Prior Auth Protocol

FDA Approved Indications:

For the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Health Net Approved Indications and Usage Guidelines:

The patient may have access to opioids

AND

For Evzio: Medical justification why patient cannot use Narcan (naloxone nasal spray)

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:

Evzio is intended for immediate administration as emergency therapy in settings where opioids may be present.
Evzio is not a substitute for emergency medical care. If the desired response is not obtained after 2 or 3 minutes, another Evzio dose may be administered. If there is still no response and additional doses are available, additional Evzio doses may be administered every 2 to 3 minutes until emergency medical assistance arrives. If no response is observed after 10 mg of naloxone hydrochloride have been administered, the diagnosis of narcotic-induced or partial narcotic induced toxicity should be questioned. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
Clinical efficacy studies were not conducted for Evzio. In one pharmacokinetic study of 30 patients, a single Evzio injection provided equivalent naloxone compared to a single dose of naloxone injection using a standard syringe.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Evzio 0.4 mg/0.4 mL	Known or Suspected Opioid Overdose Place the Black end of Evzio against the outer thigh, through clothing, if needed. Press firmly and hold in place for 5 seconds. Repeat doses of Evzio may be required depending upon the amount, type, and route of administration of the opioid being antagonized. If there is still no response and additional doses are available, additional Evzio doses may be administered every 2 to 3 minutes until emergency medical assistance arrives.	Two boxes (4 autoinjectors) per prescription. The lessor of six months or until end of benefit renewal period.
Narcan (naloxone nasal spray)	Known or Suspected Opioid Overdose 4 mg intranasally as a single spray in one nostril. Repeat as needed every 2 to 3 minutes with a new nasal spray in alternate nostrils.	Two cartons (4 single dose nasal sprays) per prescription. The lessor of six months or until end of benefit renewal period.

Product Availability:

Evzio Autoinjector containing a single dose of naloxone 0.4 mg/0.4mL
Narcan Nasal Spray 4mg, supplied as a carton containing two blister packages, each with a single dose

References:

1. Evzio [Prescribing Information]. Richmond, VA: kalio Inc.; April 2014.
2. FDAs Summary Review for Regulatory Action for Evzio accessed at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205787Orig1s000SumR.pdf
3. Narcan [Prescribing Information]. Adapt Pharma: Radnor, PA; November 2015.