National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (November Update) Instrument 2022 (Cth)

Case

PB 102 of 2022

National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (November Update) Instrument 2022

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.

Date     28 October 2022

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Highly Specialised Drugs Program) Special Arrangement 2021
(PB 27 of 2021)   2

  1. Name

(1)This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (November Update) Instrument 2022.

(2)This instrument may also be cited as PB 102 of 2022.

  1. Commencement

(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1.  The whole of this instrument 1 November 2022 1 November 2022

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

  1. Authority

This instrument is made under subsection 100(2) of the National Health Act 1953.

  1. Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)

  1. Part 1, Division 1, Section 6, definition for “CAR drug”

substitute:

CAR drug (short for Complex Authority Required drug) means any of the following highly specialised drugs:

(a)      abatacept;

(b)      adalimumab;

(c)      ambrisentan;

(d)      azacitidine;

(e)      benralizumab;

(f)      bosentan;

(g)      burosumab;     

(h)      dupilumab;

(i)       eculizumab;

(j)       elexacaftor with tezacaftor and with ivacaftor, and ivacaftor;

(k)      eltrombopag;

(l)       epoprostenol;

(m)     etanercept;

(n)      iloprost;

(o)      infliximab;

(p)      ivacaftor;

(q)      lenalidomide;

(r)      lumacaftor with ivacaftor;

(s)      macitentan;

(t)       mepolizumab;

(u)      midostaurin;

(v)      nusinersen;

(w)     omalizumab;

(x)      onasemnogene abeparvovec;

(y)      pasireotide;

(z)      pegvisomant;

(aa)    pomalidomide;

(bb)    ravulizumab;

(cc)    riociguat;

(dd)    risdiplam;

(ee)    romiplostim;

(ff)     selexipag;

(gg)    sildenafil;

(hh)    tadalafil;

(ii)      teduglutide;

(jj)      tezacaftor with ivacaftor and ivacaftor;

(kk)    tocilizumab;

(ll)      ustekinumab;

(mm)  vedolizumab.

  1. Schedule 1, entry for Abacavir with Lamivudine

omit:

Tablet containing abacavir 600 mg (as hydrochloride) with lamivudine 300 mg Oral Abacavir/Lamivudine GH 600/300 C4527 C4528 60 5

  1. Schedule 1, after entry for Bosentan in the form Tablet 125 mg (as monohydrate)

insert:

Burosumab Solution for injection 10 mg in 1 mL Injection Crysvita C13330 C13377 C13400 See Schedule 2 See Schedule 2
Solution for injection 20 mg in 1 mL Injection Crysvita C13330 C13377 C13400 See Schedule 2 See Schedule 2
Solution for injection 30 mg in 1 mL Injection Crysvita C13330 C13377 C13400 See Schedule 2 See Schedule 2

  1. Schedule 1, entry for Pomalidomide

substitute:

Pomalidomide Capsule 3 mg Oral Pomalidomide Sandoz C13141 C13144 C13145 C13252 See Schedule 2 See Schedule 2
Pomalyst C13141 C13144 C13145 C13252 See Schedule 2 See Schedule 2
Pomolide C13141 C13144 C13145 C13252 See Schedule 2 See Schedule 2
Capsule 4 mg Oral Pomalidomide Sandoz C13141 C13144 C13145 C13252 See Schedule 2 See Schedule 2
Pomalyst C13141 C13144 C13145 C13252 See Schedule 2 See Schedule 2
Pomolide C13141 C13144 C13145 C13252 See Schedule 2 See Schedule 2

  1. Schedule 1, entry for Tacrolimus in the form Capsule 5 mg

omit:

Pacrolim C5569 C9697 100 5

  1. Schedule 2, after entry for Bosentan

insert:

Burosumab C13330 C13377 C13400 Sufficient for treatment for 4 weeks 5

  1. Schedule 3, after entry for Bosentan

insert:

Burosumab C13330 X-linked hypophosphataemia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have achieved normalisation in serum phosphate levels; AND
Patient must have radiographical evidence of stabilisation/improvement in rickets in patients without growth plate fusion.
Must be treated by a a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.
Where adequate response to treatment with this drug cannot be demonstrated, the treating physician must confirm that continuing therapy has been determined to be clinically required by a second specialist physician with expertise in the treatment of X-linked hypophosphataemia.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. 		Compliance with Authority Required procedures
C13377 X-linked hypophosphataemia
Initial treatment - New patient
Patient must have a documented confirmation of PHEX pathogenic variant; OR
Patient must have a confirmed diagnosis of X-linked hypophosphataemia demonstrated by the presence of all of the following: (i) a serum phosphate concentration below the age adjusted lower limit of normal; (ii) current or historical (for those with growth plate fusion) radiographic X-ray evidence of rickets; (iii) elevated (or inappropriately normal) serum or plasma FGF-23 levels of above the mean of the assay-specific reference range; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine.
Must be treated by a a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. 		Compliance with Authority Required procedures
C13400 X-linked hypophosphataemia
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2022; AND
Patient must have a documented confirmation of PHEX pathogenic variant; OR
Patient must have, prior to commencing non-PBS-subsidised supply, a confirmed diagnosis of X-linked hypophosphataemia demonstrated by the presence of all of the following: (i) a serum phosphate concentration below the age adjusted lower limit of normal; (ii) current or historical (for those with growth plate fusion) radiographic evidence of rickets; (iii) elevated (or inappropriately normal) serum or plasma FGF-23 levels of above the mean of the assay-specific reference range; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine; AND
Patient must have achieved normalisation in serum phosphate levels; AND
Patient must have radiographical evidence of stabilisation/improvement in rickets in patients without growth plate fusion.
Must be treated by a a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.
Where adequate response to treatment with this drug cannot be demonstrated, the treating physician must confirm that continuing therapy has been determined to be clinically required by a second specialist physician with expertise in the treatment of X-linked hypophosphataemia.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. 		Compliance with Authority Required procedures
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