Prior Auth Protocol

FDA Approved Indications:

The management of breakthrough pain in cancer patients ( >16 years old for Actiq and >18 years old for Fentora, Lazanda, Subsys and Abstral) who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of cancer

AND

Member is on fentanyl transdermal patches

AND

For Abstral, Fentora, Lazanda and Subsys requests: Failure or clinically significant adverse effects to generic fentanyl citrate oral transmucosal lozenge (Actiq)

Coverage is Not Authorized For:

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:

Because of the potential risk for misuse, abuse, and overdose, the fentanyl sublingual and transmucosal products listed below are only available through restricted distribution programs. Under the transmucosal immediate release fentanyl risk evaluation and mitigation strategy (TIRF REMS) program, only prescribers, pharmacies, and patients registered with TIRF REMS are able to prescribe, dispense, and receive these products. Additional information is available at: www.tirfremsaccess.com/TirfUISplashWeb/index.html or by calling 1-866-822-1483.
These products are not interchangeable and must not be used in opioid non-tolerant patients because life-threatening hypoventilation could occur at any dose in patients not taking chronic opiates. Substantial differences exist in the pharmacokinetic profiles of these drugs that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of these products may result in fatal overdose.
Patients considered opioid tolerant are those who are taking around the clock medicine consisting of at least 60 mg morphine/day, at least 25 mcg transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.
Fentanyl absorption with different formulations of transmucosal delivery systems can be substantially different. Patients should not be converted on a mcg per mcg basis from any other transmucosal fentanyl product. Patients beginning treatment with Abstral must begin with titration from 100 mcg dose.
The initial dose of Fentora, Abstral, and Subsys is always 100 mcg with the only exception being patients already using Actiq. Patients switching from Actiq to Fentora, Abstral, or Subsys should be initiated as shown:

Actiq dose (mcg)	Fentora dose (mcg)	Abstral dose (mcg)	Subsys dose (mcg)
200	100	100	100
400	100	200	100
600	200	200	200
800	200	200	200
1200	400	200	400
1600	400	400	400

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
morphine sulfate immediate release	10 mg - 30 mg PO Q 4 H PRN Individualize dosage based on extent of pre-existing opioid tolerance	Varies
oxycodone immediate release (Roxicodone)	5 mg - 15 mg PO Q 4 to 6 H PRN Individualize dosage based on extent of pre-existing opioid tolerance	Varies
hydromorphone immediate release (Dilaudid)	2 mg - 4 mg PO Q 3 to 4 H PRN Individualize dosage based on extent of pre-existing opioid tolerance	Varies
oxymorphone immediate release (Opana)	5 mg 20 mg PO Q 4 to 6 H PRN Individualize dosage based on extent of pre-existing opioid tolerance	Varies

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Actiq	Initiate dosing with 200 mcg PO and if breakthrough episode is not relieved in 30 minutes, patients may take only 1 additional dose using the same strength and must wait at least 4 hours before taking another dose. Individually titrate to a dose that provides adequate analgesia using single dosage unit per breakthrough cancer pain episode and minimizes side effects. Initial prescription recommendation for maximum of 6 units; no more than 4 doses per day; separate by at least 4 hours.	Length of benefit
Fentora	Initiate dosing with 100 mcg PO and if breakthrough episode is not relieved in 30 minutes, patients may take only 1 additional dose using the same strength and must wait at least 4 hours before taking another dose. Maximum: 4 tablets simultaneously	Length of benefit
Abstral	Begin titration of all patients with an initial dose of Abstral of 100 mcg SL. Due to differences in the pharmacokinetic properties and individual variability, even patients switching from other fentanyl containing products to Abstral must start with the 100 mcg dose. Abstral is not equivalent on a mcg per mcg basis with all other fentanyl products; therefore, do not switch patients on a mcg per mcg basis from any other fentanyl product. The safety and efficacy of doses higher than 800 mcg have not been evaluated. Maximum two doses for each each episode of breakthrough pain. Patients must wait at least 2 hours before treating another episode.	Length of benefit
Lazanda	Initial dose of Lazanda for all patients is 100 mcg into one nostril. Individually titrate to an effective dose, from 100 mcg to 200 mcg to 400 mcg, and up to a maximum of 800 mcg, that provides adequate analgesia with tolerable side effects. Dose is a single spray into one nostril or a single spray into each nostril (2 sprays). Maximum dose is a single spray into one nostril or single spray into each nostril per episode; no more than four doses per 24 hours. Wait at least 2 hours before treating another episode of breakthrough pain with Lazanda.	Length of benefit
Subsys	Initial dose of Subsys 100 mcg SL Individually titrate to a tolerable dose that provides adequate analgesia using a single Subsys dose per breakthrough cancer pain episode. No more than two doses can be taken per breakthrough pain episode. Wait at least 4 hours before treating another episode of breakthrough pain with Subsys. Limit consumption to four or fewer doses per day once successful dose is found.	Length of benefit

Product Availability:

Actiq (oral transmucosal fentanyl): available as 200 mcg, 400 mcg, 600 mcg, 800 mcg,1200 mcg and 1600 mcg lozenges. 30 lozenges per package.
Fentora (fentanyl buccal tablet): available as 100 mcg, 200 mcg, 400 mcg, 600 mcg, and 800 mcg buccal tablets. Package of 7 blister cards containing 4 tablets in each card.
Abstral (fentanyl sublingual tablet); available in 100 mcg, 200 mcg, 300 mcg, 400 mcg (12 or 32 tablets per package), 600 mcg, and 800 mcg (32 tablets per package) sublingual tablets.
Lazanda (metered dose nasal spray): available as 100 mcg or 400 mcg per spray. Each bottle contains 8 sprays.
Subsys single spray units of 100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, and 1600 mcg per spray

References:

1. Actiq [Prescribing Information] Frazer, PA: Cephalon, Inc; December 2013.
2. Aronoff GM, Brennan MJ, Pritchard DD, et al. Evidence-based oral transmucosal fentanyl citrate (OTFC) dosing guidelines. Pain Medicine. 2005;6(4):305-14.
3. Fentora [Prescribing Information] North Wales, PA: Teva Pharmaceuticals USA, Inc.; February 2013.
4. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed January 27, 2016.
5. Fentanyl. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed January 27, 2016.
6. Abstral [Prescribing Information] Hunt Valley, MD: Pharmaceutics International, Inc.; November 2014.
7. Lazanda [Prescribing Information] Newark, CA: Depomed, Inc.; March 2015.
8. Subsys [Prescribing Information] Chandler, AZ; Insys Therapeutics; December 2014.
9. Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed January 27, 2016.