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

8 December 2022

Medicines Decision

What are we doing?

We're pleased to announce a decision 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. It will also be funded for people aged 13 to 25 years who are entering into or in their first year of specified close-living situations. Catch-up programmes will also be funded for these groups.

We have also secured ongoing supply of the shingles vaccine (Shingrix) from 1 December 2022. There are no changes to the current funding of Shingrix.

Any changes to the original proposal?

These decisions were subject to a consultation letter dated 25 October 2022. There have been no changes to the original proposal.

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

We also received feedback requesting that meningococcal B vaccine be funded for more people. This funding decision includes all the population groups for meningococcal B that we have assessed and ranked as funding options on Pharmac’s Options for Investment list. We would welcome funding applications with supporting evidence for vaccinating wider groups.

We received feedback that people would also like the shingles vaccine funded for more people. Proposals to fund this vaccine for people from 50 to 64 years of age and for people over 65 years of age who previously received Zostavax are currently on the Options for Investment list, and remain under consideration as funding options. 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 immunocompromised, and people over 65 years of age who missed their zoster vaccination at 65 years of age.

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

Who we think will be most interested

Parents, caregivers and whānau of tamariki and rangatahi
Young people who live in specific institutional close-living situations
Secondary schools with boarding facilities, universities and other tertiary educational institutions, and 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 immunisations
Suppliers and wholesalers
Organisations with an interest in immunisation

Detail about this decision

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

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

Section I changes

The eligibility criteria for meningococcal B vaccine (Bexsero) will be amended in Section I of the Pharmaceutical Schedule from 1 March 2023 as follows (new criteria in bold, deletions in strikethrough):

Any of the following:

Three doses for children up to 12 months of age (inclusive) for primary immunisation; or
Up to three doses (dependent on age at first dose) for a catch-up programme for children from 13 months to 59 months of age (inclusive) for primary immunisation, from 1 March 2023 to 31 August 2025; or

Either:

Both:
Child is under one year of age; and
Any of the following:
1. 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
2. up to three doses for close contacts of meningococcal cases of any group; or
3. up to three doses for child who has previously had meningococcal disease of any group; or
4. up to three doses for bone marrow transplant patients; or
5. up to three doses for child pre- and post-immunosuppression*; or

3. Both:

Person is one year of age or over; and
Any of the following:
1. up to two 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. up to two doses for close contacts of meningococcal cases of any group; or
3. up to two doses for person who has previously had meningococcal disease of any group; or
4. up to two doses for bone marrow transplant patients; or
5. up to two doses for person pre- and post-immunosuppression*; or

4. Both:

a. Person is aged between 13 and 25 years (inclusive); and

b. Either:

i. Two doses 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; or

ii. Two doses for individuals who are currently living in boarding school hostels, tertiary education halls of residence, military barracks, or prisons, from 1 March 2023 to 28 February 2024.

*Immunosuppression due to corticosteroid or other immunosuppressive therapy must be for a period of greater than 28 days.

Section H (Hospital Medicines List) changes

The eligibility criteria for meningococcal B vaccine (Bexsero) will be amended in Part II of Section H of the Pharmaceutical Schedule from 1 March 2023 as follows (new criteria in bold, deletions in strikethrough):

Restricted

Initiation – Primary immunisation for children up to 12 months of age

Therapy limited to three doses

Either:

Three doses for children up to 12 months of age (inclusive) for primary immunisation; or
Up to three doses (dependent on age at first dose) for a catch-up programme for children from 13 months to 59 months of age (inclusive) for primary immunisation, from 1 March 2023 to 31 August 2025

Initiation – Infants under one year of age

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
up to three doses for close contacts of meningococcal cases of any group; or
up to three doses for child who or has previously had meningococcal disease of any group; or
up to three doses for bone marrow transplant patients; or
up to three doses for person pre- and post-immunosuppression*

Initiation – Person is one year of age or over

Any of the following:

up to two 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
up to two doses for close contacts of meningococcal cases of any group; or
up to two doses for person who has previously had meningococcal disease of any group; or
up to two doses for bone marrow transplant patients; or
up to two doses for person pre- and post-immunosuppression*

Initiation – Person is aged between 13 and 25 years (inclusive)

Therapy limited to two doses

Both

Person is aged between 13 and 25 years (inclusive); and
Either:
1. Two doses 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; or
2. Two doses for individuals who are currently living in boarding school hostels, tertiary education halls of residence, military barracks, or prisons, from 1 March 2023 to 28 February 2024.

*Immunosuppression due to corticosteroid or other immunosuppressive therapy must be for a period of greater than 28 days.

The 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 are still 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 will continue to be listed with the “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)will be updated to reflect the changes to eligibility and to set out the dose scheduling for meningococcal B vaccine.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback, our responses to the feedback received are set out below.

Meningococcal B vaccine consultation feedback:

Theme	Comment
*Support for the proposal to widen access to meningococcal B vaccine*
Support for the proposal. In particular it was noted that: Meningococcal disease has an inequitable impact on Māori and Pacific children Effective meningococcal vaccination of infants has the potential to eliminate ethnic inequalities in meningococcal disease in New Zealand The funding of this vaccine would save Māori and Pacific lives	We acknowledge the significant support for this proposal and the importance of meningococcal vaccination for tamariki and rangatahi. We appreciate the feedback on the positive impact that this decision will have on improving equity for Māori and Pacific people.
*Amendments to eligibility criteria*
Requests for further widened access for a range of additional groups: All people up to 16 years of age All people 13-25 years of age Ongoing funding for all children under 5 years of age Widen the funded close-living situations for 13-25 year olds beyond specific institutions, to include large household situations Longer time for the infant catch-up programme.	We note that this decision includes all the currently unfunded groups for meningococcal B vaccine that we have assessed for funding and ranked as a funding option on our Options for Investment list. We would welcome a funding application with supporting evidence for widened access to additional groups. The duration of the infant catch-up programme was set in consultation with the National Immunisation Programme, who advised that this duration would be required to ensure that children over 15 months of age would still be eligible for a catch-up dose at their 4-year old immunisation visit. We are open to considering an extension of the catch-up in the future if good meningococcal immunisation coverage rates of children under 5 years have not been achieved.
Request to fund meningococcal B earlier, from February 2023 to allow for vaccination of tertiary students before they enter halls of residence from mid-February.	We acknowledge that an earlier start date would provide earlier protection to eligible people, however the 1 March 2023 start date allows time for the supply of the large quantities of vaccine required to support the decision.
*Other vaccines – meningococcal ACWY*
Requests to widen access for meningococcal ACWY vaccine as well: Infant immunisation programme All people 13-25 years of age, regardless of their living situations.	A number of proposals for widened access to meningococcal ACWY vaccine are currently on the Options for Investment list. We would like to fund these, subject to available budget, and they remain under consideration for funding. These proposals can be viewed on the Application Tracker(external link) and include: Adolescents at 14 years of age Adolescents at 14 years of age with catch up for 5 to 21 years Adolescents at 14 years of age with catch up for 13 to 21 years Children at 1 year of age Children at 1 year of age with catch up for 1 to 4 years
*Pharmacist vaccinators, implementation and equity considerations*
Requests for meningococcal B to be available for administration by Pharmacists to reduce barriers to access and free up time for GPs and nurses.	We acknowledge the importance of reducing barriers to access and acknowledge the role pharmacist vaccinators currently have in administering some funded vaccines. We continue to discuss with Te Whatu Ora options for changes to the funding and distribution process and implementation of the immunisation programme that would allow pharmacists to administer Bexsero and other funded vaccines, in the future.
Some respondents offered suggestions for Pharmac to work with the Te Whatu Ora National Immunisation Programme for smooth implementation, including ensuring that Māori and Pacific people are given priority in the implementation plans.	Te Whatu Ora is responsible for the implementation of any funding decision relating to vaccines through the National Immunisation Programme. However, Pharmac staff work very closely with Te Whatu Ora staff to ensure the success of this programme and achieving equitable health outcomes for Māori and Pacific peoples is a priority for us. We will share the implementation suggestions received in consultation feedback with Te Whatu Ora and continue to work closely and collaboratively to support implementation of immunisation programmes.
Responses noted that meningococcal disease has an inequitable impact on Māori and Pacific children. In addressing this it is important to improve access to primary care and childhood immunisation services. Universal access supports equity but targeted implementation is still needed to support equity. Time limits work against equity, noting a higher proportion of Māori and Pacific children are immunised later than their milestone due dates. The proposed close-living situations do not include multi-generational or overcrowded households outside of formal institutions.	We acknowledge the concerns regarding Māori and Pacific children experiencing inequities in meningococcal disease. We will share the feedback about improving equity by targeted implementation for Māori and Pacific children with Te Whatu Ora, and will continue to work closely and collaboratively with them to support implementation of immunisation programmes. We acknowledge that time limited programmes may work against health equity, particularly where there are barriers to accessing health care or delays in routine immunisations. Pharmac uses time limited programmes in some circumstances, particularly where programmes are very large and/or high cost. We try to ensure that any time limited programmes run for enough time to give everyone the chance of getting immunised, while balancing the limited funding available for pharmaceuticals and vaccines. We consider that further widening the close-living situation criteria would best be assessed as a separate funding proposal. We will be seeking clinical advice about widened access options for close living situations and any inadvertent non-coverage of previous catch-up programmes for people who remain living in specified close living situations, across both meningococcal ACWY and meningococcal B vaccines.

Zoster vaccine (Shingrix) for the prevention of shingles

Who we think will be interested

People around 65 years of age
Vaccinators and other health care practitioners involved in immunisations
Te Whatu Ora hospitals
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

Detail about this decision

Shingrix will 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 a zoster vaccine.

There will be no changes to the current eligibility criteria for Shingrix at this time. The net price will reduce through a confidential net price and Shingrix will have subsidy and delisting protection until 28 February 2026.

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

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback, our responses to the feedback received are set out below.

Zoster (shingles) vaccine consultation feedback:

Theme	Pharmac Staff Comment
Most responses were supportive of the proposal.	We acknowledge the support from these respondents for the proposal.
Requests for further widened access for a range of additional groups: All people over 65 years of age People over 65 years of age who were not able to be vaccinated with Zostavax because they were immunocompromised Māori and Pacific people from the earlier age of 55 years People from 18 years of age who are immunocompromised People over 65 years of age who missed their zoster vaccination at 65 years of age while access to immunisation services or health care was reduced during the COVID-19 pandemic	Our clinical advisors have recommended wider funding of Shingrix for a range of additional groups, including: people from 50 to 64 years of age people over 65 years of age who received Zostavax at least five years previously Māori and Pacific peoples 60 years of age and over The proposals for people from 50 to 64 years of age and people over 65 years of age who have previously received Zostavax are currently on the Options for Investment list, and remain under consideration for funding. We are still assessing the proposal for Māori and Pacific people 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 immunocompromised 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 were immunosuppressed and could not be vaccinated with Zostavax when they were 65 years of age.
Limiting eligibility to people who are 65 years of age can disadvantage people who do not engage frequently with the health system.	We acknowledge that limiting programmes to a specific age cohort may work against health equity, particularly where there are barriers to accessing health care or delays in routine immunisations. Pharmac uses time limited programmes in some circumstances, particularly where programmes are high volume or high cost. We try to ensure that these programmes run for enough time to give everyone a chance of getting immunised, while balancing the limited funding available for pharmaceuticals and vaccines. As noted above, we are seeking further clinical advice about people who may benefit from widened access to zoster vaccine.

Theme

Pharmac Staff Comment

Most responses were supportive of the proposal.

We acknowledge the support from these respondents for the proposal.

Requests for further widened access for a range of additional groups:

All people over 65 years of age
People over 65 years of age who were not able to be vaccinated with Zostavax because they were immunocompromised
Māori and Pacific people from the earlier age of 55 years
People from 18 years of age who are immunocompromised
People over 65 years of age who missed their zoster vaccination at 65 years of age while access to immunisation services or health care was reduced during the COVID-19 pandemic

Our clinical advisors have recommended wider funding of Shingrix for a range of additional groups, including:

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

The proposals for people from 50 to 64 years of age and people over 65 years of age who have previously received Zostavax are currently on the Options for Investment list, and remain under consideration for funding. We are still assessing the proposal for Māori and Pacific people 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 immunocompromised
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 were immunosuppressed and could not be vaccinated with Zostavax when they were 65 years of age.

Limiting eligibility to people who are 65 years of age can disadvantage people who do not engage frequently with the health system.

We acknowledge that limiting programmes to a specific age cohort may work against health equity, particularly where there are barriers to accessing health care or delays in routine immunisations. Pharmac uses time limited programmes in some circumstances, particularly where programmes are high volume or high cost. We try to ensure that these programmes run for enough time to give everyone a chance of getting immunised, while balancing the limited funding available for pharmaceuticals and vaccines.

As noted above, we are seeking further clinical advice about people who may benefit from widened access to zoster vaccine.

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.