Influenza vaccine for 2018 season

Medicines

Decision

We’re pleased to announce a quadrivalent influenza vaccine will be supplied for the 2018 influenza season. A quadrivalent influenza vaccine provides protection against four strains of influenza (two Influenza A and two Influenza B strains).

What we’re doing

We’re pleased to announce a quadrivalent influenza vaccine will be supplied for the 2018 influenza season. A quadrivalent influenza vaccine provides protection against four strains of influenza (two Influenza A and two Influenza B strains).

This was the subject of a previous notification letter dated 5 August 2016, detailing that Mylan EPD would be the funded influenza vaccine supplier for the 2017, 2018 and 2019 seasons and would supply a quadrivalent influenza vaccine in the first full influenza season following its approval by Medsafe.

The funded influenza vaccine details for the 2018 season will be as follows:

  • The eligibility criteria for the 2018 season are the same as last year (i.e. people 65 years of age or over and other individuals at high risk of contracting influenza); however, this year there will be two funded vaccines to cover different age ranges of eligible people. Full eligibility criteria are listed in the Details section below. 
  • The following quadrivalent vaccines will be listed in Section I and Part II of Section H of the Pharmaceutical Schedule from 1 March 2018 under the eligibility criteria set by PHARMAC:
    • Influvac Tetra for eligible people aged 3 years and over.
    • Fluarix Tetra will be listed for eligible children aged 6 months to 35 months.
  • Influvac (trivalent vaccine) will be delisted from Section I and Part II of Section H of the Pharmaceutical Schedule from 1 March 2018.

Why we're doing this?

This decision implements changes for the 2018 influenza season that were notified in 2016.  The 2016 notification letter outlined that Influvac Tetra would have sole supply status for the first full influenza season following its approval by Medsafe.

Influvac Tetra gained Medsafe approval in late 2017, however only for use in people aged 3 years and over. To ensure a Medsafe approved quadrivalent influenza vaccine is available for children aged under 3 years, Mylan EPD will source and supply Fluarix Tetra (a GSK quadrivalent vaccine) at the same price, specifically for use in this age group. 

Fluarix Tetra has Medsafe approval for use in individuals aged from 6 months to adult, but will only be funded for use in children aged 6 months to 35 months. To indicate this, the listing of Fluarix Tetra will include a reference to paediatric quadrivalent vaccine.

Who we think will be most interested

This decision will likely be of most interest to:

  • People who are eligible for funded influenza vaccination, including people 65 years and over, and individuals who are at high risk of contracting influenza.
  • Doctors in general practice, infectious disease specialists, geriatricians, public health services, practice nurses, vaccinators, pharmacist vaccinators and paediatricians.
  • DHBs, rest homes and retirement villages, organisations with an interest in immunisation.
  • Suppliers of influenza vaccines.

Details about this decision

From 1 March 2018, there will be two quadrivalent influenza vaccines listed for different eligible age groups. Influvac Tetra and Fluarix Tetra quadrivalent influenza vaccines will contain the antigens specified by the World Health Organisation for the 2018 Southern Hemisphere influenza season.

Influvac (trivalent vaccine) from previous influenza seasons will be delisted from Section I and Part II of Section H of the Pharmaceutical Schedule from 1 March 2018.

A confidential rebate will apply to both Influvac Tetra and Fluarix Tetra.

For people 3 years and over

Influvac Tetra will be listed in Section I (National Immunisation Schedule) and Part II of Section H of the Pharmaceutical Schedule as follows:

Chemical and presentation

Brand

Pack size

Subsidy and price (ex-man. ex. GST)

Influenza vaccine inj 60 mcg in 0.5 ml syringe (quadrivalent vaccine)

Influvac Tetra

10

$90.00

People 65 years and over and pregnant women will continue to have the option of getting a funded flu vaccine from their general practice or their community pharmacies.

Sole supply will not apply to Influvac Tetra due to listing of an alternative vaccine for children under 3 years.

Influvac Tetra will be listed in Section I and Part II of Section H of the Pharmaceutical Schedule with the following eligibility criteria (changes from current criteria in bold):

For children aged 6 months to 35 months

Fluarix Tetra will be listed in Section I (National Immunisation Schedule) and Part II of Section H of the Pharmaceutical Schedule as follows:

Chemical and presentation

Brand

Pack size

Subsidy and price (ex-man. ex. GST)

Influenza vaccine inj 60 mcg in 0.5 ml syringe (paediatric quadrivalent vaccine)

Fluarix Tetra

1

$9.00

Fluarix Tetra (paediatric quadrivalent vaccine) will be available as a single dose pack.

Fluarix Tetra (paediatric quadrivalent vaccine) will be subject to the XPHARM restriction in Section I of the Pharmaceutical Schedule, which means that pharmacists will not be able to administer and claim subsidies for this paediatric vaccine. These patients are not currently funded in the community pharmacy setting. 

Fluarix Tetra will be listed in Section I and Part II of Section H of the Pharmaceutical Schedule with the following eligibility criteria (changes from current criteria in bold):

Section I (Community)

a) Only on a prescription

b) No patient co-payment payable

c) INFLUENZA VACCINE – people 3 years and over

A) is available each year for patients aged 3 years and over who meet the following criteria, as set by PHARMAC:

a) all people 65 years of age and over; or

b) people under 65 years of age who:

i) have any of the following cardiovascular diseases:

a) ischaemic heart disease, or

b) congestive heart failure, or

c) rheumatic heart disease, or

d) congenital heart disease, or

e) cerebro-vascular disease; or

ii) have either of the following chronic respiratory diseases:

a) asthma, if on a regular preventative therapy, or

b) other chronic respiratory disease with impaired lung function; or

iii) have diabetes; or

iv) have chronic renal disease; or

v)  have any cancer, excluding basal and squamous skin cancers if not invasive; or

vi) have any of the following other conditions:

a) autoimmune disease, or

b) immune suppression or immune deficiency, or

c) HIV, or

d) transplant recipients, or

e) neuromuscular and CNS diseases/disorders, or

f) haemoglobinopathies, or

g) are children on long term aspirin, or

h) have a cochlear implant, or

i) errors of metabolism at risk of major metabolic decompensation, or

j) pre and post splenectomy, or

k) down syndrome, or

vii) are pregnant; or

c) children aged four years or less (but over three years) who have been hospitalised for respiratory illness or have a history of significant respiratory illness;

d) people under 18 years of age living in the Seddon/Ward and rural Eastern Marlborough region (within the Nelson Marlborough District Health Board) and Kaikoura and Hurunui areas (within the Canterbury District Health Board).

e) people under 18 years of age who have been displaced from their homes in Edgecumbe and the surrounding region;

Unless meeting the criteria set out above, the following conditions are excluded from funding:

a) asthma not requiring regular preventative therapy,

b) hypertension and/or dyslipidaemia without evidence of end-organ disease.

B) Contractors will be entitled to claim payment from the Funder for the supply of influenza vaccine to patients eligible under the above criteria pursuant to their contract with their DHB for subsidised immunisation, and they may only do so in respect of the influenza vaccine listed in the Pharmaceutical Schedule. 

C) Contractors may only claim for patient populations within the criteria that are covered by their contract, which may be a sub-set of the population described in paragraph A above.

Section H (DHB Hospitals)

Restricted
Initiation – People over 65

The patient is 65 years of age or over.

Initiation – cardiovascular disease for patients 3 years and over

Any of the following:

  1. Ischaemic heart disease; or
  2. Congestive heart failure; or
  3. Rheumatic heart disease; or
  4. Congenital heart disease; or
  5. Cerebro-vascular disease.

Note: hypertension and/or dyslipidaemia without evidence of end-organ disease is excluded from funding.

Initiation – chronic respiratory disease for patients 3 years and over

Either:

  1. Asthma, if on a regular preventative therapy; or
  2. Other chronic respiratory disease with impaired lung function.

Note: asthma not requiring regular preventative therapy is excluded from funding.

Initiation – Other conditions for patients 3 years and over

Any of the following:

  1. Any of the following:

1.1 Diabetes; or

1.2 chronic renal disease; or

1.3 Any cancer, excluding basal and squamous skin cancers if not invasive; or

1.4 Autoimmune disease; or

1.5 Immune suppression or immune deficiency; or

1.6 HIV; or

1.7 Transplant recipient; or

1.8 Neuromuscular and CNS diseases/ disorders; or

1.9 Haemoglobinopathies; or

1.10 Is a child on long term aspirin; or

1.11 Has a cochlear implant; or

1.12 Errors of metabolism at risk of major metabolic decompensation; or

1.13 Pre and post splenectomy; or

1.14 Down syndrome; or

1.15 Is pregnant; or

1.16 Is a child aged four or less (but over three years) who has been hospitalised for respiratory illness or has a history of significant respiratory illness; or

  1. Patients in a long-stay inpatient mental health care unit orwho are compulsorily detained long-term in a forensic unit within a DHB hospital; or
  2. People under 18 years of age living in the Seddon/Ward and rural Eastern Marlborough region (within the Nelson Marlborough District Health Board) and Kaikoura and Hurunui areas (within the Canterbury District Health Board); or
  3. People under 18 years of age who have been displaced from their homes in Edgecumbe and the surrounding region.

Section I (Community)

INFLUENZA VACCINE child aged 6 months to 35 months – [Xpharm]

A) is available each year for patients aged 6 months to 35 months who meet the following criteria, as set by PHARMAC:

i) have any of the following cardiovascular diseases:

a) ischaemic heart disease, or

b) congestive heart failure, or

c) rheumatic heart disease, or

d) congenital heart disease, or

e) cerebro-vascular disease; or

ii) have either of the following chronic respiratory diseases:

a) asthma, if on a regular preventative therapy, or

b) other chronic respiratory disease with impaired lung function; or

iii) have diabetes; or

iv) have chronic renal disease; or

v)  have any cancer, excluding basal and squamous skin cancers if not invasive; or

vi) have any of the following other conditions:

a) autoimmune disease, or

b) immune suppression or immune deficiency, or

c) HIV, or

d) transplant recipients, or

e) neuromuscular and CNS diseases/disorders, or

f) haemoglobinopathies, or

g) on long term aspirin, or

h) have a cochlear implant, or

i) errors of metabolism at risk of major metabolic decompensation, or

j) pre and post splenectomy, or

k) down syndrome, or

vii) have been hospitalised for respiratory illness or have a history of significant respiratory illness;

viii) are living in the Seddon/Ward and rural Eastern Marlborough region (within the Nelson Marlborough District Health Board) and Kaikoura and Hurunui areas (within the Canterbury District Health Board).

ix) have been displaced from their homes in Edgecumbe and the surrounding region;

Unless meeting the criteria set out above, the following conditions are excluded from funding:

a) asthma not requiring regular preventative therapy,

b) hypertension and/or dyslipidaemia without evidence of end-organ disease.

B) Doctors are the only Contractors entitled to claim payment from the Funder for the supply of influenza vaccine inj 60 mcg in 0.5 ml syringe (paediatric quadrivalent vaccine) to patients eligible under the above criteria for subsidised immunisation and they may only do so in respect of the influenza vaccine listed in the Pharmaceutical Schedule.

Section H (DHB Hospitals)

Restricted

Initiation – cardiovascular disease for patients aged 6 months to 35 months

Any of the following:

1 Ischaemic heart disease; or

2 Congestive heart failure; or

3 Rheumatic heart disease; or

4 Congenital heart disease; or

5 Cerebro-vascular disease.

Note: hypertension and/or dyslipidaemia without evidence of end-organ disease is excluded from funding.

Initiation – chronic respiratory disease for patients aged 6 months to 35 months

Either:

1 Asthma, if on a regular preventative therapy; or

2 Other chronic respiratory disease with impaired lung function.

Note: asthma not requiring regular preventative therapy is excluded from funding.

Initiation – Other conditions for patients aged 6 months to 35 months

Any of the following:

1 Any of the following:

1.1 Diabetes; or

1.2 chronic renal disease; or

1.3 Any cancer, excluding basal and squamous skin cancers if not invasive; or

1.4 Autoimmune disease; or

1.5 Immune suppression or immune deficiency; or

1.6 HIV; or

1.7 Transplant recipient; or

1.8 Neuromuscular and CNS diseases/ disorders; or

1.9 Haemoglobinopathies; or

1.10 Is a child on long term aspirin; or

1.11 Has a cochlear implant; or

1.12 Errors of metabolism at risk of major metabolic decompensation; or

1.13 Pre and post splenectomy; or

1.14 Down syndrome; or

1.15 Child who has been hospitalised for respiratory illness or has a history of significant respiratory illness; or

2 Child is living in the Seddon/Ward and rural Eastern Marlborough region (within the Nelson Marlborough District Health Board) and Kaikoura and Hurunui areas (within the Canterbury District Health Board); or

3 Child has been displaced from their home in Edgecumbe and the surrounding region.

Implementation and supply

The Ministry of Health is responsible for the implementation of changes to the National Immunisation Schedule and PHARMAC will work closely with it to support these changes for the 2018 seasonal influenza vaccine programme.

Stock of the seasonal influenza vaccine is typically available from early March until 31 December each year.

The exact start date for the 2018 seasonal influenza vaccination programme will be notified by the Ministry of Health in due course. The Fluarix Tetra vaccine for children under 3 years is likely to be available from mid-April 2018. 



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