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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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