Proposal for new supply agreements for funded vaccines in the National Immunisation Schedule
What we’re proposing
We are proposing to enter into new supply agreements for a number of funded vaccines following a Request for Proposals (RFP) for the supply of various vaccines and a diagnostic agent.
We have reached provisional agreements with six suppliers for the supply of 17 funded vaccines. The influenza vaccine would be funded from 1 February 2024 to 31 December 2025, with optional extensions for the 2026 and 2027 influenza seasons. All other vaccines would be funded 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 9 am, Monday, 26 June 2023 and feedback can be emailed to vaccines@pharmac.govt.nz.
What would the effect be?
In summary, this proposal would result in continued supply of 13 currently funded brands of vaccines, changes to three brands of currently funded vaccines, and a change to one type of funded vaccine. There are no proposed changes to eligibility criteria or dose schedules for any of the vaccines included in this proposal. Key elements of the proposal are summarised below.
Funded vaccines with no proposed changes
The following vaccines would continue to be supplied by the same supplier, with the same brand:
| 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 conjugate vaccine | Prevenar 13 (Pfizer) |
| Pneumococcal (PPV23) polysaccharide vaccine | Pneumovax 23 (MSD) |
| Poliomyelitis (inactivated) vaccine | IPOL (Sanofi) |
| Rotavirus oral vaccine | Rotarix (GSK) |
| Tuberculin PPD (Mantoux) test | Tubersol (Sanofi) |
* Brand name would be updated from Havrix to Havrix 1440.
Proposed changes to brands of funded vaccines
The following vaccines would continue to be funded, supplied by different suppliers with different brands:
| Vaccine | Current funded brand (supplier) | Proposed funded brand (supplier) |
|---|---|---|
| Haemophilus influenzae type b vaccine | Hiberix (GSK) | Act-HIB (Sanofi) |
| Varicella vaccine | Varivax (MSD) | Varilrix (GSK) |
| Influenza vaccine | Afluria Quad/Afluria Quad Junior (Seqirus) | Influvac Tetra (Viatris) |
Proposed change to funded meningococcal vaccine type for children under 12 months of age
We are proposing to continue to fund the currently funded brand of meningococcal ACWY vaccine, MenQuadfi. However, MenQuadfi is not approved for use in children under 12 months of age, and we have received advice from the Immunisation Advisory Committee that the currently funded meningococcal vaccine for this age group, Neisvac-C meningococcal C conjugate vaccine, does not provide sufficient protection against circulating meningococcal strains. Therefore, we are proposing to fund an alternative brand of meningococcal ACWY vaccine for children under 12 months of age: the Nimenrix brand of meningococcal ACWY vaccine (supplied by Pfizer) would be funded and Neisvac-C meningococcal C conjugate vaccine (also supplied by Pfizer) would be delisted from the Pharmaceutical Schedule.
Implementation
Te Whatu Ora’s Immunisation Handbook(external link) would be updated to reflect these proposed changes, if approved, and would continue to provide information to vaccinators on the recommended timing of dosing for particular vaccines and catch up programmes.
There are no proposed changes to ordering or distribution mechanisms for these vaccines.
Who we think will be 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, Public Health Agency and Te Aka Whai Ora
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 sought expert clinical advice from Pharmac’s Immunisation Advisory Committee in May 2022 [PDF, 245 KB] and September 2022 [PDF, 212 KB], on the suitability of new vaccines recently approved by Medsafe, the interchangeability of alternative brands and any possible funding eligibility criteria changes. In March 2023, following receipt of proposals, Pharmac sought further clinical advice from the Immunisation Advisory Committee regarding the proposed changes (the record of this discussion is not yet publicly available).
As a result of the RFP, Pharmac has entered into provisional agreements with GSK New Zealand Ltd, Merck Sharp & Dohme (New Zealand) Limited, Pfizer New Zealand Limited, Seqirus (NZ) Ltd, Sanofi-Aventis Australia Pty Ltd, and Viatris Limited for the supply of various vaccines as outlined above. Feedback to this consultation will help us to decide if these agreements should be confirmed.
Details about our proposal
The current funding criteria applying to all vaccines can be found in Section I(external link) (National Immunisation Schedule) and Part II of Section H(external link) of the Pharmaceutical Schedule.
For the vaccines outlined in the table above there would be no changes to the funded brand or supplier. Details about vaccines with proposed changes and other aspects of the proposal can be found below.
Supply and price arrangements
Principal Supply Status (PSS) would be applied to all vaccines in this proposal, with the exception of Nimenrix, which would 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 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.
Confidential net prices would apply to all vaccines where provisional agreement have been reached as a result of this RFP.
Distribution arrangements
Vaccines are distributed differently to most other pharmaceuticals. The method for ordering vaccines by vaccinators would remain the same as a result of this proposal.
Most of the vaccines (except influenza vaccine) would be listed with the “Xpharm” restriction with a $0.00 subsidy. An Xpharm listing 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 the influenza vaccine would remain the same as a result of this proposal. Influenza vaccine is listed in the Pharmaceutical Schedule and distributed in a similar way to other pharmaceuticals. While no changes are proposed at this time, this proposal does not rule out potential changes for the distribution of vaccines in the future.
Haemophilus influenzae type b vaccine
From 1 July 2024, Act-HIB (supplied by Sanofi-Aventis) would be listed in Section I (National Immunisation Schedule) and Part II of Section H as outlined below and the Hiberix brand would 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 would be no change to the eligibility criteria in Section I, which would remain as outlined below. Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
One dose for patients meeting any of the following:
- For primary vaccination in children; or
- An additional dose (as appropriate) is funded for (re-)immunisation for patients post haematopoietic stem cell transplantation, or chemotherapy; functional asplenic; pre or post splenectomy; pre- or post solid organ transplant, pre- or post cochlear implants, renal dialysis and other severely immunosuppressive regimens; or
- For use in testing for primary immunodeficiency diseases, on the recommendation of an internal medicine physician or paediatrician.
Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
Varicella (Chickenpox) vaccine
From 1 July 2024, Varilrix (supplied by GSK) would be listed in Section I (National Immunisation Schedule) and Part II of Section H as outlined below and the Varivax brand would 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 aged between 9 and 12 months 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 would be the listed brand in Section H of the Pharmaceutical Schedule from 1 July 2024. The eligibility criteria in Part II of Section H would be amended to remove references to age restrictions.
There would be no change to the eligibility criteria in Section I, which would remain as outlined below. Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
Either:
- Maximum of one dose for primary vaccination for either:
- Any infant born on or after 1 April 2016; or
- For previously unvaccinated children turning 11 years old on or after 1 July 2017, who have not previously had a varicella infection (chickenpox), or
- Maximum of two doses for any of the following:
- Any of the following for non-immune patients:
- with chronic liver disease who may in future be candidates for transplantation; or
- with deteriorating renal function before transplantation; or
- prior to solid organ transplant; or
- prior to any elective immunosuppression*, or
- for post exposure prophylaxis who are immune competent inpatients.; or
- For patients at least 2 years after bone marrow transplantation, on advice of their specialist, or
- For patients at least 6 months after completion of chemotherapy, on advice of their specialist, or
- For HIV positive non-immune to varicella with mild or moderate immunosuppression on advice of HIV specialist, or
- For patients with inborn errors of metabolism at risk of major metabolic decompensation, with no clinical history of varicella, or
- For household contacts of paediatric patients who are immunocompromised, or undergoing a procedure leading to immune compromise where the household contact has no clinical history of varicella, or
- For household contacts of adult patients who have no clinical history of varicella and who are severely immunocompromised, or undergoing a procedure leading to immune compromise where the household contact has no clinical history of varicella.
- Any of the following for non-immune patients:
* immunosuppression due to steroid or other immunosuppressive therapy must be for a treatment period of greater than 28 days
Influenza vaccine
From 1 February 2024, Influvac Tetra (supplied by Viatris Limited) would 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 would 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 current list price for influenza vaccine is $11.00 per dose. This would increase to $12.00 per dose from 1 February 2024. A confidential rebate would apply to Influvac Tetra, which would lower its net price. The list price increase may also 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 would 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 would be as outlined below. Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
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, as the health sector was expected to be under pressure managing hospitalisations from COVID-19 this winter, and influenza infections could put additional strain on the health sector during this time. That decision 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 above.
No changes to influenza vaccine technologies as a result of this RFP
As part of this RFP process, Pharmac 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 proposing to fund 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.
Supply arrangements
As part of this RFP, Pharmac considered different options for the supply of influenza vaccine, including Principal Supply Status (PSS) and dual supply. Following evaluation of the commercial proposals received for influenza vaccine, we are proposing to progress the supply of influenza vaccine as PSS, which means there would be one funded brand of influenza vaccine. As outlined in the RFP, Pharmac would 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 would be no change to the funded brand of meningococcal ACWY vaccine for eligible people aged 12 months and over which would remain as MenQuadfi. As MenQuadfi is not currently approved for the use in infants under 12 months of age, we are proposing to list Nimenrix as an alternative brand of meningococcal ACWY vaccine, that would only be funded for use in this age group.
From 1 July 2024, the Nimenrix brand of meningococcal ACWY vaccine would 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. Meningococcal C conjugate vaccine, Neisvac-C, would be delisted from 1 December 2024, as Nimenrix would also provide protection against meningococcal serotype C in addition to serotypes A, W and Y.
| 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 |
The eligibility criteria for Nimenrix in Section I would be as outlined below. Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
Both:
- The child is under 12 months of age; and
- Any of the following:
- Up to three doses 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
- One dose for close contacts of meningococcal cases of any group; or
- One dose for child who has previously had meningococcal disease of any group; or
- A maximum of three doses (dependant on age at first dose) for bone marrow transplant patients; or
- 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.
The eligibility criteria in Section I of the Pharmaceutical Schedule for MenQuadfi would remain as outlined below. Similar eligibility criteria would apply in Part II of Section H of the Pharmaceutical Schedule.
Either:
A) Any of the following:
- Up to three doses and a booster every five years 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
- One dose for close contacts of meningococcal cases of any group; or
- One dose for person who has previously had meningococcal disease of any group; or
- A maximum of two doses for bone marrow transplant patients; or
- A maximum of two doses for person pre- and post-immunosuppression*; or
B) Both:
- Person is aged between 13 and 25 years, inclusive; and
- One dose for individuals who are entering within the next three months, or in their first year of living in boarding school hostels, tertiary education halls of residence, military barracks, or prisons.
Note: children under seven years of age require two doses 8 weeks apart, a booster dose three years after the primary series and then five yearly.
*Immunosuppression due to steroid or other immunosuppressive therapy must be for a period of greater than 28 days.
The Menactra brand of meningococcal ACWY vaccine is also currently listed on the Pharmaceutical Schedule. In November 2022, Pharmac notified(external link) 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.
Proposed changes to presentation descriptions
We are proposing some minor changes to presentation descriptions in the Pharmaceutical Schedule 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) |
No changes to funded access to meningococcal ACWY vaccine or influenza vaccine as a result of this RFP
As part of this RFP process, Pharmac requested proposals for widened access for the meningococcal ACWY vaccine and the influenza vaccine. We are not proposing to widen funded access to meningococcal ACWY or influenza vaccines at this time. However, these proposals for widened access remain on the Options for Investment(external link) list for consideration of future funding when we have sufficient budget.
Further information regarding the following groups considered for the widening of access can be found on the Application Tracker on the Pharmac website:
Meningococcal ACWY vaccine:
- children 1 year of age, with or without a catch-up for children 1 to 4 years of age(external link)
- individuals at 14 years of age(external link) with or without a catch-up for either:
Influenza vaccine:
- Children up to 18 years of age(external link)
- All people 50 years of age and over(external link)
- Māori and Pacific people 50 years of age and over(external link)
- Open listing (no restrictions)(external link)
Vaccines not included in this proposal
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 weeks.
Pharmac also holds responsibility for management of COVID-19 vaccines. A plan for the ongoing management of COVID-19 vaccine funding is currently 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.
To provide feedback
Send us an email: vaccines@pharmac.govt.nz by 9am, Monday 26 June 2023.
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.
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