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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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