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Spinal muscular atrophy (SMA) Program in Pharmaceutical Benefits Scheme (PBS) 012-18053100

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This document outlines details of PBS-subsidised nusinersen, onasemnogene abeparvovec and risdiplam for patients with spinal muscular atrophy (SMA).

For information on how to process a PBS Authority, see Processing Complex Authority Required Listings.

On this page:

Spinal muscular atrophy (SMA) quick reference for nusinersen (patients aged 18 years or under)

Spinal muscular atrophy (SMA) quick reference for risdiplam (patients aged 18 years or under)

Spinal muscular atrophy (SMA) quick reference for nusinersen or risdiplam (patients aged 19 years or over)

Spinal muscular atrophy (SMA) quick reference for onasemnogene abeparvovec

Onasemnogene abeparvovec dosing table

Enquiries

Spinal muscular atrophy (SMA) quick reference for nusinersen (patients aged 18 years or under)

Table 1

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial

(all SMA)

PB233 form

Written

Electronic

 

S100:

nusinersen

No

OPA

Must be treated by, or in consultation with a:

  • specialist medical practitioner experienced in the diagnosis and management of SMA who is associated with a neuromuscular clinic of a recognised hospital in the management of SMA

Yes - delayed assessment due to DPMQ (cost)

Continuing

(all SMA)

Telephone

Electronic

S100:

nusinersen

No

OPA

Must be treated by, or in consultation with, or initiated by a:

  • specialist medical practitioner experienced in the diagnosis and management of SMA who is associated with a neuromuscular clinic of a recognised hospital in the management of SMA

Yes

Change

(IIIB/IIIC SMA)

Telephone

Electronic

S100:

nusinersen

No

OPA

Must be treated by a:

  • specialist medical practitioner experienced in the diagnosis/management of SMA
  • medical practitioner directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA

Yes

Change

(Pre-symptomatic & I/II/IIIa SMA)

Telephone

Electronic

S100:

nusinersen

No

OPA

Must be treated by, or in consultation with, or initiated by a:

  • specialist medical practitioner experienced in the diagnosis and management of SMA who is associated with a neuromuscular clinic of a recognised hospital in the management of SMA

Yes

Spinal muscular atrophy (SMA) quick reference for risdiplam (patients aged 18 years or under)

Table 2

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial

(pre-symptomatic SMA with 1-2 copies of the SMN2 gene)

PB233 form

Written

Electronic

S100:

risdiplam

No

OPA

Must be treated by, or in consultation with a:

  • specialist medical practitioner experienced in the diagnosis and management of SMA who is associated with a neuromuscular clinic of a recognised hospital in the management of SMA

Yes - delayed assessment due to DPMQ (cost)

Initial

(pre-symptomatic SMA with 3 copies of the SMN2 gene)

PB233 form

Written

Electronic

S100:

risdiplam

No

OPA

Must be treated by a:

  • specialist medical practitioner experienced in the diagnosis/management of SMA
  • medical practitioner directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA

Yes - delayed assessment due to DPMQ (cost)

Initial

(I/II/IIIa SMA)

PB233 form

Written

Electronic

S100:

risdiplam

No

OPA

Must be treated by, or in consultation with a:

  • specialist medical practitioner experienced in the diagnosis and management of SMA who is associated with a neuromuscular clinic

Yes - delayed assessment due to DPMQ (cost)

Initial

(IIIB/C SMA)

PB233 form

Written

Electronic

S100:

risdiplam

No

OPA

Must be treated by a:

  • specialist medical practitioner experienced in the diagnosis/management of SMA
  • medical practitioner directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA

Yes - delayed assessment due to DPMQ (cost)

Continuing/Change

(Pre-symptomatic & I/II/IIIa SMA)

Telephone

Electronic

S100:

risdiplam

No

OPA

Must be treated by, or in consultation with a:

  • specialist medical practitioner experienced in the diagnosis and management of SMA who is associated with a neuromuscular clinic

Yes

Continuing/Change

(IIIB/IIIC SMA)

Telephone

Electronic

S100:

risdiplam

No

OPA

Must be treated by a:

  • specialist medical practitioner experienced in the diagnosis/management of SMA
  • medical practitioner directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA

Yes

Spinal muscular atrophy (SMA) quick reference for nusinersen or risdiplam (patients aged 19 years or over)

Table 3

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial

PB334 form

Written

Electronic

S100:

nusinersen

risdiplam

No

OPA

Must be treated by a:

  • specialist medical practitioner experienced in the diagnosis and management of SMA
  • medical practitioner directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA

Yes - delayed assessment due to DPMQ (cost)

Continuing/Change

Telephone

Electronic

S100:

nusinersen

risdiplam

No

OPA

Must be treated by a:

  • specialist medical practitioner experienced in the diagnosis and management of SMA
  • medical practitioner directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA

Yes

Spinal muscular atrophy (SMA) quick reference for onasemnogene abeparvovec

Table 4

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial/Change

PB330 form

Written

Electronic

S100:

onasemnogene abeparvovec

Yes

OPA

Must be treated by, or in consultation with a:

  • specialist medical practitioner experienced in the diagnosis and management of SMA who is associated with a neuromuscular clinic of a recognised hospital in the management of SMA

Yes - delayed assessment due to DPMQ (cost)

Onasemnogene abeparvovec dosing table

Table 5: the table contains information for onasemnogene abeparvovec pack configuration and item codes.

Note: the prescriber must request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.

Patient Weight Range (kg)

5.5 mL vialᵃ

8.3 mL vialᵇ

Total vials

Item codes A*

Item codes B*

2.6 - 3.0

0

2

2

12957Y

13674Q

3.1 - 3.5

2

1

3

12955W

13663D

3.6 - 4.0

1

2

3

12951P

13671M

4.1 - 4.5

0

3

3

12961E

13678X

4.6 - 5.0

2

2

4

12958B

13669K

5.1 - 5.5

1

3

4

12977B

13670L

5.6 - 6.0

0

4

4

12971Q

13665F

6.1 - 6.5

2

3

5

12940C

13682D

6.6 - 7.0

1

4

5

12942E

13672N

7.1 - 7.5

0

5

5

12962F

13667H

7.6 - 8.0

2

4

6

12950N

13683E

8.1 - 8.5

1

5

6

12976Y

13680B

8.6 - 9.0

0

6

6

12973T

13664E

9.1 - 9.5

2

5

7

12963G

13681C

9.6 - 10.0

1

6

7

12975X

13677W

10.1 - 10.5

0

7

7

12954T

13675R

10.6 - 11.0

2

6

8

12941D

13679Y

11.1 - 11.5

1

7

8

12956X

13662C

11.6 - 12.0

0

8

8

12974W

13673P

12.1 - 12.5

2

7

9

12952Q

13668J

12.6 - 13.0

1

8

9

12964H

13666G

13.1 - 13.5

0

9

9

12949M

13676T

ᵃ Vial nominal concentration is 2 x 1013 vg/mL and contains an extractable volume of not less than 5.5 mL

ᵇ Vial nominal concentration is 2 x 1013 vg/mL and contains an extractable volume of not less than 8.3 mL

* Item codes A are for:

  • Pre-symptomatic SMA with 1-2 copies of SMN2 gene or symptomatic Type I SMA, and
  • Untreated or treated with disease modifying therapy

* Item codes B are for:

  • Pre-symptomatic SMA with 3 copies of SMN2 gene, and
  • Untreated or treated with disease modifying therapy

Enquiries

Table 6

Item

Description

1

Enquiries about prescription arrangements

Transfer enquires about prescription arrangements to PBS Complex Drugs Programs, and choose the option relevant to the condition treated.

2

Enquiries about onasemnogene abeparvovec (Zolgensma®) payments

Service Officers who receive a call about payments of onasemnogene abeparvovec (Zolgensma®) must:

  • Record the caller's details, and
  • Escalate by email to PBS Claiming Support for investigation

3

Enquiries about nusinersen payments

See Call enquiries for pharmacy online claiming and payments in Pharmaceutical Benefits Scheme (PBS) for enquiries about payments for nusinersen.