CurrentUnitedHealthcarePolicy N/A

New and Therapeutically Equivalent Medications Prior Authorization

Defines UnitedHealthcare Pharmacy prior authorization requirements for select excluded or single-source brand medications when therapeutically equivalent alternatives exist; applies to prescribers and pharmacy benefit management for covered members.

Policy Summary

PayerUnitedHealthcare

PolicyNew and Therapeutically Equivalent Medications Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain and submit medical records documenting trials and failures (dates and duration) of specified therapeutically equivalent alternatives when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration issued

numerousdrugs with step-therapy requirements

multiplestate-specific mandates noted

2025 P 2121-36program identifier

zero copayPrEP copay note

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Initial and drug-specific approval criteria

Covered when ALL of the following are met

Main criteria

Drug-specific example - Abilify: Brand Abilify: Must try generic aripiprazole AND must try one of olanzapine, quetiapine (or XR), or risperidone.
See chunk 3.
Drug-specific example - Januvia/Janumet: Januvia/Janumet: For specified fully insured states must try three-month trial each of Tradjenta AND alogliptin (Nesina authorized generic) or specified metformin combinations as listed.3 months per agent
See chunk 3 and 66.
Copaxone (example): Approval requires documented trial and failure (date and duration) of generic glatiramer acetate (Copaxone Mylan) AND trial/failure or intolerance to Glatopa; provider must explain rationale if asserting failure on therapeutically equivalent product.
See chunks 129-130.

Operational note: Provider must submit medical records documenting dates and duration of prior trials and reasons for discontinuation (failure, intolerance, contraindication); failure to provide documentation may lead to denial.

See chunk 2 and modules referencing documentation requirements.

Drug-specific coverage with step therapy / alternatives

Authorization will be issued for 12 months when criteria below are met for each listed medication.

drug_entry: Each drug entry must document: (1) product designation (Brand Only / Single Source Brand / Brand & Generic / Generic Only), and (2) required step therapy alternatives or provider attestation of medical necessity where allowed by state-specific rules. Examples: Actonel (Brand Only) requires trial of alendronate, ibandronate, risedronate; Adcirca (Brand Only) requires trial of tadalafil tablets; adalimumab biosimilars require trying two specified alternatives.

Do not flatten AND/OR; follow per-drug instructions in source.

General product-level coverage criteria

Covered when ALL of the following are met (applies per product as specified):

Authorization period: Prior authorization approved for 12 months for the listed product.12 months

Standard approval duration per policy.

Trial of alternatives: Documentation of trials (and failures where specified) of the enumerated generic or preferred alternatives for the specific product is required prior to authorization of brand/single-source products.as specified per-product

See product-specific lines in chunks 36-55.

State-specific mandates: For some products, approval may be governed by state mandates or state-specific rules (e.g., oncology or diabetes products in specified states); follow state mandate guidance where indicated.state-specific

Initial coverage and step therapy summary

Covered when the following product-specific conditions are met

General authorization: Authorization issued for 12 months for listed products unless otherwise specified.

Applies per product.

Step therapy examples: Many single-source or brand products require documented prior trials of specified preferred alternatives (examples include Geodon, Gelnique/Gemtesa, various adalimumab products). Number and duration of required trials vary by product.varies by drug

See chunks 54-55, 66, 73 for examples.

State exceptions for diabetes medications: In Florida, Maine, and Tennessee, diabetes medications may be approved if provider attests medical necessity and documents clinical characteristics that preclude use of preferred alternatives and that alternatives could worsen condition.

See chunks 19, 59, 62, 136.

Examples of drug-specific coverage criteria

Covered when the following drug-specific requirements are met (examples extracted from document):

Loestrin and related products: Approve for 12 months when provider documents criteria; brand approval in listed states may require provider to state medical necessity (DC, OR, CT, CA, DE, IL, MD, MA, NJ, NY, WV).

See chunk 73.

Maxalt (rizatriptan) and Maxalt MLT: Brand approval requires trial of rizatriptan (Maxalt/Maxalt MLT) plus two of the listed triptans (almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, zolmitriptan).

See chunk 76.

Micardis: Brand approval requires trial of five listed ARBs prior to approval (candesartan, irbesartan, losartan, telmisartan, valsartan, olmesartan as applicable).

See chunk 79.

Neupogen (vial & syringe):

Step-therapy / Required alternative criteria (selected examples)

Covered when step-therapy or alternative trials specified for each listed product are met and prior authorization is approved for 12 months.

Pattern summary: Coverage entries use the pattern: '1 = , 2 = '. Examples: Otovel (1=Single Source Brand; 2=Must try ONE of specified otic antibiotics); Oxytrol (1=Brand & Generic; 2=BOTH: try one oxybutynin option AND try ALL of listed antimuscarinics); Praluent (1=Single Source Brand; 2=Use medical necessity or step therapy).

See chunks 90, 109, 115 for examples.

Sample product-specific coverage criteria

Coverage determinations in this excerpt follow the pattern '1 = <coverage status>, 2 = <required alternative or step/PA requirement>'. Examples below capture explicit rules present in these chunks.

Taclonex ointment: 1 = Brand & Generic; 2 = Must try both: Enstilar foam and Taclonex suspension prior to approval.

Chunk 109

Talicia: 1 = Single Source Brand; 2 = Must try ONE of: the specified triple combination (amoxicillin + omeprazole + rifabutin), OR Omeclamox, OR Voquezna Dual/Triple Pak.

Chunk 109

Tascenso ODT: 1 = Single Source Brand; 2 = fingolimod (generic Gilenya) as alternative.

Chunk 110

Trospium chloride ER: 1 = Generic Only; 2 = Must try ONE of oxybutynin (IR or XR) or Oxytrol OTC AND must try ALL of solifenacin, tolterodine, trospium.

Copaxone (partial)

Copaxone specific criteria (partial): Covered when ALL of the following are met

Copaxone initial approval: (1) Submission of medical records documenting history of trial and failure, inadequate response, or intolerance to glatiramer acetate (generic Copaxone Mylan) with date and duration; AND (2) Submission of medical records documenting trial and failure or intolerance to Glatopa with date and duration; AND (3) Provider explanation of rationale if asserting failure on a therapeutically equivalent product with same active ingredient.

Chunks 129-130

Brand Truvada

Brand Truvada approval pathways (partial): Approved if ONE of the following

Truvada for PrEP pathway: Member is taking brand Truvada 200/300 mg as effective antiretroviral therapy for PrEP AND Truvada is used as part of a comprehensive prevention strategy; AND submission of medical records documenting adverse event or intolerance to generic Truvada prior (authorization issued with zero copay and deductible bypass for 12 months for PrEP).

Chunks 131-132

Truvada non-PrEP pathway: Submission of medical records documenting Truvada is not being used for PrEP and a history of adverse event or intolerance to use of generic Truvada.

Chunk 133

Medications that are not listed among the policy’s specified approved alternatives remain excluded from coverage unless the documented approval criteria are met. Specifically, the request must include submission of medical records documenting a history of trial and failure, inadequate response, or intolerance to the therapeutically equivalent covered medication(s), with dates and duration of each trial, before an excluded product will be considered for approval.

This extract does not enumerate a comprehensive exclusions list by drug in this section. Exclusions are defined on a drug-specific basis within the product lines; providers must consult the full product entries in the policy for each medication’s exclusion or coverage designation.

Coverage determinations are diagnosis-specific in some entries. For indications not explicitly approved in a given product line, exceptions may exist (for example, the policy allows approval of fluticasone propionate HFA for eosinophilic esophagitis). For other diagnoses, the policy requires trials of the listed alternatives before approving the requested product.

Certain products are designated as Brand Only or Single Source Brand in the product lines. These designations indicate that coverage is restricted to the brand formulation (or that no generic was available at time of review) and that generic substitution is not the standard pathway for approval absent the required supporting documentation.

Brand products may be excluded from coverage under the standard benefit unless the policy’s required alternative therapies or step-therapy trials are attempted and documented. Where a preferred generic or alternative exists, the generic is typically the covered product and brand coverage requires meeting the policy’s step or medical necessity conditions.

For some topical prescription benzoyl peroxide products and related acne therapies the policy references the plan’s EPDL OTC Exclusion list, implying that an OTC alternative (e.g., OTC benzoyl peroxide) should be used before a prescription product will be approved.

Preferred generic alternatives are specified for many entries (examples include oxybutynin, solifenacin, tolterodine for overactive bladder agents, or omeprazole/pantoprazole/rabeprazole for acid suppression). Brand coverage is typically restricted unless the provider documents that the preferred generic alternatives were tried and failed or attests that the brand is medically necessary.

Products listed as Single Source Brand were not available generically at the time of review and publication. State mandates and member-specific benefit plans may further affect coverage for these products, so verify drug status and applicable state rules at the time of the request.

The extract contains no blanket statements labeling products as 'not medically necessary.' However, requests that do not meet step-therapy or documentation requirements (for example, lacking medical records of prior trials/failures) are at risk for denial and therefore effectively not covered under the standard criteria.

Requests for brand products that lack documentation of required trials of specified alternatives, or that do not include a provider attestation of medical necessity where permitted, may be denied. The policy requires submission of medical records showing prior trials, durations, and reasons for discontinuation when seeking brand coverage without having used therapeutically equivalent covered products.

Several product entries indicate use of a 'Use Medical Necessity' pathway (examples include products such as Praluent, Qelbree, and other entries). That designation means coverage is considered only when the provider documents medical necessity per the policy requirements rather than by meeting a standard step-therapy alternative trial.

When an entry lists 'Use Medical Necessity' or specifies a therapy/medical necessity step, coverage is allowed only when the provider submits the required documentation demonstrating that alternatives are contraindicated, would worsen the condition, or have failed—consistent with the policy’s requirement for medical records documenting prior trials and outcomes.

Prior authorization is required for excluded or single‑source brand medications. Approval is contingent on submission of the specified documentation—medical records documenting prior trials and failures or a provider attestation of medical necessity where applicable—and, if approved, authorizations are generally issued for 12 months.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for excluded, single‑source, and many brand medications. Approvals are contingent on documented trials of therapeutically equivalent covered alternatives (include dates and duration). When the request is for a product with the same active ingredient as a covered alternative, the provider must explain why the excluded product is expected to be effective (for example, adverse reaction to an inactive ingredient in the alternative). Failure to submit medical records documenting prior trials, reasons for discontinuation (failure, intolerance, contraindication), or insufficient documentation may result in denial.

Submit medical records documenting trials and failures or intolerance (dates and duration).
If same active ingredient, provide clinical rationale for use of excluded product.
Reauthorization may require documentation of positive clinical response and claims evidence of recent use.

Prior Authorization

Authorization Duration and PA Requirement

Authorizations for products in this section are generally issued for 12 months unless otherwise specified. Some entries (noted per product) carry state‑specific adjustments or shorter trial requirements. Reauthorization may require evidence of ongoing clinical benefit and prior claims for the medication (e.g., evidence of claims in the past 120 days).

Initial Therapy Criteria

Initial therapy per drug

Initial therapy requirements are drug-specific and require documented trials of listed alternatives.

Abilify initial therapy: Must try generic aripiprazole AND must try one of olanzapine, quetiapine (or XR), or risperidone.

Chunk 3

Myrbetriq initial therapy: Must try mirabegron extended-release AND must try one of solifenacin, trospium, tolterodine AND must try one oxybutynin formulation (IR, XR or OTC Oxytrol), as specified.

Chunk 3

Concerta initial therapy: Authorization requires trials of methylphenidate extended-release generics per formulary prior to brand approval.

Chunk 37

Continuation / Reauthorization Criteria

Reauthorization for select combination products

Reauthorization rules for select combination products

Reauthorization: Documentation of positive clinical response to therapy goals is required for reauthorization of certain combination products (e.g., amlodipine‑valsartan‑hydrochlorothiazide).positive clinical response

Chunk 48

Reauthorization guidance (partial)

Reauthorization

Reauthorization guidance: Reauthorization may be approved based on documentation of positive clinical response and evidence of claims in the past 120 days; state mandates and plan benefit rules may modify reauthorization requirements.evidence of claims in past 120 days

Biosimilar Guidance

Step Therapy

Humira/adalimumab — must try TWO specified alternatives

Humira and several other adalimumab products require trying two specified adalimumab alternatives (e.g., Adalimumab-adaz/Hyrimoz and Amjevita) before approval of certain adalimumab or related entries.

Document trials of the two required adalimumab products and outcomes before requesting non-preferred adalimumab coverage.
Policy lists the exact adalimumab alternatives required per product line.

Step Therapy

Granix requires trial of Zarxio

Granix (single source brand) requires a trial of Zarxio as the alternative prior to approval.

Provide documentation that Zarxio was tried and the outcome before requesting Granix.

Step Therapy

Fulphila / Fylnetra require Neulasta and Udenyca trials

Definitions

inv-63: Thermotherapeutically Equivalent — Medications/products with essentially the same efficacy and adverse effect profile as determined by the UnitedHealthcare P&T Committee.

DefinitionMedications/products with essentially the same efficacy and adverse effect profile as determined by the UnitedHealthcare Pharmacy & Therapeutics (P&T) Committee (not intended to imply FDA Orange Book equivalence).

Decision authorityDetermination of therapeutic equivalence is made by the UnitedHealthcare P&T Committee.

Implication for coverageWhen a medication is deemed therapeutically equivalent to a covered product, prior authorization may require documentation of trial and failure, contraindication, or intolerance to the covered alternative before approving the requested medication.

Documentation requiredSubmission of medical records documenting dates and duration of prior trials and reasons for discontinuation (failure, intolerance, contraindication) is required when seeking coverage of a non-preferred/excluded medication claimed to be medically necessary despite equivalence.

Scope noteUnitedHealthcare’s definition is for plan determinations and may differ from FDA Orange Book equivalence; state mandates and member-specific benefit plans may further affect application.

Background

UnitedHealthcare defines Therapeutically Equivalent as products having essentially the same efficacy and adverse effect profile as determined by the UnitedHealthcare Pharmacy & Therapeutics Committee. This definition supports the policy rationale to restrict coverage of single‑source or excluded brand products when therapeutically equivalent alternatives are available and covered by the benefit.

Revision History

2025-05-01formulary status effective dateLatest

Multiple drug additions and status updates (including additions and revisions listed across references) become effective — verify drug status at time of claim.

2025-04reference update note

Document references list items with a 4/2025 notation leading into the 5/1/2025 effective date for several additions and revisions.

2025-01-01

Policy Summary

PayerUnitedHealthcare

PolicyNew and Therapeutically Equivalent Medications Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain and submit medical records documenting trials and failures (dates and duration) of specified therapeutically equivalent alternatives when requesting prior authorization.

SourceLink

On This Page

See chunk 136 and state-specific entries.

Region-specific trials for combination agents: For NY/NJ/CT fully insured members, certain combination products (e.g., Janumet, Janumet XR, Januvia) require three-month trials of specified alternatives before approval.3 months per agent where specified

See chunks 66 and 19.

For patients ≤12 years approve; for patients >12 years must try Zarxio first.

Otovel and Oxytrol (examples): Otovel (Single Source): must try ONE of ofloxacin 0.3% solution OR ciprofloxacin-dexamethasone otic; Oxytrol: must try ONE oxybutynin option AND ALL of solifenacin, tolterodine, trospium prior to approval.

See chunks 90 and 91.

Typical approval duration: 12 months.
Reauthorization: documentation of positive clinical response and recent claims may be required.
State or plan-level exceptions may change duration or trial requirements.

Denial Risk

Step Therapy and Denial Risk

Step‑therapy requirements must be met and documented. Many brand or single‑source products require a trial (and sometimes failure) of one or more specified generic or preferred alternatives prior to approval. Failure to meet step‑therapy or provide required documentation may lead to denial.

Provider must document trials (and failures where specified) of required alternative(s).
Number required varies by drug: some require ONE, TWO, THREE, or ALL listed alternatives.
Lack of documented trials or medical necessity attestation for bypassing steps may result in denial.

Documentation Required

State‑Specific Prior Therapy and Documentation Requirements

State‑specific prior therapy and documentation requirements apply for certain products, especially diabetes agents. For Florida, Maine, and Tennessee: provider attestation of medical necessity plus documentation that clinical characteristics preclude preferred alternatives (and could cause worsening or inadequate treatment) is required for some diabetes medications. For New York, New Jersey, and Connecticut fully insured plans, specific three‑month trial requirements apply for products such as Janumet/Janumet XR/Januvia (see product entries). Connecticut trial durations were updated (previously 60 days, now 30 days for some programs).

FL/ME/TN diabetes agents: provider attests medical necessity and documents clinical reasons precluding preferred alternatives.
NY/NJ/CT (fully insured) diabetes products: specified three‑month trials required for some agents (e.g., Janumet/Janumet XR/Januvia).
Connecticut trial duration update: 60 days -> 30 days for applicable products.

Note

Formulary Reference

Refer to the formulary and product‑specific criteria when preparing a PA request. The formulary lists each affected product along with whether it is Brand Only, Single‑Source Brand, Brand & Generic, or Generic Only and specifies the exact alternative(s) and trial lengths required.

Check the formulary for product status (Brand Only, Single Source Brand, Brand & Generic, Generic Only).
Use the formulary’s product entries to determine required alternative agents and trial durations.
State mandates and plan type (fully insured vs ASO) may alter required steps — reference the State Mandate Overview Document where indicated.

Step Therapy

Drug‑Specific Step Therapy Examples

Examples of drug‑specific step therapy and required alternatives (consolidated examples from product entries):

Abilify (Brand Only): must try generic aripiprazole AND one of olanzapine, quetiapine (or XR), or risperidone.
Myrbetriq (Brand Only): must try mirabegron ER and then try one antimuscarinic (solifenacin, trospium, tolterodine) and oxybutynin (IR or ER) or Oxytrol OTC.
Taclonex ointment: must try Enstilar foam and Taclonex suspension (or specified generic combinations) before approval.
Adalimumab products (many single‑source brands): typically require trials of two other adalimumab biosimilars or Humira (exact biosimilar alternatives listed per product).
Diabetes agents (e.g., Janumet/Januvia): may require trials of specified DPP‑4 or combination alternatives; NY/NJ/CT fully insured plans often require three‑month trials of two listed agents.

Examples of initial therapy step requirements

Initial coverage requires trial of listed preferred alternatives.

Actonel initial therapy: Actonel (Brand Only) requires trials of alendronate, ibandronate, and risedronate prior to approval.

Chunk 19

Adlarity initial therapy: Adlarity transdermal patch requires trial of donepezil AND one of galantamine, memantine, or rivastigmine transdermal patch.

Chunk 20

Asacol/Apriso examples: Some agents (e.g., Asacol HD/Apriso) require trying two listed mesalamine formulations prior to brand approval per product lines.

Chunks 6 and 24

Initial therapy requirements (examples)

Product-specific initial authorization requirements (examples):

Concerta: Authorization requires prior authorization criteria and trials of methylphenidate extended-release generics as indicated.

Chunk 37

Daytrana/Cotempla/Cotempla alternatives: ADHD stimulant products often require trials of two alternative extended-release stimulants prior to brand approval (see product entries).must try 2 alternatives where specified

Chunks 37, 38

Initial therapy trials (examples)

Examples of minimum required trials prior to approval

Jatenzo: Minimum four-week trial of BOTH Testim AND testosterone 1.62% pump (AndroGel Pump) required before approval.4 weeks

Chunks 54 and 66

Frova requires trial of frovatriptan plus two additional triptans as specified.

Chunks 54-55

Initial therapy examples

Examples of initial therapy requirements (drug-specific):

Micardis HCT: Must try all listed ARB‑HCT combinations before Micardis HCT will be approved.

Chunk 79

Novolin/Novolog insulins: Designated Single Source Brand; use therapy step rules apply—preferred insulin alternatives must be tried or provider must attest medical necessity in specified states.

Chunks 86 and 62

Oxytrol: Must try one oxybutynin formulation or Oxytrol OTC AND must try all of solifenacin, tolterodine, trospium before brand approval.

Chunk 91

Selected initial therapy rules

Initial authorization rules and required alternative trials for listed medications.

Otovel initial therapy: Authorization for 12 months; must try one of ofloxacin 0.3% solution (Floxin/Ocuflox) or ciprofloxacin‑dexamethasone otic suspension before approval.

Chunk 90

Oxytrol initial therapy: Authorization for 12 months; require BOTH: try one oxybutynin formulation or Oxytrol OTC, AND try all of solifenacin, tolterodine, trospium.

Chunks 40 and 91

Initial therapy examples

Examples of initial therapy or trial requirements present in text

Talicia initial alternatives: Talicia (Single Source) requires trial of one of the specified H. pylori regimens (amoxicillin+omeprazole+rifabutin combination) OR Omeclamox OR Voquezna pack prior to approval.

Chunk 109 and 118

Trospium initial requirements: Trospium chloride ER (Generic Only) requires trying one oxybutynin formulation AND all of solifenacin, tolterodine, trospium per product instructions.

Chunk 115

Initial authorization (partial)

Initial authorization rules (partial)

General initial authorization: Authorization is typically issued for 12 months; products categorized as Brand Only, Single Source Brand, Brand & Generic, or Generic Only may have corresponding step/alternative requirements.12 months

Chunks 126-128

Drug / Product	Step-therapy requirement (what provider must document)
Abilify (brand tablets)	Provider must document trial of generic aripiprazole AND trial of ONE of: olanzapine, quetiapine (or XR), or risperidone.
Januvia / Janumet / Janumet XR	Provider must document three-month trial of both Tradjenta AND alogliptin (Nesina authorized generic) (per product-specific entry).
Myrbetriq	Provider must document trials of: (1) mirabegron XR AND (2) ONE of solifenacin, trospium, tolterodine AND (3) ONE of oxybutynin formulations (IR or XR) or Oxytrol OTC.

Drug / Product	Number of alternatives required & specific alternatives
Adalimumab biosimilars (e.g., adalimumab-aaty, -adbm, -fkjp, -ryvk)	Must try TWO of the following adalimumab products: Adalimumab-adaz (Hyrimoz), Amjevita, or Humira prior to approval of the listed single-source adalimumab product.
Maxalt / Maxalt MLT (rizatriptan)	Must try rizatriptan (Maxalt) PLUS two of: almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, zolmitriptan.
Micardis (telmisartan)	Must try FIVE of the listed ARBs: candesartan, irbesartan, losartan, telmisartan, valsartan, olmesartan before brand approval.

Drug / Product	Prescriber must document trials of (generics/preferred alternatives)
Concerta (methylphenidate ER)	Prescriber must document trial(s) of methylphenidate extended-release generics as indicated by authorization criteria (try listed methylphenidate ER alternatives).
Geodon (ziprasidone)	Prescriber must document trial of ziprasidone AND trials of TWO additional antipsychotics from: olanzapine, quetiapine (or XR), risperidone, or aripiprazole.
Gelnique / Gemtesa (overactive bladder)	Prescriber must document trial of ONE oxybutynin formulation (or Oxytrol OTC) AND trials of ALL of solifenacin, tolterodine, and trospium prior to approval.

Drug / Product	Required product-specific alternative trials
Fulphila / Fylnetra (pegfilgrastim products)	Provider must document trials of BOTH Neulasta and Udenyca prior to approval of the single-source brand product.
Detrol / Detrol LA / Trospium ER / Oxytrol (overactive bladder products)	Provider must document trial of ONE oxybutynin option (IR or XR or Oxytrol OTC) AND trials of ALL of solifenacin, trospium, tolterodine as specified per product entries.
Neupogen (vial & syringe)	For patients older than 12 years, provider must document trial of Zarxio prior to approval of Neupogen; for patients ≤12 years approvals differ per entry.

Drug / Product	Provider must document trials of these alternatives (number/combination varies)
Otovel (otic suspension)	Provider must document trial of ONE of: ofloxacin 0.3% solution (Floxin/Ocuflox) OR ciprofloxacin-dexamethasone otic suspension prior to approval of single-source Otovel.
Taclonex ointment / suspension	Taclonex ointment: must try BOTH Enstilar foam and Taclonex suspension. Taclonex suspension: must try ALL listed generic betamethasone + calcipotriene combinations and Enstilar as specified.
Trudhesa / Trudhesa (headache product)	Provider must document trial of one oral triptan AND two nasal triptans prior to approval.

Drug / Product	Specified trials required before brand/single-source approval
Copaxone (glatiramer acetate)	Provider must submit medical records documenting trials and failures/intolerance to generic glatiramer (Copaxone Mylan) AND Glatopa (document dates and durations) prior to Copaxone approval.
Brand Truvada (for PrEP)	Brand Truvada may be approved if provider documents member is using brand Truvada for PrEP with intolerance or adverse event to generic Truvada OR documents other qualifying criteria per product entry.
Levemir (insulin detemir)	Provider must document a three-month trial with therapeutic failure, contraindication, or intolerance to both Lantus and Toujeo OR meet alternative pregnancy-related criteria as specified.

Drug / Product	Prior trial requirement / Provider attestation (where applicable)
AirDuo RespiClick / AirDuo Digihaler (inhaled ICS/LABA)	Provider must document trials of specified alternatives: Must try ONE of listed fluticasone-salmeterol products AND must try BOTH Breo Ellipta and brand Symbicort per product entry prior to approval.
Exforge / Exforge HCT / Amlodipine-valsartan combinations	Provider must document trials of all listed generic combination or component alternatives (multiple listed ARB/amlodipine combinations) and history of trial/failure per initial authorization criteria.
Janumet / Januvia (diabetes products)	For certain fully insured plans in NJ, NY, CT provider must document three-month trials of the specified alternatives (Tradjenta and alogliptin or authorized generics) as noted; provider attestation may be required in some states.