CurrentAdvanced HealthPolicy N/A

Ketorolac Drug Use Criteria

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This policy governs prior authorization and coverage of oral ketorolac tablets prescribed for outpatient use under the Oregon Health Plan. Injectable ketorolac administered in a provider office is excluded from these criteria.

Policy Summary

PayerAdvanced Health

PolicyKetorolac Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for oral ketorolac tablets prescribed for outpatient use.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 daysMaximum combined ketorolac duration

40 mg/dayMaximum daily dose

2 NSAIDsRequired formulary NSAID trials when not treating kidney stones

Oral onlyPolicy scope

High adverse-event riskRationale for restricted coverage

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CurrentAdvanced HealthPolicy N/A

Ketorolac Drug Use Criteria

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Policy Summary

PayerAdvanced Health

PolicyKetorolac Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for oral ketorolac tablets prescribed for outpatient use.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 daysMaximum combined ketorolac duration

40 mg/dayMaximum daily dose

2 NSAIDsRequired formulary NSAID trials when not treating kidney stones

Oral onlyPolicy scope

High adverse-event riskRationale for restricted coverage

Coverage Criteria

Initial Therapy

Covered when all of the following requirements are met.

Eligibility pathway

Funded condition: Medication is being used to treat a condition funded for coverage by the Oregon Health Plan.
Age-based eligibility: Member is 20 years of age or younger.≤20 years
Comorbidity-based eligibility: Member has a comorbid condition that would allow coverage.

Indication or step-therapy pathway

Kidney stones: Medication is being used to treat kidney stones.
NSAID trial and failure: Member has trialed and failed at least two formulary NSAIDs available without prior authorization.At least 2 agents
Required when the indication is not kidney stones.

Dose and duration: The prescribed dose is less than 40 mg/day and the duration does not exceed 5 days.<40 mg/day; ≤5 days

Combined duration of parenteral, oral, and nasal ketorolac must not exceed 5 days.

Safety: No contraindications to ketorolac therapy exist.

See contraindications section.

This policy applies only to oral ketorolac tablets prescribed for outpatient use. Injectable ketorolac administered in the provider office is excluded from these coverage criteria.

Ketorolac is not indicated for pediatric patients or for the treatment of minor or chronic painful conditions.

Use does not meet coverage criteria unless the medication treats a funded Oregon Health Plan condition, the member is 20 years of age or younger, or the member has a qualifying comorbid condition. When treatment is not for kidney stones, the member must also have trialed and failed at least 2 formulary NSAIDs available without prior authorization.

Use does not meet coverage criteria when the prescribed dose is 40 mg/day or higher, treatment exceeds 5 days, or a contraindication to ketorolac therapy exists. Combined oral, injectable, and nasal ketorolac use must not exceed the 5-day maximum, and doses above labeled recommendations increase the risk of serious adverse events.

Dose, Duration, and Step-Therapy Parameters

Maximum daily dose

Coverage dose limitLess than 40 mg/day

Labeled maximum dose40 mg/day

Dose above limitA dose of 40 mg/day or higher does not meet coverage criteria

Maximum treatment duration

Maximum treatment duration5 days

Combined therapy limitThe total duration of parenteral, oral, and nasal ketorolac therapy must not exceed 5 days

Approval durationWhen criteria are met, approval is for 5 days of therapy

Authorization and Documentation Requirements

Prior Authorization

Outpatient Oral Ketorolac Authorization

Prior authorization is required for outpatient oral ketorolac tablets. This drug-use criteria applies only to oral ketorolac prescribed for outpatient use; injectable ketorolac administered in the provider office is excluded from this coverage review.

Submit authorization for outpatient oral ketorolac tablets.
Do not apply this oral-drug criteria to injectable ketorolac administered in the provider office.

Step Therapy

Formulary NSAID Step Therapy

For indications other than kidney stones, document that the member has trialed and failed at least two formulary NSAIDs available without prior authorization before requesting ketorolac.

Kidney-stone treatment may proceed to dose, duration, and contraindication review without the two-NSAID trial.
Acceptable formulary alternatives include ibuprofen, naproxen, indomethacin, sulindac, and celecoxib.

Medication Background

Ketorolac is a nonsteroidal anti-inflammatory drug that reversibly inhibits COX-1 and COX-2, reducing formation of prostaglandin precursors and thereby providing analgesic and anti-inflammatory effects. It is intended for the short-term management of moderate to severe acute pain requiring analgesia at the opioid level. Oral ketorolac is generally used as continuation therapy after parenteral ketorolac when needed, with combined oral, injectable, and nasal treatment limited to 5 days.

Indication and Policy Scope

FDA-approved indication

IndicationShort-term management of moderate to severe acute pain requiring analgesia at the opioid level

Maximum durationNo more than 5 days

Oral ketorolac useOral ketorolac is indicated as continuation treatment following intravenous or intramuscular ketorolac, if necessary

Policy scope

Covered settingOutpatient use

Covered productOral ketorolac tablets

Excluded useInjectable ketorolac administered at the provider office is not included in this policy

Initial Request Requirements

Initial Request

Initial requests must satisfy the eligibility, indication or step-therapy, dose, duration, and safety requirements.

Initial request requirements

Eligibility: Medication treats a funded condition, member is 20 years of age or younger, or member has a qualifying comorbid condition.
Indication or step therapy: Treatment is for kidney stones or at least two formulary NSAIDs have been trialed and failed.≥2 failed NSAIDs when not treating kidney stones
Safe dose and duration: Dose is less than 40 mg/day and duration does not exceed 5 days.<40 mg/day; ≤5 days

Formulary NSAID Alternatives

Step	Requirement	Formulary NSAID alternatives	Exception
1	Before ketorolac, trial and failure of at least 2 formulary NSAIDs available without prior authorization	Ibuprofen; naproxen; indomethacin; sulindac; celecoxib	Not required when treating kidney stones

Ketorolac Quantity and Duration Limits

Ketorolac tablets

Coverage limitLess than 40 mg/day

Labeled maximum40 mg/day

Labeled dosing20 mg followed by 10 mg every 4 to 6 hours as needed

Ketorolac

Maximum combined duration5 days

Included routesParenteral, oral, and nasal ketorolac therapy

Duration ruleThe total combined duration of ketorolac tablets and injection, including nasal therapy, must not exceed 5 days

Applicable Site of Care

Note

Confirm the site of care

This policy applies only to oral ketorolac tablets prescribed for outpatient use. Injectable ketorolac administered at the provider office is not included in this drug use criteria for coverage.

Policy Summary

PayerAdvanced Health

PolicyKetorolac Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for oral ketorolac tablets prescribed for outpatient use.

SourceLink

On This Page

Formulary NSAID step therapy

Required trialTrial and failure of at least 2 formulary NSAIDs available without prior authorization

Kidney stone exceptionThe NSAID trial requirement does not apply when treatment is for kidney stones

Formulary alternativesIbuprofen, naproxen, indomethacin, sulindac, and celecoxib

Documentation Required

Clinical Eligibility Documentation

Provide clinical documentation supporting coverage eligibility and the requested use of ketorolac.

Funded condition eligible for Oregon Health Plan coverage, if applicable.
Member age 20 years or younger, if applicable.
Qualifying comorbid condition that allows coverage, if applicable.
Whether the medication is being used to treat kidney stones.
Results of trials and failures of at least two formulary NSAIDs when required.

Documentation Required

Dose, Duration, and Safety Documentation

Document the requested dose, treatment duration, and that no contraindications to ketorolac therapy exist. The request must remain within labeled dosing and duration limits.

Recommended oral regimen: 20 mg initially, followed by 10 mg every 4 to 6 hours as needed.
Maximum dose: less than 40 mg/day under the coverage criterion; labeled maximum is 40 mg/day.
Maximum duration: 5 days, including combined parenteral, oral, and nasal ketorolac use.
Include documentation addressing contraindications to therapy.

Denial Risk

Coverage Eligibility and NSAID Trial Denial Risks

Requests may be denied when coverage eligibility or required NSAID step therapy is not established.

Deny below the line when the condition is not funded by the Oregon Health Plan and no qualifying coverage pathway applies.
Deny when the member is over 20 and lacks a qualifying comorbid condition, when applicable to the request.
Deny for indications other than kidney stones when at least two formulary NSAIDs have not been trialed and failed.
Recommend formulary alternatives available without prior authorization when the NSAID trial requirement is not met.

Denial Risk

Dose, Duration, and Safety Limits

Deny requests that exceed the dose or duration limits or that document contraindications to therapy.

Dose at or above 40 mg/day does not meet the criterion requiring a dose less than 40 mg/day.
Duration exceeding 5 days does not meet criteria; the 5-day limit applies to combined parenteral, oral, and nasal use.
Deny when contraindications to ketorolac therapy exist.

Denial Risk

Off-Label or Noncovered Use

Ketorolac coverage is limited to labeled short-term acute-pain use. Off-label use is not a covered Oregon Health Plan benefit, and ketorolac is not indicated for pediatric patients or minor or chronic painful conditions.

FDA-approved use is short-term (5 days or less) management of moderate to severe acute pain requiring opioid-level analgesia.
Oral ketorolac is indicated only as continuation treatment following intravenous or intramuscular ketorolac, if necessary.
The total combined duration of ketorolac tablets and injection must not exceed 5 days.
Do not request coverage for minor or chronic painful conditions, pediatric use, or other off-label indications.
Increasing the dose beyond labeled recommendations does not improve efficacy and increases the risk of serious adverse events.

No contraindications: No listed contraindication to ketorolac therapy exists.