National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 8) (PB 85 of 2018) (Cth)

PB 85 of 2018

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 8)

National Health Act 1953

___________________________________________________________________________

I, NATASHA PLOENGES, Acting Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

Dated    25 September 2018

NATASHA PLOENGES

Assistant Secretary (Acting)

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

1. Name of Instrument

(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 8).

(2)This Instrument may also be cited as PB 85 of 2018.

1. Commencement

This Instrument commences on 1 October 2018.

1. 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

1. Part 1, Division 1, Section 4, definition for ‘CAR drug’

insert in alphabetical order:            ma)    lumacaftor with ivacaftor

1. Part 1, Division 1, Section 4, definition for ‘medication for the treatment of HIV or AIDS’

(a)omit:   (m)     emtricitabine

(b)omit:   (u)      indinavir

1. Schedule 1, entry for Bosentan in the form Tablet 62.5 mg (as monohydrate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

BOSENTAN DR. REDDY'S RI EMP C4628 C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D

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

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

BOSENTAN DR. REDDY'S RI EMP C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D

1. Schedule 1, omit entry for Emtricitabine

1. Schedule 1, entry for Ganciclovir

insert in numerical order in the column headed "Circumstances" for the brand "GANCICLOVIR SXP":     C5000

1. Schedule 1, omit entry for Indinavir

1. Schedule 1, entry for Infliximab

(a)omit from the column headed “Circumstances” for the brand “Inflectra”:       C7658 C7660 C7665 C7669

(b)insert in numerical order in the column headed "Circumstances" for the brand “Inflectra”:   C7942 C7989 C7994 C8009 C8011

(c)omit from the column headed “Circumstances” for the brand “Remicade”:     C7658 C7660 C7665 C7669

(d)insert in numerical order in the column headed "Circumstances" for the brand “Remicade”:           C7942 C7994 C8001 C8009 C8011

(e)omit from the column headed “Circumstances” for the brand “Renflexis”:      C7658 C7660 C7665 C7669

(f)insert in numerical order in the column headed "Circumstances" for the brand “Renflexis”:   C7942 C7989 C7994 C8009 C8011

1. Schedule 1, entry for Lipegfilgrastim

(a)omit from the column headed “Circumstances”:  C6488 C6489 C6490 C6491 C6492 C6493 C6501 C6507 C6512 C6513 C6514 C6515 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6554 C6555

(b)insert in numerical order in the column headed "Circumstances":        C7822 C7823 C7843 C7862

1. Schedule 1, after entry for Lopinavir with Ritonavir in the form Oral liquid 400 mg-100 mg per 5 mL, 60 mL

insert:

Lumacaftor with ivacaftor	Tablet containing lumacaftor 100 mg with ivacaftor 125 mg	Oral	Orkambi	VR	EMP	C8003 C8006	112	5	D
	Tablet containing lumacaftor 200 mg with ivacaftor 125 mg	Oral	Orkambi	VR	EMP	C8004 C8010	112	5	D

1. Schedule 1, entry for Pegfilgrastim

(a)omit from the column headed "Responsible Person" for the brand "Neulasta":           AN       substitute:      JU

(b)omit from the column headed "Responsible Person" for the brand “Ristempa”:          GV      substitute:      JO

1. Schedule 1, entry for Pomalidomide in each of the forms: Capsule 3 mg; and Capsule 4 mg

omit from the column headed "Circumstances":   C7792             substitute:      C7952

1. Schedule 1, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Tenofovir/Emtricitabine 300/200 APOTEX TX EMP C6985 C6986 60 5 C

1. Schedule 2, entry for Responsible Person Code "EA"

omit from the column headed "Australian Business Number":    21 147 854 484       substitute:      11 163 167 851

1. Schedule 2, omit entry for Responsible Person Code “GV”

1. Schedule 3, omit entry for Emtricitabine

1. Schedule 3, omit entry for Indinavir

1. Schedule 3, entry for Infliximab

(a)omit:

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

(b)insert in numerical order after existing text:

C7942	Moderate to severe ulcerative colitis Initial 2 - Change or Re-commencement of treatment after a break in therapy of less than 5 years 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 prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; OR Patient must have previously received PBS-subsidised treatment with a biological medicine (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 this drug for this condition in the current treatment cycle; OR Patient must not have failed PBS-subsidised treatment with this drug 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. Application for authorisation must be made 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) the number of total failures to courses of biological medicine therapy in the current treatment cycle. To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction. If the response assessment to the previous course of biological medicine therapy is not met, the patient will be deemed to have failed therapy with that particular course of biological medicine. 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 for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.	Compliance with Written Authority Required procedures
C7989	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 received PBS-subsidised treatment with 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. Patient must be 6 years of age or older. 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 only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. The measurement of response to the prior course of therapy must be documented in the patient's medical notes.	Compliance with Authority Required procedures - Streamlined Authority Code 7989
C7994	Moderate to severe ulcerative colitis Initial 1 - New patient or recommencement of treatment after more than 5 years break in therapy 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. Application for authorisation must be made 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, 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 measurement of response to the prior course of therapy must be documented in the patient's medical notes. 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
C8001	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 received PBS-subsidised treatment with 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. Patient must be 6 years of age or older. 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 only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. 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 for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.	Compliance with Authority Required procedures
C8009	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 for this condition under the Initial 1 treatment (New patient or Recommencement of treatment after more than 5 years break in therapy) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 treatment (Change or Re-commencement of treatment after a break in therapy of less than 5 years ) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); AND The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment). Patient must be 6 years of age or older.	Compliance with Authority Required procedures
C8011	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 received PBS-subsidised treatment with 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. Patient must be 6 years of age or older. 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 only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. 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 for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.	Compliance with Authority Required procedures

1. Schedule 3, entry for Lipegfilgrastim

substitute:

Lipegfilgrastim	C7822	Chemotherapy-induced neutropenia Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND Patient must be at greater than 20% risk of developing febrile neutropenia; OR Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures - Streamlined Authority Code 7822
C7823	Chemotherapy-induced neutropenia Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND Patient must be at greater than 20% risk of developing febrile neutropenia; OR Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures
C7843	Chemotherapy-induced neutropenia Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures - Streamlined Authority Code 7843
C7862	Chemotherapy-induced neutropenia Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND Patient must have had a prior episode of febrile neutropenia; OR Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.	Compliance with Authority Required procedures

1. Schedule 3, after entry for Lopinavir with ritonavir

insert:

Lumacaftor with ivacaftor	C8003	Cystic fibrosis Continuing treatment Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be aged between 6 and 11 years inclusive. 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. Patients who have an acute infective exacerbation at the time of assessment for continuing therapy may receive an additional one month's supply in order to enable the assessment to be repeated following resolution of the exacerbation. The authority application must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Cystic Fibrosis Lumacaftor with Ivacaftor Continuing Authority Application Supporting Information Form; and (3) the result of a FEV1 measurement performed within a month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1 is measured; and (4) a copy of a current medication history, including any CYP3A inhibitors and/or inducers; and (5) height and weight measurements at the time of application; and (6) the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 6 months.	Compliance with Written Authority Required procedures
C8004	Cystic fibrosis Initial treatment Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation. Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be 12 years of age or older. The patient 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. The authority application must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Cystic Fibrosis Lumacaftor with Ivacaftor Authority Application Supporting Information Form; and (3) a copy of the pathology report detailing the molecular testing for the patient being homozygous for the F508del mutation on the CFTR gene; and (4) the result of a FEV1 measurement performed within a month prior to the date of application. Note: FEV1 must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1 is measured; and (5) confirmation that the patient has either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; and (6) a copy of a current medication history, including any CPY3A inhibitors and/or inducers; and (7) height and weight measurements at the time of application; and (8) a baseline measurement of the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 12 months.	Compliance with Written Authority Required procedures
C8006	Cystic fibrosis Initial treatment Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation. Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be aged between 6 and 11 years inclusive. The patient 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. The authority application must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Cystic Fibrosis Lumacaftor with Ivacaftor Authority Application Supporting Information Form; and (3) a copy of the pathology report detailing the molecular testing for the patient being homozygous for the F508del mutation on the CFTR gene; and (4) the result of a FEV1 measurement performed within a month prior to the date of application. Note: FEV1 must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1 is measured; and (5) confirmation that the patient has either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; and (6) a copy of a current medication history, including any CPY3A inhibitors and/or inducers; and (7) height and weight measurements at the time of application; and (8) a baseline measurement of the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 12 months.	Compliance with Written Authority Required procedures
C8010	Cystic fibrosis Continuing treatment Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be 12 years of age or older. 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. Patients who have an acute infective exacerbation at the time of assessment for continuing therapy may receive an additional one month's supply in order to enable the assessment to be repeated following resolution of the exacerbation. The authority application must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Cystic Fibrosis Lumacaftor with Ivacaftor Continuing Authority Application Supporting Information Form; and (3) the result of a FEV1 measurement performed within a month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1 is measured; and (4) a copy of a current medication history, including any CYP3A inhibitors and/or inducers; and (5) height and weight measurements at the time of application; and (6) the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 6 months.	Compliance with Written Authority Required procedures

1. Schedule 3, entry for Pomalidomide

(a)omit:

C7792 Multiple myeloma
Initial treatment
The treatment must be in combination with dexamethasone; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must have experienced treatment failure with lenalidomide; AND
Patient must have experienced treatment failure with bortezomib; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, carfilzomib or thalidomide or its analogues.
Bortezomib treatment failure is the absence of achieving at least a partial response or as progressive disease during treatment or within 6 months of discontinuing treatment with bortezomib. Lenalidomide treatment failure is progressive disease during treatment or within 6 months of discontinuing treatment with lenalidomide.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma pomalidomide Authority Application Supporting Information form; and
(3) reports demonstrating the patient has failed treatment with lenalidomide and bortezomib.
Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C7952 Multiple myeloma
Initial treatment
The treatment must be in combination with dexamethasone; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must have experienced treatment failure with lenalidomide, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information; AND
Patient must have experienced treatment failure with bortezomib, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information; AND
Patient must not be receiving concomitant PBS-subsidised bortezomib, carfilzomib or thalidomide or its analogues.
Bortezomib treatment failure is the absence of achieving at least a partial response or as progressive disease during treatment or within 6 months of discontinuing treatment with bortezomib. Lenalidomide treatment failure is progressive disease during treatment or within 6 months of discontinuing treatment with lenalidomide.
If treatment with either bortezomib or lenalidomide is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.
If intolerance to either bortezomib or lenolidomide treatment develops during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Multiple Myeloma pomalidomide Authority Application Supporting Information form; and
(3) reports demonstrating the patient has failed treatment with, providing details of the contraindication to or details of the nature and severity of the intolerance to lenalidomide; and
(4) reports demonstrating the patient has failed treatment with, providing details of the contraindication to or details of the nature and severity of the intolerance to bortezomib.
Patients receiving this drug under the PBS listing must be registered in the i-access risk management program. Compliance with Written Authority Required procedures