NaloxoneDBL Naloxone Hydrochloride
Emergency treatment for known or suspected opioid overdose manifested by respiratory and/or central nervous system depression in the home, other non-medical settings, or health facility settings.
Decisions on record
- Meeting Mar 2019 Recommended Known or suspected opiate overdose
- Meeting Mar 2010 Recommended Treatment of opioid overdose no PSD
Access path
- TGA registered · DBL Naloxone Hydrochloride
TGA label narrower than the PBS population
- Mar 2019Recommended · restricted
vs naloxone 1 mg/mL injection, 2 mL prefilled syringe
- PBS listing · Unrestricted
From the public summary
7.1 The PBAC recommended the dual General Schedule and Section 100 listing of intranasal naloxone on a cost-minimisation basis to injectable naloxone, at equivalent cost per treatment. The PBAC considered that there was a public health need to increase use of naloxone, as outlined in the consumer comments received, and considered that while the clinical benefits of IN naloxone were similar to injectable naloxone, availability of the IN formulation could …PSD · Mar 2019
7.2 The PBAC agreed with the submission that IN naloxone was likely to be easier to administer than injectable forms in some scenarios, did not carry any risk of needle 7PSD · Mar 2019
6.8 The submission proposed an ex-manufacturer price equal to the approved ex- manufacture price of naloxone hydrochloride 400 microgram/mL injection, 5 x 1 mL ampoules (PBS item 10783M) and the cost of administering IM naloxone, based on contents of the NSW Users and AIDS Association (NUAA), Naloxone Kit. The cost- analysis is presented in Table 3.PSD · Mar 2019
6.9 Ancillary equipment is not a cost to the PBS for IM administration of naloxone. The Pre-PBAC response highlighted that this approach was consistent with the Manual of Resource Items and Associated Unit Costs 2016 (Section 4.4), which states that economic evaluation ‘uses a price equivalent to the average price charged to the consumer’.PSD · Mar 2019
6.7 The submission claimed non-inferior comparative effectiveness and superior comparative safety of IN naloxone (2 x 1.8mg) compared with naloxone ampules (5 x 400mcg). While no comparative safety data was provided in the submission, the claimed safety benefits relate to the manner of administration, such as reduced time to administer versus injectable naloxone, eliminated risk of needle-stick injuries, and reduced risk of acute withdrawal-related risks …PSD · Mar 2019
For more detail on PBAC’s view, see section 7 PBAC outcome. 5PSD · Mar 2019
6.2 The PBAC noted and welcomed the input from individuals (4), health care professionals (38) and organisations (9) via the Consumer Comments facility on the PBS website. The comments described a range of benefits associated with IN naloxone use in acute opioid overdose including ease of administration, increased accessibility and availability, all of which aim to reduce deaths from opioid overdose.PSD · Mar 2019
Cost-effectiveness
Cost-minimisation analysis on basis of equivalent cost per treatment to injectable naloxone; no ICER calculated
The PBAC recommended the dual General Schedule and Section 100 listing of intranasal naloxone on a cost-minimisation basis to injectable naloxone, at equivalent cost per treatment. PBAC · 2019
Decision context
PopulationAdults at risk of or likely to witness opioid overdose, suitable for use in the home or non-medical settings as part of emergency treatment for opioid overdose.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2019 | Recommended · restricted | naloxone 1 mg/mL injection, 2 mL prefilled syringe | — | Single-arm · Pharmacokinetic equivalence |
Consumer voice
Consumer input from 4 individuals, 38 health care professionals, and 9 organisations described benefits of intranasal naloxone for acute opioid overdose, including ease of administration, increased accessibility and availability, which aim to reduce deaths from opioid overdose.
The comments described a range of benefits associated with IN naloxone use in acute opioid overdose including ease of administration, increased accessibility and availability, all of which aim to reduce deaths from opioid overdose. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adults at risk of or likely to witness overdose; TGA label covers any patient with suspected opioid overdose regardless of risk status.