Decision to widen access to medicines for blood cancer, inflammatory bowel diseases, eczema and rheumatoid arthritis

10 April 2025

Medicines Decision

What we’re doing

We’re pleased to announce a decision to widen access to four medicines for six different health conditions from 1 May 2025 through an agreement with AbbVie Limited.

From 1 May 2025 the following treatments will be funded for more indications:

venetoclax (brand name Venclexta) will be funded in combination with either azacitidine or low dose cytarabine, for people with newly diagnosed acute myeloid leukaemia (AML) who are not eligible for intensive chemotherapy. Access will also be widened for the treatment of chronic lymphocytic leukaemia (CLL)
azacitidine (brand name Azacitidine Dr Reddy’s) will be available to more people with acute myeloid leukaemia (AML)
ibrutinib (brand name Imbruvica) will be available to more people with chronic lymphocytic leukaemia (CLL)
upadacitinib (brand name Rinvoq) will be funded for people with moderate to severe ulcerative colitis (UC), severe Crohn disease (CD), moderate to severe atopic dermatitis (AD), also known as eczema, and for more people with rheumatoid arthritis (RA)

This decision was subject to a consultation letter dated 16 January 2025. We received feedback from a wide range of stakeholders including people with cancer, people with inflammatory diseases, their friends and their whānau, clinicians and patient support groups. We’re grateful to everyone for their feedback and have made several changes to the original proposal in response. A summary of the main themes raised for each part of this proposal, and our responses to feedback are at the end of each section.

The Government provided additional funding to Pharmac in June 2024 to fund new medicines and widen access to medicines that are already funded. The funding increase covers medicines for both cancer and non-cancer health conditions. This decision is one of many that we’re working on to put our budget increase into action.

Media release: Funding boost means more medicines for more New Zealanders.

Venetoclax and Ibrutinib

What does this mean for people?

From 1 May 2025 venetoclax (branded as Venclexta) will be funded in combination with azacitidine or low dose cytarabine, for people with newly diagnosed acute myeloid leukaemia (AML) who are unable to receive intensive chemotherapy.

We anticipate that around 65 people will benefit from widened access to venetoclax in the first year of funding, increasing to around 70 people per year after 5 years.

We have also removed the 36-month criterion from the chronic lymphocytic leukaemia (CLL) Special Authority criteria for venetoclax and ibrutinib. This means people will be able to stop continuous therapy and not be disadvantaged from accessing subsequent treatments as a result. It is expected an additional 1-2 patients per year will benefit from this widening of access.

Who we think will be interested

People with blood cancers, their whānau, friends and caregivers
Healthcare professionals involved in the care of people with blood cancers
Groups who support and advocate for people with cancer or blood disorders
Health NZ | Te Whatu Ora and The Cancer Control Agency | Te Aho o Te Kahu
Hospital and community pharmacies
Hei Āhuru Mōwai
The Cancer Society
Pharmaceutical suppliers and wholesalers

Any changes to the original proposal?

We received feedback from clinicians, patient support and advocacy groups and patients. We want to thank everyone for their feedback. Overall, feedback was supportive.

After considering feedback and seeking further advice from our expert clinical advisors, we have amended the proposed eligibility criteria for access to venetoclax as follows:

enabled people currently receiving venetoclax privately to transition to publicly funded treatment, provided the same eligibility criteria were met prior to starting treatment.
inclusion of a “note” in the Special Authority criteria that clarifies that venetoclax can be used for myeloid sarcomas.
amendment to the venetoclax and ibrutinib Special Authority criteria for the chronic lymphocytic leukaemia (CLL) indication, removing the requirement for disease relapse to have occurred within 36 months of previous treatment.
amended the Special Authority criteria for azacitidine to enable access for those with intermediate or high-risk myelodysplastic syndrome (MDS) based on an internationally recognised scoring system.

A summary of the feedback received and our response to this is detailed below.

Details about our decision

Venetoclax (brand name Venclexta) is currently funded for the treatment of relapsed/refractory chronic lymphocytic leukaemia (CLL). From 1 May 2025 the venetoclax funding criteria will be amended to include treatment of acute myeloid leukaemia (AML) and remove the 36-month restriction on retreatment.

The Venclexta brand will have subsidy and delisting protection until 30 April 2028. As part of the proposal, the net price for venetoclax will reduce via confidential rebate from 1 May 2025.

The Special Authority criteria for venetoclax will change from 1 May 2025 as follows: (additions in bold, deletions in strikethrough):

Special Authority for Subsidy

Initial application – (relapsed/refractory chronic lymphocytic leukaemia) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 7 months for applications meeting the following criteria:

All of the following:

Individual Patient has chronic lymphocytic leukaemia requiring treatment; and
Individual Patient has received at least one prior therapy for chronic lymphocytic leukaemia; and
Individual Patient has not previously received funded venetoclax; and
The individual’s Patient’s disease has relapsed within 36 months of previous treatment; and
Venetoclax to be used in combination six 28-day cycles of rituximab commencing after the 5-week dose titration schedule with venetoclax; and
Individual Patient has ECOG performance status 0-2;

Renewal – (relapsed/refractory chronic lymphocytic leukaemia) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 6 months with for applications meeting the following criteria:

Both:

Treatment remains clinically appropriate and the patient is benefitting from and tolerating treatment; and
Venetoclax is to be discontinued after a maximum of 24 months of treatment following the titration schedule unless earlier discontinuation is required due to disease progression or unacceptable toxicity.

Initial application – (previously untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation*) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

Individual Patient has previously untreated chronic lymphocytic leukaemia; and
There is documentation that the individual patient has the 17p deletion by FISH testing or TP53 mutation sequencing; and
Individual Patient has ECOG performance status 0-2.

Renewal – (relapsed/refractory chronic lymphocytic leukaemia) only from a

relevant specialist or medical practitioner on the recommendation of a relevant specialist from any relevant practitioner. Approvals valid for 6 months where the treatment remains clinically appropriate and the patient is benefitting from and tolerating treatment.

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

Initial application – (previously untreated acute myeloid leukaemia) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either:

The individual is currently on treatment with venetoclax and met all remaining special authority criteria prior to commencing treatment; or
All of the following:
1. Individual has previously untreated acute myeloid leukaemia (see note a), according to World Health Organization (WHO) Classification; and
2. Venetoclax not to be used in combination with standard intensive remission induction chemotherapy; and
3. Venetoclax to be used in combination with azacitidine or low dose cytarabine.

Renewal – (previously untreated acute myeloid leukaemia) from any relevant practitioner. Approvals valid for 6 months where there is no evidence of disease progression.

Notes:

‘Acute myeloid leukaemia’ includes myeloid sarcoma*.
Indications marked with * are Unapproved indications.

Similar eligibility criteria will apply in Part II of Section H of the Pharmaceutical Schedule.

There are also changes to the eligibility criteria for ibrutinib and azacitidine

The Special Authority for ibrutinib (Imbruvica) will change from 1 May 2025 as follows (additions in bold, deletions in strikethrough):

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

Renewal – (chronic lymphocytic leukaemia (CLL)) from any relevant practitioner. Approvals valid for 12 months where there is no evidence of disease progression. 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

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

The Special Authority for azacitidine (Azacitidine Dr Reddy’s) will change from 1 May 2025 as follows (additions in bold, deletions in strikethrough):

Special Authority for Subsidy

Initial application - only from a haematologist or medical practitioner on the recommendation of a haematologist any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

All of the following Both:

1. Any of the following:

1.1 The patient individual has intermediate or high risk MDS based on an internationally recognised scoring system International Prognostic Scoring System (IPSS) intermediate-2 or high risk myelodysplastic syndrome; or

1.2 The patient individual has chronic myelomonocytic leukaemia (based on an intermediate or high risk score from an internationally recognised scoring system or 10%-29% marrow blasts without myeloproliferative disorder); or

1.3 The patient individual has acute myeloid leukaemia with 20-30% blasts and multi-lineage dysplasia, according to World Health Organization (WHO) Classification; and

2. The patient has performance status (WHO/ECOG) grade 0-2; and

3.2. The patient individual has an estimated life expectancy of at least 3 months

Renewal only from a haematologist or medical practitioner on the recommendation of a haematologist. any relevant practitioner Approvals valid for 12 months for applications meeting the following criteria: where there is no evidence of disease progression.

Both:

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

Similar eligibility criteria will apply to both ibrutinib and azacitidine in Part II of Section H of the Pharmaceutical Schedule.

Our responses to what you told us:

Theme	Pharmac Comment
Venetoclax for acute myeloid leukaemia
People were supportive of the proposal, referencing the improvement in health outcomes that would be expected for people unable to receive intensive chemotherapy.	We are pleased to be able to progress a proposal for four new medicines that will improve the health outcomes of New Zealanders.
People noted that the restriction to ‘previously untreated’ people in the special authority would exclude those who had been accessing venetoclax already.	We appreciate this feedback, and as a result we have updated the special authority criteria to allow people currently accessing venetoclax to receive funded venetoclax provided they met the special authority criteria for funded venetoclax prior to starting treatment for AML.
People requested that the International Consensus Classification (ICC) definition be used, which allows for use in the MDS/AML group with 10–19% blasts.	We appreciate this feedback and have sought further clinical advice from the Cancer Treatments Advisory Committee. As a result of the clinical advice we received, we are not including the ICC definition in the Special Authority criteria at this time. Our advisors have indicated that phase 3 study data is yet to be published for venetoclax in this setting. Once this evidence is published, we intend to seek advice regarding the inclusion of this group in the eligibility criteria for venetoclax.
People proposed that venetoclax-based therapy could serve as a bridge to allograft for patients with relapsed or refractory AML Others noted BCL2 inhibitor and azacitidine combinations for people with relapsed AML could be used as bridges to allogenic stem cell transplant People also proposed that venetoclax be made available for post-allograft relapse, in combination with azacitidine and donor lymphocyte infusion.	We appreciate this feedback. We are not able to widen access to include relapsed or refractory AML at this time as we have not assessed the health benefits that treatment would provide in this setting. We note that this would potentially benefit a large number of people and would need a full assessment through Pharmac’s regular funding pathway. We intend to engage with stakeholders to get further information to inform further consideration of this with our clinical advisors. This would support assessment of funding for this group.
People proposed that venetoclax be made available to people with myeloid sarcomas	We appreciate this feedback and have sought further clinical advice from the Cancer Treatments Advisory Committee (CTAC). As a result of this feedback and the clinical advice we received, we have included a note in the eligibility criteria that clarifies that ‘acute myeloid leukaemia’ in this funding setting includes myeloid sarcoma We note use of Venetoclax for myeloid sarcoma is not a Medsafe approved indication. This means myeloid sarcoma would be an unapproved use of venetoclax under Section 29 of the Medicines Act 1981. Requirements for Health Care Professionals for unapproved use of medicines are detailed on the Medsafe website. Use of unapproved medicines \| Medsafe website(external link)
People were supportive, but noted that there had been supply issues for venetoclax for rural patients	We appreciate this feedback, and will share it with the supplier to ensure rural patients aren’t impacted by supply delays.
Venetoclax for relapsed/refractory CLL
People proposed that criterion #4 of venetoclax for relapsed/refractory CLL, “The individual’s disease has relapsed within 36 months of previous treatment”, be changed to “The individual’s disease has relapsed”, noting Australasian and European CLL recommendations	We appreciate this feedback and have sought further clinical advice from the Cancer Treatments Advisory Committee. As a result of this feedback and the clinical advice we received, we have removed the 36-month criterion from the CLL special authority for both venetoclax and ibrutinib treatments.
People were supportive of the removal of the venetoclax renewal criteria for the CLL indication as proposed by Pharmac.	We appreciate this feedback. After further review we have determined that the renewal criteria need to remain to ensure that disease progression is monitored while on treatment with venetoclax. Venetoclax should be discontinued should an individual’s disease progress. Without renewal criteria, this would not necessarily need to occur and as a result, we consider that this will need to be reinstated.
People suggested extending the funding criteria for venetoclax to patients with relapsed myeloma or relapsed AL amyloidosis.	We appreciate this feedback but are not able to progress widened access to venetoclax for relapsed myeloma or AL amyloidosis at this time. We note that this would potentially widen access to a large number of people and would need a full assessment through Pharmac’s regular funding pathway. We would welcome a funding application for this group. Make a medicine funding application
People suggested removal of special authority criteria for azacitidine altogether	We appreciate this feedback and have sought further clinical advice from the Cancer Treatments Advisory Committee. As a result of this feedback and the clinical advice we received, we are not removing the special authority criteria altogether due to uncertainty about the resulting increased usage. Pharmac welcomes a funding application for the open listing of azacitidine so the health benefit and fiscal impact can be considered and assessed. Make a medicine funding application
People suggested amending the criteria for azacitidine funding to: “Individual has International Prognostic Scoring System (IPSS) intermediate-2 or high-risk OR IPSS-M moderate-high or high risk myelodysplastic syndrome; or individual has chronic myelomonocytic leukaemia (with an intermediate-2 or high CPSS-mol score OR 10%-29% marrow blasts without myeloproliferative disorder”.	We appreciate this feedback, and have sought further clinical advice from the Cancer Treatments Advisory Committee. As a result of this feedback and the clinical advice we received, we have amended the special authority criteria to state “individual has intermediate or high risk MDS based on an internationally recognised scoring system”.

Upadacitinib

What does this mean for people?

From 1 May 2025 upadacitinib (branded as Rinvoq) will be funded for people with inflammatory bowel disease, moderate to severe atopic dermatitis (eczema) and rheumatoid arthritis.

We anticipate that around 1150 people will benefit from widened access to upadacitinib in the first year of funding, increasing to around 5000 people per year after 5 years.

We expect that the widened access to upadacitinib will reduce the need for Health NZ infusion services. We estimate that people moving from current biologic treatments requiring an infusion to upadacitinib will reduce infusion hours by approximately 4,000 hours in the first 12 months, with infusion hours reducing by 20,000 hours per year by year five.

Who we think will be interested

People with inflammatory bowel disease, severe atopic dermatitis (eczema), or rheumatoid arthritis, their whānau, friends and caregivers
Healthcare professionals involved in the care of people with inflammatory bowel disease, severe atopic dermatitis (eczema), or rheumatoid arthritis
Te Whatu Ora hospitals and other organisations who deliver services and support for people, and their whānau who are affected by inflammatory bowel disease, severe atopic dermatitis (eczema), or rheumatoid arthritis
People or groups with an interest in treatments for inflammatory bowel disease, atopic dermatitis (eczema), or rheumatoid arthritis
Pharmacies and wholesalers
Pharmaceutical suppliers of medicines used to treat inflammatory bowel disease, atopic dermatitis (eczema), or rheumatoid arthritis.

Any changes to our proposal?

We received feedback from clinicians, patient support and advocacy groups and patients. We want to thank everyone for their feedback. Overall, feedback was supportive.

After considering feedback we have amended the proposed eligibility criteria for access to upadacitinib as follows:

enabling people currently receiving upadacitinib privately to transition to publicly funded treatment, provided eligibility criteria were met prior to starting treatment.
extending the renewal period for ulcerative colitis to 2 years to align with the renewal period for Crohn disease.
Amending the prescriber restriction for initiating upadacitinib for atopic dermatitis to ‘any relevant prescriber.’

Changes to upadacitinib for atopic dermatitis prescriber type

Our consultation proposed that the funding criteria for initiations of upadacitinib for atopic dermatitis would be ‘any relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. This included specialist clinicians and vocationally registered General Practitioners but excluded other prescribers.

We received a range of feedback on the appropriate prescriber type criteria for upadacitinib for atopic dermatitis. This included feedback that the prescriber types should be both widened and further restricted.

We carefully considered the consultation feedback and intend to align the prescriber restriction for both initiations and renewals for upadacitinib across all indications (including atopic dermatitis) to be ‘any relevant practitioner.’

The proposed criteria allow any relevant practitioner acting within the scope of their practice to prescribe upadacitinib. We have proposed this to ensure that everyone who would be eligible could access funded treatment and to align the prescriber type for upadacitinib for atopic dermatitis with its other funded indications.

We acknowledge that some people have concerns around wider access for this indication leading to inappropriate prescribing, our detailed response is in the responses section below.

Details about our proposal

From 1 May 2025 upadacitinib (Rinvoq) 15 mg tablets will continue to be listed in Section B and Part II of Section H of the Pharmaceutical Schedule with amended funding criteria. Two new formulations of upadacitinib, 30 mg and 45 mg tablets will also be listed from 1 May 2025 as follows.

Chemical	Formulation	Brand	Pack size	Price and subsidy
Upadacitinib	Tab modified- release 15 mg	Rinvoq	28	$1,271.00
Upadacitinib	Tab modified- release 30 mg	Rinvoq	28	$ 2,033.00
Upadacitinib	Tab modified- release 45 mg	Rinvoq	28	$ 3,049.00

Chemical

Formulation

Brand

Pack size

Price and subsidy

Upadacitinib

Tab modified-

release 15 mg

Rinvoq

$1,271.00

Upadacitinib

Tab modified-

release 30 mg

Rinvoq

$ 2,033.00

Upadacitinib

Tab modified-

release 45 mg

Rinvoq

$ 3,049.00

The Rinvoq brand will have subsidy and delisting protection until 30 April 2028. As part of the proposal, the net price for upadacitinib will reduce via confidential rebate from 1 May 2025.

The Special Authority criteria for upadacitinib will change from 1 May 2025 as follows, (additions in bold, deletions in strikethrough):

Special Authority for Subsidy

Initial application – (rheumatoid arthritis (previously treated with adalimumab or etanercept)) only from a rheumatologist or practitioner on the recommendation of a rheumatologist from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

The patient individual has had an initial Special Authority approval for adalimumab and/or etanercept for rheumatoid arthritis; and
Either:
1. The patient individual has experienced intolerable side effects from with adalimumab and/or etanercept; or
2. The patient individual has received insufficient benefit from at least a three-month trial of adalimumab and/or etanercept such that they do not meet the renewal criteria for rheumatoid arthritis; and
Either: Any of the following:
1. Rituximab is not clinically appropriate; or
2. 1 The patient individual is seronegative for both anti-cyclic citrullinated peptide (CCP) antibodies and rheumatoid factor; or
3. 2 Both:
  1. 2.1 The patient individual has been started on rituximab for rheumatoid arthritis in a Health NZ hospital; and
  2. 2.2 Either:
    1. 2.1.1 The patient individual has experienced intolerable side effects from with rituximab; or
    2. 2.1.2 At four months following the initial course of rituximab the patient individual has received insufficient benefit such that they do not meet the renewal criteria for rheumatoid arthritis.

Renewal – (Rheumatoid arthritis) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either:

Following 6 months’ initial treatment, the patient has individual has experienced at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
On subsequent reapplications, the patient demonstrates individual has experienced at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician.

Initial application – (atopic dermatitis) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either:

Individual is currently on treatment with upadacitinib for atopic dermatitis and met all remaining criteria prior to commencing treatment; or
All of the following:
1. Individual has moderate to severe atopic dermatitis, severity as defined by an Eczema Area and Severity Index (EASI) score of greater than or equal to 16 or a Dermatology Life Quality Index (DLQI) score of greater than or equal to 10; and
2. Individual has received insufficient benefit from topical therapy (including topical corticosteroids or topical calcineurin inhibitors) for a 28-day trial within the last 6 months, unless contraindicated to all; and
3. Individual has trialled and received insufficient benefit from at least one systemic therapy for a minimum of three months (eg ciclosporin, azathioprine, methotrexate or mycophenolate mofetil), unless contraindicated to all; and
4. An EASI assessment or DLQI assessment has been completed for at least the most recent prior treatment course, preferably while still on treatment but no longer than 1 month following cessation of each prior treatment course; and
5. The most recent EASI or DQLI assessment is no more than 1 month old at the time of application.

Renewal – (atopic dermatitis) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:

Either:

Individual has received a 75% or greater reduction in EASI score (EASI 75) as compared to baseline EASI prior to commencing upadacitinib; or
Individual has received a DLQI improvement of 4 or more as compared to baseline DLQI prior to commencing upadacitinib.

Initial application – (Crohn’s disease – adult) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either:

Individual is currently on treatment with upadacitinib for Crohn’s disease and met all remaining criteria prior to commencing treatment; or
Both:
1. Individual has active Crohn’s disease; and
2. Either:
  1. Individual has had an initial approval for prior biologic therapy and has experienced intolerable side effects or insufficient benefit to meet renewal criteria; or
  2. Both:
    1. Individual meets the initiation criteria for prior biologic therapies for Crohn’s disease; and
    2. Other biologic therapies for Crohn’s disease are contraindicated.

Renewal – (Crohn’s disease – adult) from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Any of the following

CDAI score has reduced by 100 points from the CDAI score when the individual was initiated on biologic therapy; or
HBI score has reduced by 3 points from when individual was initiated on biologic therapy; or
CDAI score is 150 or less; or
HBI score is 4 or less; or
The individual has experienced an adequate response to treatment, but CDAI score cannot be assessed.

Initial application – (Crohn’s disease – children*) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Either

Individual is currently on treatment with upadacitinib for Crohn’s disease and met all remaining criteria prior to commencing treatment; or
Both:
1. Child has active Crohn’s disease; and
2. Either:
  1. Child has had an initial approval for prior biologic therapy for Crohn’s disease and has experienced intolerable side effects or insufficient benefit to meet renewal criteria; or
  2. Both:
    1. Child meets the initiation criteria for prior biologic therapies for Crohn’s disease; and
    2. Other biologic therapies for Crohn’s disease are contraindicated.

Renewal – (Crohn’s disease – children*) from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Any of the following:

PCDAI score has reduced by 10 points from when the child was initiated on treatment; or
PCDAI score is 15 or less; or
The child has experienced an adequate response to treatment, but PCDAI score cannot be assessed.

Note: Indications marked with * are unapproved indications.

Initial application — (ulcerative colitis) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria.

Either:

Individual is currently on treatment with upadacitinib for ulcerative colitis and met all remaining criteria prior to commencing treatment; or
Both:
1. Individual has active ulcerative colitis; and
2. Either:
  1. Individual has had an initial approval for prior biologic therapy for ulcerative colitis and has experienced intolerable side effects or insufficient benefit to meet renewal criteria; or
  2. Both:
    1. Individual meets the initiation criteria for prior biologic therapies for ulcerative colitis; and
    2. Other biologic therapies for ulcerative colitis are contraindicated.

Renewal – (ulcerative colitis) from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria

Either:

The SCCAI score has reduced by 2 points or more from the SCCAI score when the individual was initiated on treatment; or
PUCAI score has reduced by 10 points or more from the PUCAI score when the individual was initiated on treatment.

Similar eligibility criteria will apply in Part II of Section H of the Pharmaceutical Schedule.

Our response to what you told us

Theme	Pharmac Comment
Upadacitinib for inflammatory bowel disease
People were supportive, noting that upadacitinib was an important addition to the IBD treatment paradigm and could oﬀer patients a chance for a better quality of life.	We are pleased to be able to progress a proposal for widened access to medicines that will improve the health outcomes of New Zealanders.
People were supportive, however noted that NZ Formulary for Children required updating for upadacitinib IBD dosing if the Special Authority was to allow treating of paediatric patients	We will ensure that the NZ Formulary for Children is aware of this decision to widen access to upadacitinib for IBD.
People requested the renewal period for Crohn disease and ulcerative colitis be aligned.	We have amended the Special Authority criteria to align the renewal period for both these indications.
People requested that recombinant herpes zoster (Shingles) eligibility criteria be widened to people initiating on upadacitinib for IBD.	We understand that shingles reactivation is a known side effect of JAK-inhibitors (which include upadacitinib). In March 2024, our expert clinical advisors, the Immunisation Advisory Committee considered it would be appropriate to amend the current disease modifying anti-rheumatic drug (DMARD)-related criterion for the recombinant herpes zoster virus vaccine, by removing specific diseases and to instead take a risk-based approach that combines specified immune-modulating agents with dose, duration, and patient age. March 2024 Immunisation Advisory Committee Meeting Record [PDF, 373 KB] This area is complex, and detail on the mix of which specific classes of agents and their doses, durations and patient ages is pending and still being considered by our clinical advisors. Due to the number of people that would be eligible and the high cost of the vaccine, widening access further for people who are immunocompromised is being considered as a separate funding application. Progress on the current funding application for widened access for immunocompromised people includes the requested JAK-inhibitor group, and can be viewed on our application tracker. We understand that this may be disappointing for people, and are working on seeking further clinical advice to progress this funding application. Application to widen access to shingles vaccine \| Application Tracker(external link)
Upadacitinib for atopic dermatitis
People were supportive highlighting the significant impact funding upadacitinib would have on the quality of life of people with atopic dermatitis. People considered it to be pro-equity, and also highlighted wider benefits to families/ whānau in relation to allowing people to return to work and/or childcare.	We are pleased to be able to progress a proposal for widened access to medicines that will improve the health outcomes of New Zealanders. We note that the clinical advice we received from the Dermatology Advisory Committee supported the equity and wider impact considerations outlined by respondents.
We received a wide range of requests for changes to the proposed prescriber type for upadacitinib for atopic dermatitis. These requests ranged from a desire for a narrower prescriber type to broader prescriber types. Some people expressed concern about the possibility of inappropriate prescribing by clinicians not specialised in the management of inflammatory diseases. Some people requested that the prescriber criteria for upadacitinib for atopic dermatitis be widened to ‘any relevant practitioner’, to match the criteria for inflammatory bowel disease and enable access by nurse practitioners with a medical dermatology focus. Some people were supportive of wider access, noting that dermatologists would be able to support general practitioners via telemedicine and remote consulting where required. Several clinicians were supportive of enabling GP/Primary care access due to challenges accessing dermatology services, in particular to support access for Māori and Pacific people. Some clinicians also considered that the special authority criteria could include whether the patient can access a dermatologist, to help more Māori and Pacific people access this medication.	We acknowledge the concerns about correct diagnosis or potential over-prescribing of this medicine by non-dermatologists. We have had many discussions with our advisors (both dermatologists and primary care prescribers) and other prescribers about appropriate prescriber restrictions for this medicine, to help us consider the feedback we received. While we acknowledge the concerns around prescriber type and appropriate prescribing, restricting prescribing of this medicine to dermatologists only would create significant barriers to access for many people who would benefit from this medicine. In January 2025 we consulted on proposed prescriber restrictions for atopic dermatitis of ‘any relevant specialist’ and ‘any relevant practitioner on the recommendation of a relevant specialist.’ We have now reviewed the consultation feedback and the prescriber restriction for both initiations and renewals for upadacitinib for atopic dermatitis will be ‘any relevant practitioner’ to align with the criteria for upadacitinib’s other indications. These criteria allow any relevant practitioner acting within the scope of their practice to prescribe upadacitinib. This is to ensure that everyone who would be eligible could access funded treatment. We understand access to public dermatology services in New Zealand is currently limited and varied across the country. We consider that allowing Special Authority applications from a wider range of prescribers reflects the different healthcare journeys in New Zealand and may help to reduce potential inequities in accessing this funded medicine. We understand that people have concerns around inappropriate prescribing. These appear to be clinical concerns rather than funding concerns and are more appropriately managed by prescribers operating within the appropriate scope of their practice, not by restricting funded upadacitinib to only specialists. We understand that some prescribers may need support and further training on diagnoses of atopic dermatitis and appropriate prescribing of this treatment. We intend to work closely with other stakeholders, such as Health Pathways, New Zealand Formulary and professional bodies to support education. We are pleased to hear feedback that prescribers intend to work collaboratively to make sure that people who would benefit from upadacitinib are able to access it despite challenges with healthcare access and resources.
People requested that Paediatricians with special interest in dermatology and Nurse Practitioners working in specialty scope of dermatology should be able to apply for funded upadacitinib.	Any relevant practitioner will be able to apply for a Special Authority for upadacitinib for atopic dermatitis. Therefore, nurse practitioners and paediatricians will be able to initiate and renew prescriptions for upadacitinib for atopic dermatitis.
People were supportive, however some had concerns that people would want to change treatment to upadacitinib when other options such as already funded systemic immunosuppressants may be a more appropriate choice. People told us that there would be a requirement for sufficient education for both patients and general practice on the relative risks and benefits of various systemic immunosuppressant medicines used for atopic dermatitis.	We acknowledge that there are sometimes concerns that a newly funded medicine may be preferred by people when other medicines may be more appropriate. We intend to work with health sector stakeholders to ensure that there is sufficient education and materials available for both prescribers and patients to ensure that people are able to make informed choices.
Supportive, noting that substantial implementation support, especially online tools and patient facing resources would be required, especially for people managing their disease mostly through primary care.	We are aware that upadacitinib is a medicine that many people and practitioners will be unfamiliar with, especially in primary care. We will work with the supplier and the health sector to ensure that there is sufficient support and information available for both prescribers and patients who are considering using upadacitinib for atopic dermatitis.
People noted that people with atopic dermatitis have compromised skin quality and are at a greater risk from shingles reactivation, which is a known side effect of upadacitinib. Due to this they requested funding for a shingles vaccine be prioritised for people receiving upadacitinib.	We understand that people with atopic conditions including atopic dermatitis have a greater chance of, and more severe impacts from, shingles reactivation and that shingles reactivation is a known side effect of JAK-inhibitors (which include upadacitinib). In March 2024 the Immunisation Advisory Committee considered it would be appropriate to amend the current disease modifying anti-rheumatic drug (DMARD)-related criterion for the recombinant varicella zoster virus vaccine, by removing specific diseases and to instead take a risk-based approach that combines specified immune-modulating agents with dose, duration, and patient age. March 2024 Immunisation Advisory Committee Meeting Record [PDF, 373 KB] This area is complex, and detail on the mix of which specific classes of agents and their doses, durations and patient ages is pending and still being considered by our advisors. Due to the number of people that would be eligible and the high cost of the vaccine, widening access further for people who are immunocompromised is being considered as a separate application. Progress on the current application for widened access for immunocompromised people includes the requested JAK-inhibitor group, and can be viewed on our application tracker(external link). We understand that this may be disappointing for people, and are working on seeking further advice to progress this funding application. Application to widen access to shingles vaccine \| Application Tracker(external link)
People requested funded access to dupilumab for atopic dermatitis	Pharmac has previously received clinician and consumer funding applications for dupilumab for atopic dermatitis. At present this application is on hold because the supplier has not submitted to Medsafe for approval. A submission to Medsafe is a requirement for funding applications to Pharmac (with the exception of applications for medicines for rare disorders). Application to fund dupilumab for atopic dermatitis \| Application Tracker(external link) Medsafe is the New Zealand medicines regulator, and it is important that medicines are approved by Medsafe to ensure they are of appropriate quality, safety, and efficacy. Only the supplier of dupilumab has the required information to submit an application to Medsafe.
People considered that the Special Authority criteria should provide access for people who had initiated upadacitinib on clinical trials or via the private market.	We are grateful for this feedback, and we have amended the criteria to clarify that people who are currently accessing upadacitinib will qualify for funded access if they would have met the criteria when they started treatment.
Upadacitinib for rheumatoid arthritis
People were supportive, noting that upadacitinib as an oral tablet had significant suitability advantages over rituximab (an IV treatment requiring infusion) and that rituximab was strongly associated with severe outcomes from Covid-19 infection.	We are pleased to be able to progress a proposal for widened access to medicines that will improve the health outcomes of New Zealanders.
People requested formatting changes to the proposed Special Authority criteria to improve clarity.	We have amended the ordering of the new criteria to improve readability on the Special Authority form.
People considered the requirement to trial rituximab before upadacitinib in seropositive people who have not experienced success with biologic (TNF) therapy to be unnecessary and unfair to people with rheumatoid arthritis. They also considered that there were significant suitability advantages for upadacitinib over rituximab, due to its nature as a tablet compared to requiring IV infusion, and that IV infusion time represented a significant cost for both people and hospitals.	Pharmac has existing funding applications for upadacitinib for rheumatoid arthritis (first line) and (second line). Upadacitinib for rheumatoid arthritis (First line) \| Application Tracker(external link) Upadacitinib for rheumatoid arthritis (second line) \| Application Tracker(external link) At this time we are not able to progress upadacitinib as a first or second line medicine for rheumatoid arthritis at this time.. This is because these proposals are currently under assessment. The next step, once the assessments are complete, is for these applications to be ranked on our Options for Investment list so they can be considered alongside other applications being considered for funding. About Pharmac's priority lists
Upadacitinib other indications
People requested extending the funding of upadacitinib to ankylosing spondylitis and non-radiographic ankylosing spondylitis.	We know there is an unmet health need for people with ankylosing spondylitis and non-radiographic ankylosing spondylitis. We have existing funding applications for upadacitinib for ankylosing spondylitis and non-radiographic ankylosing spondylitis as both second(external link) and third line(external link) treatment. We are not able to progress upadacitinib for ankylosing spondylitis or non-radiographic ankylosing spondylitis at this time. This is because these proposals are under assessment. The next step, once our assessments are complete, is for these applicants to be ranked on our Options for Investment list so they can be considered alongside other applications being considered for funding. About Pharmac's priority lists Further details are available on the application tracker (second(external link) line and third line(external link)).
People requested extending the funding of upadacitinib to psoriatic arthritis	We know there is an unmet health need for people with psoriatic arthritis. Upadacitinib is a treatment we would like to consider for funding for this condition if/when we have sufficient budget available. For details about our assessment and progress of applications for upadacitinib to treat psoriatic arthritis Upadacitinib for psoriatic arthritis (second line) \| Application Tracker(external link) Upadacitinib for psoriatic arthritis (third line) \| Application Tracker(external link)
People requested extending the funding of upadacitinib to plaque psoriasis.	We know there is an unmet health need for people with plaque psoriasis. Upadacitinib is not approved by regulators anywhere in the world for plaque psoriasis and we have not had a funding application to assess its effectiveness for this indication. We would welcome a funding application for plaque psoriasis when evidence supporting its use in this indication is available.

Glecaprevir with pibrentasvir (brand name Maviret)

Glecaprevir with pibrentasvir (brand name Maviret) is funded for the treatment of Hepatitis C virus infection. As part of the proposal, the net price for Maviret will reduce via confidential rebate from 1 December 2024 and Maviret will have subsidy and delisting protection until 30 April 2028.

There will be no changes to the list price and subsidy for Maviret as part of this proposal. Maviret is already listed without funding criteria. There are no proposed changes to the distribution mechanism for Maviret.

Adalimumab (brand name Humira)

Adalimumab (brand name Humira) is funded as an alternative brand of adalimumab for the treatment of a range of inflammatory conditions. Access to Humira is restricted to people who received Humira before 1 March 2022. See the previous decision to widen access to adalimumab and award Principal Supply for details on this alternative brand access.

There will be no changes to the current eligibility criteria for Humira as part of this proposal. As part of the proposal, the net price for Humira will reduce via confidential rebate from 1 December 2025. The list price and subsidy for Humira will reduce from 1 May 2025, AbbVie will provide price support to wholesalers and pharmacies for this transition.