Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Non-radiographic axial spondyloarthritis

Initial treatment - Initial 1 (New patient)

Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND

Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND

Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND

The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND

The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND

The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND

The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND

The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND

The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND

Must be treated by a rheumatologist; or

Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.

The application must include details of the NSAIDs trialled, their doses and duration of treatment.

If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.

If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.

If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.

The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:

(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and

(b) C-reactive protein (CRP) level greater than 10 mg per L.

The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.

If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.

The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.

The authority application must be made in writing and must include:

(a) details of the proposed prescription(s); and

(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

The baseline BASDAI score and CRP level must also be documented in the patient's medical records.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Non-radiographic axial spondyloarthritis

Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND

Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND

The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND

Must be treated by a rheumatologist; or

Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.

An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.

A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.

An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:

(a) a CRP measurement no greater than 10 mg per L; or

(b) a CRP measurement reduced by at least 20% from baseline.

The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.

BASDAI scores and CRP levels must be documented in the patient's medical records.

The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.

The following must be provided at the time of application and documented in the patient's medical records:

(a) the BASDAI score; and

(b) the C-reactive protein (CRP) level.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Non-radiographic axial spondyloarthritis

Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND

Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND

The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND

The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND

The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND

The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND

The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND

The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND

Must be treated by a rheumatologist; or

Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.

The following must be provided at the time of application and documented in the patient's medical records:

(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and

(b) C-reactive protein (CRP) level greater than 10 mg per L.

The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application.

If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.

The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Non-radiographic axial spondyloarthritis

Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND

The treatment must provide no more than the balance of up to 16 weeks treatment; AND

Must be treated by a rheumatologist; or

Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.