Prior Auth Protocol

FDA Approved Indications:

For the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate

Health Net Approved Indications and Usage Guidelines:

Severe chronic pain for which there is a documented, objective etiology

AND

A treatment plan is required, including:

Diagnosis or conditions that are contributing to the pain
Pain intensity (scales or ratings)
Functional status (physical and psychosocial)
Patient's goal of therapy (level of pain acceptable and/or functional status)
Current analgesic (opioid and adjuvant) regimen
Current non-pharmacological treatment
Opioid-related side effects
Indications of medical misuse
Action plan if analgesic failure occurs

Coverage is Not Authorized For:

Acute or intermittent pain
Immediate post-surgical pain
Use in patients who require opioid analgesia for a short period of time
Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature

General Information:

Embeda 100 mg/4 mg capsules are for use in opioid-tolerant patients only
Opioid tolerant patients are those receiving for one week or longer, at least 60 mg PO morphine/day, 30 mg PO oxycodone/day, 8 mg PO hydromorphone/day or an equianalgesic dose of another opioid
Morphine sulfate extended-release (Avinza), Kadian, MS Contin, Oxycontin, Opana ER, Embeda and Duragesic are not indicated as an as-needed (prn) analgesic

EQUIANALGESIC OPIOID CHART⁸
Analgesic	IM (mg)	Oral (mg)
Morphine*	10	30
Fentanyl	0.1	-
Hydromorphone	1.5	7.5
Levorphanol	2	4
Methadone	10	20
Meperidine*	75	300
Oxycodone	-	20
Oxymorphone	1	-

*Adjust dose in renal impairment

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Morphine sulfate extended-release tablet (MS Contin^R)	Initial dose for opioid naive: 15 mg every 8 to 12 hours Conversion dosing is individualized based on previous analgesic therapy	100 and 200 mg tablets are reserved only for opioid-tolerant individuals
morphine sulfate extended-release capsule (Avinza^R)	Initial dose for opioid naive: 30 mg PO Q24 hours. May titrate in increments not greater than 30 mg every 3 to 4 days. Conversion dosing is individualized based on previous analgesic therapy	Maximum dose is 1600 mg/day due to fumaric acid which can result in serious renal toxicity. Avinza 90 mg and 120 mg capsules are for use only in opioid tolerant patients
Kadian^R (morphine sulfate extended-release capsule)	Begin treatment using an immediate release morphine formulation and then convert to Kadian.	Should not be given more frequently than every 12 hours Kadian 100 mg, 130 mg, 150 mg, and 200 mg are for use only in opioid-tolerant patients
Opana ER^R(oxymorphone hydrochloride extended-release tablet)	Initial dose for opioid naive: 5 mg PO every 12 hours Conversion dosing is individualized based on previous analgesic therapy	Dose should be individually titrated, preferably at increments of 5 10 mg every twelve hours every 3 7 days
Fentanyl transdermal system (Duragesic^R)	Initiate dose at one patch applied on intact skin every 72 hours. May increase following 3 days of therapy. Some patients may require dosing every 48 hours. Conversion dosing is individualized based on previous analgesic therapy	For use only in opioid-tolerant patients
Oxycontin^R(oxycodone hydrochloride controlled-release tablet)*	Initial dose for opioid naive: 10 mg PO twice daily. Conversion dosing is individualized based on previous analgesic therapy	Patients should be started on the lowest appropriate dose. Oxycontin 60 mg, 80 mg, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are for use only in opioid-tolerant patients

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Embeda^TM (morphine sulfate/naltrexone hydrochloride extended release)	For opioid naive and opioid non-tolerant: 20 mg/0.8 mg PO every 24 hours.	3 months initially for non-malignant pain. Duration of authorization to be determined case by case up to one year. Treatment plan may be required for continued authorization. 1 year for cancer patients

Product Availability:

Embeda capsule: 20 mg/0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, 100 mg/4 mg

References:

Avinza. [package insert]. Bristol, TN: King Pharmaceuticals, Inc., April 2014.
OxyContin. [package insert]. Stamford, CT: Purdue Pharma L.P., April 2014.
Opana ER. [package insert]. Chadds Ford, PA: Endo Pharmaceuticals, Inc., April 2014.
MS Contin. [package insert]. Stamford, CT: Purdue Pharma L.P., April 2014.
Kadian. [package insert]. Morristown, NJ: Actavis Kadian LLC., April 2014.
Duragesic.[package insert].Titusville, NJ: Janssen Pharmaceuticals, Inc., April 2014.
Embeda. [package insert] Bristol, TN: King Pharmaceuticals, Inc: April 2014.
American Hospital Formulary Service Drug Information page.. Available at http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 1, 2015.