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

Electronic

Telephone

Electronic

Written

Electronic

Telephone

Electronic

Streamlined

Biologicals

Initial

Continuing/Switching from IV to SC

Balance of supply - initial/Continuing:

Originator

infliximab s.c. (Remsima®)

Written

Electronic

Written

Electronic

Telephone

Electronic

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial:

Originators

PB109 form

Written

Electronic

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab pegol

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 - immediate or delayed assessment (delayed if any free text option used)

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

Electronic

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab pegol

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 - immediate or delayed assessment (delayed if any free text option used)

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

Electronic

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab pegol

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

First continuing:

Biosimilars

Streamlined

S85:

adalimumab

etanercept

S100:

infliximab i.v.

(Telephone/Electronic 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 or Yes (Yes for increased quantities of infliximab i.v.)

Subsequent continuing:

Originators

PB111 form

Written

Electronic

S85:

infliximab s.c.

No

OPA

Must be treated by a:

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

Yes

Subsequent continuing:

Originators and biosimilars

Streamlined

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab pegol

etanercept

golimumab

tocilizumab s.c

tofacitinib

upadacitinib

S100:

abatacept i.v

infliximab i.v

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

tocilizumab i.v (Telephone/Electronic for increased quantities of tocilizumab i.v. to a maximum of 800mg)

No

N/A

Must be treated by a:

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

N/A or Yes (Yes for increased quantities of abatacept i.v., infliximab i.v. and tocilizumab i.v.)

Balance of supply

(top-up):

Originators and biosimilars

Telephone

Electronic

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab pegol

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

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
• 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
• 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

• Where major joint count has been provided, the number of active major joints must be either 2 or less, or reduced from baseline by at least 50%
• Where total joint count has been provided, the number of total active joints must be either 10 or less, or reduced from baseline by at least 50%

The same joint count must be used for each continuing application as was provided at baseline (total or major). If the joint count is not met, the application will need to be rejected.

Service Officers to assess that free text is:

Examples

Outcome

Relevant to the question

• Hypersensitivity to any components of the formulation
• Gastrointestinal adverse reactions
• Nausea and vomiting
• LFT derangement

Approve

Random text

• Happy Birthday
• Patient did not want to take
• Ikasditbn

Reject

Non-descriptive

• Toxicity (no details)

Reject

Bloods not elevated

• When prescriber has used an older application form with a reason provided
• When prescriber has used the current application form or the online self-serve system to provide a reason other than the 2 tick box options

Escalate to PA