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.

Currentharvard pilgrim health carePolicy N/A

Tufts Health Plan Direct 3-Tier Prescription Drug List (Formulary) - Coverage Criteria

Customize your policy alerts

Sign up for all harvard pilgrim health care policy alerts

Know when harvard pilgrim health care releases new policies or updates existing guidance.

Monitor payer policy activity

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

Defines the Direct 3-Tier formulary structure, coverage indicators, and pharmacy benefit management processes including tier placements, prior authorization, step therapy, quantity limits, specialty pharmacy and site-of-care restrictions for members and providers.

Policy Summary

Payerharvard pilgrim health care

PolicyDirect 3-Tier Prescription Drug List — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative - no material clinical changes

Effective DateJan 1, 2026

Last ReviewOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation when a drug is flagged 'PA' or when specialty pharmacy (SPP) enrollment is required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Direct 3-TierFormulary structure described

Optum 90-dayMail order option

multipleEntries with PA/QL

QL presentQuantity limits present

NCApplicable state

Coverage Criteria and Formulary Controls

Tier-based coverage

Covered medications are assigned to tiers and covered according to plan benefit design and any specific flags/limitations noted in the drug list.

Formulary coverage logic: Drug coverage depends on tier placement, member's specific plan benefits, and any applicable program flags (PA, ST, QL, NTM, SPP).

Members may have deductibles or plan-specific cost share that affect coverage.

Drug-specific coverage flags

Coverage notes and restrictions as listed in glossary entries

General coverage flags: Drugs are listed with tier assignments, and many include flags for PA (prior authorization), SPP (specialty pharmacy program), QL (quantity limits), and home delivery unavailability.

Operational coverage controls applied per product entry.

Requests for medical review of pharmacy drugs must be submitted by a physician and include clinical information supporting medical necessity. Drugs excluded under the pharmacy benefit are not eligible for coverage through the medical review process; only requests for drugs covered by the pharmacy benefit and subject to programs such as NTM, PA, ST, or QL will be considered. Tufts Health Plan will approve requests that meet coverage guidelines and clinical justification; denials may be appealed per the member's benefit documents.

Policy Summary

Payerharvard pilgrim health care

PolicyDirect 3-Tier Prescription Drug List — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative - no material clinical changes

Effective DateJan 1, 2026

Last ReviewOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation when a drug is flagged 'PA' or when specialty pharmacy (SPP) enrollment is required.

SourceLink

On This Page

Several injectable and specialty products are explicitly flagged in the formulary as not available through home delivery. Examples include certain enoxaparin presentations, fondaparinux, and multiple prefilled injectable anticoagulants and depot or specialty injectables; where that note appears, home-delivery fulfillment is not permitted and an alternate dispensing channel must be used.

The formulary identifies specific drugs with site-of-care restrictions stating ‘This drug is not available through home delivery’. When that note applies (seen for products such as vigabatrin formulations, VIGADRONE, SEROSTIM, and others), home delivery is effectively excluded as a dispensing channel and specialty or clinic-based dispensing may be required.

Medical review approvals are contingent on meeting the plan's coverage guidelines and providing adequate clinical justification. If the drug does not meet those criteria or the medical review does not find the submitted clinical rationale sufficient, the request will not be approved; members retain the right to appeal pursuant to their benefit documents.

Coding, Identifiers, and Formulary Flags

Formulary control flagsmixed

PA	Prior Authorization (flag shown in drug listings)
QL	Quantity Limit (flag shown in drug listings)
NTM	New-To-Market Drug Evaluation Process (flag shown in drug listings)
SPP	Specialty Pharmacy Program (flag shown in drug listings)
ST	Step Therapy (flag shown in drug listings)
ACA	Affordable Care Act $0 cost share flag
AL	Age Limit flag

NDC/CPT/other codesmixed

No codes listed

Selected product pack entriesNDC | mixed

PAXLOVID (150/100) ORAL TABLET THERAPY PACK 10 X 150 MG & 10 X 100MG	Therapy pack; QL: Maximum quantity of 20 per fill; Tier 2
PAXLOVID (300/100 & 150/100) ORAL TABLET THERAPY PACK 6 X 150 MG & 5 X 100MG	Therapy pack; Tier 2
PAXLOVID (300/100) ORAL TABLET THERAPY PACK 20 X 150 MG & 10 X 100MG	Therapy pack; QL: Maximum quantity of 30 per fill; Tier 2
LAGEVRIO ORAL CAPSULE 200 MG	QL: Maximum of 40 per fill; Tier 3

Pimavanserin (Nuplazid) entriesNDC | mixedCovered

NUPLAZID ORAL CAPSULE 34 MG	Tier 3; QL: Max. 1 per day
NUPLAZID ORAL TABLET 10 MG	Tier 3; QL: Max. 1 per day

Formulary drug entries (partial)NDC|product descriptions

LANTUS SOLOSTAR SUBCUTANEOUS SOLUTION PEN-INJECTOR 100 UNIT/ML	listed with Tier = 2
LANTUS U-100 VIAL SUBCUTANEOUS SOLUTION 100 UNIT/ML	listed with Tier = 2
LYUMJEV KWIKPEN SUBCUTANEOUS SOLUTION PEN-INJECTOR 100 UNIT/ML, 200 UNIT/ML	listed with Tier = 2
NOVOLIN 70/30 FLEXPEN RELION SUBCUTANEOUS SUSPENSION (70-30) 100 UNIT/ML	listed with Tier = 3; *NOTES = PA

Gastrointestinal agentsNDC|product descriptions

dexlansoprazole oral capsule delayed release 30 mg, 60 mg	Tier = 3; *NOTES = PA
esomeprazole magnesium oral capsule delayed release 20 mg, 40 mg	Tier = 1
pantoprazole sodium oral tablet delayed release 20 mg, 40 mg	Tier = 1; *NOTES = PA on some formulation entries

Specialty/limited channel drugsNDC|product descriptions

SEROSTIM SUBCUTANEOUS SOLUTION RECONSTITUTED 4 MG, 5 MG, 6 MG	Tier = 3; *NOTES = SPP; PA; not available through home delivery
VOQUEZNA ORAL TABLET 10 MG, 20 MG	Tier = 3; *NOTES = PA; QL: 30 tablets per 30 days

Sample injectables and depot formulationsmixed

1 mg/0.2ml	leuprolide acetate injection kit 1 mg/0.2ml
3.75 MG	LUPRON DEPOT (1-MONTH) INTRAMUSCULAR KIT 3.75 MG
11.25 MG	LUPRON DEPOT (3-MONTH) INTRAMUSCULAR KIT 11.25 MG
11.25 MG, 15 MG, 7.5 MG	LUPRON DEPOT-PED (1-MONTH) INTRAMUSCULAR KIT
11.25 MG, 30 MG	LUPRON DEPOT-PED (3-MONTH) INTRAMUSCULAR KIT
45 MG	LUPRON DEPOT-PED (6-MONTH) INTRAMUSCULAR KIT 45 MG

Oral tablets and subcutaneous solutions with QL/PA notesmixed

150 MG, 200 MG	ORILISSA ORAL TABLET 150 MG, 200 MG
150 MG	RECORLEV ORAL TABLET 150 MG
0.3 MG/ML, 0.6 MG/ML, 0.9 MG/ML	SIGNIFOR SUBCUTANEOUS SOLUTION

Quantity limit examples (DIFICID, vancomycin)

DIFICID (fidaxomicin) oral suspensionQL: Max. 136 mL per 10 days

DIFICID (fidaxomicin) oral tablet 200 mgQL: Max. 20 per 10 days

Vancomycin oral solution 25 mg/mLQL: Max. 300 mL per 10 days

Quantity limit examples (EPCLUSA, MAVYRET, PAXLOVID)

EPCLUSA (packets/tablets)QL: Max 1 tab per day (selected pack/tablet entries show 1–2 tabs/day depending on pack)

MAVYRETQL: Max 5 per day (packet) or Max 3 per day (tablet) as noted

PAXLOVID therapy packsQL: Maximum quantity varies by pack (examples: 20 per fill; 30 per fill)

ORILISSA daily limit example

ORILISSA (oral tablet 150 mg, 200 mg)QL: Max. 4 per day

ORILISSA — channel/administration noteSPP; PA; This drug is not available through home delivery (per formulary line)

ORILISSA — supply limitMaximum 30 days supply per fill (where noted with SPP/PA entries)

RECORLEV daily limit example

RECORLEV (oral tablet 150 mg)QL: Max. 8 per day

RECORLEV — supplyMaximum 30 days supply per fill

RECORLEV — channel notePA; This drug is not available through home delivery (per formulary line)

SIGNIFOR daily ampule limit example

SIGNIFOR (subcutaneous solution)QL: Max. 2 ampules per day

SIGNIFOR — supplyMaximum 30 days supply per fill

SIGNIFOR — channel noteThis drug is not available through home delivery (per formulary line)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Submit Prior Authorization for PA‑flagged drugs

Some medications listed in the formulary include the PA flag; providers must submit a prior authorization request to Tufts Health Plan's medical review process with clinical information supporting medical necessity prior to coverage.

PA flag indicates Prior Authorization is required.
Include clinical justification and submit via the plan's medical review process.

Prior Authorization

Follow PA process and adhere to Quantity Limits

Drugs annotated with PA and/or QL require providers to follow the plan's prior authorization process and ensure prescriptions do not exceed the stated quantity limits.

Respect QL values shown (examples: DIFICID QL: Max. 136 mL per 10 days; fidaxomicin QL: Max. 20 per 10 days; vancomycin QL: Max 300 mL per 10 days).
Obtain PA before dispensing when PA is noted.

Prior Authorization

Obtain PA for selected products and populations

Prior authorization is required for selected products and for specified populations; providers must obtain PA where indicated (examples include PA for members 12 and younger for certain antidepressants and PA for select specialty agents).

PA required for members 12 and younger for multiple antidepressants (see formulary lines).
PA required for various specialty products as noted.

Prior Authorization

PA and QL apply to migraine agents

Certain migraine therapies are subject to prior authorization and quantity limits; obtain PA and ensure fills respect the QL shown for each product.

Examples: AIMOVIG — PA; QL: Max. 1 syringe per 30 days and not available through home delivery.
EMGALITY and NURTEC have PA and specific QLs (EMGALITY QL: 1–3 pens per 30 days depending on presentation; NURTEC QL: 16 tablets/30 days).

Prior Authorization

PA required for select Tier 3 drugs

Prior authorization is required for select Tier 3 medications; providers must obtain PA when the formulary line includes a PA note (examples: COBENFY, NUPLAZID, EPCLUSA, HARVONI, MAVYRET).

Tier 3 antiviral/hepatitis agents (e.g., EPCLUSA, MAVYRET) are annotated SPP; PA; and have QL in many instances.
Obtain PA before coverage for listed Tier 3 drugs.

Prior Authorization

Check age‑based PA requirements

Prior Authorization is required for specific drugs and age groups; providers must check age‑based PA notes and submit PA accordingly (examples: ADHD agents requiring PA for members 25+).

ADHD extended‑release products: *NOTES = PA: Prior Authorization required for members 25 and older; QL: Max Daily Dose specified.
Verify patient age against formulary PA age restrictions before requesting coverage.

Prior Authorization

PA for age‑restricted topical products

Prior Authorization is required for certain products and/or age groups; for example, tretinoin microsphere external gel and related pumps require PA for members 26 years and older.

Tretinoin microsphere external gel/pump: *NOTES = PA for members 26 years of age and older.
Submit PA with clinical rationale for age‑based exceptions per the formulary note.

Prior Authorization

Obtain PA for select sensors/readers and insulins

Certain continuous glucose monitoring sensors/readers and specified insulin products are subject to prior authorization; providers must obtain PA for listed devices and insulin formulations before coverage.

Freestyle Libre sensors/readers: *NOTES = PA; QL (e.g., Max 2 sensors per 28 days; reader max 1 per 365 days).
Insulin aspart penfill, insulin degludec, and other insulin products include *NOTES = PA.

Prior Authorization

Claims require PA when '*NOTES = PA' shown

Formulary lines with the note '*NOTES = PA' require prior authorization; providers must secure PA prior to coverage to avoid denial.

Claims submitted without PA when '*NOTES = PA' is present may be denied per benefit rules.
Confirm PA status on the formulary line prior to submission.

Prior Authorization

Follow PA and Specialty Pharmacy (SPP) requirements

Multiple drugs are subject to prior authorization or to specialty pharmacy program (SPP) requirements; providers must follow SPP enrollment and PA submission processes where indicated.

Examples: ORILISSA, MYCAPSSA, and several leuprolide/LUPRON entries are flagged SPP; PA; and are not available through home delivery.
Initiate specialty pharmacy processes (Optum Specialty) for SPP‑flagged products.

Step Therapy

Confirm and document Step Therapy requirements

Some plans may require step therapy (ST); providers should confirm whether a step edit applies and document prior use of step agents when requesting coverage for an alternative.

ST flag indicates the member may need to try a specified medication first before alternatives will be covered.
Include documentation of prior trials when submitting an exception request.

Note

No step‑therapy sequences shown here

No explicit step‑therapy (fail‑first) sequences are described in the provided formulary excerpts; do not assume a multi‑step sequence unless the formulary or benefit plan specifically indicates ST.

If ST is not annotated in the formulary line, follow PA/QL/SPP guidance instead.

Note

See antiviral/hepatitis product notes (chunk 116)

See chunk 116 for product‑specific notes and restrictions referenced in this segment.

Chunk 116 contains antiviral/hepatitis product notes including SPP, PA, QL, and home delivery restrictions.

Note

See REPATHA and lipid agent notes (chunk 155)

See chunk 155 for REPATHA and related documentation expectations and quantity limits.

Chunk 155 lists REPATHA with *NOTES = PA; QL: Max. 2 pens per 28 days.

Prior Authorization

PA for tretinoin (age‑based); no step sequence shown

Topical tretinoin entries show prior authorization for members 26+ but no explicit step‑therapy sequences are provided; obtain PA when age restriction applies.

Tretinoin microsphere gel/pump: *NOTES = PA for members 26 years and older.
Submit PA with relevant clinical justification for members meeting the age threshold.

Prior Authorization

Higher‑tier products may require PA or step edits

Products placed on higher tiers (Tier = 3) may be subject to additional controls such as PA or step edits; providers should check the formulary line and obtain PA or follow step requirements when indicated.

Tier 3 insulin or specialty items often include *NOTES = PA or SPP.
Confirm coverage controls before prescribing higher‑tier products.

Documentation Required

Refer to device/supply guidance (chunk 221)

See chunk 221 for additional provider action details related to device supplies and fill limits noted in the formulary.

Chunk 221 includes QL notes such as 'Maximum of 30 days supply per fill' and device/supply entries.

Note

No explicit step‑therapy sequences in these excerpts

Formulary entries in these chunks do not include explicit step‑therapy sequences; check the full plan documents or formulary for any ST rules before denying coverage based on lack of prior trial.

Some entries note SPP or PA but do not define step sequences in this excerpt.

Documentation Required

Include clinical documentation with PA/medical review requests

Physician‑submitted medical review requests (for NTM, PA, ST, QL reviews) must include clinical information that supports medical necessity; provide documentation of diagnosis, prior therapies, and relevant clinical data.

Include clinical rationale and supporting records to meet coverage guidelines.
Tufts Health Plan will approve requests that meet the plan's coverage guidelines; appeals available if denied.

Documentation Required

Use formulary notes (PA/QL) when preparing submissions

Formulary lines include explicit PA and QL examples; when submitting PA requests or claims, reference the exact formulary notes shown (examples include DIFICID PA; QL: Max. 136 mL per 10 days and vancomycin QL limits).

Use the product‑level notes to determine required PA and allowable quantities.
Attach documentation that demonstrates necessity for quantities exceeding QL if requesting an override.

Documentation Required

Document and respect home delivery restrictions

Some products are flagged as not available through home delivery; providers should document the intended dispensing channel and route prescriptions accordingly.

Examples: enoxaparin, fondaparinux, FRAGMIN and other injectables are noted 'This drug is not available through home delivery.'
Do not submit these products for home delivery fulfillment; select the appropriate site of care.

Documentation Required

Submit PA and SPP documentation where required

For drugs marked PA and/or QL, prior authorization submission is required and claims must adhere to listed quantity limits; include documentation of specialty pharmacy enrollment where SPP is indicated.

Examples: EPCLUSA and MAVYRET show SPP; PA; QL and are not available through home delivery.
SPP‑flagged drugs require specialty pharmacy handling (Optum Specialty) when indicated.

Documentation Required

Attach dosing and QL evidence for specialty injectables

Prior authorization and quantity limit notes accompany many specialty injectables and agents; providers must request PA and ensure dispensed quantities conform to the QL stated in the formulary line (e.g., REPATHA, PRALUENT).

REPATHA: *NOTES = PA; QL: Max. 2 pens/syringes per 28 days.
Attach dosing schedule and clinical justification to PA requests for specialty injectables.

Billing Rule

Do not dispense home‑delivery‑restricted drugs via mail order

Some products are restricted from home delivery; when a formulary line states 'This drug is not available through home delivery' ensure the prescription is routed to an appropriate dispensing site (infusion/clinic or specialty pharmacy).

DUPIXENT and many leuprolide/LUPRON entries include the 'not available through home delivery' note.
Document site‑of‑care in the PA/claim to avoid denial.

Billing Rule

Adhere to injectable diabetes quantity limits

Quantity limits are specified for many products; providers must document and bill within the stated QL (example: OZEMPIC QL: 1 pen per 28 days).

OZEMPIC: *NOTES = PA; QL: 1 pen (3 mL) per 28 days.
MOUNJARO: *NOTES = PA; QL: 4 pens (2 mL) per 28 days.

Documentation Required

Document QLs for glucose monitoring devices and strips

Quantity limits are documented for devices and supplies (e.g., Freestyle Libre sensors/readers and test strips); providers must include QL adherence in claims and PA submissions.

Freestyle Libre sensors: PA; QL — Maximum 2 sensors per 28–30 days depending on model; reader: Max 1 per 365 days.
Test strips: QL example — 204 per 30 days for selected strips.

Billing Rule

Follow per‑fill and per‑day supply limits on claims

Some formulary entries specify maximum supply per fill or per day (e.g., 'Maximum of 30 days supply per fill'); providers must follow these limits on claims and when requesting overrides.

MYCAPSSA: QL: Max. 4 per day; Maximum 30 days supply per fill.
RECORLEV: QL: Max. 8 per day; Maximum 30 days supply per fill.

Documentation Required

Provide SPP enrollment info and PA for SPP‑flagged drugs

Prior authorization or specialty pharmacy program (SPP) enrollment documentation is required for several agents; providers must include specialty pharmacy information when SPP is flagged.

SPP‑flagged products (e.g., ORILISSA, EPCLUSA) note 'SPP; PA' and are not available through home delivery.
Coordinate with Optum Specialty when SPP is required.

Denial Risk

Do not submit medical review for excluded drugs

Requests for drugs excluded under the pharmacy benefit will not be covered through the medical review process; providers should not submit PA for excluded products and should follow benefit documents for alternative coverage routes.

Excluded drugs are not eligible for coverage via the medical review process.
If a requested drug is excluded, advise the member and consider covered therapeutic alternatives.

Denial Risk

Missing PA or exceeding QL can cause denials

Products annotated with PA and/or QL may be denied if PA is not obtained or if the quantity requested exceeds the listed limit; providers should secure PA and adhere to QL to avoid denials.

Example QL denials: ORILISSA Max. 4 per day; RECORLEV Max. 8 per day; SIGNIFOR Max. 2 ampules per day.
Claims without required PA are at risk for denial.

Prior Authorization

AIMOVIG — PA, QL, and home‑delivery restriction

AIMOVIG is noted as PA with a quantity limit (Max. 1 syringe per 30 days) and is not available via home delivery; providers must obtain PA and route dispensing appropriately to avoid denial.

AIMOVIG: *NOTES = PA; QL: Max. 1 syringe per 30 days; This drug is not available through home delivery.
Ensure claims reflect clinic/retail dispensing channel if required.

Prior Authorization

PA/QL enforcement for migraine therapies

Migraine agents such as EMGALITY and NURTEC are subject to PA and QL; obtain PA and ensure prescribed quantities do not exceed the QL listed on the formulary line.

EMGALITY: PA; QL varies by presentation (Max 1–3 pens per 30 days); not available through home delivery.
NURTEC: PA; QL: 16 tablets per 30 days.

Prior Authorization

PA/QL for select antiviral/hepatitis agents

Tier 3 antiviral and hepatitis drugs are annotated with PA and QL in several entries; providers must obtain PA and follow QL and SPP instructions to avoid coverage denial.

Examples include EPCLUSA, MAVYRET, HARVONI and LEDIPASVIR‑SOFOSBUVIR with SPP; PA; QL and home delivery restrictions.
Submit PA with required clinical documentation and coordinate SPP handling where indicated.

Prior Authorization

PA triggers for specialty injectables and select CNS agents

Prior authorization requirements are triggered for certain specialty injectables (e.g., REPATHA) and some ADHD agents; providers must obtain PA and adhere to QL where shown.

REPATHA: PA; QL: Max. 2 syringes per 28 days.
ADHD agents: PA required for members 25 and older; QL: Max Daily Dose specified.

Prior Authorization

Obtain PA for age‑restricted products

Age‑based prior authorization applies for some products; for members meeting the age thresholds (e.g., 26+), providers must obtain PA as noted on the formulary lines.

Clindamycin‑tretinoin external gel: PA for members 26 years and older.
Tretinoin microsphere products: PA for members 26 years and older.

Denial Risk

QL exceedance can cause denials — verify before dispensing

Exceeding stated quantity limits may result in denial; providers should verify QL values before authorizing larger quantities and submit clinical justification if requesting an override.

DUPIXENT: QL: Max. 2 syringes/pens per 28 days.
MOUNJARO: QL: 4 pens per 28 days.
RECORLEV, ORILISSA, SIGNIFOR have daily QLs that must be observed.

Prior Authorization

Obtain PA for specified insulin products

Prior authorization is required for many insulin products noted with PA; providers must secure PA for these insulin formulations prior to coverage.

Insulin aspart penfill, insulin degludec and NOVOLIN 70/30 entries include *NOTES = PA.
Obtain PA and document the clinical need for the specified insulin product.

Denial Risk

Claims require PA when '*NOTES = PA' present

When a formulary line includes '*NOTES = PA' providers must obtain prior authorization before claim submission; failure to do so may lead to denial under the benefit rules.

Verify PA requirement on the formulary line.
Submit PA with supporting clinical documentation to avoid claim denial.

Billing Rule

Avoid home‑delivery fulfillment for drugs restricted from mail order

If a drug is labeled 'This drug is not available through home delivery', providers must arrange dispensing through an appropriate non‑home delivery channel to avoid denial.

Examples include enoxaparin, leuprolide acetate, ORILISSA, and other specialty injectables.
Document dispensing site of care on PA/claims submissions.

Denial Risk

Adhere to daily QLs or submit justification

Exceeding quantity limits noted on the formulary may trigger claim denial; providers should confirm QL (e.g., ORILISSA Max. 4/day; RECORLEV Max. 8/day; SIGNIFOR Max. 2 ampules/day) and request PA with justification if higher quantities are needed.

ORILISSA: *NOTES = PA; QL: Max. 4 per day.
SIGNIFOR: QL: Max. 2 ampules per day.

Note

Definitions and Abbreviations

Tier definitions

Tier 1Primarily generics (or select brands); preferred, lower cost tier

Tier 2Primarily brand-name products without generic alternatives

Tier 3Drugs not included in Tier 1 or Tier 2 (often specialty/high-cost agents)

Glossary flags

ACAAffordable Care Act — eligible medications may have $0 cost share under most plans

ALAge Limit — medication may be limited to certain ages

NTMNew-To-Market — drug under review; medical review can be requested

PAPrior Authorization — coverage subject to pre-approval by the plan

SPPSpecialty Pharmacy Program — must use Optum Specialty where indicated

PA — Prior authorization definition and usage

DefinitionPrior Authorization (PA) — coverage for the medication requires pre-approval from the plan; providers must submit PA requests with clinical justification

Usage examplesPA is noted alongside many drugs (e.g., DIFICID, EPCLUSA, ORILISSA, RECORLEV) and for selected populations (age-based PA for some agents)

ConsequenceClaims for PA-required drugs may be denied if PA not obtained

QL — Quantity Limit definition and examples

DefinitionQuantity Limit (QL) — a maximum quantity permitted per specified time period for a drug

ExamplesDIFICID oral suspension: Max. 136 mL per 10 days; Vancomycin oral solution: Max. 300 mL per 10 days; XIFAXAN 200 mg: Max Daily Dose 0.3

Operational noteQLs are listed on formulary lines and must be adhered to when submitting claims or PA documentation

Formulary abbreviations — QL, PA, SPP

QLQuantity Limit — maximum units per time period (notation 'QL' on formulary lines)

PAPrior Authorization — requires approval before coverage (notation 'PA')

SPPSpecialty Pharmacy Program — 'SPP' flag indicates specialty pharmacy management (Optum Specialty)

PA — Examples related to devices/insulins

Devices and injectablesSome devices/insulins and specialty injectables are subject to PA (e.g., CEQUR Simplicity 2U Device: PA; many SPP injectables require PA)

ExamplesCarglumic acid, deferasirox and select specialty injectables are listed with PA/SPP and 30-day supply limits

Channel noteMany PA-required specialty drugs are not available through home delivery and require specialty pharmacy handling

QL — Examples for sensors and strips

Sensors (Freestyle Libre)QL examples: Maximum 2 sensors per 28–30 days depending on model; PA required for sensors/readers

Test stripsQL example: 204 strips per 30 days for selected strips (Precision Xtra, Freestyle variants)

Reader limitsFreestyle Libre reader: Max. 1 reader per 365 days

SPP — Specialty Pharmacy Program definition and flag usage

DefinitionSpecialty Pharmacy Program (SPP) — flag indicating drug is managed through specialty pharmacy (must use Optum® Specialty where indicated)

UsageSPP appears with high-cost or complex agents (e.g., EPCLUSA, DUPIXENT, ORILISSA) and often pairs with PA and QL

Channel implicationSPP items may not be available via home delivery and require specialty pharmacy dispensing

PA — Short definition (alternate)

Short definitionPA — Prior Authorization: requires pre-approval from the plan before coverage

Where shownMarked as '*NOTES = PA' or 'PA' in formulary lines

ImpactPA-required claims may be denied without prior approval

QL — Short definition (alternate)

Short definitionQL — Quantity Limit: maximum permitted quantity per time period, shown as 'QL' on formulary lines

ExamplesDIFICID, vancomycin, XIFAXAN entries include explicit QL values

Claims noteExceeding QL may trigger denial or require PA documentation

Step Therapy Indicators

Step therapy note	Coverage flag
Some plans may require members to try a specified medication first (step therapy) before coverage of alternatives is approved.	ST (Step Therapy) — indicated in glossary; plan may require trial of a preferred agent prior to covering alternatives.
searchable":true},{

Step therapy status	Details
Not specified
No explicit step-therapy (fail‑first) sequences are described in the cited formulary segments.

Pediatric PA/step note	Applies to
Prior Authorization required for members 12 and younger for multiple antidepressant agents (PA noted in formulary lines).
Applies to selected antidepressants and related CNS agents as annotated with PA for members ≤12 years; providers must submit PA per plan process.

SPP / PA for antiviral agents	Coverage implication
Hepatitis C and other specialty antiviral agents are annotated SPP and PA (e.g., EPCLUSA entries show SPP; PA; QL).
Requires specialty pharmacy handling (Optum Specialty) and prior authorization; adherence to listed quantity limits is required and home delivery may be restricted.

Specialty injectables	Authorization / QL
Certain specialty injectables (example: REPATHA) are annotated with PA and QL.
Prior authorization required; quantity limits apply (e.g., REPATHA: PA; QL: Max. 2 syringes per 28 days).

Age-based prior authorization	Products affected
Prior Authorization required for tretinoin topical products for members 26 years of age and older (age-based restriction).
Applies to tretinoin microsphere external gel and related topical tretinoin formulations annotated with PA for members ≥26 years.

Tier 3 control note	Implication
Products placed on Tier 3 may require prior authorization or step edits before coverage (tier-based control indicated).
Examples include some insulin/Novolin products listed as Tier 3 and annotated with PA (claims may require PA for coverage).

SPP / PA annotations	Interpretation
Multiple formulary entries are annotated SPP or PA indicating specialty pharmacy program management or prior authorization requirements.
Annotation signals that prior authorization or specialty pharmacy enrollment is required prior to coverage; some entries also note home delivery unavailability.

Quantity Limits (Selected Examples)

buprenorphine transdermal patch — quantity limit

buprenorphine transdermal patch (weekly)QL: Max. 4 per 28 days

Formulary noteMarked with PA; QL as shown in analgesics section

TieringListed Tier = 2 in formulary lines

fentanyl transdermal patch 72 hour — quantity limit

fentanyl transdermal patch (72-hour)QL: Max. 10 per 30 days

NotesPA indicated on formulary line

TieringListed Tier = 1

hydrocodone ER oral tablet — quantity limit

hydrocodone ER oral tablets (certain ER products)QL: Max. 2 per day (where noted)

NotesPA indicated for many ER opioid entries

TieringListed Tier = 3 for ER abuse-deterrent formulations

hydromorphone ER oral tablet — quantity limit

hydromorphone HCl ER oral tabletQL: Max. 1 per day or Max. 2 per day depending on strength (as noted)

NotesPA applied to ER strengths per formulary lines

TieringListed Tier = 1 for most strengths

DIFICID oral suspension — quantity limit

DIFICID (fidaxomicin) oral suspension 40 mg/mLQL: Max. 136 mL per 10 days

PAPA noted on formulary line

TieringListed Tier = 2

fidaxomicin tablet 200 mg — quantity limit

fidaxomicin (DIFICID) oral tablet 200 mgQL: Max. 20 per 10 days

PAPA noted on formulary line

TieringListed Tier = 2

vancomycin oral solution — quantity limit

vancomycin oral solution reconstituted 25 mg/mLQL: Max. 300 mL per 10 days

TieringListed Tier = 2

NotesQL is explicitly stated on formulary line

XIFAXAN 200 mg — quantity limit

XIFAXAN oral tablet 200 mgQL: Max Daily Dose of 0.3 (per formulary line)

PAPA noted on formulary line

TieringListed Tier = 3 for 200 mg formulation

SOLOSEC packet — quantity limit

SOLOSEC oral packet 2 GMQL: Max. quantity of 1 per fill

TieringListed Tier = (as shown) — packet entries listed in formulary

NotesQL specified on formulary line

AKYNZEO — quantity limit

AKYNZEOQL: 4 units per 28 days

PAPA noted on some antiemetic entries

TieringListed Tier = 3

aprepitant — capsule examples per 28 days

Aprepitant (various strengths)QL: Varies by strength (examples include 4 capsules/28 days; 1 capsule/28 days; 8–12 capsules/28 days)

TieringListed tiers vary by strength

NotesQL specified per strength on formulary lines

AIMOVIG — quantity limit

AIMOVIGQL: Max. 1 syringe per 30 days

PA/home deliveryPA noted; this drug is not available through home delivery

TieringListed Tier = (formulary line) — migraine biologic entries show tiering

EMGALITY — quantity limit by presentation

EMGALITY (presentations)QL: Max. 1 pen or Max. 3 pens per 30 days depending on presentation

PA/home deliveryPA noted; not available through home delivery for specified presentations

TieringListed Tier = 2

NURTEC — quantity limit

NURTECQL: 16 tablets per 30 days

PAPA indicated for some migraine oral agents

TieringListed Tier = 2

Sumatriptan nasal/injection — quantity limits

Sumatriptan (nasal sprays)QL: 12 nasal sprays per 30 days

Sumatriptan (injection)QL: 12 vials/pens per 30 days

TieringListed Tier = 1 for many sumatriptan formulations

ZURZUVAE — daily limits by strength

ZURZUVAE 20/25 mgQL: Max. 2 per day

ZURZUVAE 30 mgQL: Max. 1 per day

PAPA noted on formulary line for ZURZUVAE entries

COBENFY — quantity limit

COBENFY (oral capsule various strengths)QL: 2 tablets per day

PAPA noted on formulary line

TieringListed Tier = 3

NUPLAZID — quantity limit

NUPLAZID (pimavanserin) oral capsule/tabletQL: Max. 1 per day

TieringListed Tier = 3

NotesQL noted on both capsule and tablet formulations

LAGEVRIO — quantity limit

LAGEVRIO (molnupiravir) oral capsule 200 mgQL: Maximum of 40 per fill

TieringListed Tier = 3

NotesQL specified on formulary line

PAXLOVID therapy packs — pack limits

PAXLOVID therapy pack (150/100) 10x150 + 10x100QL: Maximum quantity of 20 per fill

PAXLOVID therapy pack (300/100) 20x150 + 10x100QL: Maximum quantity of 30 per fill

Other PAXLOVID pack typesSome pack presentations list QL: 11 per fill for alternate pack sizes (per formulary entries)

REPATHA — quantity limit

REPATHA (prefilled syringe)QL: Max. 2 syringes per 28 days

PAPA noted on formulary line

TieringListed Tier = 2

VYNDAMAX — quantity limit

VYNDAMAXQL: Max. 1 per day

SPP/PASPP; PA noted and not available through home delivery for specified entries

TieringListed Tier = 3

Select ADHD extended-release products — max daily dose notes

ADHD extended-release productsQL: Max Daily Dose often specified (examples include Max Daily Dose of 1 or 2 depending on product)

PAPA required for members 25 and older for many ADHD agents

State/Federal limitsState/Federal dispensing limits may apply (noted on several entries)

DUPIXENT — quantity limit

DUPIXENT (prefilled syringe/pen)QL: Max. 2 syringes/pens per 28 days

SPP/PA/home deliverySPP; PA; This drug is not available through home delivery (per formulary line)

TieringListed Tier = 3

MOUNJARO — quantity limit

MOUNJARO (auto-injector pens)QL: 4 pens (2 mL) per 28 days

PAPA noted on formulary line

TieringListed Tier = 2

OZEMPIC — quantity limit

OZEMPIC (pen-injector 3 mL)QL: 1 pen (3 mL) per 28 days

PAPA noted on formulary line

TieringListed Tier = 2

TRULICITY — quantity limit

TRULICITY (auto-injector pens)QL: Max. 4 pens per 28 days

PAPA noted on formulary line for some strengths

TieringListed Tier = 2

EUCRISA — quantity limit

EUCRISA external ointmentQL: 60 grams per month

ST noteST appears on EUCRISA formulary line (per glossary line)

TieringListed Tier = 2

OPZELURA — quantity limit

OPZELURA external creamQL: Max. 8.6 g per day

Supply noteDaily QL specified on formulary line

TieringListed Tier per formulary entry

CEQUR Simplicity 2U Device — limits

CEQUR Simplicity 2U DeviceQL: Maximum of 1 box per 30 days; inserter maximum 1 per year

PAPA noted on device formulary line

TieringListed Tier = 3 for device entries

FREESTYLE LIBRE sensors — quantity limits

FREESTYLE LIBRE sensorsQL: Maximum 2 sensors per 28–30 days depending on model

PA/readerPA required for sensors; reader QL: Max. 1 per 365 days

TieringSensors/readers listed Tier = 3

Test strips — QL example

Test strips (selected Freestyle/Precision/ Chemstrip)QL: 204 strips per 30 days for selected strip types

ExamplesFreestyle Lite, Precision Neo and other selected strips list QL: 204 per 30 days

TieringMost strips listed Tier = 2

FREESTYLE LIBRE reader — limit

FREESTYLE LIBRE reader deviceQL: Max. 1 reader per 365 days

PAPA noted for reader/device entries

TieringReader listed Tier = 3

carglumic acid — supply limit

Carglumic acid oral tablet soluble 200 mgQL: Maximum of 30 days supply per fill

SPP/PASPP noted for some metabolic specialty agents

TieringListed Tier = 2

deferasirox — supply limit

Deferasirox oral tablet soluble (125/250/500 mg)QL: Maximum of 30 days supply per fill

Home deliveryThis drug is not available through home delivery (per formulary line)

TieringListed Tier = 2

VOQUEZNA — quantity limit

VOQUEZNA oral tablet / therapy packsQL: 30 tablets per 30 days (specific pack limits also noted)

PAPA noted on VOQUEZNA entries

TieringListed Tier = 3

ORILISSA — max quantity

ORILISSAQL: Max. 4 (per day)

PA/SPP/home deliverySPP; PA; not available through home delivery

Supply noteMaximum 30 days supply per fill where SPP/PA indicated

RECORLEV — max quantity

RECORLEVQL: Max. 8 (per day)

PA/home deliveryPA noted; not available through home delivery

Supply noteMaximum 30 days supply per fill (per formulary line)

SIGNIFOR — max ampules

SIGNIFORQL: Max. 2 ampules per day

Supply noteMaximum 30 days supply per fill

Home deliveryThis drug is not available through home delivery

MYCAPSSA — daily and fill limits

MYCAPSSA (oral capsule 20 mg)QL: Max. 4 per day; Maximum 30 days supply per fill

PA/home deliveryPA noted; not available through home delivery

TieringListed Tier = 3

Dispensing Channel and Specialty Pharmacy Requirements

Billing Rule

Use Optum Specialty for SPP‑flagged specialty medications

Optum Specialty (SPP) is the required specialty pharmacy for SPP‑flagged products; providers must route prescriptions and documentation to Optum Specialty when the formulary indicates SPP.

SPP flag indicates Specialty Pharmacy Program — 'Must use Optum® Specialty'.
Coordinate enrollment and documentation with Optum Specialty for SPP items.

Note

Optum Home Delivery available for maintenance meds (90‑day)

Mail order/home delivery (Optum Home Delivery) is available for many maintenance medications for up to a 90‑day supply; providers may use Optum Home Delivery unless the formulary line specifically disallows home delivery.

Standard shipping is free; patients will need plan and prescription details to enroll.
Do not use home delivery for products flagged 'This drug is not available through home delivery.'

Billing Rule

Respect home delivery restrictions for injectable/specialty products

Some injectable or specialty oral products are designated as not available through home delivery; providers must arrange dispensing at the appropriate site and indicate this in documentation.

Multiple antiviral and injectable products include the note 'This drug is not available through home delivery.'
Ensure claims and PA requests reflect the correct dispensing channel.

Billing Rule

Coordinate specialty pharmacy handling for non‑home‑delivery drugs

Several specialty drugs are not available via home delivery and may require specialty pharmacy handling; providers must follow SPP routing and PA processes where indicated.

EPCLUSA, MAVYRET, ORILISSA and similar SPP items are noted as not available through home delivery.
Coordinate specialty dispensing and documentation to avoid denials.

Billing Rule

Enroll and document specialty pharmacy handling for antiviral/Specialty items

Some specialty or antiviral products are noted as not available through home delivery and require specialty pharmacy handling; providers must enroll the member in the specialty program and submit required PA documentation.

Examples include LEDIPASVIR‑SOFOSBUVIR, MAVYRET and other hepatitis C agents.
SPP items frequently carry PA and QL requirements and home delivery restrictions.

Billing Rule

Route infusion/clinic‑only products to the appropriate site of care

If a formulary line states 'This drug is not available through home delivery' and the product is used for infusion or clinic administration, providers must arrange site‑of‑care dispensing (infusion/clinic) rather than home delivery.

Some products (e.g., DUPIXENT, SEROSTIM) are marked as not available through home delivery and may be infusion/clinic only.
Document site of administration in PA/claims to avoid denials.

Billing Rule

Route SPP‑flagged, non‑home‑delivery drugs to specialty pharmacy

Multiple products flagged as not available through home delivery may instead be managed through specialty pharmacy (SPP); providers must follow the formulary note and route prescriptions to the designated channel.

Leuprolide, MENOPUR, ORILISSA and similar entries indicate SPP and no home delivery.
Use Optum Specialty when SPP is specified and include PA documentation.

Billing Rule

Comply with SPP routing and PA for specialty, non‑home‑delivery drugs

Several specialty or high‑risk products are flagged as not available through home delivery and/or require SPP; providers must comply with specialty pharmacy program routing and PA documentation requirements to secure coverage.

MYCAPSSA, ORILISSA, EPCLUSA and other specialty agents include 'SPP; PA' and home delivery restrictions.
Coordinate with Optum Specialty and submit full clinical documentation for PA and SPP enrollment.

Background and Purpose

The formulary is maintained to list therapeutically safe and effective medications for common conditions. It is reviewed and updated by Pharmacy Services and the Pharmacy & Therapeutics Committee to support selection of clinically appropriate, cost‑effective therapies. Tier assignments (Tier 1–3) and program flags (e.g., PA, QL, SPP, ST) are applied to guide coverage and utilization management.