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LAMICTALLAMICTAL
By: Patti WilsonBy: Patti Wilson
What is Epilepsy?What is Epilepsy?
• Epilepsy is a disorder of the brain's electrical
system. Abnormal electrical impulses cause
brief changes in movement, behavior, sensation,
or awareness. These interruptions, known as
seizures, may last from a few seconds to a few
minutes. People who have had two or more
seizures are considered to have epilepsy.
EpilepsyEpilepsy
• LAMICTAL is indicated as adjunctive* therapy for the
following seizure types in patients ≥ 2 years of age:
– partial seizures
– primary generalized tonic-clonic seizures
– generalized seizures of Lennox-Gastaut syndrome
* An additional substance
HOW SUPPLIEDHOW SUPPLIED
Dosage Forms And StrengthsDosage Forms And Strengths
Tablets - 25 mg (NDC 0173-0633-02).
100 mg (NDC 0173-0642-55).
150 mg (NDC 0173-0643-60).
200 mg (NDC 0173-0644-60).
Chewable Dispersible Tablets
2 mg (NDC 0173-0644-60).
5 mg (NDC 0173-0526-00).
25 mg (NDC 0173-0527-00).
Orally Disintegrating Tablets
25mg (NDC 0173-0772-02)
50mg (NDC 0173-0774-02)
100mg (NDC 0173-0776-02)
200mg (NDC 0173-0777-02)
An illustration of a SeizureAn illustration of a Seizure
The Six Protected Drug ClassesThe Six Protected Drug Classes
• ANTIPSYCHOTICS
• ANTIRETROVIRAL
• ANTINEOPLASTICS
• ANTICONVULSANTS *
• ANTIDEPRESSANTS
• IMMUNOSUPPRESSANTS
*Lamictal is an Anticonvulsant
MEDICARE NSO CRITERIAMEDICARE NSO CRITERIA
• Precert, Quantity and STEP apply to New Starts
• Member has been a Medicare Part D member
for 91 days or longer
• Member is taking medication for 1st
time
• Member is currently on medication and has
taken the medication for at least 1 day within the
last 120 days
Applies to Lamictal ODT
•LAMICTAL ODT (lamotrigine) Patient
Titration Kit for Patients Taking
Valproate (Blue ODT Kit)
25 mg, 50 mg blisterpack of 28
tablets (21/25-mg tablets and 7/50-
mg tablets) (NDC 0173-0779-00).
•LAMICTAL ODT (lamotrigine)
Patient Titration Kit for Patients Not
Taking Carbamazepine, Phenytoin,
Phenobarbital, Primidone, or
Valproate (Orange ODT Kit)
(14/25-mg tablets, 14/50-mg tablets,
and 7/100-mg tablets) (NDC 0173
-0778-00).
•LAMICTAL ODT (lamotrigine) Patient
Titration Kit for Patients Taking
Carbamazepine, Phenytoin, Phenobarbital,
or Primidone and Not Taking Valproate
(Green ODT Kit ) blisterpack of 56 tablets
(42/50-mg tablets and 14/100-mg tablets)
(NDC 0173-0780-00).
For Commercial Lamictal BRAND only:For Commercial Lamictal BRAND only:
For Illinois, Utah, Hawaii and Tennessee members Only:
As of 8-5-08, per state of Tennessee mandate and state of Hawaii mandate,
and as of 3-1-09, per state of Illinois mandate and state of Utah mandated,
Lamictal brand is approvable if:
•
• Member has documented diagnosis of Epilepsy/seizure AND
• Member has a documented/confirmed Tennessee, Hawaii, Illinois or Utah
address OR contract state is Tennessee, Hawaii, Illinois, or Utah.
• Maximum Time of Approval of Lamictal/ODT/XR including kits -1 year
Lamictal 2mg Chew Covered Base/Closed Plan for LACMITAL
Lamictal ODT
Lamictal ODT
STEP
MEx
A documented trial of one month of generic Lamotrigine.
A documented contrindication or Intolerance or Allergy or Failure of one month of generic
Lamotrigine.
Lamictal Tab; Chew; Kit MEx
for NC
New Starts -A documented Contraindication or Intolerance or Allergy or Failure of one
month each of two covered(C) alternatives, one of which must be the drug's generic equivalent or
a generic therapeutic equivalent AND one of the following-carbamazepine, Epitol, ethosuximide,
gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenytoin, primidone, valproic acid,
zonisamide, Celontin, divalproex sodium, divalproex sodium ER, topiramate
Those who have previously take or are currently on med for at least one
day in 120 days - A documented Contraindication or Intolerance or Allergy or Failure of one
month of the drug's generic equivalent
Lamictal ODT Kit MEx for
NC
A documented Contraindication or Intolerance or Allergy or Failure of one month each of two
covered(C) alternatives, one of which must be generic lamotrigine AND one of the following-
carbamazepine, Epitol, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine,
phenytoin, primidone, valproic acid, zonisamide, Celontin, divalproex sodium, divalproex sodium
ER, topiramate
Lamictal XR MEx for
NC
New Starts -A documented Contraindication or Intolerance or Allergy or Failure of one
month each of two covered(C) alternatives, one of which must be the drug's generic equivalent or
a generic therapeutic equivalent AND one of the following-carbamazepine, Epitol, ethosuximide,
gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenytoin, primidone, valproic acid,
zonisamide, Celontin, divalproex sodium, divalproex sodium ER, topiramate
Those who have previously take or are currently on med for at least one
day in 120 days - A documented Contraindication or Intolerance or Allergy or Failure of one
month of the drug's generic equivalent
Lamictal XR Kit MEx
for NC
A documented Contraindication or Intolerance or Allergy or Failure of one month each of two
covered(C) alternatives, one of which must be generic lamotrigine AND one of the following-
carbamazepine, Epitol, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine,
phenytoin, primidone, valproic acid, zonisamide, Celontin, divalproex sodium, divalproex sodium
ER, topiramate
Quiz QuestionsQuiz Questions
• 1. What is the generic to Lamictal?
• 2. True or False: The maximum time of approval for Commercial Members who live
in Tennessee, Hawaii, Illinois and Utah is 'Indefinite'
• 3. If a Member requesting Lamictal tablets has been stable on Lamictal tablets since
April 24, 2012, and has tried Lamotrigine tablets, which Criteria should be used?
• 4. If one is prone to seizures which medication should be kept (where it is easily
attainable) : Lamictal capsules or Lamotrigine capsules?
FINFIN

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LAMICTAL

  • 2. What is Epilepsy?What is Epilepsy? • Epilepsy is a disorder of the brain's electrical system. Abnormal electrical impulses cause brief changes in movement, behavior, sensation, or awareness. These interruptions, known as seizures, may last from a few seconds to a few minutes. People who have had two or more seizures are considered to have epilepsy.
  • 3. EpilepsyEpilepsy • LAMICTAL is indicated as adjunctive* therapy for the following seizure types in patients ≥ 2 years of age: – partial seizures – primary generalized tonic-clonic seizures – generalized seizures of Lennox-Gastaut syndrome * An additional substance
  • 4. HOW SUPPLIEDHOW SUPPLIED Dosage Forms And StrengthsDosage Forms And Strengths Tablets - 25 mg (NDC 0173-0633-02). 100 mg (NDC 0173-0642-55). 150 mg (NDC 0173-0643-60). 200 mg (NDC 0173-0644-60). Chewable Dispersible Tablets 2 mg (NDC 0173-0644-60). 5 mg (NDC 0173-0526-00). 25 mg (NDC 0173-0527-00). Orally Disintegrating Tablets 25mg (NDC 0173-0772-02) 50mg (NDC 0173-0774-02) 100mg (NDC 0173-0776-02) 200mg (NDC 0173-0777-02)
  • 5. An illustration of a SeizureAn illustration of a Seizure
  • 6. The Six Protected Drug ClassesThe Six Protected Drug Classes • ANTIPSYCHOTICS • ANTIRETROVIRAL • ANTINEOPLASTICS • ANTICONVULSANTS * • ANTIDEPRESSANTS • IMMUNOSUPPRESSANTS *Lamictal is an Anticonvulsant
  • 7. MEDICARE NSO CRITERIAMEDICARE NSO CRITERIA • Precert, Quantity and STEP apply to New Starts • Member has been a Medicare Part D member for 91 days or longer • Member is taking medication for 1st time • Member is currently on medication and has taken the medication for at least 1 day within the last 120 days Applies to Lamictal ODT
  • 8. •LAMICTAL ODT (lamotrigine) Patient Titration Kit for Patients Taking Valproate (Blue ODT Kit) 25 mg, 50 mg blisterpack of 28 tablets (21/25-mg tablets and 7/50- mg tablets) (NDC 0173-0779-00). •LAMICTAL ODT (lamotrigine) Patient Titration Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate (Orange ODT Kit) (14/25-mg tablets, 14/50-mg tablets, and 7/100-mg tablets) (NDC 0173 -0778-00). •LAMICTAL ODT (lamotrigine) Patient Titration Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate (Green ODT Kit ) blisterpack of 56 tablets (42/50-mg tablets and 14/100-mg tablets) (NDC 0173-0780-00).
  • 9. For Commercial Lamictal BRAND only:For Commercial Lamictal BRAND only: For Illinois, Utah, Hawaii and Tennessee members Only: As of 8-5-08, per state of Tennessee mandate and state of Hawaii mandate, and as of 3-1-09, per state of Illinois mandate and state of Utah mandated, Lamictal brand is approvable if: • • Member has documented diagnosis of Epilepsy/seizure AND • Member has a documented/confirmed Tennessee, Hawaii, Illinois or Utah address OR contract state is Tennessee, Hawaii, Illinois, or Utah. • Maximum Time of Approval of Lamictal/ODT/XR including kits -1 year
  • 10. Lamictal 2mg Chew Covered Base/Closed Plan for LACMITAL Lamictal ODT Lamictal ODT STEP MEx A documented trial of one month of generic Lamotrigine. A documented contrindication or Intolerance or Allergy or Failure of one month of generic Lamotrigine. Lamictal Tab; Chew; Kit MEx for NC New Starts -A documented Contraindication or Intolerance or Allergy or Failure of one month each of two covered(C) alternatives, one of which must be the drug's generic equivalent or a generic therapeutic equivalent AND one of the following-carbamazepine, Epitol, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenytoin, primidone, valproic acid, zonisamide, Celontin, divalproex sodium, divalproex sodium ER, topiramate Those who have previously take or are currently on med for at least one day in 120 days - A documented Contraindication or Intolerance or Allergy or Failure of one month of the drug's generic equivalent Lamictal ODT Kit MEx for NC A documented Contraindication or Intolerance or Allergy or Failure of one month each of two covered(C) alternatives, one of which must be generic lamotrigine AND one of the following- carbamazepine, Epitol, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenytoin, primidone, valproic acid, zonisamide, Celontin, divalproex sodium, divalproex sodium ER, topiramate Lamictal XR MEx for NC New Starts -A documented Contraindication or Intolerance or Allergy or Failure of one month each of two covered(C) alternatives, one of which must be the drug's generic equivalent or a generic therapeutic equivalent AND one of the following-carbamazepine, Epitol, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenytoin, primidone, valproic acid, zonisamide, Celontin, divalproex sodium, divalproex sodium ER, topiramate Those who have previously take or are currently on med for at least one day in 120 days - A documented Contraindication or Intolerance or Allergy or Failure of one month of the drug's generic equivalent Lamictal XR Kit MEx for NC A documented Contraindication or Intolerance or Allergy or Failure of one month each of two covered(C) alternatives, one of which must be generic lamotrigine AND one of the following- carbamazepine, Epitol, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenytoin, primidone, valproic acid, zonisamide, Celontin, divalproex sodium, divalproex sodium ER, topiramate
  • 11. Quiz QuestionsQuiz Questions • 1. What is the generic to Lamictal? • 2. True or False: The maximum time of approval for Commercial Members who live in Tennessee, Hawaii, Illinois and Utah is 'Indefinite' • 3. If a Member requesting Lamictal tablets has been stable on Lamictal tablets since April 24, 2012, and has tried Lamotrigine tablets, which Criteria should be used? • 4. If one is prone to seizures which medication should be kept (where it is easily attainable) : Lamictal capsules or Lamotrigine capsules?