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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 |
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:
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:
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:
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