Opioid Dependence Treatment Program
Page last updated: 1 July 2024
The Commonwealth supports access to medicines for the treatment of opioid dependence through the Pharmaceutical Benefits Scheme (PBS).
Opioid dependence treatment (ODT) medicines currently listed on the Schedule of Pharmaceutical Benefits (the PBS Schedule) include:
- methadone oral liquid
- buprenorphine sublingual tablets
- buprenorphine + naloxone sublingual films
- long-acting injectable buprenorphine products
On 1 July 2023, ODT medicines became part of the Section 100 Highly Specialised Drugs (HSD) Program (Community Access) arrangements. This means ODT medicines are now dispensed in the same way as other community access Section 100 HSD Program medicines from section 90 approved community pharmacies, section 92 approved medical practitioners, and section 94 approved hospital authorities (public and private).
Under the Section 100 HSD Program, PBS-eligible patients pay the PBS co-payment to access their treatment (for up to 28 days’ supply per pharmaceutical benefit prescribed) and the amount paid will contribute towards their PBS Safety Net threshold. Additional private dispensing or dosing fees cannot be charged by section 90 community or section 94 hospital pharmacies to patients for access to ODT medicines under the PBS.
Supplying patients with methadone liquid, buprenorphine sublingual tablets and buprenorphine + naloxone sublingual films often requires more frequent activities relating to in-pharmacy and take-away dosing. Therefore, on 1 July 2023, a community pharmacy program for ODT medicines was established, including on-site pharmacist administration of injectable buprenorphine, that introduced nationally consistent payment arrangements for ODT services provided by community pharmacists.
State and territory governments operate individual ODT programs in their respective jurisdictions. The operation of state and territory ODT programs are and will continue to be governed by the respective policies, guidelines and regulations within each of those jurisdictions.
What this means for:
Dosing sites participating in state and territory ODT programs
- ODT Overview Factsheet (PDF 209KB) - (Word 141KB)
- Information for prescribers (PDF 322KB) - (Word 133KB)
- Information for community and hospital pharmacists (PDF 209KB) - (Word 141KB)
- How to register to provide services through the ODT Community Pharmacy Program Factsheet for pharmacies (PDF 440KB) - (Word 147KB)
- ODT dispensing workflow and stock management for pharmacists (PDF 330KB) - (Word 164KB)
- Information for patients in methadone or buprenorphine programs (PDF 151KB) - (Word 123KB)
- ODT medicine transition arrangements for private clinic and non-PBS approved dosing sites (PDF 186KB) - (Word 133KB)
- ODT Frequently Asked Questions (PDF 219KB) - (Word 146KB)
Further Information
Further information regarding Section 100 HSD Program (Community Access) arrangements is available on the HSD Program website and the Services Australia website.
Information on how to apply to be a PBS Approved Supplier is available on the PBS Approved Supplier website.
For further information regarding the ODT Community Pharmacy Program please visit the Pharmacy Programs Administrator (PPA) website.
Information regarding the Post-market Review of Opioid Dependence Treatment Program medicines is available on the PMR website.
Community Pharmacies
As of 1 July 2023, section 90 community pharmacies can submit the following claims for the provision of ODT medicines:
- Under the Section 100 HSD Program, pharmacists can submit a claim to Services Australia to be reimbursed for the opioid dependence treatment medicines they supply and to receive the applicable Section 100 HSD Program dispensing fees and markups.
- Under the ODT Community Pharmacy Program, section 90 community pharmacies can submit a claim through the PPA portal for pharmacy services associated with in-pharmacy and take-away dosing of patients receiving ODT medicines (i.e., for the staged supply of these medicines) and subject to state and territory guidelines and regulations, can also submit a claim for payment for on-site pharmacist administration of buprenorphine injections. For more information see How to register to provide services through the ODT Community Pharmacy Program Factsheet for pharmacies (PDF 440KB) - (Word 147KB)
PBS dispensing
As of 1 July 2023, similar to other medicines listed on the PBS, section 90 approved community pharmacies participating in state and territory ODT programs can:
- continue to order ODT medicines from their usual pharmaceutical distributor/wholesalers (noting that ODT medicines will now be purchased as per PBS arrangements for other medicines)
- dispense PBS prescriptions for supplies of ODT medicines to eligible patients
- charge PBS co-payments to patients at a level consistent with their respective Medicare status
- submit claims to Services Australia to be reimbursed for the ODT medicines they supply and to receive payments in accordance with the remuneration structure for community access Section 100 HSD Program medicines.
Buprenorphine-containing ODT medicines are prescribed and dispensed on a per pack basis, similar to other PBS medicines. This means if different strengths are prescribed, each strength will attract one PBS co-payment.
Methadone liquid is prescribed and dispensed on a maximum millilitre (mL) basis per prescription (that is, a total quantity in mL for up to 28 days of the daily dose amount). This means pharmacists can continue to share a bottle of methadone among multiple patients, if necessary.
Section 90 community pharmacists cannot charge additional out-of-pocket (private) dispensing or dosing fees to patients for PBS supplies of ODT medicines.
Community pharmacists are, and will continue to be, required to comply with state and territory ODT program policies, guidelines and regulations.
More information about the Section 100 HSD Program (Community Access) arrangements is available on the HSD Program website and the Services Australia website.
Community Pharmacy Program for ODT medicines
In addition, under the ODT Community Pharmacy Program, section 90 approved community pharmacies participating in state and territory ODT can:
- register to participate in the ODT Community Pharmacy Program via the PPA website
- submit claims for payment relating to activities associated with in-pharmacy or take-away doses of methadone liquid, buprenorphine sublingual tablets and buprenorphine + naloxone films where they have been dispensed under PBS arrangements
- submit claims for payment for on-site pharmacist administration of injectable weekly and monthly buprenorphine dispensed under PBS arrangements.
The community pharmacy program payments include a container fee.
Section 94 approved hospital authorities (public and private) and section 92 approved medical practitioners are not eligible for payments under the ODT Community Pharmacy Program.
For further information regarding the ODT Community Pharmacy Program please visit the PPA website.
Prescribers
Under the Section 100 HSD Program, the authorised prescribers of ODT medicines are medical practitioners and nurse practitioners. Prescribers of Section 100 HSD Program (Community Access) medicines are not required to be affiliated with a hospital. Prescribers are, and will continue to be, required to comply with state and territory ODT program policies, guidelines and regulations when writing PBS prescriptions for ODT medicines.
As of 1 July 2023, ODT medicines will be Authority Required (STREAMLINED) listings under the Section 100 HSD Program (Community Access).
Similar to other medicines listed under the Section 100 HSD Program, authorised prescribers participating in state and territory ODT programs can:
- prescribe ODT medicines for PBS-eligible patients, as per the prescription of other medicines under the Section 100 HSD Program (Community Access) arrangements (often for up to 28 days’ supply)
- for methadone oral liquid, prescribe up to a maximum quantity of 4,200 mg (840 mL) with 5 repeats (the maximum quantity is equivalent to up to a maximum dose of methadone of 150 mg per day for 28 days)
- for sublingual buprenorphine and buprenorphine with naloxone, prescribe up to a maximum quantity equivalent to 32mg of buprenorphine per day for 28 days, with 5 repeats
- for injectable buprenorphine, prescribe up to a maximum quantity equivalent to 28 days (4 weeks) with 5 repeats.
Buprenorphine-containing ODT medicines are prescribed and dispensed on a per pack basis, similar to the prescribing of other PBS medicines. This means if different strengths are prescribed, each strength will attract one PBS co-payment.
Methadone liquid is prescribed and dispensed on a maximum mL basis per prescription (that is, a total quantity in mL for up to 28 days of the daily dose amount). This means pharmacists can continue to share a bottle of methadone between multiple patients if necessary.
Prescribers are encouraged to prescribe only the quantities and repeats that are suitable for the patient’s clinical needs (including during medication initiation) until their next review (to a maximum of 6 months). As per existing arrangements, prescribers should also include clear daily dosing instructions including dose variations and take away arrangements.
Further information about the Section 100 HSD Program (Community Access) is available on the Services Australia website.
Patients
As of 1 July 2023, patients may continue to be prescribed their ODT medicines from their current medical practitioner or nurse practitioner and access medicines for the treatment of opioid dependence from their current dosing site(s), however, the way in which these medicines are accessed under the PBS has changed.
As of 1 July 2023, ODT medicines are under the Section 100 HSD Program (Community Access)
These changes will mean that patients who are prescribed medicines listed on the PBS Schedule for the treatment of opioid dependence now pay a PBS co-payment (for up to 28 days’ supply per pharmaceutical benefit). Similar to other medicines on the PBS, if different strengths of an ODT medicines are prescribed, each strength will attract one PBS co-payment. PBS co-payment amounts paid for ODT medicines will count towards a patient’s PBS Safety Net threshold. It also means patients who access their ODT medicines from section 90 community pharmacies registered in the ODT Community Pharmacy Program will not pay additional out-of-pocket (private) dispensing or dosing fees and charges.
Patient Eligibility
To gain access to ODT medicines listed under the HSD Program Community Access arrangements, a patient must:
- be an Australian resident eligible for a Medicare card
- meet the specific medical criteria to receive ODT medicines (that is, for the treatment of opioid dependence).
As with other Section 100 HSD Program medicines, this includes patients who are a day-admitted or non-admitted hospital patient, or a patient on discharge from a participating hospital.
Prescriptions and dispensing
Patients may continue to obtain their prescriptions from an authorised medical or nurse practitioner.
PBS Approved Suppliers
PBS prescriptions may be dispensed by PBS Approved Suppliers participating in state and territory ODT programs. This includes section 90 approved community pharmacies, section 92 approved medical practitioners and section 94 approved hospital authorities (public and private).
As of 1 July 2023, similar to other medicines listed on the PBS Schedule, eligible patients can:
- have their ODT medicines dispensed from PBS Approved Suppliers (including community pharmacies) using a PBS prescription
- pay only the PBS co-payment to access their PBS medicine, at a level consistent with their Medicare status
- as with other PBS medicines, this can be for a quantity of up to 28 days’ supply with 5 repeats
- a PBS co-payment will be required in respect of each strength used to make up a dose (as prescribed by the patient’s medical or nurse practitioner)
- state and territory ODT program requirements regarding in-pharmacy and take-away dosing will still apply
- count their eligible PBS co-payment amounts towards their PBS Safety Net threshold.
Patients are not required to pay additional out-of-pocket (private) dispensing or dosing fees or charges associated with access to ODT medicines under the PBS from section 90 community pharmacies. This means patients do not have to pay for activities associated with the preparation of in-pharmacy or take-away doses of methadone liquid, buprenorphine sublingual tablets or buprenorphine + naloxone sublingual films.
Other dosing sites
Patients may continue to receive their ODT medicines from other dosing sites and have their medicine supplied under the PBS, with the PBS co-payment amount contributing to their Safety Net threshold.
Further information available at What this means for: dosing sites participating in state and territory ODT programs.
State and territory ODT programs
Patients are advised that their individual state and territory government ODT programs remain the first point of contact for questions about participation and enrolment in ODT Programs, including, for example, access to take-away dosing and travel arrangements.
Hospitals
As of 1 July 2023, similar to other medicines listed on the PBS, section 94 approved hospital authorities (private and public) participating in state and territory ODT programs can:
- continue to order ODT medicines from their usual pharmaceutical distributor/wholesalers (noting that ODT medicines will now be purchased as per PBS arrangements for other medicines)
- dispense PBS prescriptions for supplies of ODT medicines to eligible patients
- charge PBS co-payments to patients at a level consistent with their respective Medicare status
- submit claims for payments to Services Australia based on the existing remuneration structure for community access Section 100 HSD Program medicines.
State and territory governments may pay for the PBS co-payment for medicines dispensed by section 94 approved hospital authorities. Patients are encouraged to discuss this with their relevant state or territory ODT program.
Buprenorphine-containing ODT medicines are prescribed and dispensed on a per pack basis, similar to other PBS medicines. This means if different strengths are prescribed, each strength will attract one PBS co-payment.
Methadone liquid is prescribed and dispensed on a maximum millilitre (mL) basis per prescription (that is, a total quantity in mL for up to 28 days of the daily dose amount). This means pharmacists can continue to share a bottle of methadone among multiple patients, if necessary.
Hospitals cannot charge additional out-of-pocket (private) dispensing or dosing fees to patients for PBS supplies of ODT medicines.
Like other Section 100 HSD medicines, eligible patients are a day-admitted or non-admitted hospital patient, or a patient on discharge from a participating hospital. Patients in a correctional facility or other dosing sites will be eligible for PBS-subsidised access to ODT medicines dispensed by PBS Approved Suppliers provided both PBS patient eligibility criteria are met.
Dosing sites participating in state and territory ODT programs
Dosing sites are, and will continue to be, required to comply with their respective state and territory ODT program policies, guidelines and regulations.
Access to ODT medicines through the PBS
As of 1 July 2023, under the PBS, patients may continue to obtain their prescriptions from an authorised medical or nurse practitioner. PBS prescriptions for ODT medicines will often be for up to 28 days’ supply with up to 5 repeats.
PBS-subsidised access to ODT medicines are dispensed (and payments respectively claimed) by PBS Approved Suppliers, similar to the way in which other medicines are dispensed under PBS arrangements. PBS Approved Suppliers include section 90 approved community pharmacies, section 92 approved medical practitioners, and section 94 approved hospital authorities (public and private).
Once dispensed by the PBS Approved Supplier, the ODT medicine may be provided (however arranged) to the site of administration, such as a correctional facility, medical practice or clinic. This is in line with arrangements under the broader PBS where medicines can be administered to patients at a different setting to those in which they were dispensed (supplied).
To gain access to ODT medicines listed under HSD Program (Community Access) arrangements, a patient must:
- be an Australian resident eligible for a Medicare card
- meet the specific medical criteria to receive ODT medicines (that is, for the treatment of opioid dependence).
Like other Section 100 HSD medicines, this includes patients who are a day-admitted or non-admitted hospital patient, or a patient on discharge from a participating hospital.
Patients in a correctional facility or other dosing sites will be eligible for PBS-subsidised access to ODT medicines dispensed by PBS Approved Suppliers provided both PBS patient eligibility criteria are met.
For information about prescribing ODT medicines under the Section 100 HSD Program go to What this means for: Prescribers.
