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

Initial

Balance of supply - initial

Continuing/Switching from IV to SC

infliximab s.c. (Remsima®)

Written

Electronic

Telephone

Electronic

Streamlined

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

Continuing

Streamlined

S85:

infliximab s.c

No

N/A

Must be treated by a:

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

N/A

First continuing:

Originators

PB111 form

Written

Electronic

S85:

abatacept s.c

adalimumab

baricitinib

certolizumab pegol

etanercept

golimumab

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 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.

Prior therapy

Contraindications

methotrexate

• Hypersensitivity
• Pregnancy
• Breastfeeding
• Severe hepatic impairment
• Severe renal impairment
• Alcoholism or alcoholic liver disease
• Overt or laboratory evidence of immunodeficiency syndromes
• Bone marrow depression or pre-existing blood dyscrasias, such as bone marrow hypoplasia, leucopenia, thrombocytopenia or anaemia
• Serious, acute or chronic infections
• Peptic ulcer disease or ulcerative colitis
• Concurrent vaccinations with live vaccines
• Concomitant administration with retinoids such as acitretin

leflunomide

• Hypersensitivity to leflunomide, teriflunomide or to any of the excipients in the tablets
• Severe immunodeficiency states, example AIDS
• Significantly impaired bone marrow function or significant anaemia, leukopenia or thrombocytopenia due to causes other than rheumatoid arthritis
• Severe, uncontrolled infections
• Impairment of liver function
• Pregnancy
• Breastfeeding
• Has childbearing potential and is not using reliable contraception during treatment with leflunomide and for a certain period of time thereafter, as long as the plasma levels of the active metabolite are above 0.02 mg/L, unless undergoing washout treatment
• Severe hypoproteinaemia Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme

sulfasalazine

• Haematological, renal or hepatic dysfunction
• Allergic drug fever or skin eruptions due to sulphonamide derivatives including antibacterial sulphonamides, oral hypoglycaemics and thiazides
• Hypersensitivity to sulfasalazine, its metabolites, or any other component of the product, sulfonamides, or salicylates
• Intestinal or urinary obstruction
• Porphyria

hydroxychloroquine

• Pre-existing maculopathy of the eye
• Known hypersensitivity to 4-aminoquinoline compounds

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)
• Ineffective
• Intolerance

Reject

Bloods not elevated

• Treatment with prednisolone (or equivalent steroid)
• Treatment with a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent)

Approve

Bloods not elevated

• When prescriber has used an older application form and provided a reason other than the 2 steroid-related reasons listed above
• 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