Prior Auth Protocol

FDA Approved Indications:

Opana ER^R:

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.

Oxycontin^R:

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:

AND

Failure or clinically significant adverse effects to TWO formulary controlled-release products: controlled-release morphine sulfate, sustained-release morphine sulfate beads, sustained-release morphine sulfate, or fentanyl patch.

AND

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:

Avinza^R (45 mg, 60 mg, 75 mg, 90 mg and 120 mg), Kadian^R (100 mg and 200 mg), MS Contin^R (100 mg and 200 mg), OxyContin (60 mg and; 80 mg, a single dose greater than 40 mg or a total daily dose greater than 80 mg) and Duragesic^R are for use only in opioid tolerant patients. Opioid tolerant patients are those receiving, for one week or longer, at least 60 mg PO morphine/day, 25 mcg/hr transdermal fentanyl, 30 mg PO oxycodone/day, 8 mg PO hydromorphone/day, 25 mg PO oxymorphone/day or an equianalgesic dose of another opioid.
Avinza, Kadian, MS Contin, Oxycontin, Opana ER, and Duragesic are not indicated as an as-needed (prn) analgesic.
Because it may be difficult to determine analgesic need using a controlled-release product, it is recommended to initiate therapy with immediate-release products. The table below may be useful in determining the appropriate dosing of a variety of analgesic options.

*Adjust dose in renal impairment

Due to the potency of OxyContin, it is recommended to use the conversion factor table when converting TO oral oxycodone to avoid overestimating the dose.
Conversion back FROM prior opioid divides by the conversion factor shown in the table below.

Estimated conversion factor for converting prior opioid doses to oral oxycodone (mg/day prior opioid x factor = mg/day oral oxycodone
Prior Opioid	Oral	Parenteral
Codeine	0.15	--
Hydrocodone	0.9	--
Hydromorphone	4	20
Levorphanol	7.55	15
Meperidine	0.1	0.4
Methadone	1.5	3
Morphine	0.5	1.5 - 3
Oxycodone	1	--
Oxymorphone	2	--

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
morphine sulfate extended release tablet (MS Contin^R)	Conversion to MS Contin^R Dosing is individualized based on previous analgesic therapy. Administer at 1/2 the total daily requirement PO Q12H or 1/3 the total daily requirement PO Q8H.	The 100 mg and 200 mg tablets are reserved only for opioid-tolerant individuals who require morphine equivalent doses of 200 mg or more for the 100 mg tablet and 400 mg or more for the 200 mg tablet
morphine sulfate extended relaease capsule (Kadian^R)	Opioid naive patients 10 mg or 20 mg PO, may adjust dosage at 20 mg increment QOD Conversion to Kadian^R Dosing is individualized based on previous analgesic therapy. Administer patient's total daily requirement PO Q24H or Q12H at 1/2 the estimated total daily requirement	Should not be given more frequently than Q12H
fentanyl transdermal system (Duragesic^R)	Dosing is individualized based on previous analgesic therapy. Initiate dose at one patch TD Q72H. May increase following 3 days of therapy. Some patients may require dosing Q48H.	Doses > 25 mcg/hr patch are reserved for opioid-tolerant individuals.
morphine sulfate extended-release capsule (Avinza^R)	Opioid naive patients 30 mg PO Q24 hours, with dosage adjustments of not > 30 mg every 4 days Conversion to Avinza Dosing is individualized based on previous analgesic therapy. Administer patient's total daily morphine requirement PO Q24H	1600 mg/day Should not be given more frequently than Q24H

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
OxyContin^R(Oxycodone controlled-release abuse deterrent)	One tablet PO BID; individualized dosing may require multiple tablets and TID dosing	3 months initially for non-malignant pain. Duration of authorization to be determined for up to one year. Treatment plan may be required for continued authorization. 1 year for cancer patients.
Opana ER^R(Extended-release oxymorphone crush resistant)	One tablet PO BID; individualized dosing may require multiple tablet dosing	3 months initially for non-malignant pain. Duration of authorization to be determined for up to one year. Treatment plan may be required for continued authorization. 1 year for cancer patients.

Product Availability:

Opana ER tablet: 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg
OxyContin tablet: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg

References:

Avinza^R [Prescribing Information] Bristol, TN: King Pharmaceuticals, Inc.; May 2014.
Opana ER^R [Prescribing Information] Chadds Ford, PA: Endo Pharmaceuticals, Inc; April 2014.
OxyContin^R [Prescribing Information] Stamford, CT: Purdue Pharma; April 2014.
MS Contin^R [Prescribing Information] Stamford, CT: Purdue Pharma; March 2009.
Kadian^R [Prescribing Information] Morristown, NJ: Actavis; February 2010.
Duragesic^R [Prescribing Information] Titusville, NJ: PriCara, Janssen Pharmaceuticals, Inc.; October 2011.
DRUGDEX^RSystem [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 1, 2015.
American Hospital Formulary Service Drug Information. AHFSWeb site. Available at: http://www.medicinescomplete.com/mc/ahfs/current. Accessed June 1, 2015