Download Draft response on HCHS meds paper

Submission on Preliminary Report on the Review of Access to High Cost, Highly
Specialised Medicines in New Zealand
From the Pharmacy and Therapeutics Committee of the Paediatric Society of New
Zealand
Thank you for the opportunity to comment on the Preliminary Report of the High-Cost, HighlySpecialised Medicines Review Panel.
Exceptional Circumstances Scheme
We support the proposal to merge the EC scheme into the existing process for funding other
pharmaceuticals through PTAC and PHARMAC. We would make the following points:
 The EC scheme does not work well for paediatric patients. It does not give the paediatric
subspecialists caring for these children enough flexibility to prescribe within their field of
expertise. There is a constant demand by the panel for high level evidence (RCTs)
which is often not available for children
 We agree that the current distinction between the HEC and CEC schemes is artificial
and therefore we support combining these schemes. However as there is no
recommendation to change the budgetary responsibilities inequities will persist. Some
DHB’s, particularly quaternary centres will commence a patient on a specialised
medicine ( because of standard clinical practice) and the patient’s home DHB is
expected to continue with ongoing treatment
 The criteria for the EC scheme will need substantial revision for the incorporation into
the mainstream process to be effective. The criteria should be public to ensure an open
and transparent process. There is a much broader range of medicines available in 2010
than when the scheme’s criteria were first put in place.
Paediatric medicines
On p30 the report states In general, because there are fewer trials of medicines in forms
appropriate for children than for adults, there are relatively few medicines registered for children.
This is not correct. In general, there are fewer trials of medicines in children, reducing the
availability of appropriate dosage forms for this population. Pharmaceutical companies will not
produce and register a child friendly formulation if they do not have dosing or safety information
to use the medicine in children.
Changes in Medicine Supply: On p30 the report states As a consequence of other PHARMAC
decisions, disruptions in medicine supply pose problems for paediatric patients. This statement
is correct but requires clarification. It refers to changes made to medicine supply where a
Pharmac decision has resulted in a brand change, altering the formulation of the medicine. The
consequences are not necessarily obvious at the time the decision is made. Such changes can
alter our ability to use the funded medicine as was done previously prior to the change by
Pharmac. For example the change to amlodipine and atenolol generic tablets, changed our
ability to formulate these tablets into a liquid using the previous compounding formulation. This
has resulted in the hospital procuring an unregistered liquid from overseas or using
compounding vehicles that are not funded.
An important issue in paediatric medicine and pharmacy is the provision of medicines that are
child friendly. We thank you for emphasising the importance of access to stable liquid
formulations in the report.
Most children receive their health care in the primary health care sector. It is therefore just as
important that primary health care providers can access appropriate formulations for children.
Therefore the statement on p31 An evidence-based and available suspending agent is funded
for paediatric specialist prescribed medicines should be amended to read: An evidence-based
and available suspending agent is funded for medicines prescribed for paediatric patients.
Procurement of Pharmaceuticals (p40; recommendation 3)
Clarification of the implications of this recommendation is needed. If it implies that individual
DHB pharmacists would not be faced with managing the consequences of global or national
shortages of medicines then we would support this recommendation. However, we would be
concerned that involving PHARMAC in one off situations could result in unnecessary
bureaucratic delays in a patient receiving an essential drug. This is particularly important for
highly specialised medicines required in only a small number of patients. For example, ADHB
currently source long acting pyridostigmine tablets via section 29 for one patient. This patient is
the only person in New Zealand who requires this drug. Accessing this drug in a timely fashion
to initiate treatment and maintaining a supply in the country is crucial in enabling this patient to
be managed clinically and remain in the community. If Pharmac controlled the procurement of all
pharmaceuticals would this scenario be manageable to an acceptable level? There will always
be a need for exceptions and Pharmac would need to be able to process such requests in a
timely manner as discussed in recommendation 6 (p41).
National Formulary (p41; recommendation 5)
The Paediatric Society strongly supports the recommendation to establish a New Zealand
National Formulary. We would like to see this include pertinent paediatric information such as
licensing and formulation information. We note that there would be substantial cost and
resources required to develop this.
Availability of low cost highly specialised medicines (p43; recommendation 11)
We support this recommendation
Proposal that PHARMAC be responsible for clinical and economic assessments, funding
decisions and procurement with respect to all health technologies (e.g. pharmaceuticals,
devices, vaccines and medical and surgical procedures and equipment).(p44; recommendation
12)
We strongly disagree with this solution. We think this has come about through comparing
PHARMAC with NICE (National Institute for Health and Clinical Excellence, UK). There are
important differences. NICE is a well resourced organisation, which produces evidence based
guidelines for the NHS in England and Wales. In New Zealand the development of evidence
based guidelines is supported and largely carried out by New Zealand Guidelines Group
(NZGG). The development of quality evidence based guidelines is a costly labour intensive
process which requires input from a range of professional experts. The quality of any guideline
depends on the availability of evidence (usually from randomised controlled trials) on which to
base recommendations for clinical practice. The major barrier to guideline development (apart
from resources) is whether appropriate trials have been reported in the literature. An even
greater barrier is getting health care professionals to implement guidelines.
The PHARMAC process is very different from that of NICE. Applications to PHARMAC are
usually initiated by pharmaceutical companies. Alternatively clinicians may indicate that a
particular pharmaceutical agent is needed, for example, clinicians require statins to treat people
with high cholesterol levels. PHARMAC, on advice from PTAC, negotiates a price for those
statins which PTAC advises are appropriate to be funded. PHARMAC does not seek to advise
clinicians on the overall management of individuals with high cholesterol.
The Paediatric Society supports exploring the option of PHARMAC (or another agency)
negotiating the bulk purchase of disposables (e.g. intravenous cannulae) used in New Zealand
health services. The Paediatric Society does not support PHARMAC taking responsibility for
major capital expenditure on equipment or the development of evidence based guidelines.
Wastage (p38 & p45; recommendation 15)
We agree with the comments in the document about wastage and the need to reduce costs by
addressing this problem.
This submission prepared by members of the Pharmacy and Therapeutics Committee of the
Paediatric Society of New Zealand: Caroline De Luca, Brenda Hughes, Rosemary Marks,
Andrew Sutton and William Wong. 9 February 2010.