1 November 2023 Changes to the PBS Listings of Medicines for Severe Active Rheumatoid Arthritis
Page last updated: 1 November 2023
On 1 November 2023, changes will be made to the authority requirements of the following biological and immunomodulator medicines listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of rheumatoid arthritis – adalimumab, abatacept, baricitinib, certolizumab, etanercept, golimumab, infliximab, tocilizumab and tofacitinib.
From this date, the PBS listings of biosimilar medicines for initial therapy will change from Authority Required (Written), to Authority Required (Telephone/Immediate online assessment). The PBS listings of biosimilar medicines for first continuing therapy will change to Authority Required (Streamlined).
The PBS listings for subsequent continuing therapy for the originator (or ‘reference’) brands of the biological and immunomodulator medicines listed above will also change from Authority Required (Written) to Authority Required (Streamlined).
The intention of these changes is to ease the administrative burden for prescribers and facilitate patient access to these treatments.
Please refer to Table 1 for a summary of changes, including how different brands are affected, and any changes to PBS item codes.
Why are these changes happening?
For information about the Pharmaceutical Benefits Advisory Committee’s (PBAC) recommendations that are leading to these changes, please read the outcome statement from the March 2022 meeting, available on the PBS website.
Information for prescribers
What is changing?
From 1 November 2023, if you wish to prescribe a biosimilar medicine for your eligible patients, you no longer have to apply in writing to Services Australia. You will be able to seek approval to prescribe a biosimilar medicine for initial therapy, either via telephone or by using Services Australia’s Online PBS Authorities system (OPA). You will receive an immediate outcome for your request. Once your patient’s eligibility is confirmed, they can leave the appointment with their prescription. This includes prescriptions for changes in therapy or recommencing treatment after a break.
You will no longer need to seek prior approval from Services Australia to prescribe continuing therapy with a biosimilar medicine (for your eligible patients). Both the ‘first continuing’ and ‘subsequent continuing’ therapy listings for these medicines are now Authority Required (Streamlined).
New PBS listings for ‘first continuing’ therapy are being created for the above originator brands (where there is no biosimilar). You will need to apply in writing to Services Australia (or use the form upload function in HPOS) to prescribe therapy under these listings. However, the need to seek prior approval from Services Australia to prescribe these originator brands for ‘subsequent continuing’ therapy has been removed. The ‘subsequent continuing’ PBS listings for these products have been changed to Authority Required (Streamlined). Where your patient has already received a prescription for a medicine under the old ‘continuing’ therapy listing, you may prescribe further treatment using the corresponding Authority Required (Streamlined) ‘subsequent continuing’ listing. You do not need to use the ‘first continuing’ PBS listing for these patients. For further details please refer to Table 1.
Please note, you may need to provide Services Australia with baseline disease severity indicators when applying for authority approval to change your patient from one biological or immunomodulator medicine to a different biological or immunomodulator medicine. This change in process is required to enable the real-time assessment of authority applications for biosimilar medicines to be made and approved through the OPA system. Each authority application is assessed based on the evidence of eligibility you provide for comparison against the PBS restriction criteria. You may reuse the last set of indicators or provide a new baseline if you choose to.
What has not changed?
The PBS eligibility criteria for biological and immunomodulator medicines to treat rheumatoid arthritis have not changed. However, some of the wording in the PBS listings may have changed because of the changes to authority type.
The process for seeking authority to prescribe brands (other than biosimilars) as initial therapy has not changed. Your patient also still has the option to receive a biosimilar brand, provided that when you are applying in writing to Service Australia, you allow brand substitution on the prescription or when selecting the medicine in your prescribing software. Pharmacists can continue to substitute a reference brand with a biosimilar brand.
When prescribing continuing therapy using the Authority Required (Streamlined) listings, your patient must still meet all of the continuing therapy eligibility requirements.
Evidence of your patient’s eligibility (and continuing eligibility) must be documented in their medical record.
Information for pharmacists
All prescriptions written prior to 1 November 2023 remain valid. You may continue to dispense these as normal. The PBS item codes for etanercept (11220M, 11219L) and infliximab (11481G, 11487N) are being place in “supply only”.
A summary of new PBS items codes, by medicine and treatment phase is included in Table 1 to help you select the appropriate item code when dispensing prescriptions.
‘A’ Flagging
The changes to the authority requirements occurring on 1 November 2023 affect the substitution arrangements (‘a’ flagging) when substituting a biosimilar brand with a reference brand. Note that pharmacists can continue to substitute a reference brand with a biosimilar brand.
Initial therapy - Where the prescription for a biosimilar has been approved by Services Australia via telephone or immediate online assessment, brand substitution with the reference brand is not permitted. Brand substitution with another biosimilar brand (if applicable) is permitted. Please select the PBS item code carefully.
First continuing –where the prescription for a biosimilar is an Authority Required (Streamlined) prescription, brand substitution with the reference brand is not permitted. Brand substitution with another biosimilar brand (if applicable) is permitted.
Subsequent continuing – brand substitution between biosimilar and reference brands can occur if substitution is permitted by the prescriber.
Please refer to Table 2 for a summary of brand substitution advice.
Information for patients
Your current prescription remains valid. Your medicine will still be supplied as usual. If you have any concerns, please talk to your doctor or pharmacist.
Biosimilar brands
The Australian Government has implemented policies to encourage greater use of biosimilar brands. Biosimilar medicines encourage market competition, which makes medicines more affordable. Because most medicines in Australia are subsidised, lower prices allow the government to subsidise more medicines or spend more on other areas of health care. Biosimilar medicines give patients access to more brand options and can reduce the risk of medicine shortages. All Australian patients benefit from timely, equitable and sustainable access to safe and effective medicines through the PBS.
For further information on biosimilar brands please visit the Department of Health and Aged Care website. Information on the Government’s biosimilar uptake drivers is available on the PBS website.
|
Medicine |
Brand |
Treatment Phase |
Authority type (pre 1 Nov 2023) |
Authority type (from 1 Nov 2023) |
Use PBS item code |
Additional information |
|---|---|---|---|---|---|---|
|
ADALIMUMAB |
|
|
|
|
|
|
|
adalimumab 40 mg/0.4 mL injection, 2 x 0.4 mL pen devices or syringes |
Yuflyma |
Initial 1,2,3 |
Written |
Telephone/immediate online assessment |
13691N (pen) 13704G (syringe) |
New item codes |
|
|
Yuflyma |
First continuing |
Written |
Streamlined |
13703F (pen) 13732R (syringe) |
New item codes |
|
|
Humira
|
Subsequent continuing |
Written |
Streamlined |
13227E (pen) 13222X (syringe) |
For Humira added to existing listing for Yuflyma - No longer use 12390D (pen) 12430F (syringe)
|
|
adalimumab 40 mg/0.8 mL injection, 2 x 0.8 mL pen devices or syringes |
Amgevita Hadlima Hyrimoz Idacio |
Initial 1,2,3 |
Written |
Telephone/immediate online assessment |
13692P (pen) 13722F (syringe) |
New item codes |
|
|
Amgevita Hadlima Hyrimoz Idacio |
First continuing |
Written |
Streamlined |
13686H (pen) 13721E (syringe) |
New item codes |
|
ABATACEPT |
|
|
|
|
|
|
|
abatacept 125 mg/mL injection, 4 x 1 mL pen devices & syringes |
Orencia |
First continuing |
Written |
Written |
11684Y (pen) 1221G (syringe) |
Change of name of treatment phase only |
|
|
|
Subsequent continuing |
New treatment phase |
Streamlined |
13727L (pen) 13726K (syringe) |
New item codes. Use these listing for continuing patients who have had a prescription for item codes 1168Y or 1221G prior to 1 November 2023 |
|
abatacept 250 mg injection, 1 vial |
Orencia |
First continuing |
Written |
Written |
5605B (public) 9621J (private) |
Change of name of treatment phase only |
|
|
|
Subsequent continuing |
New treatment phase |
Streamlined |
13725J (public) 13705H (private) |
New item codes. Use these listings for continuing patients who have had a prescription for item codes 5605B or 9621J prior to 1 November 2023 |
|
BARICITINIB |
|
|
|
|
|
|
|
baricitinib 2 mg tablet, 28 |
|
First continuing |
Written |
Written |
11442F |
Change of name of treatment phase only |
|
|
|
Subsequent continuing |
New treatment phase |
Streamlined |
13689L |
New item code Use this listing for continuing patients who have had a prescription for item code 11442F prior to 1 November 2023 |
|
baricitinib 4 mg tablet, 28 |
|
First continuing |
Written |
Written |
11443G |
Change of name of treatment phase only |
|
|
|
Subsequent continuing |
New treatment phase |
Streamlined |
13702E |
New item code. Use this listing for continuing patients who have had a prescription for item code 11443G prior to 1 November 2023 |
|
CERTOLIZUMAB |
|
|
|
|
|
|
|
certolizumab pegol 200 mg/mL injection, 2 x 1 mL pen device and syringes |
Cimzia |
First continuing |
Written |
Written |
11325C (pen) 3425C (syringe) |
Change of name of treatment phase only |
|
|
|
Subsequent continuing |
New treatment phase |
Streamlined |
13701D (pen) 13735X (syringe) |
New item codes. Use these listings for continuing patients who have had a prescription for item codes 11325C or 3425C prior to 1 November 2023 |
|
ETANERCEPT |
|
|
|
|
|
|
|
etanercept 50 mg/mL injection, 4 x 1 mL pen devices & syringes |
Brenzys |
Initial 1,2,3 |
Written |
Telephone/immediate online assessment |
13687J (pen) 13698Y (syringe) |
New item codes |
|
|
|
First continuing |
Written |
Streamlined |
13708L (pen) 13707K (syringe) |
New item codes |
|
|
Enbrel |
Subsequent continuing |
Written |
Streamlined |
11218K (pen) 11211C (syringe) |
Enbrel added to existing listing for Brenzys |
|
etanercept 25 mg injection [4 vials] (&) inert substance diluent [4 x 1 mL syringes], 1 pack |
Enbrel |
Subsequent continuing |
Written |
Streamlined |
11197H |
Continue to use existing PBS item code. Change of authority type to Streamlined |
|
GOLIMUMAB |
|
|
|
|
|
|
|
golimumab 50 mg/0.5 mL injection, 0.5 mL pen devices & syringes |
Simponi |
First continuing |
Written |
Written |
11375Q (pens) 3428K (syringes) |
Change of name of treatment phase only |
|
|
|
Subsequent continuing |
New treatment phase |
Streamlined |
13706J (pens) 13699B (syringes) |
New item codes. Use these listings for continuing patients who have had a prescription for item codes 11375Q or 3428K prior to 1 November 2023 |
|
INFLIXIMAB |
|
|
|
|
|
|
|
infliximab 100 mg injection, 1 vial |
Inflectra Renflexis |
Initial 1,2,3 |
Written |
Telephone/immediate online assessment |
13723G (public) 13724H (private) |
New item codes |
|
|
|
First continuing |
Written |
Streamlined |
13734W (public) 13700C (private) |
New item codes |
|
|
Remicade |
Subsequent continuing |
Written |
Streamlined |
11483J (private) 11490R (public) |
Remicade added to existing Streamlined biosimilar listing |
|
TOCILIZUMAB |
|
|
|
|
|
|
|
tocilizumab 162 mg/0.9 mL injection, 4 x 0.9 mL pen devices & syringes |
Actemra |
First continuing |
Written |
Written |
11567T (pen) 10954M (syringe) |
Change of name of treatment phase only |
|
|
|
Subsequent continuing |
New treatment phase |
Streamlined |
13720D (pen) 13685G (syringe) |
New item codes. Use these listings for continuing patients who have had a prescription for item codes 11567T or 10954M prior to 1 November 2023 |
|
tocilizumab 200 mg/10 mL injection, 10 mL vial |
Actemra |
First continuing |
Written |
Written |
9658H (public) 9672C (private) |
Change of name of treatment phase only |
|
|
|
Subsequent continuing |
New treatment phase |
Streamlined |
13716X (private) 13684F (public) |
New item codes. Use these listings for continuing patients who have had a prescription for item codes 9658H or 9672C prior to 1 November 2023 |
|
tocilizumab 400 mg/20 mL injection, 20 mL vial |
Actemra |
First continuing |
Written |
Written |
9659J (public) 9673D (private) |
Change of name of treatment phase only |
|
|
|
Subsequent continuing |
New treatment phase |
Streamlined |
13731Q (private) 13715W (public) |
New item codes. Use these listings for continuing patients who have had a prescription for item codes 9659J or 9673D prior to 1 November 2023 |
|
tocilizumab 80 mg/4 mL injection, 4 mL vial |
Actemra |
First continuing |
Written |
Written |
9657G (public) 9671B (private) |
Change of name of treatment phase only |
|
|
|
Subsequent continuing |
New treatment phase |
Streamlined |
13696W (private) 13690M (public) |
New item codes. Use these listings for continuing patients who have had a prescription for item codes 9657G or 9671B prior to 1 November 2023 |
|
TOFACITINIB |
|
|
|
|
|
|
|
tofacitinib 5 mg tablet, 56 |
Xeljanz |
First continuing |
Written |
Written |
10511F |
Change of name of treatment phase only |
|
|
|
Subsequent continuing |
New treatment phase |
Streamlined |
13730P |
New item code. Use this listing for continuing patients who have had a prescription for item code 10511F prior to 1 November 2023 |
|
Treatment Phase [authority type] |
Presentation |
Substitutable Brands |
Item code |
Matching item code [if applicable]* |
|---|---|---|---|---|
|
ADALIMUMAB |
|
|
|
|
|
Initial 1,2,3 [Telephone/ immediate online assessment] |
adalimumab 40 mg/0.4 mL injection, 2 x 0.4 mL pen devices & |
Yuflyma, Amgevita, Hadlima, Hyrimoz, Idacio |
13691N |
13692P
|
|
Initial 1,2,3 [Telephone/ immediate online assessment] |
adalimumab 40 mg/0.4 mL injection, 2 x 0.4 mL syringes & |
Yuflyma, Amgevita, Hadlima, Hyrimoz, Idacio |
13704G |
13722F
|
|
Initial 1,2,3 [Written] |
adalimumab 40 mg/0.4 mL injection, 2 x 0.4 mL pen devices & |
Humira, Yuflyma, Amgevita, Hadlima, Hyrimoz, Idacio |
12429E |
9099X |
|
Initial 1,2,3 [Written] |
adalimumab 40 mg/0.4 mL injection, 2 x 0.4 mL syringes & |
Humira, Yuflyma, Amgevita, Hadlima, Hyrimoz, Idacio |
12400P |
8737W |
|
First continuing [Written] |
adalimumab 40 mg/0.4 mL injection, 2 x 0.4 mL pen devices & |
Humira, Yuflyma, Amgevita, Hadlima, Hyrimoz, Idacio |
12390D |
9100Y |
|
First continuing [Written] |
adalimumab 40 mg/0.4 mL injection, 2 x 0.4 mL syringes & |
Humira, Yuflyma, Amgevita, Hadlima, Hyrimoz, Idacio |
12430F |
8741C |
|
First continuing [Streamlined] |
adalimumab 40 mg/0.4 mL injection, 2 x 0.4 mL pen devices & |
Yuflyma, Amgevita, Hadlima, Hyrimoz, Idacio |
13703F |
13686H |
|
First continuing [Streamlined] |
adalimumab 40 mg/0.4 mL injection, 2 x 0.4 mL syringes & |
Yuflyma, Amgevita, Hadlima, Hyrimoz, Idacio |
13732R |
13721E |
|
Subsequent continuing [Streamlined] |
adalimumab 40 mg/0.4 mL injection, 2 x 0.4 mL pen devices & |
Humira, Yuflyma, Amgevita, Hadlima, Hyrimoz, Idacio |
13227E |
12329X |
|
Subsequent continuing [Streamlined] |
adalimumab 40 mg/0.4 mL injection, 2 x 0.4 mL syringes & |
Humira, Yuflyma, Amgevita, Hadlima, Hyrimoz, Idacio |
13222X |
12326R |
|
ETANERCEPT |
|
|
|
|
|
Initial 1,2,3 [Written] |
etanercept 50 mg/mL injection, 4 x 1 mL pen devices |
Enbrel, Brenzys |
9459W |
|
|
Initial 1,2,3 [Written] |
etanercept 50 mg/mL injection, 4 x 1 mL syringes |
Enbrel, Brenzys |
9089J |
|
|
Initial 1,2,3 [Telephone/ immediate online assessment] |
etanercept 50 mg/mL injection, 4 x 1 mL pen devices |
Brenzys only – no brand substitution permitted |
|
|
|
Initial 1,2,3 [Telephone/ immediate online assessment] |
etanercept 50 mg/mL injection, 4 x 1 mL syringes |
Brenzys only – no brand substitution permitted |
|
|
|
First continuing [Written] |
etanercept 50 mg/mL injection, 4 x 1 mL pen devices |
Enbrel, Brenzys |
9460X |
|
|
First continuing [Written] |
etanercept 50 mg/mL injection, 4 x 1 mL syringes |
Enbrel, Brenzys |
9090K |
|
|
First continuing [Streamlined] |
etanercept 50 mg/mL injection, 4 x 1 mL pen devices |
Brenzys only – no brand substitution permitted |
|
|
|
First continuing [Streamlined] |
etanercept 50 mg/mL injection, 4 x 1 mL syringes |
Brenzys only – no brand substitution permitted |
|
|
|
Subsequent continuing [Streamlined] |
etanercept 50 mg/mL injection, 4 x 1 mL pen devices |
Enbrel, Brenzys |
11218K |
|
|
Subsequent continuing [Streamlined] |
etanercept 50 mg/mL injection, 4 x 1 mL syringes |
Enbrel, Brenzys |
11211C |
|
|
INFLIXIMAB |
|
|
|
|
|
Initial 1,2,3 [Written] |
infliximab 100 mg injection, 1 vial |
Remicade, Renflexis, Inflectra |
5757B (public) |
|
|
Initial 1,2,3 [Written] |
infliximab 100 mg injection, 1 vial |
Remicade, Renflexis, Inflectra |
6397Q (private |
|
|
Initial 1,2,3 [Telephone/ immediate online assessment] |
infliximab 100 mg injection, 1 vial |
Renflexis Inflectra |
13723G (public) |
|
|
Initial 1,2,3 [Telephone/ immediate online assessment] |
infliximab 100 mg injection, 1 vial |
Renflexis Inflectra |
13724H (private) |
|
|
First continuing [Written] |
infliximab 100 mg injection, 1 vial |
Remicade, Renflexis, Inflectra |
5757B (public) |
|
|
First continuing [Written] |
infliximab 100 mg injection, 1 vial |
Remicade, Renflexis, Inflectra |
6397Q (private) |
|
|
First continuing [Streamlined] |
infliximab 100 mg injection, 1 vial |
Renflexis Inflectra |
13734W (public) |
|
|
First continuing [Streamlined] |
infliximab 100 mg injection, 1 vial |
Renflexis Inflectra |
13700C (private) |
|
|
Subsequent continuing [Streamlined] |
infliximab 100 mg injection, 1 vial |
infliximab 100 mg injection, 1 vial |
11490R (public) |
|
|
Subsequent continuing [Streamlined] |
infliximab 100 mg injection, 1 vial |
infliximab 100 mg injection, 1 vial |
11483K(private) |
|
*A ’matched item code’ included where substitution between different presentations of a medicine is permitted.
