Download Strattera

MEDICAL NECESSITY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: atomoxetine
(Strattera®)
PAGE: 1 of 7
REFERENCE NUMBER: CP.PMN.01
EFFECTIVE DATE: 09/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED: 02/14
PRODUCT TYPE: Medicaid
REVISED: 04/07, 02/08, 11/09,
02/11, 02/12, 02/13, 02/14
IMPORTANT REMINDER
This Clinical Policy has been developed by appropriately experienced and licensed health care
professionals based on a thorough review and consideration of generally accepted standards of
medical practice, peer-reviewed medical literature, government agency/program approval
status, and other indicia of medical necessity.
The purpose of this Clinical Policy is to provide a guide to medical necessity. Benefit
determinations should be based in all cases on the applicable contract provisions governing
plan benefits (“Benefit Plan Contract”) and applicable state and federal requirements, as well as
applicable plan-level administrative policies and procedures. To the extent there are any
conflicts between this Clinical Policy and the Benefit Plan Contract provisions, the Benefit Plan
Contract provisions will control.
Clinical policies are intended to be reflective of current scientific research and clinical thinking.
This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it
constitute a contract or guarantee regarding results. Providers are expected to exercise
professional medical judgment in providing the most appropriate care, and are solely
responsible for the medical advice and treatment of members.
Description: Strattera® is a selective norepinephrine reuptake inhibitor, a
non-stimulant that works differently from the other attentiondeficit/hyperactivity disorder medications available. The
precise mechanism by which atomoxetine produces its
therapeutic effects in Attention-Deficit/Hyperactivity Disorder
(ADHD/ADD) is unknown, but is thought to be related to
selective inhibition of the pre-synaptic norepinephrine
transporter, as determined in ex vivo uptake and
neurotransmitter depletion studies.
Brand:
atomoxetine (Strattera®): 10mg, 18mg 25mg, 40mg, 60mg,
80mg, and 100mg capsules
FDA
Labeled
Indications:
For the treatment of Attention-Deficit/Hyperactivity Disorder
(ADHD) and Attention Deficit Disorder (ADD) in pediatric,
adolescent and adult patients.
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.
MEDICAL NECESSITY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: atomoxetine
(Strattera®)
PAGE: 2 of 7
REFERENCE NUMBER: CP.PMN.01
EFFECTIVE DATE: 09/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED: 02/14
PRODUCT TYPE: Medicaid
REVISED: 04/07, 02/08, 11/09,
02/11, 02/12, 02/13, 02/14
Criteria for
Approval:
For patients who are ≥ 6 years old:
Physician’s documentation that the patient has:
A. Met the DSM-IV criteria for ADHD/ADD (see section “DSM
IV Diagnostic Criteria for ADHD/ADD”); and
B. Failed or responded inadequately to behavioral management
therapy; and
C. Failure of, or intolerance to, at least 2 PDL stimulants, at
maximized doses, unless contraindicated; and
D. Member will be trialed on atomoxetine mono-therapy for a
period of at least two months before dual therapy will be
approved; or
E. Member history of active substance abuse (within last 2
years) or active substance abuse in parent/guardian of
member.
For patients who are > 18 years old (not sufficiently studied in
the geriatric population):
Physician’s documentation that the patient has:
A. A childhood history consistent with ADHD/ADD; and
B. Symptoms of hyperactivity and poor concentration, 2 of the
following:
 Extreme distractibility
 Hot temper
 Inability to complete tasks and disorganization
 Stress intolerance
 Impulsivity; and
C. Been ruled out for hyperthyroidism, petit mal and partial
complex seizures and history of head injury (disease states
that may mimic ADHD/ADD); and
D. Failure of, or intolerance to, at lease 2 PDL stimulants, at
maximized doses, unless contraindicated; or
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.
MEDICAL NECESSITY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: atomoxetine
(Strattera®)
PAGE: 3 of 7
REFERENCE NUMBER: CP.PMN.01
EFFECTIVE DATE: 09/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED: 02/14
PRODUCT TYPE: Medicaid
REVISED: 04/07, 02/08, 11/09,
02/11, 02/12, 02/13, 02/14
E. Member history of active substance abuse (within last 2
years); and
F. Member will be trialed on atomoxetine mono-therapy for a
period of at least two months. Dual therapy with stimulants
requires use of immediate-release formulations.
DSM IV
Diagnostic
Criteria for
ADHD/ADD:
The specific etiology of ADHD/ADD is unknown, and there is
no single diagnostic test. Diagnosis requires the use of not only
medical, but psychological, educational, and social evaluations.
Other primary psychiatric diagnoses must be ruled out.
The clinician must balance the risks of medication, the risks of
the untreated disorder, and the expected benefits of medication
relative to other treatment options.
A. Either 1 or 2:
1. Six (or more) of the following symptoms of inattention
have persisted for at least six months to a degree that
is maladaptive and inconsistent with developmental
level:
a. Often fails to give close attention to details or
makes careless mistakes in schoolwork, work or
other activities
b. Often has difficulty sustaining attention in
tasks or play activities
c. Often does not seem to listen when spoken to
directly
d. Often does not follow though on instructions
and fails to finish schoolwork, chores, or duties
in the workplace (not due to oppositional
behavior or failure to understand instructions)
e. Often has difficulty organizing tasks and
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.
MEDICAL NECESSITY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: atomoxetine
(Strattera®)
PAGE: 4 of 7
REFERENCE NUMBER: CP.PMN.01
EFFECTIVE DATE: 09/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED: 02/14
PRODUCT TYPE: Medicaid
REVISED: 04/07, 02/08, 11/09,
02/11, 02/12, 02/13, 02/14
activities
f. Often avoids, dislikes or is reluctant to engage
in tasks that require sustained mental effort
(such as school work or homework)
g. Often loses things necessary for tasks or
activities (e.g. toys, school assignments, pencils,
books, or tools)
h. Is often easily distracted by extraneous stimuli
i. Is often forgetful in daily activities
2. Six (or more) of the following symptoms of
hyperactivity-impulsivity have persisted for at least six
months to a degree that is maladaptive and
inconsistent with developmental level:
Hyperactivity
a. Often fidgets with hands or feet or squirms in
seat
b. Often leaves seat in classroom or in other
situations in which remaining seated is
expected
c. Often runs about or climbs excessively in
situations in which it is inappropriate (in
adolescents or adults, may be limited to
subjective feelings of restlessness)
d. Often has difficulty playing or engaging in
leisure activities quietly
e. Is often “on the go” or often acts as if “driven by
a motor”
f. Often talks excessively
g. Impulsivity
h. Often blurts out answers before questions have
been completed
i. Often has difficulty awaiting turn
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.
MEDICAL NECESSITY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: atomoxetine
(Strattera®)
PAGE: 5 of 7
REFERENCE NUMBER: CP.PMN.01
EFFECTIVE DATE: 09/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED: 02/14
PRODUCT TYPE: Medicaid
REVISED: 04/07, 02/08, 11/09,
02/11, 02/12, 02/13, 02/14
j. Often interrupts or intrudes on others (e.g.
butts into conversations or games)
B. Some hyperactive-impulsive or inattentive symptoms that
caused impairment were present before age 7 years
C. Some impairment from the symptoms is present in two or
more settings (e.g. at school [or work] and at home
D. There must be clear evidence of clinically significant
impairment in social, academic, or occupational functioning
Adapted from the Diagnostic and statistical manual of mental
disorders. 5th ed. Arlington, VA.: American Psychiatric
Association, 2013.
Approval:
Initial Approval: 12 months.
Continued Approval: 12 months.
Special Instructions
 See prescribing information for dosing and precautions.
 Not FDA approved for major depressive disorder.
 Atomoxetine increased the risk of suicidal ideation in short-term studies in
pediatric patients with ADHD/ADD. This risk must be balanced with the
clinical need and the patient must be followed closely for suicidality,
clinical worsening or unusual changes in behavior.
 Not recommended in patients with narrow angle glaucoma.
 Pregnancy Category C risk.
References:
1. Strattera® prescribing information. Eli Lily & Co. Accessed
01/2014. http://pi.lilly.com/us/strattera-ppi.pdf
2. American Academy of Child and Adolescent Psychiatry
(2007), Practice Parameter for the Assessment and
Treatment of Children and Adolescents With AttentionDeficit/Hyperactivity Disorder. Accessed 01/2014.
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.
MEDICAL NECESSITY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: atomoxetine
(Strattera®)
PAGE: 6 of 7
REFERENCE NUMBER: CP.PMN.01
EFFECTIVE DATE: 09/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED: 02/14
PRODUCT TYPE: Medicaid
REVISED: 04/07, 02/08, 11/09,
02/11, 02/12, 02/13, 02/14
http://download.journals.elsevierhealth.com/pdfs/journals
/0890-8567/PIIS0890856709621821.pdf
3. CDC. Accessed 01/2014.
http://www.cdc.gov/ncbddd/adhd/index.html
http://www.cdc.gov/ncbddd/adhd/diagnosis.html
4. American Academy of Pediatrics subcommittee on attentiondeficit/hyperactivity disorder, steering committee on quality
improvement and management. ADHD: clinical practice
guideline for the diagnosis, evaluation, and treatment of
attention-deficit/hyperactivity disorder in children and
adolescents. Pediatrics 2011;128(5):1007-1022.
Revision Log
Revision
Add the following to “Criteria for Approval”: “d. Member history of
active substance abuse (within last 2 years) or active substance
abuse in parent/guardian of member”.
Add the “adolescent” to the “FDA Labeled Indications” section.
Add “or” after “d.” in the “Criteria for Approval” section for
“Patients who are > 18 years old”.
Add the following after item “d.” in the “Criteria for Approval”
section for “Patients who are > 18 years old”: “e. Member history
of active substance abuse (within the last 2 years)”.
Added “and” to the end of “Criteria for Approval” item “c” under
the “For patients who are > 6 years old (not sufficiently studied in
patients < 6 years old): Physician’s documentation that the
patient has:” section.
Added the following to the “Criteria for Approval” under the
section “For patients who are > 6 years old (not sufficiently
studied in patients < 6 years old): Physician’s documentation
that the patient has:” section: “Member will be trialed on monotherapy for a period of at least two months before dual therapy
Date
04/07
02/08
02/08
02/08
11/09
11/09
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.
MEDICAL NECESSITY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: atomoxetine
(Strattera®)
PAGE: 7 of 7
REFERENCE NUMBER: CP.PMN.01
EFFECTIVE DATE: 09/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED: 02/14
PRODUCT TYPE: Medicaid
REVISED: 04/07, 02/08, 11/09,
02/11, 02/12, 02/13, 02/14
will be approved, or”.
Added the following to the “Criteria for Approval” under the
section “For patients who are > 18 years old (not sufficiently
studied in the geriatric population): Physician’s documentation
that the patient has:” section: “Member will be trialed on monotherapy for a period of at least two months before dual therapy
will be approved, or”.
Added the following to the “Special Instructions” section: “See
prescribing information for dosing and precautions.”
Prior stimulant therapy specified as maximized dosing.
Added ADD as a separate DSM-IV condition.
References updated to reflect current literature search.
References updated to reflect current literature search.
References updated to reflect current literature search.
References updated to reflect current literature
No Changes
11/09
11/09
02/11
02/11
02/11
02/12
02/13
02/14
02/14
POLICY AND PROCEDURE APPROVAL
Pharmacy & Therapeutics Committee:
Approval on file
V.P., Pharmacy Operations:
Approval on file
Sr. V.P., Chief Medical Officer:
Approval on file
Centene Medical Policy Statements represent technical documents developed by the Medical
Management Staff. Questions regarding interpretation of these policies for the purposes of
benefit coverage should be directed to a Medical Management Staff person.