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

Medicines Consultation Closes 10 Feb

What we’re proposing

We’re asking for feedback on a proposal to widen access to three medicines for five different health conditions from 1 May 2025.

This proposal results from a provisional multiproduct agreement that we have negotiated with the supplier, AbbVie, for venetoclax and upadacitinib, which also includes a price reduction on two other medicines. These are adalimumab (brand name Humira) for a large number of inflammatory indications and glecaprevir with pibrentasvir (brand name Maviret) for treatment of hepatitis C virus infection.

We are also proposing to widen access to azacitidine so it can be used with venetoclax for acute myeloid leukaemia. The current supplier and brand of azacitidine would not change.

We estimate that around 1,100 people would benefit from these treatments in the first year of funding, increasing to 5,000 people within five years. 

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 boost covers medicines for both cancer and non-cancer health conditions. This proposal is one of many that we’re working on to put our budget increase into action.

Questions and answers on the budget increase.

We want to hear your feedback about our proposal. Consultation closes at 5pm Monday 10 February 2025. Feedback can be emailed to consult@pharmac.govt.nz or through our online form.

We acknowledge that January is often a busy time for people. To ensure everyone has enough time to consider this information and provide feedback, the consultation will remain open until 5 pm Monday 10 February 2025.

Venetoclax for acute myeloid leukemia

What would the effect be?

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

Access to azacitidine would also be widened, so it could be prescribed with venetoclax. Our clinical advisors told us that venetoclax is more effective when combined with azacitidine or cytarabine, compared to using it on its own. Cytarabine is already funded without restriction. We expect that there would be a small increase in demand for Health NZ | Te Whatu Ora infusion services due to more people receiving azacitidine.

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

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

About acute myeloid leukemia, venetoclax, azacitidine and cytarabine

Acute myeloid leukemia

Acute myeloid leukaemia (AML) is a blood cancer that happens when the bone marrow makes too many abnormal cells. These cells are immature white blood cells (called blast cells). These abnormal cells take up space in the bone marrow and prevent the marrow from making normal blood cells, like red cells, normal white cells, and platelets. The abnormal blast cells eventually spill out into the blood stream and can build up in organs like the spleen and liver. This can damage these organs, making people with AML more likely to get anaemia, recurrent infections, bruising and bleed easily.

Approximately 140 people per year are diagnosed with AML in New Zealand. About half of them are unable to receive intensive induction chemotherapy which is considered the best way to treat AML. This is often due to genetic factors as people with certain genetics have worse outcomes with AML. It can also be due to other medical conditions the person has which mean that they will not be able to tolerate intensive chemotherapy.

People unable to receive intensive induction chemotherapy instead receive low-intensity therapy which is less likely to slow or stop their cancer and many experience only small improvements in their quality of life. These are the people for whom venetoclax would be funded. Venetoclax in combination with low intensity therapy for AML improves both outcomes from treatment and overall survival compared to low intensity therapy alone.

Blood cancers are a common cancer type for Māori. Evidence indicates Māori are more likely to be diagnosed with blood cancer than New Zealand Europeans and are also more likely to die earlier from blood cancer. There are many things that contribute to this inequity. For example, Māori are more likely to have other health conditions which means they are not able to receive intensive chemotherapy. Funding venetoclax would benefit Māori with AML and provide them with another treatment option.

The Government is working to improve the availability of and access to cancer medicines in New Zealand. This proposal would support this goal.

Ministry of Health website - Government Policy Statement on Health 2024-27(external link)

Venetoclax

Venetoclax is currently funded for the treatment of chronic lymphocytic leukaemia (CLL).

Venetoclax is an oral medicine that interferes with a specific protein (called B-cell lymphoma-2 protein, BCL-2). This protein stops cancer cells dying, which means they can spread throughout the body. Venetoclax kills cells with the BCL-2 protein, which stops them spreading.

Venetoclax can be used with azacitidine or low dose cytarabine treat AML. Venetoclax is taken once every day. The dose depends on the other medicines it is used with and is increased (titrated) over the first four days.

Online Schedule – venetoclax listing(external link)

Medsafe datasheet for venetoclax [PDF](external link)

Azacitidine and cytarabine

Venetoclax can be used to treat AML in combination with azacitidine or cytarabine. These are both types of chemotherapy.

We are proposing wider access to azacitidine to allow these medicines to be used with the proposed group of people eligible for venetoclax. Cytarabine is already listed on the pharmaceutical schedule without restrictions.

Azacitidine is usually given as a once daily IV infusion for a week before a break of 21 days for at least 6 months. Cytarabine is usually given as a once daily IV infusion for 5 days every two weeks for an extended period.

Medsafe datasheet for azacitidine [PDF](external link)

Medsafe datasheet for cytarabine [PDF](external link)

Why we’re proposing this

Venetoclax was recommended for funding by the Cancer Treatment Subcommittee of PTAC (CaTSoP) in 2021 which is now the Cancer Treatments Advisory Committee (CTAC). The Committee considered venetoclax as a treatment for people with newly diagnosed AML, who are not eligible for intensive induction chemotherapy.

The Committee considered that venetoclax for AML had good evidence of a survival advantage, including a clinical benefit for a patient group who has a high unmet health need.

Application Tracker | Venetoclax for acute myeloid leukaemia, newly diagnosed, ineligible for intensive induction chemotherapy(external link)

Cancer Treatments Subcommittee (CaTSoP) April 2021 meeting record [PDF, 878 KB]

Details about our proposal

From 1 May 2025 venetoclax (Venclexta) would continue be listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Price and subsidy

Venetoclax

Tab 10 mg

Venclexta

2 OP

$13.68

Venetoclax

Tab 50 mg

Venclexta

7 OP

$239.44

Venetoclax

Tab 100 mg

Venclexta

120

$8,209.41

Venetoclax

Tab 14 × 10 mg, 7 × 50 mg, 21 × 100 mg

Venclexta

42 OP

$1,711.86

Wastage claimable would continue to apply for venetoclax tab 100 mg.

As part of the proposal, the net price for venetoclax would reduce via confidential rebate from 1 May 2025.

The Venclexta brand would have subsidy and delisting protection until 30 April 2028.

We are also proposing to amend the existing criteria for venetoclax for chronic lymphocytic leukaemia (CLL) to allow any prescriber to apply for a Special Authority and remove the requirement for renewal of the Special Authority. These changes are intended to simplify access to the medicine and reduce administrative burden for oncology services.

Venetoclax would remain listed in Section B and Part II of Section H of the Pharmaceutical Schedule. The Special Authority criteria would change from 1 May 2025 to add the following funding criteria for previously untreated AML and amend the criteria for chronic lymphocytic leukaemia (CLL). Additions in bold, deletions in strikethrough:

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

All of the following:

  1. Individual has previously untreated acute myeloid leukaemia, according to World Health Organization (WHO) Classification; and
  2. Individual must not be considered eligible for 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 for applications where there is no evidence of disease progression.

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 26 months for applications meeting the following criteria: 

All of the following:

  1. Individual Patient has chronic lymphocytic leukaemia requiring treatment; and
  2. Individual Patient has received at least one prior therapy for chronic lymphocytic leukaemia; and
  3. Individual Patient has not previously received funded venetoclax; and
  4. The individual’s patient’s disease has relapsed within 36 months of previous treatment; and
  5. Venetoclax to be used in combination with six 28-day cycles of rituximab commencing after the 5-week dose titration schedule with venetoclax; and
  6. Individual Patient has an ECOG performance status of 0-2; and
  7. 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

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

Both:

  1. Treatment remains clinically appropriate and the patient is benefitting from and tolerating treatment; and
  2. 2 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 without further renewal unless notified for 6 months for applications meeting the following criteria: 

All of the following:

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

Renewal – (relapsed/refractory chronic lymphocytic leukaemia with 17p deletion or TP53 mutation*) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. 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.

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

The changes proposed for azacitidine would widen access by:

  • no longer restricting AML usage to only those a 20-30% blast count and multi-lineage dysplasia.
  • removing ECOG performance status needing to be 2 or below.

These changes are to make sure that all people who are eligible to access venetoclax would also be able to access these chemotherapies for use alongside venetoclax. The proposed changes would  also allow azacitidine to be used in people who are more unwell, especially those receiving combined venetoclax/azacitidine. Cytarabine is already listed without restriction on the Pharmaceutical Schedule, so no changes to its listing would be required as part of this proposal.

Cancer Treatment Subcommittee (CaTSoP) July 2020 meeting record (blast count/dysplasia criteria removal) [PDF, 481 KB]  

Cancer Treatment Subcommittee (CaTSoP) April 2021 meeting record (ECOG performance criteria removal) [PDF, 878 KB]

The following changes are proposed from 1 May 2025 to the azacitidine Special Authority / Hospital indication restriction criteria (additions in bold, deletions in strikethrough):

Azacitidine 

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. The patient individual has International Prognostic Scoring System (IPSS) intermediate-2 or high-risk myelodysplastic syndrome; or
    2. The patient individual has chronic myelomonocytic leukaemia (10%-29% marrow blasts without myeloproliferative disorder); or
    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
    3The 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 where there is no evidence of disease progression. for applications meeting the following criteria:

Both:

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

Upadacitinib for inflammatory bowel diseases, atopic dermatitis (eczema) and rheumatoid arthritis

What would the effect be?

From 1 May 2025 upadacitinib 15 mg, 30 mg and 45 mg tablets (branded as Rinvoq) would be funded for people with severe atopic dermatitis (AD) (eczema), ulcerative colitis (UC) and Crohn’s disease (CD) subject to funding criteria. Access for people with rheumatoid arthritis (RA) for whom treatment with rituximab is not clinically appropriate would also be widened.

We anticipate that up to 1,050 people would benefit from widened access to upadacitinib in the first year of funding, increasing to 4,900 people by year 5. We also anticipate that people using upadacitinib instead of using other medicines such as rituximab which requires IV infusion would result in reduced demand on Health NZ | Te Whatu Ora infusion services.

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.

About upadacitinib (brand name Rinvoq)

Upadacitinib is a type of medicine known as a Janus Kinase (JAK) inhibitor. It changes the body’s immune system, which means it can treat a range of conditions. Upadacitinib inhibits an enzyme called Janus Kinase (JAK). This enzyme forms part of the body’s inflammatory response and inhibiting it can treat inflammatory conditions such as inflammatory bowel disease (IBD), atopic dermatitis (AD) (also known as eczema) and rheumatoid arthritis (RA).

Upadacitinib is available as a once-daily tablet. Many other treatments for inflammatory conditions are injected into the body, either subcutaneously or via an infusion.

Impact on populations with the highest health needs

Māori and Pacific people are more likely to have atopic dermatitis and experience worse health outcomes compared with the general population. They often experience lower access to specialist treatment as well.

Upadacitinib would be used in people with moderate to severe atopic dermatitis, for whom topical therapies and standard immunosuppressants haven’t provided sufficient benefit. While data on severe atopic dermatitis in adults is limited, Māori represent 24% of hospital discharges for ‘dermatitis’ or ‘eczema’ with Pacific peoples representing another 24%. This suggests that these groups are much more likely to experience severe impacts from atopic dermatitis. We consider a new treatment for severe atopic dermatitis would benefit them.

Upadacitinib for inflammatory bowel diseases

Ulcerative colitis (UC) and Crohn’s disease are types of inflammatory bowel diseases (IBD). Ulcerative colitis and Crohn’s disease are the most common forms of IBD. The condition you have is determined by the location of inflammation in your gut, as well as the depth of involvement of the gut wall.

In both ulcerative colitis and Crohn's disease, parts of the digestive system (the gut), which includes the intestines or 'bowels', become sore and inflamed. Crohn's disease can affect any part of the digestive system from the mouth to the anus. Ulcerative colitis affects the colon (large intestine) and rectum.

Both conditions are characterised by a repeating pattern of symptoms that commonly include diarrhoea, abdominal pain and cramping, blood in the stool, reduced appetite, weight loss and fatigue. In some patients with IBD, inflammation can also extend beyond the bowel and include skin, eye, muscle, and kidney involvement.

IBD is usually treated with immunosuppressants and corticosteroids. In some patients, IBD requires surgical management.

Our clinical advisors told us that upadacitinib would provide a clinical benefit for people with both ulcerative colitis and Crohn’s disease. This includes slowing or stopping progression of their disease, particularly for those people whose disease has not responded to other treatments (often called refractory disease).

Upadacitinib for ulcerative colitis

This proposal would fund upadacitinib for people with moderate to severe ulcerative colitis (UC) whose disease has not responded to previous treatments, including the biologic medicines adalimumab or infliximab.

Why we’re proposing this

The Gastrointestinal Advisory Committee in August 2022 and Pharmacology and Therapeutics Advisory Committee (PTAC) in November 2023 recommended funding upadacitinib for moderate to severe ulcerative colitis, subject to Special Authority criteria. The Committees told us that upadacitinib can have better outcomes to currently funded treatments and that funding would provide a further line of treatment for people with ulcerative colitis. The Committee also noted upadacitinib’s suitability advantages as an oral treatment over the currently funded treatments which are injected medicines.

Gastrointestinal Advisory Committee August 2022 meeting record [PDF, 222 KB]

PTAC November 2023 meeting record [PDF, 796 KB]

Upadacitinib for Crohn’s disease

This proposal would also fund upadacitinib for people with Crohn’s disease whose disease has not responded to previous treatments, including the biologic medicines adalimumab or infliximab.

Why we’re proposing this

The Pharmacology and Therapeutics Advisory Committee (PTAC) reviewed a funding application for upadacitinib for Crohn’s disease in May 2023. The Committee told us it needed further evidence and suggested waiting for more results of a clinical trial for this medicine to be published.

PTAC reviewed the medicine again and recommended funding upadacitinib for Crohn’s disease in November 2023, subject to Special Authority criteria. The Committee told us that upadacitinib can have better outcomes to currently funded treatments and that funding would provide a further line of treatment for people with Crohn’s disease. The Committee also noted upadacitinib’s suitability advantages as an oral treatment over the currently funded treatments which are injected medicines.

PTAC May 2023 meeting record [PDF, 1.2 MB]

PTAC November 2023 meeting record [PDF, 796 KB]

Upadacitinib for atopic dermatitis (eczema)

Atopic dermatitis (AD), also called atopic eczema or just eczema, is the most common inflammatory skin disease in the world. It affects around one in three New Zealanders at some stage in their lives. It usually causes skin dryness, itch, and rash. It is most common in people with a family history of an atopic disorder, including asthma or hay fever. It is caused by the immune system over-reacting and causes skin that is inflamed, itchy, irritated, and sore.

Many people with atopic dermatitis can manage their condition with treatments such as skin cleansers, moisturisers, and topical corticosteroids. However, some people experience more severe disease and need to use systemic immunosuppressant medicines.

People with more severe atopic dermatitis can experience extreme levels of itching and large red, dry patches of skin across their bodies. They can also experience rashes that produce clear fluid, or bleed when scratched. These symptoms can have large impacts on people’s quality of life. Severe atopic dermatitis can also lead to skin infections. If these infections enter a person’s bloodstream, they can cause severe illness.

Why we’re proposing this

Upadacitinib for atopic dermatitis has been considered by the Pharmacology and Therapeutics Advisory Committee (PTAC) in August 2021 and the Dermatology Advisory Committee in July 2022 and June 2023.  Our advisors have recommended that upadacitinib be listed for the treatment of moderate to severe atopic dermatitis, subject to Special Authority criteria. They have told us that upadacitinib is an effective treatment for people with moderate to severe atopic dermatitis who have a high health need and limited to no alternative funded treatments.

PTAC August 2021 meeting record [PDF, 649 KB]

Dermatology Advisory Committee June 2023 meeting record [PDF, 422 KB]

Upadacitinib for rheumatoid arthritis

Upadacitinib 15 mg tablets have been funded since 1 October 2021 for the treatment of rheumatoid arthritis (RA). We are now proposing to amend the eligibility criteria for upadacitinib for RA to allow people to access upadacitinib for treating RA where treatment with rituximab is not clinically appropriate.

Our expert advisors on the Rheumatology Advisory Committee told us in March 2023 the available evidence shows rituximab increases a person’s risk of poor outcomes from COVID-19 infection, including severe illness and death.

The proposed eligibility criteria allow use of upadacitinib if rituximab is not appropriate due to any clinical rationale. Currently prescribers who consider rituximab is not appropriate for an individual patient need to submit a Special Authority Waiver, asking us to consider waiving the requirement to trial rituximab. Even if this request is approved, this delays access to funded treatment. It may lead to inequitable access across the country, as some prescribers may not be familiar with our Waiver process.

Decision to fund upadacitinib for rheumatoid arthritis to support the management of the tocilizumab stock shortage

Rheumatology Advisory Committee March 2023 Meeting record [PDF, 288 KB]

Details about our proposal

Chemical

Formulation

Brand

Pack size

Price and subsidy

Upadacitinib

Tab modified-release 15 mg*

Rinvoq

28

 $1,271.00

Upadacitinib (Rinvoq) 15 mg tablets would continue to be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 May 2025 at the following prices and subsidies (ex-manufacturer, excluding GST):

*The current listing for upadacitinib 15 mg tablets does not specify ‘modified release,’ this would change if the Pharmaceutical Schedule is updated to add the new 30 and 45 mg listings.

The following new presentations of upadacitinib (Rinvoq) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 May 2025 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Price and subsidy

Upadacitinib

Tab modified-release 30 mg

Rinvoq

28

 $2,033.00

Upadacitinib

Tab modified-release 45 mg

Rinvoq

28

 $3,049.00

A confidential rebate would apply to all presentations of upadacitinib (Rinvoq) that would reduce the net price.

The Rinvoq brand would have protection from delisting and subsidy reduction until 30 April 2028.

The IBD eligibility criteria for upadacitinib are aligned with the current criteria for ustekinumab (Stelara) which is also funded for both Crohn’s and colitis as a second line biologic treatment.

Ulcerative colitis

Upadacitinib would be listed in Section B and Part II of Section H subject to the following eligibility criteria:

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

Both:

  1. Individual has active ulcerative colitis; and
  2. Either: 
    1. Individual has had an initial approval for 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 biologic therapies for ulcerative colitis; and
      2. Biologics for ulcerative colitis are contraindicated.

Renewal – (ulcerative colitis) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria.

Either:

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

Crohn’s disease

Upadacitinib would be listed in Section B and Part II of Section H subject to the following eligibility criteria:

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

Both:

  1. Individual has active Crohn’s disease; and
  2. Either:
    1. Individual has had an initial approval for 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 biologic therapies for Crohn’s disease; and
      2. Biologics 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

  1. Either:
    1. CDAI score has reduced by 100 points from the CDAI score when the individual was initiated on therapy; or
    2. HBI score has reduced by 3 points from when individual was initiated on therapy; or
  2. Either:
    1. CDAI score is 150 or less; or
    2. HBI is 4 or less; or
  3. 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:

Both:

  1. Individual has active Crohn’s disease; and
  2. Either:
    1. Individual has had an initial approval for biologic therapy for Crohn’s disease and has experienced intolerable side effects or insufficient benefit to meet renewal criteria; or
    2. Both:
      1. Individual meets the initiation criteria for biologic therapies for Crohn’s disease; and
      2. Biologics 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:

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

Note: Indications marked with * are unapproved indications.

Atopic dermatitis

Upadacitinib would be listed in Section B and Part II of Section H subject to the following eligibility criteria:

Special Authority for Subsidy

Initial application – (atopic dermatitis) only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Individual has atopic dermatitis, with severity defined by either 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 10; and
  2. Individual has received insufficient benefit from topical therapy (including topical corticosteroids or topical calcineurin inhibitors) used for a minimum of 28 days, unless contraindicated to all; and
  3. Individual has received insufficient benefit from at least one systemic therapy used 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 the most recent prior treatment course, preferably while still on treatment but no longer than 1 month following cessation of the treatment; and
  5. The most recent EASI or DQLI assessment is no more than 1 month old at the time of application.

Renewal – (atopic dermatitis) only from a relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

Either:

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

Rheumatoid arthritis

Upadacitinib would continue to be listed for rheumatoid arthritis in Section B and Part II of Section H subject to eligibility criteria. The criteria would 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:

  1. The patient individual has had an initial Special Authority approval for adalimumab and/or etanercept for rheumatoid arthritis; and
  2. 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
  3. Either: Any of the following:
    1. The patient individual is seronegative for both anti-cyclic citrullinated peptide (CCP) antibodies and rheumatoid factor; or
    2. Both:
      1. The patient individual has been started on rituximab for rheumatoid arthritis in a DHB HNZ hospital in accordance with the Section H rules; and
      2. Either:
        1. The patient individual has experienced intolerable side effects from with rituximab; or
        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; or
      3. Rituximab is not clinically appropriate.

Renewal – (Rheumatoid arthritis) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria: 

Either:

  1. Following 6 months’ initial treatment, the patient individual has 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 
  2. On subsequent reapplications, the patient individual demonstrates 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.

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 would be no changes to the current eligibility criteria for Humira as part of this proposal. The list price and subsidy for Humira would reduce from 1 May 2025, AbbVie would provide price support to wholesalers and pharmacies for this transition.

Chemical

Formulation

Brand

Pack size

Current price and subsidy

Proposed price and subsidy

Adalimumab

Inj 20 mg per 0.2 ml prefilled syringe

Humira

2

$1,599.96

$595.50

Adalimumab

Inj 40 mg per 0.4 ml prefilled syringe

Humira

2

$1,599.96

$595.50

Adalimumab

Inj 40 mg per 0.4 ml prefilled pen

HumiraPen

2

$1,599.96

$595.50

As part of the proposal, the net price for Humira would reduce via confidential rebate from 1 December 2024. There would be no subsidy and delisting protection for Humira.

Decision to widen access to adalimumab and award Principal Supply

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 would reduce via confidential rebate from 1 December 2025 and Maviret would have subsidy and delisting protection until 30 April 2028.

There would 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.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5pm, 10 February 2025 or through our online form.

We acknowledge that January is often a busy time for people so to ensure everyone has enough time to consider this information and provide feedback, consultation will remain open until 5pm 10 February 2025.

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.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.