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Currentharvard pilgrim health carePolicy N/A

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

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Defines the Direct 3-Tier formulary, coverage indicators, and pharmacy benefit management processes; includes tier assignments, utilization management flags (PA, ST, QL, NTM), specialty pharmacy routing and site-of-care limitations for members and providers.

Policy Summary

Payerharvard pilgrim health care

PolicyDirect 3-Tier Prescription Drug List (Formulary Coverage Criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan. 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization where 'PA' is noted and document clinical justification and any applicable quantity limits when submitting requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Direct 3-TierFormulary structure

90-dayMaintenance supply option

Optum SpecialtySpecialty pharmacy program

PA/ST/QL/NTMUtilization management

1-800-860-3161Customer service

Coverage and Formulary Criteria

General coverage criteria

Covered as indicated on the formulary when the member's benefit allows and utilization management requirements are satisfied.

Formulary coverage basics

Utilization management programs: Drugs may be subject to one or more utilization management controls: Prior Authorization (PA), Step Therapy (ST), Quantity Limits (QL), New‑to‑Market evaluation (NTM), or Specialty Pharmacy Program (SPP).
Provider must submit required medical review/PA requests and supporting clinical information when noted; drugs excluded under the pharmacy benefit are not eligible for the medical review process.

Formulary tiering and administrative controls

Coverage and administrative access controls are indicated at the product line level; providers must follow the limitation notes attached to each drug entry.

Tier and limitation assignment: Each formulary entry includes a tier assignment (Tier 1–3, $0, or MD) and may list administrative limitations such as PA, QL, ST, SPP (Must use Optum Specialty or named vendor), home‑delivery availability, and plan‑specific mandates (e.g., fertility benefit requirements).

Policy Summary

Payerharvard pilgrim health care

PolicyDirect 3-Tier Prescription Drug List (Formulary Coverage Criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan. 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization where 'PA' is noted and document clinical justification and any applicable quantity limits when submitting requests.

SourceLink

On This Page

Drug Listings, Codes, and Quantity Limit Examples

Drug list entries (no billing codes provided)mixed

N/A	The document contains drug names, strengths, tiers, and notes (PA, QL, ST) rather than CPT/HCPCS/ICD codes.

Selected formulary products with PA/QL annotationsmixed

OPZELURA EXTERNAL CREAM 1.5%	Listed with TIER = 2; QL: Max 8.6gm per day; ST.
QBREXZA EXTERNAL PAD 2.4%	TIER = 3; PA; QL: Max. 1 per day.
tretinoin external cream/gel/microsphere	TIER = 1; Prior Authorization required for members 26 years of age and older.
MOUNJARO SUBCUTANEOUS SOLUTION AUTO-INJECTOR	TIER = 2; PA; QL: 4 pens (2 mL) per 28 days.
OZEMPIC SUBCUTANEOUS SOLUTION PEN-INJECTOR	TIER = 2; PA; QL: 1 pen (3 mL) per 28 days.
TRULICITY SUBCUTANEOUS SOLUTION AUTO-INJECTOR	TIER = 2; PA; QL: Max. 4 pens per 28 day(s).
RYBELSUS ORAL TABLET	TIER = 2; PA; QL.

inv-15: Quantity limits examples (selected analgesics)

Fentanyl transdermal patchQL: Max. 10 per 30 days

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

Hydrocodone bitartrate ER oral tablet (abuse‑deterrent)QL: Max. 2 per day

Hydromorphone HCl ER oral tabletQL: Max. 1–2 per day (strength-dependent)

37.5–87.5 mcg/hr patch sizesQL: Max. 10 per 30 days

inv-16: Examples of quantity limits

Example — Max. 10 per 30 daysUsed for select transdermal opioid patches (see fentanyl entries)

Example — Max. 1–2 per dayApplied to some ER oral formulations (hydromorphone, morphine, etc.)

Example — Max. 1 box (2 sprays) in 15 daysNaloxone/nasal spray (OTC and prescription forms) QL: 1 box (2 sprays) per 15 days

inv-17: Quantity limit per fill

Per-fill capMaximum of 30 days supply per fill

Applies toMany specialty oral oncology and high-cost oral agents (examples in specialty sections)

Provider noteAdhere to QL and specialty pharmacy routing when submitting claims/PA

inv-18: Maximum days supply per fill

Maximum days supply per fill30 days

Common usageStandard maximum for many specialty oral agents and routine prescription fills

ExceptionsSome products have shorter or per‑pack QLs noted (see individual product lines)

inv-19: COARTEM quantity limit

COARTEM (oral tablet 20–120 mg)QL: 24 units per 30 days

TieringListed as Tier 3 in tablet entry

Provider noteObserve 24‑unit limit when dispensing; refer to product line for PA/SPP notes if present

inv-20: EMVERM quantity limit

EMVERM (oral tablet chewable 100 mg)QL: Maximum quantity of 6 per 21 days

TieringListed as Tier 3 in product line

Provider noteAdhere to 6‑tablet/21‑day limit; check product line for additional PA/SPP notes

inv-21: Ivermectin fill limits

Ivermectin (oral tablet 3 mg / 6 mg)QL: Max. 20 per fill; Max. 1 fill per 90 days

TieringListed as Tier 1 in product lines for small‑dose tablets

Dispensing noteLimits enforced per fill and per 90‑day period — document on prescription

inv-22: INBRIJA daily max

INBRIJA inhalation capsules 42 mgQL: Max. 10 per day

TieringListed as Tier 3 with PA/QL notes in product line

Provider noteDaily cap applies — follow QL when authorizing or dispensing

inv-23: Quantity limits examples for EPCLUSA, HARVONI, MAVYRET, etc.

EPCLUSAQL: Max. 1–2 tabs per day (varies by packet/strength)

HARVONIQL: Max. 1–2 per day (varies by strength/packet)

MAVYRETQL: Max. 3–5 per day depending on form (pack/tablet) — see line item

PAXLOVIDQL: Max. 11–30 per fill depending on pack size

inv-24: Max Daily Dose (mL) / Max Daily Dose (unit) examples

On‑body / biologic max daily dose exampleMax Daily Dose: 0.043 mL for certain on‑body/pegylated biologic products (FULPHILA, NEULASTA OnPro, NYVEPRIA, ZIEXTENZO)

Alternate QL exampleSome biologics have QL: 2 pens/syringes per 30 days noted

Specialty dispensingMany on‑body biologics require specialty pharmacy routing and are not available via home delivery

inv-25: Quantity limits examples (selected antivirals/others)

RELENZA DiskhalerQL: 20 units per fill

XOFLUZA (40 mg / 80 mg packs)QL: 1 tablet per fill

Tranexamic acid (650 mg)QL: Max. 1 per day

VOSEVI / SOVALDI / ZEPATIERQL: Max. 1 per day (some SOVALDI 200 mg entries Max. 2 per day)

inv-26: Quantity limits examples — syringes, injections, 30 day supply limits

Syringes / injection QLsExamples include Max. 2 syringes per 28 days (AVONEX kit = 1 kit/28 days; DUPIXENT = 2 syringes/pens per 28 days)

Injections per monthExamples: 1 injection per month noted for some agents; Radicava ORS: 50 mL per 24 days

30‑day supply cap for specialty itemsMany specialty products limited to a maximum 30‑day supply per fill (see individual product lines)

Therapy packs / starter kitsSome products have pack/kit‑specific QLs (e.g., ZEPOSIA starter kit limits)

inv-27: Quantity limits for diabetes injectables (MOUNJARO, OZEMPIC, TRULICITY)

MOUNJARO pensQL: 4 pens (2 mL) per 28 days

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

TRULICITY pensQL: Max. 4 pens per 28 days

Freestyle Libre sensors/readersSensors: max 2 per 28–30 days; Reader: max 1 per 365 days

inv-28: Additional Quantity Limits examples

Examples — 1 per dayUsed across multiple product lines as a daily cap (e.g., NUPLAZID, some antivirals)

Examples — Max. 3 per dayApplied to selected products where noted (see product QL notes)

Examples — Max. 0.12 mL per daySpecific on‑body/pen QL example (see BYNFEZIA entry)

Examples — Max. 30 days supply per fillCommon maximum supply per fill for many specialty and high‑cost drugs

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization, Specialty Pharmacy, and Coverage Risk

Prior Authorization (PA), Medication-Assisted Treatment (MAT), Quantity Limits (QL), and Specialty Pharmacy routing apply to many drugs listed in the formulary. Providers must obtain PA before dispensing drugs marked "PA"; drugs marked "PA; QL" also have enforced quantity limits. Specialty medications frequently require use of Optum® Specialty (SPP) and may be restricted from home delivery. Drugs excluded under the pharmacy benefit cannot be covered through the Medical Review/PA process.

Obtain PA for any product with NOTES containing "PA" prior to dispensing; failure to obtain PA may result in denial or noncoverage.
For PA; QL entries, document and adhere to the stated quantity limits when submitting PA/claims (e.g., DIFICID, fidaxomicin, XIFAXAN, SOLOSEC, vancomycin, SOVALDI/EPCLUSA/MAVYRET entries).
Specialty drugs marked "Must use Optum Specialty" or SPP must be filled through the specialty pharmacy program unless an exception applies (some RI plans noted). Many specialty products are not available via home delivery; verify dispensing channel.
Excluded drugs listed in the formulary are not eligible for coverage via the Medical Review Process — do not submit medical review requests for excluded pharmacy benefit drugs.

Prior Authorization

PA/MAT for Buprenorphine-containing and MAT Products

Prior Authorization and Medication-Assisted Treatment designations apply to buprenorphine-containing and other MAT agents. Prescribers must follow MAT program rules and obtain any required authorizations or document MAT status where noted.

Buprenorphine transdermal patches and buprenorphine/naloxone formulations may carry PA and/or MAT notes — check product line NOTES before prescribing.
Naloxone and other overdose-reversal products include MAT/MD/QL designations (e.g., KLOXXADO, NARCAN) — observe quantity limits and MAT routing.
If MAT status or PA is required, include supporting clinical documentation in the PA/medical review submission.

Prior Authorization

PA Requirement for Selected Antibacterials

Selected antibacterials and high-cost antibacterial agents require Prior Authorization and frequently have Quantity Limits. Providers must document clinical need and adhere to QLs when requesting PA.

Agents such as DIFICID (fidaxomicin), XIFAXAN, fidaxomicin, vancomycin oral solutions/tablets show NOTES = PA and specific QL values — include indication and course duration in PA requests.
Topical and oral antibacterials may have QL entries (e.g., vancomycin reconstituted solution QL: Max 300 mL per 10 days).
Some antibacterials (SIRTURO, NUZYRA, SIVEXTRO, SOLOSEC) are subject to PA and/or QL; verify the exact NOTES line before prescribing.

Prior Authorization

Prior Authorization for Selected Antifungals and Antimycobacterials

Certain antifungals and antimycobacterial agents are PA-restricted and may have quantity limits or specialty routing. Obtain PA and document the clinical rationale and prior therapies when required.

Posaconazole, voriconazole, and other high-tier antifungals show NOTES = PA — include susceptibility, prior antifungal therapy, and intended duration in PA documentation.
Antimycobacterials (e.g., SIRTURO) list PA in NOTES; include diagnostic evidence and treatment plan with PA requests.

Prior Authorization

Prior Authorization and Specialty Pharmacy Requirements for Specialty Medications

Many specialty and high-cost agents across oncology, hepatitis/antiviral, biologic, and hematology classes require Prior Authorization and often must be dispensed through a specialty pharmacy. Providers should verify specialty program routing, QLs, and home delivery restrictions before prescribing.

Numerous oral specialty oncology agents (IMBRUVICA, INLYTA, VENCLEXTA, etc.) list NOTES = PA; many also state "Must use Optum Specialty" and are not available via home delivery.
Hepatitis C antivirals (EPCLUSA, HARVONI, MAVYRET, SOFOSBUVIR-VELPATASVIR, SOVALDI, VOSEVI) require PA, have QLs, and generally require Optum Specialty dispensing.
Biologic and specialty injectables (DUPIXENT, DUPIXENT pens, ARANESP, EPOGEN, NEULASTA, etc.) frequently require PA and Optum Specialty; confirm QLs and that these products may not be available through home delivery.
Some specialty drugs include program-specific restrictions (e.g., Starter Packs, Therapy Packs, ST/step requirements); follow the NOTES field and include required documentation in PA submissions.

Documentation Required

Medical Review, PA Documentation, Quantity Limits, and Appeal Rights

Documentation requirements: PA/medical review requests must include physician-submitted clinical information supporting medical necessity, adherence to quantity limits, prior treatment trials when applicable, and evidence for specialty dispensing. Appeals rights apply when PA/medical review is denied.

When a QL is listed, include justification for quantities exceeding the limit and any relevant weight/dosing calculations.
If a medication requires Optum Specialty or has home delivery restrictions, document the planned dispensing channel and any benefit plan exceptions (e.g., RI plans).
For infertility-related therapies (cetrotide, cetrorelix, etc.) ensure the member's plan includes an infertility benefit and use Fuze Health when required; include benefit verification.
If the Medical Review Process is requested for NTM, PA, ST, or QL drugs, include supporting clinical notes; excluded drugs under the pharmacy benefit will not be covered through Medical Review.

Glossary and Flag Definitions

inv-101: Tier definitions ($0 / Tier 1 / Tier 2 / Tier 3 / MD indicators)

$0Indicates drug may be covered without member cost sharing for some benefit plans

Tier 1Primarily generic drugs; may include certain brand‑name drugs selected by the plan

Tier 2Primarily brand‑name drugs without generic equivalents; selected based on safety, effectiveness, cost

Tier 3Drugs not included in Tier 1 or Tier 2 (typically non‑preferred brands)

MD (Medical)Drug covered under the medical benefit and may be obtained at a retail pharmacy

inv-16: Glossary flags

ACAAffordable Care Act flag — eligible for $0 cost share under most plans (age restrictions may apply)

MATMedication‑Assisted Treatment designation — used for select substance use disorder medications

PAPrior Authorization — some medications require PA as noted

QLQuantity Limit — medications limited to a certain quantity as specified

SPPSpecialty Pharmacy — Must use Optum Specialty; specialty program notes apply

inv-103: MAT designation applied to substance use disorder medications

MATMedication‑Assisted Treatment designation applied to buprenorphine and naloxone products (documented as MAT)

ExamplesNaloxone nasal liquid and injectable forms include MAT notes and QL limits

Provider noteMAT flag signals coverage and program specifics for substance use disorder medications

inv-104: ACA marker used for certain smoking cessation products and NRT

ACA markerUsed for certain smoking cessation products and nicotine replacement therapies eligible for $0 cost share under many plans

ExamplesNicotine patches, lozenges, gums noted with ACA in glossary and product lines

Provider noteCheck benefit documents for plan‑specific ACA applicability and age limits

inv-106: Specialty Pharmacy definition — Specialty Pharmacy Medication Program

Specialty Pharmacy Medication ProgramDesignated program requiring certain medications be dispensed via named specialty pharmacies (e.g., Must use Optum Specialty)

ScopeFrequently applies to oncology, biologics, on‑body injectables and other high‑cost agents

RI exceptionSpecialty Pharmacy Medication Program not required for Rhode Island Plans in many entries — see product notes

inv-107: PA definition — Prior Authorization required

PA (Prior Authorization)Indicates prior authorization is required as annotated in product notes

ImplicationProviders must obtain PA before coverage for PA‑flagged products to avoid denial

DocumentationSubmission should include clinical justification per medical review guidance

inv-108: QL definition — Quantity Limit

QL (Quantity Limit)Maximum allowed supply frequency or units as specified in product notes

ExamplesNotations include '1 per day', 'Max. 3 per day', 'Max 0.12 mL per day', '30 days supply per fill'

Provider noteQLs must be followed when dispensing; document quantity on prescriptions when required

inv-109: PA — Prior Authorization description

PA — Prior AuthorizationCoverage requires provider submission and approval prior to dispensing when PA is noted

ConsequenceFailure to obtain PA where required may result in denial or noncoverage

ActionFollow payer PA process and include required documentation/supporting clinical information

inv-110: QL — Quantity Limit description

QL — Quantity LimitMaximum allowed units per time period as stated in notes (e.g., per day, per 28 days, per fill)

Examples'1 per day', 'Max. 3 per day', 'Max 0.12 mL per day', 'Max. 30 days supply per fill'

EnforcementExceeding QL without authorization may lead to claim denial

inv-111: Specialty Pharmacy Medication Program — designated specialty distribution notes

Designated specialty distribution programsSome drugs must be dispensed via named specialty pharmacies (e.g., Optum Specialty, Fuze Health)

ExamplesMany oncology, hematologic, and biologic agents include 'Must use Optum Specialty' in notes

Plan exceptionsSpecialty program requirement is not required for Rhode Island Plans in many listings; see product notes

Step Therapy Flags and Starter Packs

Description	Notes / Applicability
Step therapy program (ST)
Step therapy may require members to try specified preferred medication(s) before coverage of alternative agents; drugs flagged 'ST' in the formulary are subject to step therapy.

Product Group	Notes / Applicability
Anti‑addiction / MAT‑flagged products
Certain anti‑addiction agents are designated MAT (Medication‑Assisted Treatment) or carry ACA flags; no explicit step sequence is provided in this segment — MAT/ACA are coverage designators rather than step steps.

Agents / Category	Authorization / Limits
Selected agents with PA and QL (examples)
Multiple agents require Prior Authorization (PA) and have Quantity Limits (QL) prior to coverage — see individual product lines for specific PA/QL values (e.g., AKYNZEO PA; QL: 4 units/28d; ZURZUVAE PA; QL: Max 1–2/day).

Observations	Policy impact
Step therapy sequences not specified
This extract contains no explicit multi‑step therapy algorithms; utilization management is dominated by Prior Authorization and Specialty Pharmacy routing (Must use Optum Specialty) where noted.

Starter / Therapy Packs	Step therapy sequencing
Listed starter packs (examples)
Therapy/starter packs (e.g., VENCLEXTA STARTING PACK, other oral therapy packs) appear in the formulary; explicit step therapy sequencing for starter packs is not provided in the excerpt.

Agent	Step therapy flag
Cladribine (MAVENCLAD) therapy packs
Formulary entries include 'ST' in the notes for cladribine therapy packs, indicating step therapy applies where specified; QL: 40 caps per lifetime; Must use Optum Specialty; not available via home delivery.

Product group	Authorization / Step edits
Topical acne / dermatologic products
Multiple topical acne/dermatology agents (adapalene, tretinoin, tazarotene, etc.) require Prior Authorization for members aged 26 years and older; no formal step‑therapy edit sequences are shown in this extract.

Tiering / Preference	Step therapy presence
Tiered items indicate preference
The excerpt shows tier assignments that imply preferred agents (tiers 1–3) but does not include formal step therapy edits in the cited chunks. Coverage remains subject to PA/QL where noted.

Summary	Detail
No explicit step therapy sequences
Across the provided excerpt there are no explicit multi‑step therapy sequences specified — the document flags ST on select lines but primarily relies on Prior Authorization, Quantity Limits, and Specialty Pharmacy requirements to manage access.

Quantity Limits by Product Examples

inv-121: fentanyl transdermal patch — Max. 10

Fentanyl transdermal patch (72‑hour)QL: Max. 10 per 30 days

Patch sizes notedIncludes 12, 25, 37.5, 50, 62.5, 75, 87.5, 100 mcg/hr strengths

Limit contextPA/QL noted in product line — follow authorization rules when dispensing

inv-122: buprenorphine transdermal patch — Max. 4

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

TieringListed as Tier 2 in patch entry

Provider notePA; QL specified — follow PA process if required

inv-123: hydrocodone bitartrate ER oral tablet — Max. 2

Hydrocodone bitartrate ER oral tablet (24‑hr abuse‑deterrent)QL: Max. 2 per day

TieringListed as Tier 3 for ER abuse‑deterrent formulations

PA notePA noted for many ER opioid formulations — follow PA process

inv-124: hydromorphone HCl ER oral tablet — Max. 1-2

Hydromorphone HCl ER oral tabletQL: Max. 1–2 per day (dependant on strength)

Strength notesLower strengths often capped at 1/day; higher strengths may be capped at 2/day (see line entries)

PAPA noted for ER formulations — check product line

inv-125: 37.5-87.5 mcg/hr patch sizes — Max. 10 per 30 days

37.5–87.5 mcg/hr patch sizesQL: Max. 10 per 30 days

ContextApplied to listed fentanyl patch sizes in the formulary entries

Dispensing notePA; QL indicated — observe limits when authorizing refills

inv-126: hydrocodone bitartrate ER (various strengths) — Max. 2 per day

Hydrocodone ER (various strengths)QL: Max. 2 per day (ER abuse‑deterrent examples)

Related productsIncludes multiple strengths and formulations listed in ER opioid section

Provider actionPA indicated for many ER/abuse‑deterrent opioids

inv-127: methadone oral solution 10 mg/5ml — Max. 10 mL per day

Methadone oral solution 10 mg/5 mLQL: Max. 10 mL per day (other methadone forms have separate limits)

Other methadone limitsMethadone concentrate/solutions/tablets have QLs (e.g., Max. 2 per day for some tablets) — see entries

Provider noteDocument QL on prescription to support appropriate dispensing

inv-128: morphine sulfate ER tablets/capsules — Max. 1-2 per day or Max. 90 per 30 days

Morphine sulfate ER capsules/tabletsQL: Max. 1–2 per day or Max. 90 per 30 days depending on strength/formulation

Strength/formulation dependentCapsules, tablets, and ER beads may have differing per‑day or 30‑day caps — consult line item

PAPA noted for many ER morphine formulations

inv-129: naloxone nasal liquid — Max. 1 box (2 sprays) in 15 days

Naloxone nasal liquid (OTC and Rx)QL: Max. 1 box (2 sprays) in 15 days

MAT flagNaloxone entries include MAT designation in many product lines

TieringSome naloxone forms are Tier $0 or MD depending on formulation

inv-130: tramadol ER products — Max. 1 per day

Tramadol ER productsQL: Max. 1 per day

Generic availabilityGeneric Ultram ER noted in entries

PAPA noted for some biphasic/ER formulations — check product line

inv-131: DIFICID oral suspension — Max. 136 ml; DIFICID tablet — Max. 20

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

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

PAPA noted for DIFICID entries — follow PA/QL when authorizing therapy

inv-132: DIFICID oral tablet — Max. 20; SIVEXTRO — 6; SOLOSEC packet — 1 per fill

DIFICID oral tablet 200 mgQL: Max. 20 (per 10‑day course)

SIVEXTRO (tedizolid) oral tablet 200 mgQL: 6 tablets per 30 days

SOLOSEC (secnidazole) oral packet 2 gQL: Max. quantity of 1 per fill

inv-133: vancomycin hcl oral solution (25 mg/ml) — Max 300 mL

Vancomycin HCl oral solution (25 mg/mL)QL: Max. 300 mL per 10 days

DIFICID suspension/tablet notesPA; QL specified for C. difficile agents — follow PA/QL when clinically required

Provider noteDocument course length to support quantity dispensed

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

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Coverage and Formulary Criteria

Drug Listings, Codes, and Quantity Limit Examples

Prior Authorization, Step Therapy, and Documentation Requirements

Formulary Background and Scope

Glossary and Flag Definitions

Step Therapy Flags and Starter Packs

Quantity Limits by Product Examples

Dispensing Channels, Specialty Pharmacy, and Home Delivery Restrictions