Commercial 4-Tier Prescription Drug Formulary — Coverage Criteria
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Defines the Presbyterian Health Plan and Presbyterian Insurance Company Commercial 4-tier formulary structure, management processes (prior authorization, step therapy, quantity limits), and member/provider processes for exceptions and inquiries; applies to commercial plan members and providers in the plan's service area.
No material clinical or coverage changes in this revision.
Coverage Criteria and Product-Level Controls
General Medical Necessity and Prior Authorization
Covered when ALL of the following are met:
Medical Director or other clinical professional will review PA requests; non‑Formulary drugs require medical exception documentation.
Formulary utilization management controls
Products listed on the formulary are subject to the utilization management controls shown on each product line; coverage requires adherence to those controls.
Apply per‑product as annotated in the formulary entries.
Product-specific coverage criteria (examples)
Coverage of listed formulary drugs is governed by the product-specific utilization management notes shown next to each formulation (examples):
See formulary product lines for exact QL and AL values.
Apply product-specific Notes.
Follow ST and QL flags on product lines.
See specific product Notes for QL and AL.
Formulary coverage logic
Coverage is determined by formulary tier and the utilization-designation flags shown on each line item:
Providers must supply required documentation (PA, DX, evidence of step failure, etc.) when submitting requests.
Insulin products
Insulin products are covered according to tier, copay cap, and quantity limits as listed:
Document on claim/PA as required.
Follow the specific product QL in the formulary line.
GLP-1/GIP agents
Incretin mimetic agents (GLP‑1 and GIP) are subject to utilization controls as annotated:
PA required where noted on the formulary line.
Oral antidiabetics and combinations
Oral antidiabetic agents and combinations are managed with tiering and utilization edits:
Follow ST and QL flags per product line.
Supportive and specialty medications
Supportive, antidote, antiemetic, and antifungal medications have product-level UM annotations:
Refer to each product line for PA/QL/MB/SP specifics (e.g., naloxone QL 2 mL per 30 days; Vivitrol QL 1 EA per 28 days; Emend IV = PA).
Formulary utilization controls
Formulary utilization controls summarized for provider guidance:
Providers must follow the annotations on each formulary line when submitting claims or PA requests.
Formulary product-level coverage rules
Coverage and restrictions are listed per product — follow the product line entry for the exact combination of tier and utilization flags:
See individual product entries for required documentation (e.g., DX for biologics, PA for injectables).
Contraceptives - coverage and copay notes
Contraceptive products are covered with specific supply and copay guidance:
Apply PPACA $0 Copay notes per benefit plan rules; documentation of supply may be required.
Steroids and cough/cold - coverage notes
Selected corticosteroids and cough/cold products have quantity and age-based restrictions:
Follow product line entry for exact QL and AL values.
Presbyterian Health Plan maintains a closed Formulary: the Formulary is a continually updated preferred drug list intended to encourage safe, effective, and cost‑efficient medication use. Non‑Formulary drugs are not routinely reimbursed and require a medical exception showing medical necessity for coverage; the medical exception process is the route to request coverage of non‑Formulary medications.
Benefit exclusion designations identify drugs that are not a covered benefit under the plan and therefore are not eligible for reimbursement regardless of clinical justification unless otherwise specified by separate benefit language.
Within the extracted formulary segments there are no additional, explicit categorical exclusions listed; instead coverage is governed at the product level by tiering and utilization management notes (e.g., PA, QL, ST, AL) shown on individual line items.
Certain codeine‑, tramadol‑, and related combination cough/cold and analgesic products are explicitly not covered for patients under 12 years of age. For patients aged 12–18 years these products require prior authorization (PA) before coverage; consult the individual product line note for the specific PA and quantity limit (QL) that applies.
Formulary entries include the product’s tier and an associated Notes field; Notes commonly indicate utilization controls such as PA (prior authorization), ST (step therapy), QL (quantity limits), AL (age limits), and benefit flags (e.g., BH, $0, MB).
Preferred insulin products carry a copay cap (CB) of $25 per 30‑day supply when noted as the preferred formulary insulin; many insulin and specialty lines also list specific QLs (for example, common insulin QLs of 45 mL or 50 mL per 30 days) which must be followed and documented on claims or prior authorization submissions.
Formulary Entries, Codes, and Quantity Limit Examples
| palonosetron hcl intravenous solution 0.25 mg/2ml | palonosetron hcl IV solution 0.25 mg/2ml — Tier = MB; Notes = QL (2 ML per 5 days). |
| caspofungin acetate intravenous solution reconstituted 50 mg | caspofungin acetate IV solution reconstituted 50 mg — Tier = MB; Notes = listed under ECHINOCANDINS. |
| caspofungin acetate intravenous solution reconstituted 70 mg | caspofungin acetate IV solution reconstituted 70 mg — Tier = MB; Notes = listed under ECHINOCANDINS. |
| promethazine hcl injection | promethazine hcl injection — formulary entry (injectable) with corresponding notes where applicable. |
| promethazine hcl oral | promethazine hcl oral formulations (tablet/syrup) — formulary entry where applicable. |
| promethazine hcl rectal | promethazine hcl rectal formulation (suppository) — formulary entry where applicable. |
| REPATHA SUBCUTANEOUS SOLUTION PREFILLED SYRINGE 140 MG/ML | REPATHA subcutaneous solution prefilled syringe 140 mg/mL — product-level entry (ensure covered NDCs / PA/QL per biologic section where applicable). |
| amlodipine benazepril combination | amlodipine benazepril combination products — ACE/ARB combination entries included in formulary (ensure corresponding tier/QL if present). |
| ACE/ARB/HCTZ combinations | ACE/ARB/HCTZ combination products — combination antihypertensive entries included in formulary. |
| vancomycin hcl IV reconstituted 500 mg | vancomycin hcl IV reconstituted 500 mg — IV formulation entry (parenteral). |
| AMJEVITA 40 MG/0.4ML auto-injector | Covered NDCs: 55513-0482-01, 55513-0482-02; QL (1.6 ML per 28 days). |
| AMJEVITA 40 MG/0.8ML auto-injector | Covered NDCs: 72511-0400-01, 72511-0400-02; QL (3.2 EA per 28 days). |
| AMJEVITA 80 MG/0.8ML | Covered NDCs: 55513-0481-01, 55513-0481-02; QL (1.6 ML per 28 days). |
| AMJEVITA 40 MG/0.4ML prefilled syringe | Covered NDCs: 55513-0479-01, 55513-0479-02; QL (1.6 ML per 28 days). |
| HUMIRA (2 PEN) 40 MG/0.4ML | Covered per listed NDCs where applicable; QL (2 EA per 28 days). |
| KEVZARA 150 MG/1.14ML prefilled syringe | Covered examples with QL (2.28 ML per 28 days). |
| REPATHA 140 MG/ML prefilled syringe | REPATHA (evolocumab) prefilled syringe 140 mg/mL — ensure covered NDCs referenced in product list where applicable. |
| Schedule II supply limit | Schedule II medications are limited to a 34 day supply maximum (as noted on morphine sulfate ER entries). |
| QL (30 EA per 30 days) | Multiple stimulant entries (e.g., amphetamine-dextroamphetamine) — QL (30 EA per 30 days) and variations present. |
| QL (60 EA per 30 days) | Various formulations show QL (60 EA per 30 days) per line. |
| QL (90 EA per 30 days) | Some agents list QL (90 EA per 30 days). |
| QL (120 EA per 30 days) | Higher QL examples (e.g., lamotrigine ER lines). |
| QL (50 ML per 30 days) | Insulin/solution ML-based QL examples (e.g., HUMALOG QL 50 ML per 30 days). |
| QL (45 ML per 30 days) | Insulin QL examples (45 ML per 30 days) as listed for several insulin pens/solutions. |
| QL (2 ML per 5 days) | Palonosetron IV QL example: QL (2 ML per 5 days). |
| QL (1.6 ML per 28 days) | Biologic ML-based QL examples for AMJEVITA and others. |
| QL (3.2 EA per 28 days) | Biologic EA-based QL examples (AMJEVITA 0.8 mL autoinjector). |
| QL (448 EA per 365 days) | Example QL (448 EA per 365 days) appears with budesonide oral capsule entry and is included here. |
| No codes listed |
| metformin entries | Metformin ER and regular tablet lines included under BIGUANIDES. |
| insulin product entries | Humalog, Humulin, Lantus and others with CB copay cap notes and QL (45-50 ML per 30 days) present. |
| ondansetron oral dispersible 4 mg/8 mg | ondansetron oral tablet dispersible 4 mg, 8 mg — QL (90 EA per 30 days). |
| palonosetron hcl IV 0.25 mg/2ml | palonosetron hcl IV 0.25 mg/2ml — Tier = MB; QL (2 ML per 5 days). |
| aprepitant oral capsule | aprepitant oral capsule 125 mg, 40 mg — PA; QL (1 EA per 30 days). |
| nitrofurantoin products | Nitrofurantoin macrocrystal and monohydrate forms included; oral suspension QL noted. |
| chloroquine phosphate 250/500 mg | Chloroquine phosphate oral tablet 250 mg, 500 mg included. |
| hydroxychloroquine sulfate 200 mg | Hydroxychloroquine oral tablet 200 mg included. |
| REPATHA 140 mg/mL | REPATHA SUBCUTANEOUS SOLUTION PREFILLED SYRINGE 140 MG/ML noted among biologic entries — ensure PA/coverage per policy where applicable. |
| various antineoplastics | Multiple antineoplastic agents listed with PA/QL/DX requirements (e.g., ALECENSA, ALUNBRIG, KEYTRUDA QLEX). |
| DX (Diagnosis Validation Required) | Many biologic and antineoplastic entries require diagnosis validation at point of sale or prior authorization. |
| QL examples | Consolidated QL statements preserved (30/60/90 per 30 days, ML per 28/30 days, EA per 365 days such as 448 EA per 365 days). |
| QL (2 ML per 5 days) | palonosetron IV QL example preserved. |
| QL (448 EA per 365 days) | Budesonide oral capsule QL example preserved. |
| QL (50 ML per 30 days) | Insulin copay cap QL examples preserved (50 ML/HUMALOG etc.). |
Prior Authorization, Step Therapy, Documentation, and Denial Risks
Prior Authorization Required
Prior authorization (PA) is required for many specific formulary products including select biologics, specialty and oncology agents, certain antivirals/hepatitis agents, select opioids and cough/cold preparations for pediatric ages, and other listed drugs. When a drug entry includes a PA note or PA flag, prescribers must submit a Prior Authorization request and supporting clinical documentation. PA requests are reviewed by a Medical Director or other clinical professional to determine medical necessity and benefit coverage; PA approval does not guarantee payment if coverage ends before service delivery.
- PA required when 'PA' appears in formulary Notes for the product.
- Many biologics/specialty agents require both PA and diagnosis validation (DX) and may restrict to covered NDCs — provide NDC when requested.
- PA applies to numerous oncology and antineoplastic agents; diagnosis validation (DX) is commonly required at PA or point of sale.
- Select antiviral/hepatitis agents (e.g., MAVYRET, sofosbuvir-velpatasvir, entecavir, valganciclovir) require PA and may have QL/NDS/SP flags.
- Some injectables/long-acting therapies (e.g., ABILIFY MAINTENA, CABENUVA, SPRAVATO) require PA and have quantity and age limits.
- Select opioids and codeine-containing cough/cold products are subject to PA and pediatric age-based coverage limits (not covered under certain ages; PA required for adolescents).
- Schedule II controlled medications are limited to a 34-day supply maximum where noted.
- PA approvals may require prescriber-supplied clinical information, diagnosis codes, prior trials (for step therapy), and covered NDCs for product-specific coverage.
- If required PA, DX, QL, ST, BH, CB or AL notes are not followed or documentation is missing, requests may be denied.
- Expedited PA requests are processed within 24 hours when delay could jeopardize health; standard requests processed within 72 hours when complete.
Step Therapy Applies — Prescribe/Document Prerequisite Trials
Step therapy (ST) applies to numerous formulary items. Where a product is noted with 'ST' or step edits, coverage requires prior use of prerequisite FDA‑approved drugs (the plan does not publish a specific algorithm in this document). Prescribers should document prior therapies tried and reasons for failure or intolerance to meet step therapy requirements. Common examples include DPP‑4 combinations, certain inhaled asthma products (DULERA), anticonvulsants and some antidiabetic combinations and insulins where ST is indicated.
- Step therapy applies when the formulary Notes include 'ST' or list prerequisite agents.
- No explicit step therapy algorithm is provided here; prescribers must document prior trials or request a medical exception.
- Step therapy examples: JANUMET XR (ST), DULERA (ST), saxagliptin‑metformin er (PA/QL) and certain SGLT2/DPP4 combinations.
Documentation Required for PA / Medical Exceptions
Provide complete clinical documentation with PA or medical exception requests. This includes diagnosis validation (DX) when required, relevant patient history, prior therapy trials and failures, NDCs for product‑specific coverage, and any supporting labs or notes. Missing or incomplete information is a common denial trigger.
- Prescribers must provide clinical rationale and documentation to support PA/medical exceptions.
- When DX is required in the Notes, include the diagnosis code and any requested clinical validation.
- Provide the NDC when coverage is limited to approved products or NDCs are listed.
- Follow all Notes flags: PA, ST, QL, BH, CB, AL, DX, NDS, SP as applicable to avoid denials.
Benefit-Based Coverage Controls and Flags
Benefit‑based coverage controls (BH, CB, QL, AL, NDS, SP) are applied across the Formulary and impact PA decisions and point-of-sale coverage. Providers must follow note flags and stated limits; exceeding QLs or missing PA/ST can result in claim denial or request for additional information.
- BH indicates behavioral‑health related coverage rules (may include zero cost‑share in some plans).
- CB indicates copay cap rules (e.g., insulin $25 cap) and must be documented where applicable.
- QL (quantity limits) and AL (age limits) must be adhered to; requests exceeding these require justification via PA.
- NDS (non‑standard dispensing/special handling) and SP (specialty) flags denote specialty or non-routine distribution requirements.
PA and Quantity Limit (QL) Triggers
PA and QL triggers — many products are subject to quantity limits and PA; exceeding QL or bypassing PA may prompt utilization review or denial. Copay cap (CB) documentation also applies for insulins and must be considered when processing claims.
- Quantity Limits (QL) are specified per product (daily, per 30 days, per year); observe and document any requests exceeding those limits.
- Copay cap (CB) for preferred insulins must be applied and documented per plan rules.
- Requests that present PA+QL conflicts require prescriber justification and may be subject to denial without adequate documentation.
Prior Authorization and Age-Based Limits
PA for age‑specific use: Several products include age limits (AL) or are not covered under certain ages. Examples include codeine- and opioid-containing cough/cold products, tramadol (pediatric age restrictions), and many behavioral health agents requiring PA for patients under defined ages. Prescribers must confirm patient age and include age‑appropriate justification when requesting PA.
- Not covered for patients under specified ages — do not submit PA unless plan Notes permit (e.g., some codeine products not covered <12 years).
- PA required for adolescent age group (e.g., 12–18) for certain opioid/cough products — include age in the request.
- Some long‑acting injectables and intramuscular products have minimum age requirements (AL) listed; verify prior to submission.
PA for Specialty and Oncology Drugs — DX and NDCs Required
Specialty and oncology agents frequently require PA plus diagnosis validation and may be limited to specific covered products/NDCs. Prescribers should supply diagnosis, staging or indication details, requested regimen, prior therapies, and NDCs when the Notes require coverage only for approved products.
- Many antineoplastics list PA and DX (Diagnosis Validation Required) — include clinical oncology documentation.
- Coverage often limited to approved NDCs; see product Notes (e.g., AMJEVITA covered NDCs).
- Specialty flags (SP) and non‑standard dispensing (NDS) may necessitate specialty pharmacy routing.
Denial Risk — Follow PA/ST/DX and Documentation Requirements
Denial risk if PA/ST/DX/documentation missing: Requests that do not meet PA, step therapy, quantity, age, diagnosis validation, or required documentation criteria will be denied. Ensure full adherence to formulary Notes and submit all requested information to reduce adverse determinations.
- Denials are common when prior authorization is not obtained for PA‑flagged drugs or when step therapy prerequisites are unmet.
- Incomplete clinical information, missing DX, or not providing required NDCs can trigger adverse determinations.
- Expedite requests only when medically necessary — otherwise follow standard 72‑hour processing timelines.
Initiation and Pediatric Initiation Controls
Pediatric initiation constraints
Pediatric initiation constraints for certain opioid‑containing and related products:
Examples and exact QLs are listed on product lines (see acetaminophen‑codeine solution/tablet entries).
Initiation controls
Initiation controls captured in formulary notes govern access at start of therapy:
Examples: selected GLP‑1/GIP agents require PA and QL (e.g., QL 2 mL per 28 days); select oral antidiabetics and combinations are marked ST with specified QLs.
Step Therapy Rules and Examples
| Step therapy definition | Notes |
|---|---|
| Step therapy requires prior use of one or more FDA‑approved prerequisite drugs that treat the same condition before covering a step‑therapy medication. | Prerequisite drugs are specified by the plan; prescribers must document trial and failure or contraindication to those agents when submitting requests. |
| Step therapy promotes use of equally effective lower‑cost formulary drugs first; coverage of the requested drug is contingent on meeting ST requirements. | ST is applied as noted on formulary product lines; when ST applies, documentation of prior drug trials is required for approval. |
| Presence of explicit algorithm | Notes |
|---|---|
| No explicit multi‑step algorithm is specified in the extracted formulary chunks. | Many products instead rely on prior authorization (PA), diagnosis validation (DX), quantity limits (QL), age limits (AL), or specialty pharmacy (SP) flags as the primary utilization controls. |
| When an explicit ST sequence is not provided, PA and DX requirements should be followed as indicated in the product Notes. | Absence of a detailed algorithm means prescribers must follow product‑level Notes and contact the plan for required prerequisite agents if unclear. |
| Class / examples | Notes |
|---|---|
| Certain extended‑release (ER) opioid products (e.g., morphine ER, oxymorphone ER) | Formulary Notes indicate ST applies to some ER opioid formulations; Schedule II products also have a 34‑day supply maximum. |
| Selected ER opioids listed with 'ST' in product Notes | Where ST applies, prior use of prerequisite opioid therapy as defined by the plan is required; PA and QL also commonly apply. |
| Example product | ST / Notes |
|---|---|
| DULERA inhalation aerosol | Notes = ST; QL (13 GM per 30 days). |
| XOLAIR (example in doc) | Listed with utilization controls; ST flag appears on multiple agents in this class. |
| clobazam (oral suspension and tablets) | Notes = ST; QL (8 mL per 1 day for suspension; 2 EA per 1 day for tablets). |
| diazepam rectal gel | Notes = ST; BH; QL (5 EA per 30 days); AL. |
| NAYZILAM nasal solution | Notes = QL (10 Delivery Systems per 30 days); ST flag appears on related anticonvulsant entries. |
| VALTOCO nasal liquid / therapy packs | Notes = ST; QL (10 EA per 30 days or 5 packs per 30 days depending on strength); AL (Min 2 Years). |
| Products annotated 'ST' | Specific step therapy requirement (summary) |
|---|---|
| clobazam (oral suspension, tablets) | Notes indicate ST; prescriber must document trial/failure of prerequisite agents; QL specified (suspension 8 mL/day; tablets 2 EA/day). |
| diazepam rectal gel | Annotated ST; documentation of prior trials required; QL 5 EA per 30 days; BH note present. |
| lacosamide oral solution | Notes = ST; QL (1200 mL per 30 days) for solution formulation. |
| VALTOCO (various strengths/packs) | Notes = ST; QL varies by formulation (10 EA or 5 packs per 30 days); minimum age requirements apply. |
| Other anticonvulsants referenced with ST | When ST is annotated, plan requires trial of specified prerequisite agent(s) before covering the ST drug. |
| DPP‑4 / combinations | ST / Notes |
|---|---|
| JANUMET XR (sitagliptin‑metformin XR) / alogliptin‑metformin combinations | Notes = ST (JANUMET XR = ST; alogliptin‑pioglitazone combos = ST); QL examples (JANUMET XR QL 60 EA per 30 days). |
| saxagliptin‑metformin ER combinations | Notes = PA; some DPP‑4 inhibitors and combinations are annotated ST or PA per formulary lines. |
| Oral antidiabetics / antiemetics | ST / Notes |
|---|---|
| Steglujan, dapagliflozin, Steglatro, Segluromet | Notes = ST on multiple oral antidiabetic combinations; QL commonly 30 EA per 30 days (Steglujan, dapagliflozin examples). |
| Granisetron / ondansetron / aprepitant (antiemetics) | Some antiemetics (e.g., granisetron noted elsewhere) and aprepitant entries show ST or PA; ondansetron noted with QL (90 EA per 30 days). |
| ST enforcement | Supporting note |
|---|---|
| Where product Notes include 'ST', step therapy edits are enforced at claim/authorization processing. | Prescribers must document prior use/failure of required prerequisite agents or provide justification for medical exception. |
| If ST is absent but PA/DX flags present, PA/DX remain primary controls. | No universal step sequence specified in this extract; follow product‑level Notes for required prerequisites. |
| Oral oncology agents | ST / Notes |
|---|---|
| Some oral oncology agents (examples: VENCLEXTA, erivedge, daurisimo) note PA and DX; QLs are listed per product. | No explicit multi‑step ST algorithm is present for oral oncology agents in these chunks; PA and DX are the primary utilization controls. |
| Specialty handling flags (NDS, SP) and QL often accompany PA/DX for oral oncology agents. | When step edits are needed, the plan will specify them on the product line; none are detailed here. |
| Specialty oncology agents | Implication |
|---|---|
| Multiple specialty oncology agents are marked with PA, DX, NDS, and SP (e.g., LENVIMA, INLYTA, ALECENSA). | These flags imply specialty pathways and required documentation but do not provide explicit step therapy sequencing in this excerpt. |
| Prescribers must submit diagnosis validation and follow PA requirements for approval. | Quantity limits and specialty pharmacy handling are common controls for these agents. |
| sacubitril‑valsartan (Entresto) | ST / QL |
|---|---|
| sacubitril‑valsartan oral tablet | Notes = ST; QL (60 EA per 30 days). ENTRESTO sprinkle noted as PA; sacubitril‑valsartan explicitly annotated 'ST' indicating step therapy applies. |
| Guaifenesin‑codeine / cough products | Coverage / PA / Age limits |
|---|---|
| guaifenesin‑codeine oral solution / G Tussin AC / guaiatussin AC | Notes = PA; Not covered for patients under 12 years of age. Prior authorization required for patients 12–18; AL Min 12 Years specified. |
| Guaifenesin‑codeine oral solution (100‑10 mg/5 mL) examples | Coverage requires prior authorization for ages 12–18 and is not covered for <12 years. Documentation must support PA per formulary Notes. |
Quantity Limits and Per-Product Examples
Site of Care and Specialty Pharmacy Handling
Key Terms and Abbreviations
Formulary Purpose and Policy Scope
A Formulary is a preferred drug list maintained to encourage safe, effective, and cost‑efficient medication use. The plan manages utilization through tools such as prior authorization, step therapy, and quantity limits, applied per product line as indicated by formulary notes and tier assignments.
Presbyterian operates a closed Formulary, meaning non‑Formulary drugs require a documented medical exception to be reimbursed; reviewers (Medical Director or clinical professional) evaluate medical necessity when exceptions or prior authorization requests are submitted.
The extracted formulary lines are presented as product entries that show tier, notes, and any quantity or age limits. These segments do not provide separate, standalone medical necessity criteria; instead coverage decisions rely on adherence to the per‑product Notes (for example, PA, ST, QL, AL, and benefit flags) and on documentation submitted with authorization requests.
Biosimilar Coverage Notes
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