National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 2) (PB 17 of 2020) (Cth)
PB 17 of 2020
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 2)
National Health Act 1953
___________________________________________________________________________
I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.
Dated 27 February 2020
BEN SLADIC
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 2).
(2)This Instrument may also be cited as PB 17 of 2020.
Commencement
This Instrument commences on 1 March 2020.
Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1 Amendments
Part 1, Division 1, Section 4, definition for ‘medication for the treatment of HIV or AIDS’
substitute:
medication for the treatment of HIV or AIDS means any of the following:
(a) abacavir
(b) abacavir with lamivudine
(c) abacavir with lamivudine and zidovudine
(d) atazanavir
(e) atazanavir with cobicistat
(f) azithromycin
(g) bictegravir with emtricitabine with tenofovir alafenamide
(h) darunavir
(i) darunavir with cobicistat
(j) dolutegravir
(k) dolutegravir with abacavir and lamivudine
(l) dolutegravir with rilpivirine
(m) doxorubicin - pegylated liposomal
(n) efavirenz
(o) emtricitabine with rilpivirine with tenofovir alafenamide
(p) emtricitabine with tenofovir alafenamide
(q) enfuvirtide
(r) etravirine
(s) fosamprenavir
(t) ganciclovir
(u) lamivudine
(v) lamivudine with zidovudine
(w) lopinavir with ritonavir
(x) maraviroc
(y) nevirapine
(z) raltegravir
(aa) rifabutin
(bb) rilpivirine
(cc) ritonavir
(dd) saquinavir
(ee) tenofovir
(ff) tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat
(gg) tenofovir with emtricitabine
(hh) tenofovir with emtricitabine and efavirenz
(ii) tipranavir
(jj) valganciclovir
(kk) tipranavir
(ll) zidovudine
Schedule 1, entry for Dolutegravir with abacavir and lamivudine
(a)omit from the column headed “Circumstances”: C9934
(b)insert in numerical order in the column headed “Circumstances”: C10116
Schedule 1, entry for Levodopa with Carbidopa
substitute:
| Levodopa with carbidopa | Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL | Intra‑ intestinal | Duodopa | VE | EMP | C10138 C10160 C10161 C10169 | P10138 P10161 | 28 | 5 | C |
| EMP | C10138 C10160 C10161 C10169 | P10160 P10169 | 56 | 5 | C |
Schedule 1, entry for Nusinersen
(a)omit from the column headed “Circumstances”: C7848
(b)omit from the column headed “Circumstances”: C7870
(c)insert in numerical order in the column headed “Circumstances”: C10112
Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL
omit:
| Hospira Pty Limited | PF | EMP | C6369 C6390 C8165 C9232 C9233 C9289 | 90 | 11 | D |
Schedule 1, entry for Pegfilgrastim
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Ziextenzo | SZ | EMP | C7822 C7843 C9235 C9303 | 1 | 11 | D |
Schedule 1, after entry for Tacrolimus in the form Capsule 2 mg
insert:
| Capsule 3 mg (once daily prolonged release) | Oral | ADVAGRAF XL | LQ | EMP | C5569 C9697 | 100 | 3 | C |
Schedule 1, omit entry for Tenofovir with emtricitabine, elvitegravir and cobicistat
Schedule 1, omit entry for Tenofovir with Emtricitabine and Rilpivirine
Schedule 3, entry for Dolutegravir with abacavir and lamivudine
(a)omit:
| C9934 | HIV infection Continuing treatment Patient must have previously received PBS‑subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9934 |
(b)insert in numerical order after existing text:
| C10116 | HIV infection Continuing treatment Patient must have previously received PBS-subsidised therapy for HIV infection. | Compliance with Authority Required procedures - Streamlined Authority Code 10116 |
Schedule 3, entry for Levodopa with carbidopa
substitute:
| Levodopa with carbidopa | C10138 | P10138 | Advanced Parkinson disease Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND The treatment must be commenced in a hospital-based movement disorder clinic. | Compliance with Authority Required procedures - Streamlined Authority Code 10138 |
| C10160 | P10160 | Advanced Parkinson disease Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND The treatment must be commenced in a hospital-based movement disorder clinic; AND Patient must be undergoing continuous treatment with a dose greater than 2000 mg of levodopa per day without an overnight break. | Compliance with Authority Required procedures - Streamlined Authority Code 10160 | |
| C10161 | P10161 | Advanced Parkinson disease Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND The treatment must be commenced in a hospital-based movement disorder clinic. | Compliance with Authority Required procedures - Streamlined Authority Code 10161 | |
| C10169 | P10169 | Advanced Parkinson disease Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND The treatment must be commenced in a hospital-based movement disorder clinic; AND Patient must be undergoing continuous treatment with a dose greater than 2000 mg of levodopa per day without an overnight break. | Compliance with Authority Required procedures - Streamlined Authority Code 10169 |
Schedule 3, entry for Nusinersen
(a)omit:
| C7848 | Spinal muscular atrophy (SMA) Grandfather patients Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA. Patient must have previously received non‑PBS‑subsidised treatment for this condition with this drug prior to 1 June 2018; AND The condition must 5q homozygous deletion, mutation of, or compound heterozygous mutation in the SMN1 gene of type I, II or IIIa; AND Patient must have had experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND Patient must have previously received at least one of the four loading doses at days 0, 14, 28 and 63; AND The treatment must be given concomitantly with standard of care for this condition; AND The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug. Patient must have been 18 years of age or under at the time treatment with this drug was initiated for this condition; OR Patient must have previously received treatment with this drug for this condition under the care of clinicians with the authorised prescriber number of AP17/83146. Defined signs and symptoms of type I SMA are: i) Onset before 6 months of age; and ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or iii) Proximal weakness; or iv) Hypotonia; or v) Absence of deep tendon reflexes; or vi) Failure to gain weight appropriate for age; or vii) Any active chronic neurogenic changes; or viii) A compound muscle action potential below normative values for an age‑matched child. Defined signs and symptoms of type II SMA are: i) Onset between 6 and 18 months; and ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or iii) Proximal weakness; or iv) Weakness in trunk righting/derotation; or v) Hypotonia; or vi) Absence of deep tendon reflexes; or vii) Failure to gain weight appropriate for age; or viii) Any active chronic neurogenic changes; or ix) A compound muscle action potential below normative values for an age‑matched child. Defined signs and symptoms of type IIIa SMA are: i) Onset between 18 months and 3 years of age; and ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or iii) Proximal weakness; or iv) Hypotonia; or v) Absence of deep tendon reflexes; or vi) Failure to gain weight appropriate for age; or vii) Any active chronic neurogenic changes; or viii) A compound muscle action potential below normative values for an age‑matched child. Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day. Recognised hospitals in the management of SMA are Lady Cilento Children's Hospital (Brisbane), Royal Children's Hospital Melbourne, Monash Children's Hospital (Melbourne), John Hunter Hospital (Newcastle), Sydney Children's Hospital Randwick, Children's Hospital at Westmead, Adelaide Women and Children's Hospital and Perth Children's Hospital. Application for authorisation of grandfathering treatment must be in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Spinal muscular atrophy PBS Authority Application for Grandfather patients ‑ Supporting Information Form which includes the following: (i) specification of SMA type (I, II or IIIa); and (ii) sign(s) and symptom(s) that the patient has experienced; and (iii) patient's age at the onset of sign(s) and symptom(s); and (iv) if relevant, a copy of a TGA‑approval letter to clinician with the authorised prescriber number of AP17/83146. A patient may qualify for PBS‑subsidised treatment under this restriction once only. For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Written Authority Required procedures |
(b)omit:
| C7870 | Spinal muscular atrophy (SMA) Continuing treatment ‑ Maintenance Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA. Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND The treatment must be given concomitantly with standard of care for this condition; AND The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug. Recognised hospitals in the management of SMA are Lady Cilento Children's Hospital (Brisbane), Royal Children's Hospital Melbourne, Monash Children's Hospital (Melbourne), John Hunter Hospital (Newcastle), Sydney Children's Hospital Randwick, Children's Hospital at Westmead, Adelaide Women and Children's Hospital and Perth Children's Hospital. Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day. | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text:
| C10112 | Spinal muscular atrophy (SMA) Continuing treatment - Maintenance Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or initiated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be given concomitantly with standard of care for this condition; AND The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug. Recognised hospitals in the management of SMA are Lady Cilento Children's Hospital (Brisbane), Royal Children's Hospital Melbourne, Monash Children's Hospital (Melbourne), John Hunter Hospital (Newcastle), Sydney Children's Hospital Randwick, Children's Hospital at Westmead, Adelaide Women and Children's Hospital and Perth Children's Hospital. Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day. | Compliance with Written Authority Required procedures |
Schedule 3, omit entry for Tenofovir with emtricitabine, elvitegravir and cobicistat
Schedule 3, omit entry for Tenofovir with emtricitabine and rilpivirine
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