LCQ20: Diagnoses and treatments for patients with cancers, uncommon diseases and terminal illnesses
******************************************************************************************
Question:
At present, there are four categories of drugs in the Hospital Authority Drug Formulary (HADF), i.e. General Drugs, Special Drugs, Self-Financed Items (SFIs) with Safety Net (Safety Net drugs) and SFIs without Safety Net. Some patient groups have relayed that it takes up to 10 years for a new drug to go through the process from application for its registration in Hong Kong, approval given for its registration, its being listed on HADF as a Safety Net drug by the Hospital Authority (HA), to its being reclassified as a General or Special Drug. During such period, there may be quite a number of patients (especially those with cancers) who have missed the golden opportunity for receiving treatments with the new drugs. On the other hand, the Government advised at a meeting with a concern group in November last year that a mechanism would be established to support patients with uncommon diseases. Regarding the provision of diagnoses and treatments for patients with cancers, uncommon diseases and terminal illnesses, will the Government inform this Council:
(1) given that at present, an application for registration of a pharmaceutical product containing a new chemical or biological entity must be accompanied by official evidence of registration approval of the product in two or more specified countries, whether the Government has made a comparison to see if (i) the relevant requirements in neighbouring countries/regions (e.g. Taiwan, Singapore, Malaysia, Korea and Thailand) are less stringent than those in Hong Kong and (ii) the time taken for registration of pharmaceutical products in those countries/regions is shorter than that in Hong Kong; if it has compared and the outcome is in the affirmative, of the details, and whether it will expeditiously study the relaxation of the relevant registration requirements in order to expedite the registration process for pharmaceutical products; if so, of the details; if not, the reasons for that;
(2) given that the Drug Advisory Committee (DAC) under HA currently meets once every three months to vet and approve applications for listing of new drugs on HADF, but the health conditions of some cancer patients may deteriorate rapidly within a short period of time, whether the Government knows if HA will (i) request DAC to meet more frequently and provide it with the necessary manpower and resources, so as to expedite the vetting and approval of applications for listing of new drugs on HADF, and (ii) introduce a fast-track mechanism for vetting and approval of applications for listing of drugs for treating cancers on HADF; if HA will, of the details; if not, the reasons for that;
(3) as the main reason for the applications for listing of drugs for treating cancers on HADF being rejected in the past two years was that the justification of the treatments' cost of the drugs in relation to their benefits was insufficient, but the listing of such drugs as SFIs without Safety Net (i) will not increase HA's expenditure, (ii) will provide more treatment options for patients to choose, and (iii) will help HA accumulate clinical data, whether the Government knows if HA will consider afresh the applications for the listing of such category of drugs on HADF as SFIs without Safety Net;
(4) of the details of the mechanism to be established by the Government for supporting patients with uncommon diseases, including the government department responsible for and the progress of its co-ordination work; whether it knows if HA will establish specialties to provide treatments to such patients; if HA will, of the specific arrangements;
(5) given that most uncommon diseases are hereditary diseases, whether the Government will step up publicity on premarital health check-up, so as to enable newly-wed couples to know the chances of their next generation having such diseases before reproduction; if so, of the details; if not, the reasons for that;
(6) whether it knows (i) the current number of public hospitals with palliative care specialty; if so, of the types of terminally-ill patients receiving palliative care and the service quotas, with a breakdown of such information by name of hospital, and (ii) if HA has adopted the Quality of Death Index in reviewing the services provided by such specialty; and
(7) given that according to the Quality of Death Index published by a think tank in 2015, Hong Kong was ranked 22nd among 80 countries and regions, whether the Government will review and improve palliative and healthcare in terms of the environment, human resources, affordability of the services, quality of the services and community engagement, so as to raise the ranking of Hong Kong in that index?
Reply:
President,
My reply to different parts of the question raised by the Dr Hon Elizabeth Quat is as follows:
(1) Under the Pharmacy and Poisons Ordinance (Chapter 138), pharmaceutical products should meet the criteria of safety, efficacy and quality, and be registered with the Pharmacy and Poisons Board of Hong Kong (PPB) before they can be sold in Hong Kong. For pharmaceutical products containing new chemicals or biological entities (i.e. active ingredients which have not been registered in Hong Kong), applications should be submitted to the PPB for approval. In such cases, legislative amendments are required in order to incorporate the new chemicals or biological entities into the relevant schedules to the Ordinance.
For registration of a pharmaceutical product containing new chemicals or biological entities, a "secondary review" approach is adopted in Hong Kong, i.e. the approval of the product should make reference to the reviews conducted by drug regulatory authorities of two or more designated reference countries. When applying for registration of a pharmaceutical product containing a new chemical or biological entity in Hong Kong, the applicant should provide supporting documents as set out in the "Guidance Notes on Registration of Pharmaceutical Products/Substances", including expert evaluation reports on the safety, efficacy and quality of the new product, and documentary proof of registration of the product (such as free sale certificates) issued by the drug regulatory authorities of two or more designated reference countries.
The Drug Office of the Department of Health (DH) has published and uploaded to its website a detailed guide on the registration of pharmaceutical products to help the pharmaceutical industry better understand the registration requirements of pharmaceutical products. In addition, the DH regularly organises talks on the registration of pharmaceutical products to explain the registration requirements to the industry and answer enquiries. Stakeholders are also encouraged to direct their enquiries to and seek assistance from the DH.
The DH has always emphasised service efficiency and has pledged that at least 90 per cent of applications for pharmaceutical product registration would be processed within five months upon the submission of all required documents by the applicants. In 2016-17, the Drug Office of the DH fulfilled the above performance pledge with about 99 per cent of applications processed within five months. The DH will continue to maintain close communication and liaison with the pharmaceutical industry, and review and improve the registration mechanism for pharmaceutical products in due course.
(2) and (3) Being the major provider in the publicly-funded public healthcare services, the Hospital Authority (HA) places high importance on providing appropriate treatment for all patients while ensuring rational use of public resources so as to protect public health and patients' interests.
As for introduction of new drugs, the HA has an established mechanism under which experts conduct meeting once every three months to evaluate new drugs (including drugs for treating cancers and uncommon disorders). The evaluation process follows principles such as evidence-based medical practice, rational use of public resources, targeted subsidy, opportunity cost consideration and facilitation of patients' choice, and takes into account safety, efficacy and cost-effectiveness of the drugs and other relevant factors, including international recommendations and practices, advance in technology, actual experience in the use of drugs as well as the views of relevant professionals and patient groups. The HA will include approved new drugs in the HA Drug Formulary (HADF) or in the scope of subsidies under the safety net as appropriate.
Drug evaluation is an on-going process driven by evolving medical evidence, latest clinical developments and market dynamics. Currently, some newly developed drugs for treating uncommon disorders and anti-cancer drugs are very expensive or even ultra-expensive. The HA notes that there is normally a lack of large-scale scientific research data and evidence of long-term efficacy, and that these drugs vary greatly in terms of evidence in safety and efficacy as well as the clinical response of patient. Hence, when evaluating applications of these new drugs, apart from adhering to the principles and considering the factors stated above, the relevant committee takes into account internationally published scientific research data. In respect of treatment, the HA will monitor the clinical conditions of individual patients and consider the drug efficacy and the risks involved in individual patients through an independent expert panel, so as to evaluate their suitability of using the drugs concerned.
The Government and the HA understand the financial pressure and burden on patients as well as their strong aspirations for the listing of certain Self-Financed Items on the HADF. The HA will continue to pay close attention to international medical research studies and the healthcare policies on uncommon disorders in other regions, listen to views and suggestions of patient groups, and continue to keep the HADF under review having regard to the principles of effective use of limited public resources and maximising health benefits for more patients.
(4) In August 2017, the Government and the HA introduced a new Community Care Fund (CCF) Medical Assistance Programme to provide subsidy for eligible patients in need to purchase ultra-expensive drugs (including those for treating uncommon disorders), and implemented on a pilot basis the adjusted financial assessment criteria and patients' co-payment mechanism. A consultancy study has been commissioned by the HA to review the mechanism, and it is expected that recommendations for improvement measures will be put forward in the first half of 2018 with a view to refining the financial assessment criteria for the CCF programme and lowering the patient's maximum contribution to drug expenses.
The Government and the HA are also examining the extension of the scope of the CCF Medical Assistance Programme to provide patients with subsidies for specific drug treatments according to individual patients' special clinical needs, including subsidising eligible patients to participate in compassionate programmes of individual pharmaceutical companies. The HA is in active discussion with the pharmaceutical company concerned, and specific arrangements and details of relevant programmes are being considered. The Government and the HA will announce the details in due course.
(5) Genetic diseases are diseases caused by abnormalities in genetic materials. Most of the uncommon disorders are either hereditary or due to genetic mutation. The Newborn Screening Programme for Inborn Errors of Metabolism is now underway. Certain relatively common inborn errors of metabolism can be detected and thus early follow-up care can be provided. Among various genetic diseases, thalassaemia is an autosomal recessive genetic disease relatively common in Hong Kong and can readily be diagnosed with blood tests.
The Family Health Service (FHS) of the DH provides woman health service for women aged at or below 64 years at its three Women Health Centres and 10 Maternal and Child Health Centres, which covers such services as health education, assessments and counselling. The health assessments include taking personal and family medical history, performing physical examinations and conducting investigations (such as blood tests and cervical screening). If a woman indicates that she is planning for pregnancy and gives a history of possible familial genetic conditions, the healthcare personnel will refer her to the Clinical Genetic Service of the DH for genetic counselling and testing as necessary. In addition, the FHS has put in place, in collaboration with the HA's obstetric departments, an antenatal shared-care programme for pregnant women, under which thalassaemia screening is provided. Pregnant women identified to have risk factors including familial genetic conditions will be referred to the HA's obstetric departments for follow-up.
(6) and (7) Currently, palliative care service in Hong Kong is mainly provided by the HA. Palliative care service of the HA provides holistic care and support for patients suffering from life-threatening or life-limiting illnesses and their families to meet their physical, psychological, social and spiritual needs, so as to facilitate a more peaceful dying process. Currently, palliative care service is provided by the HA in all its seven clusters, which includes inpatient service, outpatient service, day care service, home care service and bereavement counselling. With the aim to provide holistic care for patients, the HA has been providing appropriate palliative care with a comprehensive service model for terminally-ill patients and their families through a multi-disciplinary team, which comprises doctors, nurses, medical social workers, clinical psychologists, physiotherapists, occupational therapists, etc.
The palliative care service provided by the HA is led by palliative care specialists under the specialties of Medicine and Oncology. In the past, the service focused mainly on the care of advanced cancer patients. In the last decade, it has been gradually extended to cover patients with other diseases, such as patients suffering from end-stage organ failure (e.g. renal failure and chronic obstructive pulmonary disease).
In-patient palliative care service provides care for those with more complex conditions or dying patients. The HA also provides a range of ambulatory palliative care services including outpatient services for patients with less acute or complex symptoms, day care services for rehabilitation and psychosocial support, and home care services to optimise symptom control in the community and to empower informal care-givers. In addition, families are supported by bereavement care before and after patients’ death. Statistics on the utilisation of various palliative care services provided by the HA in 2014-15, 2015-16 and 2016-17 (up to December 31, 2016) are set out at the Annex.
In 2017, the HA developed the "Strategic Service Framework for Palliative Care" to guide the development of palliative care service in the coming five to ten years. The framework is to set out specific guidelines on its service model and system infrastructure. Measures will be introduced to provide palliative care and end-of-life care services for an increased number of terminally-ill patients within hospital settings and in the community. Such measures include offering home palliative care service, increasing the frequency of home visits by nurses each year and providing training for the staff of residential care homes for the elderly. Moreover, enhancing medical-social collaboration with community partners, such as non-governmental organisations, patient groups and volunteers, for supporting patients and their families or carers is also highlighted among the strategies.
With the aim of formulating the long-term development direction of healthcare services in response to the challenges of an ageing population, including palliative care service, the Food and Health Bureau commissioned in 2015 the Chinese University of Hong Kong to conduct a three-year research study on the quality of healthcare for the ageing. By making reference to the findings and recommendations of the study, the Government will continue to enhance the palliative care service in Hong Kong, including considering amendment to the relevant legislation.
Ends/Wednesday, January 31, 2018
Issued at HKT 19:23
Issued at HKT 19:23
NNNN