Proposal for changes to funded vaccines in the National Immunisation Schedule

Medicines Consultation Closed

We are proposing to make changes to the funding of vaccines in the National Immunisation Schedule following a Request for Proposals (RFP) for the supply of various vaccines.

What we're proposing

We are proposing to make changes to the funding of vaccines in the National Immunisation Schedule following a Request for Proposals (RFP) for the supply of various vaccines.

In summary, through provisional agreements with a number of suppliers, this proposal would result in the following vaccine brand, eligibility and dose changes: 

Brand Changes

Vaccine

Current

Proposal

Hepatitis B recombinant vaccine

HBvaxPRO (MSD)

Engerix-B (GSK)

Influenza vaccine

Influvac Tetra (Mylan)

Alfuria Quad (Seqirus)

Varicella vaccine

Varilrix (GSK)

Varivax (MSD)

Adult diphtheria and tetanus vaccine

ADT Booster (Seqirus)

Delisted and replaced with Boostrix – see below

Eligibility and Dose Changes

Vaccine

Proposed Change

Diphtheria, tetanus and pertussis (Tdap) vaccine (Boostrix)

Tdap (Boostrix) vaccine would replace the Adult diphtheria and tetanus vaccine (ADT Booster), and eligibility criteria would be amended to restrict the tetanus booster at age 45 to individuals who have not received 4 tetanus vaccinations in their lifetime.

Hepatitis B recombinant vaccine (Engerix-B)

Only the 20 mcg per 1 ml strength would be listed. This vaccine is suitable for use in children, adults and transplant patients.

Meningococcal C conjugate vaccine (Neisvac-C)

Eligibility criteria would be amended to limit use to children under 9 months of age who are too young to receive the Meningococcal ACWY conjugate vaccine, with a maximum of 3 doses.

Pneumococcal conjugate vaccine (PCV10) (Synflorix)

Eligibility criteria would be amended from a 4-dose schedule to a 3-dose schedule.

Pneumococcal conjugate vaccine (PCV13) (Prevenar 13)

Eligibility criteria would be amended from 4 additional doses to 3 additional doses for high risk children under 5 years of age.

Varicella vaccine (Varivax)

Eligibility would be changed to infants from 12 months of age - the Varivax brand is not approved for infants under 12 months of age.

For infants between 9 and 12 months of age at high risk, an alternative vaccine would be available through DHB hospitals.

The brand and eligibility criteria for other funded vaccines would not change.

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

Provisional agreements have been reached with the following suppliers:

  • GSK New Zealand Ltd
    • Diphtheria, tetanus and pertussis vaccine (Boostrix)
    • Diphtheria, tetanus, pertussis and polio vaccine (Infanrix IPV)
    • Diphtheria, tetanus, pertussis, polio, hepatitis B and haemophilus influenzae type B vaccine (Infanrix-hexa)
    • Hepatitis A vaccine (Havrix and Havrix Junior)
    • Hepatitis B recombinant vaccine (Engerix-B)
    • Measles, mumps and rubella vaccine (Priorix)
    • Pneumococcal conjugate vaccine, PCV10 (Synflorix)
    • Rotavirus vaccine (Rotarix)
  • MSD Pharmaceuticals Ltd
    • Pneumococcal polysaccharide vaccine (Pneumovax 23)
    • Varicella vaccine (Varivax)
  • Seqirus New Zealand Ltd
    • Bacillus Calmette-Guerin vaccine (BCG Vaccine)
    • Human papillomavirus vaccine (Gardasil 9)
    • Influenza vaccine (Afluria Quad)
  • Sanofi-Aventis Ltd
    • Meningococcal (groups A, C, W and Y) conjugate vaccine (Menactra) – no change to current eligibility criteria
    • Poliomyelitis vaccine (IPOL)
    • Tuberculin PPD Mantoux test (Tubersol)

The Haemophilus influenzae type B vaccine (Hib only) would remain listed without a supply agreement. All proposed changes, except for influenza vaccine, would occur on 1 July 2020 with Sole Supply Status awarded for all newly contracted vaccines from 1 October 2020 until 30 June 2024. Influenza vaccine would be listed from 1 February 2020, with Sole Supply Status awarded until 31 December 2023. 

The Ministry of Health’s Immunisation Handbook 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.

Consultation closes at 4pm on Friday, 31 May 2019 and feedback can be emailed to vaccines@pharmac.govt.nz.

Who we think will be interested

Doctors in general practice, nurses, vaccinators, paediatricians, infectious disease specialists, public health services, DHBs, people who need vaccines and organisations with an interest in immunisation.

Why we’re proposing this

PHARMAC released a Request for Proposals (RFP) for the supply of various vaccines in New Zealand on 20 November 2018.

We sought expert clinical advice from the Immunisation Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) in May 2018 [PDF, 190 KB] and September 2018 [PDF, 457 KB], on the suitability of new vaccines recently approved by Medsafe, the interchangeability of alternative brands and possible funding eligibility criteria changes. In March 2019, following receipt of proposals, PHARMAC sought further clinical advice from the Immunisation Subcommittee regarding proposed changes (minutes not yet publicly available).

As a result of the RFP, PHARMAC has entered into provisional agreements with the GSK New Zealand Ltd, Seqirus New Zealand Ltd, Sanofi-Aventis Ltd and MSD Pharmaceuticals Ltd 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) and Section H(external link) of the Pharmaceutical Schedule and would be amended to implement any changes to eligibility and/or the number of doses, should these proposals be accepted.

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

Diphtheria, tetanus and pertussis vaccine

From 1 July 2020, the diphtheria, tetanus and pertussis (Tdap) (Boostrix) vaccine would replace the adult diphtheria and tetanus vaccine (ADT Booster).  The ADT Booster brand would be delisted from 1 October 2020.

Current eligibility criteria for Boostrix would be widened to include the eligibility criteria currently in place for the ADT Booster vaccine, but amended to restrict the tetanus booster at age 45 to individuals who have not received 4 tetanus vaccinations in their lifetime.

From 1 July 2020, the current eligibility criteria for Boostrix vaccine would be amended in Section I and Part II of Section H of the Pharmaceutical Schedule as follows (additions in bold):

Funded for any of the following:

  1. A single vaccine for pregnant woman between gestational weeks 28 and 38; or
  2. A course of up to four vaccines is funded for children from age 7 up to the age of 18 years inclusive to complete full primary immunisation; or
  3. An additional four doses (as appropriate) are funded for (re-)immunisation for patients post haematopoietic stem cell transplantation or chemotherapy; pre or post splenectomy; pre- or post solid organ transplant, renal dialysis and other severely immunosuppressive regimens; or
  4. A single dose for vaccination of patients aged 65 years old; or
  5. A single dose for vaccination of patients aged 45 years old who have not had 4 previous tetanus doses; or
  6. For vaccination of previously unimmunised or partially immunised patients; or
  7. For revaccination following immunosuppression; or
  8. For boosting of patients with tetanus-prone wounds.

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

Hepatitis B recombinant vaccine

From 1 July 2020, Engerix-B would be listed on the National Immunisation Schedule as outlined below and all strengths of the HBVaxPro brand would be delisted from 1 October 2020.

Chemical

Presentation

Brand

Pack size

Subsidy

Hepatitis B recombinant vaccine

Inj 20 mcg per 1 ml prefilled syringe

Engerix-B

1

$0.00

Only the 20 mcg per 1 ml strength would remain listed. This strength is suitable to be used in all eligible people (children and adults including dialysis patients and liver or kidney transplant patients). There are no proposed changes to the current eligibility criteria.


Meningococcal C conjugate vaccine

We are not proposing any changes to the supply of meningococcal C conjugate vaccine, meaning that the Neisvac-C brand would continue to be listed in the Pharmaceutical Schedule.

From 1 July 2020, the access criteria for Neisvac-C would be amended to restrict the vaccine to children under 9 months of age who are too young to receive the Meningococcal ACWY conjugate vaccine (Menactra). The current restrictions for Neisvac-C would be amended in Section I and Part II of Section H of the Pharmaceutical Schedule as follows (additions in bold, deletions in strikethrough):

Both

  1. The child is under 9 months of age
  2. Any of the following:

2.1.   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

2.2.   One dose Three doses for close contacts of meningococcal cases; or

2.3.   A maximum of two Three doses for bone marrow transplant patients; or

2.4.   A maximum of two Three doses for patients following immunosuppression*.

Note: children under seven yearsnine months of age require two doses 8 weeks apart, a booster dose with Meningococcal ACWY vaccine 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.

Pneumococcal conjugate vaccine (PCV10)

From 1 July 2020, the dosing regimen for pneumococcal conjugate vaccine (PCV10) (Synflorix) would move from a 4-dose schedule to a 3-dose schedule.

We received clinical advice from the Immunisation Subcommittee in September 2018 that supported this proposed change in dosing [PDF, 457 KB].

The current eligibility criteria for Synflorix would be amended in Section I and Part II of Section H of the Pharmaceutical Schedule as follows (additions in bold, deletions in strikethrough):

Either:

  1. A primary course of  four three doses for previously unvaccinated individuals up to the age of 59 months inclusive; or
  2. Up to three two doses as appropriate to complete the primary course of immunisation for individuals under the age of 59 months who have received one to three doses of PCV13;

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

Pneumococcal conjugate vaccine (PCV13)

We are not proposing any changes to the supply of pneumococcal conjugate vaccine (PCV13), meaning that the Prevenar 13 brand would continue to be listed in the Pharmaceutical Schedule as it is currently.

From 1 July 2020, the dosing regimen for pneumococcal conjugate vaccine (PCV13) (Prevenar 13) would move from a 4 additional doses to 3 additional doses for high risk children under the age of 5 years. The current restrictions for Prevenar 13 would be amended in Section I and Part II of Section H of the Pharmaceutical Schedule as follows (additions in bold, deletions in strikethrough):

Any of the following:

  1. One dose is funded for high risk children (over the age of 17 months and under 18 years) who have previously received four three doses of PCV10; or
  2. Up to an additional four three doses (as appropriate) are funded 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
  3. Up to an additional four doses (as appropriate) are funded for (re-)immunisation of patients 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, or primary immunodeficiency; or
  4. 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.

Varicella vaccine

From 1 July 2020, Varivax would be listed on the National Immunisation Schedule as outlined below and the Varilrix brand would be delisted from 1 October 2020.

Chemical

Presentation

Brand

Pack size

Subsidy

Varicella vaccine

Inj 1350 PFU prefilled syringe

Varivax

1

$0.00

Varicella vaccine

Inj 1350 PFU prefilled syringe

Varivax

10

$0.00

The strength of the proposed Varivax brand is 1350 PFU per dose compared to the currently funded Varilrix brand which is 2000 PFU per dose. We received clinical advice from the Immunisation Subcommittee that these brands are clinically interchangeable. The current eligibility criteria for varicella vaccine would be remain unchanged for Varivax.

The currently listed brand of varicella vaccine (Varilrix) is approved for use in children from 9 months of age, but Varivax is not approved for use in infants under 12 months of age. To allow continued access to varicella vaccine for high risk infants between 9 and 12 months of age, the eligibility criteria for varicella vaccine would be listed in Part II of Section H of the Pharmaceutical Schedule with no specified brand as outlined below. This would mean that any brand of varicella vaccine with approval for this age group could be used for infants between 9 and 12 months of age, regardless of whether or not the brand is listed on the Schedule.

Initiation – infants between 9 and 12 months of age

Therapy limited to 2 doses

Any of the following:

  1. Any of the following for non-immune patients:
    1. with chronic liver disease who may in future be candidates for transplantation; or
    2. with deteriorating renal function before transplantation; or
    3. prior to solid organ transplant; or
    4. prior to any elective immunosuppression*, or
    5. for post exposure prophylaxis who are immune competent inpatients.; or
  2. For HIV positive non immune to varicella with mild or moderate immunosuppression on advice of HIV specialist, or
  3. For patients with inborn errors of metabolism at risk of major metabolic decompensation, with no clinical history of varicella, or
  4. 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
  5. 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.

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

Influenza vaccine

From 1 February 2020, Alfuria Quad would be listed in the Sections I and H of the Pharmaceutical Schedule as outlined below and the Influvac Tetra and Fluarix Tetra brands would be delisted from 1 February 2020.

Chemical

Presentation

Brand

Pack size

Subsidy
(Manufacturer’s price)

Influenza vaccine

Inj 60 mcg in 0.5 ml prefilled syringe (quadrivalent vaccine)

Afluria Quad

10

$90.00

A confidential rebate would apply to Afluria Quad, which would lower its net price.

The current separate vaccine listing with eligibility criteria for children from 6 months to 35 months would be removed as it is expected that Afluria Quad would be suitable for all ages from 6 months onwards, subject to Medsafe approval for use in children under 5 years of age. 

Other types of influenza vaccines

We requested proposals for other types of influenza vaccines that are not currently funded (live attenuated, high dose and adjuvanted influenza vaccines). We are not proposing to fund these types of influenza vaccine at this time, but would welcome funding applications for live attenuated, high dose or quadrivalent adjuvanted influenza vaccines in the future. This proposal would not prevent PHARMAC funding any of these other types of influenza vaccine before 31 December 2023. 

No proposed changes to distribution of vaccines

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.

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.

The distribution of 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. 

No proposed changes to other funded vaccines

There are no proposed changes to the other funded vaccines listed below:

Vaccine

Brand (supplier)

Bacillus Calmette-Guerin vaccine

BCG Vaccine (Seqirus)

Diphtheria, tetanus, pertussis and polio vaccine

Infanrix IPV (GSK)

Diphtheria, tetanus, pertussis, polio, hepatitis B and haemophilus influenzae

Infanrix-hexa (GSK)

Haemophilus influenzae type B vaccine

Hiberix (GSK)

Hepatitis A adult vaccine

Havrix (GSK)

Hepatitis A paediatric vaccine

Havrix Junior (GSK)

Human papillomavirus vaccine

Gardasil 9 (Seqirus)

Measles, mumps and rubella vaccine

Priorix (GSK)

Meningococcal ACWY conjugate vaccine (current eligibility criteria)

Menactra (Sanofi)

Pneumococcal (PPV23) polysaccharide vaccine

Pneumovax 23 (MSD)

Poliomyelitis (inactivated) vaccine

IPOL (Sanofi)

Rotavirus oral vaccine

Rotarix (GSK)

Tuberculin PPD (Mantoux) test

Tubersol (Sanofi)

Vaccines not considered as part of this RFP

Varicella zoster vaccine (Zostavax) for the prevention of shingles is currently listed in the Pharmaceutical Schedule with subsidy and delisting protection until 30 June 2021. As this vaccine is subject to a listing agreement that overlaps with the RFP supply period, this vaccine was not included in the RFP. 

Meningococcal vaccines

We requested proposals for the meningococcal B vaccine (new listing) and meningococcal ACWY vaccine (widening access) in the RFP.

Following the RFP, updated clinical advice on the funding of meningococcal vaccines was sought from the Immunisation Subcommittee in March 2019 and we are continuing to assess these products for funding.

More information, including links to the PTAC and Immunisation Subcommittee minutes for meningococcal vaccines, can be found on PHARMAC’s Application Tracker(external link).

We will provide an update on this in the coming months.

To provide feedback

Send us an email: vaccines@pharmac.govt.nz by 4pm on 31 May 2019.

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.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.