Proposal for changes to funded vaccines in the National Immunisation Schedule

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

Eligibility and Dose Changes

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):

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.

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):

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):

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):

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.

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.