Proposal for the supply of influenza vaccine

Medicines

Consultation Closed

Following a Request for Proposals (RFP) for the supply of influenza vaccine, issued on 3 February 2016, PHARMAC is seeking feedback on a provisional agreement with BGP Products Pty. Ltd

Following a Request for Proposals (RFP) for the supply of influenza vaccine, issued on 3 February 2016, PHARMAC is seeking feedback on a provisional agreement with BGP Products Pty. Ltd (trading as Mylan EPD) to list an influenza vaccine in the Pharmaceutical Schedule for the 2017, 2018, and 2019 influenza seasons.

In summary, this proposal would result in:

  • Influvac being 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 being awarded to Mylan EPD, for its brand(s) of influenza vaccine.
  • A change from the trivalent vaccine (Influvac) to the quadrivalent vaccine (Influvac Tetra) from the first full influenza season following market approval by Medsafe for Influvac Tetra.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 4 pm, Monday, 20 June 2016 to:

Christine Chapman
Senior Therapeutic Group Manager
PHARMAC
PO Box 10254
Wellington 6143

Email: christine.chapman@pharmac.govt.nz

Fax: 04 460 4995

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.

Details of the proposal

The proposal would result in the following brand of influenza vaccine being listed on the Pharmaceutical Schedule from 1 January 2017:

Chemical Presentation Brand Pack size Price and subsidy
Influenza vaccine Inj 45 mcg in 0.5 ml syringe Influvac 10 $90.00
  • Influvac would contain the antigens specified by the World Health Organization for the relevant Southern Hemisphere influenza season.
  • Influvac Tetra would be listed on the Pharmaceutical Schedule for the first full influenza season following approval by Medsafe. This is anticipated to be the 2018 season. Influvac would be delisted at the time of listing Influvac Tetra.
  • A confidential rebate would apply to Influvac and Influvac Tetra.
  • Community sole supply status would be awarded to Mylan EPD, for its brand(s) of influenza vaccine for the 2017, 2018, and 2019 influenza seasons.
  • All other brands of influenza vaccine would be de-listed from the Pharmaceutical Schedule from 1 January 2017.

Eligibility criteria

Influenza vaccine would 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, would remain largely unchanged, as follows (the proposed amendments are shown in strike through):

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 the following cardiovascular diseases:

1) ischaemic heart disease,

2) congestive heart disease,

3) rheumatic heart disease,

4) congenital heart disease, or

5) cerebo-vascular disease; or

ii) have 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, 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).

It is proposed to remove the criteria relating to individual DHBs funding influenza vaccination over and above the listed criteria.

Distribution and promotional activities

Influenza vaccines would be available for distribution early in each influenza season as has been the case in the past three years.

Mylan EPD would liaise with the National Influenza Strategy Group (NISG) with respect to promotional activities related to influenza vaccine.

Background

On 3 February 2016, PHARMAC released an RFP for influenza vaccine. Proposals sought were for the 2017, 2018 and 2019 influenza seasons, and suppliers were asked to submit proposals for one or more of the following:

  • a two supplier arrangement, as has been the case in the past with one supplier delivering a fixed volume of 250,000 doses and the other supplier delivering sufficient product to cover the rest of the market;
  • sole supply with one supplier supplying the entire market; or
  • a fixed volume supply which would have enabled any number of suppliers to be involved in the market.

The RFP allowed for proposals to be for the supply of trivalent vaccines, quadrivalent vaccines or an arrangement whereby trivalent vaccines were supplied for the first one or two seasonal campaigns, followed by the supply of quadrivalent vaccines.

BGP Products Pty. Ltd has been under contract for supply of influenza vaccine to the New Zealand market for the 2014, 2015 and 2016 seasons and has supplied approximately 750,000 doses in each of seasons. These doses have been used in both the publicly funded and private markets.

In early 2013 the Immunisation Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) was formed. The Immunisation Subcommittee members have expertise in adult and childhood immunisations, and the role of the Subcommittee is to provide recommendations to PHARMAC (via PTAC) on which products should be funded and the appropriate funded criteria.

Since 2013 the funded criteria for influenza vaccine have been widened by PHARMAC to include a number of new indications in both the community and hospital setting.

To maintain national consistency of eligibility for funded influenza vaccination, applications for variations on the current criteria must be sent to PHARMAC. PHARMAC will generally seek advice and recommendations on these applications from the Immunisation Subcommittee and/or PTAC.

Information about how to submit a funding application is available on the PHARMAC website.