ModifiedBlue Cross Blue Shield - MichiganPolicy N/A

Prior Authorization and Step Therapy Coverage Criteria — Pharmacy & Specialty Drugs

Governs Blue Cross Blue Shield of Michigan and Blue Care Network prior authorization and step therapy requirements for pharmacy and certain medical benefit drugs; affects providers prescribing and dispensing medications to members under these plans.

Policy Summary

PayerBlue Cross Blue Shield - Michigan

PolicyPrior Authorization and Step Therapy Coverage Criteria — Pharmacy & Specialty Drugs

Policy CodePolicy N/A

Change TypeMultiple new and revised drug coverage criteria

Effective DateN/A

Next Review DateN/A

Key ActionObtain and document required prior authorization with specified clinical criteria (diagnosis, age, labs/genetic confirmation, prior trial/failure) before prescribing listed specialty medications.

SourceLink

POLICY UPDATE CHANGES

New coverage criteria for Dawnzera expanded required prior-trial medications to include Andembry with a publish date 5/1/2026 and effective date 7/1/2026.

New coverage criteria for multiple specific drugs (examples: Lybalvi, Lynkuet, Lyvispah, Mavyret, Vivlodex, Namzaric, Fortamet, Methergine, Korlym, Zavesca/Yargesa, milnacipran, Myrbetriq, Motpoly XR, Myalept, Myfembree, Myqorzo, Myrbetriq granules, Naftifine, Neupro, Nexlizet, Nicotrol, Tasigna, Nilandron, Ofev, Orfadin, Noctiva, Nubeqa) added to the prior authorization/step therapy criteria.

Revised coverage criteria and approval durations for multiple drugs (examples include Vowst, Voydeya, Vraylar, Vykat XR, Vyleesi, Vyndaqel, Vyvgart Hytrulo, Wainua, Wayrilz, Wegovy, Winrevair, Xcopri, Xeljanz, Xelpros, Xepi).

Document revision date updated to 06-01-2026 on page footer.

Document revision date updated to Revised: 06-01-2026 in multiple sections.

15+

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drug entries in excerpt

60d–1yrinitial approval durations

OncoHealthoncology prior auth admin

NCNot Covered indicator

clinical benefitrenewal theme

Drug-Specific Coverage Criteria

Blue Cross Blue Shield of Michigan and Blue Care Network use evidence-based clinical criteria and Pharmacy & Therapeutics Committee recommendations to determine which drugs require prior authorization or step therapy. Drugs administered in a physician office or under the medical benefit may be subject to separate utilization management lists.

Coverage status codes used in this section: = Prior Approval/Step Therapy may apply; NC = Not Covered.

Fabhalta — PNH

Fabhalta (pegcetacoplan) — Initial Therapy

Criteria: Coverage is provided for paroxysmal nocturnal hemoglobinuria (PNH) when ALL of the following are met:

- Diagnosis of PNH

- Age ≥ 18 years old

- Flow cytometric confirmation of PNH type III red cells

- One of the following within the preceding 6–12 months: had at least one transfusion OR documented history of major adverse thrombotic vascular events OR high disease activity (LDH ≥ 1.5 × ULN) with symptoms (weakness, fatigue, hemoglobinuria, abdominal pain, dyspnea, hemoglobin <10 g/dL, a major vascular event, dysphagia, or erectile dysfunction)

- Not used in combination with Soliris®, Ultomiris®, or other PNH complement inhibitors

- Trial and failure, contraindication, or intolerance to Empaveli (or documentation why Empaveli is not appropriate)

Notes: Initial approval duration as specified by plan; renewal requires documentation of clinical benefit and ongoing criteria.

Empaveli — Indications and Initial Therapy

Empaveli (pegcetacoplan alternative pathway) — Initial Therapy and Indication-Specific Coverage

Coverage for PNH when ALL of the following are met:

- Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)

- Age ≥ 18 years old

- Flow cytometric confirmation of PNH type III red cells

- One of the following: at least one transfusion in prior 12 months; OR history of major thrombotic event; OR high disease activity defined as LDH ≥ 1.5 × ULN with associated symptoms (weakness, fatigue, hemoglobinuria, abdominal pain, dyspnea, hemoglobin <10 g/dL, major vascular event, dysphagia, erectile dysfunction)

- Not to be used in combination with Soliris®, Ultomiris®, or other PNH complement inhibitors

Consolidated Indication-Specific and Selected Drug Criteria

Selected additional initial-therapy and indication-specific criteria (consolidated). The list below consolidates multiple drug entries and ensures inclusion of indication-specific thresholds, specialist requirements, prior trials, age limits, and combination exclusions.

ALL of the following

Epclusa (sofosbuvir + velpatasvir) — Initial Therapy: Coverage requires documentation of chronic hepatitis C infection appropriate for sofosbuvir/velpatasvir per current AASLD/IDSA guidance; prior authorization required when benefit-specific restrictions apply.
Epclusa (glecaprevir/pibrentasvir/Mavyret note): See Mavyret entry — pan-genotypic HCV coverage per guidelines; ensure benefit-specific check.
Epidiolex (cannabidiol) — Initial Therapy: Coverage for Lennox-Gastaut syndrome or Dravet syndrome when ALL of the following are met: diagnosis confirmed by a neurologist, trial and failure or intolerance to two appropriate anticonvulsant therapies as applicable, and documentation of seizure frequency and baseline assessments; initial approval per plan (commonly 1 year).

Initial Therapy / Prior Authorization Conditions

Renewal / Continuation Requirements

Prior Authorization, Step Therapy, Documentation, and Denial Risk

Prior Authorization

Prior Authorization Required

Blue Cross and BCN require prior authorization (PA) for many medications and some drug-specific programs (see BCN Custom Drug List, BCBSM Clinical Drug List, Preferred Therapy, Lite PA, Off-Label and High‑Cost Specialty). Prior authorization confirms medical necessity, documents required trials or contraindications, specialist prescribing where applicable, and that genetic or laboratory confirmation is provided when required. Most approvals are time-limited (commonly 60 days up to 1 year); renewals require evidence of ongoing clinical benefit. Failure to obtain PA when required or failure to meet step-therapy or other criteria may result in denial and member financial responsibility.

Prior auth applies to many agents listed in this guideline (see drug-specific entries).
Electronic PA submissions are supported (provider portals/Availity; oncology requests via OncoHealth for Oncology Value Management).
PA approvals typically expire and require reauthorization (commonly 3 months to 1 year depending on agent).

Step Therapy

Step Therapy Overview

Step Therapy Rules and Required Prior Trials

Step therapy rule	Notes / examples
Preferred-first requirement	Step therapy requires trying one or more preferred/generic drugs before coverage of a more expensive alternative is approved (try preferred agents first).
Documentation requirement	Providers must document prior trials and clinical response; coverage allowed for alternatives only after required steps (trials/failures) are met or contraindication/intolerance documented.
Common initial approval durations	Typical initial approvals range from 60 days to 1 year depending on the drug and indication.
Examples (aggregate)	Examples across the policy: trials of generic stimulants before ADHD branded agents; trials of generic PPIs before Dexilant; trials of preferred DAAs (Epclusa) before Harvoni or Sovaldi; trials of generic long‑acting opioids before select ER opioid approvals.

Requirement	Policy language / examples
Document prior trials/failures	Step therapy requirements include documented trial and failure of specified alternative therapies unless contraindicated or intolerant; the plan may require documentation of prior trials before approval (e.g., Hemlibra trial required prior to Alhemo; generic stimulants required prior to Azstarys).
Specialist-dispensed therapies	For certain specialty agents, documentation must include specialist prescribing/dispensing (e.g., hemophilia treatment center dispensing required for Alhemo).
Genetic/lab confirmation may be required	Some step requirements are tied to diagnostic confirmation (for example CFTR variant confirmation for Alyftrek or genetic confirmation for Aqvesme) and those trials must be documented as part of the request.

Product / class	Step requirement (trial/failure/intolerance)
Cladribine (Mavenclad)	Requires trial and failure or intolerance to one generic or preferred MS medication (examples: Avonex, Betaseron, Copaxone, Kesimpta, Vumerity).
Deferiprone (Ferriprox)	Requires treatment failure or intolerance to generic Jadenu or generic Exjade prior to coverage; documented inadequate current chelation therapy required.
Solaraze (diclofenac 3% gel)	Requires trial and failure or intolerance to cryotherapy/phototherapy, topical fluorouracil, and generic imiquimod 5% before approval; initial approval 3 months.
Doxepin topical cream	Requires trial and failure or intolerance to generic doxycycline monohydrate AND generic doxycycline hyclate immediate release (and indication‑specific topical trials) prior to coverage.

Selected product	Required prior trials / step details
Entyvio Pen	Requires trial and treatment failure of TWO specified agents from a listed group (e.g., adalimumab biosimilar, Simponi, preferred ustekinumab biosimilar, Tremfya, Xeljanz/XR, Rinvoq*) unless patient is established on Entyvio IV; must document trials or ongoing IV use.
Briviact (brivaracetam)	Requires treatment failure or intolerance to 3 generic preferred seizure alternatives before approval; initial approval typically 1 year.
Imiquimod (Zyclara)	For actinic keratosis requires trial and failure or intolerance to cryotherapy/phototherapy, topical fluorouracil, and generic imiquimod 5%; for genital warts age and indication‑specific criteria apply.
Immunoglobulins (non-preferred)	Non‑preferred immunoglobulin products require trial and failure of preferred products (e.g., Gammagard, Hizentra) with documentation of the trials.

Generic required	Example / documentation
Doxepin topical cream	Coverage requires documented trials and failures or intolerance to specified generics (generic doxycycline monohydrate AND generic doxycycline hyclate immediate release) prior to approval; provider must submit documentation of those trials.
Oracea / doxycycline IR/DR	Requires trial and failure or intolerance to generic doxycycline monohydrate AND generic doxycycline hyclate immediate release; initial approval 1 year.
Solaraze (diclofenac gel)	Requires trial and failure/intolerance to cryotherapy/phototherapy and topical fluorouracil and generic imiquimod 5% before coverage; document prior therapies.

Entyvio Pen prior step	Acceptable documentation
Required prior biologics	Document trials and treatment failure of TWO agents from the specified list (preferred adalimumab biosimilar, Simponi, Skyrizi, preferred ustekinumab biosimilar, Tremfya, Xeljanz/XR, Rinvoq) unless patient is established on Entyvio IV.
Alternative pathway	If patient is established on Entyvio IV, document current IV use instead of prior failures of listed agents.

Specific required prior trials	Examples
Eslicarbazepine (Aptiom)	Requires failure or intolerance to at least 3 generic seizure alternatives (one must be generic topiramate/topiramate listed in policy).
Flector patch	Requires trial or intolerance to generic oral diclofenac and at least two other oral traditional NSAIDs prior to coverage; document trials.
Pitavastatin (Livalo)	Requires treatment failure or intolerance to at least two generic statins (e.g., atorvastatin, rosuvastatin, simvastatin); document prior statin trials.

Product	Preferred/generic trial reminder
Harvoni (ledipasvir + sofosbuvir)	Trial of preferred Epclusa in adult patients is required prior to Harvoni coverage; documentation of trial/failure should be provided.
Gattex (teduglutide)	Coverage requires dependence on parenteral support ≥12 months and documentation of prior supportive measures; preferred/medical‑benefit details noted in policy.
Immunoglobulins (non‑preferred)	Non-preferred immunoglobulins require trial and failure of preferred immunoglobulin products (e.g., Gammagard, Hizentra); document prior trials.

Preferred-product examples	Step requirement
Imiquimod (Zyclara) — actinic keratosis	Requires trial and failure/intolerance to cryotherapy/phototherapy and generic topical fluorouracil and generic imiquimod 5% before coverage; document trials.
Immunoglobulins (non-preferred)	Coverage of non-preferred IV or SC immunoglobulin products requires documented trial and failure of preferred products (Gammagard, Hizentra) prior to approval.

General summary	Policy note / examples
Widespread step therapy requirement	Many agents require step therapy: documented trial and failure (or intolerance/contraindication) to preferred/generic alternatives is commonly required before approving a non-preferred or higher‑cost drug.
Examples	Examples include antipsychotics (Lybalvi requires two preferred 2nd‑gen antipsychotic failures), hepatitis C agents (Epclusa preferred before Harvoni/Mavyret pathways), and weight‑loss/GLP‑1 agents with lifestyle documentation pathways.

Opzelura prior step	Required prior agent(s)
Opzelura (topical)	Requires documented trial and treatment failure of one of: a topical steroid, generic Elidel (pimecrolimus), or generic Protopic (tacrolimus) before approval; document prior therapy.

Orencia SC prior requirement	Required trials
Orencia SC	For rheumatoid arthritis: trial and failure of one DMARD (≥3 months) plus trial and failure of two specified biologics/agents (examples listed in policy) are required; similar step sequences apply per indication and must be documented.

Nurtec ODT (acute) prior	Required prior trials
Nurtec ODT — acute treatment	Requires failure or contraindication to two generic triptan medications before approval for acute migraine; document prior triptan trials.

Opioid step examples	Policy detail
Opana ER (oxymorphone ER)	Requires trial and failure or intolerance to three generic long‑acting opioids prior to coverage; coverage will not be provided if patient is on more than one long‑acting opioid concurrently; document prior opioid trials.
Tapentadol (Nucynta) IR/ER	Immediate release: requires failure/intolerance to three generic immediate release opioids; ER formulations require failure of three generic long‑acting opioids and other specified conditions; document trials.

CGRP/combination constraint	Policy note
CGRP antagonist combination use	Some preventive migraine agents shall not be used in combination with other CGRP antagonists for the same indication (policy prohibits combination biologic CGRP antagonists).

Prior trial documentation allowed as alternative	Policy examples
Intolerance/contraindication alternative	Where documented intolerance or contraindication to a required prior agent exists, that documentation may substitute for trial/failure in many step therapy rules; provider must supply supporting clinical rationale and records.
Examples	PCSK9-related agents: trial of high‑intensity statin or documented statin intolerance may substitute; many specialty drugs allow contraindication/intolerance in lieu of failure when documented.

Treximet prior trials	Requirement
Treximet (sumatriptan + naproxen)	Requires failure or intolerance to generic sumatriptan + naproxen combination and failure/intolerance to a second generic triptan (pediatric exceptions apply); document prior triptan trials.

Multiple opioid trials required example	Policy detail
Tapentadol (Nucynta) IR/ER	IR: requires failure/intolerance to three generic immediate‑release opioids. ER: requires failure of three generic long‑acting opioids and other specified trials; document prior opioid trials and clinical rationale.
Topiramate formulations	Branded/ER topiramate products require prior failure/intolerance to at least three generic alternatives including generic topiramate; document prior trials.

Epclusa preferred reminder	Policy implication
Epclusa as preferred DAA	Policy notes Epclusa (sofosbuvir + velpatasvir) as the preferred direct‑acting antiviral; trials of Epclusa are required in some pathways before coverage of alternative DAAs such as Harvoni or Sovaldi; document trial/failure.

Must document trials before approval	Examples
General requirement	Approval for many specialty drugs requires documented trials of required prior agents (number and identity vary by drug); provider must submit specific trial dates, durations, and reason for discontinuation if applicable.
Examples: Imiquimod, immunoglobulins	Imiquimod for actinic keratosis requires prior cryotherapy/fluorouracil; non‑preferred immunoglobulins require trial/failure of preferred IG products before coverage.

Prior trials of alternatives required	Aggregate examples
Antipsychotics / Vraylar	Vraylar requires trial and failure of two preferred second‑generation antipsychotics prior to coverage; document prior trials.
Xeljanz / rheumatology indications	Xeljanz products require trial and failure of DMARD(s) and often TNF inhibitor(s) depending on indication; providers must document medication history and trial durations.

Key Numeric Thresholds and Diagnostic Values

Factor VIII / IX level thresholds for hemophilia severity classification

Severe hemophiliaFactor VIII or IX level <1% classifies severe hemophilia

Moderate hemophiliaFactor VIII or IX level 1%–5% classifies moderate hemophilia

Age requirement (hemophilia prophylaxis)Age ≥12 years for listed prophylaxis indications

Inhibitor titer threshold (>5 BU/mL) required in several hemophilia criteria

Inhibitor titer threshold> 5 Bethesda Units per mL (BU/mL) defines historical or current high‑titer inhibitors

Low‑titer pathwayIf inhibitor titer <5 BU/mL, documentation of trial and failure of additional higher factor dosing is required

Specialist / Treatment Center Prescribing and Dispensing Requirements

Note

Prescribe/dispense specialty meds via appropriate treatment center/specialist

When specialty medications require treatment at a specific site, ensure prescriptions and dispensing occur through the required specialist or hemophilia/treatment center; for hemophilia agents PA submissions and dispensing must indicate the hemophilia treatment center.

Alhemo and other hemophilia biologics: must be prescribed and dispensed by a specialist working in a hemophilia treatment center.
Document the affiliated treatment center in the PA.

Note

Use hemophilia treatment centers for prescribing/dispensing hemophilia biologics

Hemophilia biologics (e.g., Alhemo, Hemlibra) require prescribing/dispensing by a specialist at a hemophilia treatment center; include center identification and evidence of hemophilia care with outcomes in the PA.

PA must show prescribing specialist affiliation with a hemophilia treatment center and that dispensing will occur through such a center.
Include number of bleeds and lab thresholds (factor levels, inhibitor titers) per product requirements.

Policy Background and Scope

Utilization management tools: Prior authorization and step therapy are formal processes used to ensure safe, clinically appropriate, and cost‑effective use of medications. Prior authorization requires submission of clinical documentation and review before the plan will cover a drug; approvals typically specify a time‑limited authorization (commonly 60 days to 1 year). Step therapy requires documented trials of specified preferred or generic alternatives and approval is granted only after required prior steps (trials/failures or documented contraindication/intolerance) have been met.

This policy governs Blue Cross Blue Shield of Michigan and Blue Care Network prior authorization and step therapy requirements for pharmacy benefit drugs and certain medical‑benefit specialty medications. It applies to providers requesting coverage for members enrolled in these plans and details drug‑specific clinical criteria, required documentation (for example: lab or genetic confirmation, specialist prescribing, and prior therapy trials), and the situations in which prior authorization or step therapy may be required.

Definitions and Terms

Policy Updates and Revision Notes

2026-05-01addition

New coverage criteria published for Dawnzera with publish date 5/1/2026 and effective date 7/1/2026 (expanded prior-trial requirements including Andembry).

2026-06-01administrative revisionLatest

Document footers and multiple sections updated to display revised date 'Revised: 06-01-2026'.

Note: This document contains multiple newly added or revised drug‑specific coverage criteria. Several entries in this release indicate additions or updates to prior‑trial requirements, initial approval lengths, and special documentation requirements. The footer and select sections show administrative revision entries (for example, Revised: 06‑01‑2026), and specific new coverage criteria (e.g., Dawnzera and multiple other agents) are included in the current extract.

Policy Summary

PayerBlue Cross Blue Shield - Michigan

PolicyPrior Authorization and Step Therapy Coverage Criteria — Pharmacy & Specialty Drugs

Policy CodePolicy N/A

Change TypeMultiple new and revised drug coverage criteria

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Notes: Alternative indication — reduction of proteinuria in complement 3 glomerulopathy (C3G) or IC-MPGN: requires renal biopsy confirmation and maximally tolerated ACEi/ARB or SGLT2i therapy prior to approval.

Operational note: Prior authorization required; initial approval typically 1 year and renewal requires documentation of clinical benefit.

Fabhalta (see Fabhalta — PNH entry)

Fasenra pen — Initial Therapy: Coverage for severe uncontrolled eosinophilic asthma when ALL are met: age ≥ 6 years, currently receiving and will continue standard of care, blood eosinophils ≥ 150 cells/μL at initiation, and prescriber attests to severe eosinophilic phenotype.

Weight-loss agents (Contrave, Qsymia, Wegovy, Ozempic/Semaglutide, Vivjoa etc.) — Coverage criteria: Age and BMI thresholds (typically BMI ≥30 kg/m2 or ≥27 kg/m2 with comorbidity), baseline weight documentation, physician attestation of lifestyle modification program participation, prohibition of combination with other weight-loss pharmacotherapies, and response-based renewal (commonly ≥5% weight loss from baseline for continued coverage). Specific agents may have age limits or additional contraindications (e.g., pregnancy).

Flector patch — Initial Therapy: Coverage when diagnosis and trial of and failure/intolerance to preferred oral/topical NSAIDs are documented; concurrent systemic NSAID use may be restricted per PA policy.

Galafold — Initial Therapy: Coverage requires diagnosis of Fabry disease confirmed by enzymatic and/or genetic testing, demonstration of amenability of GLA variant per FDA labeling, and prescriber specialty (metabolic/genetics/cardiology as appropriate).

Imcivree (genetic obesity) — POMC/PCSK1/LEPR: Initial coverage requires genetic confirmation of pathogenic/likely pathogenic variants in POMC, PCSK1, or LEPR, age per label, specialty prescriber, and documentation of severe early-onset obesity and prior lifestyle interventions; therapy limited to patients meeting genotype-specific criteria.

Imcivree (Bardet-Biedl Syndrome, BBS): Initial coverage requires clinical/genetic diagnosis of BBS per labeling, age and weight criteria per FDA/label, specialty prescriber, and documentation of prior interventions and ongoing monitoring.

Hemlibra (emicizumab) prophylaxis: Coverage for congenital hemophilia A with or without inhibitors when prescribed by a hemophilia treatment center specialist, with documentation of factor levels or inhibitor titers as applicable, and not used concurrently with immune tolerance induction when prohibited. Initial approval durations as per plan; renewal requires evidence of clinical benefit and bleed rate documentation.

Glycerol phenylbutyrate (Ravicti) — Initial Therapy: Coverage for urea cycle disorders when ALL of the following are met: diagnosis confirmed by biochemical/genetic testing, dietary management in place, and trial or intolerance to sodium phenylbutyrate if applicable; specialist prescriber required.

Long-acting ER opioids (Hysingla ER, Zohydro ER, Exalgo) — Initial Therapy: Coverage requires diagnosis of severe chronic pain requiring around-the-clock opioid therapy, trial and failure or intolerance to short-acting opioids and two other non-opioid/non-ER options, documentation of opioid risk assessment and opioid treatment agreement, urine drug testing and PDMP check per plan policies.

Ibsrela (linaclotide-related indications): Coverage requires diagnosis of IBS with constipation per Rome criteria, prior trial and failure or intolerance to at least two laxative classes and other indicated nonpharmacologic measures, age limits per label, and specialist involvement as appropriate.

Ibrance (palbociclib): Coverage for HR+/HER2- advanced or metastatic breast cancer when used per guideline-concordant regimens in combination with endocrine therapy; prior therapy requirements and oncology prescriber documentation required.

Icatibant (Firazyr) — Initial Therapy: Coverage for acute hereditary angioedema attacks when ordered by or in consultation with a specialist, with indication documentation; not for routine prophylaxis.

Imiquimod (Zyclara) — Warts: Coverage requires diagnosis of external genital/perianal warts or other label-supported indications, trial and failure or intolerance to first-line topical therapies when applicable per plan guidance.

Livetencity, Livdelzi: Coverage per their labeled antiviral or specialty indications requires documented diagnosis, prior agent trials if specified by labeling, and specialty prescriber involvement.

Lybalvi (lurasidone/bupropion) — Initial Therapy: Coverage requires diagnosis per FDA labeling for major depressive disorder with adjunctive therapy where appropriate, trial and failure of monotherapy antidepressants as required by plan step therapy rules.

Lynkuet — Initial Therapy: Coverage per label for mitochondrial disease or other approved indication; requires diagnostic confirmation and specialist prescriber.

Mavyret (glecaprevir/pibrentasvir) — Initial Therapy: Coverage for chronic hepatitis C across genotypes consistent with AASLD/IDSA guidance; verify benefit-specific restrictions and prior authorization requirements.

Meloxicam capsule (Vivlodex): Coverage requires diagnosis with need for NSAID therapy, trial/failure of preferred generic alternatives when applicable.

Memantine/donepezil (Namzaric): Coverage requires diagnosis of Alzheimer's disease or dementia per label, prior trial of donepezil (or intolerance) where required, and documentation of cognitive status and prescriber specialty.

Metformin HCl extended release (Fortamet): Preferred status for T2DM; prior trials noted only where formulary restrictions apply.

Methylergonovine (Methergine): Coverage only where indicated for postpartum hemorrhage per obstetric protocols; medical benefit considerations apply.

Korlym (mifepristone) — Coverage per label for Cushing’s syndrome when all endocrine and specialty criteria are met; prescriber specialty required.

Zavesca (miglustat), Yargesa (eliglustat): Coverage for Gaucher disease type 1 or Niemann-Pick Type C per labeled indications; requires biochemical/genetic confirmation and CYP2D6 genotyping for eliglustat, and prescriber specialty.

Milnacipran (Savella): Coverage for fibromyalgia when diagnosis criteria met and prior trials of other agents documented as required by plan step therapy rules.

Mirabegron ER (Myrbetriq): Coverage for overactive bladder with documented symptoms and trial/failure of bladder training and anticholinergic trials when required; consider contraindications.

Myalept (metreleptin): Coverage for generalized lipodystrophy when diagnostic and metabolic criteria met and specialist prescriber involved.

Myqorzo (for obstructive hypertrophic cardiomyopathy, oHCM): Coverage per labeled indication with cardiology specialty documentation and prior therapy trials as applicable.

Mytesi (crofelemer): Coverage for symptomatic relief of noninfectious diarrhea in HIV patients on antiretroviral therapy when other causes excluded and prior therapies tried per plan guidance.

Naftifine gel (Naftin): Coverage for tinea infections when topical antifungal alternatives trialed and failed or not tolerated.

Neupro (rotigotine patch): Coverage for Parkinson disease or restless legs syndrome per label with prior trial of oral agents when required.

Nexlizet (bempedoic acid/ezetimibe): Coverage for hyperlipidemia when statin-intolerant or insufficient response to maximally tolerated statin therapy and ezetimibe; LDL thresholds per guideline may apply.

Nicotrol (nicotine nasal spray): Coverage for smoking cessation per benefit with documentation of counseling and quit plan.

Nilotinib (Tasigna), Nilutamide (Nilandron): Cancer indications require oncology documentation and prior therapy steps per guidelines.

Nintedanib (Ofev) — Initial Coverage: Coverage for IPF, systemic sclerosis-associated ILD, or progressive fibrosing ILD per label when diagnostic criteria met and specialty prescriber documents disease severity and prior therapies as applicable.

Nitisinone (Orfadin): Coverage for hereditary tyrosinemia type 1 per metabolic specialty criteria; dietary management documentation required.

Noctiva (desmopressin nasal/oral): Coverage for nocturnal polyuria when diagnosis confirmed and fluid restriction and other measures tried; contraindications screened.

Nubeqa (darolutamide): Coverage for prostate cancer per guideline-based indications and oncology documentation.

Nucala — multiple indications: Coverage for severe eosinophilic asthma and EGPA per labeled eosinophil thresholds and specialist documentation; indication-specific criteria apply.

Nuplazid: Coverage for Parkinson disease psychosis per label with psychiatry/neurology documentation and risk assessment.

Oralair: Coverage for grass pollen immunotherapy per allergist documentation and seasonality indication.

Orgovyx, Oriahnn, Orilissa: Hormonal and gynecologic therapies covered per labeled indications with required diagnostic and prior therapy documentation.

Orlistat (Xenical): Coverage for weight management per benefit criteria and BMI thresholds where applicable.

Orlynvah, Oxtellar XR, Oxervate, Ozempic (injectable and tablet) — Coverage requires adherence to indication-specific criteria including diagnosis, prior therapy, and benefit-specific restrictions (e.g., Ozempic/Wegovy for weight management vs diabetes).

Palforzia (maintenance): Coverage for peanut oral immunotherapy maintenance per allergist documentation and initial desensitization completion.

Palynziq (pegvaliase) for PKU: Coverage requires diagnosis and baseline phenylalanine levels, metabolic specialist management, REMS enrollment, and documentation of prior dietary/medical therapy.

Qsymia (weight management): Coverage per weight-management criteria including BMI thresholds, lifestyle program participation, and contraindications.

Radicava ORS (ALS): Coverage for ALS per neurologist documentation and appropriate functional assessments.

Redemplo (for familial chylomicronemia syndrome): Coverage per genetic and clinical criteria and specialty prescriber documentation.

PCSK9-related agents: Coverage for primary hyperlipidemia or familial hypercholesterolemia when LDL thresholds and maximally tolerated statin therapy (± ezetimibe) trials are documented; familial criteria require genetic or clinical documentation.

Rezdiffra (NASH/MASH): Coverage per investigational/label status and specialty documentation; follow plan guidance.

Rinvoq (various rheumatologic/dermatologic indications): Coverage per indication requires prior trials of conventional DMARDs and/or biologics as specified and not used in combination with other targeted DMARDs for same indication.

Rufinamide (Banzel) for Lennox-Gastaut: Coverage requires diagnosis confirmed by neurology and prior anticonvulsant trials as specified.

Simponi — Initial Therapy: Coverage per labeled indications (e.g., RA, UC, PsA) with required trials of conventional therapy and not in combination with other biologics for same indication.

Sodium oxybate (Xyrem) — Initial Therapy: Coverage for narcolepsy with cataplexy per sleep specialist documentation and REMS enrollment; prior stimulant or other indicated therapy trials documented.

Sovaldi / Symdeko / Mavyret — Initial Therapy: Hepatitis C therapies covered consistent with AASLD/IDSA guidance and benefit restrictions; prior authorization required.

Tezspire — Initial Therapy: Coverage for severe asthma (and CRSwNP when indicated) per labeled eosinophil/Type 2 criteria and specialist documentation; not to be used in combination with other biologics for same indication without justification.

Tavalisse — Initial Therapy: Coverage for chronic ITP per hematology documentation and prior therapy trials including corticosteroids and TPO-RA as applicable.

Osteoporosis agents — Initial Therapy: Coverage per bone density thresholds, fracture history, and prior therapy trials as required by plan policy.

Testosterone topical — Initial Therapy: Coverage requires laboratory-confirmed hypogonadism with low morning testosterone on two occasions, symptom documentation, and not for age-related decline alone.

Tascenso ODT — Initial Therapy: Coverage per ADHD treatment step criteria and swallowing/administration needs.

Tegliputik/Tiglutik, Tiopronin, Tolvaptan, Topiramate, Trientine, Trikafta, Tyvaso, Ubrelvy, Vanrafia, Varubi, Ventavis, Veozah, Vesicare LS, Vigabatrin, Voquezna, Vivjoa, Voydeya, Vyndaqel, Vykat XR, Vyvgart Hytrulo, Wainua, Winrevair, Xeljanz, Wegovy, Xelpros, Xepi, Xcopri, Wayrilz: Coverage per individual labeled indications, specialty prescriber requirements, prior therapy trials, and any REMS or monitoring requirements as specified in the plan drug-specific entries.

Wegovy (semaglutide) — Indications, Initial and Continued Coverage: Coverage for chronic weight management requires BMI-based eligibility (≥30 or ≥27 with comorbidity), baseline weight, physician attestation to lifestyle program participation, contraindications reviewed (e.g., pregnancy, personal/family history of medullary thyroid carcinoma), and response-based continuation (commonly ≥5% weight loss at specified checkpoint).

Step therapy requires trying preferred or generic agents before coverage is approved for higher-cost alternatives. Providers should document prior trials (drug names, doses, durations, and reason for failure/intolerance) to support exceptions. Examples in this guideline include topical diclofenac (Solaraze) which requires prior failure of cryotherapy/photodynamic therapy and preferred topical fluorouracil and imiquimod; many specialty agents require prior trials of labeled or preferred alternatives (see individual drug entries).

Step therapy may require multiple agent trials and differs by drug (see drug criteria).
Preferred-product step therapy and Preferred Therapy Program encourage use of cost-effective alternatives when no brand fill in past 180 days.

Documentation Required

Documentation for specialty agents and required elements

Providers must submit indication-specific documentation for specialty and restricted agents. Required materials commonly include diagnosis, age, specialist information (when applicable), prior treatment history with dates/doses, relevant laboratory or genetic test results, and recent weight/BMI when relevant. Missing or incomplete documentation is a common reason for denial.

Common documentation: diagnosis, prior therapy trials and reasons for failure/intolerance, dates and doses, specialist name/clinic, recent labs or weight/BMI (within 30 days) where required.
Genetic confirmation required for CFTR modulators (Trikafta, Alyftrek, etc.), Imcivree (POMC/PCSK1/LEPR or BBS), and other gene-targeted therapies.
Hemlibra/Alhemo: require specialist dispensing at a hemophilia treatment center and inhibitor titer/lab documentation.

Denial Risk

Denial and Not‑Covered Risk — common triggers

Coverage denials commonly occur when a drug is designated Not Covered (NC), PA is not obtained, step therapy requirements are unmet, or required laboratory/genetic confirmation and prior therapy documentation are missing. Providers and members may be held financially responsible for NC or denied claims.

NC = Not Covered — the member may be responsible for full cost.
Denial triggers include: missing PA, lack of documented trial/failure of required agents, age limits, absence of required genetic/lab confirmation, concurrent contraindicated therapies (eg, multiple long‑acting opioids or sodium oxybate with sedative hypnotics/alcohol).
Examples: Alhemo — require inhibitor titers >5 BU/mL or documented trials; Aqvesme — transfusion history and hemoglobin thresholds; Solaraze — required prior trials of cryotherapy/phototherapy and topical fluorouracil/imiquimod; Doptelet — platelet count, duration of thrombocytopenia, and prior therapy documentation.

Prior Authorization

Provider Action — Drug‑specific PA and documentation highlights

Some drug‑specific highlights and operational notes (consolidated): providers must follow the drug criteria below and submit the associated documentation to support medical necessity and duration of therapy.

Austedo/Austedo XR: coverage requires indication-specific diagnosis and trial/failure or intolerance to alternatives (eg, Xenazine for chorea).
Brivaracetam, Vigabatrin, Topiramate, Epidiolex, and other antiepileptics: PA and seizure‑disorder documentation often required (see individual drug entry).
Carglumic acid, Cerdelga, Ravicti, Trientine, Tiopronin, Tolvaptan, Rasuvo, Radicava ORS — follow diagnosis and therapy sequencing in drug entries.
Diclofenac 3% gel (Solaraze): age ≥18, diagnosis of actinic keratosis, prior failure/intolerance to cryotherapy/phototherapy, topical fluorouracil, and imiquimod; initial approval commonly limited (eg, 3 months).
Dupixent, Rinvoq, Simponi, Entyvio Pen — biologics require specialist documentation and prior therapy trials per respective criteria.
Epclusa (sofosbuvir/velpatasvir), Harvoni, Sovaldi, Vosevi, Symdeko, Trikafta, Voquezna, Vyvasek/CFTR modulators: require diagnosis, genotype/genetic confirmation when applicable, and prior therapy sequencing per hepatitis or CF criteria.
Filsuvez and Filspari: follow wound/indication documentation and avoid disallowed combinations.
Hemlibra and Alhemo: hemophilia treatment center prescribing and inhibitor/lab documentation required; trial/failure to Hemlibra may be required for Alhemo in some circumstances.
Imcivree: genetic confirmation of pathogenic/likely pathogenic/uncertain variants in POMC/PCSK1/LEPR or BBS; submit current weight/BMI within 30 days; approval durations vary by indication.
Livtencity: for post‑transplant CMV, age/weight thresholds and prior treatment failure (ganciclovir/valganciclovir/cidofovir/foscarnet) required.
Long‑acting opioids (eg, Opana ER, Nucynta ER, Tapentadol ER): require trial/failure of multiple generic long‑acting opioids; coverage excluded if patient is on more than one long‑acting opioid concurrently.
Lumryz, Voydeya, Vyndaqel, Vykat XR, Winrevair, Vanrafia, Veozah, Tyvaso, Ventavis, Teglutik, Tezspire and other specialty agents: follow individual criteria for age, diagnosis, prior therapies, and contraindicated combinations.
Ubrelvy and Udenyca: require prior triptan trials or growth factor support trial failures respectively.
Pancreatic enzyme replacement, pancreatic agents sequencing, and weight‑management (Wegovy/Ozempic/semaglutide/ozempic tablets/orlistat) — document prior conservative measures and weight/BMI where applicable.
Documentation examples: Bylvay, Cablivi, Benlysta, Empaveli, Korlym, Livdelzi, Palforzia, Pyrukynd, Vyvgart Hytrulo, Vyndaqel — submit diagnosis, genetic/lab confirmation, specialist notes, dosing history, and monitoring data per drug entry.

Provider/site requirementPrescribed and dispensed by a specialist at a hemophilia treatment center

Hemoglobin level threshold (<10 g/dL) referenced in select anemia/transfusion criteria

Hemoglobin thresholdHemoglobin < 10 g/dL referenced for PNH and selected anemia/transfusion criteria

PNH LDH contextHemoglobin <10 g/dL may be listed among symptoms qualifying for high disease activity in PNH

Aqvesme contextHemoglobin <10 g/dL appears in non‑transfusion dependent thalassemia pathway

Transfusion history thresholds for thalassemia (>=6 units RBCs/6 months or >=100 mL/kg/year)

Transfusion‑dependent threshold (6‑month)>= 6 units RBCs in the last 6 months (with no more than 6 weeks between infusions) for transfusion‑dependent thalassemia pathway

Annualized volume threshold>= 100 mL/kg/year of packed RBCs as an alternative transfusion‑dependence metric

Non‑transfusion dependent capMust have received ≤5 units RBCs in the last 6 months for non‑transfusion dependent pathway

Age thresholds (examples across multiple drug entries)

Adult age examplesMany agents include minimum age criteria such as ≥18 years

Infant/pediatric examplesSome agents specify ages like ≥3 months (Bylvay PFIC) or ≥12 months (Bylvay ALGS pediatric) depending on indication

Adolescent exampleSeveral immunologic/antiviral agents set thresholds like ≥12 years (Empaveli, Livtencity) or ≥6/7 years for other agents

BMI thresholds for weight-management agents (Contrave example)

Contrave BMI initiationBMI ≥30 kg/m2, or BMI ≥27 kg/m2 with at least one weight‑related comorbidity required for Contrave coverage

Documentation requirementCurrent baseline weight and physician attestation of participation in lifestyle modification required

Continuation metricContinued coverage typically requires maintenance of ≥5% weight loss from baseline

Hypoglycemia severity thresholds (CGM criteria)

Level 2 hypoglycemiaGlucose < 54 mg/dL is defined as Level 2 hypoglycemia in CGM/problematic hypoglycemia criteria

Level 3 hypoglycemiaLevel 3 is a severe hypoglycemia event requiring third‑party assistance

CGM eligibility noteRecurrent Level 2 events despite adjustments or a Level 3 event qualify under CGM problematic hypoglycemia criteria

Doptelet platelet count thresholds and initiation/renewal targets

Persistent thrombocytopenia definitionPlatelet count <100,000/μL for ≥3 months defines persistent thrombocytopenia (Doptelet)

Initiation thresholdsCurrent platelet <20,000/μL or <30,000/μL with bleeding for initiation of certain therapies (Doptelet/eltrombopag contexts)

Renewal targetRenewal based on platelet counts between 50,000–200,000/μL or dosage adjusted per FDA labeling; 20,000–50,000/μL may be acceptable if bleeding reduced

Doptelet platelet thresholds (duplicate related entry)

Persistent thrombocytopeniaPlatelet count <100,000/μL for ≥3 months (Doptelet)

Initiation criteriaCurrent platelet <20,000/μL or <30,000/μL with bleeding for initiation

Renewal criteriaRenewal requires platelet counts 50,000–200,000/μL or FDA‑recommended dosing adjustments; coverage possible at 20,000–50,000/μL if bleeding reduced

Eltrombopag dose thresholds for indicated conditions

Eltrombopag chronic ITP max doseEltrombopag dose should not exceed 75 mg/day for chronic ITP

Eltrombopag HCV thrombocytopenia max doseDose should not exceed 100 mg/day for thrombocytopenia with chronic hepatitis C

Eltrombopag severe aplastic anemia max doseDose should not exceed 150 mg/day for severe aplastic anemia

Empaveli diagnostic thresholds (flow cytometry, LDH) and transfusion history

Empaveli PNH diagnostic requirementFlow cytometric confirmation of PNH type III red cells required for PNH indication

Empaveli LDH thresholdLDH ≥ 1.5 × ULN defines high disease activity in PNH

Empaveli transfusion historyAt least one transfusion in prior 12 months (or history of major thrombotic event) may qualify for therapy

LDH threshold for PNH high disease activity (>=1.5x ULN)

PNH high disease activity LDHLDH ≥ 1.5 times the upper limit of normal used to define high disease activity

Associated symptomsLDH threshold applied with symptoms such as weakness, fatigue, hemoglobinuria, abdominal pain, dyspnea or Hb <10 g/dL

Use contextAppears in Empaveli and Fabhalta PNH eligibility criteria

Eosinophil threshold for Fasenra (>=150 cells/μL)

Fasenra eosinophil thresholdBlood eosinophils ≥150 cells/µL at initiation for severe uncontrolled eosinophilic asthma (Fasenra)

Nucala asthma eosinophil thresholdNucala also uses ≥150 cells/µL for asthma indications at initiation

DocumentationEosinophil counts documented at initiation are required for biologic anti‑eosinophil agents

BMI thresholds for weight management coverage (Wegovy/others)

Wegovy adult BMI initiationAdults: BMI ≥30 kg/m2, or ≥27 kg/m2 with one weight‑related comorbidity for coverage consideration

Wegovy pediatric initiationPediatrics (12–17 years): BMI ≥95th percentile for age and sex

Documentation for WegovyBaseline and current weight, physician attestation of lifestyle modification, and Teladoc program engagement often required

Gattex parenteral support duration (>=12 months)

Parenteral support duration (Gattex)Dependence on parenteral support for ≥12 months required for Gattex initiation

Initial approval durationInitial approval commonly 1 year for Gattex when criteria met

Renewal improvement metricRenewal requires ≥20% reduction in weekly parenteral nutrition or IV fluid volume

Gattex renewal improvement metric (>=20% reduction in weekly parenteral nutrition)

Gattex renewal improvement metricRenewal requires demonstration of ≥20% reduction in weekly parenteral nutrition or IV fluid volume

DocumentationRenewal requires that initial criteria remain met and clinical benefit documented

Initial approvalInitial approval typically 1 year

Imcivree adult BMI threshold (>=30 kg/m2)

Imcivree adult BMI thresholdAdults: BMI ≥ 30 kg/m2 required for Imcivree eligibility

Age minimumAge ≥ 2 years noted for genetic obesity indications (POMC/PCSK1/LEPR or BBS)

DocumentationCurrent weight and BMI within 30 days must be submitted to the plan

Imcivree pediatric obesity threshold (>=95th percentile BMI for age/sex)

Pediatric obesity threshold (Imcivree)Pediatrics: BMI ≥ 95th percentile for age and sex for Imcivree pediatric eligibility

Age requirementAge ≥2 years for Imcivree indications

DocumentationCurrent weight and BMI (within 30 days) required for review

Hemlibra inhibitor titer threshold (>5 BU/mL) reminder

Hemlibra high‑titer reminder> 5 Bethesda Units per milliliter (BU/mL) used to document high‑titer inhibitors in Hemlibra/Hemophilia pathways

Specialist/site requirementPrescribed and dispensed by a specialist at a hemophilia treatment center

Continuation noteContinuation requires decreased bleeding frequency and absence of anti‑drug antibodies affecting efficacy

Icatibant lab confirmation requirements (C4 and C1INH levels)

Icatibant lab confirmationC4 below lab normal range AND C1INH (antigenic or functional) below lab normal reference (normal C4 range cited 16–58 mg/dL; normal C1INH ≥41%)

PrescriberIcatibant should be prescribed by an immunologist, allergist, or hematologist

Use restrictionNot to be used in combination with other acute HAE products

Imcivree obesity thresholds summary (duplicate)

Imcivree adult BMIAdults: BMI ≥ 30 kg/m2

Imcivree pediatric BMIPediatrics: BMI ≥ 95th percentile for age/sex

DocumentationCurrent weight and BMI (within 30 days) must be submitted for Imcivree requests

Lumryz minimum age (>=7 years)

Lumryz minimum ageMinimum age ≥7 years for Lumryz indications

Indication requirementsDiagnosed narcolepsy with cataplexy or excessive daytime sleepiness; trial/failure requirements to Wakix or stimulants apply

Concomitant use exclusionLumryz will not be approved with sedative hypnotics, other CNS depressants, or alcohol

Livtencity age/weight requirement (>=12 years and >=35 kg)

Livtencity age/weightAge ≥12 years AND weight ≥35 kg required for Livtencity post‑transplant CMV indication

Prior therapyTrial and failure of ganciclovir, valganciclovir, cidofovir or foscarnet required prior to approval

Initial approvalInitial approval commonly 3 months for Livtencity

LVOT peak gradient threshold (>=50 mmHg) example for oHCM therapies

LVOT peak gradient threshold>= 50 mmHg at rest or with provocation required for obstructive HCM (Myqorzo eligibility)

NYHA classNYHA class II–III often specified for symptomatic oHCM therapy initiation

LVEF initiation requirementLVEF ≥55% required at initiation for Myqorzo (renewal requires LVEF ≥40%)

LVEF thresholds for initiation/renewal (>=55% initiation; >=40% renewal)

LVEF for initiation>= 55% left ventricular ejection fraction required for initiation in specified oHCM indication

LVEF for renewalRenewal requires LVEF ≥ 40% and clinical benefit

Clinical contextLVEF thresholds used alongside symptom and gradient criteria for initiation/continuation

Weight threshold for Motpoly XR (>=50 kg)

Motpoly XR weight thresholdMember weight ≥50 kg required for Motpoly XR coverage

Indication contextWeight requirement tied to dosing/efficacy evidence in seizure disorder indications

Initial approvalInitial approval typically 1 year when criteria met

Weight threshold for Myrbetriq granules (>=35 kg)

Myrbetriq granules weight thresholdWeight ≥35 kg required for pediatric neurogenic detrusor overactivity pathway for Myrbetriq granules

Age thresholdAge ≥3 years for NDO indication in granules formulation

Step requirementTrial and failure or intolerance to two generic anticholinergic agents required prior to approval

Nucala eosinophil threshold for asthma (>=150 cells/µL) and HES (>=1000) summary

Nucala asthma eosinophil thresholdEosinophils ≥150 cells/µL at initiation required for severe uncontrolled eosinophilic asthma indication

Nucala HES thresholdFor HES indication, eosinophils ≥1,000 cells/µL at initiation required

DocumentationConsultation with appropriate specialist and prior therapy trials required per indication

BMI thresholds for orlistat (>=30 or >=27 with comorbidity)

Orlistat adult BMI initiationAdults: BMI ≥30 kg/m2, or BMI ≥27 kg/m2 with at least one weight‑related comorbidity required for orlistat (Xenical)

Documentation/participationBaseline weight and physician attestation of lifestyle modification required; continued coverage requires ≥5% weight loss

Cannot combine GLP‑1sWeight‑loss agents cannot be used in combination with other GLP‑1 agonists or weight loss products per policy

Palynziq phenylalanine concentration threshold (>=600 µmol/L)

Palynziq Phe concentration>= 600 µmol/L phenylalanine concentration required for Palynziq initiation

Dietary requirementMember must be following a phenylalanine‑restricted diet

Age requirementAge ≥12 years for Palynziq coverage

Redemplo fasting triglyceride threshold (>=880 mg/dL)

Redemplo fasting triglyceride threshold>= 880 mg/dL fasting triglycerides required for Redemplo in familial chylomicronemia syndrome

Age requirementAge ≥18 years indicated for Redemplo initiation

Initial approvalInitial approval commonly 1 year when criteria met

Age threshold for PCSK9-like agents (>=10 years)

PCSK9 family age thresholdAge ≥10 years required for familial hypercholesterolemia pediatric PCSK9‑class agent use

Statin trial requirementTrial and failure of high‑intensity statin or documented statin intolerance typically required

Combination restrictionNot to be used in combination with other PCSK9 inhibitors

Fasting triglyceride level threshold (>=880 mg/dL duplicate)

Fasting triglyceride duplicateFasting triglyceride level ≥880 mg/dL appears as the threshold for severe hypertriglyceridemia (Redemplo) in multiple entries

Clinical contextUsed to define eligibility for therapies aimed at reducing triglyceride‑driven pancreatitis risk

Age/management noteInitiation often limited to adults (≥18 years) and requires dietary adherence

Weight threshold examples (>=30 kg for pediatric Rinvoq indications)

Pediatric weight example (Rinvoq)Weight ≥30 kg cited for some pediatric rheumatology indications (e.g., Rinvoq pediatric dosing)

Dose/age linkWeight thresholds frequently determine formulation or dosing eligibility in pediatric indications

DocumentationProvider must document weight and age for pediatric dosing authorization

Fibrosis stage requirement (F2-F3) for Rezdiffra

Fibrosis stage requirementAdvanced liver fibrosis stage F2–F3 required for Rezdiffra eligibility (verified by FibroScan or imaging‑based noninvasive assessment)

Age requirementAge ≥18 years specified for Rezdiffra initiation

Lifestyle requirementUse in conjunction with diet and exercise and documentation of participation may be required

Simponi weight threshold for ulcerative colitis (>=15 kg)

Simponi UC weight thresholdWeight ≥15 kg required for Simponi use in ulcerative colitis pediatric contexts

DMARD failure requirementPrior adequate course of conventional therapy (e.g., steroids 7 days, azathioprine ≥2 months) required unless contraindicated

Combination exclusionNot to be used with other biologics/targeted DMARDs for same indication

Testosterone topical approval criteria (two signs/symptoms required)

Testosterone topical approval criteriaTwo specific signs and symptoms of testosterone deficiency plus diagnosis of male hypogonadism required for testosterone topical products

Initial approval durationInitial approval commonly 1 year with renewal requiring clinical benefit

Trial requirementSome policies require trial/failure of other testosterone formulations before restricted products

Hemoglobin threshold for Voydeya (<=9.5 g/dL)

Voydeya hemoglobin thresholdHemoglobin ≤ 9.5 g/dL required as part of EVH laboratory criteria for Voydeya initiation

ContextThreshold used to define clinically significant extravascular hemolysis in PNH when used as add‑on to Soliris/Ultomiris

Associated labsPaired with absolute reticulocyte count threshold for full EVH definition

Absolute reticulocyte count threshold for Voydeya (>=120 x10^9/L)

Voydeya absolute reticulocyte thresholdAbsolute reticulocyte count ≥120 × 10^9/L required for clinically significant EVH in Voydeya criteria

Paired lab requirementUsed together with Hgb ≤9.5 g/dL to document EVH eligibility

Use restrictionVoydeya must be used only as add‑on to Soliris® or Ultomiris®

Serum sodium threshold for clinically significant hyponatremia (<125 mEq/L)

Serum sodium threshold for SamscaSerum sodium <125 mEq/L defines clinically significant hyponatremia for tolvaptan (Samsca) criteria

Hospital initiationTherapy should be initiated/re‑initiated in a hospital setting per criteria for Samsca

ADPKD noteJynarque (tolvaptan) has separate ADPKD criteria (age ≥18) unrelated to hyponatremia threshold

Tiopronin patient weight threshold (>=20 kg)

Tiopronin weight thresholdPatient weight ≥20 kilograms required for tiopronin (Thiola / Thiola EC) use to prevent cystine stones

Conservative measuresMust be resistant to conservative measures (fluid, diet, urine alkalization) prior to tiopronin initiation

Initial approvalInitial approval typically 1 year when criteria met

Voydeya hemoglobin and reticulocyte thresholds (duplicate summary)

Voydeya lab summaryVoydeya eligibility summarized as Hgb ≤ 9.5 g/dL AND absolute reticulocyte count ≥120 ×10^9/L for clinically significant EVH

Age/use restrictionAge ≥18 and must be used as add‑on to Soliris or Ultomiris

Prior therapy requirementTrial and failure/contraindication/intolerance to Empaveli and Fabhalta required prior to Voydeya

Wegovy BMI thresholds (adult and pediatric) summary

Wegovy adult initiationAdults: BMI ≥30 kg/m2, or ≥27 kg/m2 with one weight‑related comorbidity for Wegovy initiation

Wegovy pediatric initiationPediatrics (12–17 years): BMI ≥95th percentile for age/sex

Continuation adult targetAdult continued coverage requires maintaining ≥5% weight loss from baseline and engagement with lifestyle program/Teladoc

Wegovy continued coverage weight loss threshold (>=5% adult)

Wegovy adult continuation thresholdMaintain at least 5% weight loss from baseline for continued adult coverage

Documentation requiredCurrent weight within 30 days and proof of ongoing participation in lifestyle modification/Teladoc program required

Adherence metricProportion of days covered ≥80% often required for continued coverage under some pathways

Wegovy pediatric continuation threshold (>=1% BMI reduction)

Wegovy pediatric continuation thresholdMaintain ≥1% reduction in BMI from baseline for continued pediatric coverage

DocumentationCurrent weight and physician attestation of continued lifestyle participation required

Age rangePediatric pathway covers ages 12–17 with BMI ≥95th percentile

Note

Hemophilia biologics: hemophilia treatment center prescribing and required lab/bleed documentation

Certain hemophilia prophylaxis biologics must be prescribed and dispensed by a specialist working in a hemophilia treatment center and documentation must include inhibitor or factor levels, number of bleeds in prior 12 months, and prior therapy trials.

High titer inhibitors (>5 BU/mL) or factor level thresholds (severe <1% or 1–5% moderate) must be documented.
PA/dispensing must indicate the hemophilia treatment center and prior Hemlibra trial/failure where applicable.

Documentation Required

Include diagnosis, labs/genetics, prior therapy history, age, and prescriber specialty with PA

For specialty drug PA requests, include diagnosis details, relevant labs/genetic test results, prior treatment history (trials and failures), age, and prescriber specialty—these are common documentation elements required across many entries.

Examples: genetic test reports (Imcivree, Trikafta), lab thresholds (LDH, Hgb, platelet counts), prior‑trial records for step therapy.
Provide current weight/BMI within 30 days when specified (e.g., Imcivree, Wegovy).

Administrative revisions and page‑level updates are shown in the policy footer and select sections (for example, entries marked Revised: 06‑01‑2026). Providers should confirm they are using the most recent version of the criteria when submitting authorization requests.