Palivizumab is currently funded through the COVID-19 budget. This proposal relates to the extension of funding from the 2024 RSV season onwards under the Combined Pharmaceutical Budget (CPB).
The headings in the following summary are based on our Factors for Consideration. We apply the factors to all our assessments.
General
Latest Clinical Recommendation: High – PTAC May 2023
Condition: Prevention of respiratory syncytial virus (RSV) among at-risk infants. Infants eligible to receive palivizumab are:
- Those born < 28 weeks gestational age (wGA)
- Those born 29-32 wGA who have chronic lung disease
- Those born 29-32 wGA who have haemodynamically significant heart disease
- Those born 29-32 wGA who are Māori or Pacific
Comparator: No prophylaxis, hospitalisation and care in the intensive care unit as required for severe infections.
Availability of existing alternatives: There are currently no treatments funded to prevent RSV.
Need
Health need of the person
8 (Moderate) for those who are infected
RSV is a common and highly contagious virus that primarily affects the respiratory system. RSV infections are most common during the autumn, winter, and early spring months.
RSV is especially concerning in infants, young children, older adults, and people with weakened immune systems. In healthy people, RSV infections generally result in mild cold-like symptoms, such as a runny nose, cough, sneezing, and a low-grade fever. However, in some cases, especially in vulnerable populations, RSV infections can lead to more severe respiratory problems, such as bronchiolitis and pneumonia. RSV is the leading cause of hospitalisation for lower respiratory tract infections (LRTIs) in infants (children aged less than 12 months) worldwide.
Health need of family, whānau and others
Hospitalisation (especially when prolonged), intensive care admission, and death due to RSV-related illness will have a significant impact on the infant’s family/whānau. Pokrzywinski et al. (Clin Pediatr (Phila). 2019;58:837-50)(external link) reported that caregivers of pre-term infants in the US, who were hospitalised with RSV, experience stress, poor health, and productivity loss at discharge. Even after hospitalisation caregivers may continue to experience an emotional impact, disruption of family routine, financial concerns, and medical concerns.
Māori Health Areas of Focus
Respiratory Health (Romaha Ora)
Māori health need
In February 2022 PTAC noted that respiratory disease inequitably impacts Māori and is one of Pharmac’s Hauora Arotahi (Māori health areas of focus). RSV-related illness and hospitalisation significantly and disproportionately impacts Māori infants born pre-term in their first year of life. These infants and their whānau experience a higher rate of RSV-related hospitalisation compared with European and other (non-Pacific) ethnicities, even after accounting for other factors, such as socioeconomic deprivation, (adjusted relative risk (RR) 3.64, 95% CI 2.27 to 5.85) (Grimwood et al. Epidemiol Infect. 2008;136:1333-41(external link)).
February 2022 PTAC Meeting Record [PDF, 531 KB]
Māori infants have a greater risk of pre-term birth compared with European infants (Edmonds et al. Int J Gynaecol Obstet. 2021;155:239-46)(external link).
From 2018–2022, there were 7,027 discharges under the ICD codes associated with RSV in infants (J121, J205, J210) overall. 2,708 discharges were for Māori. This represents 38.5% of hospitalisations, which is higher than the share of the age group < 2 years old who are Māori, ~29.9%.
The ICD codes will include cases caused by viruses other than RSV, however internal advice indicates that this is likely to be a small amount.
The relevant objective from Interim Government Policy Statement on Health 2022-2024 [PDF](external link) is 1.1 Māori will attain equitable health and wellbeing outcomes
In the last financial year, 37% of palivizumab units were dispensed to Māori.
Impact on population groups experiencing disparities
In February 2022, PTAC noted that RSV also disproportionately impacts Pacific infants born pre-term in their first year of life. The rate of RSV-related hospitalisation was also higher in Pacific children (RR 3.60, 95% CI: 2.14 to 6.06) compared with European or other ethnicities (Grimwood et al. Epidemiol Infect. 2008;136:1333-41(external link)).
February 2022 PTAC Meeting Record [PDF, 531 KB]
The Committee noted that living in an area of low socio-economic status (SES) (deprivation index 8 to 10) independently increased the risk of an RSV-associated hospitalisation in children (RR 1.3, 95% CI 1.0 to 1.6) (Prasad et al. Epidemiol Infect. 2019;147:e246(external link)).
From 2018–2022, there were 7,027 discharges under the ICD codes associated with RSV in infants (J121, J205, J210) overall. 1,179 discharges were for Pacific infants. This represents 16.8% of hospitalisations, which is line with the share of the age group < 2 years old who are Pacific, which is ~16.3%.
The ICD codes will include cases caused by viruses other than RSV, however internal advice indicates that this is likely to be a small amount.
The relevant objective from IGPS 2022-24 is 1.2 Pacific families are thriving in Aotearoa New Zealand.
In the last financial year, 12% of palivizumab units were dispensed to Pacific.
Government condition priorities
Infectious diseases
Health benefits
Health benefit to the person
Palivizumab is a prophylactic treatment given to infants at high risk of RSV to reduce the incidence and severity of RSV infections. Evidence shows that, among these infants, palivizumab prophylaxis reduces the likelihood of hospitalisation by ~56% (The IMpact-RSV Study Group. Pediatrics 1998;102(3 Pt 1):531-7(external link), Feltes et al. 2003; Journ. Pediatrics 143(4):532-40(external link), Garegnani et al. Cochrane Database Syst Rev. 2021;11(11):CD013757(external link)).
In 2021, prior to palivizumab funding, 2,861 infants were hospitalised under the ICD codes associated with RSV. In 2022, after palivizumab funding, there were 1,804 hospitalisations, a decrease of 36.9%. This should be interpreted with caution, because:
- there is large variability in the number of these hospitalisations year to year
- there may be other factors influencing the number of hospitalisations.
Health-related quality of life (HRQOL) is difficult to measure for infants, but it is assumed that infants who avoid hospitalisation have improved HRQOL. There is limited evidence of a reduction in mortality for infants who receive palivizumab (Garegnani et al. Cochrane Database Syst Rev. 2021;11(11):CD013757(external link)).
Māori and Pacific infants born 29–32 weeks gestational age are at higher risk of severe RSV infection. The main trials were conducted overseas and did not include infants from these ethnic groups. However, there is no evidence to indicate that overseas evidence would not be applicable to the New Zealand population.
The undiscounted quality adjusted life year (QALY) gain from palivizumab treatment is estimated to be 0.009.
More about how Pharmac calculates a QALY [PDF, 3.4 MB]
Health benefit to family, whānau, others
The parents of infants who avoid hospitalisation due to receiving palivizumab would have improved HRQOL, particularly relating to the anxiety and depression dimension of health. This is particularly significant because:
- of the age at which infants contract RSV
- of the vulnerability of infants who are at higher risk of RSV
- whānau of infants in this group have already experienced a lot of time supporting their child in hospital or other health care.
Consequences for health system
Palivizumab prevents hospitalisations and outpatient events, reducing pressure on the health system. However, palivizumab is administered through an intramuscular (IM) injection. Our dispensing data from 2022 indicates that infants have 3.4 injections on average every RSV season. The reduced burden on the health system from the availability of palivizumab would be offset, to some extent, by the need to administer palivizumab for these individuals.
Some infants who are admitted to the paediatric intensive care unit (ICU) need transport to hospital by aircraft or helicopter (retrievals), which costs about $40,000–$50,000 per retrieval. Because palivizumab reduces hospitalisations and ICU admissions, it is expected that it would reduce the health system costs associated with retrievals.
Government system priorities
Child wellbeing | Prevention
Costs and savings
Health costs to the person
None to the infant - see below for costs to the family.
Health costs to family, whānau, others
Palivizumab is administered by intramuscular (IM) injection, so parents would need to take their child to receive the injection, incurring time and travel costs. For those living rurally and those in lower socioeconomic groups, these costs are likely to be less affordable. However, these groups would also be more severely affected if their child was hospitalised, since they would need to travel and/or take time off work.
Costs to rest of health sector, per person
There would be a cost to the health system associated with the administration of palivizumab. This is estimated to be less than the savings from reduced hospitalisation and ICU admissions, outpatient visits, and retrievals. The saving to the rest of the health sector is estimated to be $426 per person. This does not include the pharmaceutical cost.
Suitability
Impact on use by the person
None, since palivizumab would be administered by another person.
Impact on use by others
Parents and caregivers would need to travel to receive palivizumab each month, since palivizumab is administered monthly at the hospital or a clinic.
Impact on health workforce
The additional administration requirements are likely to be outweighed by the reduced hospitalisations resulting from palivizumab prophylaxis.
Cost-effectiveness
Cost-utility analysis (CUA) notes
The cost-effectiveness of palivizumab for the prevention of RSV is estimated to be very low. This is due to several factors.
- The high pharmaceutical cost of multiple treatments for each infant.
- Many infants who would not be infected receive treatment with no incremental benefit, due to the preventative nature of treatment.
- Palivizumab does not have any health benefits beyond the period of infection and recovery. There is no evidence that it reduces the risk of mortality or long-term effects of infection (sequelae). As such, the HRQOL benefit is limited to the period of infection and recovery, which is estimated to be ~45 days.
