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Following is a question by the Hon Alan Leong and a written reply by the Secretary for Food and Health, Dr York Chow, in the Legislative Council today (July 7):
Question:
According to a paper provided by the Government to the Panel on Health Services of this Council on May 11 of this year, Ranibizumab (Lucentis), which is licensed in Hong Kong for the treatment of wet age-related macular degeneration (AMD), is a self-financed drug on the Hospital Authority (HA) Drug Formulary (the Formulary), and it is not covered by the safety net provided by the Samaritan Fund (the Fund) either. However, the governments of more than 20 countries and regions across the globe, including Korea and Australia in our neighbourhood, have committed to bear the full medical costs for the treatment of wet AMD. In this connection, will the Government inform this Council:
(a) whether it knows if the Drug Utilisation Review Committee (DURC) of HA has made any recommendation to the Fund on the inclusion in its scope of subsidies those drugs listed on the Formulary which are for treating wet AMD (such drugs); if DURC has made such recommendations, of the reasons for the Fund not accepting them; if not, the reasons for that;
(b) whether it knows, apart from the aforesaid drug, if there was any recommendation made in the past three years by DURC on the inclusion of other drugs in the scope of subsidies of the Fund, which had eventually not been accepted; if there were such recommendations, of the reasons for that, and how the public knows whether or not individual drugs have been recommended by DURC to be included in the scope of subsidies of the Fund; and
(c) given that certain countries provide subsidies to patients for drugs used in the treatment of wet AMD while such drugs are still undergoing clinical tests, whether the authorities will consider making reference to the practices adopted in those countries and introduce measures to provide subsidies to all needy patients for using such drugs during the testing stage, irrespective of whether the patients participate in the tests, before such drugs are listed as standard drugs on the Formulary, with a view to providing assistance to needy patients suffering from wet AMD and so as to avoid their not being able to receive the most appropriate treatment due to financial reasons; if they will, of the details of such measures; if not, the reasons for that?
Reply:
President,
There are two vascular endothelial growth factor (VEGF) inhibitors commonly used by ophthalmologists 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 for the treatment of wet AMD in 2007. 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 for the treatment of colorectal cancer in 2005. 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 international practice.
The reply to various parts of the question is as follows:
(a) Over the past year, the Drug Utilisation Review Committee (DURC) of HA has discussed twice whether recommendations should be made to the Samaritan Fund Management Committee (SFMC) to include Ranibizumab (Lucentis) in the scope of subsidies of the Samaritan Fund (the Fund). However, the treatment options for the disease are still evolving, and no international consensus has been reached on the optimum regimen of the drug in treating wet AMD (i.e. the number of injections to be administered). Also, the long-term safety, efficacy and cost-effectiveness of the drug require further study to prove. Hence, the DURC of HA has not hitherto made a recommendation to the SFMC for including the drug in the scope of the Fund.
Large-scale studies are being conducted in six overseas countries (including the United Kingdom, the United States and Germany) to further ascertain the efficacy, drug safety and cost-effectiveness of various treatment options for wet AMD. The findings will be published by end of 2010 to early 2011. On the other hand, HA is planning to conduct a local clinical study this year to compare two VEGF inhibitors commonly used for wet AMD treatment, including Ranibizumab (Lucentis) and Bevacizumab (Avastin), so as to accumulate more local experience in the use of the drugs. HA will summarise the data of the local clinical study, closely observe the latest developments in international scientific evidence, and take into account the findings of the large-scale studies to be published in determining the appropriate positioning of such drugs in the Formulary for the treatment of wet AMD.
(b) In the past three years (2007/08 to 2009/10), all recommendations made by the DURC on the inclusion of drugs in the scope of the Fund were accepted by HA. During the same period, a total of 7 additional new drugs and a total of 13 new indications were included in the scope of the Fund.
The Formulary and information on the Fund (including the list of specified drugs subsidised by the Fund) have been uploaded to the HA website for public information. Patients may also make enquiries with their doctors or medical social workers. Besides, HA will meet regularly with patient groups to collect their views on the Formulary.
(c) As mentioned above, HA is planning to conduct a local clinical study this year to compare, under specific treatment options, the efficacy, drug safety and cost-effectiveness of two VEGF inhibitors commonly used for wet AMD treatment, including Ranibizumab (Lucentis) and Bevacizumab (Avastin). Patients with suitable conditions will be invited to participate in the clinical study and use the relevant drugs on a trial basis without any charge by HA. If patients do not participate in the clinical study, HA will continue to provide them with traditional treatment through highly-subsidised public healthcare services. Patients may also opt to use Ranibizumab (Lucentis) at their own expense for the treatment of wet AMD.
Given that the findings of the large-scale international studies will be published by the end of this year to early next year, and that HA will be informed of the preliminary data of the local clinical study around the same time, we will, at a suitable juncture, expeditiously review the positioning of such drugs in the Formulary for treatment of wet AMD.
HA will make reference to the practices in different countries and continue to closely monitor the needs of wet AMD patients so as to provide them with appropriate support.
Ends/Wednesday, July 7, 2010
Issued at HKT 15:24
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