Proposal on the funding of infliximab, rituximab and tocilizumab
What we’re proposing
PHARMAC are proposing to change how three hospital medicines are managed within the Pharmaceutical Schedule.
The medicines are:
- Infliximab (Remicade)
- Rituximab (Mabthera)
- Tocilizumab (Actemra)
These medicines are currently listed in Section H with restrictions applying to their use in DHB hospitals. This change would result in these medicines also being listed in Section B of the Pharmaceutical Schedule from 1 February 2019, with a two-month phase-in period, meaning that the changes would be fully implemented from 1 April 2019.
A listing in Section B would mean that these products would be subject to subsidy claims and Special Authority requirements, just like hospital-administered cancer treatments and community medicines. We note that this situation already applies to rituximab for its use in blood cancers.
In addition to the listing of these medicines in Section B of the Schedule, we would also be making relevant modifications to the Schedule Rules.
We are interested in receiving any feedback that you have on this proposal, including feedback on the draft Special Authority criteria, the implementation arrangements, the practical impacts or any other aspects of the overall proposal.
Consultation closes on Friday, 5 October 2018, and feedback can be emailed to hmconsult@pharmac.govt.nz.
What would the effect be?
This proposal would change how these three medicines are managed within DHB hospitals, and would mean that these medicines would, in effect, be treated in the same way as related treatments, such as adalimumab and etanercept.
The expected impact of this proposal is that:
- Prescribers would need to submit Special Authority applications for these treatments to access funding for their use,
- Dispensing of these treatments would need to occur at an individual level for each person with a valid Special Authority approval (i.e. these medicines could not be managed as imprest items),
- DHB hospitals would need to submit pharmaceutical subsidy claims for their use,
- DHBs would no longer be able to undertake NPPA Rapid Assessments for these treatments, as DHBs would not be able to approve a subsidy for individuals, and
- Alternative brands of these treatments (such as DV purchases) would not be subsidised unless PHARMAC also listed other brands in Section B of the Schedule.
Who we think will be interested
Anyone with an interest in the supply, provision or use of infliximab, rituximab or tocilizumab within DHB hospitals. As this proposal is an administrative change, we expect that patients would not notice any differences in the way they access these treatments if the proposal is accepted.
We expect that this proposal will be of particular interest to DHB hospital staff who are involved in the care of patients using these medicines, such as pharmacists, prescribers, nurses and administrative staff. We note that these three medicines are used in a wide range of specialities including:
- Rheumatology
- Ophthalmology
- Gastroenterology
- Dermatology
- Neurology
- Haematology
- Nephrology
- Transplant medicine
- Respiratory medicine
Why we’re proposing this
The Government has decided to expand the scope of the CPB to encompass the cost of all hospital medicines, in addition to its current scope of:
- Community medicines
- Community medical devices
- Hospital-administered cancer treatments
- Haemophilia treatments
- Vaccines
To support the implementation of this decision, we are proposing to initiate subsidy payments for all funded use of three biologic agents, infliximab (Remicade), rituximab (Mabthera), and tocilizumab (Actemra). This would bring the funding arrangements for these medicines in line with how the funding of hospital-administered cancer treatments is managed.
This proposal represents the next step in PHARMAC assuming greater responsibility for the management of hospital medicines. We expect to make further changes in relation to other hospital medicines over the next few years, and we are working with DHBs to determine how these other products will be managed within the CPB in the interim.
Details about our proposal
Changes to Schedule listings
We are proposing to list the following pharmaceuticals in Section B of the Pharmaceutical Schedule under Special Authority criteria for all currently funded indications. This would be in addition to their current listings in Section H.
- Infliximab
- Rituximab
- Tocilizumab
Rituximab (Mabthera) is already funded in Section B of the Pharmaceutical Schedule for its use in blood cancers. This change would result in the current Special Authority criteria being extended to include its other current hospital uses, including rheumatoid arthritis, haemophilia with inhibitors and steroid-resistant nephrotic syndrome.
Infliximab (Remicade) and tocilizumab (Actemra) would be listed in Section B of the Pharmaceutical Schedule subject to Special Authority restrictions that match the current Section H restrictions applying to their use.
These products would be subject to a “PCT only” restriction, meaning that only DHB hospitals would be able to make subsidy claims.
To enable subsidy claims by DHB hospitals for doses that are prepared by Baxter Healthcare, we would also list a “1 mg for ECP” presentation:
|
Chemical |
Presentation |
Brand |
Pack size |
Proposed price and subsidy |
|---|---|---|---|---|
|
Infliximab |
Inj 1 mg for ECP |
Baxter |
1 mg |
$8.29 |
|
Tocilizumab |
Inj 1 mg for ECP |
Baxter |
1 mg |
$2.85 |
To reflect both the current practice in Section H restrictions, and the operating environment within hospitals, Special Authority applications would be able to be submitted by a wide group of prescribers, either independently or on the recommendation of a particular sub-specialist, as appropriate, for example:
Initial application – (graft vs host disease) from any relevant practitioner
Initial application – (rheumatoid arthritis) only from a rheumatologist or any practitioner on the recommendation of a rheumatologist
An example of the proposed Special Authority criteria, and comparison with the existing Section H criteria is below.
Rituximab – current Section H wording
Initiation – immune thrombocytopenic purpura (ITP)
Haematologist
Re-assessment required after 4 weeks
Both:
- Either:
- Patient has immune thrombocytopenic purpura* with a platelet count of less than or equal to 20,000 platelets per microlitre; or
- Patient has immune thrombocytopenic purpura* with a platelet count of 20,000 to 30,000 platelets per microlitre and significant mucocutaneous bleeding; and
- Any of the following:
- Treatment with steroids and splenectomy have been ineffective; or
- Treatment with steroids has been ineffective and splenectomy is an absolute contraindication; or
- Other treatments including steroids have been ineffective and patient is being prepared for elective surgery (e.g. splenectomy).
Rituximab – proposed Special Authority wording
Initial application - (immune thrombocytopenic purpura (ITP)) only from a haematologist or Practitioner on the recommendation of a haematologist. Approvals valid for one month for applications meeting the following criteria:
Both:
- Either:
- Patient has immune thrombocytopenic purpura* with a platelet count of less than or equal to 20,000 platelets per microlitre; or
- Patient has immune thrombocytopenic purpura* with a platelet count of 20,000 to 30,000 platelets per microlitre and significant mucocutaneous bleeding; and
- Any of the following:
- Treatment with steroids and splenectomy have been ineffective; or
- Treatment with steroids has been ineffective and splenectomy is an absolute contraindication; or
- Other treatments including steroids have been ineffective and patient is being prepared for elective surgery (e.g. splenectomy).
Changes to Schedule Rules
We are proposing the following amendments to the Pharmaceutical Schedule Rules to support the proposal:
- Redefining the use of “PCT” within the Schedule to accommodate the listing of and subsidy claiming for pharmaceuticals with non-cancer indications, with consequential changes to rules 3.1, 6.5 and 8.1.
- Deleting Rule 6.7 (below) as we consider these provisions are adequately covered elsewhere within the Schedule Rules.
6.7 DHB Hospital Funding: The default funding arrangement for Pharmaceuticals administered, provided or dispensed by DHB Hospitals is that they are to be funded by the relevant DHB Hospital from its own budget, with the exception of:
6.7.1 Pharmaceutical Cancer Treatments which are funded through a Subsidy claim
6.7.2 Community Pharmaceuticals that have been brought to the DHB Hospital by the patient who is being treated by outpatient services or who is admitted as an inpatient
6.7.3 Community Pharmaceuticals that have been dispensed to a mental health day clinic under a PSO
6.7.4 Unlisted Pharmaceuticals that have been brought to the DHB Hospital by the patient who is admitted as an inpatient
6.7.5 non-seasonal vaccines, and
6.7.6 haemophilia treatment
Other changes
The change in funding arrangements for these three pharmaceuticals would have some additional impacts. These include:
- DHBs would no longer be able to undertake NPPA Rapid Assessments for these pharmaceuticals, as DHBs would not be able to approve a subsidy for individuals. This means all NPPA applications for these pharmaceuticals would be required to be submitted to PHARMAC.
- Alternative brands of these pharmaceuticals (such as DV purchases) would not be subsidised unless PHARMAC also listed other brands in Section B of the Schedule
- Because Special Authority approvals and subsidy claims relate to individual patients, DHB hospitals would need to ensure that dispensing of these products was managed at an individual level, and not managed as imprest items.
Implementation
We propose to make these changes in the Pharmaceutical Schedule from 1 February 2019, with a two-month phase-in period, meaning that the changes would be fully implemented from 1 April 2019.
This phase-in period means that DHBs would not be required to submit subsidy claims until April 2019, but would allow time for Special Authority approvals to be in place for patients. Any claims submitted during this time would be treated as ‘information only’ claims, and would not accrue to the CPB.
All patients on these treatments at 1 February 2019 would be automatically eligible for Special Authority approval. To enable this, the initial application criteria on the Special Authority forms would temporarily include an option for ‘use prior to 1 February 2019’, in situations where only treatment-naïve patients would be able to meet the current criteria.
We are also looking to make some modifications to the claiming mechanism for hospital-administered cancer treatments to support this change. We will be engaging with DHBs, the Ministry of Health and software vendors to decide on what changes would be required, and how they would be implemented, if this proposal is accepted.
To provide feedback
Send us an email: hmconsult@pharmac.govt.nz by Friday, 5 October 2018.
All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.
Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.
We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.