Agreement for supply of influenza vaccine approved

5 August 2016

Medicines Decision

PHARMAC is pleased to announce the approval of an agreement with BGP Products Pty Ltd (trading as Mylan EPD) for the supply of influenza vaccine for the 2017, 2018 and 2019 influenza seasons.

This was the subject of a consultation letter dated 2 June 2016.

The decision is as consulted on. In summary, the effect of this decision is that:

Influvac will continue to be listed in Section H and Section I of the Pharmaceutical Schedule from 1 January 2017 under the eligibility criteria set by PHARMAC.
Community Sole Supply Status has been awarded to Mylan EPD for its brands of influenza vaccine from 1 February 2017.
There will be a change from the trivalent vaccine (Influvac) to the quadrivalent vaccine (Influvac Tetra) from the first full influenza season following Medsafe approval of Influvac Tetra.

Details of the decision

Influvac will contain the antigens specified by the World Health Organization for the relevant Southern Hemisphere influenza season.
Influvac Tetra (quadrivalent vaccine) will be listed on the Pharmaceutical Schedule for the first full influenza season following approval by Medsafe at the same price as Influvac (trivalent vaccine). This is anticipated to be the 2018 season. Influvac will be delisted at the time of listing Influvac Tetra.
A confidential rebate will apply to Influvac and Influvac Tetra.
Community Sole Supply Status has been awarded to Mylan EPD for its brands of influenza vaccine for the 2017, 2018, and 2019 influenza seasons.
The other brand of influenza vaccine (Fluarix) will be delisted from the Pharmaceutical Schedule at a date to be determined.

Eligibility criteria

Influenza vaccine will be subsidised for eligible patients for the period of the funded influenza season each year. The exact start and end dates for each season will be notified each year.

The current eligibility criteria, as described in Section I of the Pharmaceutical Schedule, remain largely unchanged, with the only change being that the criteria relating to individual DHBs funding influenza vaccination over and above the other listed criteria will be removed from 1 January 2017, as follows (deletions are shown in strikethrough):

A) is available each year for patients who meet the following criteria, as set by PHARMAC:

a) all people 65 years of age and over;
b) people under 65 years of age who

i) have any of the following cardiovascular diseases:

1) ischaemic heart disease, or
2) congestive heart disease, or
3) rheumatic heart disease, or
4) congenital heart disease, or
5) cerebo-vascular disease; or

ii) have either of the following chronic respiratory diseases:

1) asthma, if on a regular preventative therapy, or
2) 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 in 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 and under who have been hospitalised for respiratory illness or have a history of significant respiratory illness.

Unless meeting the criteria 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 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.

~~C) Individual DHBs may fund patients over and above the above criteria. The claiming process for these additional patients should be determined between the DHB and Contractor.~~

DC) Stock of the seasonal influenza vaccine is typically available from February until late July with suppliers being required to ensure supply until at least 30 June. Exact start and end dates for each season will be notified each year.

In addition to the above criteria, patients who are compulsorily detained long-term in a forensic unit within a DHB hospital are also eligible for funded influenza vaccination (as per the Section H restriction).

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 20 June 2016 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme	Comment
A number of responders requested the removal of XPHARM to enable pharmacists to provide influenza vaccinations to eligible patients.	PHARMAC is keen to develop the ability for pharmacies to initiate subsidised access to certain pharmaceuticals such as influenza vaccine; however, we note that removal of XPHARM would not enable pharmacists access to subsidy claims. To enable this to happen there needs to be changes to the Community Pharmacy Services Agreement (CPSA, which is currently being negotiated), and to the Ministry of Health’s payment system and the Pharmaceutical Schedule rules. We understand that the Ministry is working on changes to the payment system. PHARMAC will subsequently work on changes to the Schedule rules which would enable pharmacists to provided funded influenza vaccinations. In April 2016 PHARMAC wrote to all DHBs explaining how they could enable pharmacists in their DHB to provide influenza vaccination to eligible patients for the 2016 season. If the necessary changes have not been made prior to the 2017 season PHARMAC would extend the allowance to the 2017 season.
A number of DHBs raised concerns about removing criterion C – the criterion allowing DHBs to use the influenza vaccine outside Pharmaceutical Schedule rules.	As criterion C stands, it enables inequitable funding of influenza vaccination across the country. To maintain national consistency of eligibility for funded influenza vaccination, applications for variations on the current criteria should be sent to PHARMAC. PHARMAC will generally seek advice and recommendations on these applications from the Immunisation Subcommittee and/or PTAC. An example of this would be the funding of people under the age of 18 within the boundaries of the Canterbury District Health Board. This was brought into place following the earthquakes to help reduce the possible workload on primary healthcare. That makes sense for the exemption to be with one DHB. Other examples are where some DHBs fund vaccination of parents of children in paediatric intensive care facilities. This would be something that should be addressed on a national level.
Two responders requested information on vaccine efficacy of Influvac Tetra.	The Influvac Tetra vaccine is not yet registered in New Zealand. Information on this product would be publically available after that time.
A number of responders requested widening access to influenza vaccine for a number of groups: parents and siblings of at risk children; patients living with a mental health condition who are compulsorily detained under the Mental Health Act in a DHB hospital. Children with chronic liver disease All children under 5 years Patients who have previously had rheumatic fever Parents and siblings of children undergoing chemotherapy	In December 2015 PHARMAC received a Schedule funding application from the Paediatric Society of New Zealand regarding widening access to influenza vaccine for family members of high-risk paediatric patients. A further submission from Canterbury and West Coast DHBs for this group was received in February 2016. These applications were considered by the Immunisation Subcommittee at its May 2016 meeting. Minutes are not yet finalised and will be provided to the applicant when available and then published. In March 2016 PHARMAC received a funding application from Waitemata DHB to widen access to influenza vaccine for people living with a mental health condition who are admitted to a long-stay inpatient mental health care unit. This proposal was considered by the Immunisation Subcommittee at its May 2016 meeting. Minutes are not yet finalised and will be provided to the applicant when available and then published. PHARMAC has not received funding applications for children with chronic liver disease or for all children under 5 years but we would welcome these.
One responder was supportive of the proposal as long as Influvac is safe to use in children and pregnancy and this is stated in Medsafe datasheet.	The currently listed Influvac is registered for use in infants as young as 6 months old and for use in pregnancy. PHARMAC will not list the quadrivalent influenza vaccine Influvac Tetra until it has been registered by Medsafe and confirmed to cover the same range of use as the trivalent vaccine.
One responder requested timely responses to information required following cold chain breaches.	PHARMAC staff will follow this up with the supplier.
Some responders considered there may be a risk with Sole Supply.	PHARMAC has agreed with the supplier that volumes of vaccine will be supplied from separate batches at discreet intervals to reduce the effect a failure of any one batch may have. BGP has had an excellent supply record over the past three years with Influvac being the first influenza vaccine to arrive in New Zealand each year. The agreement with the supplier contains obligations relating to continuity of supply.
Two responders questioned if it is usual to award Sole Supply for three years.	Sole Supply periods of three years are normal practice. All PHARMAC’s annual tenders and the majority of PHARMAC’s Requests for Proposals include up to three years of Sole Supply.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz.