidance of specified contraindicated concomitant medications (extensive drug interaction list). Do not use in moderate or severe hepatic impairment (Child‑Pugh B or C). Prescriber should be gastroenterology/hepatology/ID or transplant specialist. Coverage: typically 12 weeks per guideline/labeling.

HCV RNA within past 6 months required.
Contraindicated concomitant meds listed in policy (e.g., amiodarone, rifampin, certain statins, interacting antivirals).
Do not use in Child‑Pugh B/C hepatic impairment.

Prior Authorization

Vowst — recurrent C. difficile prior authorization and treatment course limits

Prior authorization required. Vowst for recurrent C. difficile infection limited to patients with recurrent CDI (defined as ≥3 prior episodes treated with antibiotics) who have completed the qualifying antibiotic regimen 2–4 days prior and completed bowel prep per product instructions. Single treatment course only; coverage duration: 10 days.

Indication: recurrent CDI as defined in policy (≥3 prior episodes).
Timing: complete antibiotics 2–4 days before initiation and required magnesium citrate bowel prep.
Limit: single treatment course only; coverage 10 days.

Prior Authorization

Vumerity — relapsing MS prior authorization and prior therapy requirement

Prior authorization required. Vumerity for relapsing forms of multiple sclerosis requires diagnosis of relapsing MS and prior inadequate response or contraindication to at least one disease‑modifying therapy (teriflunomide, dimethyl fumarate, fingolimod, or glatiramer). Coverage duration: 12 months.

Require prior trial/failure or contraindication to at least one listed DMT.
Coverage duration: 12 months; dosing limited to FDA labeling.

Prior Authorization

Xdemvy — prior authorization, prescriber requirement, and renewal documentation

Prior authorization required. Xdemvy for indicated dermatologic conditions requires prescriber specialty and follow‑up documentation demonstrating response for renewals. Coverage duration and renewal evidence requirements follow typical biologic policies (12 months with positive response documentation).

Prescriber restriction: specialist (dermatology) or consult.
Renewal requires evidence of clinical response.

Prior Authorization

Xeljanz — prior authorization and concurrent biologic exclusion

Prior authorization required. Xeljanz must not be used concurrently with other biologic therapies. Initial approval requires failure or contraindication to required step therapies (examples vary by indication). Prescriber should be a specialist (rheumatologist, gastroenterologist, dermatologist) as appropriate. Coverage duration: 12 months.

Concurrency exclusion: no concurrent biologic therapy.
Step therapy: inadequate response to at least two preferred drugs for many indications.
Prescriber restriction: specialist consultation recommended; coverage 12 months.

Prior Authorization

Xermelo — carcinoid diarrhea prior authorization and prerequisite therapy

Prior authorization required. Xermelo for carcinoid syndrome diarrhea requires documentation that diarrhea is inadequately controlled with a somatostatin analog for at least 3 months and that Xermelo will be used in combination with SSA therapy. Renewal requires evidence of response (reduced stool frequency). Coverage: 6 months initial then 12 months if response.

Require documented trial of SSA (e.g., octreotide) ≥3 months.
Used concomitantly with SSA; prescriber specialty: oncology/endocrinology/gastroenterology.
Coverage duration: 6 months initial; renewal to 12 months if response.

Prior Authorization

Xifaxan — indication‑specific prior authorization and durations

Prior authorization required. Xifaxan (rifaximin) coverage depends on indication: hepatic encephalopathy (12 months), IBS‑D (14 days, dose limited to 550 mg TID), travelers' diarrhea (3 days). For IBS‑D retreatment: limited to patients with prior positive response and additional retreatment limits per policy. Prescriber for IBS‑D should be a gastroenterologist when used for that indication.

Hepatic encephalopathy: 12 months coverage; require lactulose dose‑limiting side effects or inadequate response.
IBS‑D: 14‑day course, dose 550 mg TID; retreatment limited to responders.
Travelers' diarrhea: 3 days.

Note

Formulary/index content — index‑only (no PA rules)

This section contains index‑only entries and navigation pointers; no additional prior authorization rules are encoded here.

Index content present in the source is preserved in the document index sections.
No PA rules apply to index‑only fragments.

Valchlor quantity limit — example

Valchlor quantity limitTwo 60‑gram tubes per month

Initial coverage duration6 months initial, then 12 months if renewal criteria met

Valchlor quantity (numeric)

Numeric quantity2 (sixty‑gram tubes per month)

ContextApproval limited to quantity of two 60 g tubes per month

Xifaxan (IBS‑D) dosing

Xifaxan (IBS‑D) dosing550 mg three times daily for 14 days

Retreatment/limitsRetreatment limited to patients with prior positive response and per policy-specified conditions

XIFAXAN dosing (duplicate)

XIFAXAN dosing (repeat)550 mg three times daily

Indication-specific durationsHE: 12 months; IBS‑D: 14 days; Travelers' diarrhea: 3 days

ZURZUVAE — dosing guidance

ZURZUVAE dosing standardFDA‑labeled dosing (per 14‑day treatment course) — follow labeled regimen

Safety counseling requirementPrescriber attestation re driving/impairment counseling required prior to initiation

Alpha‑1 antitrypsin deficiency thresholds (definition)

AATD pretreatment thresholdAAT < 11 micromoles/L (or <80 mg/dL by radial immunodiffusion or <57 mg/dL by nephelometry)

Clinical requirementClinically evident emphysema required along with continuation of conventional therapy

Obstructive sleep apnea (OSA) diagnostic threshold (definition)

OSA definition — events/hour>=15 obstructive respiratory events/hour OR >=5 events/hour with associated symptoms

Associated symptoms examplesDaytime sleepiness, unintentional sleep episodes, unrefreshing sleep, fatigue, insomnia, gasping/choking, loud snoring

Group 1 PAH hemodynamic criteria (definition)

Group 1 PAH hemodynamic criteriaConfirmed by right heart catheterization with mean PAP >=20 mmHg, PCWP <=15 mmHg, and PVR >2 Wood units

Clinical confirmationOften requires specialist (cardiology/pulmonology) involvement

Positive response (example definition)

Positive response — renewal exampleDecreased frequency of exacerbations, decreased rescue medication use, reduced symptom severity, or improved % predicted FEV1

DocumentationProvider must document clinical benefit at renewal per product-specific criteria

Eosinophilic asthma (definition)

Eosinophilic asthma definitionAsthma phenotype with documented peripheral blood eosinophil count >=150 cells/mcL supporting eligibility for certain biologics

Clinical contextUsed to determine eligibility for agents like Nucala and dupilumab (asthma pathway)

HAE prophylaxis (definition)

HAE prophylaxis definitionProphylactic therapy to prevent HAE attacks when diagnosis confirmed by decreased C4 and C1‑INH antigenic or functional levels or known pathogenic mutation

Medication reviewMedications known to cause angioedema should be evaluated and discontinued when appropriate

Short bowel syndrome (SBS) dependence (definition)

SBS dependence definitionDependence on parenteral nutrition support for at least one year with inability to taper parenteral requirements

Specialist involvementPrescribed by or in consultation with a gastroenterologist

HAE diagnostic criteria (detailed)

HAE diagnostic criteriaDiagnosis confirmed by C1‑INH antigenic level, C1‑INH functional level, and C4 level consistent with Type I/II or known HAE‑causing mutation

Use for acute vs prophylaxisSame confirmatory testing required for both prophylaxis and acute attack treatment per policy

OFF episodes (Parkinson's disease) definition

OFF episodes (Parkinson's disease)Periods when effects of levodopa wear off; Inbrija indicated for PD patients with OFF episodes on carbidopa/levodopa

Inhaler educationProvider attestation required regarding inhaler technique education

Progressive fibrosing ILD criteria (definition)

Progressive fibrosing ILD progression>10% fibrotic features on HRCT plus FVC decline >=10% OR FVC decline >=5% with worsening symptoms/imaging within 24 months

Baseline lung function thresholdsBaseline FVC >=50% (IPF) or >=45% (progressive fibrosing ILD); %DLCO >=30%

Inadequate asthma control (definition)

Inadequate asthma control definitionAt least one exacerbation requiring >=3 days oral systemic corticosteroids in last 12 months or at least one serious exacerbation requiring hospitalization/ER visit in last 12 months

Use in renewal/eligibilityUsed to determine eligibility and renewal for asthma biologics

IPF diagnostic confirmation (definition)

IPF diagnostic confirmationExclusion of other known causes of ILD and HRCT pattern of usual interstitial pneumonia (UIP) or supportive HRCT/histopathology combinations

Specialist involvementPrescribed by or in consultation with pulmonologist or rheumatologist as appropriate

Baseline platelet thresholds (definition)

Baseline platelet threshold (ITP/severe aplastic anemia)< 50,000/mm3

Baseline platelet threshold (chronic hepatitis C thrombocytopenia)< 75,000/mm3

WHO Group 1 PAH diagnostic criteria (definition)

WHO Group 1 PAH diagnostic criteria (sildenafil context)Mean PAP >=20 mmHg, PCWP <=15 mmHg, and PVR >=3 Wood units confirmed by right heart cath

Acute vasodilator testingNegative acute vasodilator test or failure/contraindication to calcium channel blockers may be required

ADA‑deficient SCID (definition)

ADA‑deficient SCID definitionADA deficiency confirmed by decreased erythrocyte ATP, biallelic ADA1 mutation, ADA deficiency in cells/plasma, or positive TREC screen

Treatment contextREVCOVI indicated when HSCT not an option or failed

Inadequate asthma control (duplicate definition)

Inadequate asthma control (duplicate definition)>=1 exacerbation requiring >=3 days systemic corticosteroids in last 12 months OR >=1 serious exacerbation requiring hospitalization/ER visit

Positive response examplesDecreased exacerbations, decreased rescue med use, improved FEV1

Positive response to therapy (renewal) — examples

Positive response to therapy (renewal) — examplesDecreased frequency of exacerbations, decreased rescue medication use, reduced symptom severity/frequency, or improvement in % predicted FEV1

DocumentationProvider must show clinical benefit at renewal per product-specific criteria