Ankylosing spondylitis (AS) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051102

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial:

originators

PB073 form

Written

Electronic

S85:

adalimumab

bimekizumab

certolizumab pegol

etanercept

golimumab

infliximab s.c.

ixekizumab

secukinumab

tofacitinib

upadacitinib

S100:

infliximab i.v.

No

OPA

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of ankylosing spondylitis

Yes - delayed assessment (due to exercise program attachment and 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 ankylosing spondylitis

Yes

Grandfather

PB352 form

Written

Electronic

S85:

bimekizumab

No

OPA

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of ankylosing spondylitis

Yes - delayed assessment (due to exercise program attachment and any free text option used)

Change

or

recommencement:

originators

PB251 form

Written

Electronic

S85:

adalimumab

bimekizumab

certolizumab pegol

etanercept

golimumab

infliximab s.c.

ixekizumab

secukinumab

tofacitinib

upadacitinib

S100:

infliximab i.v.

No

OPA

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of ankylosing spondylitis

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 ankylosing spondylitis

Yes

First continuing:

originators

PB074 form

Written

Electronic

S85:

adalimumab

bimekizumab

certolizumab pegol

etanercept

golimumab

infliximab s.c.

ixekizumab

secukinumab

tofacitinib

upadacitinib

S100:

infliximab i.v.

No

OPA

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of ankylosing spondylitis

Yes

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 ankylosing spondylitis

N/A

Subsequent continuing: originators

PB074 form

Written

Electronic

S85:

adalimumab

bimekizumab

certolizumab pegol

etanercept

golimumab

infliximab s.c.

ixekizumab

secukinumab

tofacitinib

upadacitinib

S100:

infliximab i.v.

No

OPA

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of ankylosing spondylitis

Yes

Subsequent 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 ankylosing spondylitis

N/A

Balance of supply

(top-up):

originators and biosimilars

Telephone

Electronic

S85:

adalimumab

bimekizumab

certolizumab pegol

etanercept

golimumab

infliximab s.c.

ixekizumab

secukinumab

tofacitinib

upadacitinib

S100:

infliximab i.v.

No

OPA

Must be treated by a:

• rheumatologist
• clinical immunologist with expertise in the management of ankylosing spondylitis

Yes

Biologicals

Initial

Balance of supply:

initial

First continuing

Subsequent continuing

Balance of supply:

continuing

Originator

Written

Electronic

Telephone

Electronic

Written

Electronic

Written

Electronic

Telephone

Electronic

Biosimilar

Telephone

Electronic

Telephone

Electronic

Streamlined

Streamlined

N/A

Biologicals

Initial

Balance of supply:

initial

Continuing

Balance of supply:

continuing

Balance of supply:

all

Originator

(excluding infliximab s.c.)

Written

Electronic

Telephone

Electronic

Written

Electronic

Telephone

Electronic

N/A

Originator

infliximab s.c. (Remsima®)

Written

Electronic

N/A

Written

Electronic

N/A

Telephone

Electronic

Item

Action

1

Erythrocyte Sedimentation Rate (ESR)

Where ESR has been provided:

• ESR must be either 25 or less, or reduced by 20% from the baseline level
• a response cannot be assessed against ESR if ESR is not documented at baseline
• if both ESR and CRP are provided at baseline, either can be used to demonstrate a response to treatment

2

C-Reactive Protein (CRP)

Where CRP has been provided:

• CRP must be either 10 or less, or reduced by 20% from the baseline level
• a response cannot be assessed against CRP if CRP is not documented at baseline
• if both ESR and CRP are provided at baseline, either can be used to demonstrate a response to treatment

3

Response to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

• The BASDAI must be either 2 or less, or reduced by 2 units compared to the baseline score
• If the patient is not responding on their BASDAI, the application must be rejected

Prior therapy

Contraindication

NSAID

• Known hypersensitivity to aspirin or other NSAIDs
• Asthma or other allergic-type reactions that are aspirin or NSAIDs sensitive
• Active, or a history of, peptic or gastrointestinal ulceration, bleeding or perforation
• Active, or history of, haemorrhage, chronic dyspepsia, or conditions involving an increased tendency or active bleeding
• Active inflammatory bowel disease
• Previous myocardial infarction or stroke
• Unstable ischaemic heart disease
• Congestive heart failure or severe heart failure
• Severe renal impairment
• Severe liver impairment
• Undergoing treatment of perioperative pain in a setting of coronary artery bypass surgery (CABG)
• Pregnancy or planned pregnancy
• Breastfeeding
• Other contraindications based on TGA-approved PI

Delayed assessment checks for uploaded document / free text

Examples

Outcome

Uploaded document

• A completed exercise program self-certification attached which must include the following details:
• Dates and relevant ticks to indicate exercise(s) undertaken, and
• Patient’s declaration including full name, signature and date, and
• Prescriber’s declaration including full name, signature and date, and
• It is for the correct patient on the application

Approve

• An incomplete exercise program with any of the details listed above missing, and/or it is for the incorrect patient on the application

Reject

• Unrelated document(s) attached

Reject

Free text - relevant to the question

• Intolerances to prior therapies:
• Heart condition
• Worsened renal failure
• Nausea and vomiting
• Elevated or deranged etc. liver function test
• Gastrointestinal toxicity
• Common NSAIDs (originator brands in the bracket) to treat AS:
• ibuprofen (Nurofen)
• naproxen (Naprosyn)
• celecoxib (Celebrex)
• diclofenac (Voltaren)
• meloxicam (Mobic)
• piroxicam (Feldene)
• ketoprofen (Orudis, Oruvail)

Approve

Free text - random

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

Reject

Free text - non-descriptive

• Toxicity (no details)
• Intolerance
• Ineffective

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 provided a reason other than the 2 steroid-related reasons listed above

Escalate to PA

Contraindications to prior NSAID therapy

• When prescriber has used written application form with contraindication(s) other than the list of contraindications in OPA
• When prescriber has used the online self-serve system to provide contraindication(s) and select free text other than ticking the box of listed contraindications in OPA

Escalate to PA