Decision to fund palivizumab for infants and young children at high risk of respiratory syncytial virus during the COVID-19 pandemic

16 May 2022

Medicines Decision

Pharmac will fund palivizumab from 1 June 2022 until 31 December 2023.

What we’re doing

We're pleased to announce a decision to fund palivizumab (brand name Synagis) from 1 June 2022 until 31 December 2023 to prevent severe illness caused by respiratory syncytial virus (RSV) for infants and young children at high risk of RSV during the COVID-19 pandemic. This is through an agreement with AstraZeneca Pty Ltd (AstraZeneca).

We estimate this proposal will benefit approximately 470 infants and young children each year and will reduce the number of infants hospitalised from severe RSV-related illness.

Who we think will be most interested

Whānau or caregivers of infants or young children who are at high risk of RSV.
DHBs and other organisations who deliver services and support for whānau or caregivers of infants and young children at high risk of RSV.
Healthcare professionals who provide care for infants or young children at high risk of RSV
Hospital pharmacists.
Wholesalers and suppliers of products that reduce people’s risk of RSV.

About RSV

RSV is a highly contagious, common respiratory virus that causes lung and respiratory tract infections. RSV is the leading cause of hospitalisation for lower respiratory tract infections in infants. RSV is usually present in the community between May and October in New Zealand. This is called the RSV season.

Infants who were born early, or have certain risk factors, are more likely to develop severe RSV-related illnesses and need to be hospitalised.

We understand from our clinical advisors that there may be increased numbers of infants and children infected with RSV in the 2022 and 2023 RSV seasons. Our clinical advisors and experts working in DHB hospitals have told us COVID-19 may have changed the timing and impact of the RSV season, as well as the importance of keeping these vulnerable infants out of hospital during this time.

About palivizumab

Palivizumab is a humanised monoclonal antibody (IgG) that prevents severe respiratory illnesses caused by RSV. Palivizumab is not used to treat RSV once someone already has the infection.

Palivizumab is administered as an intramuscular injection by a healthcare professional. The dose of palivizumab is based on an infant’s weight, at a dose of 15 mg per kg. It is administered once a month during the expected RSV season.

We understand from our expert clinical advisors that palivizumab reduces the risk of an infant being hospitalised with RSV.

Why we’ve made this decision

In 2021, we were notified of a large increase in the number of RSV cases being reported, compared to previous years. This was considered to be a result of the COVID-19 pandemic. Pharmac authorised the use of palivizumab for a limited group of high-risk infants. This authorisation was valid until the end of the 2021 RSV season.

We received a funding application in July 2021 for the ongoing funding of palivizumab. We sought advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) in February 2022, as well as from the Respiratory Advisory Committee and DHB stakeholders.

PTAC recommended palivizumab should be funded for the next two RSV seasons with a high priority. PTAC and other experts told us that the size and impact of the upcoming RSV seasons are uncertain. They also told us that it is particularly important to prevent vulnerable infants from developing severe disease from RSV and potential complications, because of the spread of COVID-19 and its impact on the healthcare sector.

PTAC and other experts told us how the evidence indicates Māori and Pacific infants are at increased risk of hospitalisation from RSV, as are young children living in the community with severe diseases who need be ventilated. These were key considerations for the eligibility criteria.

You can read the record from PTAC in full on the Pharmac Application Tracker(external link).

We estimate that this decision will result in savings to DHBs from a reduction in hospitalisations. We understand this decision will reduce the risk of eligible infants developing RSV-related illness and potential complications. While this decision does require resource for administration, it reduces the chance that these infants will need to be hospitalised. Our clinical advisors told us resource reduction, from hospitalisations, would be important given the pressures on DHBs from COVID-19.

This decision does not prohibit Pharmac from considering widened access if new information becomes available that supports the use of palivizumab in other groups.

Any changes to the original proposal?

To enable potential funding as early as possible (from 1 June 2022), we undertook a shortened, targeted consultation with clinicians and DHBs. We circulated a consultation letter in early May to relevant clinicians and stakeholders who are involved in the management and/or treatment of infants at high risk of RSV-related illness and complications. We specifically sought feedback on implementation considerations and the proposed eligibility criteria.

We are really grateful for the feedback we received. Based on this feedback, we have added an additional criterion to the eligibility criteria, to enable young children less than 2 years of age with severe lung, airway, neurological or neuromuscular disease who require, community ventilatory support to access funded palivizumab.

We are also exploring the option of enabling access for the infants at highest risk prior to 1 June and the potential funding of a 50 mg vial pending available supply.

We received thoughtful and detailed feedback on the potential implementation of a funding decision for palivizumab and the associated resource that would be required. We will share this information with DHBs to support resource conversations to help ensure eligible infants can access funded palivizumab.

A summary of the feedback we received and our responses can be found at the end of this notification.

Detail about this decision

The following changes will occur in Section B and Part II of Section H of the Pharmaceutical Schedule.

Palivizumab inj 100 mg per ml, 1 ml vial will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 June 2022 to 31 December 2023 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand (Supplier)	Pack size	Price and subsidy
Palivizumab	Inj 100 mg per ml, 1 ml vial	Synagis (AstraZeneca Pty Ltd)	1	$1,700.00

A confidential rebate will apply to palivizumab (Synagis) that reduces the net price to the Funder. Synagis will have protection from delisting and subsidy reduction until 31 December 2023.

We intend to review the funding of palivizumab and RSV prophylaxis treatments prior to the 2024 RSV season.

Palivizumab will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule to include the preventive treatment for infants at high risk of RSV-related illness who meet the following criteria (additions from consultation feedback in bold):

Special Authority for Subsidy

Initial application (palivizumab for RSV for the 2022/2023 RSV seasons, in the context of the COVID-19 pandemic) only from a paediatrician. Approvals valid for 6 months for applications meeting the following criteria:

Either:

Infant was born in the last 2 years and has severe lung, airway, neurological or neuromuscular disease that requires community ventilation; or
Both:
1. Infant was born in the last 12 months; and
2. Any of the following:
  1. Patient was born at less than 28 weeks gestation; or
  2. Both:
    1. Patient was born at less than 32 weeks gestation; and
    2. Either:
      1. Patient has chronic lung disease; or
      2. Patient is Māori or any Pacific ethnicity; or
  3. Both:
    1. Patient has haemodynamically significant heart disease; and
    2. Any of the following:
      1. Patient has unoperated simple congenital heart disease with significant left to right shunt (see note a); or
      2. Patient has unoperated or surgically palliated complex congenital heart disease; or
      3. Patient has severe pulmonary hypertension (see note b); or
      4. Patient has moderate or severe LV failure (see note c)

Note:

a) Patient requires/will require heart failure medication, and/or patient has significant pulmonary hypertension, and/or patient will require surgical palliation/definitive repair within the next 3 months

b) Mean pulmonary artery pressure more than 45 mmHg

c) LV Ejection Fraction less than 40%

Renewal – (RSV prophylaxis for the 2022/2023 RSV seasons, in the context of COVID-19) only from a paediatrician. Approvals valid for 6 months for applications where the patient still meets initial criteria.

A similar restriction will apply in Part II of Section H of the Pharmaceutical Schedule.

The listing of palivizumab in Section B of the Pharmaceutical Schedule will be PCT only for claiming purposes. This means that only DHB hospitals will be able to make a subsidy claim.

We understand that supply of palivizumab may be limited for the first half of the 2022 RSV season, until approximately August 2022. We are working with the supplier and DHBs to ensure supply for all eligible infants.

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, and changes we have made after listening is set out below.

Theme	Comment
Support for the proposal
Support for the funding of palivizumab and eligibility criteria	We acknowledge the thoughtful responses that many people and organisations took the time to submit in support of the proposal.
Support for the specific targeting of Māori and Pacific infants via the eligibility criteria	We understand that Māori and Pacific infants are at increased risk from RSV from our clinical advisors and feedback we have received. We are pleased to be supporting improved health outcomes for Māori and Pacific infants who are at especially high risk from circulating RSV.
Changes to funding proposal
Concern that RSV is already circulating in the community and palivizumab should be funded prior to the 1 June 2022 start date.	Palivizumab will be listed from 1 June 2022, however we are currently exploring the option of enabling access to infants at highest risk prior to this date. We will provide an update should this be possible.
Request for ongoing funding to protect vulnerable infants and to support embedding of practice and sustainable infrastructure	This proposal is specifically for the funding of palivizumab in response to the COVID-19 pandemic, in line with the recommendation from our clinical advisors. We have proposed funding until 31 December 2023 in order to enable DHBs to plan beyond one year. We intend to review the funding of palivizumab and RSV prophylaxis treatments prior to the 2024 RSV season.
Request to fund the 50 mg vial to reduce wastage	We acknowledge that a smaller vial size would reduce wastage and are exploring the option of securing supply. We will provide an update if supply of a 50 mg vial presentation is secured.
Request to fund palivizumab for additional groups including: infants less than 24 months of age who require life-sustaining, community ventilatory support infants born at 29 weeks gestation infants who have been admitted to paediatric intensive care within the last two years	We received feedback from experts and advice from our Respiratory Advisory Committee that infants under the age of 2 who require ongoing community ventilation are at high risk from RSV, and we have amended the eligibility criteria to include this group. We acknowledge there is a wider group of infants who may also be expected to receive benefit from palivizumab. The criteria proposed are in line with the clinical advice received and are intended to target those at the highest risk of illness from circulating RSV. We would welcome additional evidence which supports the use of palivizumab in other groups. This would enable us to seek clinical advice on the potential clinical benefit of treatment and the health need for any additional groups. For infants who do not meet the proposed criteria and whose clinical circumstances could be considered exceptional or who meet the intent of the criteria, Pharmac’s exceptional circumstances framework (eg NPPA pathway or SA waiver) may be an appropriate option.
Implementation of the proposal
System barriers are likely to disproportionately disadvantage Māori and Pacific infants in accessing treatments	We acknowledge that there are other system barriers beyond whether a medicine is funded, that are outside Pharmac’s direct control. We are keen to support equitable access of palivizumab to infants and will be monitoring uptake. We will continue to engage with the sector, and to help identify ways we can support equitable access if required.
Request for palivizumab administration to be recorded on the National Immunisation Register	We are currently exploring this possibility with the Ministry of Health Immunisation team, and we will update relevant clinicians and DHB hospitals on this.
Concerns regarding the identification of eligible infants	We engaged early with relevant clinicians and DHB stakeholders as we developed this proposal in order to allow more time to identify eligible infants. We understand that there are systems in place to identify those eligible for palivizumab.
Indication that some DHBs would run monthly vaccination days or clinics in hospitals and/or develop a process to administer palivizumab in the community	We understand that planning and implementation of the funding of new medicines can take time and that the approach may vary between DHBs. The proposed listing would provide DHB hospitals with flexibility on how they administer palivizumab. We engaged with experts, relevant clinicians and DHB stakeholders as we developed this proposal, in order to support equitable implementation for all eligible infants. We intend to share the information we received during consultation with relevant DHB stakeholders to support discussions on medicine administration.

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.