Replies to LegCo questions
LCQ2: Hospital Authority listens to views on introduction of new drugs
Following is a question by the Hon Alan Leong Kah-kit and a reply by the
Secretary for Food and Health, Dr York Chow, in the Legislative Council today
(December 9):
Question:
Many different patient groups have complained to me that newer drugs with fewer
side effects on the market are not listed on the Hospital Authority Drug
Formulary (the Formulary) in a timely manner, or listed as third-line drugs,
thus patients who need to take such drugs are not subsidised. Some of the
complaints are from patients suffering from Thalassaemia who have pointed out
that at present patients with Thalassaemia major of the Hospital Authority (HA)
are only prescribed first-line and second-line drugs on the Formulary, which may
cause severe side effects, and doctors of public hospitals rarely prescribe
Deferasirox, which is a third-line drug for treating Thalassaemia and has fewer
side effects. In this connection, will the Government inform this Council
whether it knows:
(a) the number of times that Thalassaemia patients of public hospitals were
prescribed Deferasirox in each of the past three years and for how long on
average the drug prescribed lasted; whether HA will list Deferasirox as a
first-line drug for the treatment of Thalassaemia; if it will, of the specific
timetable; if not, the reasons for that;
(b) the details of the clinical guidelines for doctors of public hospitals to
determine if Deferasirox should be prescribed; if HA will review and amend the
contents of the guidelines to allow more Thalassaemia patients to be prescribed
the drug; and
(c) if HA will consider inviting representatives from patient groups to sit on
the Drug Advisory Committee, so that the Committee will take into account the
views of patients when considering introducing new drugs; if it will, of the
details; if not, the reasons for that?
Reply:
President,
The drug policy of the Hospital Authority (HA) is to ensure equitable access by
patients to cost effective drugs of proven efficacy and safety through
implementation of the HA Drug Formulary (the Formulary) to standardise the drug
policy and drug utilisation in all HA hospitals and clinics. The guiding
principle of the Formulary is that public resources should be utilised with
maximal effect to provide equitable access to healthcare services by all
patients. It is also based on the principles of evidence-based medical practice,
targeted subsidy and opportunity cost, as well as considerations of patients'
choice.
(a) At present, the following three drugs in the Formulary are used for iron
chelation therapy for Thalassaemia patients. These three drugs are classified as
General or Special Drugs and covered by standard fees and charges which are
highly subsidised. Patients who meet the specific clinical conditions and
require the drug for treatment would be prescribed with the drug by doctors and
provided with the drug at standard fees and charges by HA.
Desferrioxamine
Desferrioxamine (DFO) is an injection drug classified as General Drug (i.e.
drugs with well-established indications and effectiveness which are available
for general use as indicated by the relevant clinical conditions of the patient)
in the Formulary. The drug is currently recognised by the medical profession as
an efficacious, safe and reliable iron chelating drug. There are also
established scientific evidences on the long-term efficacy of the drug on
patients' survival. Serious side effects caused by the use of DFO are not
common. Some of the side effects may also be observed in patients using
Deferasirox. At present, DFO is still the "gold standard" drug for iron
chelation therapy from the perspective of doctors.
Deferiprone
Deferiprone is an oral drug and its registered indication specifies it as a
second line drug after DFO. It is classified as Special Drug (i.e. drugs to be
used under specified clinical conditions with specific specialist authorisation)
in the Formulary. Patients who cannot adapt to injection or are not suitable for
treatment with DFO because of side effects or other clinical reasons can shift
to Deferiprone or use DFO alternately with Deferiprone. At present, HA patients
who cannot adapt to injection are widely prescribed with Deferiprone.
Deferiprone has similar efficacy as DFO and has cardio-protective function. But
Deferiprone may cause cytopenia under few individual circumstances.
Deferasirox
Like Deferiprone, Deferasirox is also an oral drug. It is classified as Special
Drug in the Formulary. Patients whose clinical conditions are not suitable for
the use of DFO and Deferiprone can be prescribed with Deferasirox.
Some research findings show that Deferasirox is not superior to Deferiprone in
terms of efficacy in iron chelation therapy for Thalassaemia in general.
Deferasirox may also have the side effect of damaging renal functions.
Deferasirox has only been in the market for a short time. Its long-term efficacy
and safety remain to be observed and require accumulation of further data to
prove.
HA included Deferasirox into the Special Drug category of the Formulary in
January 2009. As at September 2009, 354 patients in HA have been prescribed with
DFO, 227 with Deferiprone (of which 121 use DFO in combination with Deferiprone)
and 12 with Deferasirox. In general, patients who are prescribed with
Deferasirox will continue to use this drug.
Doctors will closely monitor the clinical conditions of patients after
prescribing the drugs and make suitable adjustments to the treatment plan in the
light of the clinical conditions and treatment needs of the patient.
(b) HA's clinical guideline for Deferasirox is as follows:
"Patients with Thalassaemia major or transfusion-dependent patients with iron
overload who fail Desferrioxamine & Deferiprone due to significant side effects
including severe allergy / bony dysplasia / osteonecrosis / neutropenia /
agranulocytosis."
HA has issued the guideline to doctors of various clusters. Patients who meet
the specific clinical conditions specified in the guideline would be provided
with the drug at standard fees and charges.
HA reviews the treatment guidelines from time to time in the light of the
development of the drugs and scientific evidence. Having regard to the
development of various treatment approaches, HA has revised the guidelines for
iron chelation treatment for Thalassaemia in 2004 and 2009.
(c) The Drug Advisory Committee (DAC) of HA is a professional structure
comprising doctors, clinical pharmacologists and pharmacists. The DAC mainly
assists HA in appraising new drugs using professional principles in medicine and
science. Its meetings involve professional consideration and discussion of
issues requiring scientific and clinical analysis. HA has in place a regular
consultation mechanism and holds a patient consultation meeting on the Formulary
once a year to directly listen to the views of patient groups on the
introduction of new drugs by HA. Patients are also invited to submit their views
in writing to HA. Furthermore, HA maintains communication and liaison with
patients through other channels such as regular gatherings, newsletters and
talks to listen to their views on the introduction of new drugs. After receiving
patients' views, HA will follow up and reflect their views to the relevant drug
assessment and review committees (including the DAC).
Ends/Wednesday, December 9, 2009
Issued at HKT 14:05
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