Decision on a new supply agreement for human papillomavirus vaccine

What we’re doing

We're pleased to announce a decision to enter a new supply agreement for human papillomavirus (HPV) vaccine (Gardasil 9) following the Request for Proposals (RFP) for the supply of various vaccines and a diagnostic agent.

We have reached an agreement with Seqirus (NZ) Ltd for the supply of its HPV vaccine (Gardasil 9). The agreement for the Principal Supply of HPV vaccine will be effective from 1 July 2024 to 30 June 2027.

This decision secures continued supply of the currently funded brand of HPV vaccine (Gardasil 9). There are no substantive changes to eligibility criteria or the maximum number of funded doses for HPV vaccine.

Implementation

Health New Zealand | Te Whatu Ora (Health NZ) is responsible for the implementation of the National Immunisation Schedule and will lead communications with service providers about the vaccination programme.

Health NZ’s Immunisation Handbook(external link) will continue to provide information to vaccinators and healthcare professionals about HPV vaccine, including the recommended timing of doses.

Funded vaccine supply will continue to be available through ProPharma and Healthcare Logistics, as with other funded vaccines and as currently occurs for Gardasil 9. Further information on Pharmac’s role in vaccines is available on our website.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 18 December 2023.

We received some consultation responses from clinicians highlighting that it would save health sector resource if the HPV vaccine was given as a one dose schedule.

We are aware that some countries are moving to implement a single dose(external link) schedule for HPV vaccine for the routine immunisation of young people. The single dose schedule(external link) is not currently approved by Medsafe(external link) or any other international regulatory agency. We are not making any changes to the maximum number of doses funded by Pharmac at this time. We would consider this if a single dose schedule gained Medsafe approval in the future. Information about the unapproved use of medicines is available on the Medsafe website(external link).

Who we think will be interested

  • Healthcare professionals working in primary care and outreach vaccination settings
  • Healthcare professionals with an interest in preventing HPV associated disease
  • Health NZ and the National Public Health Service
  • Suppliers and wholesalers
  • Organisations with an interest in immunisation, including the Immunisation Advisory Centre (IMAC), Ministry of Health - Manatū Hauora, Public Health Agency - Te Pou Hauora Tūmatanu and the Māori Health Authority - Te Aka Whai Ora

Detail about this decision 

The HPV vaccine (Gardasil 9) will continue to be listed in Section I and Part II of Section H of the Pharmaceutical Schedule from 1 July 2024 as follows:

Chemical Formulation Brand Pack size Price*
Human papillomavirus (6, 11, 16, 18, 31, 33, 45, 52 AND 58) Vaccine [HPV] Inj 270 mcg in 0.5 ml syringe Gardasil 9 10 inj $0.00*

*Vaccines are listed with zero cost in the Pharmaceutical Schedule as they are distributed free of charge to vaccinators.

A confidential net price will apply to Gardasil 9.

Section I eligibility criteria

There will be no substantive change to the eligibility criteria in Section I. The criteria will remain as outlined below with minor wording updates (additions in bold, deletions in strikethrough).

a) Maximum of 1 inj per prescription

b) Only on a prescription

c) No patient co-payment payable

d)

a) A) Any of the following:

1)  Maximum of two doses for children aged 14 years and under; or

2)  Maximum of three doses for people patients meeting any of the following criteria:

1)  People aged 15 to 26 years inclusive; or

2)  Either:

People aged 9 to 26 years inclusive who have

1) Confirmed HIV infection; or

2) Received a transplant Transplant (including stem cell) patients: or

3) Maximum of four doses for people aged 9 to 26 years inclusive post chemotherapy

B) Contractors will be entitled to claim payment from the Funder for the supply of Human papillomavirus vaccine to people patients eligible under the above criteria pursuant to their contract with Te Whatu Ora Health New Zealand for subsidised immunisation, and they may only do so in respect of the Human papillomavirus vaccine listed in the Pharmaceutical Schedule.

C) Contractors may only claim for patient populations within the criteria that are covered by their contract, which may be a sub-set of the population described in paragraphs A above.

Section H (Hospital Medicines List) eligibility criteria

Restricted

Initiation – Children aged 14 years and under

Therapy limited to 2 doses

Children aged 14 years and under.

 

Initiation – other conditions

Either:

1 Up to 3 doses for people aged 15 to 26 years inclusive; or

2 Both:

2.1 People aged 9 to 26 years inclusive; and

2.2 Any of the following:

2.2.1 Up to 3 doses for confirmed HIV infection; or

2.2.2 Up to 3 doses for people with a transplant (including stem cell) patients; or

2.2.3 Up to 4 doses for Post chemotherapy.

Initiation – Recurrent Respiratory Papillomatosis

All of the following:

1 Either:

1.1 Maximum of two doses for children aged 14 years and under; or

1.2 Maximum of three doses for people aged 15 years and over; and

2 The person patient has recurrent respiratory papillomatosis; and

3 The person patient has not previously had an HPV vaccine.

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. This is an important part of our decision-making process. It gives the opportunity to listen to the voices of the community and acknowledge and response to feedback.

Theme

Pharmac comment

Supportive of proposal
Some respondents were fully supportive of the proposal to enter into a new listing agreement for human papillomavirus vaccine.

We are pleased to have secured ongoing supply of human papillomavirus vaccine through a new listing agreement.

Request inclusion of the ability to implement single dose schedule in listing agreement 

Some clinicians supported the listing agreement but requested the inclusion of a clause in the listing agreement to allow implementation of a single dose schedule during the contracted supply period.

The single dose schedule is not currently approved by Medsafe or any other international regulatory agency.

We are not currently planning to reduce the number of funded doses during the principal supply period. 

If a single dose schedule gained Medsafe approval within the principal supply period, we would seek advice from our expert advisors. If they were supportive, we would work with Health NZ and other stakeholders on how this could be implemented. We would publicly consult ahead of making any changes to the maximum number of funded doses.

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.