Replies to LegCo questions
LCQ2: Uncommon disorders and Drug Formulary
Following is a question by the Dr Hon Fernando Cheung and a reply by the
Secretary for Food and Health, Dr Ko Wing-man, in the Legislative Council today
(May 24):
Question:
The Hospital Authority currently adopts an evidence-based approach for, and
follows the three major principles of safety, efficacy and cost-effectiveness of
the drugs, in evaluating applications for inclusion of drugs in its Drug
Formulary. At present, as quite a number of drugs for treatment of uncommon
disorders have not been included in the Drug Formulary, patients have to
purchase those drugs at their own expenses. Recently, the passing away of a
female patient with Tuberous Sclerosis Complex who was unable to afford the huge
drug expenses has aroused public concern. In this connection, will the
Government inform this Council:
(1) as it is difficult to obtain clinical data to prove the "efficacy" of drugs
for treatment of uncommon disorders due to the limited number of cases involving
their usage, and it is difficult for such drugs to conform with the principle of
"cost-effectiveness" because of their high prices, whether the authorities will,
by making reference to the practices of other countries or regions (for example,
the setting of criteria for designating a drug as an orphan drug to treat
uncommon disorders by the United States through the enactment of the Orphan Drug
Act), introduce separate clinical evidence requirements for drugs for treatment
of uncommon disorders that are more lenient than those for commonly used drugs,
thereby lowering the threshold for the inclusion of such drugs in the Drug
Formulary; if so, of the details; if not, the reasons for that;
(2) as some patient groups have relayed that patients are currently required to
pass a household-based means test in order to receive drug subsidies provided
under the Community Care Fund (CCF) or the Samaritan Fund, resulting in quite a
number of middle-income families depleting their savings due to payment of
millions of dollars a year for the drugs for members with uncommon disorders,
leading to a drastic drop in their living standards and discord between family
members caused by financial pressure, whether the authorities will consider
waiving the requirement that means test must be conducted on a household basis
and lowering the maximum contribution to drug expenses payable by patients; if
so, of the details; if not, the reasons for that; and
(3) as the Government has proposed in this year's Policy Agenda to invite CCF to
consider implementing a pilot scheme to provide drug subsidies for eligible
patients with uncommon disorders, whether the authorities will provide a
definition for the term "uncommon disorder" to facilitate the provision of
subsidies for patients with various types of uncommon disorders under the pilot
scheme upon its implementation; if so, of the details; if not, the reasons for
that?
Reply:
President,
The Government and the Hospital Authority (HA) place high importance on
providing optimal care for all patients and ensuring the use of public resources
in the fairest and most effective way, with a view to assuring patients an
equitable access to cost-effective drugs with safety and efficacy under the
highly subsidised public healthcare system. My reply to the question raised by
the Dr Hon Fernando Cheung on uncommon disorders and the Drug Formulary is as
follows:
(1) The HA has an established mechanism under which experts will evaluate new
drugs regularly and determine whether a drug should be included in the Drug
Formulary. During the process, it will base on principles such as evidence-based
medical practice, rational use of public resources, targeted subsidy and
opportunity cost. Due consideration will also be given to the safety and
efficacy of drugs, international recommendations and practices as well as the
views of professionals and patient groups. The HA understands that due to the
small number of patients with uncommon disorders, it is not easy to get hold of
reliable information and data on the causes of such diseases. It also knows the
inadequacies and limitations of the cost-effectiveness considerations which are
generally taken into account when evaluating and introducing new drugs. Added to
these is the lack of large-scale scientific research data accepted on an
international basis in support of the long-term efficacy of the drugs for
treatment of these disorders. Given the relatively recent discovery of ways to
treat some of these disorders, the responses of individual patients to different
treatment plans may vary. The relevant committee has already taken these factors
into account when evaluating these drugs for listing.
The HA will monitor the clinical conditions of individual patients and examine
the efficacy of the treatments and the risks involved, through an independent
expert panel, to decide whether the treatments are suitable for them. In
evaluating new drugs (especially the ultra-expensive drugs), the HA will also
carefully examine the long-term financial sustainability of the drug therapies.
To provide patients suffering from uncommon disorders with appropriate
healthcare services, the HA will continue to pay close attention to
international medical researches and healthcare policies on uncommon disorders
in other regions, assess new drugs according to the established mechanism by
keeping abreast of the latest development of clinical treatment and scientific
evidence, maintain communication with stakeholders, and heed the views and
suggestions of patients' groups.
(2) The current financial assessment criteria for drug subsidies under the
Samaritan Fund (SF) and the Community Care Fund (CCF) Medical Assistance
Programme (First Phase) are based on the principle of targeted subsidy, i.e. the
level of a patient's contribution to drug expenses depends on the patient's
household affordability. Patients with lower annual disposable financial
resources (ADFR) are required to contribute a smaller amount of the drug cost.
Moreover, the contribution rate of patients is capped at 20 per cent of their
ADFR to ensure that patients' quality of life would be largely maintained even
if they need to purchase more costly drugs.
Like other publicly-funded safety nets (e.g. the Comprehensive Social Security
Assistance Scheme), the financial assessment for drug subsidies is
household-based. Applications should be submitted on a household basis because
families constitute the core units of a community, hence members of the same
family should render assistance and support to each other. However, after taking
into account public opinions and the definitions of "family" adopted by other
existing financial assistance schemes in Hong Kong, the SF will amend its
definition of "family" and count only the patient and the core family members
living together with him/her (including parents, spouse, children, and brothers
and sisters who are under 18 years old or who are 18 to 25 years old and
receiving full-time education or adults with disabilities) in the financial
assessments. The above amendments will also be applicable to applications under
the CCF Medical Assistance Programme.
Some patients might worry that the mechanism of patient contribution to drug
expenses will place a sustained financial burden on them. Recognising the above
concern, the Government and the HA have proposed earlier to implement a pilot
CCF programme subsidising eligible patients to purchase ultra-expensive drugs,
and to adjust the financial assessment criteria of the proposed programme
accordingly by setting a ceiling on the contribution rate of the patients and
introducing a maximum annual contribution. Through the proposed new CCF
assistance programme, we hope to test the feasibility and recognition of the
above adjusted financial assessment criteria. The Government and the HA will
monitor the progress of the proposed programme, actively solicit public
opinions, continuously review the existing drug subsidy schemes (including those
under the SF and the CCF Medical Assistance Programmes) and make enhancements
where necessary to benefit more needy patients.
(3) Currently, there is no internationally agreed definition of uncommon
disorders. The definition varies among countries/regions depending on their own
healthcare system and situation. That said, we continue to strive to ensure
appropriate treatment for patients with uncommon disorders. As mentioned earlier
in my reply, the relevant committee of the HA has already taken into account the
lack of large-scale scientific research data in support of the efficacy of the
drugs for treatment of uncommon disorders when evaluating these drugs for
listing, and will formulate individualised treatment plans for patients with
uncommon disorders according to their clinical conditions through the
independent expert panel so as to provide them with appropriate treatments. The
Government and the HA will also continue to provide drug subsidies for patients
having genuine needs or financial difficulties through various subsidy
programmes such as the SF, the CCF Medical Assistance Programme and the proposed
new CCF assistance programme to enable purchase of ultra-expensive drugs by
needy patients.
In Hong Kong, healthcare services are heavily subsidised and available to
members of the public at low rates. Patients receiving public healthcare
services have equal opportunities to receive appropriate treatments. For all
patients attending public hospitals and clinics, HA clinicians will assess their
conditions in accordance with established procedures. After diagnosis,
clinicians will provide appropriate medical treatment services for patients
based on their clinical conditions and the treatment guidelines.
Ends/Wednesday, May 24, 2017
Issued at HKT 15:00
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