Questions and answers about the Factors for Consideration
What are the Factors for Consideration all about?
PHARMAC is responsible for making decisions on the funding of medicines, vaccines and medical devices. The Factors for Consideration guide this decision-making, and help PHARMAC to achieve its legislative objective, which is “to secure for eligible people in need of pharmaceuticals, the best health outcomes that are reasonably achievable from pharmaceutical treatment and from within the amount of funding provided.”
Why has PHARMAC changed the way it makes decisions?
As part of a wide ranging review of all PHARMAC’s Operating Policies and Procedures, the Decision Criteria were selected as being the first significant area for review. In recent years PHARMAC has taken on a wider range of work, including all community and hospital medicines, vaccines and medical devices. The Decision Criteria, which were used up until 1 July 2016, served us well, but we wanted to ensure we had a decision-making framework that reflected what people thought we should take into consideration.
What are the main differences between the Factors for Consideration and the Decision Criteria?
The decision criteria helped PHARMAC to meet its legislative objective. As the legislative objective has not changed, the Factors for Consideration similarly assist PHARMAC. They reflect the intent of the decision criteria, but provide greater clarity on what PHARMAC considers relevant to its decision-making.
Instead of a list of nine items to consider, PHARMAC now look at the relevant impact of the decision on the person; their family, whanau and wider society; and to the broader health system.
These impacts are considered across four dimensions: need, health benefits, costs and savings, and suitability. Within each dimension, there are a number of Factors that are taken into account when we make funding decisions. The main changes include:
- A new “family, whānau and wider society” impact has been included to more explicitly acknowledge the scope of what we may consider for a given funding decision.
- The Factor “the impact on the Māori health areas of focus and Māori health outcomes” acknowledges the areas of focus outlined in PHARMAC’s Māori Responsiveness Strategy, Te Whaioranga, and the impact on Māori health with respect to the Treaty of Waitangi/Te Tiriti o Waitangi.
- The health needs of Pacific people and other populations with health disparities are taken into account. PHARMAC has included a Factor that considers “the impact on the health of population groups experiencing health disparities”
How does PHARMAC use the Factors for Consideration?
The Factors for Consideration help PHARMAC make decisions. This includes decisions about the funding of medicines, vaccines and medical devices. The Factors are used for decisions related to Pharmaceutical Schedule listings (for populations), and for individual named patients under the Named Patient Pharmaceutical Assessment (NPPA) policy.
What level of input have the public had into this process?
PHARMAC extensively sought the community’s views on what it should consider when it makes funding decisions. We issued a discussion paper in 2013, and held 12 community forums to seek people’s views. A Māori focus group provided specific input from a Māori stakeholder perspective.
People’s feedback was then incorporated into a proposal that we issued in April 2014. The inclusion of the impact on family, whānau and wider society is a result of input from the community during the consultation process.
What are the Māori health areas of focus and how were these decided?
PHARMAC’s Māori Responsiveness Strategy, Te Whaioranga, outlines areas of health focus that the Māori community has identified as equally important for PHARMAC. These are:
Hauora Arotahi Māori health areas of focus
Hauora hinengaro Mental health
Manawa Ora Heart health-high blood pressure and stroke
Romaha Ora Respiratory Health
Mate Pukupuku Cancer – Lung and Breast
We sought input from the community in developing the priorities identified in Te Whaioranga. The strategy is updated regularly to ensure we identify and update the Māori health areas of focus.
How is this likely to change the impact on Māori health outcomes?
We realise that Māori may have specific health needs and priorities, as we’ve outlined through Te Whaioranga, our Māori Responsiveness Strategy. The Factors for Consideration ensure full consideration of these, while also making sure we also consider other groups with health disparities, such as Pacific peoples.
What if Māori would like another health area of focus considered in PHARMAC’s decision making that is not currently captured?
We are continuing to work alongside Māori through Te Whaioranga, which will help inform us of how we can best consider Māori needs. If Māori identify new health areas of focus, these can be incorporated in Te Whaioranga.
Why are Māori not considered in the ‘groups experiencing disparities’ Factor?
The Factor ‘the impact on Māori health areas of focus and Māori health outcomes’ specifically considers Māori health needs. This was guided by feedback we received during our public consultation period and also highlights our obligations under the Treaty of Waitangi and commitment to being a great Te Tiriti partner.
Are the health needs of Pacific peoples taken into consideration in the Factors for Consideration?
The health needs of Pacific people are considered under the Factors for Consideration. The Factor `the impact on the health of population groups experiencing health disparity’ includes the needs of Pacific people, and also helps us to consider the needs of other populations experiencing health disparity.
We are continuing to develop our Pacific Responsiveness Strategy which will strengthen our engagement with Pacific peoples. This will better inform us of how we can best consider Pacific peoples’ health needs.
Named Patient Pharmaceutical Application (NPPA)
Are the Factors for Consideration used to make NPPA funding decisions?
Yes – PHARMAC use the Factors for Consideration to support all funding decisions, including those for named patients. Applications for NPPA still need to meet the requirements of the NPPA policy before being considered.
How have the Factors for Consideration affected the pre-requisites and decision-making?
The Named Patient Pharmaceutical Application (NPPA) pre-requisites remain the same and all NPPA applications that meet the pre-requisites are assessed against the Factors for Consideration.
What additional information do I have to provide with a NPPA application?
Information which previously may not have been relevant under the Decision Criteria may now be with the Factors for Consideration. We encourage you to include any additional information you may have to support your application in the context of the Factors for Consideration.
My NPPA application was declined using the Decision Criteria, can I reapply under the Factors for Consideration?
You can resubmit any application that had been declined using the Decision Criteria.
Pharmaceutical Schedule applications
Will previously unfunded medications now be funded because of the new decision-making framework?
The decision criteria helped PHARMAC to meet its legislative objective. As the legislative objective has not changed, the Factors for Consideration similarly will assist PHARMAC. They reflect the intent of the decision criteria, but provide greater clarity on what PHARMAC considers relevant to its decision-making.
While we do not expect that the use of these factors in themselves would require remaking of decisions, we are always willing to consider funding applications when new information is available.
However, the Factors will allow us to include a wider breadth of considerations when assessing funding applications.
Are there more specific Factors for Consideration for medical devices considering products are so different?
The Factors apply to all pharmaceuticals – under the legislation establishing PHARMAC that includes medical devices and medicines. The new framework gives us the flexibility to consider differences between medicines and medical devices in our decision making.
As we continue to progress our medical devices role, we will provide more information on how the Factors will be considered.
Does the level of data that is available on medicines and medical devices impact on how the Factors for Consideration will be applied to these products?
PHARMAC currently considers varying levels of information on the effectiveness of products when assessing, against the Decision Criteria, the funding applications it receives. The Factors for Consideration similarly support PHARMAC’s future consideration of products that have varying levels of evidence of effectiveness, benefits and risks.
Last updated: 7 February 2020