CurrentUnitedHealthcarePolicy 1 = 2025 P 3136-6

Step therapy for Sprix (ketorolac) nasal spray

Defines UnitedHealthcare's step therapy requirements for coverage of Sprix (ketorolac) nasal spray, applying to adult members for short-term (up to 5 days) management of moderate to moderately severe pain. Affects providers seeking prior authorization for Sprix under the Step Therapy program.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for Sprix (ketorolac) nasal spray

Policy CodePolicy 1 = 2025 P 3136-6

Change TypeNo material change

Effective DateNov 16, 2025

Next Review DateSep 1, 2025

Key ActionObtain prior authorization and document either failure/intolerance/contraindication to three specified oral NSAIDs or inability to swallow oral products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3required prior-step oral NSAIDs (choices)

12 moauthorization duration if approved

≤5 daysindicated duration of therapy for Sprix

adultsindicated population

Coverage Criteria

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Initial therapy — Covered when ONE of the following is met

Covered when ONE of the following is met

Primary approval path: History of failure, contraindication, or intolerance to three of the following oral products: diclofenac; flurbiprofen; ibuprofen (prescription strength); naproxen (prescription strength).3 failed/contraindicated/intolerant agents

Evidence must be in prior medication history or clinical documentation.

Alternative approval path: Member is unable to swallow oral products due to dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting.documented swallowing impairment or related condition

Coverage criteria in this policy may be affected by applicable state mandates and the member's specific benefit plan. Any federal regulatory requirements and the member-specific benefit plan coverage may also impact coverage criteria. Additionally, other UnitedHealthcare policies and utilization management programs may apply and could affect approval, documentation requirements, or duration of authorization.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Sprix (ketorolac) nasal spray.

Program: Step Therapy (Program Number: 1 = 2025 P 3136-6)
Authorization duration: 12 months
P&T approval history: 4/2020, 6/2021, 6/2022, 7/2023, 8/2024, 9/2025
Effective Date: 2025-11-16

Step Therapy

Step Therapy Requirement

Sprix is managed under a Step Therapy program. Approval requires meeting the step criteria below (failure/intolerance/contraindication to required prior agents or documented inability to take oral NSAIDs).

Program: Step Therapy
Medication: Sprix (ketorolac) nasal spray

Documentation Required

Required Clinical Documentation

Documentation must support the clinical rationale for Sprix, including evidence of prior therapies tried or clinical inability to use oral NSAIDs. Examples of acceptable documentation include progress notes, medication history, chart notes describing adverse reactions or contraindications, and clinical notes describing swallowing impairment or persistent vomiting.

If approval requested under prior-step failure: documentation of trials and reasons for discontinuation (failure, intolerance, or contraindication) for three oral NSAIDs from the list: diclofenac, flurbiprofen, prescription-strength ibuprofen, prescription-strength naproxen.
If approval requested due to inability to swallow oral products: clinical documentation of dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting.
Include dates and duration of trials where available.

Denial Risk

Prior-Step Failure Required

Denial risk if member has not tried/failed three listed oral NSAIDs and no documentation of inability to swallow oral products is provided.

Prior-step failure required: failure, intolerance, or contraindication to three of the following oral products: diclofenac; flurbiprofen; prescription-strength ibuprofen; prescription-strength naproxen.
Alternate approval route: documented inability to swallow oral products (dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting).

Initial Therapy Criteria

Initial therapy — Initial approval criteria

Initial approval criteria

Step therapy path A: Documented failure, contraindication, or intolerance to three of: diclofenac; flurbiprofen; ibuprofen (prescription strength); naproxen (prescription strength).3 agents

Failure should be demonstrated in prior medication history or clinical documentation; lack of documentation may result in denial.

Step therapy path B: Unable to swallow oral products due to dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting.documented swallowing impairment

Clinical documentation should support the inability to swallow oral products (e.g., dysphagia, esophagitis, mucositis, uncontrollable nausea/vomiting).

Requirement	Details
Step therapy requirement
Member must have history of failure, contraindication, or intolerance to three of the following oral NSAIDs: diclofenac; flurbiprofen; ibuprofen (prescription strength); naproxen (prescription strength), unless the member is unable to swallow oral products (e.g., dysphagia, esophagitis, mucositis, uncontrollable nausea/vomiting).

Definitions

Short-term use — Use of Sprix for up to 5 days for management of moderate to moderately severe pain

Indicated durationShort-term use: up to 5 days for management of moderate to moderately severe pain in adults.

Indicated populationAdult patients requiring opioid-level analgesia for short-term pain management.

Step therapy contextSprix is managed under a Step Therapy program to encourage lower-cost alternatives; prior authorization required when criteria apply.

Approval pathwaysAuthorization is approved when the member meets one of the criteria: documented failure/contraindication to three specified oral NSAIDs OR inability to swallow oral products (dysphagia, esophagitis, mucositis, uncontrollable nausea/vomiting).

Background

Sprix (ketorolac) is a nasally administered nonsteroidal anti-inflammatory drug (NSAID) indicated in adult patients for short-term use (up to 5 days) to manage moderate to moderately severe pain that requires analgesia at the opioid level. When managed under UnitedHealthcare's Step Therapy program, Sprix coverage is subject to the criteria described in this policy and prior authorization requirements; if approved, authorization will be issued for 12 months.