Proposal to widen access to the meningococcal B vaccine and secure supply of the shingles vaccine

What we’re proposing

We are seeking feedback on a proposal to:

• fund meningococcal B vaccine (Bexsero) from 1 March 2023 to protect against meningococcal disease in children up to 12 months of age administered as part of the childhood immunisation programme, and people aged 13 to 25 years who are entering into or in their first year of specified close-living situations. Catch-up programmes would also be funded for these groups. 

• secure ongoing supply of the shingles vaccine (Shingrix) from 1 December 2022. No changes would be made to the current funding of Shingrix.

The provisional agreement with the supplier of Bexsero and Shingrix, GSK, includes price reductions and other amendments to the existing contractual terms for these products.

Further details on this proposal, including how to provide feedback can be found below.

We welcome your feedback in this proposal. Consultation closes at 5pm on Tuesday 8 November 2022 and feedback can be emailed to vaccines@pharmac.govt.nz   

Meningococcal B vaccine (Bexsero) for the prevention of meningococcal B infection

What would the effect be?

From 1 March 2023, funded access to meningococcal B vaccine (Bexsero) would be widened to include the following people:

• children up to 12 months of age would receive three doses, as part of their regular childhood immunisations
• people aged 13 to 25 years who are entering into or in their first year of close-living situations such as boarding school hostels, tertiary education halls of residence, military barracks, or prisons would receive two doses.

A catch-up programme would be funded for:

• children from 13 to 59 months of age (inclusive) to 31 August 2025
• people aged 13 to 25 years who are already living in close-living situations such as boarding school hostels, tertiary education halls of residence, military barracks, or prisons, to 28 February 2024.

We estimate that approximately 300,000 people would be eligible for vaccination during the catch-up period, and approximately 60,000 people in each following year.

Vaccination of eligible people would reduce their risk of meningococcal disease. Meningococcal infection rates are higher in Māori and Pacific peoples compared to non-Māori and non-Pacific people. This proposal would help improve access to meningococcal vaccination for Māori and Pacific peoples in the groups proposed for funding. 

For service providers

Te Whatu Ora is responsible for supporting the implementation of changes to the National Immunisation Schedule and would lead communications with service providers about the vaccination programme.

Funded vaccine supply would be available through ProPharma, as with other funded vaccines. Further information on Pharmac’s role in vaccines is available on our website.

As with most other funded vaccines, pharmacist vaccinators would not be able to administer this funded vaccine at this time. Significant changes would be required to the current funding and distribution process to allow pharmacists to administer all funded vaccines. We continue to consider options for changes to the funding and distribution process that would allow pharmacists to administer all funded vaccines in the future.

Who we think will be interested

• Parents, caregivers and whānau of children
• People who live in institutional close-living situations
• Secondary schools with boarding facilities, universities and other tertiary educational institutions, student health services
• Te Whatu Ora hospitals and public health units
• Department of Corrections prisons
• New Zealand Defence Force and military health services
• Vaccinators and other health care professionals involved in childhood immunisations
• Suppliers and wholesalers
• Organisations with an interest in immunisation

About meningococcal disease

Meningococcal disease is caused by the Neisseria meningitidis bacterium. Meningococcal bacteria are commonly carried in the nose and throat, and do not usually cause disease. Carriage rates are highest in teenagers and young adults, but children under five years of age have the highest rates of meningococcal disease. Occasionally a person who is carrying the bacterium may develop severe (invasive) disease such as meningitis (inflammation of the membranes around the brain), septicaemia (blood infection) or pneumonia (lung infection). The bacterium can be spread from those who carry the bacterium without being infected (carriers) or people with meningococcal disease to other people by coughing, sneezing or contact with saliva.

People who survive meningococcal disease may live with long term consequences from the disease, including skin scarring, amputation of limbs and extremities, hearing loss, seizures or brain injury. Even when meningococcal disease is diagnosed and treated early, 10% to 20% of affected people may die from the disease. On average in New Zealand, meningococcal group B causes around two-thirds of meningococcal disease each year. The remaining meningococcal cases each year are caused by other meningococcal groups. 

The numbers of people with invasive meningococcal disease being notified to health authorities in New Zealand is increasing. In 2019 there were 62 cases notified, including five deaths, that were caused by meningococcal group B. While the overall number of cases caused by meningococcal group B has been lower since then (likely due to the public health measures in place for COVID-19 which have reduced the transmission of several diseases), cases have increased again each year from 2020. There have been 37 cases in 2022 reported up to mid-October, including one death caused by meningococcal group B. Meningococcal disease incidence is highest in Māori compared to non-Māori, with 18 cases notified in 2022 reported up to mid-October.

About the meningococcal B vaccine

The Bexsero brand of meningococcal vaccine is approved for immunisation for the prevention of invasive meningococcal disease caused by meningococcal group B strains. Each 0.5 ml dose of Bexsero meningococcal group B vaccine is administered by deep intramuscular injection.  Infants under one year of age require three doses, usually given in the thigh. Older children and adults require two doses which are usually given in the upper arm.

Further information regarding Bexsero dosing and administration can be found in the product datasheet on the Medsafe website(external link).

Bexsero is already funded for people who are close contacts of meningococcal cases or at higher risk of meningococcal disease due to reduced immune function.

Why we’re proposing this

We first received a funding application for meningococcal B vaccine (Bexsero) in 2018. In July 2021 we funded Bexsero for close contacts of cases and people at higher risk of meningococcal disease. Our clinical advisors, the Pharmacology and Therapeutics Advisory Committee (PTAC) and the Immunisation Advisory Committee, have recommended funding for meningococcal B vaccine for a range of different patient groups, including:

• infant immunisation schedule – low priority
• people moving into close living situations (13 to 25 years of age) with catch-up – high priority
• people moving into close living situations (13 to 25 years of age) with no catch-up – high priority

Pharmac has evaluated all of these recommendations using our Factors for Consideration.

We are proposing to fund these groups now as we have reached a provisional agreement with the supplier, GSK, that also includes a price reduction on another funded medicine. This, in combination with our recent budget uplift, has enabled us to progress a funding proposal for the infant immunisation schedule and entrants into close living situations groups, including catch-up programmes.  

More information about the assessment of funding for the all of these groups, including links to the relevant clinical advice, can be found on the Application Tracker(external link).

Our clinical advisors have reviewed and recommended several other options for funding meningococcal vaccines. Options for widening funded access to Menactra, which provides protection against meningococcal groups A, C, W and Y, remain under consideration. Menactra is already funded for people aged 13 to 25 years in close living situations, as well as people who are close contacts of meningococcal cases or at higher risk of meningococcal disease due to reduced immune function.

Details about our proposal

The meningococcal B vaccine (Bexsero) would continue to be listed in Section I and Part II of Section H of the Pharmaceutical Schedule.   

A confidential net price would apply from 1 March 2023 and Bexsero would have subsidy and delisting protection until 28 February 2026. 

The eligibility criteria for meningococcal B vaccine (Bexsero) would be amended in Section I of the Pharmaceutical Schedule from 1 March 2023, with similar changes in Section H, as follows (proposed new criteria in bold):

The proposed eligibility criteria allow for three doses for children up to 12 months of age. Children who receive their first two doses while under 12 months of age, would still be eligible for the third dose, even if their 12 month immunisation visit was delayed and they were older than 12 months when completing the vaccination course. 

Bexsero would continue to be listed with “Xpharm” restriction.  An Xpharm listing means that community pharmacies cannot claim subsidy because Pharmac has made alternate distribution arrangements.

Te Whatu Ora is responsible for supporting the implementation of changes to the National Immunisation Schedule. The Ministry of Health’s Immunisation Handbook(external link)would be updated to reflect the changes to eligibility and to set out the dose scheduling for meningococcal B vaccine. 

Zoster vaccine (Shingrix) for the prevention of shingles

What would the effect be?

Shingrix would continue to be the funded zoster vaccine for people who are 65 years age for the prevention of shingles. Each year approximately 50,000 people receive zoster vaccine.

There would be no changes to the current eligibility criteria for Shingrix at this time.

Who we think will be interested

• People around 65 years of age
• Te Whatu Ora hospitals
• Vaccinators and other health care practitioners involved in immunisations
• Suppliers and wholesalers
• Organisations with an interest in immunisation
• Consumer groups focused on the elderly, such as Grey Power, Age Concern and rest homes and retirement villages

About shingles

Herpes zoster, commonly known as shingles, is a painful blistering rash caused by the same virus that causes chickenpox. Anyone who has previously had chickenpox may subsequently develop shingles, which tends to occur more often in older people. Shingles is more common and more severe in patients with poor immunity.

One in every three people can expect to suffer at least one attack of shingles in their lifetime. Particularly for older people, shingles and post-herpetic neuralgia can be very painful, prolonged and debilitating and may affect their ability to carry out simple daily activities, such as dressing and bathing.

About zoster vaccine (Shingrix)

Shingrix is approved for the prevention of herpes zoster (shingles) and for prevention of post herpetic neuralgia (prolonged nerve pain in the rash area) in people aged 50 years and older, and adults 18 years of age and older who are at increased risk of herpes zoster. The vaccination schedule consists of two doses, given several months apart, which both contain the vaccine and an adjuvant. An adjuvant is used to improve the body’s response to the vaccine.

Shingrix can be administered at the same time as unadjuvanted influenza and COVID-19 vaccines, except Nuvaxovid (supplied by Novavax) which is given with a 3 day gap to separate the novel adjuvants.

Why we’re proposing this

In July 2022, Pharmac notified that the Zostavax shingles vaccine was being discontinued by the supplier. We secured a short-term supply of Shingrix as an alternative vaccine for the prevention of shingles. Shingrix was listed in the Pharmaceutical Schedule from 1 August 2022 and is now the only zoster vaccine being distributed to vaccinators. This proposal would secure the ongoing supply of the Shingrix vaccine through a provisional agreement with GSK.

We continue to assess wider funding of Shingrix. Our clinical advisors, the Immunisation Advisory Committee, has recommended funding for Shingrix vaccine for a range of additional patient groups, including:

• people from 50 to 64 years of age
• people over 65 years of age who have received Zostavax at least 5 years previously
• Māori and Pacific peoples 60 years of age and over.

The proposals for people from 50 to 54 years of age and people over 65 years of age who have previously received Zostavax are currently an option for investment, meaning that it is something we would like to fund when we have available budget. We are still assessing the proposal for Māori and Pacific peoples 60 years of age and over.

We are also assessing and seeking further clinical advice about other groups that may benefit from Shingrix, including:

• people 18 years of age and over who are at risk of shingles because their immune system has reduced function
• people over 65 years of age who missed their zoster vaccination at 65 years of age while access to immunisation services or health case was reduced during the COVID-19 pandemic
• people over 65 years of age who are immunosuppressed and could not be vaccinated with Zostavax when they were 65 years of age.

More information about the assessment of funding for these groups, including links to the relevant clinical advice, can be found on the Application Tracker(external link).

Details about our proposal

Zoster vaccine (Shingrix) is currently funded for people who are 65 years of age. Shingrix requires two doses given 6 months apart. Both doses are be funded if the person being vaccinated is 65 when they receive their first dose.

There would be no changes made to the funding of Shingrix as a result of this proposal. The net price would reduce through a confidential net price and Shingrix would have subsidy and delisting protection until 28 February 2026.

Shingrix would remain listed with the “Xpharm” restriction. An Xpharm listing means that pharmacies cannot claim subsidy because Pharmac has made alternate distribution arrangements.

To provide feedback

Send us an email: vaccines@pharmac.govt.nz by 5pm on Tuesday 8 November 2022.

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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Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity. 

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