Prior Authorization Protocol EMBEDA ® ( sulfate/ hydrochloride) extended-release

NATL

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.

I. FDA Approved Indications: • For the management of pain severe enough to require daily, around-the-clock, long term treatment and for which alternative treatment options are inadequate

II. Health Net Approved Indications and Usage Guidelines: • Severe 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 (opioid and adjuvant) regimen  Current non-pharmacological treatment  Opioid-related side effects  Indications of medical misuse  Action plan if analgesic failure occurs

III. 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

IV. 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 oral morphine/day, 30 mg oral /day, 8 mg oral /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 CHART Analgesic IM (mg) Oral (mg) Morphine* 10 30

Confidential and Proprietary Page - 1 Draft Prepared: 08.28.09 P. Belcher Approved By Health Net National Pharmacy & Therapeutics Committee: 02.23.10, 11.17.10, 11.9.11, 11.14.12, 11.20.13, 11.19.14, 11.18.15 Revised: 7.29.10 J Spears, 6.16.11 D.Duane , 05.24.12 A Giordano , 06.21.13 S. Tabarangao , .07.18.14 TScharenberg, 06.01.15 S Lafzi, 05.27.16 T Scharenberg, 12.15.16 M Del Nero

Prior Authorization Protocol EMBEDA ® (morphine sulfate/naltrexone hydrochloride) extended-release

NATL

EQUIANALGESIC OPIOID CHART Analgesic IM (mg) Oral (mg) 0.1 - Hydromorphone 1.5 7.5 2 4 10 20 Meperidine* 75 300 Oxycodone - 20 1 - *Adjust dose in renal impairment

V. Therapeutic Alternatives: Drug Dosing Regimen Dose Limit/Maximum Dose Morphine sulfate Initial dose for opioid naive: 15 mg 100 and 200 mg tablets are for use extended-release PO Q8 to 12H. only in opioid-tolerant individuals tablet Conversion dosing is individualized (MS Contin ®) based on previous analgesic therapy.

morphine sulfate Initial dose for opioid naive: 30 mg Maximum dose is 1600 mg/day. extended-release PO Q24H. Avinza 90 mg and 120 mg capsules beads capsule Conversion dosing is individualized are for use only in opioid-tolerant (Avinza ) based on previous analgesic individuals. therapy.

Kadian ® Initial dose for patients who are not Should not be given more frequently (morphine sulfate opioid tolerant: 30 mg PO QD than every 12 hours. extended-release Kadian 100 mg, 130 mg, 150 mg, capsule) and 200 mg are for use only in opioid-tolerant individuals. Opana ER ® Initial dose for opioid naïve: 5 mg Should not be given more frequently (oxymorphone PO Q12H. than every 12 hours. hydrochloride Conversion dosing is individualized extended-release based on previous analgesic tablet) therapy. Fentanyl patch Dosing is individualized based on Should not be applied more (Duragesic ®) previous analgesic therapy. frequently than every 48 hours. Initiate dose at one patch TD Q72H. Oxycontin ® * Initial dose for opioid naïve: 10 mg Oxycontin 60 mg, 80 mg, a single (oxycodone PO Q12H. dose greater than 40 mg, or a total hydrochloride Conversion dosing is individualized daily dose greater than 80 mg are for controlled- based on previous analgesic use only in opioid-tolerant patients. Confidential and Proprietary Page - 2 Draft Prepared: 08.28.09 P. Belcher Approved By Health Net National Pharmacy & Therapeutics Committee: 02.23.10, 11.17.10, 11.9.11, 11.14.12, 11.20.13, 11.19.14, 11.18.15 Revised: 7.29.10 J Spears, 6.16.11 D.Duane , 05.24.12 A Giordano , 06.21.13 S. Tabarangao , .07.18.14 TScharenberg, 06.01.15 S Lafzi, 05.27.16 T Scharenberg, 12.15.16 M Del Nero

Prior Authorization Protocol EMBEDA ® (morphine sulfate/naltrexone hydrochloride) extended-release

NATL

Drug Dosing Regimen Dose Limit/Maximum Dose release tablet) therapy. Oxycontin should not be given more frequently than every 12 hours. *Requires Prior Authorization

VI. Recommended Dosing Regimen and Authorization Limit: Drug Dosing Regimen Authorization Limit Embeda For opioid naïve and opioid non- Length of benefit (morphine tolerant: 20 mg/0.8 mg PO Q24H sulfate/naltrexone hydrochloride extended release capsule)

VII. 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

VIII. References: 1. Embeda [Prescribing Information] New York, NY: Pfizer, Inc: October 2014. 2. American Hospital Formulary Service Drug Information. Available at http://www.medicinescomplete.com/mc/ahfs/current/ . Accessed May 27, 2016. 3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 27, 2016.

The materials provided to you are guidelines used by this health plan to authorize, modify, or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual needs and the benefits covered under your contract.

Confidential and Proprietary Page - 3 Draft Prepared: 08.28.09 P. Belcher Approved By Health Net National Pharmacy & Therapeutics Committee: 02.23.10, 11.17.10, 11.9.11, 11.14.12, 11.20.13, 11.19.14, 11.18.15 Revised: 7.29.10 J Spears, 6.16.11 D.Duane , 05.24.12 A Giordano , 06.21.13 S. Tabarangao , .07.18.14 TScharenberg, 06.01.15 S Lafzi, 05.27.16 T Scharenberg, 12.15.16 M Del Nero