Proposal to fund long-acting paliperidone for people with schizophrenia and ibrutinib for people with chronic lymphocytic leukaemia
What we’re proposing
We are seeking feedback on a proposal to fund two new medicines:
- Paliperidone three-monthly depot injection (brand name Invega Trinza) for people with schizophrenia
- Ibrutinib (brand name Imbruvica) for people with relapsed/refractory chronic lymphocytic leukaemia following treatment with venetoclax
As part of this proposal, we would also amend the contractual arrangements for paliperidone one-monthly depot injection and risperidone depot injection through a provisional agreement with Janssen-Cilag Pty Ltd (Janssen).
Consultation closes at 4pm, Thursday 29 September, 2022 and feedback can be emailed to consult@Pharmac.govt.nz
Paliperidone three-monthly depot injection for people with schizophrenia
What would the effect be?
This proposal would mean that people with schizophrenia who meet the eligibility criteria would have access to paliperidone three-monthly depot injection (Invega Trinza).
We estimate that in the first year, over 330 people would be eligible for funding. We expect that this would increase with each year of funding, and after five years, over 1400 people per year would be eligible for treatment with paliperidone three-monthly depot injection.
Who we think will be interested
- People with schizophrenia, their whānau, friends and caregivers
- Healthcare professionals
- Te Whatu Ora hospitals and other organisations who deliver services and support for people, and their whānau who may be treated with paliperidone
- Pharmacies and wholesalers
- Pharmaceutical suppliers
About schizophrenia
Schizophrenia is a mental health condition characterised by recurring episodes of psychosis. It can have a significant impact on a person’s perception, thoughts, mood and behaviour. Schizophrenia is debilitating and other conditions can occur with it. Māori are approximately three times more likely than non-Māori to experience schizophrenia.
About paliperidone three-monthly
Paliperidone is medicine used to treat schizophrenia and is administered by a healthcare professional. It helps to correct a chemical imbalance in the brain associated with this condition. It can also be used to lessen the chance of schizophrenia symptoms coming back.
Currently a one-monthly depot injection formulation is funded (Invega Sustenna). We are now proposing to also fund a three-monthly depot injection formulation (Invega Trinza), meaning that people would need less frequent injections as part of their treatment programme.
The three-monthly formulation could be used after someone has had at least four doses of the one-monthly formulation. Information regarding dose conversions from the one-monthly to the three-monthly formulation can be found on the Medsafe Datasheet(external link).
In addition to being as effective as the one-monthly formulation, studies have reported that paliperidone three-monthly depot injection can improve adherence, which may reduce relapses, reduce carer burden and may impact the frequency of hospital admissions compared to the one-monthly formulation.
Our clinical advisors have told us that benefits from paliperidone three-monthly depot injection would be experienced by those most disadvantaged and that funding paliperidone three-monthly depot injection may have a positive influence on improving inequities currently observed with schizophrenia. We know that Māori are more likely than non-Māori to experience schizophrenia and that over 40% of people currently taking paliperidone one-monthly depot injection identify as Māori. We anticipate that many Māori would directly benefit from the funding of three-monthly presentation.
Why we’re proposing this
We first received a funding application to fund paliperidone three-monthly depot injection in 2016. We sought advice from:
- the Mental Health Subcommittee in 2016, which recommended it be funded if it didn’t result in any additional medicines expenditure
- the Pharmacology and Therapeutics Advisory Committee (PTAC) in 2017, which recommended that it be funded with a low priority.
In December 2021 Pharmac received new evidence for consideration and sought further advice from the Mental Health Advisory Committee (previously the Mental Health Subcommittee) in early 2022, which recommended that paliperidone three-monthly be funded with a high priority.
You can see the history of the application and the advice we’ve received here(external link).
Details about our proposal
Paliperidone (Invega Trinza) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 December 2022, at the following price and subsidy:
| Chemical | Formulation | Brand | Pack size | Price and subsidy |
|---|---|---|---|---|
| Paliperidone | Inj 175 mg syringe | Invega Trinza | 1 | $815.85 |
| Paliperidone | Inj 263 mg syringe | Invega Trinza | 1 | $1,072.26 |
| Paliperidone | Inj 350 mg syringe | Invega Trinza | 1 | $1,305.36 |
| Paliperidone | Inj 525 mg syringe | Invega Trinza | 1 | $1,305.36 |
A confidential rebate would apply to Invega Trinza that would reduce the net price to the funder. Invega Trinza would have protection from delisting and subsidy reduction until 30 November 2025.
Paliperidone three-monthly depot injection would be listed in Section B and Part II of Section H subject to the following eligibility criteria:
Special Authority for Subsidy/Hospital Indication restriction:
Initial application from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:
Both:
- The patient has schizophrenia; and
- The patient has had an initial Special Authority approval for paliperidone once-monthly depot injection.
Renewal from any relevant practitioner.
Approvals valid for 12 months where the initiation of paliperidone depot injection has been associated with fewer days of intensive intervention than was the case during a corresponding period of time prior to the initiation of an atypical antipsychotic depot injection.
Ibrutinib for people with relapsed/refractory chronic lymphocytic leukaemia
What would the effect be?
This proposal would mean that people with chronic lymphocytic leukaemia (CLL), whose disease progresses during, or relapses after, treatment with venetoclax, or for whom venetoclax is intolerable, would have access to funded ibrutinib (Imbruvica) from 1 December 2022.
We estimate that in the first year, approximately 30 people would be eligible for funding. We expect that this this would increase with each year of funding, and after five years over 100 people would be eligible for treatment with ibrutinib each year.
Who we think will be interested
- People with CLL, their whānau, friends and caregivers
- Healthcare professionals
- Te Whatu Ora hospitals and other organisations who deliver services and support for people, and their whānau who may be treated with ibrutinib
- Pharmacies and wholesalers
- Pharmaceutical suppliers
About chronic lymphocytic leukaemia (CLL)
CLL is a type of slow-growing blood cancer affecting a type of white blood cell called B-cells. In CLL, these B-cells cells multiply too quickly, live too long and are unable to function properly. For many people with CLL, the condition can remain stable for many months or even years and may have little if any impact on lifestyle or general health. Over time, an excess number of B-cells crowd the bone marrow and interfere with normal blood cell production which can result in anaemia (causing persistent tiredness), recurrent infections and easy bruising.
Once the disease has progressed to the stage where symptoms become problematic, treatment is usually required. CLL is not usually curable and it typically comes back (relapses) after treatment, meaning that subsequent lines of treatment are often required. Those with unfavourable genetic mutations have a considerably worse prognosis and their disease is resistant to usual chemotherapy-based treatments – this is termed being treatment refractory. Venetoclax is currently funded for people with relapsed or refractory CLL and as a first-line treatment for people with certain mutations. There are currently limited treatment options for people whose disease progresses during, or relapses after, treatment with venetoclax, or for people who cannot tolerate venetoclax treatment.
We understand that approximately 12% of people that currently receive venetoclax are Māori, which is slightly higher than the proportion of Māori in the general population at the average age of diagnosis for CLL. From what we know about the burden of disease and outcomes for people with leukaemia and other blood cancers in general, we expect that the age standardised incidence may be higher and outcomes worse for Māori compared to non Māori with CLL.
About ibrutinib
Ibrutinib is an anticancer medicine that works by blocking a protein called Bruton's tyrosine kinase (BTK) and belongs to a class of medicines known as “BTK inhibitors”. By blocking this protein, ibrutinib blocks the growth of the B-cells and kills the cancerous B cells, which also can help slow the spread of the cancer.
Our clinical advisors have told us that when venetoclax is not effective or not tolerated, ibrutinib could be an effective treatment option for patients, because the two medicines work in different ways. Evidence shows that ibrutinib is effective at increasing progression free survival and overall survival for people with CLL, meaning that people with CLL are expected to stay well for longer and live longer by taking ibrutinib.
Ibrutinib is a capsule which is taken orally each day. People would continue to take ibrutinib until their cancer progresses. Ibrutinib is easy to administer and could be of particular benefit in the treatment of very frail patients.
We consider that it is likely that the availability of an oral, once daily treatment option would be more suitable compared to the alternative treatment options available for those who progress or are refractory/intolerant to venetoclax-containing regimens, as these options involve injectables given in a hospital setting.
Why we’re proposing this
We first received a funding application to fund ibrutinib in 2015 for relapsed/refractory CLL. In 2019 we funded venetoclax, a different type of treatment for people with CLL, in accordance with our advice at the time that venetoclax and ibrutinib were similarly effective. After the funding of venetoclax, we sought updated clinical advice as we had been told there remained a need for a BTK inhibitor for people with CLL. Our expert advisors told us that ibrutinib should be funded after venetoclax, or for people where venetoclax is intolerable, with a high priority.
You can see the expert advice we received about funding ibrutinib in this proposed setting on the Application Tracker here(external link).
We have also received funding applications for ibrutinib in other indications:
- CLL
- mantle cell lymphoma(external link)
- Waldenström macroglobulinemia
These applications are at varying stages through our process and are not being proposed for funding at this stage.
We have also received an application to fund acalabrutinib(external link) (branded as Calquence), another BTK inhibitor, in this setting. Our clinical advisors have also recommended that it be funded and that these two BTK inhibitors would provide the same or similar health benefit for this patient group. This application is currently an option for investment, meaning that it is something we would like to fund when we have available budget. This proposal for ibrutinib would not prevent us from funding acalabrutinib at a later date.
Details about our proposal
Ibrutinib (Imbruvica) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 December 2022, at the following price and subsidy:
| Chemical | Formulation | Brand | Pack size | Price and subsidy |
|---|---|---|---|---|
| Ibrutinib | Tab 140 mg | Imbruvica | 30 | $3,217.00 |
| Ibrutinib | Tab 420 mg | Imbruvica | 30 | $9,652.00 |
A confidential rebate would apply to Ibrutinib (Imbruvica) that would reduce the net price to the funder. Ibrutinib would have protection from delisting and subsidy reduction until 30 November 2025.
Ibrutinib would be listed in Section B and Part II of Section H subject to the following eligibility criteria:
Special Authority for Subsidy
Initial application – (chronic lymphocytic leukaemia (CLL)) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:
All of the following:
- Patient has chronic lymphocytic leukaemia (CLL) requiring therapy; and
- Patient has not previously received funded ibrutinib; and
- Ibrutinib is to be used as monotherapy; and
- Any of the following:
- Both:
- There is documentation confirming that patient has 17p deletion or TP53 mutation; and
- Patient has experienced intolerable side effects with previously funded venetoclax monotherapy; or
- All of the following:
- Patient has received at least one prior immunochemotherapy for CLL; and
- Patient’s CLL has relapsed within 36 months of previous treatment; and
- Patient has experienced intolerable side effects with previously funded venetoclax in combination with rituximab regimen; or
- Patient’s CLL is refractory to or has relapsed within 36 months of a venetoclax regimen.
- Both:
Renewal – (chronic lymphocytic leukaemia (CLL)) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:
Both:
- No evidence of clinical disease progression; and
- The treatment remains appropriate and the patient is benefitting from treatment.
Other changes associated with this proposal
Paliperidone one-monthly depot injection
Paliperidone one-monthly depot injection is currently funded for people with schizophrenia or other psychotic disorders. As part of this proposal, the net price for paliperidone one-monthly depot injection (Invega Sustenna) would reduce via confidential rebate from 1 December 2022 and there would be protection from delisting and subsidy reduction until 30 November 2025.
There would be no changes to the current eligibility criteria or list price for paliperidone one-monthly as part of this proposal.
Risperidone depot injection
Risperidone depot injection is funded for people with schizophrenia or other psychotic disorders. As part of this proposal, the net price for risperidone depot injection (Risperdal Consta) would reduce via confidential rebate from 1 December 2022 and there would be protection from delisting and subsidy reduction until 30 November 2025.
There would be no changes to the current eligibility criteria or list price for risperidone depot as part of this proposal.
To provide feedback
Send us an email: consult@Pharmac.govt.nz by 4pm, Thursday 29 September, 2022
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.
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