PBS subsidy arrangements for medicines subject to a Serious Scarcity Substitution Instrument

Page last updated: 5 December 2025

Pharmacists can dispense substitutable medicines in place of prescribed medicines that are in shortage (scarce medicines) without prior approval from the prescriber in circumstances where the Therapeutic Goods Administration (TGA) has issued a Serious Scarcity Substitution Instrument (SSSI) in respect of that medicine.  PBS listed scarce medicines and the respective substitutable medicines that are eligible for PBS subsidy under these arrangements are listed below.

Information about the conditions and specified permitted circumstances that apply to an SSSI are published on the TGA website. Please note that all substitutions must be supplied in accordance with the TGA SSSI.

Section 5 of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 outlines the conditions that must be met for PBS subsidised supply.

Frequently Asked Questions about PBS subsidy arrangements for PBS listed medicines subject to an SSSI may be accessed at PBS subsidy for medicines subject to a Serious Scarcity Substitution Instrument (PDF 188KB) - (Word 35KB).

In addition to subsidising SSSIs to manage medicine shortages, the Department also works with sponsors of section 19A medicines to implement PBS subsidisation where possible. Further information is available at Section 19A products subsidised by the Pharmaceutical Benefits Scheme.

NOTE: The estradiol (brand: Estramon Germany) packs of 24 are not included in the estradiol SSSI.

PBS Listed Scarce and Substitutable Medicines

 

Scarce medicine(s)

Substitutable medicine(s)

Item codes for substitution where applicable

Notes

For

Use

ESTRADIOL

Estradiol 25 microgram/24 hours patch, 8 (PICMI)

Estradot 25

ESTRADIOL

Estradiol 25 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 25

8761D

8311K

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 25 microgram/24 hours patch is equivalent to one patch that releases estradiol 25 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 25 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 25

ESTRADIOL

Estradiol 25 microgram/24 hours patch, 8 (PICMI)

Estradot 25

8311K

8761D

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 25 microgram/24 hours patch is equivalent to one patch that releases estradiol 25 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 50 microgram/24 hours patch, 8 (PICMI)

Estradot 50

ESTRADIOL

Estradiol 50 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 50

8763F

8140K

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 50 microgram/24 hours patch is equivalent to one patch that releases estradiol 50 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 50 microgram/24 hours patch, 8 (PICMI)

Estradot 50

ESTRADIOL

Estradiol 25 microgram/24 hours patch, 8 (PICMI)

Estradot 25

8763F

8761D

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 50 microgram/24 hours patch is equivalent to two patches that releases estradiol 25 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 50 microgram/24 hours patch, 8 (PICMI)

Estradot 50

ESTRADIOL

Estradiol 25 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 25

8763F

8311K

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 50 microgram/24 hours patch is equivalent to two patches that releases estradiol 25 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 50 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 50

ESTRADIOL

Estradiol 50 microgram/24 hours patch, 8 (PICMI)

Estradot 50

8140K

8763F

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 50 microgram/24 hours patch is equivalent to one patch that releases estradiol 50 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 50 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 50

ESTRADIOL

Estradiol 25 microgram/24 hours patch, 8 (PICMI)

Estradot 25

8140K

8761D

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 50 microgram/24 hours patch is equivalent to two patches that releases estradiol 25 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 50 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 50

ESTRADIOL

Estradiol 25 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 25

8140K

8311K

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 50 microgram/24 hours patch is equivalent to two patches that releases estradiol 25 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 75 microgram/24 hours patch, 8 (PICMI)

Estradot 75

ESTRADIOL

Estradiol 37.5 microgram/24 hours patch, 8 (PICMI)

Estradot 37.5

Estradiol Transdermal System (Sandoz, USA)

8764G

8762E

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 75 microgram/24 hours patch is equivalent to two patches that releases estradiol 37.5 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 100 microgram/24 hours patch, 8 (PICMI)

Estradot 100

ESTRADIOL

Estradiol 100 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 100

8765H

8312L

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 100 microgram/24 hours patch is equivalent to one patch that releases estradiol 100 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 100 microgram/24 hours patch, 8 (PICMI)

Estradot 100

ESTRADIOL

Estradiol 50 microgram/24 hours patch, 8 (PICMI)

Estradot 50

8765H

8763F

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 100 microgram/24 hours patch is equivalent to two patches that releases estradiol 50 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 100 microgram/24 hours patch, 8 (PICMI)

Estradot 100

ESTRADIOL

Estradiol 50 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 50

8765H

8140K

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 100 microgram/24 hours patch is equivalent to two patches that releases estradiol 50 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 100 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 100

ESTRADIOL

Estradiol 100 microgram/24 hours patch, 8 (PICMI)

Estradot 100

Estradiol Transdermal System (Sandoz, USA)

8312L

8765H

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 100 microgram/24 hours patch is equivalent to one patch that releases estradiol 100 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 100 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 100

ESTRADIOL

Estradiol 50 microgram/24 hours patch, 8 (PICMI)

Estradot 50

8312L

8763F

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 100 microgram/24 hours patch is equivalent to two patches that releases estradiol 50 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

ESTRADIOL

Estradiol 100 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 100

ESTRADIOL

Estradiol 50 microgram/24 hours patch, 8 (PICMI)

Estraderm MX 50

8312L

8140K

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one patch that releases estradiol 100 microgram/24 hours patch is equivalent to two patches that releases estradiol 50 microgram/24 hours patch.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

INSULIN ISOPHANE

Insulin isophane human 100 units/mL injection, 5 x 3 mL pen devices (PICMI)

Protaphane InnoLet

INSULIN ISOPHANE

Insulin isophane human 100 units/mL injection, 5 x 3 mL cartridges (PICMI)

Protaphane Penfill 3 mL

12262J

1761Q

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one 3 mL (300 unit) cartridge of the substitutable medicine is equivalent to one 3 mL (300 unit) pre‑filled cartridge of the scarce medicine.

NICORANDIL

Tablets 10 mg, 60

(PI, CMI)

APO-Nicorandil

NICORANDIL

Tablets 20 mg, 60

(PI, CMI)

APO-Nicorandil

Ikotab

13550E

8228C

13551F

8229D

Supply must be in accordance with the TGA SSSI

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one tablet containing 10 mg of nicorandil is equivalent to half of a 20 mg nicorandil tablet.

NICORANDIL

Tablets 10 mg, 60

(PI, CMI)

Ikotab

NICORANDIL

Tablets 20 mg, 60

(PI, CMI)

APO-Nicorandil

Ikotab

13550E

8228C

13551F

8229D

Supply must be in accordance with the TGA SSSI

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one tablet containing 10 mg of nicorandil is equivalent to half of a 20 mg nicorandil tablet.

NICORANDIL

Tablets 20 mg, 60

(PI, CMI)

APO-Nicorandil

NICORANDIL

Tablets 10 mg, 60

(PI, CMI)

APO-Nicorandil

Ikotab

13551F

8229D

13550E

8228C

Supply must be in accordance with the TGA SSSI

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one tablet containing 20 mg of nicorandil is equivalent to two tablets containing 10 mg of nicorandil.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

NICORANDIL

Tablets 20 mg, 60

(PI, CMI)

Iko tab

NICORANDIL

Tablets 10 mg, 60

(PI, CMI)

APO-Nicorandil

Ikotab

13551F

8229D

13550E

8228C

Supply must be in accordance with the TGA SSSI

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one tablet containing 20 mg of nicorandil is equivalent to two tablets containing 10 mg of nicorandil.

If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance.

If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance.

SIMVASTATIN

simvastatin 5 mg tablet, 30 (PICMI)

Zimstat

SIMVASTATIN

simvastatin 10 mg tablet, 30 (PICMI)

APO-Simvastatin

SIMVASTATIN-WGR

Simvar 10

Simvastatin Sandoz

Zimstat

13559P

2013Y

13528B

2011W

Supply must be in accordance with the TGA SSSI

The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one tablet containing 5 mg of simvastatin is equivalent to half of a 10 mg simvastatin tablet.