Proposal to award Principal Supply for bevacizumab and to fund medicines for liver and ovarian cancers

What we’re proposing

Pharmac is consulting on widening access to and funding one main brand of bevacizumab. From 1 March 2025 we are proposing to:

• list Vegzelma, supplied by Celltrion, in the Pharmaceutical Schedule as the principal funded brand of bevacizumab
• fund the Vegzelma brand of bevacizumab for the treatment of:
  • unresectable hepatocellular carcinoma (liver cancer)
  • advanced ovarian cancer
  • recurrent respiratory papillomatosis
  • ocular conditions
• widen access to atezolizumab (Tecentriq) for unresectable hepatocellular carcinoma, in combination with bevacizumab
• fund the Vegzelma brand of bevacizumab for treatment of recurrent respiratory papillomatosis, which means people would need to change to the Vegzelma brand between 1 March and 1 August 2025
• continue to allow people with ocular conditions to use any brand of bevacizumab.

We anticipate widening access to bevacizumab for ovarian cancer and liver cancer would increase access for about 140 more people in the first year of funding.

We had originally indicated that we were aiming to widen access to bevacizumab by 1 April 2025. We have been working hard to bring more medicines to New Zealanders as quickly as we can. We are proposing that funded access to bevacizumab would be widened from 1 March 2025. 

Through our Request for Tenders process we sought bids for wider access to explore if bevacizumab could also be funded for cervical cancer and glioblastoma. Following the bids received and expert clinical advice, we are not proposing funding for these cancers at this time. More detail is provided below under ‘Why we’re proposing this’.

We will consider the feedback we receive in this consultation before a final funding decision is made in early 2025.

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 action our budget increase.

Questions and answers on Pharmac's budget increase

Consultation closes at 4pm Monday 6 January 2025.

Feedback can be emailed to consult@pharmac.govt.nz or submitted through our online form.

We know that the holiday period is a busy time for everyone. We are keeping the consultation open until early January rather than late December. This means we can consider your feedback, make a decision and let you know the outcome as soon as possible, while giving people more time to respond. You can provide your feedback at any time during the consultation period.

Who we think will be interested

• People with ovarian cancer, liver cancer, ocular conditions, or recurrent respiratory papillomatosis, their whānau and caregivers
• Health professionals involved in the care of people with ovarian cancer, liver cancer, ocular conditions or recurrent respiratory papillomatosis
• Groups who support and advocate for people with cancer
• Health New Zealand | Te Whatu Ora and Te Aho o Te Kahu | Cancer Control Agency
• Hospital pharmacies
• Hei Āhuru Mōwai and other healthcare professional groups
• Pharmaceutical suppliers and wholesalers

About bevacizumab

Bevacizumab is a type of medicine called a biologic, which means it is made from living organisms. We are proposing to fund the Vegzelma brand of bevacizumab, which is a biosimilar. Biosimilars are very similar versions of a biological medicine. They aren’t identical because biological medicines are made from living organisms, which are never exactly the same.

Biological and biosimilar medicines

Bevacizumab works by disrupting blood supply to cancer tumours, which helps to stop tumours growing and spreading. When used for liver and ovarian cancers it is given as an intravenous (IV) infusion every three weeks. It doesn’t cure the cancer, but it helps fight it so that people can live longer.

Bevacizumab is currently funded for people with ocular neovascularisation and exudative ocular angiopathy. These conditions can cause loss of vision. Bevacizumab is injected directly into the eye by a healthcare professional and helps to slow vision loss.

Bevacizumab is also currently funded for people with recurrent respiratory papillomatosis, who meet certain eligibility criteria. Bevacizumab is used in addition to surgery and may reduce the growth of wart-like tumours (papillomas), improve a person’s voice quality and increase the time between surgical procedures, helping to reduce the number of operations a person needs.

Vegzelma is Medsafe approved for a range of cancers, including ovarian cancer. Like other bevacizumab products approved by Medsafe in New Zealand, including the reference biologic brand Avastin, Vegzelma is not approved for use in the eye or to treat recurrent respiratory papillomatosis. It would need to be prescribed under Section 25 of the Medicines Act for any off-label indications.

Use or Unapproved Medicines and Unapproved Use of Medicines | Medsafe website(external link)

Vegzelma is available in a number of other countries, including the United Kingdom and the United States.

Bevacizumab for recurrent respiratory papillomatosis and ocular conditions

What would the effect be?

Bevacizumab is currently funded(external link) for use by Health New Zealand Hospitals for recurrent respiratory papillomatosis and ocular conditions, subject to restrictions [PDF](external link). Hospitals can currently purchase any brand of bevacizumab.

From 1 August 2025, everyone receiving bevacizumab for recurrent respiratory papillomatosis would need to receive the Vegzelma brand of bevacizumab. People with recurrent respiratory papillomatosis who are currently treated with a different brand of bevacizumab would need to change to the Vegzelma brand between 1 March 2025 and 1 August 2025. If individual circumstances meant it was clinically inappropriate for someone to undergo a brand change, Pharmac would assess this through the Exceptional Circumstances framework. These applications would be different to those of our Named Patient Pharmaceutical Applications (NPPA). We would include more details on how to apply to our Exceptional Circumstances Framework if this proposal is approved.

Exceptional Circumstances framework

Hospitals would be able to continue purchasing alternative brands of bevacizumab for people with ocular conditions. There would be no requirement to change brands for people with ocular conditions. However, the Vegzelma brand would be funded for ocular conditions and only the Vegzelma brand could be claimed as a ‘PCT medicine’.  

Why we’re proposing this

Clinical advice about a change to a biosimilar

We sought clinical advice on whether it would be appropriate for people currently receiving treatment with bevacizumab for recurrent respiratory papillomatosis, or ocular conditions to change to a biosimilar of bevacizumab.

• Our clinical advisors told us that it would be clinically appropriate to use a biosimilar for people with recurrent respiratory papillomatosis and that most people currently being treated with a different brand could change if only one brand were funded.
  • This was because biosimilars have similar efficacy to the reference biological medicine.
  • Advice indicated that a small group of people may have more difficulty with a brand change, or it may be inappropriate, where people have rapidly recurrent disease or those needing intravenous medication for lower airway papilloma.
  • We are proposing to consider funding of an alternative brand for anyone who could not undergo a brand change, or has difficulty with the change, through our Exceptional Circumstances framework.
• Our clinical advisors told us that it would not be clinically appropriate for people receiving bevacizumab for ocular conditions to receive a biosimilar bevacizumab.
  • This was because there is currently limited evidence about the safety and efficacy of any biosimilar bevacizumab for ocular use.
  • As a result of this advice, we propose to maintain the ‘any brand’ listing on Part II of Section H of the Pharmaceutical Schedule for use in ocular conditions, so any relevant brand could continue to be purchased by Health New Zealand Hospitals for treatment of certain ocular conditions.

The funding process

In September 2024, we released a competitive procurement process (a Request for Tender, “RFT”) to source a brand of bevacizumab. We ran a competitive process as there are multiple suppliers of bevacizumab. As a government entity, Pharmac must ensure our procurement processes are fair and open. The competitive processes also helped us secure the best price for bevacizumab, enabling us to fund more medicines from our fixed medicines budget for New Zealanders.

Celltrion was selected as the preferred supplier through this process, and we have entered into a provisional agreement for the supply of its brand of bevacizumab, Vegzelma.

Impact on the health sector

For recurrent respiratory papillomatosis

People using bevacizumab for recurrent respiratory papillomatosis would need to change to the Vegzelma brand between 1 March 2025 and 1 August 2025.

If individual circumstances meant it was clinically inappropriate for someone to undergo a brand change, Pharmac would assess this through the Exceptional Circumstances framework. These applications would be different to those of our Named Patient Pharmaceutical Applications (NPPA). We would develop a streamlined process to minimise the impact on prescribers and minimise delays in ongoing funded treatment for people. We would include more details on how to apply to our Exceptional Circumstances Framework if this proposal is approved.

For ocular conditions

Bevacizumab would continue to be available as it is now. Healthcare professionals could choose whether to use the Vegzelma brand of bevacizumab or continue to use another brand.

Details about our proposal

We had originally indicated that an updated listing of bevacizumab may be from 1 April 2025, we now propose that it would be from 1 March 2025. 

The Vegzelma brand of bevacizumab would be listed in Section B as a PCT only medicine and in Part II of Section H of the Pharmaceutical Schedule from 1 March 2025, as follows:

PRESENTATION	FORMULATION	BRAND	PACK SIZE	PRICE AND SUBSIDY
Bevacizumab	Inj 25 mg per ml, 4 ml vial	Vegzelma	1	$69.00
Bevacizumab	Inj 25 mg per ml, 16 ml vial	Vegzelma	1	$276.00
Bevacizumab	Inj 1 mg for ECP	Baxter	1 mg	$0.71

Vegzelma would be listed in Section B of the Pharmaceutical Schedule as a PCT only pharmaceutical, which means that only Health New Zealand hospitals would be able to claim for reimbursement.

Vegzelma would be subject to a confidential rebate, reducing the cost to Pharmac.

The “any brand” listing of bevacizumab would continue to be listed in Part II of Section H. The Hospital Indication Restrictions for recurrent respiratory papillomatosis would continue until 31 July 2025. After this date, people with recurrent respiratory papillomatosis:

• starting on treatment would need to start on the Vegzelma brand of bevacizumab
• receiving the Vegzelma brand of bevacizumab could continue on this brand
• receiving a different brand of bevacizumab would need to change to the Vegzelma brand.

People receiving bevacizumab for ocular conditions could continue on their current brand for as long as they require bevacizumab treatment.

Pharmaceutical Schedule listing – bevacizumab “any brand”(external link)

Access criteria

There would be no changes to the Hospital Indication Restrictions for bevacizumab for recurrent respiratory papillomatosis and ocular conditions. However, we are proposing to remove the prescriber restriction for recurrent respiratory papillomatosis, this would mean that any relevant practitioner could prescribe bevacizumab in this setting (change marked in strikethrough). Both bevacizumab “any brand” and Vegzelma would be funded for ocular conditions. These access criteria are as follows:

Bevacizumab for liver cancer (with atezolizumab) and ovarian cancer

What would the effect be?

From 1 March 2025 until 31 August 2028, the Vegzelma brand would have Principal Supply Status. This means that Vegzelma would be the main funded brand for the bevacizumab market until 31 August 2028.

The Vegzelma brand of bevacizumab would be funded for people with hepatocellular carcinoma and ovarian cancer who meet the eligibility criteria. Access to atezolizumab would also be widened from 1 March 2025 for people with hepatocellular carcinoma.

Until recently there were no funded treatment options for unresectable hepatocellular carcinoma. Pharmac has now funded lenvatinib from 1 December 2024 for people. We received feedback that:

• some people may prefer atezolizumab with bevacizumab
• lenvatinib should be funded when people have experienced intolerable side effects on atezolizumab with bevacizumab, but remain well enough for treatment.

We are proposing that people who started treatment with funded lenvatinib before 1 March 2025 could access atezolizumab with bevacizumab as a second-line treatment. We are also proposing that if people experience treatment-limiting toxicity to either lenvatinib or atezolizumab with bevacizumab, they would be able to change to the other funded treatment.

About atezolizumab

Atezolizumab is a targeted cancer therapy (an immune checkpoint inhibitor form of immunotherapy) that works by helping the body’s immune system fight cancer cells. Atezolizumab is currently funded for advanced non-small cell lung cancer. Atezolizumab is approved for the treatment other cancers as well, including hepatocellular carcinoma, in combination with bevacizumab.

Current eligibility criteria for atezolizumab [PDF](external link)

About these health conditions

Hepatocellular carcinoma

Hepatocellular carcinoma (HCC) is a type of cancer that affects the liver. There are around 400 people diagnosed with liver cancer in New Zealand each year, approximately two thirds of those have HCC.

HCC is often diagnosed at a late stage in the disease. Around 40% of people diagnosed with HCC have intermediate or advanced disease. The survival outcomes for people with HCC are poor. The risk of developing liver cancer is higher in people with long-term liver diseases, people with chronic hepatitis (most commonly B or C) and people who have alcohol use disorder or consume large amounts of alcohol over a long time.

Māori and Pacific peoples have a disproportionate risk of developing liver cancer compared with non-Māori, non-Pacific. There are many different reasons for this, which include:

• reduced access to primary health care services
• reduced access to secondary care and surveillance programmes
• a lack of culturally safe services and lived experiences of racism when accessing care
• reduced vaccination rates for hepatitis B compared to non-Māori, non-Pacific people
• reduced access to curative hepatitis C treatments compared to non-Māori, non-Pacific.

As a result, Māori and Pacific people experience the greatest health inequities and are more likely to be diagnosed with advanced disease, be diagnosed at a younger age, and they are more likely to die from liver cancer.

Ovarian cancer, fallopian tube cancer and primary peritoneal cancer

Ovarian cancer is the second most common gynaecological cancer in New Zealand after endometrial cancer. Gynaecological cancers are a type of cancer that affects the female reproductive system.  Around 370 people are diagnosed with ovarian cancer each year. Fallopian tube cancer and primary peritoneal cancer are less common in NZ.

Ovarian cancer is associated with poor health outcomes and high mortality. Māori and Pacific people have a higher incidence of ovarian cancer, with poorer health outcomes compared with non-Māori, non-Pacific people. Pacific people are more likely to be affected by ovarian cancer compared to all other ethnicities.

These gynaecological cancers can improve and worsen throughout a person’s journey with cancer. Therefore, people need regular ongoing treatments to respond to the different phases of the cancer process. For some people, the time between the need for treatment gets progressively shorter.

Currently people with newly diagnosed advanced ovarian cancer are treated first-line with surgery (to reduce the size of the tumour), with or without radiotherapy followed by platinum-based chemotherapy (carboplatin or cisplatin, with paclitaxel).

People who have a partial or complete response to chemotherapy are then eligible to receive a type of medicine called a PARP inhibitor (e.g. niraparib) as maintenance treatment. 

Why we’re proposing this

Clinical advice about liver cancer and ovarian cancer

Funding applications for bevacizumab for hepatocellular carcinoma and ovarian cancer have been recommended for funding by the Pharmacology and Therapeutics Advisory Committee (PTAC) and/or the Cancer Treatments Subcommittee of PTAC (now the Cancer Treatments Advisory Committee, CTAC).

Our advisors told us bevacizumab would improve outcomes for people with these cancers. The improvements include both progression-free survival and overall survival. This means people would live longer lives and have a better quality of life.

Atezolizumab and bevacizumab for hepatocellular carcinoma, unresectable, 1st line | Application Tracker(external link)

Bevacizumab for ovarian cancer, advanced | Application Tracker(external link)

The funding process

In September 2024, we released a competitive procurement process (a Request for Tender, “RFT”) to source a brand of bevacizumab. We ran a competitive process as there are multiple suppliers of bevacizumab. As a government entity, Pharmac must ensure our procurement processes are fair and open. The competitive processes also helped us secure the best price for bevacizumab, enabling us to fund more medicines from our fixed medicines budget for New Zealanders.

Celltrion was selected as the preferred supplier through this process, and we have entered into a provisional agreement for the supply of its brand of bevacizumab, Vegzelma.

Funding bevacizumab for glioblastoma and cervical cancer

In the RFT, we tendered two scenarios. One scenario also included the funding of bevacizumab for glioblastoma (a type of brain cancer) and for cervical cancer in addition to the conditions included in this consultation.

We are not proposing to progress funding of bevacizumab for glioblastoma and cervical cancer at this time. In October 2024, Pharmac sought further clinical advice regarding the funding application for bevacizumab for glioblastoma. The Cancer Treatments Advisory Committee (CTAC) recommended that the funding application for bevacizumab (with and without lomustine) for the treatment of glioblastoma be declined. The Committee told us that while there is a high health need for people with high-grade glioma, there is a lack of evidence of meaningful, clinical benefit from bevacizumab for people with glioblastoma. You can read more about this advice on the Application Tracker. If more information becomes available in the future, we would ask our expert clinical advisors to reconsider this application.

Bevacizumab for glioblastoma | Application Tracker(external link)

The proposal to fund bevacizumab for cervical cancer remains on our Options for Investment list. This means that bevacizumab for cervical cancer is something we would be interested in funding in the future. We have updated our assessment to include the pricing for Vegzelma. Based on where this proposal sits on the Options for Investment list and the amount of budget currently available, we are not progressing the funding of bevacizumab for cervical cancer at this time.  

Bevacizumab for cervical cancer | Application Tracker(external link)

We acknowledge that not progressing the funding of bevacizumab for these cancers now is not the outcome people would have hoped for. We are aware that there remains a need for more funded, effective treatments for people with glioblastoma and cervical cancer.

We have to make difficult decisions about what medicines to fund because Pharmac has a limited budget. We make our decisions by drawing on the best available clinical evidence, and advice from our expert clinical advisors.

We remain open to funding bevacizumab for more conditions in the future. This would occur if these proposals were considered the next best option for investment. 

How we decide which medicines need funding first

Impact on the health sector

For cancers

We anticipate that for hepatocellular carcinoma an additional 1,350 infusion hours would be required in the first year, increasing to 1,660 hours each year by the fifth year of funding.

For ovarian cancer, our clinical advisors have told us that the use of infusion services would not change for the initial cycles, as bevacizumab would be administered in combination with other chemotherapy infusions. However, if bevacizumab treatment continues after chemotherapy, infusion requirements would increase.

Details about our proposal

We had originally indicated that bevacizumab may be available from 1 April 2025. We now propose that it would be funded from 1 March 2025.  

The Vegzelma brand of bevacizumab would be listed in Section B as a PCT only medicine and in Part II of Section H of the Pharmaceutical Schedule from 1 March 2025, as follows:

PRESENTATION	FORMULATION	BRAND	PACK SIZE	PRICE AND SUBSIDY
Bevacizumab	Inj 25 mg per ml, 4 ml vial	Vegzelma	1	$69.00
Bevacizumab	Inj 25 mg per ml, 16 ml vial	Vegzelma	1	$276.00
Bevacizumab	Inj 1 mg for ECP	Baxter	1 mg	$0.71

Vegzelma would be listed in Section B of the Pharmaceutical Schedule as a PCT only pharmaceutical, which means that only Health New Zealand hospitals would be able to claim for reimbursement.

Vegzelma would be subject to a confidential rebate, reducing the cost to Pharmac.

Access criteria

Hepatocellular carcinoma

The following criteria would apply to both bevacizumab (Vegzelma) and atezolizumab (Tecentriq) from 1 March 2025:

As part of this decision, we also propose to update the lenvatinib (Lenvima) Special Authority criteria from 1 March 2025, as follows (additions in bold):

Ovarian cancer

The following criteria would apply to bevacizumab (Vegzelma) from 1 March 2025:

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4pm Monday 6 January 2025 or submit using our online form.

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

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We will consider your views when assessing whether the feedback has to be released.

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