Lamictal is a brand name drug containing the active ingredient lamotrigine, which is used as an adjunctive therapy to treat partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients aged 2 or older. It is available in several forms including tablets, chewable dispersible tablets, orally disintegrating tablets, and patient titration kits. The document provides dosage forms and strengths, illustrations, information on protected drug classes and Medicare criteria, state-specific requirements for commercial Lamictal brand, and quiz questions about Lamictal and its generic equivalent lamotrigine.
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
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?