Decision to fund long-acting paliperidone for people with schizophrenia and ibrutinib for people with chronic lymphocytic leukaemia

Medicines Decision

We are pleased to announce a decision to fund two new medicines.

What we’re doing

We are pleased to announce a decision to fund two new medicines:

  • Paliperidone palmitate three-monthly depot injection (brand name Invega Trinza) for people with schizophrenia
  • Ibrutinib (brand name Imbruvica) for people with relapsed or refractory chronic lymphocytic leukaemia, following treatment with venetoclax

We will also be amending the pricing and exclusivity arrangements for paliperidone one-monthly depot injection and risperidone depot injection through an agreement with Janssen-Cilag Pty Ltd (Janssen).

These products will remain fully funded, but the net price will change and these products will have protection from delisting and subsidy reduction until 30 November 2025.

Paliperidone palmitate three-monthly depot injection for people with schizophrenia

What does this mean for people?

People with schizophrenia who meet the eligibility criteria will have access to paliperidone three-monthly depot injection (Invega Trinza).

We estimate that in the first year, over 300 people will be eligible for funding. We expect that this will increase each year. After five years over 1,400 people will be eligible for treatment with paliperidone three-monthly depot injection every year.

We understand that both Māori and Pacific peoples are more likely to experience schizophrenia than non-Māori, non-Pacific peoples. We anticipate that many Māori and Pacific peoples will directly benefit from the funding of three-monthly paliperidone. We will monitor uptake to ensure these population groups have equitable access to this presentation.

Who we think will be most 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 have schizophrenia
  • 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 three times more likely and Pacific people are nearly twice as likely to experience schizophrenia compared to non-Māori and non-Pacific people.

About paliperidone palmitate three-monthly depot injection

Paliperidone palmitate is medicine used to treat schizophrenia. It 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 reduce the chance of schizophrenia symptoms coming back.

With the funding of a three-monthly depot injection formulation (Invega Trinza), people will need less frequent injections as part of their treatment programme.

The three-monthly formulation Medsafe approved for use 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 palmitate three-monthly depot injection can improve treatment adherence, which may reduce relapses, reduce carer burden and may reduce the frequency of hospital admissions compared to the one-monthly formulation.

Any changes to the proposal

This decision was subject to a consultation letter dated 14 September 2022.

We received lots of feedback which highlighted the benefit this decision would have. We’re really grateful to everyone who took the time to share their support and provide us with feedback.

There have been no changes as a result of consultation feedback. All consultation feedback received, and our responses, have been summarised at the end of this notification letter.

Details about this decision

Paliperidone palmitate (Invega Trinza) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 December 2022, at the following prices and subsidies:

Chemical

Formulation

Brand

Pack size

Price and subsidy

Paliperidone palmitate 

Inj 175 mg syringe

Invega Trinza

1

$815.85

Paliperidone palmitate 

Inj 263 mg syringe

Invega Trinza

1

$1,072.26

Paliperidone palmitate

Inj 350 mg syringe

Invega Trinza

1

$1,305.36

Paliperidone palmitate

Inj 525 mg syringe

Invega Trinza

1

$1,305.36

A confidential rebate will apply to Invega Trinza that will reduce the net price to the Funder. Invega Trinza will have protection from delisting and subsidy reduction until 30 November 2025.

Paliperidone palmitate three-monthly depot injection will 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:

  1. The patient has schizophrenia; and
  2. 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 does this mean for people?

People with chronic lymphocytic leukaemia (CLL) and certain clinical circumstances will have access to funded ibrutinib (Imbruvica) from 1 December 2022. This will mean funded access for people:

  • whose disease progresses during treatment with venetoclax
  • whose disease relapses within 3 years of treatment with venetoclax
  • for whom venetoclax results in intolerable side effects

We estimate that in the first year approximately 30 people will be eligible for funding. We expect that this will increase with each year of funding. After five years over 100 people will be eligible for treatment with ibrutinib each year.

We understand that approximately 12% of people that currently receive venetoclax are Māori. 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.

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 medications given by injection and given in a hospital setting. While this would be expected to reduce impact on infusion resources, there will be a cost to Te Whatu Ora from the high list price and availability through community pharmacy.

Who we think will be most interested

  • People with chronic lymphocytic leukaemia, 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 have chronic lymphocytic leukaemia
  • Pharmacies and wholesalers
  • Pharmaceutical suppliers

About chronic lymphocytic leukaemia (CLL)

Chronic lymphocytic leukaemia (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.

About ibrutinib

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 an anticancer medicine belongs to a class of medicines known as “BTK inhibitors”. Ibrutinib is a capsule that is taken orally each day, and 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.

Any changes to the proposal

This decision was subject to a consultation letter dated 14 September 2022.

Following consultation feedback, we have clarified that as with venetoclax, those with small lymphocytic lymphoma and B-cell prolymphocytic leukaemia are part of the group intended for funding. In addition, we have removed the term “previously funded” from the criteria, as we understand that there are people who have received venetoclax via other means and they meet the intent of the criteria, and increased the renewal period to 12 months.

We received substantial feedback requesting wider access to ibrutinib (or another BTK inhibitor). These requests for widened access are related to the following applications:

These applications are at varying stages through our assessment process, and will be considered separately from this funding decision. This decision will not prevent us from considering wider access in the future.

All consultation feedback received has been summarised at the end of this notification letter.

Details about this decision

Ibrutinib (Imbruvica) will 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 will apply to Ibrutinib (Imbruvica) that will reduce the net price to the funder. Ibrutinib will have protection from delisting and subsidy reduction until 30 November 2025.

Ibrutinib will be listed in Section B and Part II of Section H subject to the following eligibility criteria (additions in bold, deletions in strikethrough):

Special Authority for Subsidy/Hospital Indication restriction

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:

  1. Patient has chronic lymphocytic leukaemia (CLL) requiring therapy; and
  2. Patient has not previously received funded ibrutinib; and
  3. Ibrutinib is to be used as monotherapy; and
  4. Any of the following:
    1. Both:
      1. There is documentation confirming that patient has 17p deletion or TP53 mutation; and
      2. Patient has experienced intolerable side effects with previously funded venetoclax monotherapy; or
    2. All of the following:
      1. Patient has received at least one prior immunochemotherapy for CLL; and
      2. Patient’s CLL has relapsed within 36 months of previous treatment; and
      3. Patient has experienced intolerable side effects with previously funded venetoclax in combination with rituximab regimen; or
    3. Patient’s CLL is refractory to or has relapsed within 36 months of a venetoclax regimen.

Renewal - (chronic lymphocytic leukaemia (CLL)) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

Both:

  1. No evidence of clinical disease progression; and
  2. The treatment remains appropriate and the patient is benefitting from treatment.

Note: ‘Chronic lymphocytic leukaemia (CLL)’ includes small lymphocytic lymphoma (SLL) and B-cell prolymphocytic leukaemia (B-PLL)*. Indications marked with * are Unapproved indications.

Changes to other pharmaceuticals associated with this decision

Paliperidone palmitate one-monthly depot injection

Paliperidone one-monthly depot injection is currently funded for people with schizophrenia or other psychotic disorders. As part of this decision, the net price for paliperidone one-monthly depot injection (Invega Sustenna) will reduce via confidential rebate from 1 December 2022. It will also be protected from delisting and subsidy reduction until 30 November 2025.

There will be no changes to the current eligibility criteria or list price for paliperidone one-monthly as part of this decision.

Risperidone depot injection

Risperidone depot injection is funded for people with schizophrenia or other psychotic disorders. As part of this decision, the net price for risperidone depot injection (Risperdal Consta) will reduce via confidential rebate from 1 December 2022. It will also be protected from delisting and subsidy reduction until 30 November 2025.

There will be no changes to the current eligibility criteria or list price for risperidone depot as part of this decision.

Our response to what you told us

We’re really grateful for the time people took to respond to consultation. A summary of the main themes raised in feedback and our responses to the feedback received are set out below. 

Theme

Comment

Paliperidone palmitate three monthly depot injection

Support for the funding of paliperidone palmitate three-monthly depot injection, the following benefits were highlighted in particular:

  • improved quality of life, independence, mana and treatment satisfaction for individuals
  • many Māori would benefit from this proposal
  • potential for people whose condition is stable to be managed in primary care
  • improve acceptability and adherence and reduced risk of loss to follow up
  • better clinical outcomes; reduce inpatient admissions and associated clinical resource and cost
  • more time can be focused on holistic care and less time on medication
  • reduce trauma of administration and negative impacts on whānau
  • potential for reduced police involvement to ensure treatment of people who have a compulsory treatment order
  • promote wellness and tino rangatiratanga through strengthening individuals’ ability to work, through less days off for medication administration, as well as fewer admissions and general disruptions from episodes of ill-health
  • significant benefit for those with schizophrenia living in rural areas due to reduced requirement for travel for treatment

We are pleased to be proposing to progress a proposal that would improve the health outcomes of New Zealanders. This feedback is in line with the advice we have received and what we have heard from individuals, their whānau and the sector.

Funding should not be restricted to only those who have had four loading doses.

There is no restriction in the funding criteria regarding the number of loading doses. The requirement in the criteria that the patient has had a previous approval for paliperidone one-monthly depot injection is in line with the Medsafe approved indication for paliperidone three-monthly depot injection, which is for those who have been adequately treated with paliperidone one-monthly depot injection for at least four months.

Request for clarity on the application process to access funding for the medicine.

Access to funding for paliperidone three-monthly depot injection will operate in the same way as other antipsychotic agents under Special Authority.

More detail can be found here. 

Request for wider access for other related illnesses such as schizoaffective and bipolar affective disorders.

We have not received a funding application for the use of paliperidone three-monthly depot injection for other indications. We would welcome an application to consider this. We note that paliperidone three-monthly depot injection is only indicated for the treatment of schizophrenia.

See Medsafe datasheet here.(external link)

You can read more about submitting a funding application on our website.

Ibrutinib

Support for proposal. In particular, it was highlighted that:

  • Funding ibrutinib in this setting would address an area of urgent unmet need
  • Ibrutinib is a life extending and possibly life-saving medicine
  • Ibrutinib will help patients and their whānau

We are pleased to be progressing a proposal that will improve the health outcomes of New Zealanders. This feedback is in line with the clinical advice we have received.

Request removal of the requirement for relapse to occur within 36 months to be eligible.

We appreciate that there will remain an unmet need as a result of this decision to fund ibrutinib for those whose disease relapses after 36 months.

The advice that we have received is that this decision will address the most pressing unmet need for people with CLL. This has been described in the record of the Cancer Treatments Advisory Committee April 2022. [PDF, 846 KB]

At this meeting, the Committee considered that there remains an unmet need for those patients whose disease progresses after 36 months of previous treatment. We intend to seek advice regarding how to best address this unmet need at a future meeting of the Cancer Treatments Advisory Committee, which could include widening of access to venetoclax and other BTK inhibitors that are Medsafe approved or under Medsafe evaluation.

Sought clarification that for the purpose of these criteria, small lymphocytic lymphoma and B-cell prolymphocytic leukaemia are considered part of the intended group.

 

People with small lymphocytic lymphoma and B-cell prolymphocytic leukaemia currently meet the intent of the criteria for venetoclax. We have added a note to the ibrutinib criteria to clarify that this group meets the intent of the criteria to ensure consistent access across Aotearoa New Zealand.

Sought clarification that partial response with lymphocytosis’ (PR-L) does not constitute progression.

 

We consider that this meets the intent of the criteria, however we consider this to be clinical guidance, which is not in line with the intent of funding criteria so we have not included this in the criteria. We understand that haematologists are aware of this and that this distinction would be best considered by the appropriate clinician, operating within their scope of practice.

Considered that the term ‘previously funded’ in the proposed Special Authority criteria would disadvantage those who received treatment via clinical trial.

 

We have removed the criteria that would limit access to ibrutinib to only those who have previously received funded venetoclax, as this would potentially disadvantage those patients that had previously received venetoclax via another means, such as a clinical trial, and meet the intent of the criteria.

Requested an extension of the renewal criteria duration to 12 months to reduce clinician burden

 

We consider that this amendment is appropriate and aligns with our desire to remove barriers and reduce sector impacts where possible. As a result, we have amended the renewal criteria to enable renewals to be sought every 12 months.

Requested that access be widened to enable combination treatment with venetoclax and ibrutinib

We have not yet received an application for the combination use of ibrutinib and venetoclax for the treatment of CLL, but we would welcome a funding application with supporting evidence for the use of these agents in combination.

You can read more about submitting a funding application on our website.

Requested access to ibrutinib for patients currently receiving ibrutinib via compassionate access or self-funding.

Patients who met the criteria at the time they started treatment with ibrutinib will be able to access funded ibrutinib.

A Special Authority waiver would need to be submitted by their prescriber to enable this.

If this is not the case, patients would be able to move onto one of the other funded treatments for CLL, if they met the relevant criteria prior to commencing treatment with ibrutinib.

A Special Authority waiver would need to be submitted by their prescriber to enable this.

We know that some people are receiving ibrutinib for indications not included in this decision or commenced treatment prior to the funding of venetoclax. These patients will not be eligible for funded ibrutinib treatment as a result of this decision, as we consider it would be inequitable to advantage those patients with means and ability to access treatment in a private setting. We acknowledge that there are other proposals under consideration, which if funded would likely enable access to a BTK inhibitor for those currently receiving treatment with ibrutinib privately:

It is our expectation that compassionate access would continue for those who do not meet the criteria for funding.

Requests for wider access to ibrutinib for:

  • Waldenströms Macroglobulinemia;
  • Relapsed or refractory mantle cell lymphoma; and
  • Funding earlier lines of treatment, where ibrutinib is more suitable than venetoclax

We have received funding applications:

These applications are at varying stages through our assessment process, and will be considered separately from this funding decision. This decision will not prevent us from considering wider access in the future.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our 0800 number (9 am to 5 pm, Monday to Friday) on 0800 660 050.