25 March 2011
Bryce Wigodsky
PHARMAC
PO Box 10-254
Wellington 6143

Dear Bryce,

Submission from Access to Medicines Coalition

ATM is pleased to present our submission on the current consultation on the review of exceptional circumstances.

Key message

The Access to Medicines Coalition welcomes a further opportunity to submit on the topic of Pharmac’s Exceptional Circumstances policy. We continue to view these submissions as an opportunity to dialogue with Pharmac to reach the state desired by all parties – the improved health and wellbeing of New Zealand people through a fair and transparent funding of medicines.

The new consultation appears to have focused away from the cost of medicines in favor of the particular disease and the uniqueness and seriousness of the clinical circumstances of the patient. In theory, whilst the new scheme appears to be a promising compromise that will benefit a number of patients, the ATM Coalition questions how will it operate in practice to benefit patients, in terms of increasing affordable access to medicine? Overall, we are concerned that on the face of this revised document the proposals will result in a lower number of people being able to access medicines than the current scheme. We therefore we do not think this proposal meets the best interests of patients.

Discussion

Firstly, we would like to highlight what we see as positive aspects of Pharmac’s proposal.

1. We are pleased to see the inclusion of a category that focuses on the urgency and seriousness of a condition. With some flexibility of these boundaries, this category promises to broaden access to medicine through the EC scheme
2. We are pleased to see an emphasis on ‘clinical circumstances’ in the Unique Clinical Circumstances (UCC) category, rather than focusing on a disease state itself. Often it is one particular symptom within a disease state that is problematic for a patient, and prompts an application for Exceptional Circumstances (EC) funding.
3. We acknowledge that the previous focus on the ‘high cost’ of innovative medicines and which categories might be considered for funding has diminished. We felt that this emphasis on cost, rather than other problematic factors, was misleading and only presented part of the picture.
4. We welcome the increased transparency on the part of Pharmac.  This is another step that will lead to more open dialogue between the organisation, stakeholders and consumers in general.
5. We agree that well defined categories for situations where an application to the EC scheme might be successful would be better than the current model which involves considerable time spent on submitting applications, most of which are declined.
6. We welcome the inclusion of an official review process, provided that it will occur in a timely manner, befitting the urgency of the clinical circumstances of the patient concerned.
7. Pharmac have announced that the budget for the NPPA scheme would be likely to increase. We welcome a raised budget for patients with exceptional circumstances.
   

Points of concern

Our major concern is that ‘exceptional circumstances’ have been redefined as ‘extraordinary circumstances’, creating the extremely narrow category of Unique Clinical Circumstances. Our call was, and remains, that the size of the population group considered should be increased to greater than ten people.

The ATM Coalition notes that the proposed Unique Clinical Circumstances pathway effectively narrows the range of patients who could be considered for Exceptional Circumstances, from ten to one. This effectively means that nine patients who would previously have been given consideration as ‘rare’ will now be declined via this stream.

This is an extremely narrow category, which will now only cater for the ‘very rare’ individual and may be so narrow, that very few or no patients will qualify to be considered for funding. This in itself may legally be considered to be ‘unreasonable’ or to constitute a legal error on the part of Pharmac.

Whilst ‘exceptional’ can mean ‘uncommon’, ‘unusual’, ‘special’, ‘anomalous’, ‘atypical’ and ‘out of the ordinary’, the definition that Pharmac has taken and applied to the UCC stream appears to be, ‘extraordinary’. While we welcome the widened emphasis on clinical circumstances we would prefer that the UCC acronym became one of “Unusual Clinical Circumstances”. Unusual would have broader parameters than unique, which does indicate a single person.

There remain in New Zealand small groups of people who are suffering from either an unusual disease or an unusual manifestation of a disease for whom access to a pharmaceutical will be life enhancing. These small groups of people are significantly disadvantaged by the current medicines system – and the new EC scheme will exacerbate the existing health inequalities for these people. We urge Pharmac to reconsider the size of the group – unusual rather than unique so that we can decrease the growing disparity in health outcomes.

The emphasis on ‘individuals’ and hence individual circumstances, will potentially give rise to difficulties in practice, in assessing ‘individuals’ with decision criteria explicitly designed for populations. We feel that these criteria need to be redesigned, rather than Pharmac attempting to shape their use to fit the assessment of named patients. Included in this redesign should be an ethical framework that can take into consideration community values and the fairness of any funding decision.

Moreover, in the more general understanding of ‘exceptional circumstances’ as being circumstances not catered for by the Schedule, small population groups whose pharmaceutical requirements will fail Schedule assessment also fall within its remit. We see this to some extent, within the Urgent Assessment category, where albeit Pharmac’s general statement on catering for ‘individuals’, the descriptors refer to the inclusion of individuals in ‘small population groups’. This creates ambiguity about assessing individuals in similar clinical circumstances as ‘individuals’ as opposed to a small population group.

The proposal highlights that any application for a group of patients, even a small group, that was not considered to be urgent or life threatening would be subject to the normal application process through the Community Pharmaceutical Scheme. Given the concerns that have been raised through a number of consultations and meetings about the delays in the approval process we have major concerns about this as an alternative route to funding for small groups of patients.

It is already the experience of members of the coalition that even pharmaceuticals that receive a high priority for funding through the PTAC process are subject to delays of many months, and often years, for the promised subsidisation - apparently due to the commercial negotiations Pharmac undertakes with pharmaceutical suppliers.

While we acknowledge that the low cost of pharmaceuticals in New Zealand is a direct result of these commercial negotiations, we remain concerned that drugs that are assessed as being a high or medium-high priority can remain unfunded for long indefinite periods, with the resulting loss of quality of life, disease progression and even loss of life, for patients.

About the Access to Medicines Coalition

The Access to Medicines coalition represents 26 not-for-profits representing support groups for hundreds of thousands of New Zealand patients across a wide range of rare and common disorders. We formed in 2005 to promote improved policy for medicine decisions, and improved funding for medicines, under the slogan “equitable and affordable access to medicines for all” in New Zealand.

This submission from ATM represents a consensus among the working group set up to organise the affairs of ATM. Further information about ATM can be found at www.atmcoalition.org.nz

Dr Fiona Coyle
Policy Advisor, NZORD
On behalf of the Access to Medicines Coalition