Explanatory Statement
National Health Act 1953
National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Rituximab) Instrument 2022
Authority
The Pharmaceutical Benefits Scheme (PBS) is established under the National Health Act 1953 (the Act) and provides Australians with timely, reliable and affordable access to necessary and cost-effective medicines. The Act regulates the listing, pricing, prescribing, supply, and claiming and payment of subsidies for supply of drugs and medicinal preparations as pharmaceutical benefits.
Subsection 100(1) of the Act provides that the Minister may make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to certain persons. These are persons: who are living in isolated areas; or who are receiving treatment in circumstances in which pharmaceutical benefits are inadequate for that treatment; or if the pharmaceutical benefits covered by the arrangements can be more conveniently or efficiently supplied under the arrangements.
Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII, have effect subject to a special arrangement made under subsection 100(1).
Along with section 100 of the Act, this instrument is also made under sections 85 (Pharmaceutical benefits), 85A (Determinations of forms of pharmaceutical benefits or pharmaceutical items with respect to classes of persons) and 88 (Prescribing of pharmaceutical benefits) of the Act.
Purpose
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Rituximab) Instrument 2022 (the Instrument) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (the HSD Special Arrangement) to implement a revised PBS listing for the drug rituximab as an unrestricted pharmaceutical benefit under the Section 100 Highly Specialised Drugs (HSD) Program, consistent with a recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC) made in September 2021.
On 3 September 2021, the PBAC recommended that the PBS listings for all listed brands of rituximab be amended to “unrestricted” benefit listings (unrestricted listings). Central to the intent of the PBAC’s September 2021 recommendation for an unrestricted listing for rituximab is the removal of the prescription circumstances previously applying to pharmaceutical benefits containing rituximab (i.e. each listed brand of the drug rituximab in each of the determined forms and with each of the determined manners of administration). These circumstances “restrict” the prescribing of a pharmaceutical benefit by specifying the condition for which PBS-subsidised treatment is indicated (the indication) and treatment phase as well as the clinical, treatment and/or population criteria that apply. Circumstances also include specification of applicable authority requirements in accordance with which prescribers must obtain authority approval to prescribe a pharmaceutical benefit.
Consistent with the central intent of the September 2021 recommendation of the PBAC, the Instrument removes all prescription circumstances previously specified in Schedules 1 and 3 to the HSD Special Arrangement for HSD pharmaceutical benefits containing rituximab. The removal of these circumstances enables an ‘authorised prescriber’ under section 7 of the HSD Special Arrangement to prescribe HSD pharmaceutical benefits containing rituximab for an ‘eligible patient’ under section 8 of the HSD Special Arrangement at their discretion within their scope of clinical practice (i.e. for the subsidised treatment of a wider range of conditions) instead of solely in compliance with specified prescription circumstances. It also removes the requirement for an authorised prescriber to comply with ‘Authority Required procedures’ as previously specified as part of the prescription circumstances for HSD pharmaceutical benefits containing rituximab.
The listing of medicines as unrestricted pharmaceutical benefits to which no prescription circumstances (and therefore no authority requirements other than those applying to increases in maximum quantity and number of repeats) apply has no precedent under the HSD Program. The Instrument therefore makes the following changes to the HSD Special Arrangement to support the removal of all prescription circumstances for HSD pharmaceutical benefits containing rituximab:
the creation of a new definition in section 6 of the HSD Special Arrangement for an ‘Unrestricted—No Authority Required’ (UNAR) drug, which includes rituximab (noting that rituximab was previously defined as a Complex Authority Required (CAR) drug prior to the removal of prescription circumstances and associated authority requirements). The same supply/dispensing parameters as apply for CAR drugs are specified as applying for the new category of UNAR drugs, meaning that an HSD prescription for rituximab originating in the public hospital setting will continue to be able to be dispensed by an approved pharmacist under section 90 of the Act (a section 90 community pharmacy) as well as by an approved hospital authority for a public hospital under section 94 of the Act (a section 94 public hospital pharmacy);
changes to section 13 (Definition of special arrangement supply), section 15 (Prescription circumstances—general) and section 16 (Prescription circumstances—authority required procedures) of the HSD Special Arrangement to reflect the removal of all prescription circumstances for HSD pharmaceutical benefits containing rituximab and therefore accommodate the prescribing and supply of rituximab as an unrestricted pharmaceutical benefit under the HSD Program; and
a change to exclude persons receiving treatment for conditions intended to be covered under the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (the EFC Special Arrangement) from being an ‘eligible patient’ under section 8 of the HSD Special Arrangement for an HSD pharmaceutical benefit that contains a UNAR drug. This distinguishes the prescription and supply of rituximab under the EFC Special Arrangement (i.e. as an EFC pharmaceutical benefit) from the prescription and supply of rituximab as an HSD pharmaceutical benefit in the absence of the distinct prescription circumstances that previously distinguished between the relevant restricted listings under the HSD and EFC Programs respectively (noting that all prescription circumstances for rituximab pharmaceutical benefits are also being removed from the EFC Special Arrangement effective 1 September 2022).
The amendments made by the Instrument are consistent with amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) (the Listing Instrument) concerning rituximab, which commence on the same day. The Listing Instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
The Instrument also relies on subsection 33(3) of the Acts Interpretation Act 1901, where the Instrument repeals or amends another instrument and there is no express power in the enabling legislation to do so.
Consultation
The amendments made by the Instrument accord with recommendations made by the PBAC.
The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation in relation to matters relevant to the HSD Special Arrangement.
The PBAC is an independent expert body, established by section 100A of the Act, which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits.
PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of these interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC. In addition, an industry nominee has been appointed to the PBAC membership under the PBS Access and Sustainability Package of reforms announced in May 2015. When recommending the listing of a medicine on the PBS, the PBAC takes into account the medical condition for which listing is sought and the medicine’s clinical effectiveness, safety and cost-effectiveness compared with other treatments. Pharmaceutical companies are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings. This includes consultation through the PBAC process.
Services Australia was consulted on the Instrument in connection with changes made to this agency’s PBS Online Claims system to support the administration of claims for payment from dispensing pharmacies for the supply of rituximab as an unrestricted HSD pharmaceutical benefit from 1 September 2022. Further consultation on the Instrument was considered unnecessary due to the nature of the consultation that had already taken place throughout the listing process.
This instrument commences on 1 September 2022.
This instrument is a legislative instrument for the purposes of the Legislation Act 2003.
Details of this instrument are set out in the Attachment.
Attachment
Details of the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Rituximab) Instrument 2022
Section 1 Name
This section provides that the name of the instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Rituximab) Instrument 2022 (the Instrument) and that it may also be cited as PB 80 of 2022.
Section 2 Commencement
This section provides that the Instrument commences on 1 September 2022.
Section 3 Authority
This section provides that the Instrument is made under sections 85 and 85A, and subsection 100(2), of the National Health Act 1953 (the Act).
Section 4 Schedules
This section provides that each instrument that is specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Instrument has effect according to its terms.
Schedule 1 Amendments
Schedule 1 sets out the amendments to the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (the HSD Special Arrangement) made by the Instrument.
Item 1 – Section 6 (paragraph (dd) of the definition of CAR drug)
Item 1 amends section 6 to remove the drug rituximab from the list of drugs forming the definition of a ‘CAR drug’ (short for ‘Complex Authority Required’ drug), meaning that rituximab is no longer defined as a CAR drug. This reflects the implementation of an amended PBS listing for rituximab as an unrestricted pharmaceutical benefit under the HSD Special Arrangement, which involves the removal of all prescription circumstances—including the authority requirements that form a part of the prescription circumstances—that previously applied to HSD pharmaceutical benefits containing rituximab.
Item 2 – Section 6
Item 2 amends section 6 to add a new definition for an ‘EFC patient’, which refers to the meaning given by new subsection 8(7) (refer Item 7 below).
Item 3 – Section 6 (definition of non-CAR drug)
Item 3 amends section 6 to repeal the definition of a ‘non-CAR drug’. This definition is not required as it is not referred to in any other instance in the HSD Special Arrangement, including as amended by the Instrument.
Item 4 – Section 6
Item 4 amends section 6 to add a new definition for a ‘UNAR drug’ (short for ‘Unrestricted—No Authority Required’ drug) consisting of a list of highly specialised drugs including rituximab only at this time, meaning that rituximab is defined as a UNAR drug. This reflects the implementation of an amended PBS listing for rituximab as an unrestricted pharmaceutical benefit under the HSD Special Arrangement, which involves the removal of all prescription circumstances—including the authority requirements that form a part of the prescription circumstances—that previously applied to HSD pharmaceutical benefits containing rituximab.
Item 5 – Subsection 8(1)
Item 5 amends subsection 8(1) to limit the definition of an ‘eligible patient’ for an HSD pharmaceutical benefit, in circumstances where the person is receiving treatment by medical practitioners at or from a public hospital other than as an admitted patient (inpatient) of the hospital, to only apply if the person is not an ‘EFC patient’ (per the meaning given by new subsection 8(7) (refer Item 7 below)) for the benefit. This exclusion applies only for HSD pharmaceutical benefits that have (or in other words contain) a UNAR drug based on the definition of an ‘EFC patient’ as specified in new subsection 8(7). This distinguishes, in the public hospital setting, the prescription and supply of rituximab as an EFC pharmaceutical benefit (i.e. under the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (the EFC Special Arrangement)) from the prescription and supply of rituximab as an HSD pharmaceutical benefit in the absence of the distinct prescription circumstances that previously applied to HSD and EFC pharmaceutical benefits containing rituximab respectively (it is noted that all prescription circumstances for rituximab pharmaceutical benefits are simultaneously being removed from the EFC Special Arrangement as of 1 September 2022).
Item 6 – Subsection 8(4)
Item 6 amends subsection 8(4) to limit the definition of an ‘eligible patient’ for an HSD pharmaceutical benefit, in circumstances where the person is receiving treatment by medical practitioners in, at or from a private hospital, to only apply if the person is not an ‘EFC patient’ (per the meaning given by new subsection 8(7) (refer Item 7 below)) for the benefit. This exclusion applies only for HSD pharmaceutical benefits that contain a UNAR drug based on the definition of an ‘EFC patient’ as specified in new subsection 8(7). This distinguishes, in the private hospital setting, the prescription and supply of rituximab as an EFC pharmaceutical benefit (i.e. under the EFC Special Arrangement) from the prescription and supply of rituximab as an HSD pharmaceutical benefit in the absence of the distinct prescription circumstances that previously applied to HSD and EFC pharmaceutical benefits containing rituximab respectively (it is noted that all prescription circumstances for rituximab pharmaceutical benefits are simultaneously being removed from the EFC Special Arrangement as of 1 September 2022).
Item 7 – Section 8
Item 7 amends section 8 to add new subsection 8(7), which specifies that a person is an ‘EFC patient’ for an HSD pharmaceutical benefit that contains a UNAR drug if the benefit is or will be prescribed to the person either in accordance with the EFC Special Arrangement or for the purposes of chemotherapy treatment for cancer. These conditions, which are not mutually exclusive, describe scenarios in which it is the intention that the prescription and supply of rituximab continue to occur under the EFC Special Arrangement rather than under the HSD Special Arrangement. They define an ‘EFC patient’ relevantly to the amendments to subsections 8(1) and 8(4) (refer Items 5 and 6 above), which exclude a person who is an ‘EFC patient’ from being an eligible patient for an HSD pharmaceutical benefit that contains a UNAR drug.
Item 8 – Subparagraph 13(1)(b)(ii)
Item 8 amends subparagraph 13(1)(b)(ii) to expand the definition of a ‘special arrangement supply’, for prescriptions written for public hospital patients, to include a supply by an approved pharmacist of an HSD pharmaceutical benefit that contains a UNAR drug (in addition to the existing inclusion of a supply by an approved pharmacist of an HSD pharmaceutical benefit that contains a CAR drug), where all other requirements specified in subsection 13(1) for the supply are met. This provides for HSD pharmaceutical benefits containing rituximab that have been prescribed for patients receiving medical treatment in, at or from a public hospital to continue to be supplied by approved pharmacists under section 90 of the Act, noting that rituximab is defined as a UNAR rather than a CAR drug per amendments to section 6 (refer Items 1 and 4 above).
Item 9 – Subparagraphs 13(1)(c)(iii) and (2)(c)(iii)
Item 9 amends subparagraphs 13(1)(c)(iii) and (2)(c)(iii) to expand the definition of a ‘special arrangement supply’, for prescriptions written for public hospital and private hospital patients respectively, to include a supply on the basis of a prescription written for an HSD pharmaceutical benefit that contains a UNAR drug (where there are no circumstances mentioned in Schedule 3 nor circumstances codes mentioned in Schedule 1 for such a benefit). This applies where all other requirements specified in subsections 13(1) and 13(2) (for prescriptions written for public hospital and private hospital patients respectively) for the supply are met. The expansion of the definition of a ‘special arrangement supply’ is given effect via the application of an exception for a prescription written for an HSD pharmaceutical benefit that contains a UNAR drug from the requirement for the prescription to have been written ‘in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit’ (as is otherwise required in order for a supply on the basis of a prescription written for an HSD pharmaceutical benefit to meet the definition of a ‘special arrangement supply’). This provides for HSD pharmaceutical benefits containing rituximab to continue to be prescribed and supplied under the HSD Special Arrangement in the absence of the prescription circumstances that previously applied to these pharmaceutical benefits.
Item 10 – Subsections 14(1) and (3)
Item 10 amends subsections 14(1) and (3) to provide that only an HSD pharmaceutical benefit mentioned in Part 1 of Schedule 1 to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the Listing Instrument) (ready-prepared pharmaceutical benefits for prescription and supply) is ‘determined’, for the purposes of subsection 88(1) of the Act applying to a medical practitioner (subsection 14(1)) or for the purposes of subsection 88(1E) of the Act applying to an authorised nurse practitioner (subsection 14(3)), who is an authorised prescriber for the benefit. This has the effect that these subsections only apply where an HSD pharmaceutical benefit is mentioned in Part 1 of Schedule 1 to the Listing Instrument, meaning in turn that an authorised prescriber for an HSD pharmaceutical benefit is only authorised under section 88 of the Act to write a prescription for the supply of the benefit if the benefit is mentioned in Part 1 of Schedule 1 to the Listing Instrument (and is therefore ‘determined’ for the purposes of subsection 88(1) or (1E) of the Act by subsection 14(1) or (3) respectively). This retains the relevant aspect of the intent of repealed subsection 14(4) (refer Item 11 below) – i.e. that authorised prescribers for HSD pharmaceutical benefits be authorised under the Act to prescribe those HSD pharmaceutical benefits mentioned in Part 1 of Schedule 1 to the Listing Instrument.
Item 11 – Subsection 14(4)
Item 11 repeals subsection 14(4). This has the effect that subsections 14(1) and (3) still apply to an HSD pharmaceutical benefit mentioned in Part 2 of Schedule 1 to the Listing Instrument (ready-prepared pharmaceutical benefits for supply only) where the benefit is also mentioned in Part 1 of Schedule 1 to the Listing Instrument (ready-prepared pharmaceutical benefits for prescription and supply). This is required to ensure that authorised prescribers for HSD pharmaceutical benefits containing rituximab are authorised under the Act to prescribe all HSD pharmaceutical benefits containing rituximab mentioned in Part 1 of Schedule 1 to the Listing Instrument, even where such a benefit is also mentioned in Part 2 of Schedule 1 to the Listing Instrument. It is noted that for a period of one month only from 1 September 2022, one HSD pharmaceutical benefit containing rituximab will temporarily be listed in Part 2 of Schedule 1 to the Listing Instrument for the purposes of enabling repeat supplies of the benefit on the basis of an existing prescription validly written in one of two specific prescription circumstances prior to 1 September 2022 to be honoured by a dispensing pharmacy during this period (even though a new prescription can no longer be validly written in these circumstances from 1 September 2022 due to their removal). The temporary listing of this benefit in Part 2 of Schedule 1 to the Listing Instrument reflects that the benefit, as prescribed in compliance with the previously applicable prescription circumstances prior to 1 September 2022 (as opposed to consistent with its listing as an unrestricted pharmaceutical benefit from 1 September 2022), is available as a pharmaceutical benefit for “supply only”.
Item 12 – Subsections 15(1) and (2)
Item 12 amends subsection 15(1) to exclude an HSD pharmaceutical benefit that contains a UNAR drug from being determined, for the purposes of paragraph 85(7)(a) of the Act, to be a relevant pharmaceutical benefit for the purposes of section 88A of the Act. Where a pharmaceutical benefit is determined, under paragraph 85(7)(a) of the Act, to be a relevant pharmaceutical benefit for the purposes of section 88A of the Act, the writing of a prescription for the supply of the benefit is authorised under Part VII of the Act only in circumstances specified in a determination under paragraph 85(7)(b) of the Act. This amendment therefore provides that the writing of a prescription for the supply of an HSD pharmaceutical benefit containing rituximab—dissimilarly to what would apply in the case of any other HSD pharmaceutical benefit—is not limited to being authorised under Part VII of the Act only in circumstances specified in a determination under paragraph 85(7)(b) of the Act (i.e. in specified prescription circumstances). This gives effect to the implementation of an amended PBS listing for rituximab as an unrestricted pharmaceutical benefit under the HSD Special Arrangement, which involves the removal of all prescription circumstances previously specified as applying to HSD pharmaceutical benefits containing rituximab.
Item 12 also amends subsection 15(2) to exclude an HSD pharmaceutical benefit that contains a UNAR drug from the specification contained therein for the purposes of paragraph 85(7)(b) of the Act that the circumstances in which a prescription for a special arrangement supply of an HSD pharmaceutical benefit may be written are the ‘circumstances mentioned in Schedule 3 to this instrument for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 to this instrument for the benefit.’ This reflects, for clarity, that HSD pharmaceutical benefits containing rituximab are no longer determined under paragraph 85(7)(a) of the Act to be relevant pharmaceutical benefits for the purposes of section 88A of the Act, and that accordingly there are no circumstances specified in a determination under paragraph 85(7)(b) of the Act (as constituted by subsection 15(2)) that restrict the scenarios in which a prescription for a special arrangement supply of these pharmaceutical benefits may be written. This reflects in turn the removal of all prescription circumstances previously specified in Schedules 1 and 3 to the HSD Special Arrangement as applying to HSD pharmaceutical benefits containing rituximab.
Item 13 – Subsection 16(1)
Item 13 amends subsection 16(1), which (along with subsection 16(2)) does not apply in the case of an HSD pharmaceutical benefit that contains a UNAR drug, to insert the words ‘if any’ in parentheses at the appropriate point so that this subsection reflects, for clarity, that there are now HSD pharmaceutical benefits (i.e. HSD pharmaceutical benefits that contain a UNAR drug) for which there are no circumstances mentioned in Schedule 3 in which a prescription for a special arrangement supply of the benefit is or will be written. This reflects in turn the removal of all prescription circumstances previously specified in Schedule 3 to the HSD Special Arrangement as applying to HSD pharmaceutical benefits containing rituximab.
Item 14 – Subsection 18(1) (heading)
Item 14 amends the heading of subsection 18(1) to read ‘HSD pharmaceutical benefits that have CAR drugs or rituximab [emphasis added to reflect the additional text]’. This reflects the provision made by subsection 18(1) as amended (refer Item 15 below).
Item 15 – Subsection 18(1)
Item 15 amends subsection 18(1) to provide that subparagraph 39(a)(ii) of the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations) does not apply to a prescription for a special arrangement supply of an HSD pharmaceutical benefit that contains rituximab (in addition to the existing exclusion of the application of subparagraph 39(a)(ii) of the Regulations to a prescription for a special arrangement supply of an HSD pharmaceutical benefit that contains a CAR drug). This reflects that a medication chart prescription is not able to be written for rituximab in accordance with section 41 of the Regulations (a condition that remains unchanged), with this drug now requiring separate specification in subsection 18(1) as it is no longer defined as a CAR drug.
Item 16 – Schedule 1
Item 16 amends Schedule 1 to repeal the previous table entry for the listed drug rituximab and replace it with a new table entry for this listed drug, which:
- removes all circumstances codes previously specified in the column headed ‘Circumstances’ as applying to pharmaceutical benefits containing rituximab (i.e. each brand of the drug rituximab in each determined form with each determined manner of administration). The columns headed ‘Circumstances’ and ‘Purposes’ are intentionally left blank in the new table entry (N.B. the column headed ‘Purposes’ was also blank in the previous table entry). In conjunction with the amendment to Schedule 3 (refer Item 18 below), this gives effect to the removal of all prescription circumstances previously specified as applying to HSD pharmaceutical benefits containing rituximab; and
- specifies the maximum quantity and maximum number of repeats for each listed rituximab pharmaceutical benefit as apply to its listing as an unrestricted pharmaceutical benefit. It is noted that a single specified maximum quantity and number of repeats now applies for each listed rituximab pharmaceutical benefit (as opposed to multiple maximum quantity and repeat values as previously differentiated by circumstances). As such, the previous reference to Schedule 2 to the HSD Special Arrangement (via the appearance of the text ‘See Schedule 2’ in each of the columns headed ‘Maximum quantity’ and ‘Maximum repeats’) is no longer required.
Item 17 – Schedule 2
Item 17 amends Schedule 2 to repeal the previous table entry for the listed drug rituximab in its entirety. As the specified maximum quantities and numbers of repeats applying for listed rituximab pharmaceutical benefits no longer differ for each pharmaceutical benefit according to circumstances (refer Item 16 above), these (single) values (per rituximab pharmaceutical benefit) are now specified instead in Schedule 1 to the HSD Special Arrangement.
Item 18 – Schedule 3
Item 18 amends Schedule 3 to repeal the previous table entry for the listed drug rituximab in its entirety. In conjunction with the amendment to Schedule 1 (refer Item 16 above), this gives effect to the removal of all prescription circumstances previously specified as applying to HSD pharmaceutical benefits containing rituximab.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Rituximab) Instrument 2022
PB 80 of 2022
This instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Instrument
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (Rituximab) Instrument 2022 (the Instrument) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (the HSD Special Arrangement) to implement an amended Pharmaceutical Benefits Scheme (PBS) listing for the drug rituximab as an unrestricted pharmaceutical benefit under the PBS Highly Specialised Drugs (HSD) Program, consistent with a recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC) made in September 2021.
On 3 September 2021, the PBAC recommended that the PBS listings for all listed brands of rituximab be amended to “unrestricted” benefit listings (unrestricted listings). Central to the intent of the PBAC’s September 2021 recommendation for an unrestricted listing for rituximab is the removal of the prescription circumstances previously applying to pharmaceutical benefits containing rituximab (i.e. each brand of the drug rituximab in each of the determined forms and with each of the determined manners of administration). These circumstances “restrict” the prescribing of a listed pharmaceutical benefit by specifying the condition for which PBS-subsidised treatment is indicated (the indication) and treatment phase as well as the clinical, treatment and/or population criteria that apply, therefore denoting a “restricted” pharmaceutical benefit. Circumstances also include specification of authority requirements applying as part of the determination of circumstances, in accordance with which prescribers must obtain authority approval to prescribe the pharmaceutical benefit.
Consistent with the central intent of the September 2021 recommendation of the PBAC, the Instrument removes all prescription circumstances previously specified in Schedules 1 and 3 to the HSD Special Arrangement for HSD pharmaceutical benefits containing rituximab. The removal of these circumstances enables an ‘authorised prescriber’ under section 7 of the HSD Special Arrangement to prescribe HSD pharmaceutical benefits containing rituximab for an ‘eligible patient’ under section 8 of the HSD Special Arrangement at their discretion within their scope of clinical practice (i.e. for the subsidised treatment of a wider range of conditions) instead of solely in compliance with specified prescription circumstances. It also removes the requirement for an authorised prescriber to comply with ‘Authority Required procedures’ previously specified as part of the prescription circumstances for HSD pharmaceutical benefits containing rituximab.
The listing of medicines as unrestricted pharmaceutical benefits to which no prescription circumstances (and therefore no circumstances-related authority requirements) apply has no precedent under the HSD Program. The Instrument therefore makes changes to the existing legislative framework for the HSD Program as set out in the HSD Special Arrangement to support the removal of all prescription circumstances for HSD pharmaceutical benefits containing rituximab and thus accommodate the prescribing and supply of rituximab as an unrestricted pharmaceutical benefit under the HSD Program.
Human Rights Implications
The Instrument engages Articles 2, 9 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to social security and to the enjoyment of the highest attainable standard of physical and mental health.
The Instrument assists with the advancement of these human rights by expanding access to all listed brands of PBS-subsidised rituximab under the HSD Program in recognition of the wide range of conditions for which this drug is used as part of the standard-of-care in Australian specialist centres (previously without subsidy in many cases on the basis of its former listing as a restricted pharmaceutical benefit). The Instrument achieves this via the implementation of changes enabling authorised prescribers under the HSD Special Arrangement (generally specialist clinicians in the hospital setting) to prescribe rituximab as an HSD pharmaceutical benefit for eligible patients under the HSD Special Arrangement at their discretion within their scope of clinical practice – i.e. for the subsidised treatment of a wider range of conditions than was previously permissible. By removing the specified prescription circumstances previously applying to HSD pharmaceutical benefits containing rituximab and implementing supporting changes to the HSD Special Arrangement, the Instrument provides that the prescribing of (and therefore patient access to) rituximab under the HSD Program is no longer restricted to specific circumstances that are limited to specified conditions and associated eligibility criteria. The Instrument therefore ensures more equitable and timely access to this medicine for eligible people by providing for wider access on a subsidised basis.
The exclusion of patients who meet the definition of an ‘EFC patient’ as specified in the Instrument from being eligible patients for the prescription and supply of rituximab as an HSD pharmaceutical benefit is implemented by the Instrument for the purposes of distinguishing between the prescription and supply of rituximab under the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (the EFC Special Arrangement) (i.e. as an EFC pharmaceutical benefit) and the prescription and supply of this drug as an HSD pharmaceutical benefit. This distinction is necessary in the absence of the distinct prescription circumstances that previously applied to HSD and EFC pharmaceutical benefits containing rituximab respectively (noting that all prescription circumstances for rituximab pharmaceutical benefits are also being removed from the EFC Special Arrangement effective 1 September 2022). It is beneficial to EFC patients (generally those receiving chemotherapy treatment for cancer) as it clarifies that the prescription and supply of rituximab for these patients should continue to occur under the EFC Special Arrangement, which provides that no patient co-payment may be charged for a repeat supply (and also specifies higher maximum numbers of repeats as applying to rituximab pharmaceutical benefits).
Broadly, the PBS is a benefits scheme that assists with the advancement of these human rights by providing subsidised access to medicines for people in the community. The recommendatory role of the PBAC ensures that decisions about subsidised access to medicines listed on the PBS are evidence-based.
Conclusion
The Instrument is compatible with human rights because it advances the protection of human rights.
Kirsten Buckingham
Acting Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Health Resourcing Group
Department of Health and Aged Care