Medical Necessity Criteria for Pharmacy Edits
Customize your policy alerts
Sign up for Premera Bluecross Policy 5.01.605 alerts
Get alerted when Policy 5.01.605 changes without checking for updates manually.
Monitor payer policy activity
Defines medical necessity and prior authorization criteria for medications in the plan's pharmacy benefit prior authorization program; applies to providers submitting pharmacy prior authorization requests under Premera Bluecross.
No material clinical or coverage changes in this revision.
Coverage Criteria for Selected Drugs
Vonoprazan (Voquezna) — Covered Indications
Voquezna (vonoprazan) coverage rules
OTC esomeprazole, lansoprazole, or omeprazole use qualifies when documented in chart notes.
Use of OTC esomeprazole, lansoprazole, or omeprazole qualifies when documented in chart notes.
Voquezna (vonoprazan) — erosive esophagitis
Voquezna may be considered medically necessary when ALL of the following are met
OTC PPI use qualifies when documented in chart notes
Voquezna (vonoprazan) — non-erosive GERD (heartburn)
Voquezna may be considered medically necessary for relief of heartburn with ALL of the following
OTC PPI use qualifies when documented in chart notes
Brand stimulants and atomoxetine (ADHD) — general medical necessity
Brand stimulants for ADHD and other psychiatric conditions may be considered medically necessary when ANY of the following apply
Applies to brand stimulant products per policy
Atoncy (atomoxetine) — ADHD
Atomoxetine may be considered medically necessary when ALL criteria are met
Documentation required for oral solution necessity
Lisdexamfetamine (Arynta, Vyvanse) — ADHD and Binge Eating Disorder (BED)
Lisdexamfetamine products may be considered medically necessary for ADHD or BED when specified criteria are met
Arynta-specific quantity limit
Full DSM-5 BED criteria required in chart notes
Vyvanse quantity limit
Sensipar (cinacalcet) — covered with criteria
Sensipar (cinacalcet) may be considered medically necessary when ALL of the following are met
Prescriber specialty and supporting diagnosis documentation required
Cardamyst (etripamil) nasal spray — covered with criteria
Cardamyst may be considered medically necessary for conversion of acute symptomatic PSVT when ALL are met
Prescriber specialty and episode history required
Katerzia, Norliqva, Sdamlo (amlodipine formulations) — covered with criteria
May be considered medically necessary when the following are met
Applies to Katerzia, Norliqva, Sdamlo formulations
Chelation agents and Wilson's disease agents (Chemet, penicillamine, trientine, Cuvrior, Syprine) — covered with criteria
Coverage rules for use in acute poisoning and Wilson's disease or cystinuria when ALL applicable criteria are met
Chemet (succimer) for pediatric lead poisoning
Hospital-initiated continuation only
Documentation required
Brand penicillamine requires prior generic trial/documentation
Dose limits and specialist involvement required
Constipation and OIC agents (Amitiza, Linzess, Motegrity, Movantik, Pizensy, Relistor, Symproic, Trulance) — covered with criteria
Agents for IBS-C, CIC, FC, and OIC may be authorized when listed age, diagnosis, prior therapy trials, and quantity limits are met
Amitiza requires prior generic lubiprostone trial
Pediatric and adult pathways described
Age-specific criteria
Applies to naloxegol, methylnaltrexone, naldemedine per OIC criteria
Trulance requires prior generic lubiprostone trial
Ohtuvayre (ensifentrine) for COPD — covered with criteria
Maintenance treatment may be considered when ALL criteria are met
Specialist involvement and prior LAMA/LABA trial required
Brinsupri (brensocatib) for non-CF bronchiectasis — covered with criteria
May be authorized when ALL criteria are met
Initial therapy may be approved up to 12 months
Reauthorization requires documented clinical benefit
Eohilia (budesonide oral suspension) for eosinophilic esophagitis — covered with criteria
May be authorized when the following criteria are met
Initial authorization up to 12 weeks; reauthorization rules apply
Reauthorization intervals specified in policy
Gimoti (metoclopramide nasal spray) for diabetic gastroparesis — covered with criteria
May be authorized when ALL criteria are met
Prescriber specialty and prior therapy documentation required
Heart disease / heart failure agents (Lodoco/Colchicine, Camzyos, Corlanor) — covered with criteria
Selected cardiovascular agents authorized when listed criteria are met
Cardiovascular prevention context per policy
Specialist prescribing required
Adult heart failure pathway
Pediatric DCM indication
Kerendia (finerenone) for CKD with type 2 diabetes — covered with criteria
May be authorized when ALL criteria are met
Kerendia chronic HF pathway per policy
Arixtra (fondaparinux) — covered with criteria
Managed under pharmacy benefit when prior therapies failed
Prior therapy requirement for anticoagulant coverage
Camzyos (mavacamten) — obstructive HCM (adults)
Camzyos may be considered medically necessary when ALL of the following are met
Specialist prescribing and LVEF requirement per policy
Corlanor (ivabradine) — adults
Corlanor may be considered medically necessary for adults when ALL of the following criteria are met
Specialist involvement required
Corlanor (ivabradine) — pediatric
Corlanor may be considered medically necessary for pediatric individuals when ALL of the following criteria are met
Pediatric-specific criteria per policy
Kerendia (finerenone) — chronic heart failure
Kerendia may be considered medically necessary when ALL of the following are met
Chronic HF indication per policy
Myqorzo (aficamten) — obstructive HCM
Myqorzo may be considered medically necessary when ALL of the following are met
Specialist prescribing required
Verquvo (vericiguat) — HFrEF
Verquvo may be considered medically necessary when ALL of the following are met
Specialist involvement and recent clinical events required
Carospir (spironolactone oral suspension) and other diuretics (liquid formulations)
May be considered medically necessary when specified diagnosis and formulation necessity documented
Oral suspension necessity and prior generic trial required
Formulation-specific criteria
Soaanz (torsemide tablet)
May be considered medically necessary when ALL are met
Prior generic trial required
Clonidine oral solution and clonidine XR
Brand formulations may be considered medically necessary when:
Applies to clonidine oral solution and extended‑release formulations
Tryvio (aprocitentan)
May be considered medically necessary when ALL of the following are met
Combination therapy failure required prior to Tryvio
Hypnotics (listed brands)
Brand hypnotics may be considered medically necessary when:
Applies to listed brand hypnotic products
Lithostat (acetohydroxamic acid)
May be considered medically necessary as adjunctive therapy when ALL are met
Pregnancy verification required
Oxervate (cenegermin-bkbj) — neurotrophic keratitis
Oxervate may be considered medically necessary when ALL are met
Initial approval 8 weeks; reauthorization criteria referenced
Nitisinone products (Harliku, generic, Nityr, Orfadin) — hereditary tyrosinemia type 1 and alkaptonuria
May be considered medically necessary when diagnosis and confirmatory testing are documented
Generic and branded nitisinone products addressed; some brands require prior generic trial
Urinary HGA threshold specified for alkaptonuria
Intranasal brand corticosteroid products
Brand intranasal corticosteroids may be considered medically necessary when:
Applies to listed brand intranasal corticosteroid products
Xhance (fluticasone propionate) — chronic rhinosinusitis without nasal polyps
May be considered medically necessary when:
Applies to chronic rhinosinusitis without nasal polyps
Accrufer (ferric maltol) — iron deficiency anemia
May be considered medically necessary when:
Prior oral and IV iron trials required
Viberzi (eluxadoline) — IBS-D
May be considered medically necessary when:
Prior anti-diarrheal trials required
Zelsuvmi (berdazimer) — molluscum contagiosum
May be considered medically necessary when ALL are met
Treatment duration limited per policy
Brand oral corticosteroids and Alkindi Sprinkle
Brand oral corticosteroids may be considered medically necessary when:
Alkindi Sprinkle quantity limits specified
Overactive bladder agents (brands) and generic mirabegron
Brand agents may be considered medically necessary when:
Generic mirabegron may be used after failure of listed agents
Palforzia (peanut allergen powder)
May be considered medically necessary when ALL are met
Specialist involvement and attestation required
Tolvaptan (generic and Jynarque) — progressing ADPKD
May be considered medically necessary when:
REMS enrollment required for tolvaptan
Liver monitoring and REMS required for Jynarque
Proton Pump Inhibitors (brands) — when brand may be covered
Brand or certain formulations may be considered medically necessary when:
Step therapy applies per PPI policy
Nuedexta (dextromethorphan/quinidine) — Pseudobulbar Affect
May be considered medically necessary when:
Nuedexta quantity limit per policy
Cystic Fibrosis therapies (Bronchitol, Pulmozyme)
May be considered medically necessary when specified clinical criteria met
BTT required and concurrency excluded
Pulmozyme criteria include spirometry requirement
PPI medical necessity
Proton Pump Inhibitors (selected brands/generics) may be considered medically necessary when:
OTC use of esomeprazole, lansoprazole, omeprazole qualifies when documented
Bronchitol (mannitol) initial therapy
Bronchitol (mannitol) may be considered medically necessary when ALL of the following are met:
BTT required to confirm appropriateness
Pulmozyme (dornase alfa)
Pulmozyme (dornase alfa) may be considered medically necessary when ALL of the following are met:
Pulmozyme off-label pediatric context noted
Nuedexta (PBA)
Xdemvy (lotilaner) may be considered medically necessary when ALL of the following are met:
Re-authorization beyond 6 weeks considered investigational; retreatment within <1 year reviewed as new request
Elmiron (interstitial cystitis)
Elmiron (pentosan polysulfate sodium) may be considered medically necessary when:
Prior therapy requirement specified
Initial therapy — Xdemvy (lotilaner)
Xdemvy (lotilaner) for Demodex blepharitis is covered when ALL of the following are met:
Re-authorization beyond 6 weeks is considered investigational; retreatment within <1 year handled as new request
Re-authorization / Investigational
Re-authorization and investigational stance:
Re-authorization beyond initial 6-week course not supported by guideline
Oral tetracycline prior trial requirement
Oral tetracycline agents consideration:
Documentation of inadequate response required
Initial therapy: Xdemvy (lotilaner)
Xdemvy (lotilaner) coverage criteria
Prescriber specialty and objective exam documentation required
Re-authorization / investigational
Xdemvy re-authorization stance
Policy disfavors continuation beyond initial 6-week course
Step therapy for branded tetracyclines
Branded doxycycline/minocycline (Targadox, Ximino) criteria
Medical records documenting inadequate response required
Xdemvy (lotilaner) initial therapy
Covered when ALL of the following are met
Prescriber specialty and exam documentation required
Xdemvy re-authorization / retreatment
Re-authorization criteria / limits
Reauthorization beyond initial course generally not supported
Oral doxycycline/minocycline prior therapy requirement
Targadox, Ximino, and similar products may be considered medically necessary when ALL of the following are met
Required prior trials before branded tetracyclines are considered
Initial therapy — Xdemvy (lotilaner)
Covered when ALL of the following are met:
Objective exam documentation and prescriber specialty required
Re-authorization / repeat treatment
Re-authorization and repeat treatment rules:
Policy restricts frequency and duration of Xdemvy courses
Prerequisite trial for certain oral tetracyclines
Coverage for Targadox (doxycycline) and Ximino (extended-release minocycline):
Medical records documenting inadequate response required prior to branded tetracyclines
Initial therapy - Xdemvy (lotilaner)
Xdemvy (lotilaner) ophthalmic drops are covered when ALL of the following are met:
Objective slit-lamp exam documentation required
Dose and quantity limits enforced
Re-authorization beyond 6 weeks is considered investigational
Oral tetracycline step-therapy (Targadox, Ximino)
Targadox and Ximino may be considered medically necessary when ALL of the following are met:
Documentation of inadequate response required before branded tetracyclines
Initial approval criteria
Covered when ALL of the following are met:
Slit-lamp findings must be documented in medical records
Per dosing limits in policy
One bottle per initial 6-week course
Specialist prescribing requirement
Re-authorization and repeat treatment rules
Re-authorization beyond initial course is investigational
Minimum interval before treating same indication as new request
Referenced oral antibiotic trial (other products)
Prerequisite for branded doxycycline/minocycline products
Initial coverage criteria for Xdemvy (lotilaner)
Xdemvy (lotilaner) for Demodex blepharitis is covered when ALL of the following are met:
Objective exam findings required
Per dosing guidance
One bottle per initial course
Specialist prescribing required
Coverage criteria for branded oral tetracyclines (Targadox, Ximino)
Targadox and Ximino may be considered medically necessary when ALL of the following are met:
Documentation in medical records required
Initial Therapy
Covered when ALL of the following are met
Initial approval duration: 6 weeks
Re-authorization / Subsequent Therapy
Re-authorization and subsequent use
Retreatment within <1 year restricted; >=1 year reviewed as new request
Frequency limitation
Timing restriction for new review
Limits frequency of approved courses
Initial therapy for Xdemvy (lotilaner)
Covered when ALL of the following are met
Objective exam documentation and prescriber specialty required
Re-authorization and prior-treatment interval
Re-authorization / Not recommended
Policy does not support continuation beyond initial course
Coverage criteria for certain doxycycline/minocycline branded products
Covered when ALL of the following are met
Documentation of prior trials required
Any request for a medication in this policy that does not meet the stated age, diagnosis, prior therapy/trial, or quantity requirements is not supported by these coverage criteria and may be denied. For example, coverage of Voquezna (vonoprazan) is limited to adults (aged ≥18) and requires either ≥8 consecutive weeks of prior PPI therapy for erosive esophagitis or documented failure/intolerance to 3 listed generic PPIs for non‑erosive GERD, with the prescribed quantity limited to 1 tablet per day. Requests missing documentation of these elements (age, diagnosis, prior PPI trials/duration, or the specified quantity) are at risk for denial.
Certain therapies are explicitly excluded when used concurrently with incompatible treatments. For example, Bronchitol (mannitol) is approved as add‑on maintenance therapy for cystic fibrosis but its use concurrent with hypertonic saline is excluded; documentation must confirm the regimen is not being used concurrently. Requests that do not document the required exclusion (or other required clinical prerequisites) may be denied.
A branded topical or suppository steroid will only be considered when the policy’s step requirements are met. Specifically, a brand steroid formulation does not qualify for coverage unless the individual has tried and had an inadequate response to the required number of generic alternatives (e.g., two prescription generic topical steroids, or a generic steroid suppository when applicable). Note that a generic alternative does not qualify if it is not the exact same product or formulation.
Bronchitol (mannitol) coverage requires documentation of cystic fibrosis diagnosis, age ≥18, and completion of a Bronchitol Tolerance Test (BTT). Additionally, the policy excludes use of Bronchitol when it is administered concurrently with hypertonic saline — the record must confirm the patient is not receiving hypertonic saline at the same time. When these conditions and the dose/quantity limits (e.g., 800 mg/day; quantity limits as specified) are not documented, the request may be denied.
For Xdemvy (lotilaner), initial authorization is limited to a single 6‑week treatment course (dose: one drop in each eye twice daily; quantity: one bottle per 6‑week course) and must be prescribed by or in consultation with an optometrist or ophthalmologist. Re‑authorization beyond 6 weeks is considered investigational and is not routinely approved; similarly, retreatment with Xdemvy within less than 1 year of completing a prior course will not be treated as a routine continuation and is subject to review as a new request. Providers should expect re‑authorization requests beyond the 6‑week initial course to be denied unless compelling evidence and rationale consistent with investigational use are provided.
Initial Therapy Criteria
Continuation and Re-authorization Criteria
For reauthorization or retreatment with Xdemvy (lotilaner), the policy treats any request for therapy beyond the initial 6‑week course as investigational. Additionally, retreatment after a prior course will generally be considered a new request only if at least 1 year has elapsed since completion of the previous treatment course.
Future re-authorization of Xdemvy (lotilaner) beyond the initial 6‑week approval is considered investigational and therefore not supported by this guideline. Requests for retreatment within less than 1 year of completing a prior course will not automatically be treated as a new eligible course and are restricted.
Step Therapy and Prior-Trial Requirements
| Requirement | Details |
|---|---|
| Trial and inadequate response or intolerance to 3 listed generic proton pump inhibitors is required prior to vonoprazan for non‑erosive GERD. | |
| Esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole (OTC use of esomeprazole, lansoprazole, or omeprazole qualifies when documented). |
| Documentation Requirement | Notes |
|---|---|
| Medical records or chart notes must document trials of prior PPIs or intolerance before vonoprazan is considered. | |
| Use of OTC esomeprazole, lansoprazole, or omeprazole qualifies as a prior trial when documented in chart notes. |
| Requirement | Action / Documentation |
|---|---|
| Providers must document prior trials, inadequate responses, or intolerances to the specific generic alternatives listed in each drug section (see individual drug criteria). | |
| Documentation should be medical records/chart notes showing the trial duration and inadequate response or intolerance as specified. |
| Policy Expectation | Provider Action |
|---|---|
| Brand product coverage requires documented trials and failures (inadequate response or intolerance) of relevant generic alternatives. | |
| Providers must submit documentation of prior generic trials and outcomes with prior authorization requests. |
| Step Therapy Area | Requirement |
|---|---|
| Trials of generic alternatives are required prior to coverage of listed branded or alternative PPI formulations; inability to swallow has alternate pathway requiring trial of specified suspension/ODT formulations. |
| Drug Group | Required Prior Trials |
|---|---|
| Trials of listed generic NSAIDs (and where applicable combinations) and documentation of inadequate response or intolerance are required prior to brand or alternative coverage. |
| Requirement | Duration / Documentation |
|---|---|
| At least a 3-month trial of generic doxycycline and generic minocycline with documentation of inadequate response is required before Targadox/Ximino/Solodyn will be considered medically necessary. |
| Step Requirement | Documentation |
|---|---|
| Trial and inadequate response to generic doxycycline AND generic minocycline are required before branded doxycycline/minocycline products will be considered. | |
| Documentation of the trials and inadequate responses must be provided in medical records. |
| Requirement | Provider Documentation |
|---|---|
| Requests for certain branded tetracycline products require medical-record documentation showing prior trials and inadequate responses to specified generics. |
| Requirement | Evidence Needed |
|---|---|
| Documentation in medical records of at least a 3-month trial and inadequate response to generic doxycycline and generic minocycline is required before Targadox or Ximino may be considered. |
| Prerequisite | Action |
|---|---|
| The individual must have trialed generic doxycycline and generic minocycline prior to consideration of Targadox or Ximino; inadequate response must be documented in medical records. |
| Referenced Requirement | Notes |
|---|---|
| Multiple sections reference a required at least 3-month trial and inadequate response to generic doxycycline and generic minocycline before branded tetracyclines may be considered. |
| Documentation Expectation | Specifics |
|---|---|
| Documentation in medical records of the trials and inadequate response to generic doxycycline and generic minocycline is required before Targadox or Ximino will be considered. |
| Requirement | Scope |
|---|---|
| Prior trials of oral tetracyclines (generic doxycycline and generic minocycline) are required before consideration of certain branded extended-release minocyclines and related products. |
| Step | Duration / Requirement |
|---|---|
| A trial of generic doxycycline and generic minocycline for at least 3 months with documentation of inadequate response is required before Targadox or Ximino may be considered. |
Dose, Age, and Quantity Coding Highlights
Quantity Limits Summary
Provider Actions, Prior Authorization & Documentation
Prior authorization for vonoprazan
Prior authorization is required for Voquezna (vonoprazan). Document age (≥18 years), diagnosis (erosive esophagitis or non‑erosive GERD as specified), prior PPI therapy (≥8 consecutive weeks for erosive disease; for non‑erosive GERD trial/failure/intolerance to 3 listed generic PPIs), and prescribed quantity of 1 tablet per day.
- Age ≥18 years
- Erosive esophagitis: ≥8 consecutive weeks of PPI therapy
- Non‑erosive GERD: inadequate response/intolerance to 3 generic PPIs (esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole)
- Quantity = 1 tablet per day
Prior authorization required for select stimulants and ADHD agents
Prior authorization applies to selected brand stimulants and related ADHD agents; requests must document prior trials or contraindications per product criteria and adhere to dose/quantity limits.
- Document inadequate response to generic stimulant or justification that generic is unavailable
- Follow product-specific age and dose limits (e.g., atomoxetine age ≥6 years, dose ≤100 mg/day; Arynta/Vyvanse quantity limits)
Prior authorization required for listed drugs
Prior authorization is required for listed drugs in the policy and must include documentation that the member meets the medical necessity criteria (age, diagnosis, prior therapy trials/intolerance, and prescriber specialty when required).
- Provide diagnosis and age
- Provide records of prior therapy trials or documented intolerances
- If required, indicate prescriber specialty or consultation (e.g., cardiologist, pulmonologist, gastroenterologist)
Prior authorization: specialist, prior trial, and dose/quantity documentation
Prior authorization requests must include documentation of age, diagnosis, prior therapy failures or intolerances, specialist prescribing or consultation when required, and adherence to dose/quantity limits specified in each drug section.
- Specialist prescription/consultation when policy requires (e.g., cardiologist, pulmonologist)
- Medical records showing prior trials and inadequate response or intolerance
- Compliance with stated dose and quantity limits
Prior authorization for listed drugs (PPI examples)
Prior authorization for certain listed proton pump inhibitor formulations requires documentation of specified prior trials or inability to swallow; for PPIs the policy requires trial and inadequate response or intolerance to three specified generic PPIs (OTC use may qualify when documented).
- Document trials of 3 generics (esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole) or inability to swallow with trial of suspension/ODT alternatives
- OTC esomeprazole, lansoprazole, omeprazole count when documented in chart notes
Xdemvy (lotilaner) initial authorization
Initial authorization for Xdemvy (lotilaner) requires prior authorization; approval will be limited to a single 6‑week treatment course with specified dosing and quantity limits.
- Dose: one drop in each eye twice daily
- Quantity: one bottle per 6‑week treatment course
- Initial approval duration: 6 weeks
Xdemvy (lotilaner) prior authorization
Prior authorization for Xdemvy (lotilaner) will be granted only when the clinical entry criteria and prescriber requirements are documented; re‑authorization beyond the initial 6‑week course is considered investigational.
- Document slit‑lamp findings consistent with Demodex blepharitis
- Prescribed by or in consultation with an optometrist or ophthalmologist
- Re‑authorization beyond 6 weeks is investigational
Xdemvy (lotilaner) prior authorization requirement
Initial approval for Xdemvy is limited to one 6‑week course; quantity and dosing limits apply and the prescription must be by or in consultation with an optometrist or ophthalmologist.
- One bottle per 6‑week treatment course
- One drop in each eye twice daily
- Prescriber: optometrist or ophthalmologist (or consult)
Xdemvy (lotilaner) initial authorization
Initial authorization for Xdemvy (lotilaner) is for 6 weeks and requires documentation of the specified clinical findings (e.g., eyelid exam) and prescriber specialty; dosing and quantity limits must be followed.
- Clinical finding: more lashes on the upper lid on slit‑lamp exam or other Demodex signs
- Dose: one drop each eye twice daily
- Quantity: one bottle per 6‑week course
Xdemvy (lotilaner) prior authorization
Prior authorization for Xdemvy (lotilaner) requires documentation of clinical findings and prescriber specialty; initial approval is limited to 6 weeks and re‑authorization beyond that is considered investigational.
- Provide slit‑lamp exam documentation
- Prescriber must be an optometrist or ophthalmologist or document consultation
- Initial approval duration: 6 weeks; re‑authorization beyond 6 weeks investigational
Prior authorization requirement (general)
Prior authorization is required for initial approvals and continuation where specified; initial approvals will be for specified durations (e.g., 6 weeks for Xdemvy) and require documentation of indicated clinical findings.
- Documentation of indicated clinical findings (per drug)
- Adhere to stated initial approval durations
- Re‑authorization beyond specified durations may be investigational
Xdemvy (lotilaner) prior authorization (prescriber requirement)
For Xdemvy (lotilaner), the prescriber must be an optometrist or ophthalmologist or the request must document consultation with one; include prescriber specialty in the prior authorization submission.
- Prescriber specialty: optometrist or ophthalmologist
- If prescribed after consultation, document the consult in chart notes
Prior authorization and initial approval (Xdemvy)
Initial approval for Xdemvy requires prior authorization and will be granted for 6 weeks when clinical entry criteria and prescriber requirements are met; dosing and quantity limits apply.
- One drop in each eye twice daily
- One bottle per 6‑week treatment course
- Prescribed by or in consultation with an optometrist or ophthalmologist
- Initial approval duration: 6 weeks
Prior authorization required for Xdemvy
Prior authorization is required for Xdemvy (lotilaner); initial approval is limited to a single 6‑week treatment course and must include documentation of eyelid findings and prescriber specialty.
- Document slit‑lamp exam showing eyelid findings (e.g., more lashes on upper lid)
- Include prescriber specialty (optometrist/ophthalmologist)
- Initial approval: one 6‑week course (one bottle)
Step requirements for non‑erosive GERD
Non‑erosive GERD step therapy: prior to vonoprazan, document trial and inadequate response or intolerance to three listed generic PPIs; OTC use of esomeprazole, lansoprazole, or omeprazole qualifies when documented.
- Trials of 3 generics (esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole) with inadequate response/intolerance
- OTC PPI use may qualify when chart notes document use
Voquezna step therapy
Voquezna (vonoprazan) requires prior PPI therapy for erosive esophagitis (≥8 consecutive weeks) and, for non‑erosive GERD, failure/intolerance to three specified generic PPIs before consideration.
- Erosive esophagitis: ≥8 consecutive weeks of PPI therapy required
- Non‑erosive GERD: inadequate response/intolerance to 3 listed generics
Step therapy / prior failure requirements (general)
Many products require documented prior failure or intolerance to specified generic or alternative therapies before approval; confirm and submit supporting medical records as required by the product-specific criteria.
- Provide medical records documenting inadequate response or intolerance
- Follow the exact prior‑therapy sequence specified in each section
PPI step requirements
For proton pump inhibitors, prior authorization requires documentation of trial and inadequate response or intolerance to three specified generic PPIs; if unable to swallow, document trial/intolerance to specified suspension or ODT alternatives.
- Trials of 3 generics or documented inability to swallow plus trial of suspension/ODT
- OTC esomeprazole/lansoprazole/omeprazole may count if documented
General step/step-down expectations
Multiple branded formulations require documented inadequate response or intolerance to specified generic alternatives; provide medical records showing prior trials and outcomes.
- Document each generic trial with duration and outcome
- If oral suspension/solution was used, include clinical justification
Oral tetracycline step requirement
Before Targadox, Ximino, or Solodyn are considered, submit medical records showing at least a 3‑month trial with inadequate response to generic doxycycline and generic minocycline.
- Minimum 3‑month trial of generics required
- Medical record documentation of inadequate response or intolerance must be provided
Branded tetracycline step therapy
Branded tetracyclines (Targadox, Ximino) require documented inadequate response to both generic doxycycline and generic minocycline after at least a 3‑month trial before they will be considered medically necessary.
- Trial of generic doxycycline AND generic minocycline for ≥3 months
- Medical records documenting inadequate response/intolerance
Oral tetracycline step therapy
To consider Targadox or Ximino, the individual must have had at least a 3‑month trial with inadequate response to generic doxycycline AND generic minocycline; include medical records documenting the trials.
- 3‑month duration of prior trials
- Documentation must be in the form of medical records
Antibiotic step requirement for doxycycline/minocycline agents
Requests for Targadox or Ximino must include documentation of inadequate response to at least a 3‑month trial of generic doxycycline and generic minocycline; provide supporting medical records.
- Medical records showing prior antibiotic trials and outcomes
- Specify durations and reasons for discontinuation if intolerant
Targadox / Ximino prior trial note
Prior trial of referenced oral antibiotics (generic doxycycline and generic minocycline) is required before certain therapies; include 3‑month trial details and outcomes in medical records.
- At least a 3‑month trial documented
- Record objective evidence of inadequate response or intolerance
Referenced antibiotic trial
When prior‑therapy trials are referenced, include medical records documenting duration and inadequate response or intolerance as required by the policy section for the requested product.
- Documentation of trials and inadequate response in medical records
- Follow exact generic product list required by the policy
Referenced oral antibiotic trial
Before certain branded oral tetracyclines will be covered, document at least a 3‑month trial and inadequate response to both generic doxycycline and generic minocycline with medical records.
- 3‑month minimum trial for each generic antibiotic
- Medical-record evidence of inadequate response/intolerance
Antibiotic step therapy requirement
A 3‑month documented trial and inadequate response to generic doxycycline AND generic minocycline is required before Targadox or Ximino will be considered medically necessary; submit medical records.
- Duration: ≥3 months
- Documentation: medical records showing inadequate response or intolerance
Required documentation
Providers must include clinical documentation in the prior authorization (diagnosis, age, prior medication history including duration of prior PPI therapy when applicable, and the prescribed quantity).
- Diagnosis and age
- Prior medication history with durations (e.g., ≥8 weeks PPI for erosive esophagitis)
- Prescribed quantity (e.g., 1 tablet/day for vonoprazan)
OTC PPI documentation qualifies as prior trial
Documentation in chart notes that OTC esomeprazole, lansoprazole, or omeprazole was used qualifies as a prior PPI trial for Voquezna criteria; include dates/duration in the medical record.
- Chart note documenting OTC PPI use and duration
- Include that OTC trial counts toward required PPI trials
Required clinical documentation (general)
Provide clinical documentation supporting diagnosis, age, prior therapy trials or intolerances, specialist consultation when required, and any required labs or imaging (e.g., biopsy for EoE) with the prior authorization request.
- Diagnostic testing results (e.g., biopsy for EoE)
- Specialist consultation notes where required
- Laboratory or imaging results if specified
Documentation of prior inadequate response/intolerance and specialist consultation
Document prior inadequate response or intolerance to required generic alternatives and include evidence of specialist consultation/prescription when the policy specifies such involvement.
- Medical records of prior therapy outcomes
- Specialist prescribing or consultation notes when required
PPI trial documentation
For PPI step requirements, include documentation of trials and inadequate response or intolerance to three different generic PPIs, or if unable to swallow, documentation of trial/intolerance to specified suspension/ODT formulations.
- Trials of 3 specified generics or trial of suspension/ODT alternative with documentation
- Chart notes showing duration and outcome of each trial
Oral solution/suspension necessity documentation
When oral solution or suspension formulations are requested, provide medical records documenting clinical necessity (e.g., unable to swallow, body weight dosing) to justify use of the formulation.
- Document inability to swallow or dosing reasons in medical records
- Show that no generic provides an equivalent dose if claiming necessity
Bronchitol documentation
For Bronchitol, include documentation of cystic fibrosis diagnosis, age ≥18, completion of a Bronchitol Tolerance Test (BTT), and confirmation that use is not concurrent with hypertonic saline.
- BTT test result in chart notes
- Confirmation of no concurrent hypertonic saline use
- Age and CF diagnosis documentation
Xdemvy documentation requirements
For Xdemvy, prior authorization must include documentation confirming Demodex blepharitis (slit‑lamp findings or eyelash microscopy/collarettes) and that the prescriber is an optometrist or ophthalmologist or consulted with one.
- Slit‑lamp exam showing more lashes on the upper lid or collarettes on ≥10 lashes, or microscopy showing mites
- Prescriber specialty or documentation of consultation with optometrist/ophthalmologist
Medical record documentation for prior therapies
Medical records demonstrating inadequate response to prior therapies are required when requesting certain oral tetracycline agents (Targadox, Ximino, Solodyn); include duration and outcome of the trials.
- Medical‑record evidence of prior antibiotic trials
- Documentation of reasons for discontinuation or inadequate response
Documentation of prior trials
Documentation of prior trials must be provided in the form of medical records showing an inadequate response after at least a 3‑month trial of generic doxycycline and generic minocycline before considering branded doxycycline/minocycline products.
- 3‑month trial duration documented
- Evidence of inadequate response/intolerance to each generic
Documentation for oral tetracyclines
Provide medical-record documentation showing inadequate response to at least a 3‑month trial of generic doxycycline and generic minocycline when requesting Targadox or Ximino; records must detail trial duration and outcomes.
- Specify start/end dates and clinical response for each antibiotic trial
- Include clinician notes documenting lack of benefit
Prerequisite antibiotic trial documentation
When an antibiotic prerequisite is required, submit medical records documenting at least a 3‑month trial of generic doxycycline and generic minocycline with evidence of inadequate response or intolerance.
- Medical records of both generic antibiotic trials for ≥3 months
- Documentation of inadequate response or intolerance
Medical records required for antibiotic trial documentation
Medical records are required to document prior antibiotic trials (generic doxycycline and generic minocycline) including duration (≥3 months) and clinical outcome before branded tetracyclines will be considered.
- Include dates and clinician assessment of response
- Attach pharmacy fill history if available
Required clinical documentation for eyelash/collarette findings
For eyelid/eyelash‑based therapies, include slit‑lamp exam documentation showing more lashes on the upper lid of the eye requiring treatment and any prior trials described in the policy.
- Slit‑lamp exam findings in chart notes
- Prior therapy history related to eyelid disease
Trials of generics required
Trials of available generics are required and must be documented in medical records before considering many branded agents; include trial duration, response, and reason for switching to brand.
- Medical-record evidence of generic trials and outcomes
- Rationale for switching to branded product
Clinical documentation (slit-lamp exam) required
A slit‑lamp examination demonstrating increased lashes on the upper lid of the eye requiring treatment is required for Xdemvy prior authorization.
- Slit‑lamp exam note documenting the finding
- Specify which eye requires treatment
Documentation of prior antibiotic trials
Submit medical records documenting prior antibiotic trials (generic doxycycline and generic minocycline) of at least 3 months with inadequate response before certain branded doxycycline/minocycline products will be authorized.
- 3‑month trial documentation for each generic antibiotic
- Clinical notes describing inadequate response or intolerance
Coverage triggers/denial risk (vonoprazan)
Requests that do not meet the listed age, diagnosis, prior therapy, or quantity requirements for vonoprazan (Voquezna) are at risk for denial—ensure all criteria are documented.
- Age ≥18 documented
- Diagnosis (erosive esophagitis or non‑erosive GERD) documented
- Required prior PPI trials and prescribed quantity (1 tablet/day) documented
Voquezna coverage triggers
Voquezna requests lacking documentation of age ≥18, the required diagnosis (erosive esophagitis or non‑erosive GERD with prior PPI failures), required prior PPI therapy (≥8 weeks or 3 generic failures), or the prescribed quantity (1 tablet/day) may be denied.
- Missing age or diagnosis
- No documentation of prior PPI therapy or generic PPI failures
- Prescribed quantity not equal to 1 tablet/day
Missing clinical or prescriber documentation
Requests missing clinical findings, age, prior therapy documentation, or required prescriber specialty are at risk for denial across multiple products (e.g., Sensipar, Cardamyst).
- Ensure diagnosis, age, prior‑therapy history, and prescriber specialty are included in submission
- Missing any required item can trigger denial
No documented clinical benefit on reauthorization
Reauthorization may be denied for Brinsupri if chart notes do not document reduction or stabilization in annualized pulmonary exacerbation rate compared with baseline.
- Provide comparative exacerbation rate documentation
- Include pulmonary specialist notes when available
Lack of required documentation may trigger denial
Lack of documentation of required specialist involvement, absence of required prior trials, or exceeding dose/quantity limits may trigger denial for many products.
- Specialist involvement required where stated
- Provide records of prior trials
- Do not exceed stated dose/quantity limits
PPI prior therapy documentation (denial risk)
Failure to document trials or intolerances to required generic PPIs, or inability to swallow when that pathway is used, may result in denial for PPI-related requests.
- Document three generic PPI trials or documented inability to swallow plus trial of suspension/ODT alternative
- Include dates and outcomes of each trial
Xdemvy re-authorization risk
Requests for Xdemvy (lotilaner) beyond the initial 6‑week approval or for retreatment within less than 1 year of completing a prior course will be considered investigational and may be denied.
- Re‑authorization beyond 6 weeks is investigational
- Requests within <1 year of prior course are restricted; ≥1 year will be reviewed as new request
Re-authorization denial risk (Xdemvy)
Future re‑authorization of Xdemvy (lotilaner) beyond 6 weeks is considered investigational and may be denied; document and plan accordingly.
- Re‑authorization beyond an initial 6‑week course is investigational
- Provide justification if requesting beyond standard limits (likely to be denied)
Re-authorization investigational (Xdemvy)
Re‑authorization requests for Xdemvy beyond 6 weeks are considered investigational and are at risk of denial unless supported by documentation meeting investigational exceptions.
- Requests beyond 6 weeks typically denied
- Treat repeat courses within <1 year as restricted
Re-authorization denial risk (summary)
Requests for Xdemvy for treatment beyond a 6‑week course (re‑authorization) are considered investigational and likely to be denied.
- Initial approval: 6 weeks only
- Re‑authorization beyond 6 weeks is investigational
Re-authorization beyond 6 weeks investigational
Re‑authorization of Xdemvy beyond 6 weeks is considered investigational and therefore not medically necessary under this guideline; requests will likely be denied.
- Do not expect routine approval beyond 6 weeks
- If re‑treatment needed, wait ≥1 year for review as new request
Prior-treatment interval (Xdemvy)
Requests for Xdemvy within one year of completing a prior treatment course will be handled as restricted/continuation requests and are at risk for denial; requests after ≥1 year will be reviewed as new.
- Interval rule: ≥1 year required before review as a new request
- Requests <1 year may be denied or restricted
Re-authorization denial trigger (Xdemvy)
Xdemvy re‑authorization beyond the initial course is considered investigational; include clear justification and supporting clinical data if submitting such requests, but expect likely denial.
- Initial course limited to 6 weeks
- Re‑authorization beyond 6 weeks is investigational
- Retreatment reviewed as new request only after ≥1 year
Background
The pharmacy prior authorization program ensures members receive appropriate therapy while limiting unnecessary or wasteful use. It defines medical necessity criteria and prior authorization requirements (age, diagnosis, prior medication trials, prescriber specialty, dose/quantity limits and required documentation) that providers must meet when submitting pharmacy prior authorization requests under Premera Bluecross.
Definitions and Diagnostic Thresholds
Site of Care / Prescribing Requirements
Office — prescribing by/consult with optometrist or ophthalmologist required
Prescriptions for Xdemvy must be written by or in consultation with an optometrist or ophthalmologist; prior authorization submissions should include the prescriber's specialty and consultation notes when applicable.
- Prescriber: optometrist or ophthalmologist
- If prescribed after consultation, include documentation of the consult
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.