Rheumatoid arthritis (RA) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051134

Biologicals

Initial

Balance of supply:

initial

First continuing

Balance of supply:

first continuing

Subsequent continuing

Biosimilars

Telephone

Electronic

Telephone

Electronic

Streamlined

N/A

Streamlined

Originators

(excluding infliximab s.c.)

Written

Telephone

Electronic

Written

Telephone

Electronic

Streamlined

Biologicals

Initial

Balance of supply:

initial

Continuing

Balance of supply:

continuing

Balance of supply:

Originator

infliximab s.c. (Remsima®)

Written

N/A

Written

N/A

Telephone

Electronic

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial:

Originators

PB109 form

Written

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab

etanercept

golimumab

infliximab s.c

tocilizumab s.c

tofacitinib

upadacitinib

S100:

abatacept i.v

infliximab i.v

tocilizumab i.v

Yes

OPA

Database

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of rheumatoid arthritis

No

Initial:

Biosimilars

Telephone

Electronic

S85:

adalimumab

etanercept

S100:

infliximab i.v

No

OPA

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of rheumatoid arthritis

Yes

Change or

Recommencement:

Originators

PB247 form

Written

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab

etanercept

golimumab

infliximab s.c

tocilizumab s.c

tofacitinib

upadacitinib

S100:

abatacept i.v

infliximab i.v

tocilizumab i.v

Yes

OPA

Database

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of rheumatoid arthritis

No

Change or

Recommencement:

Biosimilars

Telephone

Electronic

S85:

adalimumab

etanercept

S100:

infliximab i.v

No

OPA

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of rheumatoid arthritis

Yes

First continuing:

Originators

PB111 form

Written

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab

etanercept

golimumab

infliximab s.c

tocilizumab s.c

tofacitinib

upadacitinib

S100:

abatacept i.v

infliximab i.v

tocilizumab i.v

No

OPA

Database

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of rheumatoid arthritis

No

First continuing:

Biosimilars

Streamlined

S85:

adalimumab

etanercept

S100:

infliximab i.v.

(Telephone for increased quantities of infliximab i.v. for patients>100kg)

No

N/A

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of rheumatoid arthritis

N/A

Subsequent continuing:

Originators

PB111 form

Written

S85:

infliximab s.c.

No

OPA

Database

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of rheumatoid arthritis

No

Subsequent continuing:

Originators and biosimilars

Streamlined

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab

etanercept

golimumab

tocilizumab s.c

tofacitinib

upadacitinib

S100:

abatacept i.v

infliximab i.v

(Telephone for increased quantities of infliximab i.v. and abatacept i.v. for patients>100kg)

tocilizumab i.v

No

N/A

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of rheumatoid arthritis

N/A

Balance of supply

(top-up):

Originators and biosimilars

Telephone

Electronic

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab

etanercept

golimumab

infliximab s.c

tocilizumab s.c

tofacitinib

upadacitinib

S100:

abatacept i.v

infliximab i.v

tocilizumab i.v

No

OPA

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of rheumatoid arthritis

Yes

Demonstration of response:

Originators

PB247 form

Written

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab

etanercept

golimumab

infliximab s.c

tocilizumab s.c

tofacitinib

upadacitinib

S100:

abatacept i.v

infliximab i.v

tocilizumab i.v

No

Database

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of rheumatoid arthritis

No

Medical Break:

Originators

Written

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab

etanercept

golimumab

infliximab s.c

tocilizumab s.c

tofacitinib

upadacitinib

S100:

abatacept i.v

infliximab i.v

tocilizumab i.v

Yes

Database

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of rheumatoid arthritis

No

Application type

Action

Initial

• Create a patient record on the database if needed
• Create a new pended entry in the database
• Send to a Pharmaceutical Advisor (PA) for assessment
• Once PA has assessed application, complete the entry in the database

Change from JIA/sJIA to RA

• Create a patient record on the database if needed
• Create a new pended entry with application type Change even if it is the first application on the database
• Send to a PA for assessment
• Once PA has assessed application, complete the entry in the database

First continuing

If approved:

• Create and complete an entry in the database
• Enter the next assessment date (NAD)

Subsequent continuing

(for infliximab s.c. only)

• No line in the database needed
• If approved, enter the NAD

Grandfather

• Create a patient record on the database if needed
• Create a new pended entry in the database
• Send to a PA for assessment
• Once PA has assessed application, complete the entry in the database

Change

or

Recommencement

• Create a new pended entry in the database
• Send to a PA for assessment
• Once PA has assessed application, complete the entry in the database

Balance of supply

No database entry is needed.

Demonstration of Response

• Create and complete a new entry in the database
• Update the drug history

Medical break

• Create a new pended entry in the database
• Send to a PA to action

Baseline

Action

ESR

Erythrocyte Sedimentation Rate (ESR)

Where ESR has been provided:

• ESR must be either 25 or less, or reduced by 20% from baseline levels
• The target level is found on the database
• A response cannot be assessed against ESR if ESR is not recorded at baseline
• If both ESR and CRP are provided at baseline, either can be used to demonstrate a response to treatment

CRP

C-Reactive Protein (CRP)

Where CRP has been provided:

• CRP must be either 15 or less, or reduced by 20% from baseline levels
• The target level is found on the database
• A response cannot be assessed against CRP if CRP is not recorded at baseline
• If both ESR and CRP are provided at baseline, either can be used to demonstrate a response to treatment

Joint count

Response to Joints

The database will provide the target for response the patient must meet:

• The number of active joints must be reduced from baseline by at least 50%
• Where the baseline is shown with the suffix M (major) - ignore the joints of the hands and feet
• If the joint target is not met, reject the application

Step

Action

1

Is the previous next assessment date within 3 months of date of processing?

• Yes, approve
• No, go to Step 2

2

Has the prescriber completed current treatment or supplied dates of most recent treatment course on the application form?

• Yes, approve
• No, go to Step 3

3

Check dispensing history. Is there a dispensing in the last 3 months?

• Yes, approve
• No, go to Step 4

4

Is there a letter or note from the prescriber about a break in treatment?

• Yes, escalate to a Pharmaceutical Advisor (PA) with a clear reason for escalation in the notes
• No, reject

Step

Action

1

A prescriber calls to say their patient is not meeting criteria based on their blood markers due to a medical or clinical reason

• Check the patient’s dispensing history. If there are repeats outstanding, tell the prescriber to reassess response after remaining treatment has been used by the patient
• If no repeats are available, advise to complete a continuing application and document the reason for elevated bloods

2

Patient not meeting blood marker/s criteria and prescriber has included a medical or clinical reason in writing

• Escalate to a Pharmaceutical Advisor (PA)

3

Approval decision

If:

• approving request, only a one-month supply can be given
• rejecting request, a rejection letter must be sent