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Following is a question by the Dr Hon Kwok Ka-ki and a written reply by the Secretary for Food and Health, Dr Ko Wing-man, in the Legislative Council today (May 20):
Question:
The Hospital Authority (HA) has implemented the Drug Formulary (Formulary) since 2005 with a view to ensuring equitable access by patients to cost-effective drugs of proven efficacy and safety through standardisation of policies on drugs and drug utilisation. Drugs in the Formulary are categorised into General Drugs, Special Drugs and Self-financed Drugs (SFDs). Drugs in the first two categories are subsidised by public funds while those in the last category need to be purchased by patients at their own expense. A patient group has pointed out that 14 new cancer drugs were registered in Hong Kong in the past two years, but they have not been incorporated by HA into the list of SFDs on the grounds that "there is no sufficient evidence to prove the cost-effectiveness of the drugs". This patient group has also pointed out that since many new target therapy drugs for cancers have not been incorporated by HA into the list of SFDs, healthcare personnel in public hospitals generally will not take the initiative to provide patients with information about such drugs, thus undermining patients' right to know. In this connection, will the Government inform this Council if it knows:
(1) regarding the new drugs that came onto the market in the past five years, (i) the average length of time between registration in Hong Kong and incorporation by HA into the Formulary, and
(ii) the percentage of drugs that were not incorporated into the Formulary and the reasons for that;
(2) the specific criteria currently adopted by HA when considering the incorporation or otherwise of new drugs into the list of SFDs; the standards adopted by HA for determining the cost-effectiveness of new drugs;
(3) whether the Drug Advisory Committee (DAC) of HA will adopt measures (such as increasing the frequency of meetings) to speed up the process of vetting and approval of new drugs, with a view to keeping pace with the rapid development of healthcare technology; if DAC will, of the details; whether HA has considered expanding the membership of DAC and inviting stakeholders from various sectors (including representatives from patient groups) to join, so as to enhance the transparency of DAC's work; and
(4) whether HA will conduct a comprehensive review of the Formulary system; if HA will, of the details and specific timetable; whether HA will consider issuing guidelines to healthcare personnel requiring them to provide patients with comprehensive information about drugs outside the Formulary (especially target therapy drugs for cancers that are of greater concern to patients); if HA will, of the details; if not, the reasons for that?
Reply:
President,
The Hospital Authority (HA) Drug Formulary (Formulary) was implemented in July 2005 with a view to ensuring equitable access by patients to cost-effective drugs of proven safety and efficacy by standardising the drug utilisation and drug policy in the HA. At present, there are four categories of drugs in the Formulary:
i) General drugs: drugs with well-established indications and cost-effectiveness which are available for general use as indicated by patients with relevant clinical conditions. These drugs are provided at standard fees and charges in public hospitals and clinics;
ii) Special drugs: drugs which are used under specific clinical conditions with specific specialist authorisation. These drugs are provided at standard fees and charges in public hospitals and clinics when prescribed under specific conditions. Patients who do not meet the specified clinical conditions but choose to use special drugs have to pay for the drugs;
iii) Self-financed drugs with safety net: drugs which are proven to be of significant benefits but extremely expensive for the HA to provide as part of its standard services. These drugs are not covered by the standard fees and charges in public hospitals and clinics. Patients who need these drugs and can afford the costs have to purchase the drugs at their own expense. However, a safety net is provided through the Samaritan Fund to subsidise the drug expenses of patients who need the drugs but have financial difficulties; and
iv) Self-financed drugs without safety net: including drugs with preliminary medical evidence only, drugs with marginal benefits over available alternatives but at significantly higher costs, and lifestyle drugs (e.g. weight-loss drugs). These drugs are not provided at standard fees and charges. Patients have to purchase these drugs at their own expense.
My reply to the various parts of the question is as follows:
(1) and (2) The HA has put in place a mechanism to regularly appraise new drugs and review the prevailing drug list in the Formulary with the support of 20 expert panels. Under the current mechanism, the Drug Advisory Committee (DAC) of the HA appraises new drugs regularly and determines whether a drug and its clinical use should be included in the Formulary. Nevertheless, the DAC does not automatically appraise all new drugs registered in Hong Kong. Clinicians would, in accordance with service needs, submit applications for drug appraisal to the DAC.
Since appraisal of new drugs is an on-going process and is driven by evolving medical evidence, latest clinical developments and market dynamics, the HA has no record on the average length of time between registration of new drugs in Hong Kong and their inclusion in the Formulary; and has no statistics on the percentage of drugs that are not included in the Formulary.
Cost-effectiveness is only one of the factors taken into account by the HA when considering whether a specific drug should be included in the Formulary. In appraising a new drug, the HA experts adopt an evidence-based approach and specific clinical criteria, follow principles of safety, efficacy and cost-effectiveness, and take into account various factors, including international recommendations and practices, technological changes, pharmacological class, disease state, medication compliance and quality of life of patients, practical experience in the use of drugs, comparison with available alternatives, impacts on healthcare costs, views of professionals and patients groups, etc.
The HA will introduce appropriate drugs in the light of its service development and operational needs so as to ensure equitable access by patients to cost-effective drugs of proven safety and efficacy.
(3) The DAC of the HA conducts meeting once every three months to appraise new drugs. There is no limit on the number of new drug applications for each meeting and the DAC has so far been able to complete all new drug appraisals as scheduled. Therefore, the HA has no plan to increase the frequency of DAC meetings at present.
The HA is cognisant of the strong expectation of the public and patient groups for enhancing the transparency of the Formulary and increasing patient involvement. The HA maintains close communication with patient groups on the Formulary through established liaison channels. Stakeholder engagement and communication channels have been formalised to ensure proper consultation and appropriate participation of stakeholders and service partners.
To enhance accountability and partnership with the community, HA convenes two consultation meetings with patient groups every year to keep them abreast of the latest developments of the Formulary, gather their views on the introduction of new drugs and review of the existing drug list in the Formulary. Patient groups are invited to attend meetings and submit their views and proposals to the HA for reference and consideration by relevant drug committees. With the establishment of the Patient Advisory Committee in early 2011, the Chief Executive of the HA meets patient representatives regularly to collect their views on various areas of patient services, including matters related to the Formulary. Ad hoc meetings are also convened with individual patient groups to discuss specific issues of concerns where necessary.
To enhance the transparency of the decision-making process for including new drugs in the Formulary and improve the communication with patient groups, the HA would upload to its intranet and the internet websites the professional composition of the DAC, the drug lists discussed at each DAC meeting, the review outcome of each application and the reference materials used in new drug appraisals for stakeholders' reference.
In view that enlisting representatives of patient groups in the DAC may give rise to conflicts of interest and hinder the objective discussion and expression of views by experts, the HA does not consider it appropriate to include representatives of patient groups in the DAC. Nevertheless, the HA will continue to consult patient groups on the Formulary through established liaison channels to ensure their participation.
(4) As a publicly-funded healthcare organisation, the HA has to ensure rational use of public resources so as to protect public health and patients' interest. Under the current mechanism, in addition to the DAC that appraises new drugs regularly, the HA Drug Formulary Committee is responsible for regular review of the prevailing drug list in the Formulary. General drugs that have become obsolete and are no longer required or used will be removed from the Formulary, while the clinical indications of individual Special drugs may be modified as appropriate.
Since its implementation in July 2005, the Formulary mechanism has been operating effectively and has become an important cornerstone of drug therapies in the public health sector. To cope with the continuous rapid advancement in medical technology, the Formulary is regularly updated. Apart from putting the drug policy of Hong Kong in line with international developments, this mechanism also ensures that new drugs are continuously introduced to the public healthcare system. The HA will keep on reviewing the Formulary in accordance with the principle of rational use of limited public resources to benefit more patients and with reference to the latest developments in clinical research and scientific evidence.
At present, there are different drugs in the Formulary for treatment of various diseases. Specialists would prescribe appropriate drugs and provide necessary treatments for patients, having regard to their clinical needs and in accordance with the established treatment guidelines.
Ends/Wednesday, May 20, 2015
Issued at HKT 15:27
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