Decision relating to the funding of haemophilia treatments
PHARMAC has decided to list a range of haemophilia treatments in Section B of the Pharmaceutical Schedule.
In summary, the effect of the decision is that recombinant blood factors (VIIa, VIII and IX) and factor eight inhibitors bypassing agent (FEIBA) will be listed in Section B of the Pharmaceutical Schedule from 1 December 2013 and will be funded from within the Combined Pharmaceutical Budget (CPB).
Details of the decision
The proposal which was consulted upon was approved in its entirety except for the change to Rule 2 in Section H, which was slightly redrafted as below (additions in bold, deletions in strikethrough):
2.1 Section H Part II contains the list of Hospital Pharmaceuticals that must be funded by DHB Hospitals. Section H Part II does not currently encompass the following categories of pharmaceuticals except for any items specifically listed in this Section H Part II:
a) Medical Devices;
b) whole or fractionated blood products
except for any items specifically listed in this Section H Part II;
c) diagnostic products which have an ex vivo use, such as pregnancy tests and reagents;
d) disinfectants and sterilising products, except those that are to be used in or on a patient;
e) foods and probiotics;
f) radioactive materials;
g) medical gases; and
h) parenteral nutrition.
Subject to rule 2.2, the funding of pharmaceuticals identified in a) – h) above is a decision for individual DHB Hospitals.
We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 16 October 2013 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:
Risk-pooling based on the population-based funding formula (PBFF) should continue.
The decision allows this to continue.
Concerns that this proposal could further limit treatment choices currently available to the National Haemophilia Management Group (NHMG) and add an additional level to the approval process, thus delaying treatment.
The decision allows the NHMG to maintain its current role and it will have discretion to manage expenditure up to an agreed funding provision from the CPB. Expenditure above the provision will be determined by PHARMAC. The level of funding to be managed by the NHMG reflects current usage. PHARMAC will also discuss the appropriate agreed funding provision levels in the years going forward with the NHMG to allow for growth in this area.
The ability to integrate all stakeholders and provide comprehensive care (treatment products and services) to patients with haemophilia has enabled the NHMG to be very successful. Any proposed change should provide the NHMG the flexibility to continue to do this.
This decision allows the NHMG to continue to have discretion to manage the usage of the recombinant blood factors (VIIa, VIII and IX) and FEIBA up to an agreed funding provision from the CPB.
The funding of plasma-derived blood products and haemophilia services would continue to be managed by DHBs, under terms agreed by the NHMG with the 20 District Health Boards.
Savings made on any haemophilia products should remain available for re-investment into the national haemophilia service.
Savings obtained from haemophilia treatments in the CPB would not be ‘ring-fenced’ for the haemophilia service because this would be inconsistent with how pharmaceuticals are managed within the CPB. We note that savings obtained from spending on other pharmaceuticals could be used to fund haemophilia treatments.
It would be appropriate for the NHMG and the Haemophilia Treaters Group (HTG) to review new haemophilia treatments first and PHARMAC may then be asked for funding through the same PHARMAC processes currently applying to other pharmaceuticals. PHARMAC also must seek clinical advice from the HTG when considering applications for the funding of new haemophilia treatments.
PHARMAC would consult with NHMG and HTG on issues relating to the management of the Pharmaceutical Schedule which are likely to affect haemophilia treatment and it would assess new haemophilia treatments (recombinant products) for funding in line with its Operating Policies and Procedures. PHARMAC has the discretion to decide if it needs to seek clinical advice prior to any funding decision whether from PTAC or its Subcommittees or elsewhere. We generally seek clinical advice and consult prior to any funding decision.
If you have any questions about this decision, you can call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.