LCQ15: Provision of drugs for patients
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Question:
There are views pointing out that patients with rare diseases and cancers in Hong Kong encounter obstacles after obstacles on their way to recovery and suffer a lot from torments of their body and mind. Their family members even have to bear enormous financial and psychological pressure. Being able to receive treatment with new drugs as soon as possible is the only hope for those patients to survive. Regarding the provision of drugs for patients, will the Government inform this Council:
(1) as it is learnt that earlier on, the National Healthcare Security Administration had a live video broadcast of the process of its on-the-spot price negotiation with pharmaceutical enterprises and successful procurement of a number of drugs, whether the Government will follow such procurement mode and practice (e.g. negotiating prices with pharmaceutical manufacturers directly on the spot to enhance the procurement efficiency, and disclosing information such as the procurement progress and evaluation results of drugs for public reference and monitoring);
(2) whether it will, by drawing reference from the practices of overseas regions (e.g. the United Kingdom and Australia), introduce a mechanism similar to the Health Technology Assessment to improve the procedure of including new drugs in the Drug Formulary of the Hospital Authority; if so, of the details and the timetable; if not, the reasons for that;
(3) as it is learnt that some advanced countries have introduced some new polices on drug registration (e.g. allowing the conduct of a "bundled assessment" for new drugs with multiple indications) to reduce the manpower cost of drug vetting and approval, whether the Government has plans to follow such policies or improve the existing approach to drug registration; if so, of the details; if not, the reasons for that; and
(4) as it is learnt that cancer patients' "biomarker" testing results are currently used in Hong Kong to determine whether the patients concerned can receive subsidies for immunotherapy drugs, resulting in a situation of "different drugs for the same disease", and there are even some patients who cannot receive subsidies due to the special conditions of their diseases (e.g. lung cancer patients who do not have epidermal growth factor receptor (EGFR) mutation, whose tumours have a programmed cell death ligand 1 (PD-L1) expression of less than 50%, and who do not have metastatic squamous non-small cell lung cancer), causing delays in treatment, whether the Government is aware of such situations, and what specific solutions it has in place?
Reply:
President,
In consultation with the Department of Health (DH) and the Hospital Authority (HA), the consolidated reply to the question raised by the Hon Elizabeth Quat is as follows:
(1) The HA’s prevailing procurement policy aims to ensure efficient operations, uphold fairness and accountability while actively introducing market competition with a view to achieving economies of scale, so as to acquire value-for-money pharmaceutical products and medical consumables. The HA has clearly stipulated the relevant requirements in its Procurement and Materials Management Manual, including administrative guidelines and procurement procedures guidelines, to ensure the procurement of pharmaceutical products in the most cost effective manner through an efficient, fair and competitive mechanism, so as to promote market price competition.
In order to achieve economies of scale, currently the HA mainly purchases pharmaceutical products through a centralised bulk procurement model. The HA will also, where necessary, invite registered suppliers to submit tenders through open tendering to achieve the highest level of cost-effectiveness. To enhance the transparency of the procurement process, the HA has been publishing Tender Notices and Contract Award Notices, containing the name of the tenderer awarded the contract and the contract sum, for public reference. Moreover, the HA has been maintaining close liaison with suppliers or manufacturers through established channels to grasp the latest market information and initiate discussion as appropriate.
Furthermore, the DH procures pharmaceutical products for its various clinical services according to an established mechanism. The Drug Monitoring Committee (DMC) comprising doctors of different specialties and pharmacists has been established under the DH to devise the Drug Formulary of the department according to clinical needs. The Formulary is reviewed and updated on a regular basis. Pharmaceutical products that satisfied the relevant requirements are procured from the market in accordance with the decisions of the DMC and the strict procedures set out in the Stores and Procurement Regulations promulgated by the Government Logistics Department.
Having regard to the above considerations, the Government currently has no plans to adopt the drug procurement approaches under which on-the-spot price negotiations between the HA and/or the DH and drug companies are live-streamed.
(2) In accordance with the HA’s current established mechanism, the Drug Advisory Committee will conduct regular appraisal of registered new drugs or their indications as well as review of the Hospital Authority Drug Formulary (HADF) and the coverage of the safety net with the support of multiple expert panels of different specialties, in order to cater for prevailing and evolving service needs.
The review process follows an evidence-based approach, having regard to the safety, efficacy and cost-effectiveness of drugs and other relevant considerations, which include international recommendations and practices as well as professional views, so as to ensure equitable and effective use of public resources in providing optimal treatment for patients. In evaluating the considering factors for application of new drug listing, the relevant committees of the HA will make reference to recommendations of national and international authorities (Note) for disease management and reimbursement status of the concerned drugs in regions with similar healthcare systems where applicable.
The HA will keep in view the latest clinical developments and research findings from around the world (including the Mainland) and expand the coverage of the HADF so that patients can have access to appropriate drug treatment in a timely manner.
(3) According to the Pharmacy and Poisons Ordinance (Cap. 138), pharmaceutical products must satisfy the criteria of safety, efficacy and quality for registration with the Pharmacy and Poisons Board of Hong Kong (the Board) before they can be sold or supplied in Hong Kong. The DH is responsible for providing professional and executive support to the Board. Applicants for registration of pharmaceutical products are required to submit the necessary documents in accordance with the Guidance Notes on Registration of Pharmaceutical Products/Substances as promulgated by the Board. Generally speaking, applicants for registration of pharmaceutical product containing new chemical or biological entities (NCEs, i.e. containing active ingredients which have not been registered in Hong Kong) are required to provide necessary information, including documentary proof for registration issued by at least two drug regulatory authorities of reference places in accordance with the Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity as promulgated by the Board, in order to provide supporting evidence that the product has been rigorously evaluated before being placed in the market. At present, there are 36 such drug regulatory authorities, including those of Mainland China, Brazil, Korea and Singapore, which were added on November 1, 2022.
In order to facilitate timely registration of new pharmaceutical products containing NCEs in Hong Kong for the treatment of patients, the Government has introduced various measures in the past few years to expedite the registration of pharmaceutical products containing NCEs. These included the amendment to the Pharmacy and Poisons Ordinance in 2015 so that the legislative amendments relating to NCEs could be made via the negative vetting procedure in order to expedite the registration of new pharmaceutical products containing NCEs in Hong Kong. To further expedite the processing of application for registration, the Board implemented the Enhanced Procedures for Registration of New Drugs (Enhanced Procedures) in 2018. Upon receipt of an application for registration of a new pharmaceutical product containing NCEs by a pharmaceutical company, or when a new pharmaceutical product containing NCEs is covered under the Expanded Access Programme of the HA, or other relevant drug programmes subsidised by the Government, the Board will initiate the legislative procedures simultaneously with a view to shortening the time required for registration of the pharmaceutical product. With the implementation of the Enhanced Procedures, the application time for registration of pharmaceutical products is generally shortened by two to three months.
The DH has pledged that no less than 90 per cent of applications for pharmaceutical product registration would be completed within five months upon the submission of all required documents by the applicants. In the past three years, the DH were able to fulfill the above performance pledge. During 2020 to 2022, 99.4 per cent of the applications were completed within five months on average upon the receipt of all required documents. In view of the above refinement measures that are already in place, there is no plan at this stage to take forward the practice of "bundled assessment".
(4) As the major provider of public healthcare services, the HA attaches great importance to providing optimal care for all patients while ensuring proper use of public resources. The clinical condition, treatment needed and drug response of each patient vary, and doctors will prescribe appropriate drugs based on professional judgement and the clinical conditions of patients. Traditionally, the same type of cancer medications are prescribed to patients with the same type of cancer. With genetic testing nowadays, clinicians can better determine the most optimal treatment options for patients in providing more personalised and precise disease treatment.
Regarding drug management, the HA regularly evaluates new drugs as well as reviews the HADF and the coverage of the safety net (including the Samaritan Fund and the Community Care Fund Medical Assistance Programmes) according to the established mechanisms. At present, the safety net covers a number of immunotherapy and cancer drugs for treatment of lung cancer having regard to different clinical indications.
Evaluation of new drugs as well as review of the HADF and the coverage of the safety net (in terms of subsidisation and clinical indications) is an on-going process driven by evolving medical evidence, the latest clinical developments and market dynamics. The HA understands the financial pressures and burden faced by cancer patients, as well as the strong aspiration to include certain self-financed cancer drug treatments in the HADF and the safety net and to relax clinical indications of individual drugs.
The HA will continue to keep in view of the latest development of clinical and scientific evidence of cancer drugs and immunotherapy, listen to the views and suggestions of patient groups, and, under the principle of proper use of limited public resources, continue to review HADF and coverage of the safety net, including the drugs covered and their clinical indications, through the established mechanisms, so as to benefit more patients in need.
Note: Including the National Institute for Health and Care Excellence (NICE) of England, the Scottish Medicines Consortium (SMC) of Scotland, the Pharmaceutical Benefits Scheme (PBS) of Australia etc.
Ends/Wednesday, May 3, 2023
Issued at HKT 16:00
Issued at HKT 16:00
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