Decision to fund vedolizumab for inflammatory bowel disease and brentuximab for rare lymphomas

What we’re doing  

We're pleased to announce a decision to fund two new treatments: vedolizumab for inflammatory bowel disease and brentuximub vedotin for rare lymphomas through a supply agreement with Takeda New Zealand Limited (Takeda). In summary: 

  • vedolizumab (brand name Entyvio) will be funded for the treatment of people with inflammatory bowel disease (ulcerative colitis or Crohn’s disease) that has not responded to prior treatments, from 1 February 2023. 
  • brentuximab vedotin (brand name Adcetris) will be funded for the treatment of people with Hodgkin lymphoma and anaplastic large cell lymphoma that has relapsed or not responded to treatment. Brentuximab vedotin is not yet registered with the medicines regulator (Medsafe) and will not be listed on the national Pharmaceutical Schedule until it is approved by Medsafe. In the meantime, Pharmac funding will start from 1 December 2022 via application for individual patients through our Exceptional Circumstances Framework for people who meet eligibility criteria. Applicants will be able to fill out a simple form. 

As a part of the supply agreement with Takeda, there will also be a reduction to the confidential net price of icatibant (Firazyr) from 1 December 2022. 

This decision does not prevent Pharmac from funding additional treatment options for patients with IBD or rare lymphomas. Public consultation on a separate proposal to fund ustekinumab for inflammatory bowel disease closed on 26 October 2022 and we are currently considering the feedback. We expect to make a decision on the funding of ustekinumab in the coming month. 

Further details about this decision can be found below.

Vedolizumab for inflammatory bowel disease

What does this mean for people?

Vedolizumab is a humanised monoclonal antibody (a biologic therapy) which is Medsafe approved(external link) for the treatment of inflammatory bowel disease (IBD). 

This decision means that from 1 February 2023 vedolizumab (Entyvio) will be funded for people with ulcerative colitis or Crohn’s disease that has not responded to, or are intolerant to, conventional therapies and/or anti-tumour necrosis factor (TNF) alpha therapy (adalimumab and infliximab), subject to eligibility criteria. 

Our clinical advisors have told us that evidence suggests that vedolizumab offers clinically significant health benefits in terms of response and remission in patients with these conditions, which are forms of IBD. 

We understand that new infusion treatments can increase burden for clinicians and support services. We expect vedolizumab will reduce the requirement for disease-related surgeries and hospitalisations due to uncontrolled disease overtime. In addition, due to the shorter infusion time of vedolizumab compared to infliximab, another biologic treatment for IBD, we estimate there will be a reduction of infusion hours for any patients moving from infliximab to vedolizumab. 

We estimate that approximately 780 people with IBD will benefit from this decision in the first full year of funding, increasing up to 1390 people after five years. 

Who we think will be interested

  • People with IBD and their whānau, and caregivers
  • Gastroenterologists, specialist nurses, and other health professionals involved in the care of people with IBD
  • Hospital and community pharmacists,
  • Te Whatu Ora
  • Pharmaceutical suppliers and wholesalers
  • Other organisations with an interest in IBD and its treatment 

Any changes to the original proposal

This decision was subject to a consultation letter dated 19 September 2022, which closed on 5 October 2022. 

We would like to thank everybody who took the time to provide us with their feedback. Responses were generally supportive of this proposal, with some requests for changes to the proposed funding criteria, wider access and funding of additional treatments. More details of the feedback and our responses can be found at the end of this notification. 

After carefully considering the consultation feedback we have made some changes to the proposed Special Authority criteria. These changes were made to amend the Special Authority renewal periods to be 12-monthly, to clarify the patient population intended for funding and to remove any unnecessary barriers to access. 

Details about this decision

Vedolizumab (Entyvio) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 February 2023 at the following prices and subsidies (ex-manufacturer, excluding GST): 

Chemical Formulation Brand Pack size Price and subsidy
Vedolizumab Inj 300 mg vial Entyvio 1 $3,313.00

A confidential rebate will apply to vedolizumab (Entyvio) that will reduce the net price to the Funder. Entyvio will have protection from delisting and subsidy reduction until 1 February 2026.

Entyvio will be listed as a PCT only pharmaceutical in Section B of the Pharmaceutical Schedule, meaning that only Te Whatu Ora hospitals will be able to make subsidy claims. 

Entyvio will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule subject to the following eligibility criteria (changes in response to consultation shown – additions in bold and deletions in strikethrough):

Special Authority for Subsidy/Hospital Indication Restrictions

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

  1. Patient has active Crohn’s disease; and
  2. Any of the following:
    1. Patient has had an initial approval for prior biologic therapy and has experienced intolerable side effects or insufficient benefit to meet renewal criteria (unless contraindicated); or
    2. Patient has a CDAI score of greater than or equal to 300, or HBI score of greater than or equal to 10; or
    3. Patient has extensive small intestine disease affecting more than 50 cm of the small intestine; or
    4. Patient has evidence of short gut syndrome or would be at risk of short gut syndrome with further bowel resection; or
    5. Patient has an ileostomy or colostomy, and has intestinal inflammation; and
      Patient has tried but had an inadequate response to, or has experienced intolerable side effects from, prior therapy with immunomodulators (unless contraindicated) and corticosteroids; and
  3. Any of the following:
    1. Patient has tried but experienced an inadequate response to (including lack of initial response and/or loss of initial response) from prior therapy with immunomodulators and corticosteroids; or
    2. Patient has experienced intolerable side effects from immunomodulators and corticosteroids; or
    3. Immunomodulators and corticosteroids are contraindicated; and
  4. Surgery (or further surgery) is considered to be clinically inappropriate.


Renewal – (Crohn’s disease – Adult) any relevant practitioner. Approvals valid for 12 6 months for application meeting the following criteria:

Both:

  1. Any of the following:
    1. CDAI score has reduced by 100 points, or HBI score has reduced by 3 points, from when the patient was initiated on biologic therapy on vedolizumab; or
    2. CDAI score is 150 or less, or HBI is 4 or less; or
    3. The patient has demonstrated an adequate response to treatment, but CDAI score and/or HBI score cannot be assessed; and
  2. Vedolizumab to administered at a dose no greater than 300 mg every 8 weeks. 

 

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

All of the following:

  1. Paediatric patient has active Crohn’s disease; and
  2. Any of the following:
    1. Patient has had an initial approval for prior biologic therapy and has experienced intolerable side effects or insufficient benefit to meet renewal criteria (unless contraindicated); or
    2. Patient has a Paediatric Crohn’s Disease Activity Index (PCDAI) score of greater than or equal to 30; or
    3. Patient has extensive small intestine disease; and
      Patient has tried but had an inadequate response to, or has experienced intolerable side effects from, prior therapy with immunomodulators and corticosteroids;
  3. Any of the following:
    1. Patient has tried but experienced an inadequate response to (including lack of initial response and/or loss of initial response) from prior therapy with immunomodulators and corticosteroids; or
    2. Patient has experienced intolerable side effects from immunomodulators and corticosteroids; or
    3. Immunomodulators and corticosteroids are contraindicated; and
  4. Surgery (or further surgery) is considered to be clinically inappropriate. 

Note: Indication marked with * is an unapproved indication 

 

Renewal – (Crohn’s disease – children*) any relevant practitioner. Approvals valid for 6 12 months for application meeting the following criteria: 

Both:

  1. Any of the following:
    1. PCDAI score has reduced by 10 points from when the patient was initiated on biologic therapy on vedolizumab; or
    2. PCDAI score is 15 or less; or
    3. The patient has demonstrated an adequate response to treatment, but CDAI score cannot be assessed; and
  2. Vedolizumab to administered at a dose no greater than 300mg every 8 weeks.

Note: Indication marked with * is an unapproved indication 

 

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

All of the following:

  1. Patient has histologically confirmed ulcerative colitis; and
  2. Any of the following:
    1. Patient has had an initial approval for prior biologic therapy and has experienced intolerable side effects or insufficient benefit to meet renewal criteria (unless contraindicated); or
    2. Patient has a SCCAI score is greater than or equal to 4; or
    3. Patient’s PUCAI score is greater than or equal to 65*; and
      Patient has tried but had an inadequate response to, or has experienced intolerable side effects from, prior therapy with immunomodulators and corticosteroids;
  3. Any of the following:
    1. Patient has tried but experienced an inadequate response to (including lack of initial response and/or loss of initial response) from prior therapy with immunomodulators and corticosteroids; or
    2. Patient has experienced intolerable side effects from immunomodulators and corticosteroids; or
    3. Immunomodulators and corticosteroids are contraindicated; and
  4. Surgery (or further surgery) is considered clinically inappropriate. 

Note: Indication marked with * is an unapproved indication 

 

Renewal – (moderate to severe ulcerative colitis) from any relevant practitioner. Approvals valid for 6 12 months for application meeting the following criteria:

Both:

  1. Either
    1. The SCCAI score has reduced by 2 points or more from the SCCAI score since initiation on biologic therapy on vedolizumab; or
    2. The PUCAI score has reduced by 30 points or more from the PUCAI score since initiation on biologic therapy on vedolizumab *; and
  2. Vedolizumab will be used at a dose no greater than 300 mg intravenously every 8 weeks.

Note: Indication marked with * is an unapproved indication

Other treatments for inflammatory bowel disease

We understand that there remains a clinical need for additional funded treatment options for patients with IBD following this decision. On 11 October 2022 we released a consultation letter on a proposal to fund ustekinumab for IBD from 1 February 2023. This consultation period closed on Wednesday 26 October 2022, and we are currently working through the feedback that we have received. We expect to make a decision on the funding of ustekinumab in the coming month. 

Brentuximab vedotin for the treatment of Hodgkin and anaplastic large-cell lymphoma

What does this mean for people? 

This decision means that from 1 December 2022, we will consider applications for funded access to brentuximab vedotin prescribed and used in accordance with Section 29 of the Medicines Act 1981(external link) for patients who consent to treatment and meet the eligibility criteria. 

Applicants will need to fill out a simple form, which will be available on our website closer to the time. 

Once Medsafe approval has been granted, brentuximab vedotin will be listed on the Pharmaceutical Schedule, subject to the same eligibility criteria, for the treatment of:

  • relapsed or refractory Hodgkin lymphoma after, or for those that are ineligible for, autologous stem cell transplant; and
  • CD30-positive systemic anaplastic large-cell lymphoma 

We estimate that approximately 20-25 people with relapsed or refractory Hodgkin or anaplastic large cell lymphoma will benefit from treatment each year. 

Who we think will be interested

  • People with lymphoma and their whānau and caregivers
  • Oncologists/haematologists, specialist nurses, and other health professionals involved in the care of people with Hodgkin’s or anaplastic large cell lymphoma
  • Hospital and community pharmacists,
  • Te Whatu Ora
  • Pharmaceutical suppliers and wholesalers
  • Other organisations with an interest in the treatment of lymphoma 

About brentuximab vedotin

Brentuximab vedotin is a targeted cancer therapy that works by ‘targeting’ the changes in cancer cells that help a cancer cell to survive and multiply within the body.  Our advisors have told us that brentuximab vedotin increases the likelihood of remission and reduces the likelihood of disease progression or death. 

Brentuximab vedotin is administered as an intravenous infusion at a dose of 1.8mg/kg over 30 minutes every 3 weeks. 

Details about our decision

Brentuximab vedotin (Adcetris) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as soon as practicable following Medsafe approval at the following prices and subsidies (ex-manufacturer, excluding GST): 

Chemical Formulation Brand Pack size Price and subsidy
Brentuximab vedotin Inj 50 mg vial Adcetris 1 $5,275.18

A confidential rebate will apply to Adcetris that will reduce the net price to the Funder. Adcetris will have protection from delisting and subsidy reduction until 1 December 2025. 

Adcetris will be listed as a PCT only pharmaceutical in Section B of the Pharmaceutical Schedule, meaning that only Te Whatu Ora hospitals will be able to make a subsidy claims. 

Adcetris will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule subject to the following eligibility criteria:

Special Authority for Subsidy/Hospital Indication Restrictions

Initial application - (relapsed/refractory Hodgkin lymphoma) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Either:
    1. Both:
      1. Patient has relapsed/refractory CD30-positive Hodgkin’s lymphoma after two or more lines of chemotherapy; and
      2. Patient is ineligible for autologous stem cell transplant; or
    2. Both:
      1. Patient has relapsed/refractory CD30-positive Hodgkin’s lymphoma; and
      2. Patient has previously undergone autologous stem cell transplant; and
  2. Patient has not previously received funded brentuximab vedotin; and
  3. Response to brentuximab vedotin treatment is to be reviewed after a maximum of 6 treatment cycles; and
  4. Brentuximab vedotin to be administered at doses no greater than 1.8 mg/kg every 3 weeks.

 

Renewal - (relapsed/refractory Hodgkin lymphoma) - from any relevant practitioner. Approvals valid for 9 months for applications meeting the following criteria:

All of the following:

  1. Patient has experienced a partial or complete response to brentuximab vedotin after 6 treatment cycles; and
  2. Treatment remains clinically appropriate and the patient is benefitting from treatment and treatment is tolerable; and
  3. Patient is to receive a maximum of 16 total cycles of brentuximab vedotin treatment. 

 

Initial application - (anaplastic large cell lymphoma) - from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Patient has relapsed/refractory CD30-positive systemic anaplastic large cell lymphoma; and
  2. Patient has an ECOG performance status of 0-1; and
  3. Patient has not previously received brentuximab vedotin; and
  4. Response to brentuximab vedotin treatment is to be reviewed after a maximum of 6 treatment cycles; and
  5. Brentuximab vedotin to be administered at doses no greater than 1.8 mg/kg every 3 weeks.

 

Renewal - (anaplastic large cell lymphoma) - from any relevant practitioner. Approvals valid for 9 months for applications meeting the following criteria:

All of the following:

  1. Patient has experienced a partial or complete response to brentuximab vedotin after 6 treatment cycles; and
  2. Treatment remains clinically appropriate and the patient is benefitting from treatment and treatment is tolerable; and
  3. Patient is to receive a maximum of 16 total cycles of brentuximab vedotin treatment

Other changes associated with this decision

Icatibant

Icatibant is funded for the treatment of hereditary angioedema, a rare disease that can present as attacks of swelling that can occur anywhere in the face, larynx (throat), gut or limbs. 

As part of this decision, the net price for Icatibant (Firazyr) will reduce via confidential rebate from 1 December 2022 and Firazyr will have protection from delisting and subsidy reduction until 1 December 2024. There will be no changes to the current eligibility criteria for Firazyr.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. The feedback we received was strongly supportive. A summary of the main themes raised in feedback, and our responses to the feedback received, are set out in the table below.  

Theme

Pharmac Comment

Vedolizumab 

Responders requested consideration of alternative funded agents for the treatment of Crohn’s and ulcerative colitis, namely ustekinumab and upadacitinib.

 

 

We understand there remains a clinical need for additional treatment options for patients with IBD, particularly for those whom anti-TNF therapy has been ineffective.

We have reached a provisional agreement for the funding of ustekinumab for the treatment of IBD in patients for whom previous biologic therapies have been ineffective or not tolerated. Public consultation started 11 October 2022 and closed 26 October 2022. We are currently considering this consultation feedback and expect to make a decision on the funding of ustekinumab in the coming month.

We have received a funding application for upadacitinib for IBD. We recently sought clinical advice from our Gastroenterology Advisory Committee. The records from this meeting are in draft and once published will be available from the Application tracker(external link).

Responders considered that the clinical disease activity scores reflected in the Special Authority criteria should be amended to enable access for patients with moderate Crohn’s disease.

Specifically, responders requested lowering the Crohn’s Disease Activity Index (CDAI) from 300 to 220 and the Harvey Bradshaw Index (HBI) from 10 to 8

 

We acknowledge that there are health benefits associated with initiating biologic therapy at a lower level of disease activity.

We consider the request to fund earlier access to vedolizumab needs to be considered across all funded biologics for IBD. We have received a funding application to widen access to adalimumab for patients with moderate Crohn’s disease. Full details about the application are available from the Application tracker(external link). We recently sought clinical advice from our Gastroenterology Advisory Committee at its August 2022 meeting. The records from this meeting are in draft and once published will be available from the Application tracker(external link).

Responders considered that the paediatric disease activity (PUCAI) score in the Special Authority for ulcerative colitis should include patients with moderate disease, to align with the criteria applying to the adult population. be aligned with moderate disease, as it is for the adult population. 

We consider the request to align the paediatric funding criteria for ulcerative colitis to the adult funding criteria requires further clinical advice. We intend to seek further clinical advice on this before a decision is made on the separate proposal to fund ustekinumab. We expect to make a decision on the funding of ustekinumab, and this requested change, in the coming month. Any change to ustekinumab would also be made to vedolizumab. 

Responders considered that access should include the option of dose escalation for vedolizumab, alongside infliximab.

Our clinical advisors, the Pharmacology and Therapeutics Advisory Committee (PTAC) and the Gastroenterology Advisory Committee, recommended funding vedolizumab with a dose restriction of 300mg per 8 weeks.

Evidence to support dose escalation of vedolizumab in this patient group would need to be reviewed in full. We would welcome a funding application for consideration of dose escalation. Information on how to submit a funding application is on the Pharmac website.

We have received a funding application for dose escalation of infliximab for people with IBD. We are currently undertaking additional assessment of the proposal considering the impact of the decision to fund vedolizumab. More details about the funding application for dose escalation of infliximab can be found in the application tracker(external link)

Responders requested a number of additional changes to the vedolizumab Special Authority criteria, including:

  • A renewal period of two years.
  • To enable use as a second-line biologic agent if the patient has trialled alternatives.
  • To remove the requirement for patients to have tried immunomodulators and/or corticosteroids previously.
  • To include a provision for patients contraindicated to prior therapies.

 

Renewal Period of two years

We are mindful of the impact that Special Authority renewal requirements can have on outpatient services and hospital pharmacy resource. We include renewal criteria where there is ongoing fiscal risk associated with expensive treatments. However, to reduce this administrative burden we have increased the renewal period to 12 months to help alleviate some of this burden.

Second-line biologic agent

We have amended the criteria to enable use of vedolizumab for patients who have experienced an inadequate response to other biologics.

Requirement for immunomodulators and/or corticosteroids

The criteria are based on the clinical advice we have received, that those who have tried immunomodulators and/or corticosteroids are the group most likely to benefit with the highest health need. More information, including links to the Advisory Committee records can be found in the Application record for vedolizumab for Crohn’s disease(external link) and Ulcerative Colitis(external link).  We would welcome any new information/evidence, that has not been considered previously, to support earlier treatment in these patient groups.

Contraindications to prior therapies

The intent of the criteria is to include funded access for patients where prior treatments are contraindicated. We have clarified the criteria to reflect this intent.

Brentuximab vedotin

Responders requested that access be provided for patients with previously untreated systemic anaplastic large cell lymphoma (ALCL).

We appreciate that there may be an unmet need for brentuximab for the first line treatment of people with systemic ALCL.

We would welcome a funding application for the use of brentuximab vedotin for the first line treatment of people with systemic ALCL. Information on how to submit a funding application is on the Pharmac website

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