Post on 28-Aug-2020
transcript
Submission on the policy address by the Hong Kong Association of the
Pharmaceutical Industry
Introduction
Found in 1968, the Hong Kong Association of the Pharmaceutical Industry (HKAPI)
represents 39 research and development (R&D) multi-national pharmaceutical
companies that supply 70% of prescription drugs in Hong Kong. Our mission is to
drive the expedient access to innovative healthcare solutions for the people of Hong
Kong and Macao with high ethical standards.
Like many other developed economies, the healthcare system in Hong Kong is facing
challenges, such as a rapidly aging population and the increasing cost of treatment.
Recently, the Hong Kong Government increased spending on healthcare. We are glad
to see that the Government is placing more emphasis on improving the healthcare
system for Hong Kong people. Nevertheless, resources are not unlimited and
therefore, we need to ensure there will be better resource allocation and a more
efficient system that will help to achieve improved outcomes.
It is the belief of the HKAPI that Hong Kong should adopt the framework announced
by WHO at the Sixty-Ninth World Health Assembly for integrated people-centred
health services. This includes:
• Equity in access: For everyone, everywhere to access the quality health services
they need, when and where they need them. In other words, achieving and
sustaining universal health coverage including utilization of primary health care
as part of strengthening the health system.
• Efficiency: Reducing duplication of services including hospitalizations and
lengths of stays.
• Engagement: Increased ability for individuals to self-manage and control
long-term health conditions as well as greater participation and shared decision
making about the use of health resources.
The HKAPI proposes that the above-mentioned principles be consolidated into two
clear directions:
1. Implementing structural changes in the healthcare service delivery system to
improve the system’s efficiency and effectiveness through developing an
integrated process thus providing better support to the patient journey.
2. Transforming healthcare provision into a model for sustainable economic
development by leveraging stakeholders and talent to build a holistic R&D
ecosystem.
Content
A. Building a Visionary and Efficient Healthcare Service Delivery System
1. Preventative and Primary Healthcare
2. Timely and Equitable Access to Innovative Medicines
2.1. Proposal of a New Review Process for NCE with Unmet Need
2.2. Timely and Equitable Access of Innovative Medicines to the Hospital
Authority Drug Formulary (HADF)
3. Develop a Comprehensive Rare Disease Policy in Hong Kong
B. Holistic Approach to Enhancing the R&D Eco-system in Hong Kong
4. Structural Support to Champion the Vision
5. Develop Hong Kong into Centre of Excellence for Clinical Trials in Asia
6. Unveil the Big Data in Public Hospital system
Conclusion
A. Building a Visionary and Efficient Healthcare Service Delivery System
Developing a structured primary healthcare system with reference to the patient
pathway with Community Health Centres (CHCs) providing integrated healthcare
services such as health education, disease prevention and screening, detection and
palliative services, private and GOPC PPP network doctors.
Creating a systematic framework for disease prevention (e.g. vaccination) and
screening (e.g. chronic diseases such as stroke and dementia) with relevant
resources.
Ensuring healthcare vouchers are used for their designated purpose according to
the care protocol developed for various chronic diseases and advised by family
doctors, to ensure money follows patients and encourages patients actively
participating in the management of their disease.
Establish a visionary pledge for the drug enlistment process to be completed in 12
months in the public sector to bring more new and innovative medicines to needy
patients in Hong Kong.
Set up a comprehensive rare disease policy in Hong Kong
1. Preventive and Primary Healthcare
Primary Healthcare became WHO’s core policy in 1978, with the adoption of the
Declaration of Alma-Ata. It identified Primary Healthcare as the key to the attainment
of health for all with guidance on:
• universal access to care and coverage on the basis of need;
• commitment to health equity as part of social justice;
• community participation in defining and implementing health agendas;
• intersectoral and multi-disciplinary approaches to healthcare provision.
Based on the philosophy of people-centred care, the patient pathway is core when
considering the delivery of healthcare services. The patient pathway should
encompass prevention, screening, diagnosis, treatment and palliative care as a basis
for building a model of Primary Healthcare.
Graphic 1: A primary healthcare model based on the patient pathway
We are pleased that the Hong Kong Government unveiled its plan in the policy
address last October to develop a comprehensive Primary Healthcare model by
setting up District Healthcare Centres (DHCs) throughout the city. People visiting
these DHCs will receive a comprehensive supportive service including healthcare
promotion, patient empowerment programs, disease screening and detection and
palliative programs organized by multi-disciplinary allied healthcare professionals
including specialist nurses, pharmacists, nutritionists, physiotherapists and
optometrists. The HKAPI welcomes this plan.
These care centers could further be enhanced through the integration of clinical care
and services provided by front line general practitioners (GPs) and providers of other
ancillary and supportive services.
HKAPI recommends:
1.1 Prevention and Screening
According to numerous research studies, disease prevention and screening are
the most effective ways to reduce downstream healthcare costs. As preventive
measures and earlier treatments generally cost less than the treatments for most
advanced diseases, the HKAPI proposes that the Government put more
resources into these two areas and extends screening programs to diseases that
have a profound social as well as cost impact on society and families, such as
hepatitis, flu and dementia.
1.2 Diagnosis and Treatment
Early diagnosis allows reductions in hospital stays, disabilities, faster recovery and
less strain on healthcare manpower. Diagnosis and treatment can be supported
by GPs via Public-Private-Partnership (PPP) programs that aim to reduce patient
wait times and help existing public hospitals to refocus their resources on
secondary and tertiary care.
1.3 Integration with Doctors Network
The General Outpatient Clinic Public-Private Partnership Programme (GOPC PPP)
was launched by the Hospital Authority (HA) in mid-2014 with the aim of
providing choice to patients. People may receive Primary Healthcare services
from the private sector. The scheme seeks to enhance access to Primary
Healthcare services, promote the family doctor concept, help the HA manage
demand for general outpatient services and foster the development of the
territory-wide Electronic Health Record Sharing System. As of 20 August 2018,
there were 369 service providers from 18 districts participating in the
programme.
The HKAPI recommends integration of this program and the DHC Doctors
Network in order to avoid duplication of effort since the two networks have
similar objectives and job responsibilities are also highly likely to overlap.
Graphic 2: Reference patient’s journey in healthcare system
1.4 Building Capacity with Performance-based Incentive Models
To familiarize GPs with new care protocols, training and educational support for
managing chronic diseases should be provided in collaboration with academic
and medical societies through accredited courses endorsed by the industry.
Accredited courses leading to certification can help GPs prepare for the
expansion of PPP to cover more chronic diseases.
As it is important to monitor and improve treatment outcomes of people joining
the PPP program, performance-based incentive models can be introduced in the
Primary Healthcare setting. Quality measurements should be developed to
support assessment of care services at the provider level. Quality metrics have
proved to be valuable in helping healthcare professionals enhance patient
outcomes along the care pathways in the United Kingdom.
1.5 Designated Use of Healthcare Vouchers
The HKAPI supports the important principle that people should have a choice in
terms of choosing their services, services providers and also treatment options. In
addition, people should also be encouraged to take responsibility for their own
healthcare by actively participating in disease management. A healthcare voucher
with a designated purpose could be an effective vehicle for achieving this goal.
We propose that family doctors could be empowered to determine the usage of
the vouchers in accordance with the care protocols developed for chronic
diseases. The vouchers should be provided on an annual basis with no rollover to
subsequent years and used as co-payment for procuring healthcare solutions.
Under this scheme, the concept of “family doctors” could be promoted and the
scheme would allow people to make their own choices and play a more
prominent part in managing their own health.
Graphic 3: DHC Concept and Utilization of Healthcare Vouchers
2. Timely and Equitable Access to Innovative Medicines
2.1 Proposal of a New Review Process for NCE with Unmet Need
It is now universally accepted practice for health authorities to expedite the
availability of innovative drugs that treat serious or life-threatening diseases
particular those which are first in class or have advantages over existing
treatments. Food and drug administrations have developed approaches to
making such drugs available as rapidly as possible through priority or fast track
review and accelerated approval.
Hong Kong has adopted a “secondary review” for the registration of a
pharmaceutical product containing new chemical entities (NCEs)1 with two
Certificates of Pharmaceutical Products (CPPs) required before NCE application.
There is, on average, a time lag of six to nine months between the first and
second CPP of a new product. To catch up with the world trend as well as to
better support critically ill patients, the HKAPI recommends introducing a special
review process for drugs in areas of unmet need as is the case in Singapore.
HKAPI recommends
2.1.1 Scope
The proposed scheme would apply to the registration of products for oncology,
rare diseases2 and life-threatening diseases that currently lack safe and effective
treatments.
2.1.2 Criteria for Special Review
The applicant would be required to provide scientific evidence to substantiate
the claim that there is a local unmet medical need. The proof should include a
review of current available treatments and standard therapies and the
1 “Primary review” means a full review on the safety, efficacy and quality of the drug by scrutinizing
all the preclinical (i.e. animal) studies, clinical studies and manufacturing and quality control
documentation. “Secondary review” means approval of drugs based on the reviews conducted by one
or more of the reference drug regulatory authorities (e.g. US or EU).
2 Rare diseases as per the classification used in a reputable reference country or by China's Food and
Drug Administration.
limitations of these therapies. The applicant should provide epidemiological data
to support the application.
The Department of Health may examine the evidence in association with one or
more independent reviewers3
The Department of Health could hold a pre-submission meeting to let the
applicant respond to certain preliminary questions before allowing a special
Review for the application. If the request for review is not granted, the applicant
would have to follow the normal NCE submission requirements.
2.1.3. Evaluation on Efficacy, Safety and Quality
The Department of Health can evaluate the efficacy, safety and quality of a
product based on the Clinical Technical Dossiers and one CPP issued by a
reference country. The independent reviewer can evaluate the efficacy and
safety of the product based on the clinical data provided. The introduction of an
independent reviewer would provide the scientific justification for the use of a
product without the requirement for two CPPs.
2.1.4. Pharmacy Poisons Board (PPB) Approval
PPB may invite independent reviewers to address questions in the review
meeting. During the session, the PPB may, if deemed appropriate, impose
additional licensing conditions e.g. annual product license review and additional
risk minimization measures. It may also have the right to revoke a registration
license if the product in question is withdrawn or suspended in the reference
country owing to any safety issues.
3 An independent reviewer is a local clinical expert teaching at a university. He or she would be invited by the Department of Health to join the review panel.
2.2 Timely and Equitable Access of Innovative Medicines to the Hospital Authority
Drug Formulary (HADF)
The Hospital Authority (HA) has operated the HADF since 2005 with a view to
ensuring equitable access by patients to cost-effective drugs with proven safety
and efficacy by standardizing the drug policy and utilization in all public
hospitals.
Recently (June 2018), the HKAPI conducted a survey on oncology treatment
access as there is a narrow treatment window to enhance survival for cancer
patients. The result showed that it takes around 34 months for a registered drug
to be enlisted in all the HA hospitals. From DAC approval, it takes 19 months
before drugs are listed in Safety Net (Samaritan Fund and Community Care Fund).
It is critical that Hong Kong people have speedier access to medical
advancements.
HKAPI calls for the HA to develop a visionary pledge to ensure timely patient
access to innovative and effective new treatments within 12 months from drug
registration. All patients in the HA should have equitable access to innovative
medicines at the same time and stage of their disease.
Figure 1: Current Safety Net Enlistment Process and Timeline (HKAPI oncology
enlistment survey June 2018)
It takes almost 34 months to introduce new treatments to the HADF
Step 1: Drug and Therapeutics Committee (DTC)
Applications for inclusion of new drugs into the HADF must be initiated by
clinicians, endorsed by the heads of the clinical departments and reviewed and
recommended by at least one DTC of the relevant hospital cluster or hospital.
Step 2: Drug Advisory Committee (DAC)
Drugs are evaluated and approved by the DAC. New drug will be approved under
General Drug or Special Drug or Self-Financed Item (SFI) without Safety Net.
Step 3: Drug and Therapeutics Committee (DTCs)
After DAC approval, many patients still have to wait for the review and decision
of the remaining relevant DTCs in different clusters/hospitals before they can
access the drugs.
On average, it takes almost 34 months to complete the whole process.
Additional 19 months to access Safety Net
Step 1: Central Committee (CC) and Coordinating Committee (COC)
If a clinician wants to prescribe a SFI treatment to a patient who cannot pay out
of pocket, he/she has to initiate an application to the respective CC and COC for
the relevant disease area. To fulfill the application requirements, the clinician
needs to collate drug information including pricing as well as information on
clinical criteria.
Step 2: Drug Management Committee (DMC)
After deliberation, the proposing COC or CC will present clinical evidence and
pricing information to the DMC.
Step 3: Medical Services Development Committee (MSDC)
The DMC will then evaluate and prioritize all recommendations to the Samaritan
Fund Management Committee (SFMC). After that, the SFMC will pass the
application to the MSDC for endorsement, where a final verdict will be passed. If
the application fails, the clinician has to begin the process again by launching
another application to the COC and CC.
HKAPI Recommends
2.2.1 Streamline the DTC process and shorten the lead time for patients to gain
access to needed new treatmentsEliminate the requirement for
hospital/cluster DTC scientific evaluation after DAC approval. This will
avoid duplicating administrative efforts and ensure equitable and timely
access to treatments between clusters.
• Expedite the post-DAC administrative procedure, reducing the drug code
creation, from three months to a more reasonable timeline.
• Recognize that for oncology patients where weeks matter, early access to
new treatments is even more critical to survival time and quality of life by
fast-tracking the review for all cancer treatments at the initial DTC stage.
Figure 2: Suggested Improvements (From 1st DTC to post DAC)
2.2.2 HADF Value-based Decision Making
HKAPI recommends that DAC refers to the following when considering whether a
treatment should be included in the HADF:
• Benchmark decisions of other key health authorities e.g. United Kingdom,
Australia and Taiwan.
• Take into account priority review or breakthrough status by international
regulatory authorities or treatment guidelines.
• Reference the International Society of Pharmcoeconomics and Outcomes
Research (ISPOR) recommendations by considering the costs of other
condition-related healthcare services provided by the HA e.g. physicians
and emergency visits, hospitalization, diagnostic and surgical procedures
and laboratory testing in addition to the cost of new drugs, when assessing
the cost effectiveness of introducing a new treatment.
Figure 3: “Drug Value” in DAC Enlistment Decisions
2.2.3 Delineating the process of Safety Net Evaluation
• Currently, the decision to include a drug in Safety Net has to go through 6
committees: DAC, CC, COC, DMC, SMFC and MSDC with duplicated criteria
and a lengthy process. The HKAPI calls for clearly delineating the
decision-making criteria of these committees.
• In additions, many countries have consulted patient groups in their drug
reimbursement decisions and we recommend that the HA follows suit and
collects individual patient and patient groups’ opinions on their treatment
needs. This would also fit with the people-centered care approach which
WHO advocates.
2.2.4 Conclusion: Improvement Outcomes and Benefits to Stakeholders
With the adoption of the proposed changes: -
From drug registration, a new treatment could be made available in 7
months (compared to 34 months in the current process).
New treatments, especially in Oncology, where time is critical to patient
survival and which can be relatively more expensive than other disease
areas, would have Safety Net enlistment 14 months after new drug
registration.
Figure 4: Improved Enlistment
Process
3. Develop a Comprehensive Rare Disease Policy in Hong Kong
To remove the considerable barriers that exist in terms of access to appropriate care,
delayed diagnosis and limited or non-existing treatment options, HKAPI recommends
the Government considers establishing an integrated and comprehensive Rare
Disease Policy in Hong Kong. HKAPI recommends:
3.1 Defining Rare Disease
To optimize people-centred care, a clear definition of rare diseases is of critical
importance. People affected by rare diseases should be provided with timely
access to relevant medical and social support. HKAPI recommends Hong Kong
follow the European Union’s example and define rare diseases as those with a
prevalence rate of less than 5 in 10,000 persons. Hong Kong should adopt the
first list of rare diseases released by the China Government. It would also be
prudent to establish a rare diseases registry to monitor the prevalence of rare
diseases in Hong Kong and support better evidence-based strategic planning and
decision making in future.
3.2. Detection and Awareness
HKAPI recommends that the current neonatal screening protocol and genetic
clinic services be reviewed to enable early diagnosis and access to innovative
treatments. There is potential for the Hong Kong Children’s Hospital to establish
a Centre for Rare Diseases providing medical and social support to people and
families affected by a rare disease. More education on screening and diagnosing
rare diseases should be provided to obstetric and neonatal healthcare
professionals, as well as parents-to-be.
3.3. Fast tracking Regulatory Approval for Rare Disease Treatments
To shorten the time from product licensure in the country of origin to access for
people in Hong Kong, HKAPI recommends relaxing the registration requirements
to one CPP for treatments falling into the rare disease definition. The CPP can be
issued by any overseas authorities including US FDA, EU EMA, Taiwan FDA and
China CFDA.
A treatment for a disease of extreme rarity (e.g. only one person affected in
Hong Kong) should be considered for a special named patient program thus
removing any further delays if the treatment has been approved by an overseas
authority.
3.4 Accelerating Enlistment and Reimbursement in the Hospital Authority
HKAPI recommends that treatments suitable for managing rare diseases
(including medications for peripheral symptom relief) should be eligible for
fast-track enlistment and reimbursement evaluation to enhance the timeliness of
treatment accessibility. This includes setting up an expert panel for rare diseases,
with members composing of a geneticist, pharmacist, paediatrician and internal
medicine for the HA. A support network of experts in nearby Asian countries
could also be included to facilitate exchange in knowledge and best practices in
rare diseases management and support decision making for enlistment and
reimbursement.
3.5. Enhancing the Sustainability of Treatment Funding
HKAPI recommends operational improvements to ensure treatments and
funding are accessible to people affected by rare diseases at optimum speed.
This includes:
• Building a sustainable budget pool separated from the recurrent HA drug budget
for rare disease treatments. An annual review should be put in place to assess
the need for additional budget injections according to new treatments approved.
• Consideration of risk sharing schemes between pharmaceutical companies
manufacturing rare disease treatments and the HA or co-payment schemes for
people affected by rare diseases.
B. Holistic Approach to Enhancing the R&D Eco-system in Hong Kong
The Government has identified biomedical technology as one of the potential new
drivers of Hong Kong’s economy. In 2017, the total research and development (R&D)
investment by the bio-pharmaceutical industry was estimated to be US$ 158 billion.
On a regional basis, Asia’s pharmaceutical industry has the largest share of both
global GDP and the sector’s workforce.4 Many countries have grown their share of
this investment through the provision of infrastructure, streamlined processes,
enhanced tax and other economic benefits.
Other advantages of participating in R&D
• Participation in clinical research is crucial to the training of healthcare
4 Ostwald, D. A. / Zubrzycki, K. / Knippel, J. (2015): The Economic Footprint of the Pharmaceutical Industry – Regional Breakdown and Differentiation between Originators and Generics. Berlin.
Enhancing Clinical Research and Development will transform Hong Kong
healthcare into a profitable bio-medical industry, as well as a service to improve
outcomes for our people. Setting a clear vision is crucial e.g. to include 10% of
patients within 10 years into clinical trials.
Appoint a Government Chief Scientific Officer (CSO) reporting to the Chief
Executive and Secretary for Food and Health to coordinate this transformation
with a cohesive strategy.
Establish a Dedicated Clinical Trials organization. This should be separated from
the “Risk and Quality department” and set up as a central part of good clinical
care; staffed by nurses, to implement the acceleration of the start-up of studies
(single ethics committee and removal of delays).
Leveraging big data will be a unique opportunity to assess patient population size
estimates and better prioritize Hong Kong to be a chosen location for research.
The Big Data strategy should be led by the CSO.
Extend research conducted in Hong Kong to include people across the Greater
Bay Area taking the research population from 7.4 million to over 60 million
people and developing a centre of excellence for clinical trials in Asia
professionals and can enable Hong Kong to keep pace with new scientific
advances.
• Scientists participating in clinical drug development will gain access to privileged
scientific information, which may stimulate their own research.
• Enhancing clinical trial opportunities will reduce academic/clinician “Brain Drain”
4. Structural Support to Champion the Vision
In the 2017 policy address, to encourage research and development (R&D)
investment by enterprises, the Government proposed to introduce a 300% tax
deduction for the first $2 million eligible R&D expenditure, with the remainder at
200%.
HKAPI Recommends
4.1 Set a Vision and Define Success for R&D in Hong Kong
Visionary key performance indicators can outline the future state of Hong Kong
R&D development. Currently, less than 0.1% of patients in Hong Kong are
recruited to take part in clinical trials. However, in the UK, 10 % of patients have
already been involved in clinical trials. Therefore Hong Kong should set a goal
and work toward having 10% of local patients participating in clinical trial in 10
years.
4.2 Create a dedicated role to champion the mission
Appoint a Chief Scientific Officer, reporting to the Chief Executive and Secretary
for Food and Health5, to lead the implementation of the Hong Kong SAR vision to
develop the R&D bio-medical hub and related core projects including initiatives
to develop a prioritized clinical trial centre and create a Healthcare Data
Analytics platform. The officer, as a coordinator, should advise relevant
5 The UK Government Chief Scientific Adviser (GCSA) is the personal adviser on science and technology-related activities and
policies to the Prime Minister and the Cabinet; and head of the Government Office for Science.
In Canada, the Chief Scientific Adviser has a significant public role as the government's most visible scientific expert. They are also head
of the Science and Engineering Profession in government.
• provide advice on the development and implementation of guidelines to ensure that government science is fully available to the
public and that federal scientists are able to speak freely about their work;
• provide advice on creating and implementing processes to ensure that scientific analyses are considered when the Government
makes decisions;
• assess and recommend ways to improve the existing science advisory function within the federal government; and
• Assess and recommend ways for the Government to better support quality scientific research within the federal system.
Government departments and stakeholders such as the Science Park and
academics on matters relating to funding or manpower development.
5 Develop Hong Kong into Centre of Excellence for Clinical Trials in Asia
As the pharmaceutical industry is engaged in many types of research and
development, this paper focuses on the clinical development of medicines in human
subjects. Such clinical research is the prerequisite for growth of pre-clinical and other
research.
The HKAPI carried out a survey among its member companies in 2017. The results
demonstrated that the top 5 drivers attracting research to Hong Kong were:
• High data quality
• Experienced and credible investigators
• Mutual recognition of trial data between Hong Kong and Mainland China
• Well-equipped hospitals and
• Simple and transparent approval procedures for the regulatory authority
There were also some deterring factors such as the time for setting up clinical trials,
lack of supporting incentives and the cost of clinical trials. Among all of these factors,
the most impactful one is the time spent on setting up clinical trials. Hong Kong
ranked behind South Korea, Singapore and Taiwan for regulatory and ethics
committee approval time. In total, the time taken by healthcare institutions in Hong
Kong to process trial contracts is 4 times longer than in Singapore.
Figure 6: Setting Up Clinical Trials in Hong Kong vs. Singapore
Therefore, to develop Hong Kong as the centre of excellence for clinical trials,
expediting the time to set up clinical trials is an important area to address.
HKAPI recommends
5.1 Creating a Clinical Trials Unit (CTU), to accelerate procedures to set up clinical
trials with the following responsibilities:
• Acting as a single point of contact to lead on trial feasibility and set-up
• Establishing a single Hong Kong ethics committee
• Accelerating legal review for contracts and indemnity
• Setting and measuring targets and standards for hospital clusters to deliver
clinical trials
• Training and providing dedicated staff in the hospitals to recruit and manage
patients
• Reviewing the existing facilities, such as hospital diagnostics equipment and
ensure that they are fit for the purpose
5.2 Providing Incentives for Companies to Initiate R&D
5.2.1 Provide a direct Government monetary incentive such as tax breaks or grants to
companies placing clinical trials in Hong Kong.
5.2.2 Introduce Adaptive Pathways (AP) and Managed Entry Agreements (MEA) to
enhance access as incentives
The rationale behind APs is the same which led to the development of coverage with
evidence development MEAs; enabling patients early to access new drugs while
collecting real-life data in order to update the final decision.
Definitions:
MEAs - it is the final reimbursement decision and the related restrictions or
recommendations on how a medicine should be used within the health system.
AP - it is about whether the drug should be made accessible to all patients or a
sub-population.
APs
The EMA launched a pilot in 2014 on AP. The aim of AP is to foster and facilitate the
pathway of product development to potentially achieve earlier access to medicines
through an early dialogue involving all stakeholders. Essentially APs are an
instrument to balance early access to new medicines to patients with the need of
collecting information on the drug benefits and harms. The concept is to initially focus
on a population of good responders followed by adaptation of the licensing
conditions as more evidence becomes available. There are two models for APs:
In the first model, the manufacturer secures approval in a well-defined
subpopulation with a high level of unmet clinical need, before expanding the
indication to a larger population.
In the second model, the manufacturer secures an early marketing authorization,
possibly on the basis of surrogate endpoints, subject to a commitment to reduce
uncertainty by gathering more evidence.
MEAs
Stretched health care budgets, increasing availability of potentially life-saving
high-cost drugs mean that manufacturers seeking reimbursement need to
demonstrate that their drugs can provide additional benefit in relation to current
therapies and value-for-money in order to obtain coverage. Data and the overall
evidence base available at registration are often insufficient to accurately estimate
the clinical and cost-effectiveness of a drug in clinical practice or its budget impact in
real life (e.g. oncology drugs). Uncertainty, due to lack of information on
effectiveness, may delay reimbursement decisions and patient access. There are two
main ways to address uncertainty relating to clinical and/or cost effectiveness:
The first is to grant reimbursement for a limited time period during which
additional evidence on the drug effectiveness will be collected and to update the
reimbursement decision afterwards based on the new cost-effectiveness results
(used in the Netherlands, Sweden and Portugal).
The second way is to decrease the price or to limit utilization so that the
cost-effective ratio is improved because of lower costs (UK, Czech Republic).
One of the most important instruments for MEAs is drug-monitoring registries. These
registries aim to asses and track patient eligibility, evaluate utilization in clinical
practice, collect epidemiological data including data on the safety profile and collect
additional information which was missing at the first evaluation stage. This should
guarantee appropriate use of medicines according to the therapeutic indications
while providing important information on the tolerability of a new drug and
prescribing appropriateness and can be especially useful in rare diseases.
5.3 Leveraging the China factor
Hong Kong should leverage its proximity to China as well as its advanced medical
infrastructure, high-quality and experienced research investigators to position
itself as the principal clinical trials site for conducting clinical research and
facilitate industry collaboration with research institutions in China.
The Government should facilitate the accreditation of additional clinical trial sites
and ensure clinical data transferability for trials conducted in Hong Kong. At the
same time, clinical trial in approved sites in Hong Kong could be recognized by
China’s authority automatically if they use the same clinical trial protocol. If Hong
Kong trial data was recognised by China FDA for registration of medicines in China,
this would be significantly attractive to global pharmaceutical companies.
Furthermore, to solve the problem of the limited number of subject matters
because of the limited population size, access to people in the Greater Bay Area
through R&D launched in Hong Kong would significantly increase the chances of
attracting clinical trials.
6.6. Unveil the Big Data in Public Hospital system
This clinical database empowers the HA to become the sole public health service
provider, serving a local population of 7.4 million and managing 87% of all hospital
beds in Hong Kong. Since its birth, database in HA has been collecting patient data for
more than 25 years and it contains essential real-world clinical information including
patient demographics, hospitalizations, visits to outpatient clinics and emergency
departments, diagnoses, laboratory results, procedures, prescriptions, dispensing of
medications and deaths. It can be anonymized for collective analyses and patients
are assigned a unique patient identifier in the system.
The Chief Executive announced that the HA will develop a Big Data Analytics Centre
to achieve the set goal of leveraging the database for R&D.
HKAPI Recommends
6.1 To ensure the data is user-friendly and future focused, invite relevant
stakeholders including academics, medical scientists and the pharmaceutical
industry to support the set up of the HA Big Data Analytics Centre.
6.2 To drive the formation of a consortium by relevant stakeholders to develop and
govern a transparent and structured system for open access to CDARS ensuring
access to data under a structured system with clear approval procedures, criteria
and timelines, similar to the databases operated in other countries such as the US
FDA and UK CPRD.
6.3 Establish a dedicated body to handle the administrative work for the
applications for accessing data. Ensure the database will be a publicly available
resource with access strictly controlled by an independent department and
granted by the consortium. The criteria and timeline for granting access to
specific clinical parameters will be clearly listed for applicants.
Conclusion
We believe that the Government is dedicated to enhancing healthcare services for
Hong Kong people and developing Hong Kong as biomedical hub. The HKAPI
recommendations outlined in this document are intended to provide clear direction
and to support the Government in developing a visionary and efficient
people-centred healthcare system in Hong Kong.