Submission to Pharmac on review of Exceptional Circumstances Scheme

Pharmac has indicated tougher rather than improved access to new medicines – March 2011

The latest round in the long saga of attempts to improve access to specialised new medicines in New Zealand, is Pharmac’s review of the exceptional circumstances scheme, consulted on early in 2011. Health Minister Tony Ryall and Associate Minister Peter Dunne both indicated in a press release they wished to see this review deal with problems of access to medicines that are not on the Pharmaceutical schedule. There was a significantly improved consultation process undertaken by Pharmac, but initial hopes of some real progress through this review, were quickly dashed when the detail of the consultation document indicated a determination by Pharmac to retain tight criteria, and in fact toughen them up.

The need for a high level policy direction to be set by government in relation to specialised new medicines for small patient populations is very obvious. Pharmac cannot be relied on to produce an acceptable high level policy framework when their approach is so strongly influenced by their day to day operational priorities and their narrow perspective on the issues involved. NZORD’s full submission can be accessed here in Word or here in PDF.

Here is the executive summary of NZORD’s submission to Pharmac:

Positives in the consultation:

  • The consultation process undertaken by PHARMAC is an improvement on past experiences.
  • Recognising urgency and seriousness as explicit entry criteria for EC consideration is an important step promoted by support groups over many years.
  • Focusing on clinical symptoms as an entry point is also supported as a positive move.
  • Recognition of fairness as a guiding principle is specifically addressed at last.
  • Less emphasis on the cost of the medicine as a starting point is something we support.

However we have a number of concerns that the proposed scheme is not robust enough to make significant changes to past experiences of trying to access medicines through the EC scheme, as expected by patient groups. Nor will it meet the expectations set out by Health Minister Tony Ryall, and Associate Minister Peter Dunne, in the press releases announcing the review.

Specific concerns identified by NZORD regarding the proposed new scheme include:

  • The entry criteria for exceptional circumstances consideration have been made clearer but at the same time narrowed down in a more restrictive way.
  • The narrowing of criteria is so restrictive it appears to counter the legal obligations in the Act and other public law obligations that PHARMAC has.
  • Many patients groups, especially those needing innovative medicines relevant to very rare diseases, and which would struggle with standard schedule listing, appear to be mostly excluded from EC consideration as well.
  • The drive by PHARMAC to exert total control over all medicine markets has led them to overlook some aspects of duty and responsibility.
  • The requirements of the Medicine Strategy to include fairness, equity, access and community values into decision criteria has not been adequately addressed in PHARMAC’s proposed new scheme.
  • One consequence of this exclusion is the retention by PHARMAC of an inappropriate bias towards the narrower criteria of cost-utility, cost effectiveness and budget management. These important factors need to be balanced with the ethical criteria.
  • There is a duty on PHARMAC to specify its approach to ethical matters in decision criteria.
  • PHARMAC’s interpretation of fairness as being limited to the opportunity for all patients to apply for EC consideration is too narrow. It does not comply with the high-level directions of the Act, the NZ Health Strategy or the NZ Medicine Strategy. Fairness is a principle that PHARMAC are bound to include into actual medicine funding decisions.

Specific recommendations from NZORD for noting by PHARMAC and government, the most important of which are summarised as the need for:

  • A higher level policy commitment to fair access to innovative new medicines that does not leave both policy and implementation entirely to PHARMAC.
  • A clear commitment of resources to enable the improved access to specialised medicines as indicated by the Ministers.
  • Specific mechanisms in policy to redress inequities of medicine access for rare disorders populations as disadvantaged groups, as provided in several comparable countries, and an EC or similar scheme that effectively improves that access.
  • A major review is required of how the moral dimension is incorporated into decision making criteria in the EC scheme and more broadly in all of PHARMAC’s work.
  • Decision criteria need detailed review to also ensure they are fit for purpose and include all relevant matters.

John Forman
Executive Director