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

S85:

adalimumab

bimekizumab

certolizumab pegol

etanercept

golimumab

infliximab s.c.

ixekizumab

secukinumab

tofacitinib

upadacitinib

S100:

infliximab i.v.

Yes

OPA

Database

Must be treated by a:

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

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 ankylosing spondylitis

Yes

Grandfather

PB352 form

Written

S85:

bimekizumab

Yes

OPA

Database

Must be treated by a:

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

No

Change

or

recommencement:

originators

PB251 form

Written

S85:

Adalimumab

bimekizumab

certolizumab pegol

etanercept

golimumab

infliximab s.c.

ixekizumab

secukinumab

tofacitinib

upadacitinib

S100:

infliximab i.v.

Yes

OPA

Database

Must be treated by a:

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

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 ankylosing spondylitis

Yes

First continuing:

originators

PB074 form

Written

S85:

Adalimumab

bimekizumab

certolizumab pegol

etanercept

golimumab

infliximab s.c.

ixekizumab

secukinumab

tofacitinib

upadacitinib

S100:

infliximab i.v.

No

OPA

Database

Must be treated by a:

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

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 ankylosing spondylitis

N/A

Subsequent continuing: originators

PB074 form

Written

S85:

adalimumab

bimekizumab

certolizumab pegol

etanercept

golimumab

infliximab s.c.

ixekizumab

secukinumab

tofacitinib

upadacitinib

S100:

infliximab i.v.

No

OPA

Database

Must be treated by a:

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

No

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

Demonstration of response:

originators

PB251 form

Written

S85:

adalimumab

bimekizumab

certolizumab pegol

etanercept

golimumab

infliximab s.c.

ixekizumab

secukinumab

tofacitinib

upadacitinib

S100:

infliximab i.v.

No

Database

Must be treated by a:

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

No

Medical break:

originators

Written

S85:

adalimumab

bimekizumab

certolizumab pegol

etanercept

golimumab

infliximab s.c.

ixekizumab

secukinumab

tofacitinib

upadacitinib

S100:

infliximab i.v.

Yes

Database

Must be treated by a:

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

No

Biologicals

Initial

Balance of supply:

initial

First continuing

Subsequent continuing

Balance of supply:

continuing

Originator

Written

Telephone

Electronic

Written

Written

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

Telephone

Electronic

Written

Telephone

Electronic

N/A

Originator

infliximab s.c. (Remsima®)

Written

N/A

Written

N/A

Telephone

Electronic

Application type

Action

Initial

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

Grandfather

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

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

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 required.

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

Step

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
• The target level is found on the database
• A response cannot be assessed against ESR if ESR is not recorded at baseline

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
• The target level is found on the database
• A response cannot be assessed against CRP if CRP is not recorded at baseline

3

Response to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

The BASDAI must be reduced by 2 compared to baseline:

• Where the baseline is high (near 10) and the continuing is below 5, for example - a detailed measurement is not needed
• If the current BASDAI does not appear greatly reduced, an accurate measurement is needed. Refer to a Pharmaceutical Advisor (PA)
• If the patient is not responding on their BASDAI, the application must be rejected

Step

Action

1

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

• Yes, approve
• No, go to Step 2

2

Is the application a subsequent continuing for a drug with a biosimilar brand listing?

• Yes, approve
• No, go to Step 3

3

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

• Yes, approve
• No, go to Step 4

4

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

• Yes, approve
• No, go to Step 5

5

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

• Yes, refer to a Pharmaceutical Advisor (PA)
• No, Step reject

Scenario

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