Erenumab funding application; gender impact assessment for funding applications
8 December 2021
Dear [name and contact details withheld]
Request for information
Thank you for your request dated 5 November 2021 under the Official Information Act 1982 (OIA) for information relating to the funding application for erenumab and gender impact assessment for funding applications.
Further to our response to you on 3 December 2021, please find our response to your remaining questions below. You wrote:
2. Given migraines predominately affect women (who in turn have disproportionate caring responsibilities), can you please advise at what point a gender impact assessment will be undertaken to ensure that the disproportionate impacts on women and their families are considered in the final decision?
3. Can you please advise on how gender impact is assessed at Pharmac more generally. That is, what steps are taken to ensure that access to drugs is equitable according to gender?
Gender impact assessment
We value funding decisions that improve an individual's health-related quality of life however, in making our decisions, we do not consider what could be achieved by an individual with that increased quality of life. That is, we do not take a societal perspective when assessing funding applications, instead taking a health system perspective. This is because our statutory objective requires us to focus on the “best health outcomes” that can be achieved within our funding.
When assessing funding applications, we seek to understand the characteristics and current health state of the patient group being considered and what incremental change in health, suitability, and costs/savings would occur should the proposed medicine be funded.
We use the Factors for Consideration (FFC) as a framework for evaluating funding decisions. This framework is used in all steps of our assessment and decision-making process. The FFC consists of four quadrants (Need, Health Benefit, Suitability, and Costs and Savings) and within each quadrant, there are several factors by which we seek to understand the impact on the person being treated, their family/whānau, the health system, and wider society.
Gender is not a specific Factor within the framework but within the Need quadrant there are six factors, one of which is the health need of family, whānau and wider society. This Factor considers the effect of the person’s illness on the health of family, whānau and wider society. This could include, for example, parents, caregivers, and children. All significant health effects, physical and mental, are relevant.
Our assessment process is geared around the Factors for Consideration. At the beginning of a funding application, we seek information related to the Factors from suppliers, clinicians, and consumers through the funding submission process. When we seek clinical advice, principally from PTAC and our specialist advisory committees, the advice sought is structured explicitly around the Factors for Consideration. This means that if a health condition significantly impacts caregivers for example, it is highly likely that we will be told about it by the applicant and/or through clinical advice.
If a proposal is recommended for funding by PTAC or a specialist advisory committee then its normal course is to be assessed by the Health Economics team. A summary of Factors, including the potential impact on caregivers, is undertaken before a proposal is ranked in prioritisation. Assessments are living processes – when new information, including pricing or new evidence related to the Factors, comes to hand assessments are updated.
The Prescription for Pharmacoeconomic Analysis (2015) (PFPA) describes the economic methods currently adopted by Pharmac. Noting that the PFPA is currently being reviewed by Pharmac, the guidelines note that subgroup analysis in cost-utility analysis “may be defined by age, gender, other demographic factors, disease-related factors (symptom complexes, severities), comorbidities, or intractability and factors affecting treatment effectiveness.” Noting patient subgroups may have different responses to treatment or magnitudes of benefit. The degree of subgroup analysis depends upon the complexity of the targeting decisions to be made.
We trust that this information answers your queries. We are making our information more freely available, so we now publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this.
Manager, Policy and Government Services