Low Clinical Impact Drugs - Rx
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Defines Univera Healthcare's coverage stance and drug-specific requirements for 'low clinical impact' prescription drugs across applicable commercial and public plan lines of business; affects prescribers, pharmacists, and prior authorization staff for the listed products.
No material clinical or coverage changes in this revision.
Coverage Criteria — Low Clinical Impact Drugs
Not Medically Necessary (listed drugs)
Drugs listed below are determined not medically necessary and will not be covered because lower‑cost options that are likely to produce equal therapeutic results are available.
Applies to all drugs enumerated in chunk 6
Drug-specific approval criteria
Low Clinical Impact Drugs with specific, product-level approval requirements. Each product below is covered only when ALL numbered requirements are met for that product.
See chunk 13
See chunk 14
See chunk 15
See chunk 16
See chunk 17
See chunk 18
See chunk 19
Duobrii
Duobrii (halobetasol and tazarotene lotion) is covered when ALL of the following are met:
See chunk 18
Azelastine/Fluticasone combination
Covered when ALL of the following are met:
See chunk 19
Baclofen oral suspensions
Covered when ALL of the following are met:
See chunk 21
Fluticasone Furoate Ellipta
Covered when ALL of the following are met:
See chunk 22
Fluticasone-Salmeterol HFA
Coverage stance:
See chunk 23
Fluticasone-Vilanterol
Coverage stance:
See chunk 24
Kristalose (lactulose packets)
Covered when ALL of the following are met:
See chunk 25
Quiofic (folic acid solution)
Covered when ALL of the following are met:
See chunk 26
Reltone (ursodiol)
Covered when ALL of the following are met:
See chunks 27 and 29
Rezvoglar
Coverage stance:
See chunk 30
Ryaltris (mometasone/olopatadine)
Covered when ALL of the following are met:
See chunk 31
Specified migraine acute therapy
Covered when ALL of the following are met for the specified migraine product:
See chunk 31
Subvenite (lamotrigine suspension)
Covered when ALL of the following are met:
See chunk 32
Tezruly
Covered when ALL of the following are met:
See chunk 34
Umeclidinium-vilanterol
Coverage stance:
See chunk 35
Exceptions to required trial of preferred drugs
Exceptions to required trial of preferred drugs (where New York laws are applicable):
See chunk 38
Approval duration and continued coverage
Approval duration and requirements for continued coverage:
See chunk 39
Drugs identified as low clinical impact are designated as non‑preferred. These products will not be approved for any non‑FDA approved indications. The health plan has determined that medications listed as not medically necessary are such because lower‑cost alternatives exist that are likely to produce equivalent therapeutic results and therefore the listed products will not be covered.
Requests for coverage of drugs on this policy will not be approved for any indication that is not FDA‑approved. For brand or specialty products with limited labeled uses, requests outside those labeled indications are expressly excluded from approval under this policy.
When packets of lactulose are clinically required, Kristalose packets will be the authorized product. Prior to authorizing Kristalose or lactulose 10g/20g packets, all lactulose solution formulations (Constulose, Enulose, Generlac and other lactulose solutions) must be tried and documented as having serious side effects or therapeutic failure. If packets are determined required, lactulose 10g/20g packets other than Kristalose will not be authorized.
Coverage, utilization management, and specific criteria in this policy may vary by contract. Refer to the member’s specific contract and benefit language for any contract‑level exclusions or differences in coverage before making an authorization determination.
The medications enumerated in the section titled ‘Low Clinical Impact Drugs that are considered Not Medically Necessary’ are determined to be not medically necessary because lower‑cost alternatives likely provide equivalent therapeutic results; as such, those listed products will not be covered under the plan.
For ursodiol products, patients must generally use lower‑cost generic equivalents at the closest equivalent dose before brand coverage is considered. Brand Reltone may only be authorized where specific criteria are met (for example, treatment of gallbladder stones <20 mm when surgery is not an option, or prevention of gallstones in rapid weight‑loss scenarios) and when there is a documented clinical reason why the generic alternatives cannot be used. Coverage of generic ursodiol 200 mg or 400 mg capsules requires documentation of serious side effects or failure to brand Reltone.
Provider Actions, Prior Authorization & Documentation
Airsupra — try budesonide/formoterol first
Member must be trialed on a budesonide/formoterol product (for example, Breyna) before Airsupra will be authorized unless the prescriber provides adequate justification why a budesonide/formoterol formulation cannot be used. See Quantity Limit Policy (Pharmacy-43) for quantity limits.
- Use budesonide/formoterol first; document clinical justification if not feasible
Consensi — document diagnoses and generic alternative use
For Consensi, document diagnoses of BOTH hypertension and osteoarthritis and the patient’s age (must be ≥18). The provider must also document use of separate generic amlodipine and celecoxib (as individual tablets) unless there is adequate justification why separate generics are inappropriate; include quantity request details (30 tablets/30 days).
- Diagnosis: hypertension AND osteoarthritis
- Age ≥18 years
- Trial/use of generic amlodipine and celecoxib as separate pills or justification why not appropriate
- Quantity limit: 30 tablets per 30 days
Prior authorization required — follow product-specific prerequisites
Prior authorization is required for the listed low clinical impact drugs per formulary rules. Requests must meet the drug‑specific prerequisites such as appropriate prescriber specialty, documented diagnosis, required prior trials of preferred or component agents, and applicable quantity limits as specified for each product.
- Confirm prescriber specialty when required (e.g., dermatologist for Duobrii)
- Provide diagnosis and age where required
- Document prior trials or component-agent trials as specified
- Request quantity consistent with stated limits
Prior auth approvals typically 1 year; recertification requires ongoing benefit
Unless otherwise stated in an individual drug entry, prior authorizations are issued for a 1‑year period. At recertification, the provider must submit documentation demonstrating ongoing benefit (improvement or stability) and that dosing remains consistent with FDA or guideline-supported recommendations.
- Default approval period: 1 year
- Recertification requires objective/subjective documentation of ongoing benefit (progress notes, imaging, labs)
Dymista — must try azelastine and fluticasone separately first
Dymista (azelastine/fluticasone combination) will only be approved if the member has tried azelastine and fluticasone as separate products and either failed those trials or the prescriber documents a valid medical reason for combination therapy.
- Document prior trials of azelastine and fluticasone as separate products and outcomes or provide medical justification for combination use
- Quantity limit: 23 grams per 30 days
Step therapy — trial separate components and preferred agents first
Step‑therapy expectations require trialing separate component products or preferred agents before approving combination or higher‑cost formulations. Providers must document prior trials (or provide justification) per the product-specific rules (e.g., separate azelastine/fluticasone before Dymista; multiple triptans and combinations before specified migraine products; lactulose solutions before packets).
- Try separate components before combination sprays
- Attempt all listed generic/solution alternatives before brand/specialty formulations
- Document each trial and outcome in progress notes
Preferred‑drug trial requirements and NY law exceptions
When a trial of a preferred drug is required, providers must document a trial of the preferred agent(s) unless an exception under NY Insurance Law §4903(c-1) or Public Health Law §4903(3‑a) applies (e.g., contraindication, likely adverse reaction, prior failure, expected ineffectiveness, adherence barrier, or patient stability). Note: the NY law exceptions do not apply when a brand has an AB‑rated generic — a generic trial may still be required.
- If claiming an exception under NY law, include supporting clinical rationale
- Be aware AB‑rated generic trials may still be required despite exceptions
Atoncy — swallowing disorder and speech/swallow evaluation required
For Atoncy oral solution, submit documentation that the patient has a swallowing disorder preventing use of oral pills and include a speech and swallow evaluation in the medical record.
- Provide speech and swallow evaluation documenting inability to use oral pills
- Confirm patient age meets product criteria (≥6 years) and include quantity requested (100 mL/30 days)
Cardizem CD 360 mg — document failure/intolerance to generics
For Cardizem CD 360 mg (diltiazem CD 360 mg), document that lower‑cost generic alternatives (diltiazem LA/ER) are inappropriate and provide evidence of serious side effects or failure of diltiazem CD 180 mg to justify use of the 360 mg product.
- Document trials and failures or serious adverse effects with lower‑cost generics
- If citing 180 mg failure, note that a 360 mg daily dose can be obtained with two 180 mg capsules
Required documentation — trials, swallowing evaluations, and product‑specific evidence
Providers must include required supporting documentation in progress notes for any requested exceptions or when prior trials are required — examples include trial documentation for lactulose solutions before packets, trials of mometasone and olopatadine separately before Ryaltris, speech and swallow evaluations for oral suspensions, and documentation of prior medication failures or side effects.
- Attach progress notes documenting each prior trial and outcome
- Include evaluations (e.g., speech/swallow) where required
- List specific prior medications tried, dates, and reasons for discontinuation
Documentation to support missing claims history and recertification
If a required preferred‑agent trial is not found in claims history, submit supportive documentation of previous drug use (chart notes, medication lists, or discharge summaries). For recertification, provide documentation demonstrating ongoing clinical benefit (progress notes, imaging, labs, or other objective/subjective measures).
- When claims do not show prior trial, include clinical records verifying the trial and outcome
- At recertification, document continued benefit and adherence to formulary/dosing guidance
Non‑preferred status and no coverage for non‑FDA indications
Drugs listed as low clinical impact are non‑preferred and will not be approved for non‑FDA indications. Brand requests with AB‑rated generics may still require a generic trial. Providers should not expect coverage for listed products when the indication is not an FDA‑approved use.
- Listed drugs are non‑preferred
- Requests for non‑FDA indications will not be approved
Denial triggers — missing trials, non‑FDA uses, incorrect formulations
Common denial triggers include absence of required trials of specified lower‑cost or alternative formulations (e.g., lactulose solutions before packets, separate azelastine/fluticasone trials), requests for non‑FDA indications, or requests for formulations that do not meet the product‑specific criteria (such as lacking required prescriber specialty or age).
- Missing documentation of required prior trials
- Requesting non‑FDA indications
- Failure to meet prescriber, age, or quantity criteria
Contract‑dependent denial risk — verify member benefit language
Coverage and utilization management requirements are contract dependent. Providers should verify member benefit/contract language because contract‑specific criteria or exclusions may lead to denial even if policy criteria are otherwise met.
- Check specific contract/benefit language for exclusions or differing requirements
- Understand that utilization rules may change with contract renewal
Initial Therapy and Step Requirements
Airsupra initial requirement
Initial therapy requirement for Airsupra:
See chunk 13
Initial therapy requirements
See chunks 19, 31, 25, 21
Initial therapy / step requirements
Preferred-agent trial expectations and exceptions:
See chunk 38
Step Therapy Details
| Step therapy requirement | Details |
|---|---|
| Prior trial of separate agents required before approving combination product | |
| Member must try azelastine and fluticasone as separate products (or other specified separate component agents) and demonstrate failure, intolerance, or provide a valid medical reason for combination therapy prior to approval of the combination product. |
| Step therapy requirement | Details |
|---|---|
| Prefer budesonide/formoterol formulations over Airsupra | |
| Based on comparable indications, efficacy, and safety, member will be required to use a budesonide/formoterol formulation (e.g., Breyna) unless adequate justification is provided why a budesonide/formoterol formulation cannot be used. Quantity limits per Quantity Limit Policy (Pharmacy-43). |
| Step therapy requirement | Details |
|---|---|
| Must try separate agents before combination spray (Dymista) | |
| Member will be required to use azelastine and fluticasone as separate products unless they have tried the separate products and have a valid medical reason for requiring the combination spray. Quantity limit 23 grams per 30 days. |
| Step therapy requirement | Details |
|---|---|
| Multiple specified triptan trials required prior to approval | |
| For the specified migraine acute therapy, member must have had serious side effects or drug failure of ALL: two different triptans with different active ingredients (as monotherapy), one oral triptan in combination with an NSAID (as separate pills), and sumatriptan-naproxen tablet. Member must be ≥18 and product is for acute migraine. Quantity limit: 9 tablets per 30 days. |
| Step therapy requirement | Details |
|---|---|
| Attempt all lactulose solutions first before authorizing Kristalose packets | |
| Member must use lactulose solution formulations (Constulose, Enulose, Generlac, lactulose solution) unless inadequate; to determine inadequacy, all solution formulations must be attempted with documentation of serious side effects or drug failure prior to approval of Kristalose or lactulose packets. If packets are required, Kristalose packets will be authorized and other lactulose packets will not be authorized. |
| Step therapy requirement | Details |
|---|---|
| Trial of preferred drug(s) required unless exception criteria are met | |
| When specified, a trial of preferred drug(s) is required prior to coverage of a requested non-preferred agent. Exceptions apply where a provider substantiates contraindication, likely adverse reaction, expected ineffectiveness, prior documented trial and failure or adverse event, significant barrier to adherence or decreased functional ability, or the patient is stable on the requested drug; these exceptions apply per Insurance Law §4903(c-1) and Public Health Law §4903(3-a). The requirement to try an AB‑rated generic before a brand is not covered by these exceptions. |
Quantity Limits by Product / Formulation
Definitions and Background
Low clinical impact drugs are formulations or minor variations of existing medications (changes in dosage, form, or strength) that do not provide meaningful therapeutic advantage or improved clinical outcomes over established alternatives. The Pharmacy & Therapeutics Committee directs management of these products to prioritize therapies that demonstrably improve patient outcomes and to limit coverage for redundant or higher‑cost formulations without added clinical benefit.
Continuation / Recertification Criteria
Continuation/Recertification
Recertification for continued coverage requires demonstration of ongoing benefit and may require additional documentation.
See chunk 39
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