Proposal for a new supply agreement for human papillomavirus vaccine
What we’re proposing
We are proposing 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 a provisional agreement with Seqirus (NZ) Ltd for the supply of its HPV vaccine (Gardasil 9). The provisional agreement for the Principal Supply of HPV vaccine would be effective from 1 July 2024 to 30 June 2027.
Feedback to this consultation will help us decide whether to go ahead with this proposal. Consultation closes at 9am, 23 January 2024 and feedback can be emailed to vaccines@pharmac.govt.nz
What would the effect be?
This proposal would result in continued supply of the HPV vaccine (Gardasil 9). There are no proposed changes to eligibility criteria or the maximum number of funded doses for HPV vaccine. This is also the same brand that is currently funded.
Implementation
Te Whatu Ora is responsible for the implementation of the National Immunisation Schedule and would lead communications with service providers about the vaccination programme.
Te Whatu Ora’s Immunisation Handbook(external link) would continue to provide information to vaccinators and healthcare professionals about HPV vaccine, including the recommended timing of doses.
Funded vaccine supply would 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(external link) is available on our website.
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
- Te Whatu Ora and the National Public Health Service
- Suppliers and wholesalers
- Organisations with an interest in immunisation, including the
- Immunisation Advisory Centre (IMAC), Manatū Hauora – Ministry of Health, Te Pou Hauora Tūmatanu – Public Health Agency and Te Aka Whai Ora
About human papilloma virus and the vaccine
The human papillomavirus virus (HPV) causes a number of cancers, with cervical cancer being the most prevalent. Approximately 70% of cervical cancers are caused by HPV types 16 and 18. Approximately 90% of cases of genital warts and warty growths in the throat are caused by types 6 and 11.
HPV vaccine (Gardasil 9) protects against human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52 and 58. In addition to cervical cancer, HPV vaccination also protects against a number of other cancers including anal, penile, vulval, vaginal, and some forms of oropharyngeal cancers. It is administered by intramuscular injection and is available in 0.5 ml single dose syringes. Currently in New Zealand, for people 9 to 14 years of age, two doses are given at least five months apart. For people 15 to 26 years of age, three doses are given. The second dose is given two months after the first, and the third is given six months after the second. Up to four doses are given for people 9 to 26 years of age who have had chemotherapy. All these recommended doses are fully funded.
Why we’re proposing this
Pharmac released a Request for Proposals (RFP) for the supply of various vaccines in New Zealand on 11 November 2022.
We previously notified of our decision to enter into supply agreements with a number of suppliers for their vaccines as a result of this RFP. However, at that time we were still in the process of contracting for the continued supply of HPV vaccine, which was complex and has taken longer than expected.
We have now reached a provisional agreement with Seqirus (NZ) Ltd for the supply of HPV vaccine (Gardasil 9) as outlined above. Feedback to this consultation will help us to decide if this supply agreement should be confirmed.
Details about our proposal
The HPV vaccine (Gardasil 9) would 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* |
*Vaccine prices are listed with zero cost in the Pharmaceutical Schedule as Pharmac distributes them free of charge to vaccinators.
A confidential net price would apply to Gardasil 9.
Eligibility Criteria
There would be no substantive change to the eligibility criteria in Section I, which would remain as outlined below with minor wording updates (additions in bold, deletions in strikethrough). Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
a) Maximum of 1 inj per prescription
b) Only on a prescription
c) No patient co-payment payable
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
1) Confirmed HIV infection; or
2) 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
Supply and price arrangements
Principal Supply Status (PSS) would be applied to Gardasil 9. PSS means that the principal supplier’s brand would be the main brand funded in the community and/or bought by hospitals, with an alternative brand allowance which would enable up to 5% of the market to be supplied by another brand.
A confidential net price would apply to Gardasil 9.
Distribution arrangements
Vaccines are distributed differently to most other pharmaceuticals. The method for ordering HPV vaccine by vaccinators would remain the same as a result of this proposal. Funded HPV vaccine would continue to be available from ProPharma and Healthcare Logistics.
Dose counts and schedules
Currently in New Zealand, for people 9 to 14 years of age, two doses are funded. For people 15 to 26 years of age, three doses are funded. Up to four doses are funded for people 9 to 26 years of age who have had chemotherapy. As noted above, we are not proposing any changes to the eligibility criteria or the maximum number of funded doses.
We are aware that some countries are moving to implement a single dose schedule for HPV vaccine for the routine immunisation of young people. The single dose schedule is not currently approved by Medsafe or any other international regulatory agency. We are not proposing any changes to the maximum number of doses funded by Pharmac. Information about the unapproved use of medicines is available on the Medsafe website.
Gardasil datasheet - showing approved dose schedule - Medsafe(external link)
Unapproved use of medicines - Medsafe(external link)
To provide feedback
Please send us an email: vaccines@pharmac.govt.nz by 9am, 23 January 2024.
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.
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