Decision to enter into new supply agreements for funded vaccines in the National Immunisation Schedule

Medicines Decision

We're pleased to announce decisions related to the National Immunisation Schedule for the supply of vaccines.

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What we’re doing

We're pleased to announce decisions related to the National Immunisation Schedule following a Request for Proposals (RFP) for the supply of various vaccines, including influenza vaccine.

In summary, this will result in the continued supply of 13 currently funded brands of vaccines, changes to three brands of currently funded vaccines, and a change to the type of meningococcal vaccine for high-risk infants. There are no substantial changes to the eligibility criteria as a result of this RFP.

Funded vaccines with no changes

The following vaccines will continue to be supplied by the same supplier, with the same brand from 1 July 2024 to 30 June 2027:

Vaccine Brand (Supplier)
Bacillus Calmette-Guerin vaccine BCG Vaccine (Seqirus)
Diphtheria, tetanus, and pertussis vaccine Boostrix (GSK)
Diphtheria, tetanus, pertussis and polio vaccine Infanrix IPV (GSK)
Diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b vaccine Infanrix-Hexa (GSK)
Hepatitis A adult vaccine Havrix 1440* (GSK)
Hepatitis A paediatric vaccine Havrix Junior (GSK)
Hepatitis B adult recombinant vaccine Engerix-B (GSK)
Hepatitis B paediatric recombinant vaccine Engerix-B Paediatric (GSK)
Measles, mumps and rubella vaccine Priorix (GSK)
Meningococcal (groups A, C, Y and W-135) conjugate vaccine MenQuadfi (Sanofi)
Pneumococcal (PCV13) conjugate vaccine Prevenar 13 (Pfizer)
Pneumococcal (PPV23) polysaccharide vaccine Pneumovax 23 (MSD)
Poliomyelitis vaccine IPOL (Sanofi)
Rotavirus oral vaccine Rotarix (GSK)
Tuberculin PPD (Mantoux) test Tubersol (Sanofi)

* Brand name will be updated from Havrix to Havrix 1440.

Changes to brands of funded vaccines

The following vaccines will continue to be funded, supplied by different suppliers with different brands:

Vaccine Current funded brand (supplier) New funded brand (supplier)
Haemophilus influenzae type b vaccine Hiberix (GSK) Act-HIB (Sanofi)
Varicella vaccine [Chickenpox vaccine] Varivax (MSD) Varilrix (GSK)
Influenza vaccine Afluria Quad/Afluria Quad Junior (Seqirus) Influvac Tetra (Viatris)

Act-HIB and Varilrix will be funded from 1 July 2024 until 30 June 2027. Influenza vaccine changes will occur from 1 February 2024 and supply will continue until 31 December 2025. The supply agreement for influenza vaccine includes optional extensions for the 2026 and 2027 influenza seasons.  The list price for influenza vaccine will increase from $11.00 to $12.00 per dose from 1 February 2024.

Change to funded meningococcal vaccine type for children under 12 months of age

The currently funded brand of meningococcal ACWY vaccine (MenQuadfi, supplied by Sanofi) will be the Principal Supply brand. MenQuadfi is approved for use in people over 12 months of age. For high-risk infants under 12 months of age, an alternative brand of meningococcal ACWY vaccine, Nimenrix (supplied by Pfizer), will be funded from 1 July 2024. Meningococcal C conjugate vaccine (Neisvac-C), which is currently funded for high-risk infants under 12 months of age, will be delisted from the Pharmaceutical Schedule from 1 December 2024 as Nimenrix will provide better protection against circulating meningococcal strains.

Implementation

Te Whatu Ora’s Immunisation Handbook will be updated to reflect these changes, and will continue to provide information to vaccinators on the recommended timing of dosing for particular vaccines and catch up programmes.(external link)

There are no changes to the ordering or distribution mechanisms for these vaccines as a result of the RFP.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 29 May 2023.

The following change has been made from the original proposal in response to feedback received during consultation:

Meningococcal ACWY vaccine (Nimenrix)

The eligibility criteria for Nimenrix has been amended to allow for up to three doses to be administered so that infants under 6 months of age who are close contacts of meningococcal cases or have previously had meningococcal disease will be able to receive a full three dose course in line with recommended dosing.(external link)  

We have heard that people would like wider access to meningococcal ACWY vaccine and influenza vaccine as well as access to a differentiated influenza vaccine for people 65 years and over. These proposals were unable to be progressed at this time within available funding from Pharmac’s fixed budget. This is discussed in further detail below.

Who we think will be most interested

  • Healthcare professionals working in primary care and outreach vaccination settings
  • Paediatricians
  • Infectious disease specialists
  • Te Whatu Ora
  • Suppliers and wholesalers
  • Organisations with an interest in immunisation, including Manatū Hauora, Te Pou Hauora Tūmatanui (the Public Health Agency), Te Aka Whai Ora and Immunisation Advisory Centre

Detail about this decision

The current funding criteria applying to all vaccines can be found in:

The Schedule will be amended to implement the approved changes as a result of these decisions.

Details about individual products in this decision can be found below.

Supply and price arrangements

Principal Supply Status (PSS) will be applied to all vaccines in this proposal, with the exception of Nimenrix, which will be an Alternative Brand listing to allow for meningococcal ACWY vaccination of eligible children under 12 months of age. PSS means that the principal supplier’s brand is the main brand funded in the community and/or purchased by hospitals, with an alternative brand allowance which enables up to 5% of the market to be supplied by another brand.  PSS will apply from 1 April 2024 for influenza vaccine and from 1 July 2024 for all other vaccines included in the RFP.

Confidential net prices will apply to all vaccines where agreements have been reached as a result of this RFP.

Distribution arrangements

There will be no changes to the distribution of vaccines as a result of these decisions. Vaccinators will continue to use the current processes to order vaccines.

Most of the vaccines (except influenza vaccine) will be listed with the “Xpharm” restriction with a $0.00 subsidy. The Xpharm restriction means that pharmacies cannot claim subsidy because Pharmac has made alternative distribution arrangements. A small number of vaccines are currently listed without the Xpharm restriction, which allows pharmacies that have contracted with Te Whatu Ora to administer specific vaccines and claim the Immunisation Subsidy.

The distribution of influenza vaccine will remain the same as a result of this decision. Influenza vaccine is listed in the Pharmaceutical Schedule and distributed in a similar way to other pharmaceuticals.

Haemophilus influenzae type b vaccine

From 1 July 2024, Act-HIB (supplied by Sanofi-Aventis) will be listed in Section I (National Immunisation Schedule) and Part II of Section H, as outlined below. The Hiberix brand will be delisted from 1 December 2024.

Chemical Presentation Brand Pack Size Subsidy
Haemophilus influenzae type b vaccine Haemophilus influenzae type B polysaccharide 10 mcg conjugated to tetanus toxoid as carrier protein 18-30 mcg; prefilled syringe plus vial 0.5 ml Act-HIB 1 $0.00

There will be no change to the eligibility criteria in Section I and Section H of the Pharmaceutical Schedule.

Varicella (Chickenpox) vaccine

From 1 July 2024, Varilrix (supplied by GSK) will be listed in Section I (National Immunisation Schedule) and Part II of Section H, as outlined below and the Varivax brand will be delisted from 1 December 2024.

Chemical Presentation Brand Pack Size Subsidy
Varicella vaccine [Chickenpox Vaccine] Inj 2000 PFU prefilled syringe plus vial Varilrix 10 $0.00

Varicella (chickenpox) vaccine (inj 2000 PFU prefilled syringe plus vial) is currently listed in Part II of Section H of the Pharmaceutical Schedule with no specified brand to allow access to varicella vaccine for infants between 9 and 12 months of age who are at high risk of the complications of varicella infection. As Varilrix is approved for use in infants from 9 months of age, it will be the listed brand in Section H of the Pharmaceutical Schedule from 1 July 2024. The eligibility criteria in Part II of Section H will be amended to remove references to these age restrictions.

There will be no changes to the eligibility criteria in Section I and similar eligibility criteria will apply in Part II of Section H of the Pharmaceutical Schedule.

Influenza vaccine

From 1 February 2024, Influvac Tetra (supplied by Viatris Limited) will be listed in Section I (National Immunisation Schedule) and Part II of Section H of the Pharmaceutical Schedule as outlined below and the Afluria Quad and Afluria Quad Junior brands will be delisted from 1 April 2024. 

Chemical Presentation Brand Pack Size Subsidy
Influenza Vaccine Inj 60 mcg in 0.5 ml syringe (quadrivalent vaccine) (60 units of active ingredient) Influvac Tetra 10 $120.00

The list price for influenza vaccine will increase from $11.00 per dose to $12.00 per dose from 1 February 2024. A confidential rebate will apply to Influvac Tetra, which will lower its net price. The list price increase may result in a higher purchase price for people who are not eligible for funded influenza vaccine and purchase it privately.

The current separate vaccine listing with eligibility criteria for children from 6 months to 35 months will be removed as Influvac Tetra is approved for use in all ages from 6 months onwards.

The eligibility criteria in Section I (National Immunisation Schedule) from 2024 will be as outlined below. Similar eligibility criteria will 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

d)

A. Influenza Vaccine is available each year for people who meet the following criteria, as set by Pharmac:

a. all people 65 years of age and over; or

b. people under 65 years of age who:

i. have any of the following cardiovascular diseases:

a. ischaemic heart disease, or

b. congestive heart failure, or

c. rheumatic heart disease, or

d. congenital heart disease, or

e. cerebro-vascular disease; or

ii. have either of the following chronic respiratory diseases:

a. asthma, if on a regular preventative therapy, or

b. other chronic respiratory disease with impaired lung function; or

iii. have diabetes; or

iv. have chronic renal disease; or

v. have any cancer, excluding basal and squamous skin cancers if not invasive; or

vi. have any of the following other conditions:

a. autoimmune disease, or

b. immune suppression or immune deficiency, or

c. HIV, or

d. transplant recipients, or

e. neuromuscular and CNS diseases/disorders, or

f. haemoglobinopathies, or

g. are children on long term aspirin, or

h. have a cochlear implant, or

i. errors of metabolism at risk of major metabolic decompensation, or

j. pre and post splenectomy, or

k. Down syndrome, or

vii. are pregnant; or

c. children 4 years of age and under who have been hospitalised for respiratory illness or have a history of significant respiratory illness; or

d. people under 65 years of age who:

i. have any of the following serious mental health conditions:

a. schizophrenia, or

b. major depressive disorder, or

c. bipolar disorder, or

d. schizoaffective disorder, or

ii. are currently accessing secondary or tertiary mental health and addiction services.

Unless meeting the criteria set out above, the following conditions are excluded from funding:

a. asthma not requiring regular preventative therapy,

b. hypertension and/or dyslipidaemia without evidence of end-organ disease.

B. Contractors will be entitled to claim payment for the supply of influenza vaccine to 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 influenza 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 paragraph A above.

The eligibility criteria for influenza vaccine were widened to include all Māori and Pacific people aged 55 and 64 years of age and all children up to 12 years of age for the 2023 influenza season only.

The health sector was expected to be under pressure managing hospitalisations from COVID-19 over this time with influenza infections anticipated to put additional strain on the health sector. The decision to widen access only for the 2023 influenza season was made outside of this RFP process and does not apply to the 2024 influenza season, so these additional population groups are not included in the criteria for 2024 onwards.

No changes to influenza vaccine technologies as a result of this RFP

We requested proposals for the supply of different influenza vaccine technologies: adjuvanted influenza vaccine, high dose influenza vaccine and live attenuated influenza vaccine. We are not funding any of these influenza vaccine technologies at this time. However, these technologies may be considered again as part of any future RFP process for influenza vaccines.

Supply arrangements

Influvac Tetra will be listed with Principal Supply Status (PSS) which means that there will be one funded brand of influenza vaccine. Pharmac will underwrite 75% of the net cost of 100,000 doses of Influvac Tetra per influenza season if not all vaccine has been distributed by the end of the influenza season. 

Meningococcal ACWY vaccine for infants under 12 months of age

There will be no change to the funded brand of meningococcal ACWY vaccine for eligible people aged 12 months and over which will remain as MenQuadfi. As MenQuadfi is not currently approved for the use in infants under 12 months of age, Nimenrix will be listed as an alternative brand of meningococcal ACWY vaccine for use in this age group.

From 1 July 2024, the Nimenrix brand of meningococcal ACWY vaccine will be listed in Section I (the National Immunisation Schedule) and Part II of Section H of the Pharmaceutical Schedule for high-risk infants aged 12 months and under, as outlined below.

Chemical Presentation Brand Pack Size Subsidy
Meningococcal (groups A, C, Y and W-135) conjugate vaccine Inj 5 mcg of each meningococcal polysaccharide conjugated to a total of approximately 44 mcg of tetanus toxoid carrier per 0.5 ml vial Nimenrix 1 $0.00

In response to feedback received during consultation, the eligibility criteria for Nimenrix have been amended from those consulted on to allow up to three doses to be administered (bold text in criteria below indicates changes). The eligibility criteria for Nimenrix in Section I will be as outlined below. Similar eligibility criteria will apply in Part II of Section H of the Pharmaceutical Schedule.

Both:

  1. The child is under 12 months of age; and
  2. Any of the following:
    1. A maximum of three doses (dependant on age at first dose) for patients pre- and post- splenectomy and for patients with functional or anatomic asplenia, HIV, complement deficiency (acquired or inherited), or pre- or post- solid organ transplant; or
    2. A maximum of three doses (dependant on age at first dose) for close contacts of meningococcal cases of any group; or
    3. A maximum of three doses (dependant on age at first dose) for child who has previously had meningococcal disease of any group; or
    4. A maximum of three doses (dependant on age at first dose) for bone marrow transplant patients; or
    5. A maximum of three doses (dependant on age at first dose) for child pre- and post-immunosuppression*.

Note: infants from 6 weeks to less than 6 months of age require a 2+1 schedule, infants from 6 months to less than 12 months of age require a 1+1 schedule. Refer to the Immunisation Handbook for recommended booster schedules with meningococcal ACWY vaccine.

*Immunosuppression due to steroid or other immunosuppressive therapy must be for a period of greater than 28 days.

There will be no change to the eligibility criteria in Section I and Section H of the Pharmaceutical Schedule for MenQuadfi.

The Menactra brand of meningococcal ACWY vaccine is also currently listed on the Pharmaceutical Schedule.

In November 2022, Pharmac notified the sector that Menactra will continue to be listed in the Pharmaceutical Schedule until previously purchased stock is exhausted so vaccinators can use all existing stock before changing to MenQuadfi.

Menactra will be delisted from the Pharmaceutical Schedule in the coming months, once all existing stock has been used.

Meningococcal C conjugate vaccine, Neisvac-C, will be delisted from 1 December 2024, as Nimenrix will also provide protection against meningococcal serotype C in addition to serotypes A, W and Y.

No changes to funded access to meningococcal ACWY vaccine or influenza vaccine as a result of this RFP

We have heard that people would like wider access to meningococcal ACWY vaccine and influenza vaccine. We are unable to widen access to these vaccines at this time within available funding from Pharmac’s fixed budget. However, we would like to widen access to these vaccines and these funding proposals remain on the Options for Investment(external link) list for consideration of future funding when we have sufficient budget.

Further information regarding the groups considered for widened access can be found on the Application Tracker on the Pharmac website:

Changes to presentation descriptions

The following minor changes to presentation descriptions in the Pharmaceutical Schedule will be implemented from 1 July 2024 to more accurately represent the presentation of the product (additions in bold):

Vaccine Presentation Brand (Supplier)
Diphtheria, tetanus, and pertussis vaccine Inj 2 IU diphtheria toxoid with 20 IU tetanus toxoid, 8 mcg pertussis toxoid, 8 mcg filamentous haemagglutinin and 2.5 mcg pertactin in 0.5 ml prefilled syringe Boostrix (GSK)
Diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b vaccine Inj 30 IU diphtheria toxoid with 40 IU tetanus toxoid, 25 mcg pertussis toxoid, 25 mcg pertussis filamentous haemagglutinin, 8 mcg pertactin, 80 D-AgU polio virus, 10 mcg hepatitis B antigen, 10 mcg H. influenzae type b with tetanus toxoid 20-40 mcg Infanrix-Hexa (GSK)

Vaccines not included in this decision

Meningococcal B vaccine (Bexsero) and varicella zoster vaccine (Shingrix) are currently listed on the Pharmaceutical Schedule with subsidy and delisting protection until 1 March 2026. These vaccines are subject to a listing agreement that overlaps with the RFP supply period, so they were not included in the RFP.

We are currently in the process of contracting for the continued supply of human papillomavirus (HPV) vaccine, subject to consultation at a later date. We hope to be able to issue a consultation letter on this in the coming months.

Pharmac also holds responsibility for management of COVID-19 vaccines. A plan for the ongoing management of COVID-19 vaccine funding is being developed, and therefore these vaccines were not included in the RFP. We are exploring options for this vaccine and expect to provide more information at a later date.

Our response to what you told us

We are grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback, our responses to the feedback received and the changes we have made after listening to you are available below.

Theme

Pharmac Comment

Supportive of the proposal

A number of responses were supportive of most elements of the proposal.

We are pleased to be entering into new supply agreements that will secure ongoing supply of a range of vaccines. 

Supportive of the change to the Varilrix brand of varicella vaccine. This is approved for use from a younger age than the currently funded Varivax, so has the potential to reduce vaccination errors where the wrong vaccine is given to a younger age than it is approved for, if a different vaccine is funded for older children.

We are grateful for the feedback outlining the benefits of a brand change for varicella vaccine to allow one vaccine to be used for all eligible children.

Request funding of differentiated influenza vaccines for people 65 years and over

Requested that Pharmac funds differentiated influenza vaccines for people 65 years of age and over.

Some respondents considered that adjuvanted or high dose influenza vaccines would provide better protection for people 65 years of age and over.

We sought proposals for supply through the RFP that would enable us to fund a differentiated influenza vaccine for people 65 years and over.

This followed advice from the Immunisation Advisory Committee its May 2022 meeting recommending the adjuvanted influenza vaccine be funded only if it was cost neutral to the cost of standard funded influenza vaccine. [PDF, 245 KB] 

In September 2022, the Committee recommended the high-dose influenza vaccine be funded with a high priority. [PDF, 212 KB]

At this meeting, the Committee considered that either the adjuvanted or high dose influenza vaccine would be more effective for the population aged 65 years and over than the currently funded influenza vaccine. This advice has been taken into account through the RFP process.

The funding of these vaccines was unable to be progressed within available funding from Pharmac’s fixed budget. This means we are not funding any of these influenza vaccine technologies at this time. However, these technologies may be considered as part of any future RFP process for influenza vaccines.

Request for widened access to influenza vaccine

Support for Pharmac to widen access to influenza vaccines:

  • Some respondents considered that not proposing to widen access does not adequately reflect the disease burden for Māori, Pacific peoples and children.
  • Considered that the current widened eligibility for Māori and Pacific peoples from 55 years of age and children from 6 months to 12 years for the 2023 influenza season should be retained permanently.

We have heard that people would like to see widened access to funded influenza vaccine retained.

At its May 2022 meeting, the Immunisation Advisory Committee recommended widened access for a range of additional population groups. [PDF, 245 KB]

Through the RFP we asked for proposals that would enable us to consider widened access to these groups. The funding of influenza vaccine for these additional groups was unable to be progressed within the funding available from Pharmac’s fixed budget.

In March 2023 we widened access for Māori and Pacific peoples from 55 years of age and children from 6 months to 12 years for the 2023 influenza season.

Widened access for these groups of people for the 2023 influenza season was in the context of managing the impact on the health sector by reducing hospitalisations when the health sector was expected to be under pressure managing COVID-19 cases and influenza admissions.

The groups recommended for widened access by the Immunisation Advisory Committee at its May 2022 meeting, including those provided with widened access for the 2023 influenza season, are ranked on the Options for Investment list(external link). This means that even though we are not widening access for future seasons now, we would like to widen access when we have available budget.

Request for widened address to meningococcal ACWY vaccine

Strong support for widened access to meningococcal ACWY vaccine for more young people.

 

We understand there is a strong desire to have meningococcal vaccines funded for more people. We have sought expert advice and assessed applications to widen access to meningococcal vaccines for different groups of people on multiple occasions.

The Immunisation Advisory Committee has considered widened access to meningococcal ACWY vaccine at its meetings in:

PTAC has considered widened access at its meetings in

Through the RFP we asked for proposals that would enable us to consider widened access to these groups. The funding of meningococcal ACWY vaccine for these additional groups was unable to be progressed within the funding available.

The groups recommended for widened access by our expert clinical advisors are all ranked on the Options for Investment list(external link). This means that even though we are not widening access now, we would like to widen access when we have available budget.

Feedback on the choice of meningococcal ACWY vaccine

Clinicians provided feedback on the proposed choice of funded meningococcal ACWY vaccine:

  • the proposed eligibility criteria for Nimenrix should allow for up to three doses to allow children under 12 months of age who are close contacts or have previously had meningococcal disease to complete a full course.
  • funding the Nimenrix brand for all eligible age groups would eliminate the need for a separate vaccine to be approved for use in children under 12 months of age. This would reduce the potential for vaccination errors where the wrong vaccine is given to children under 12 months of age.

We appreciate the feedback on the proposed dosing for children under 12 months of age who are close contacts of cases or previously had meningococcal disease. As a result of this feedback, we have amended the proposed criteria to include the extra doses.

We acknowledge that funding the Nimenrix brand for all eligible age groups would avoid the need to fund two meningococcal ACWY vaccines to cover all ages. Unfortunately, we were unable to fund the Nimenrix brand for all eligible age groups within the funding available from Pharmac’s fixed budget.

We understand that the MenQuadfi brand funded for all children is expected to gain approval for use in children under 12 months during the proposed three-year supply period. Once approved, this would allow for one meningococcal ACWY vaccine to be used in all age groups.

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.