National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 4) (PB 40 of 2018) (Cth)
PB 40 of 2018
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 4)
National Health Act 1953
___________________________________________________________________________
I, JULIANNE QUAINE, Assistant Secretary, Private Health Insurance and 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 29 May 2018
JULIANNE QUAINE
Assistant Secretary
Private Health Insurance and 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 2018 (No. 4).
(2)This Instrument may also be cited as PB 40 of 2018.
Commencement
This Instrument commences on 1 June 2018.
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 CAR drug
insert in alphabetical order:
oa) nusinersen
Part 1, Division 1, Section 4, definition for medication for the treatment of hepatitis B
omit:
(d) interferon alfa 2b
Part 1, Division 1, Section 4, definition for medication for the treatment of HIV or AIDS
omit:
h) didanosine
Part 1, Division 1, Section 4, definition for medication for the treatment of HIV or AIDS
omit:
(zf) stavudine
Part 2, Division 4, Section 24(2)
omit:
(q) for HSD pharmaceutical benefits that have the drug omalizumab, for initial PBS-subsidised treatment of uncontrolled severe allergic asthma in a patient who has previously received non-PBS-subsidised therapy with omalizumab (grandfather patients)—a quantity of units that are sufficient to provide for 24 weeks treatment;
Part 2, Division 4, Section 24(2)(x)
omit:
(i) for Grandfathered patients—the maximum quantity authorised will be limited to provide sufficient supply for 1 month.
Part 2, Division 4, Section 24(2)(y)
omit:
(i) for Grandfathering—maximum of 24 weeks of treatment.
Part 2, Division 4, Section 24(2)(z)(ii)
omit:
Initial 4 (Grandfathered patients), Initial 5 (Grandfathered patients),
Part 2, Division 4, Section 24(2)
insert in alphabetical order:
(zf) for HSD pharmaceutical benefits that have the drug nusinersen, for PBS-subsidised treatment of spinal muscular atrophy:
(i) for initial treatment with loading doses at days 0, 14, 28 and 63—up to 2 x solution for injection 12 mg in 5 mL for days 0 and 14; up to 1 x solution for injection 12 mg in 5 mL for day 28 or 63.
(ii) for continuing treatment—0 repeat supplies
Part 2, Division 4, Section 25(2)(zb)
omit:
(i) for grandfathering—up to 5 repeat supplies
Part 2, Division 4, Section 25(2)(zc)(ii)
omit:
Initial 4 (Grandfathered patients), Initial 5 (Grandfathered patients),
Part 2, Division 4, Section 25(2)(zc)(ii)
insert in alphabetical order:
(zi) for nusinersen, for the treatment of spinal muscular atrophy:
(i)for initial treatment loading doses —up to 1 x solution for injection 12 mg in 5 mL
(ii)for continuing treatment—up to 1 x solution for injection 12 mg in 5 mL
Schedule 1, omit entry for Didanosine
Schedule 1, entry for Infliximab
(a)omit from the column headed “Circumstances” (all brands): C6901 C6909 C6943
(b)omit from the column headed “Circumstances” (all brands): C7037
(c)insert in numerical order in the column headed “Circumstances” (all brands): C7658 C7660 C7665 C7669
Schedule 1, omit entry for Interferon Alfa-2b
Schedule 1, entry for Interferon Gamma-1b
omit from the column headed “Responsible Person”: BY substitute: EU
Schedule 1, entry for Ivacaftor in each of the forms: Sachet containing granules 50 mg; and Sachet containing granules 75 mg
omit from the column headed “Circumstances”: C6857
Schedule 1, entry for Lamivudine
omit:
Oral solution 5 mg per mL, 240 mL Oral Zeffix RW EMP C4993 C5036 5 5 D
Schedule 1, after entry for Nevirapine
insert:
Nusinersen Solution for injection 12 mg in 5 mL Injection Spinraza BD EMP C7627 C7649 C7650 P7627 P7649 1 0 D EMP C7627 C7649 C7650 P7650 1 1 D
Schedule 1, entry for Omalizumab in each of the forms: Injection 75 mg in 0.5 mL single dose pre filled syringe; and Injection 150 mg in 1 mL single dose pre filled syringe
(a)omit from the column headed “Circumstances”: C4875 C4879
(b)omit from the column headed “Circumstances”: C6596
(c)omit from the column headed “Circumstances”: C6788
(d)insert in numerical order in the column headed “Circumstances”: C7634 C7636
Schedule 1, entry for Riociguat in each of the forms: Tablet 500 micrograms; Tablet 1 mg; Tablet 1.5 mg; Tablet 2 mg; and Tablet 2.5 mg
(a)omit from the column headed “Circumstances”: C6624 C6641
(b)omit from the column headed “Circumstances”: C6746
(c)omit from the column headed “Circumstances”: C6774
(d)insert in numerical order in the column headed “Circumstances”: C7629
Schedule 1, omit entry for Stavudine
Schedule 1, entry for Valganciclovir in the form Tablet 450 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Valganciclovir AN”: EA substitute: JO
Schedule 1, entry for Vedolizumab
(a)omit from the column headed “Circumstances”: C6583 C6589
(b)omit from the column headed “Circumstances”: C6617
(c)insert in numerical order in the column headed “Circumstances”: C7668 C7672 C7683
Schedule 2, after details relevant to Responsible Person code EA
insert:
EU Emerge Health Pty Ltd 72 145 180 865
Schedule 2, after details relevant to Responsible Person code JC
insert:
JO Juno Pharmaceuticals Pty Ltd 55 156 303 650
Schedule 3, omit entry for Didanosine
Schedule 3, entry for Eltrombopag
(a)for Circumstances Code C6724, omit from the column headed 'Authority Requirements - Part of Circumstances':
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(b)for Circumstances Code C6725, omit from the column headed 'Authority Requirements - Part of Circumstances':
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(c)for Circumstances Code C6738, omit from the column headed 'Authority Requirements - Part of Circumstances':
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(d)for Circumstances Code C6739, omit from the column headed 'Authority Requirements - Part of Circumstances':
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(e)for Circumstances Code C6790, omit from the column headed 'Authority Requirements - Part of Circumstances':
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
Schedule 3, entry for Infliximab
(a)omit:
C6901 Moderate to severe ulcerative colitis
Change or Re-commencement of treatment after a break in therapy (Initial 2)
Patient must have previously received PBS-subsidised treatment with adalimumab, infliximab or vedolizumab for this condition in this treatment cycle; OR
Patient must have previously received PBS-subsidised treatment with adalimumab or infliximab for this condition in this treatment cycle if aged 6 to 17 years; AND
Patient must not have failed PBS-subsidised treatment with infliximab for this condition in the current treatment cycle; OR
Patient must not have failed PBS-subsidised treatment with infliximab for this condition in the current treatment cycle more than once if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
Applications for authorisation of initial treatment must be in writing and must include:(a) a completed authority prescription form; and(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy];
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.
Up to a maximum of 2 repeats will be authorised.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses or 2 repeats may be requested by telephone by contacting the Department of Human Services.Compliance with Authority Required procedures C6909 Moderate to severe ulcerative colitis
Balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug under the Initial 2 (Change or Recommencement of treatment after a break in therapy) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 3 doses (Initial 1 and Initial 2 restrictions) or 2 repeats (Continuing restriction).
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses or 2 repeats may be requested by telephone by contacting the Department of Human Services.Compliance with Authority Required procedures C6943 Moderate to severe ulcerative colitis
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; OR
Patient must have previously received induction therapy with this drug for an acute severe episode of ulcerative colitis in the last 4 months and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a PUCAI score less than 10 (if aged 6 to 17 years).
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the signed patient acknowledgement or guardian acknowledgement.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8-weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 1 month old at the time of application.
Where treatment for an acute severe episode has occurred, an adequate response to induction therapy needs to be demonstrated by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 (if aged 6 to 17 years), within the first 12 weeks of receiving this drug for acute severe ulcerative colitis.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 within the first 12 weeks of receiving this drug for ulcerative colitis, or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2 and 6 (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
The patient or guardian (required if patient is aged 6 to 17 years) must have signed a patient acknowledgement indicating that he or she understands and acknowledges that the PBS-subsidised treatment will cease if he or she does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.Compliance with Written Authority Required procedures
(b)omit:
C7037 Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.
The authority application must be made in writing
Up to a maximum of 2 repeats will be authorised.Compliance with Written Authority Required procedures
(c)insert in numerical order after existing text:
C7658 Moderate to severe ulcerative colitis
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug under the Initial 2 (Change or Recommencement of treatment after a break in therapy) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment.
Patient must be 6 years of age or older.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses or 2 repeats may be requested by telephone by contacting the Department of Human Services.Compliance with Authority Required procedures C7660 Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years.
Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.
Up to a maximum of 2 repeats will be authorised.Compliance with Authority Required procedures C7665 Moderate to severe ulcerative colitis
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; OR
Patient must have previously received induction therapy with this drug for an acute severe episode of ulcerative colitis in the last 4 months and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a PUCAI score less than 10 (if aged 6 to 17 years).
Patient must be 6 years of age or older.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the signed patient acknowledgement or guardian acknowledgement.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8-weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 1 month old at the time of application.
Where treatment for an acute severe episode has occurred, an adequate response to induction therapy needs to be demonstrated by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 (if aged 6 to 17 years), within the first 12 weeks of receiving this drug for acute severe ulcerative colitis.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 within the first 12 weeks of receiving this drug for ulcerative colitis, or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2 and 6 (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
The patient or guardian (required if patient is aged 6 to 17 years) must have signed a patient acknowledgement indicating that he or she understands and acknowledges that the PBS-subsidised treatment will cease if he or she does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.Compliance with Written Authority Required procedures C7669 Moderate to severe ulcerative colitis
Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS-subsidised treatment with adalimumab, golimumab, infliximab or vedolizumab for this condition in this treatment cycle; OR
Patient must have previously received PBS-subsidised treatment with adalimumab or infliximab for this condition in this treatment cycle if aged 6 to 17 years; AND
Patient must not have failed PBS-subsidised treatment with infliximab for this condition in the current treatment cycle; OR
Patient must not have failed PBS-subsidised treatment with infliximab for this condition in the current treatment cycle more than once if aged 6 to 17 years.
Patient must be 6 years of age or older.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
Applications for authorisation of change or recommencement treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.
Up to a maximum of 2 repeats will be authorised.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses or 2 repeats may be requested by telephone by contacting the Department of Human Services.Compliance with Written Authority Required procedures
Schedule 3, omit entry for Interferon alfa-2b
Schedule 3, entry for Ivacaftor
omit:
C6857 Cystic fibrosis
Initial treatment - Grandfather patients
Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND
Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; OR
Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND
Patient must have received treatment with ivacaftor for this condition prior to 1 May 2017; AND
Patient must have received treatment with ivacaftor within the last 6 months at the time of application; AND
Patient must have a sweat chloride value of at least 60 mmol/L by quantitative pilocarpine iontophoresis; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 2 to 5 years of age.
Patients receiving PBS-subsidised ivacaftor must be registered in the Australian Cystic Fibrosis Database Registry.
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug.
Dosage of ivacaftor must not exceed the dose of one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 sachets of ivacaftor will last for 28 weeks.
Dosage of ivacaftor must not exceed the dose of one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 sachets of ivacaftor will last for 8 weeks.
Ivacaftor is not PBS-subsidised for this condition as a sole therapy.
Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
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.
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis Ivacaftor Application Supporting Information Form; and
(3) an acknowledgement signed by a parent, or authorised guardian if applicable; and
(4) a copy of the pathology report detailing the molecular testing for G551D mutation or other gating (class III) mutation on the CFTR gene performed prior to commencing treatment with ivacaftor; and
(5) a copy of a current medication history, including any CYP3A4 inhibitors and/or CYP3A4 inducers; and
(6) a copy of sweat chloride result performed prior to commencing treatment with ivacaftor for this condition; and
(7) height and weight measurements at the time of application; and
(8) height and weight measurements performed immediately prior to commencement of ivacaftor; and
(9) a baseline measurement of number of days of CF-related hospitalisation (including hospital-in-the home) in the 12 months prior to commencement of ivacaftor; and
(10) a measurement of the number of days of CF-related hospitalisation (including hospital-in the home) in the 6 months prior to the date of application; and
(11) dates of prior ivacaftor therapy.Compliance with Written Authority Required procedures
Schedule 3, after entry for Nevirapine
insert:
Nusinersen C7627 P7627 Spinal muscular atrophy (SMA)
Initial 2 - 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 Princess Margaret Hospital (Perth).
Applications 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.
Where a grandfather patient has received all four loading doses at days 0, 14, 28 and 63 by 1 June 2018, one completed authority prescription should be submitted with the application for this drug. The prescription should be written for maintenance doses every 4 months, specifying a quantity of 1 vial and 0 repeats.
Where a grandfather patient has not received loading doses for days 14, 28 and 63 by 1 June 2018, two completed authority prescriptions should be submitted with the application for this drug. One prescription should be written for loading doses of 12 mg at days 14 and 28, specifying a quantity of 2 vials and no repeats. The second prescription should be for the loading dose at day 63, specifying a quantity of 1 vial and no repeats.
Where a grandfather patient has not received loading doses for days 28 and 63 by 1 June 2018, one completed authority prescription should be submitted with the application for this drug. The prescription should be written for loading doses of 12 mg at days 28 and 63, specifying a quantity of 1 vial and 1 repeat.
Where a grandfather patient has not received the loading dose for day 63 by 1 June 2018, one completed authority prescription should be submitted with the application for this drug. The prescription should be written for the loading dose of 12 mg at day 63, specifying a quantity of 1 vial and 0 repeats.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.Compliance with Written Authority Required procedures C7649 P7649 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 Princess Margaret Hospital (Perth).
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 C7650 P7650 Spinal muscular atrophy (SMA)
Initial treatment - Loading doses
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.
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 experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND
The treatment must be given concomitantly with standard of care for this condition; AND
The treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction.
Patient must be 18 years of age or under.
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.
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 Princess Margaret Hospital (Perth).
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Spinal muscular atrophy PBS Authority Application - 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).
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written for the loading doses of 12 mg at days 0 and 14, specifying a quantity of 2 vials and no repeats. The second prescription should be for the loading doses at days 28 and 63, specifying a quantity of 1 vial and one repeat.Compliance with Written Authority Required procedures
Schedule 3, entry for Omalizumab
(a)omit:
C4875 P4875 Uncontrolled severe allergic asthma - Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment,
AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.Compliance with modified Authority Required procedures C4879 P4879 Uncontrolled severe allergic asthma - Initial treatment - balance of supply
Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment,
AND
The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction.
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.Compliance with modified Authority Required procedures
(b)omit:
C6596 Uncontrolled severe allergic asthma
Initial and continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction or Grandfather treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 28 weeks treatment available under the Initial restriction or up to 24 weeks treatment available under the Continuing or Grandfather restrictions.
Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.Compliance with modified Authority Required procedures
(c)omit:
C6788 Uncontrolled severe allergic asthma
Initial treatment - Grandfather patients
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2016; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have had, prior to commencement of omalizumab, a diagnosis of asthma confirmed and documented by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician, defined by the following standard clinical features: forced expiratory volume (FEV1) reversibility or airway hyperresponsiveness or peak expiratory flow (PEF) variability; AND
Patient must have had a duration of asthma of at least 1 year prior to commencement of omalizumab; AND
Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE; AND
Patient must have failed to achieve adequate control with optimised asthma therapy prior to omalizumab therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must have demonstrated an adequate response to treatment; AND
Patient must be under the care of the same physician for at least 6 months.
Patient must be aged 6 to less than 12 years.
Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.
Optimised asthma therapy includes:
(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;
AND
(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.
If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.
A review of the patient's records should be conducted to extract pre- and post-omalizumab data on symptoms, quality of life, medication doses, exacerbations and hospitalisations. Examples of parameters to establish response include:
(i) a reduction in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire Interviewer Administered (ACQ-IA) score of at least 0.5;
(ii) maintenance oral corticosteroid dose reduced by at least 25% from baseline; and/or
(iii) a reduction in the number of hospitalisations or severe exacerbations requiring use of systemic corticosteroids, compared to the 12 months prior to commencement of omalizumab.
The assessment of the patient's response to the initial PBS subsidised course of treatment must be made at around 18 to 22 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The same parameters used to establish response to non-PBS-subsidised therapy with omalizumab should be used for the assessment.
This assessment, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with omalizumab.
Patients will be eligible to receive continuing courses of omalizumab treatment of up to 24 weeks providing they continue to demonstrate an adequate response to treatment.
Patients may qualify for PBS-subsidised treatment under this restriction once only.
A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for an initial course of omalizumab of up to 24 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Grandfather Severe Allergic Asthma PBS Authority Application - Supporting Information Form,
which includes the following:
(i) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and
(ii) details of pre- and post-omalizumab data on symptoms, quality of life, medication doses, exacerbations and hospitalisations; and
(iii) acknowledgement signed by a parent or authorised guardian.Compliance with modified Authority Required procedures
(d)insert in numerical order after existing text:
C7634 Uncontrolled severe allergic asthma
Initial and continuing treatment - balance of supply
Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.
Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 28 weeks treatment available under the Initial restriction or up to 24 weeks treatment available under the Continuing restriction.Compliance with Authority Required procedures C7636 Uncontrolled severe allergic asthma
Initial and continuing treatment - balance of supply
Must be treated by a respiratory physician, clinical immunologist, allergist or general physician experienced in the management of patients with severe asthma.
Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 28 weeks treatment available under the Initial restriction or up to 24 weeks treatment available under the Continuing restriction.Compliance with Authority Required procedures
Schedule 3, entry for Riociguat
(a)omit:
C6624 Chronic thromboembolic pulmonary hypertension (CTEPH)
Grandfathered patients
Patient must have previously received treatment with this drug for this condition prior to 1 January 2017; AND
Patient must have a documented history of WHO Functional Class II, III or IV CTEPH; AND
The condition must be inoperable by pulmonary endarterectomy; OR
The condition must be recurrent or persistent following pulmonary endarterectomy; AND
The treatment must be the sole PBS-subsidised agent for this condition.
Patient must be aged 18 years or older.
Must be treated in a centre with expertise in the management of CTEPH.
CTEPH that is inoperable by pulmonary endarterectomy is defined as follows:
Right heart catheterisation (RHC) demonstrating pulmonary vascular resistance (PVR) of greater than 300 dyn*sec*cm-5measured at least 90 days after start of full anticoagulation; and
A mean pulmonary artery pressure (PAPmean) of greater than 25 mmHg at least 90 days after start of full anticoagulation.
CTEPH that is recurrent or persistent subsequent to pulmonary endarterectomy is defined as follows:
RHC demonstrating a PVR of greater than 300 dyn*sec*cm-5measured at least 180 days following pulmonary endarterectomy.
Where a RHC cannot be performed due to right ventricular dysfunction, an echocardiogram demonstrating the dysfunction must be provided at the time of application.
Applications for authorisation must be in writing and must include:(1) A completed authority prescription form; and (2) a completed CTEPH PBS Initial Authority Application - Supporting Information form which includes results from the 3 tests below, to establish baseline measurements, where available:(i) RHC composite assessment, and(ii) ECHO composite assessment, and(iii) 6 Minute Walk Test (6MWT); and(3) a signed patient acknowledgment form; and(4) confirmation of evidence of inoperable CTEPH including results of a pulmonary vascular resistance (PVR), a mean pulmonary artery pressure (PAPmean) and the starting date of full anticoagulation; or(5) confirmation of evidence of recurrent or persistent CTEPH including result of PVR and the date that pulmonary endarterectomy was performed; or(6) confirmation of an echocardiogram demonstrating right ventricular dysfunction.
Where it is not possible to perform all 3 tests above on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:(1) RHC plus ECHO composite assessments;(2) RHC composite assessment plus 6MWT;(2) RHC composite assessment only.
In circumstance where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:(1) ECHO composite assessment plus 6MWT;(2) ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
The test results provided must not be more than 2 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats will be authorised.
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.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBSsubsidised therapy with this agent.Compliance with modified Authority Required procedures C6641 Chronic thromboembolic pulmonary hypertension (CTEPH)
Balance of supply
Patient must have received insufficient therapy with this agent under the Initial treatment restriction to complete a maximum of 20 weeks of treatment; OR
Patient must have received insufficient therapy with this agent under the Continuing treatment restriction to complete a maximum of 24 weeks of treatment; OR
Patient must have received insufficient therapy with this agent under the Grandfathering restriction to complete a maximum of 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 20 or 24 weeks of treatment available under the above respective restriction; AND
The treatment must be the sole PBS-subsidised agent for this condition.
Patient must be aged 18 years or older.
Must be treated in a centre with expertise in the management of CTEPH.Compliance with modified Authority Required procedures
(b)omit:
C6746 Pulmonary arterial hypertension (PAH)
Initial 4 (Grandfathered patients)
Patient must have previously received treatment with this drug for this condition prior to 1 February 2017; AND
Patient must be receiving treatment with this drug at the time of application; AND
Patient must have been assessed by a physician at a designated hospital; AND
Patient must have a documented history of WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH) or anorexigen-induced PAH or hereditable PAH; OR
Patient must have a documented history of WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease; AND
Patient must have a documented history of a mean right atrial pressure of 8 mmHg or less as measured by right heart catheterisation (RHC); OR
Patient must have a documented history of right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; AND
Patient must have a documented history of failure to respond to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT); and
(3) a signed patient acknowledgement.
Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Test requirements to establish baseline for initiation of treatment are as follows: The first written application for PBS-subsidised treatment should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements. The test results provided must not be more than 2 months old at the time of application.Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment: (1) RHC plus ECHO composite assessments;(2) RHC composite assessment plus 6MWT; (3) RHC composite assessment only. In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference: (1) ECHO composite assessment plus 6MWT; (2) ECHO composite assessment only. Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
Details of prior vasodilator treatment, including the dose and duration of treatment, must be provided at the time of application. Where the patient has an adverse event to a vasodilator or where vasodilator treatment is contraindicated, details of the nature of the adverse event or contraindication according to the Therapeutic Goods Administration (TGA) approved Product Information must also be provided with the application.
Response to prior vasodilator treatment is defined as follows:
For patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
For patients aged less than 18 years, response to treatment is defined as at least one of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.
Approval for authority prescriptions will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 5 repeats.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
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.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.Compliance with modified Authority Required procedures
(c)omit:
C6774 Pulmonary arterial hypertension (PAH)
Initial 5 (Grandfathered patients)
Patient must have previously received treatment with this drug for this condition prior to 1 February 2017; AND
Patient must be receiving treatment with this drug at the time of application; AND
Patient must have been assessed by a physician at a designated hospital; AND
Patient must have a documented history of WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, and a mean right atrial pressure of greater than 8 mmHg, as measured by right heart catheterisation (RHC); OR
Patient must have a documented history of WHO Functional Class III idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH, with right ventricular function assessed by echocardiography (ECHO) where a RHC cannot be performed on clinical grounds; OR
Patient must have a documented history of WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC; OR
Patient must have a documented history of WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease with right ventricular function assessed by ECHO where a RHC cannot be performed on clinical grounds; OR
Patient must have a documented history of WHO Functional Class IV idiopathic pulmonary arterial hypertension (iPAH), or anorexigen-induced PAH or hereditable PAH; OR
Patient must have a documented history of WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; OR
Patient must have a documented history of WHO Functional Class III or IV pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology); AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT); and
(3) a signed patient acknowledgement.
Idiopathic pulmonary arterial hypertension, anorexigen-induced pulmonary arterial hypertension, hereditable pulmonary arterial hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Test requirements to establish baseline for initiation of treatment are as follows: The first written application for PBS-subsidised treatment should be accompanied by the results of a right heart catheter (RHC) composite assessment plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements. The test results provided must not be more than 2 months old at the time of application. Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment: (1) RHC plus ECHO composite assessments; (2) RHC composite assessment plus 6MWT; (3) RHC composite assessment only. In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference: (1) ECHO composite assessment plus 6MWT; (2) ECHO composite assessment only. Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
Approval for authority prescriptions will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 5 repeats.
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.
The assessment of the patient's response to the initial 6 month course of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.
Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.Compliance with modified Authority Required procedures
(d)insert in numerical order after existing text:
C7629 Chronic thromboembolic pulmonary hypertension (CTEPH)
Balance of supply
Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete a maximum of 20 weeks of treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete a maximum of 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 20 or 24 weeks of treatment available under the above respective restriction; AND
The treatment must be the sole PBS-subsidised agent for this condition.
Must be treated in a centre with expertise in the management of CTEPH.
Patient must be aged 18 years or older.Compliance with Authority Required procedures
Schedule 3, entry for Romiplostim
(a)for Circumstances Code C6694, omit from the column headed 'Authority Requirements - Part of Circumstances':
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(b)for Circumstances Code C6737, omit from the column headed 'Authority Requirements - Part of Circumstances':
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(c)for Circumstances Code C6738, omit from the column headed 'Authority Requirements - Part of Circumstances':
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
(d)for Circumstances Code C6766, omit from the column headed 'Authority Requirements - Part of Circumstances':
Compliance with modified Authority Required procedures
substitute:
Compliance with Written Authority Required procedures
(e)for Circumstances Code C6789, omit from the column headed 'Authority Requirements - Part of Circumstances':
Compliance with modified Authority Required procedures
substitute:
Compliance with Authority Required procedures
Schedule 3, omit entry for Stavudine
Schedule 3, entry for Vedolizumab
(a)omit:
C6583 Moderate to severe ulcerative colitis
Change or Re-commencement of treatment after a break in therapy (Initial 2)
Patient must have previously been issued with an authority prescription for adalimumab, infliximab or vedolizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with vedolizumab for this condition more than once in the current treatment cycle; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services.Compliance with modified Authority Required procedures C6589 Moderate to severe ulcerative colitis
Balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug under the Initial 2 (Change or Recommencement of treatment after a break in therapy) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 3 doses (Initial 1 and Initial 2 restrictions) or 2 repeats (Continuing restriction); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Authority approval for sufficient therapy to complete a maximum of 3 initial doses or 2 repeats may be requested by telephone by contacting the Department of Human Services.Compliance with modified Authority Required procedures
(b)omit:
C6617 Moderate to severe ulcerative colitis
Initial treatment (new patient – Initial 1)
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the signed patient acknowledgement.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 1 month old at the time of application.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2 and 6 (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
Patients must have signed a patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.Compliance with modified Authority Required procedures
(c)insert in numerical order after existing text:
C7668 Moderate to severe ulcerative colitis
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug under the Initial 2 (Change or Recommencement of treatment after a break in therapy) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 3 doses (Initial 1 and Initial 2 restrictions) or 2 repeats (Continuing restriction); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.Compliance with Authority Required procedures C7672 Moderate to severe ulcerative colitis
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the signed patient acknowledgement.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 1 month old at the time of application.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2 and 6 (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
Patients must have signed a patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.Compliance with Written Authority Required procedures C7683 Moderate to severe ulcerative colitis
Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2)
Patient must have previously received PBS-subsidised treatment with adalimumab, golimumab, infliximab or vedolizumab for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with vedolizumab for this condition in the current treatment cycle; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be aged 18 years or older.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.
Applications for authorisation of change or recommencement treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) Mayo clinical assessment (to demonstrate response to prior treatment).
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services.Compliance with Written Authority Required procedures
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