PRIOR AUTHORIZATION GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: oxycodone SR
(Oxycontin®)
PAGE: 1 of 4
REFERENCE NUMBER: NH.PPA.04
EFFECTIVE DATE: 09/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED: 02/14, 02/15
PRODUCT TYPE: Medicaid
REVISED: 02/08, 05/08, 02/10,
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: Oxycodone is a pure agonist opioid whose principal therapeutic
action is analgesia. It is a Schedule II controlled substance with
a high abuse liability requiring a black box warning.
Brand:
oxycodone SR (Oxycontin®): 10, 15, 20, 30, 40, 60, and 80mg
controlled release tablets
FDA
Labeled
Indications:
The management of severe chronic pain when continuous,
around-the-clock analgesia is needed for an extended period of
time.
Criteria for
Approval:
A. Documented severe chronic pain requiring around-the-clock
analgesia, and
B. Trial and failure of, or intolerance to, two PDL long-acting
narcotic analgesics at maximum doses (defined as MS
Contin at 400 mg/day, fentanyl patches 100 mcg/hr 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.
PRIOR AUTHORIZATION GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: oxycodone SR
(Oxycontin®)
PAGE: 2 of 4
REFERENCE NUMBER: NH.PPA.04
EFFECTIVE DATE: 09/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED: 02/14, 02/15
PRODUCT TYPE: Medicaid
REVISED: 02/08, 05/08, 02/10,
02/11, 02/12, 02/13, 02/14
methadone at 60 mg/day), in combination with short-acting
narcotic analgesics for break-through pain, and
C. Adherent use of adjunctive pain treatment, consistent with
first line treatment of chronic pain. Ancillary treatment may
include acetaminophen, NSAIDs, anticonvulsants, or
antidepressants as their use may apply to the member’s
condition. OR
D. Member is hospice or end of life
Approval:






Initial Approval: 6 months. Quantity limit: 2 per day; Approved
only for once-daily (QD) or twice-daily (BID) dosing; no prn use.
Continued Approval: 12 months. Quantity limit: 2 per day;
Approved only for once-daily (QD) or twice-daily (BID); no prn
use.
Special Instructions
Safety and efficacy not established in children so not to be used in this
population.
80mg tablets should only be used in opioid-exposed patients as they may
cause fatal respiratory depression.
Tablets must not be broken, crushed, split….may result in rapid release
and absorption of potentially fatal dose of oxycodone.
The occurrence of nausea and vomiting while on PDL long acting narcotics
without the use of anti-emetics will not be considered a treatment failure
due to adverse effects and will require the trial of PDL anti-emetics to
mitigate this opioid class-wide adverse effect.
Oxycontin pharmacokinetic profile exhibits a biphasic absorption pattern
with two absorption half-lives of 0.6 and 6.9 hours, which coordinates with
the initial release of oxycodone from the tablet followed by a prolonged
release. Dosing more often than designed creates a spike in Oxycontin
levels resulting in an undesired euphoric effect in patients.
Routinely monitor patients for signs of abuse, misuse, and addiction.
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.
PRIOR AUTHORIZATION GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: oxycodone SR
(Oxycontin®)
PAGE: 3 of 4
REFERENCE NUMBER: NH.PPA.04
EFFECTIVE DATE: 09/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED: 02/14, 02/15
PRODUCT TYPE: Medicaid
REVISED: 02/08, 05/08, 02/10,
02/11, 02/12, 02/13, 02/14
References:
1. OxyContin® prescribing information. Accessed January,
2015.
http://www.purduepharma.com/pressroom/news/Oxyconti
nPI.pdf
2. Prescription Drug: Oxycontin® Abuse and Diversion Efforts
to Address the Problem, US General Accountant Office, Dec
2003. http://www.gao.gov/new.items/d04110.pdf
Revision Log
Revision
Add 15mg, 30mg, 60mg strengths of oxycodone SR and omit
the 160mg strength.
Add “and” after “Criteria for Approval” item “a.”. Delete
“failure or intolerance to one long-acting analgesics on PDL”
from item “b.”. Add item “c.” “Failure or intolerance to two
long-acting analgesics on the PDL, and”.
Delete 160mg strength.
Criteria changed to be consistent with the prior authorization
criteria for fentanyl patches.
Updated reference section to reflect current literature search.
Removed specialty prescribing (pain management, oncologist)
requirement. Defined maximum dosing of MS Contin and
methadone.
Updated reference section to reflect current literature search.
Added fentanyl patches as a PDL “trials and failures” option.
Added anticonvulsants and antidepressants as options for
ancillary pain treatment.
Updated reference section to reflect current literature search.
Updated reference section to reflect current literature search.
Updated reference section to reflect current literature search.
Updated reference section to reflect current literature search.
Date
02/08
02/08
05/08
02/10
02/10
02/11
02/11
02/12
02/12
02/12
02/13
02/14
02/15
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.
PRIOR AUTHORIZATION GUIDELINE
DEPARTMENT: Pharmacy
DOCUMENT NAME: oxycodone SR
(Oxycontin®)
PAGE: 4 of 4
REFERENCE NUMBER: NH.PPA.04
EFFECTIVE DATE: 09/06
REPLACES DOCUMENT:
RETIRED:
REVIEWED: 02/14, 02/15
PRODUCT TYPE: Medicaid
REVISED: 02/08, 05/08, 02/10,
02/11, 02/12, 02/13, 02/14
Added hospice or end of life as a requirement for approval
06/15
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
NOTE: The electronic approval is retained in Compliance 360.
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.