Replies to LegCo questions
LCQ18: Drugs for wet age-related macular degeneration treatment
Following is a question by the Hon Ronny Tong and a written reply by the Acting
Secretary for Food and Health, Professor Gabriel Leung, in the Legislative
Council today (July 13):
Question:
In response to media enquiries, the Hospital Authority (HA) indicated on June
16, this year that HA would conduct a local clinical trial in collaboration with
the University of Hong Kong and the Chinese University of Hong Kong on the use
of Avastin and Lucentis in wet Age-Related Macular Degeneration (AMD) patients
by the end of this year, in order to gather local evidence and experience for
devising a specific treatment protocol in public hospitals. In addition, with
additional funding from the Government, HA reserved a sum of $12 million in the
year 2010-2011 for providing subsidies to wet AMD patients in suitable clinical
conditions for their treatment. In this connection, will the Government inform
this Council:
(a) whether it knows if the aforesaid funding already reserved in the last
financial year has to date been used for subsidising wet AMD patients to receive
treatment; if so, of the number of patients who have received the subsidy; if
not, the reasons for that; of the number of patients estimated by the
authorities who were not given timely treatment because the funding had remained
unused last year;
(b) whether it knows if HA will use the funding for conducting the aforesaid
clinical trial;
(c) whether it knows the purposes of the plan of HA and the aforesaid two
universities to launch the clinical trial on the use of Avastin in the treatment
of wet AMD; whether testing the safety of the drug is among such purposes; if
so, of the protocols and standards based on which such clinical trial will be
conducted; whether such clinical trial will meet the highest safety requirements
for drugs approved by drug regulatory authorities of European countries and the
United States;
(d) given that the manufacturer of Avastin has not indicated that the drug can
be used for the treatment of wet AMD, whether the authorities have assessed if
HA or the Government are liable for compensation to wet AMD patients who suffer
from severe side-effects or blindness induced by receiving Avastin treatment, or
damages associated with the quality problems of the drug itself; if the
assessment outcome is in the affirmative, of the maximum amount of compensation
for each patient; of the justifications for the Government to deploy public
funds to bear such liability for compensation;
(e) whether it knows, under the current policy, if HA will solely base on the
indications of drugs registered with the Department of Health in considering
listing the relevant drugs, including general, special and self-financed drugs,
on the Hospital Authority Drug Formulary; if it will, of the reasons for and
purposes of introducing such policy; if not, the reasons and justifications; and
(f) whether it knows if HA monitors the prescription of drugs for patients in
public hospitals to ensure that drugs are used only for their registered
indications, and restricts public hospitals from prescribing drugs in treatments
which are beyond their registered indications, in order to safeguard the safety
of patients; if it does, how these are enforced?
Reply:
President,
There are two vascular endothelial growth factor inhibitors commonly used by
ophthalmologists worldwide to treat wet age-related macular degeneration (AMD),
namely Ranibizumab (Lucentis) and Bevacizumab (Avastin). The two drugs are
derived from the same monoclonal antibody and hence have similar molecular
structure. Ranibizumab (Lucentis) is licensed in Hong Kong in 2007 for the
treatment of wet AMD. It is a self-financed drug on the Hospital Authority (HA)
Drug Formulary (the Formulary) for wet AMD treatment. Bevacizumab (Avastin) is
licensed in Hong Kong in 2005 for the treatment of colorectal cancer. It is a
self-financed drug on the Formulary for cancer treatment. Although Bevacizumab (Avastin)
is not licensed for the treatment of wet AMD, prescription of the drug beyond
its licensed indication (or off-label use) for treating wet AMD is a common
worldwide practice.
The reply to various parts of the question is as follows:
(a) to (d) HA was granted an additional funding of $12 million in 2010-11 to
launch a special programme for wet AMD patients under suitable clinical
conditions to receive subsidies to use the above two drugs for treatment. The
special programme consists of two parts, namely, a clinical study and a special
project. The clinical study will be conducted jointly with the two universities
to compare the treatment options as well as the efficacy and cost-effectiveness
of the two drugs, so as to accumulate more clinical data and local experience in
the use of the drugs. Meanwhile, under the special programme, wet AMD patients
under suitable clinical conditions will be subsidised to use Ranibizumab (Lucentis).
The Administration reported to the Legislative Council Panel on Health Services
the above special programme on May 11, 2010. As the clinical study has to go
through established and stringent approval procedures, and there is a need for
negotiations with the drug companies on the detailed arrangements for the
special project, the special programme is still under processing and scheduled
for implementation in 2011-12. HA has made arrangements for the additional
funding that has not been used in 2010-11 to be carried forward to 2011-12 for
implementation of the programme.
HA has been adopting evidence-based medical practices and, with patient safety
as its primary consideration, providing patients with treatments proven to be
safe, efficacious and appropriate. The clinical study to be conducted by HA and
the two universities must be approved by an independent Ethics Committee before
implementation to ensure its safety and feasibility. A clinical study is a
medical procedure conducted with patients' knowledge and informed consent. It
has to be conducted by registered healthcare professionals. The scope of an
ethical review mainly covers the theoretical basis of the clinical study,
patient safety and information pertinent to the "Participant's Consent Form".
The entire design of a clinical study must be target-oriented and it is
necessary to ensure that the risks borne by the participants are kept to the
minimum within the known extent of the risks. The design of the clinical study
must also comply with HA's guidelines and requirements on patient safety and
participants need to be provided with appropriate medical support throughout the
study. Besides, a mechanism for notification of serious incidents should be set
up for the clinical study.
Institutions and researchers conducting a clinical study must explain the key
aspects of the study to participants in detail and obtain their informed and
voluntary consent in writing. Participants have a full right to decide and make
their own choice as to whether or not to participate in the clinical study. They
can also withdraw from the clinical study during the study period. HA is
discussing with its insurance consultant the insurance arrangements for the
clinical study.
(e) and (f) The HA Drug Formulary is developed with evaluation of new drugs and
review of the prevailing list of drugs by relevant experts on a regular basis.
The review process is based on scientific and clinical evidence on the safety,
efficacy and cost-effectiveness of the drugs, taking into account different
factors, including patients' actual experience in the use of the drugs and the
views of patient groups, etc. Under the prevailing mechanism for the Formulary,
HA will neither evaluate any unregistered new drugs nor incorporate such drugs
into the Formulary. All the existing drugs on the Formulary have been registered
with the Department of Health.
Most off-label use of drugs is to meet clinical needs for treatment purposes.
There is usually extensive medical literature to support off-label use of drugs.
However, it is purely a commercial decision for the drug traders to decide
whether to register individual drugs or indications, and to choose between
places of registration. As in most advanced countries and regions, doctors in
Hong Kong may prescribe drugs for off-label use based on their clinical
expertise and judgement and professional ethics, having regard to the clinical
conditions of individual patients. As a general principle of HA, doctors should
ensure that the drugs prescribed (including drugs prescribed for off-label use)
are clinically safe and appropriate for the patients. HA also has an established
mechanism to report and review the suspected adverse drug reactions of patients
so as to safeguard patient safety.
Ends/Wednesday, July 13, 2011
Issued at HKT 20:09
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