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“A health policy think tank [the Centre for International Public
Health Policy, University of Edinburgh] has called for the Department of
Health in England to withdraw guidance that allows patients to top up
their NHS treatment with drugs bought privately,” states Kmietowicz.[1]
But is this really the best way forward?
Recently the Department of Health put the top-up guidance out to
consultation[2] on three key issues: 1. Is the principle of separateness
clear? 2. Are sufficient safeguards in place? and 3. Should there be more
mechanisms in place to ensure the guidance is followed and does not lead
to any untended consequences? Each of these issues is considered in turn
below with the aim of further stimulating debate.
1. Is the principle of separateness clear?
The fundamental idea at the heart of the consultation document[2] is
to separate out NHS care from private care, ensuring that any additional
drugs purchased by a patient are paid for separately (including any
administration and monitoring costs) and are also provided in a different
facility to NHS care, whether this be a private ward/room or a private
healthcare facility (informally referred to as ‘top-ups’). As pointed out
by Appleby and Maybin,[3] however, there is a certain amount of ‘fudge’
involved in identifying separateness of NHS and private health care.
In the first case study used in the consultation document,[2] a
relatively straight forward example of a patient privately funding a
cancer drug, together with any monitoring tests and administration costs
in a private setting is presented. There does not, however, appear to be
any consideration of adverse event costs. Most cancer drugs have
substantial adverse events associated with them, some are relatively cheap
and simple to treat, whilst others, such as neutropenia and
agranulocytosis, are not. Will the NHS bear these costs or must these
additional costs be paid for privately by the patient? Furthermore, when
complex chemotherapy regimens made up of more than one drug or when
courses of radiotherapy are required concomitantly, the issue of
identifying the culprit of the adverse event may be difficult requiring
even more ‘fudging’.
The second example describing the private purchase of a medical
device is more problematic. Using the case of a multifocal lens for
cataract surgery, the guidance states, ‘it is not possible to pay for the
multifocal lens while carrying out the surgery on the NHS as it is not
possible to separate out the private element from the NHS element of
care.’[2] Medical devices are used routinely and successfully in a wide
range of procedures ranging from coronary stenting to catheters for
administering drugs and fluids. To deny patients the same purchase
options for medical devices as they have for drugs seems fundamentally
unfair. Furthermore, as has been previously highlighted by Appleby and
Maybin,[3] it is debatable that separateness is really such an issue,
simply treating the operation as a separate entity from the medical device
may be sufficient to ameliorate this situation. This argument, however,
still does not circumnavigate the issue that under the current guidance,
all private care is required to be provided in a private setting and since
it is impossible to physically separate the procedure from the device it
is impossible to meet the separateness criteria with many medical devices.
Hence, special consideration for medical devices may need to be issued to
redress this problem.
2. Are sufficient safeguards in place?
The NHS was founded on the principle of providing a health care
service based on need, not ability to pay. By introducing an explicit
scheme under which patients who have the ability to pay can top-up their
care by buying additional drugs in a private setting, automatically
undermines this principle. There is, therefore, no way to fully safeguard
this founding principle, but there still needs to be sufficient safeguards
in place to limit the damage, in particular, with regards to equity.
There is no denying that this guidance is a major step forward in
addressing the much publicised[4, 5] and important problem of cancer
patients having to sell all their worldly goods in order to access
unfunded drugs privately. But even with the option of top-ups many
individuals will still be unable to afford to purchase the drugs.
Furthermore, often those individuals in greatest need of treatment are the
very same individuals who are least able to afford it. This represents a
potentially huge problem in terms of equity which cannot be ignored.
An interesting solution to this problem was put forth by Thomas
Holme, et al., in relation to medical devices,[6] in which the government
offered a low interest loan to cover the costs, in a similar fashion to
student loans. In theory, this solution could be applied across the board
for all patients who could not afford to purchase unfunded drugs or
devices that are recommended by the treating clinician. The practicality
of this is uncertain, especially considering the credit crunch, but if the
fundamental principle of an NHS based on need not ability to pay is to be
at all safeguarded, this issue needs to be resolved not swept under the
carpet.
3. Should there be more mechanisms in place to ensure the guidance is
followed and does not lead to any unintended consequences?
The potential unintended consequences of this guidance are numerous
and unfortunately the mechanisms of avoidance may not be in place. The
guidance appears to only consider the consequences in terms of the doctor-
patient relationship and not in terms of supplier-provider relationships
and policy implications, which is a major concern.
Currently within the NHS, new drugs licensed or soon to be licensed
by the European Medicines Agency (EMEA) are evaluated by the National
Institute for Health and Clinical Excellence (NICE) in terms of their
clinical and cost effectiveness. Drugs that do not meet the requirements
(usually taken to mean a cost per quality adjusted life year in excess of
£30,000) are not recommended for funding on the NHS.
Following the guidance set out in the consultation document,[2] it
seems likely that many of these drugs will be available privately to
patients if they are deemed clinically useful. By doing this, however,
there are reduced incentives for drug manufacturers to ‘negotiate on
price’ and enter into ‘patient access schemes’, which potentially
conflicts with the Richard’s review recommendation to ‘promote more
flexible approaches to pricing and availability of new drugs’[7] and the
new Pharmaceutical Price Regulation Scheme.[8]
Under the new Pharmaceutical Price Regulation Scheme,[8] it is
envisaged that NICE will play a greater role in the pricing process and
that drug prices will be based on the ‘value the drug provides to NHS
patients’ rather than just set by the manufacturer.[9] The limited
information coming out of NICE,[10] however, indicates that it has only
been ‘agreed in principle’ to take this forward as part of the 2009-2010
business plan, dependant on additional resources being made available by
the Department of Health.
How this pricing initiative shapes up will be fundamental to the NHS
and must not be overshadowed by the new guidance for NHS patients who wish
to pay for additional private care. Mechanisms need to be put in place to
ensure that all of the policy changes suggested by the Richard’s review[7]
(end of life treatments, pricing schemes, and purchasing private drugs via
top-ups) work in harmony and not in competition.
In summary, there are a number of fundamental problems with the top-
up guidance as it stands. Further clarification is needed to ensure the
policy is consistent and allied with other policy changes. But this does
not automatically mean that top-ups are a disastrous idea or that the
guidance should be withdrawn. If sufficient safeguards and systems are
put in place, top-ups may be beneficial in terms of improving patient
autonomy and meeting the challenge of increasing drug costs.
Disclaimer: the views expressed herein are those of the authors and
do not necessarily represent those of the group (LRiG).
Top-ups: The end of the NHS as we know it or one small step for patients?
“A health policy think tank [the Centre for International Public
Health Policy, University of Edinburgh] has called for the Department of
Health in England to withdraw guidance that allows patients to top up
their NHS treatment with drugs bought privately,” states Kmietowicz.[1]
But is this really the best way forward?
Recently the Department of Health put the top-up guidance out to
consultation[2] on three key issues: 1. Is the principle of separateness
clear? 2. Are sufficient safeguards in place? and 3. Should there be more
mechanisms in place to ensure the guidance is followed and does not lead
to any untended consequences? Each of these issues is considered in turn
below with the aim of further stimulating debate.
1. Is the principle of separateness clear?
The fundamental idea at the heart of the consultation document[2] is
to separate out NHS care from private care, ensuring that any additional
drugs purchased by a patient are paid for separately (including any
administration and monitoring costs) and are also provided in a different
facility to NHS care, whether this be a private ward/room or a private
healthcare facility (informally referred to as ‘top-ups’). As pointed out
by Appleby and Maybin,[3] however, there is a certain amount of ‘fudge’
involved in identifying separateness of NHS and private health care.
In the first case study used in the consultation document,[2] a
relatively straight forward example of a patient privately funding a
cancer drug, together with any monitoring tests and administration costs
in a private setting is presented. There does not, however, appear to be
any consideration of adverse event costs. Most cancer drugs have
substantial adverse events associated with them, some are relatively cheap
and simple to treat, whilst others, such as neutropenia and
agranulocytosis, are not. Will the NHS bear these costs or must these
additional costs be paid for privately by the patient? Furthermore, when
complex chemotherapy regimens made up of more than one drug or when
courses of radiotherapy are required concomitantly, the issue of
identifying the culprit of the adverse event may be difficult requiring
even more ‘fudging’.
The second example describing the private purchase of a medical
device is more problematic. Using the case of a multifocal lens for
cataract surgery, the guidance states, ‘it is not possible to pay for the
multifocal lens while carrying out the surgery on the NHS as it is not
possible to separate out the private element from the NHS element of
care.’[2] Medical devices are used routinely and successfully in a wide
range of procedures ranging from coronary stenting to catheters for
administering drugs and fluids. To deny patients the same purchase
options for medical devices as they have for drugs seems fundamentally
unfair. Furthermore, as has been previously highlighted by Appleby and
Maybin,[3] it is debatable that separateness is really such an issue,
simply treating the operation as a separate entity from the medical device
may be sufficient to ameliorate this situation. This argument, however,
still does not circumnavigate the issue that under the current guidance,
all private care is required to be provided in a private setting and since
it is impossible to physically separate the procedure from the device it
is impossible to meet the separateness criteria with many medical devices.
Hence, special consideration for medical devices may need to be issued to
redress this problem.
2. Are sufficient safeguards in place?
The NHS was founded on the principle of providing a health care
service based on need, not ability to pay. By introducing an explicit
scheme under which patients who have the ability to pay can top-up their
care by buying additional drugs in a private setting, automatically
undermines this principle. There is, therefore, no way to fully safeguard
this founding principle, but there still needs to be sufficient safeguards
in place to limit the damage, in particular, with regards to equity.
There is no denying that this guidance is a major step forward in
addressing the much publicised[4, 5] and important problem of cancer
patients having to sell all their worldly goods in order to access
unfunded drugs privately. But even with the option of top-ups many
individuals will still be unable to afford to purchase the drugs.
Furthermore, often those individuals in greatest need of treatment are the
very same individuals who are least able to afford it. This represents a
potentially huge problem in terms of equity which cannot be ignored.
An interesting solution to this problem was put forth by Thomas
Holme, et al., in relation to medical devices,[6] in which the government
offered a low interest loan to cover the costs, in a similar fashion to
student loans. In theory, this solution could be applied across the board
for all patients who could not afford to purchase unfunded drugs or
devices that are recommended by the treating clinician. The practicality
of this is uncertain, especially considering the credit crunch, but if the
fundamental principle of an NHS based on need not ability to pay is to be
at all safeguarded, this issue needs to be resolved not swept under the
carpet.
3. Should there be more mechanisms in place to ensure the guidance is
followed and does not lead to any unintended consequences?
The potential unintended consequences of this guidance are numerous
and unfortunately the mechanisms of avoidance may not be in place. The
guidance appears to only consider the consequences in terms of the doctor-
patient relationship and not in terms of supplier-provider relationships
and policy implications, which is a major concern.
Currently within the NHS, new drugs licensed or soon to be licensed
by the European Medicines Agency (EMEA) are evaluated by the National
Institute for Health and Clinical Excellence (NICE) in terms of their
clinical and cost effectiveness. Drugs that do not meet the requirements
(usually taken to mean a cost per quality adjusted life year in excess of
£30,000) are not recommended for funding on the NHS.
Following the guidance set out in the consultation document,[2] it
seems likely that many of these drugs will be available privately to
patients if they are deemed clinically useful. By doing this, however,
there are reduced incentives for drug manufacturers to ‘negotiate on
price’ and enter into ‘patient access schemes’, which potentially
conflicts with the Richard’s review recommendation to ‘promote more
flexible approaches to pricing and availability of new drugs’[7] and the
new Pharmaceutical Price Regulation Scheme.[8]
Under the new Pharmaceutical Price Regulation Scheme,[8] it is
envisaged that NICE will play a greater role in the pricing process and
that drug prices will be based on the ‘value the drug provides to NHS
patients’ rather than just set by the manufacturer.[9] The limited
information coming out of NICE,[10] however, indicates that it has only
been ‘agreed in principle’ to take this forward as part of the 2009-2010
business plan, dependant on additional resources being made available by
the Department of Health.
How this pricing initiative shapes up will be fundamental to the NHS
and must not be overshadowed by the new guidance for NHS patients who wish
to pay for additional private care. Mechanisms need to be put in place to
ensure that all of the policy changes suggested by the Richard’s review[7]
(end of life treatments, pricing schemes, and purchasing private drugs via
top-ups) work in harmony and not in competition.
In summary, there are a number of fundamental problems with the top-
up guidance as it stands. Further clarification is needed to ensure the
policy is consistent and allied with other policy changes. But this does
not automatically mean that top-ups are a disastrous idea or that the
guidance should be withdrawn. If sufficient safeguards and systems are
put in place, top-ups may be beneficial in terms of improving patient
autonomy and meeting the challenge of increasing drug costs.
Disclaimer: the views expressed herein are those of the authors and
do not necessarily represent those of the group (LRiG).
Contact: claire.mcleod@liv.ac.uk
References
[1] Kmietowicz Z. Think tank calls for withdrawl of guidance allowing
patients to top-up. BMJ. 2009;338:b413.
[2] Department of Health. Guidance on NHS patients who wish to pay
for additional private care - A consultation. 2008 19th January 2009
[cited; Available from:
http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_089926
[3] Appleby J, Maybin J. Topping up NHS care. BMJ. 2008;337:a2449.
[4] Wilkes D. Mum denied cancer drug funding has to sell her house.
Mail Online 2007 [cited; Available from:
http://www.dailymail.co.uk/news/article-464101/Mum-denied-cancer-drug-
funding-sell-house.html#
[5] BBC News. Cancer patient 'may sell house' 2007 [cited; Available
from: http://news.bbc.co.uk/1/hi/england/west_midlands/6961730.stm
[6] Holme T, Rowland S, Cobb J. Co-payment for medical devices: BMJ
Response to BMJ 2009;338:b3. 2009.
[7] Richards M. Improving access to medicines for NHS patients: a
report for the Secretary of State for Health by Professor Mike Richards.
2008 [cited; Available from:
www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPoli...
[8] Department of Health. The Pharmaceutical Price Regulation Scheme.
2008 [cited; Available from:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/DH_091825
[9] Collier J. Changes to the regulation of drug prices in the UK.
BMJ. 2008;337:a2735.
[10] Dillon A. January 2009 Board Meeting - Chief Executive's Report.
2009 [cited 2009 26 January ]; Available from:
http://www.nice.org.uk/media/D4D/6C/Board210109ChiefExecReport.pdf
Competing interests:
None declared
Competing interests: No competing interests