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ph-1077

Topiramate ER Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1077

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
07-01-2024	10-01-2018

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Qudexy XR® (topiramate ER)* Capsules	Epilepsy: Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age or older Preventative treatment of migraine in patients 12 years of age and older	* generic available	1
Trokendi XR® (topiramate ER)* Capsules	Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older; adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox Gastaut syndrome in patients 6 years of age and older Preventative treatment of migraine in patients 12 years of age and older	* generic available	2

Agent(s)

FDA Indication(s)

Notes

Ref#

Qudexy XR®

(topiramate ER)*

Capsules

Epilepsy: Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age or older

Preventative treatment of migraine in patients 12 years of age and older

* generic available

Trokendi XR®

(topiramate ER)*

Capsules

Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older; adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox Gastaut syndrome in patients 6 years of age and older

Preventative treatment of migraine in patients 12 years of age and older

* generic available

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Safety

Qudexy XR has no FDA labeled contraindications for use.(1)

Trokendi XR is contraindicated in patients with recent alcohol use (i.e., within 6 hours prior to and 6 hours after Trokendi XR use).(2)

REFERENCES

Number	Reference
1	Qudexy XR prescribing information. Upsher-Smith Laboratories, LLC. December 2022.
2	Trokendi XR prescribing information. Supernus Pharmaceuticals Inc. October 2022.

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Available MSC	Final Age Limit	Preferred Status

Trokendi xr	topiramate cap er	100 MG ; 200 MG ; 25 MG ; 50 MG	M ; N ; O ; Y	O ; Y
Qudexy xr	topiramate cap er	100 MG ; 150 MG ; 200 MG ; 25 MG ; 50 MG	M ; N ; O ; Y	O ; Y

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

Qudexy xr	Topiramate Cap ER 24HR Sprinkle 100 MG	100 MG	30	Capsules	30	DAYS
Qudexy xr	Topiramate Cap ER 24HR Sprinkle 150 MG	150 MG	30	Capsules	30	DAYS
Qudexy xr	Topiramate Cap ER 24HR Sprinkle 200 MG	200 MG	60	Capsules	30	DAYS
Qudexy xr	Topiramate Cap ER 24HR Sprinkle 25 MG	25 MG	30	Capsules	30	DAYS
Qudexy xr	Topiramate Cap ER 24HR Sprinkle 50 MG	50 MG	30	Capsules	30	DAYS
Trokendi xr	Topiramate Cap ER 24HR 100 MG	100 MG	30	Capsules	30	DAYS
Trokendi xr	Topiramate Cap ER 24HR 200 MG	200 MG	60	Capsules	30	DAYS
Trokendi xr	Topiramate Cap ER 24HR 25 MG	25 MG	30	Capsules	30	DAYS
Trokendi xr	Topiramate Cap ER 24HR 50 MG	50 MG	30	Capsules	30	DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Qudexy xr	topiramate cap er	100 MG ; 150 MG ; 200 MG ; 25 MG ; 50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Trokendi xr	topiramate cap er	100 MG ; 200 MG ; 25 MG ; 50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Qudexy xr	Topiramate Cap ER 24HR Sprinkle 100 MG	100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Qudexy xr	Topiramate Cap ER 24HR Sprinkle 150 MG	150 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Qudexy xr	Topiramate Cap ER 24HR Sprinkle 200 MG	200 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Qudexy xr	Topiramate Cap ER 24HR Sprinkle 25 MG	25 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Qudexy xr	Topiramate Cap ER 24HR Sprinkle 50 MG	50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Trokendi xr	Topiramate Cap ER 24HR 100 MG	100 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Trokendi xr	Topiramate Cap ER 24HR 200 MG	200 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Trokendi xr	Topiramate Cap ER 24HR 25 MG	25 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Trokendi xr	Topiramate Cap ER 24HR 50 MG	50 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Initial Evaluation Target Agent(s) will be approved when ALL of the following are met: ONE of the following: The patient has been treated with an anti-seizure medication that is not topiramate OR The patient has ONE of the following diagnoses: Partial onset seizures OR Primary generalized tonic-clonic seizures OR Lennox-Gastaut Syndrome OR Migraine AND If the patient has an FDA labeled indication, then ONE of the following: The patient’s age is within FDA labeling for the requested indication for the requested agent OR The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met: The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND ONE of the following: The patient has a medication history of use of an anti-seizure medication that is not topiramate OR The patient has had clinical benefit with the requested agent AND The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Module

Clinical Criteria for Approval

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

ONE of the following:
1. The patient has been treated with an anti-seizure medication that is not topiramate OR
2. The patient has ONE of the following diagnoses:
  1. Partial onset seizures OR
  2. Primary generalized tonic-clonic seizures OR
  3. Lennox-Gastaut Syndrome OR
  4. Migraine AND
If the patient has an FDA labeled indication, then ONE of the following:
1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
ONE of the following:
1. The patient has a medication history of use of an anti-seizure medication that is not topiramate OR
2. The patient has had clinical benefit with the requested agent AND
The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR ALL of the following: The requested quantity (dose) exceeds the program quantity limit AND The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR ALL of the following: The requested quantity (dose) exceeds the program quantity limit AND The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication Length of Approval: up to 12 months

Module

Clinical Criteria for Approval

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

The requested quantity (dose) does NOT exceed the program quantity limit OR
ALL of the following:
1. The requested quantity (dose) exceeds the program quantity limit AND
2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
ALL of the following:
1. The requested quantity (dose) exceeds the program quantity limit AND
2. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
3. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

Commercial _ PS _ Topiramate_ER_PAQL _ProgSum_ 07-01-2024