Decision to widen access to the PCV13 pneumococcal conjugate vaccine for immunisation against pneumococcal disease

Medicines Decision

What we’re doing

We're pleased to announce a decision to widen access to the PCV13 pneumococcal conjugate vaccine in the Pharmaceutical Schedule from 1 December 2022, for immunisation against pneumococcal disease. 

Any changes to the original proposal?

This decision was subject to a consultation letter dated 21 September 2022. 

The decision was approved as consulted on, with minor amendments to the language used in the funding criteria. 

We received supportive feedback regarding this proposal and really appreciate the thoughtful feedback. We would like to thank everyone who responded. 

We also received feedback requesting catch-up programmes for children who have already partially or fully completed their vaccination schedule with the currently funded vaccine, as well as requests to add Māori and Pacific children to the high-risk programme to address inequities in the burden of pneumococcal disease. 

We are seeking further advice from our clinical advisors about catch-up doses and changes to the high-risk programme. Once the clinical advice is finalised we will consider any recommended options for future funding.

Who we think will be most interested

  • Parents and whānau of tamariki
  • Vaccinators and other healthcare professional involved in childhood immunisations
  • Te Whatu Ora hospitals
  • Vaccine manufacturers, suppliers, wholesalers, and distributors
  • Organisations with an interest in immunisation 

Details about this decision

The PCV13 pneumococcal conjugate vaccine (Prevenar 13) will continue to be listed in Section I and Part II of Section H of the Pharmaceutical Schedule from 1 December 2022 as follows:

Chemical Formulation Brand Pack size Price*
Pneumococcal (PCV13) conjugate vaccine Inj 30.8 mcg of pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in 0.5ml syringe Prevenar 13 1 inj $0.00*
Pneumococcal (PCV13) conjugate vaccine Inj 30.8 mcg of pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in 0.5ml syringe Prevenar 13 10 inj $0.00*

*Vaccine prices are listed with zero cost in the Pharmaceutical Schedule as Pharmac distributes them free of charge to vaccinators.

PCV13 will be listed with the Xpharm restriction in Section I. An Xpharm listing means that community pharmacies cannot claim subsidy because Pharmac has made alternate distribution arrangements.

PCV13 will be listed in Section I and Part II of Section H of the Pharmaceutical Schedule with widened eligibility criteria as follows (new criteria in bold, deletions in strikethrough):

Section I 

Any of the following:

  1. A course of three doses for previously unvaccinated children up to the age of 59 months inclusive; or
  2. Two doses are funded for high-risk children individuals (over the age of 12 months and under 18 years) who have previously received two doses of the primary course of PCV10; or
  3. Up to an additional four doses (as appropriate) are funded for the (re)immunisation of for high-risk children aged under 5 years for (re-)immunisation of patients with any of the following:
    1. on immunosuppressive therapy or radiation therapy, vaccinate when there is expected to be a sufficient immune response; or
    2. with primary immune deficiencies; or
    3. with HIV infection; or
    4. with renal failure, or nephrotic syndrome; or
    5. who are immune-suppressed following organ transplantation (including haematopoietic stem cell transplant); or
    6. with cochlear implants or intracranial shunts; or
    7. with cerebrospinal fluid leaks; or
    8. receiving corticosteroid therapy for more than two weeks, and who are on an equivalent daily dosage of prednisone of 2 mg/kg per day or greater, or children who weigh more than 10 kg on a total daily dosage of 20 mg or greater; or
    9. with chronic pulmonary disease (including asthma treated with high-dose corticosteroid therapy); or
    10. pre-term infants, born before 28 weeks gestation; or
    11. with cardiac disease, with cyanosis or failure; or
    12. with diabetes; or
    13. with Down syndrome; or
    14. who are pre-or post-splenectomy, or with functional asplenia; or
  4. Up to an additional four doses (as appropriate) are funded for the (re-)immunisation of patients individuals 5 years and over with HIV, for patients pre or post haematopoietic stem cell transplantation, or chemotherapy; pre- or post splenectomy; functional asplenia, pre- or post- solid organ transplant, renal dialysis, complement deficiency (acquired or inherited), cochlear implants, intracranial shunts, cerebrospinal fluid leaks or primary immunodeficiency; or
  5. For use in testing for primary immunodeficiency diseases, on the recommendation of an internal medicine physician or paediatrician.

Note: please refer to the Immunisation Handbook for the appropriate schedule for catch up programmes

Section H

Restricted

Initiation – Primary course for previously unvaccinated children aged under 5 years

Therapy limited to 3 doses

A primary course of three doses for previously unvaccinated children up to the age of 59 months inclusive.

Initiation – High risk children individuals who have received PCV10

Therapy limited to 1 dose 2 doses

Two doses are funded for high-risk children individuals (over the age of 12 months and under 18 years) who have previously received two doses of the primary course of PCV10.

Initiation – High risk children aged under 5 years

Therapy limited to 4 doses

Both:

  1. Up to an additional four doses (as appropriate) are funded for the (re)immunisation of for high-risk children aged under 5 years for (re-)immunisation of patients; and
  2. Any of the following:
    1. on immunosuppressive therapy or radiation therapy, vaccinate when there is expected to be a sufficient immune response; or
    2. with primary immune deficiencies; or
    3. with HIV infection; or
    4. with renal failure, or nephrotic syndrome; or
    5. who are immune-suppressed following organ transplantation (including haematopoietic stem cell transplant); or
    6. with cochlear implants or intracranial shunts; or
    7. with cerebrospinal fluid leaks; or
    8. receiving corticosteroid therapy for more than two weeks, and who are on an equivalent daily dosage of prednisone of 2 mg/kg per day or greater, or children who weigh more than 10 kg on a total daily dosage of 20 mg or greater; or
    9. with chronic pulmonary disease (including asthma treated with high-dose corticosteroid therapy); or
    10. pre-term infants, born before 28 weeks gestation; or
    11. with cardiac disease, with cyanosis or failure; or
    12. with diabetes; or
    13. with Down syndrome; or
    14. who are pre-or post-splenectomy, or with functional asplenia. 

Initiation – High risk adults and children individuals 5 years and over

Therapy limited to 4 doses

Up to an additional four doses (as appropriate) are funded for the (re-)immunisation of patients individuals 5 years and over with HIV, for patients pre or post haematopoietic stem cell transplantation, or chemotherapy; pre- or post splenectomy; functional asplenia, pre- or post- solid organ transplant, renal dialysis, complement deficiency (acquired or inherited), cochlear implants, intracranial shunts, cerebrospinal fluid leaks or primary immunodeficiency. 

Initiation – Testing for primary immunodeficiency diseases

For use in testing for primary immunodeficiency diseases, on the recommendation of an internal medicine physician or paediatrician. 

Note: Please refer to the Immunisation Handbook for the appropriate schedule for catch up programmes.

The PCV10 pneumococcal conjugate vaccine (Synflorix) will continue to be listed in the Pharmaceutical Schedule so it would still be funded if it was administered, but vaccinators can start using PCV13 for childhood immunisations immediately from 1 December 2022. Vaccinators can return any unused PCV10 to ProPharma.

The National Immunisation Programme at Te Whatu Ora – Health New Zealand is responsible for supporting the implementation of changes to the National Immunisation Schedule.

The Ministry of Health’s Immunisation Handbook will be updated to reflect the changes to pneumococcal conjugate vaccines.(external link) 

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you are provided below: 

Theme

Pharmac comment

Supportive of the proposal, including implementing this change as soon as possible.

We acknowledge the significant support for this proposed change and the feedback to implement the change as soon as possible.

Request that eligibility for funded pneumococcal conjugate vaccine be further widened to:

  • All adults aged 65 years and over
  • Adults with asthma and serious lung disorders

In 2015, Pharmac considered an application to fund PCV13 for adults aged over 65 years(external link). Our expert clinical advisors recommended the application be declined. The application was subsequently declined by Pharmac on 8 March 2022.

Pharmac has not considered funding of pneumococcal vaccination for people with asthma or serious lung disorders.

Pharmac staff would welcome a funding application for people with asthma or serious lung disorders through our usual funding application processes.

Further clarification was requested about whether children who have started but not completed a course of PCV10 would be eligible for PCV13 to complete their full immunisation schedule.

All children under the age of 5 would be able to receive PCV13 as part of their regular childhood immunisations, including those who were given PCV10 at previous milestones.

A maximum of three doses in total (all PCV10, all PCV13, or a combination) would be funded, unless the child has a condition making them eligible for up to four doses of PCV13. 

Request for a catch-up programme for children who were previously vaccinated with a full course of PCV10.

We note that this decision is focused on the urgent need to change the funded vaccine to PCV13 to provide broader protection against invasive pneumococcal disease.

We are seeking further clinical advice on a proposal for a catch-up programme to re-vaccinate all or a subset of children who previously received PCV10. We will work closely with our health system partners to understand how any recommended catch-up could be implemented, if approved.

Request that all Māori and Pacific children be included in the high-risk programme to address the disproportionate rates of pneumococcal disease in these children.

Responders considered that Māori and Pacific children have higher rates of pneumococcal disease because they have lower immunisation rates, so introducing a better vaccine into an underperforming immunisation system would have the effect of increasing inequities as those who receive immunisation at higher rates would benefit most.

We acknowledge the concern regarding Māori and Pacific children experiencing inequities in rates of pneumococcal disease, where the incidence of invasive pneumococcal disease is over four times higher in Māori and almost five times higher in Pacific people than in non-Māori non-Pacific.

We consider that including Māori and Pacific children in the high-risk programme would be best assessed as a separate funding proposal and we will work our expert clinical advisors to develop this. Given the extent of invasive pneumococcal disease inequities, we will do this as soon as we can.

Te Whatu Ora – Health New Zealand is responsible for the implementation of vaccines funding decisions through the National Immunisation Programme. We note that funding decisions ensure the vaccine is available for use in the programme. A successful immunisation implementation programme could strongly influence equity of access by ensuring services are targeted to priority groups within the overall funded population.

Pharmac staff work closely and collaboratively with Te Whatu Ora to support implementation of immunisation programmes.

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.