Download Sedative Hypnotics

STEP THERAPY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: Sedative
Hypnotics
PAGE: 1 of 4
REFERENCE NUMBER: CP.PST.XX
EFFECTIVE DATE: 12/14
REPLACES DOCUMENT:
CP.PMN.44
RETIRED:
REVIEWED: 12/14
PRODUCT TYPE: All
REVISED:
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:
This step therapy guideline outlines the process by which
non-PDL sedative/hypnotics may be granted coverage under
the plan.
Medications
covered in
policy:
Edluar (zolpidem): 5 mg, 10 mg sublingual tablets
Intermezzo (zolpidem): 1.75 mg, 3.5 mg sublingual tablets
Rozerem (ramelteon): 8 mg tablet
Silenor (doxepin): 3 mg, 6 mg tablets
zolpidem CR: 6.25 mg, 12.5 mg tablets
Zolpimist (zolpidem): oral spray 5mg/ACT
flurazepam: 7.5 mg, 22.5 mg capsules
Doral (quazepam): 15mg tablets
Somnote (chloral hydrate): 500 mg capsules
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.
STEP THERAPY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: Sedative
Hypnotics
PAGE: 2 of 4
REFERENCE NUMBER: CP.PST.XX
EFFECTIVE DATE: 12/14
REPLACES DOCUMENT:
CP.PMN.44
RETIRED:
REVIEWED: 12/14
PRODUCT TYPE: All
REVISED:
Criteria for
Approval:
A. This policy will be carried out through electronic steptherapy edits. For the therapy to be approved, the patient
must be Age ≥ 18 years
B. Approval of non-PDL sedative/hypnotics will require
documented failure, up to maximum indicated doses, of a
14 day trial for each of 2 PDL alternatives for sleep (e.g.
zolpidem, zaleplon, temazepam, etc.)
Approval:
Initial Approval: 3 months.
NOTE: Maximum approval period for Somnote is two weeks.
Continued Approval: 6 months if patient continues to
remain on mono-therapy.
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Special Instructions
A variety of cognitive and behavior changes have been reported to occur in
association with the use of hypnotics. In primarily depressed patients,
worsening of depression (including suicidal ideation and completed
suicides) has been reported in association with the use of hypnotics.
Safety and effectiveness of sedative/hypnotics in children have not been
established.
Caution should be used when using sedative/hypnotics in patients with
severe liver impairment. Dosing reductions are advised.
Sedative/hypnotics should be ingested just before bedtime. Caution
patients against engaging in hazardous activities requiring complete mental
alertness or motor coordination (eg, driving a motor vehicle, operating
machinery) after ingesting the drug.
Flurazepam, Temazepam, Triazolam, and Quazepam (Doral®) are classified
in FDA pregnancy risk category X and should not be used during
pregnancy; All other PDL/non-PDL sedative hypnotics listed are classified
in FDA pregnancy risk category C.
Due to gender differences in the elimination of zolpidem, FDA recommends
a lower initial dose in women.
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.
STEP THERAPY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: Sedative
Hypnotics
PAGE: 3 of 4
REFERENCE NUMBER: CP.PST.XX
EFFECTIVE DATE: 12/14
REPLACES DOCUMENT:
CP.PMN.44
RETIRED:
REVIEWED: 12/14
PRODUCT TYPE: All
REVISED:
References:
1. Rozerem® prescribing information.
http://www.rozeremhcp.com, Accessed September 2014
2. Zaleplon monograph. Clinical Pharmacology. Accessed
September 2014.
3. Sonata® prescribing information.
http://www.pfizer.com/products/rx/rx_product_sonata.
jsp, Accessed Sept 2014
4. Zolpidem monograph. Clinical Pharmacology. Accessed
September 2014.
5. Ambien® prescribing information.
http://products.sanofi-aventis.us/ambien/ambien.pdf,
Accessed Sept. 2014.
6. Intermezzo® prescribing information.
http://www.accessdata.fda.gov/drugsatfda_docs/label/
2011/022328lbl.pdf, Accessed Oct. 2014.
7. Lunesta® prescribing information.
http://www.lunesta.com/PostedApprovedLabelingText.p
df. Accessed Oct. 2014.
8. FDA Drug Safety Communication: FDA requires lower
recommended doses for certain drugs containing
zolpidem.
http://www.fda.gov/Drugs/DrugSafety/ucm334033.ht
m. Accessed September 2014.
Revision Log
Revision
Date
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.
STEP THERAPY GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: Sedative
Hypnotics
PAGE: 4 of 4
REFERENCE NUMBER: CP.PST.XX
EFFECTIVE DATE: 12/14
REPLACES DOCUMENT:
CP.PMN.44
RETIRED:
REVIEWED: 12/14
PRODUCT TYPE: All
REVISED:
Created step-therapy policy
12/14
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.