Palivizumab available for eligible patients at risk of RSV

Medicines Decision

Pharmac has authorised the use of palivizumab to prevent severe illness caused by the respiratory syncytial virus (RSV).

What we’re doing

We're pleased to let you know that Pharmac has authorised the use of palivizumab to prevent severe illness caused by the respiratory syncytial virus (RSV) for babies at high risk during the 2021 RSV season.

This decision was made due to the unprecedented rates of RSV this year, and is in response to an urgent request to fund palivizumab. This authorisation is valid until the end of the 2021 RSV season.

Earlier this year, Pharmac authorised the use of palivizumab for a small group of babies due to supply restrictions. Since then, we have widened access to palivizumab, enabling more babies to receive this medicine during this year.

We have received a funding application for the ongoing funding of palivizumab beyond this RSV season (2021).(external link)

We intend to assess this application for funding via our usual processes.

What does this mean for people?

Our clinical advice network has helped us to identify a group of babies at high risk of complications from RSV who would expect to benefit the most from palivizumab. These babies are able to receive palivizumab for the remainder of this RSV season (2021).

We have recently communicated the widened eligibility criteria directly with clinicans involved in the care of babies at high risk of complications from RSV. In response to some further feedback, we have amended this widened criteria for those babies with congenital heart disease to clarify the criteria intent and more appropriately target those at the highest risk.

We estimate that the eligibility criteria below may enable access to palivizumab for approximately 250 infants. Please note the changes from the recently communicated criteria are located in below section - changes to recently communicated eligibility criteria.

Eligibility criteria

  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. Patient has chronic lung disease; or
    3. Both:
      1. Patient has hemodynamically significant heart disease; and
      2. Any of the following:
        1. Patient has unoperated simple congenital heart disease with significant left to right shunt (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); or
        2. Patient has unoperated or surgically palliated complex congenital heart disease; or
        3. Patient has severe pulmonary hypertension (mean pulmonary artery pressure more than 45mmHg); or
        4. Patient has moderate or severe LV failure (LV Ejection Fraction less than 40%)

Note: Italicised wording to help clarify intent of criteria.

About palivizumab and RSV

RSV is a highly contagious, common respiratory virus that causes lung and respiratory tract infections.

Palivizumab is a humanized monoclonal antibody (IgG) directed against the antigens of the RSV and used to prevent complications from the RSV. The dose of palivizumab is 15 mg per kg and is given once a month for the expected peak duration of the RSV season.

Funding of palivizumab for future RSV seasons

At this stage palivizumab is authorised for use specifically for 2021 RSV season only.

We have received a funding application for the ongoing funding of palivizumab beyond this RSV season (2021).(external link)

We intend to assess this application for funding via our usual processes.

We remain open to considering additional variables (eg. ethnicity criteria) that could influence a persons risk of complications from circulating RSV. We intend to consider these further when palivizumab undergoes assessment via our usual processes for ongoing funding beyond the 2021 RSV season.

Changes to recently communicated eligibility criteria

Please note the changes from the recently communicated criteria are in bold (additions) and strikethrough (deletions).

Eligibility criteria

  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. Patient has chronic lung disease; or
    3. Both:
      1. Patient has hemodynamically significant heart disease; and
      2. Any of the following:
        1. Patient has unoperated simple congenital heart disease with significant left to right shunt (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); or
        2. Patient has unoperated or surgically stage 1 palliated complex congenital heart disease prior to cavopulmonary shunt surgery or complete repair; or
        3. Patient has severe pulmonary hypertension (mean pulmonary artery pressure more than 45mmHg); or
        4. Patient has moderate or to severe LV failure (LV Ejection Fraction less than 40% moderate or <20% severe)

Who we think will be most interested

  • Whānau or caregivers of babies born pre-term
  • DHBs and other organisations who deliver services and support for whānau or caregivers of babies born pre-term
  • Healthcare professionals who provide care for pre-term babies
  • Suppliers of products that prevent complications from RSV
  • Hospital pharmacists.

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.