Changes to funding of haemophilia treatments
Recombinant factor VIII (rFVIII) plays an essential role in helping blood to clot in people with haemophilia A.
In New Zealand, there are three brands of rFVIII funded for people with haemophilia. These brands are Xyntha (supplied by Pfizer), Kogenate FS (supplied by Bayer) and Advate (supplied by Baxalta).
PHARMAC has recently changed the way brands of rFVIII are funded so these treatments can continue to be available for people that need them.
From 1 September 2015 Xyntha (Pfizer) is the preferred brand of rFVIII. The other two brands will continue to be funded for people, via application to a Haemophilia Treatments Panel administered by PHARMAC.
This approach is similar to those used in other countries, including the UK and Australia.
A six-month changeover period started on 1 September 2015.
What are the changes?
- Xyntha (Pfizer) will have Preferred Brand Status. It is the first treatment choice for people needing rFVIII. This means most people that need rFVIII will use Xyntha.
- Kogenate FS (Bayer) will have Second Brand Status. This means if Xyntha is unsuitable for a patient, specialists can apply for funded access to Kogenate.
- Advate (Baxalta) will have Rare Clinical Circumstances Brand Status. This means if Xyntha or Kogenate are unsuitable for a patient, specialists can apply for funded access to Advate.
- Applications for Kogenate and Advate will be made to the Haemophilia Treatments Panel that is being established to assess applications for funded access to those brands.
Why is the brand changing?
PHARMAC has reached an agreement with the suppliers of rFVIII that will achieve significant savings. Savings are important, because they enable medicines or other health services to be purchased to provide benefit to more New Zealanders.
Who is on the Haemophilia Treatments Panel?
The Haemophilia Treatments Panel is made up of clinicians (doctors and nurses) who treat people with haemophilia in New Zealand, and is chaired by a senior clinician from another clinical specialty. The Panel is administered and funded by PHARMAC, and determines funded access to Kogenate FS and Advate for people where Xyntha may not be suitable.
When will the changes occur?
The changes started on 1 September 2015. There will be a six-month transition period through to 29 February 2016 to enable people to safely change their treatment if required.
What will happen during the change?
Haemophilia treatment centres will contact people who are using Kogenate FS or Advate, to discuss the options available, and to develop a plan to transition to Xyntha if suitable. This change will occur in discussion with specialists during scheduled clinic appointments, or in an extra session specifically allocated to talk people through the brand switch.
Specialists will need to apply to the Haemophilia Treatments Panel for people where Xyntha is considered unsuitable.
Is changing brands of rFVIII safe to do?
Yes. Before making this change, PHARMAC sought advice from the National Haemophilia Management Group, the Haemophilia Treaters Group, the Haematology Subcommittee of the Pharmacology and Therapeutic Advisory Committee (PTAC), and clinicians in Australia, on the appropriateness of introducing brand changes for funded rFVIII.
Similar changes have been successfully introduced in other countries, including the United Kingdom and Australia, without compromising the quality and safety of treatment. There are a number of rFVIII brands now available worldwide and international experience supports the safety of national brand changes.
What do specialists need to look out for when changing brands of rFVIII?
Our clinical advisers have told us that a brand change may not be suitable for some people because they are at greater risk of developing inhibitors. In line with this advice, PHARMAC has made provisions to continue to fund specific brands of rFVIII for those people by application to the Haemophilia Treatments Panel. Such clinical situations include people who:
- previously had high titre inhibitor levels
- are undergoing active or have undergone immune tolerance therapy
- have a known product allergy
- have recently commenced therapy (Previously Untreated Patients or PUPs)
- live in the same residential setting with other people with haemophilia who are unable to switch, as it would be safer to have only one brand kept in the household.
There may be other clinical situations where a switch to Xyntha may not be suitable. Specialists can make applications to the Haemophilia Treatments Panel for consideration of Kogenate FS and Advate funding for people in these situations.
Is there a risk of developing inhibitors as a result of the change?
The development of inhibitors is a potential risk during product switches. However, national product switches have occurred in other countries and switching was not observed to be associated with an enhanced inhibitor risk (Lillicrap D et al. Haemophilia 2014: 20 (4): 87-93).
In the unlikely event people develop inhibitors, they would be provided with the required treatment.
Is any monitoring needed for people who change brands?
People who change brands should be closely monitored by their specialists. The number of blood tests and frequency of blood tests should be tailored to the person’s needs. The clinical advice we have received indicates that this may involve around four blood tests - one test before the change, and then tests one month, three months and six months after a change in product.
What does Xyntha look like?
Important dates to remember for transition
|August 2015||The following resources will be available from PHARMAC’s website:
||Haemophilia treatment centres should contact people currently using Kogenate FS or Advate, to discuss the options available and to develop a plan to transition to Xyntha, if suitable.|
|1 September 2015||The Haemophilia Treatments Panel will start to consider applications for funded access to Kogenate FS and Advate.||No application to the Haemophilia Treatments Panel will be required for people prescribed Xyntha.|
|1 September 2015 to 29 February 2016||People can transition from their current brand to Xyntha during this time.||Transition should occur at the person’s next visit to their haemophilia treatment centre or at the earliest and most convenient time.|
|1 March 2016||Xyntha becomes the Preferred Brand of rFVIII for people with haemophilia A.||Only people whose applications have been approved by the Haemophilia Treatments Panel will have funded access to Kogenate FS or Advate.|
Last updated: 2 October 2018