Download Waltham Forest

NHS Waltham Forest
POLICY FOR MANAGING REQUESTS TO
FUND TREATMENTS UNDER EXCEPTIONAL
CIRCUMSTANCES
Mar 2009
‘This policy is currently under review in light of the 09/10 commissioning cycle and
the NHS Constitution: Local Decision Making about Funding of Medicines and
other Treatments’
Version:
Ratified by:
4 – September 2008
Exceptional Treatments Group – 4th April 2008
Chair of CECAG – 4th April 2008
Health for All Committee (meeting deferred –
Chairs action to approve 6th June 2008).
Date ratified:
Name & job title of author
Linda Bailey
Name of responsible committee
Health for All Sub-Committee
Date published on intranet::
March 2009
Review date:
September 2010
May 2008
1
CONTENTS
1.
POLICY STATEMENT .............................................................................3
2.
INTRODUCTION ......................................................................................3
3.
PURPOSE AND JUSTIFICATION OF POLICY .......................................4
4.
RESPONSIBILITIES ................................................................................4
5.
SCOPE OF THE POLICY.........................................................................5
6.
PRINCIPLES ............................................................................................5
7.
APPLICATION PROCESS.......................................................................5
8.
PANEL CONSIDERATION ......................................................................6
9.
RIGHT OF APPEAL & ETG APPEALS PANEL ......................................8
10. POLICY IMPLEMENTATION, REVIEW AND MONITORING .................8
11. DISSEMINATION OF AND ACCESS TO THE POLICY ..........................9
12. REVIEW, UPDATING AND ARCHIVING OF THE POLICY.....................9
13. REFERENCES .........................................................................................9
APPENDIX 1 – FLOW CHART OF APPLICATION PROCESS....................11
APPENDIX 2 – DECISION MAKING TREE ..................................................12
APPENDIX 3 – ETG TERMS OF REFERENCE............................................13
APPENDIX 4 – ETG APPEALS PROCESS & TERMS OF REFERENCE....15
APPENDIX 5 – ETHICAL FRAMEWORK .....................................................20
APPENDIX 6 – COMMISSIONING FOR EFFECTIVENESS POLICY...........22
APPENDIX 7 – LIST OF OTHER INTERVENTIONS FOR CONSIDERATION38
APPENDIX 8 - EQUALITY IMPACT ASSESSMENT TOOL .........................39
APPENDIX 9 – POLICY APPROVAL FORM................................................40
APPENDIX 10 - VERSION CONTROL SHEET.............................................42
2
1. POLICY STATEMENT
This Policy will ensure that requests for funding of treatments under exceptional
circumstances are dealt with in a manner which is robust, transparent and fair.
2. INTRODUCTION
Waltham Forest PCT is responsible for commissioning healthcare services for
local residents. In respect of this responsibility the PCT is allocated a finite level of
resources. The most cost-effective way to fund accessible, appropriate and
effective health care for the local population is through contracts or service level
agreements (SLA) that are agreed in advance, and which cover a period of at
least one year. The PCT recognises the diversity of our patients and potential
patients, and the aim is therefore to provide a safe environment free from
discrimination and a place where all patients are treated fairly, with dignity and
appropriately to their need.
The PCT’s existing SLAs give access to a comprehensive and geographically
convenient range of services. However, it is recognised there are instances where
treatment is requested but for which no agreement exists (or is believed not to
exist). There are a number of reasons why no agreement exists including
treatments which are new interventions or drugs which become available in year,
or because the treatment or condition for which the treatment is requested is rare,
or because there is limited evidence to support an intervention and the potential
health gain. To gain the maximum benefit for the local population, the PCT needs
to focus on treatments, which result in greatest population health gain.
The PCT does not impose a blanket ban on treatments not provided within the
current service level agreements, and recognises there will be cases where there
will be exceptional circumstances. This policy sets out the process by which these
requests will be considered, and the terms of reference of the group established
to determine the requests.
This policy should be read in conjunction with the Waltham Forest PCT
“Commissioning for Effectiveness Policy” (Appendix 6) which gives information
about the majority of treatments which should be requested under this policy.
Other treatments for which prior approval is necessary are given in Appendix 7,
however this list is not exhaustive, as new interventions become available on a
regular basis.
Patients accessing private health care have a right to revert to NHS funding at any
point during their care. However, if they wish to exercise this right, the PCT will
expect their care to be transferred to local pathways. Funding for the individual to
continue care in a private facility, or to transfer to an NHS provider with which a
clinician consulted privately has a link, will not routinely be authorised. Where
personal circumstances may make such funding appropriate, the case will require
consideration under the terms of this policy.
3
3. PURPOSE AND JUSTIFICATION OF POLICY
3.1
PURPOSE
The purpose of this Policy is to describe the process for managing requests for a
treatment for which no contractual arrangement currently exists, or for which a
contractual arrangement may exist but prior authorisation is required.
This Policy will ensure that requests for funding of such treatments are dealt with
in a manner which is robust, transparent and fair. The group established to
manage requests under this policy is the Exceptional Treatments Group (ETG)
and their terms of reference are given in Appendix 3 of this policy.
3.2
JUSTIFICATION
The Primary Care Trust has a duty of care towards patients living within the
borough of Waltham Forest. The duty of care and provision of services is covered
by a number of Acts of Parliament covering the National Health Services. The law
covering the NHS is also developed in an iterative way, often following testing
through the judicial process, so that guidance to supplement the various acts
published frequently. Public law can be tested both here in the UK but also in the
European Court of Justice. Some of the relevant legislation, guidance and some
relevant case-law covering aspects of this policy is as below :•
•
•
•
•
The Human Rights Act 1998 (specifically Articles 2, 3, 5 and 8).
The National Health Service Act 2006
R v Cambridge Health Authority ex p Child B (1995)
R (on the application of Rogers) v. Swindon NHS Primary Care Trust and
Secretary of State for Health (2006)
North Derbyshire HA ex p Fisher (1988)
Decisions about exceptional treatments are governed by public law in England.
PCTs, as a public body, cannot be sued but can be challenged through a judicial
review.
4.
RESPONSIBILITIES
•
•
•
•
The Chief Executive has overall responsibility for the commissioning and
delivery of services by Waltham Forest Primary Care Trust.
The Director of Commissioning is responsible for ensuring the policy is
implemented and adhered to.
The Director of Public Health is responsible for the provision of Public
Health advice to ensure the policy is evidence-based and robust.
It is the responsibility of PCT Clinical staff and GPs who make referrals to
ensure their practice is in line with this policy, and Exceptional Treatment
requests are made in accordance with this policy.
4
5.
SCOPE OF THE POLICY
This policy relates to any new or existing treatment (including drug treatment) for
which NHS funding is requested and which falls into one of the following
categories :
ƒ
ƒ
ƒ
ƒ
a treatment not currently commissioned through the Primary Care Trust’s
(PCT) existing Service Level Agreements (SLAs) with provider trusts or
contractors.
a treatment which is commissioned by, or on behalf of, the PCT but for
which prior authorisation is required
a treatment which is not commissioned on behalf of the PCT through NHS
specialist commissioning or risk-sharing arrangements.
any other treatment not falling into the above categories but included in the
Waltham Forest PCT “Commissioning for Effectiveness” policy.
The policy applies to any treatment in the four categories above, requested on
behalf of any person eligible for National Health Service care purchased by
Waltham Forest PCT.
Interventions that have received approval from the National Institute for Health &
Clinical Excellence (NICE) do not need to be discussed under this policy, however
some interventions may still require prior notification to the PCT under separate
commissioning arrangements.
6.
PRINCIPLES
When dealing with requests under this policy the following principles will be
applied
•
•
•
•
•
•
7.
The safety of patients is paramount
Decisions should be made efficiently and results disseminated quickly
Decisions should be made in accordance with principles of evidence-based
health care, and should be
o Conscientious
o Judicious and with explicit use of current best evidence
o Integrating clinical expertise and best external evidence
Decisions will be made equitably and with consistency
Decisions will be made within budgetary limits taking into account issues
such as cost-effectiveness and affordability
Decisions will be made with regard to an ethical framework (Appendix 5)
APPLICATION PROCESS
7.1 Requests for treatment will be made by GPs or NHS Consultants on
behalf of patients.
7.2 Applications should be made to the Exceptional Treatment Group on the
appropriate form providing all the information required so that
unnecessary patient delays are avoided.
5
7.3 Applications for Drug treatment should also be submitted on the
appropriate form.
7.4 Initial screening will be undertaken by a senior commissioning Manager
and additional information requested (e.g. secondary care assessment,
previous treatment already undertaken). Some treatment requests can
be refused at this stage if they do not have any recognised clinical
indications, e.g. split earlobes from ear piercing.
7.5 Cases will be presented to ETG for consideration of funding within one
month of receipt of request.
7.6 Where the referral is deemed urgent, the Chair of ETG will contact other
panel members by e-mail / phone in order to arrive at a decision in a
timely fashion.
7.7 The Panel has three options:
o To agree to the request
o To refuse the request or
o To ask for additional information (including further clinical
assessment)
7.8 The ETG Commissioning representative will ensure that all outcomes are
communicated to the person who made the request, together with
information on the complaints procedure.
8.
PANEL CONSIDERATION
The panel will take the following issues into consideration when determining the
outcome of a referral to ETG, and a flow chart to illustrate these steps is given in
Appendix 1 :
Clinical effectiveness
Evidence for the effectiveness of the proposed treatment will be taken into
account. Funding decisions will be guided by advice from public health
specialists, and regional or national bodies, including NICE.
The following should be considered: • Is the treatment of proven benefit?
• What is the nature, extent and significance of the health gain?
• Is the condition rare so that there is a lack of available evidence
from Randomised Controlled Trials to support the application?
Capacity to Benefit
The treatment / procedure / intervention should be expected to significantly
improve the individual’s health or quality of life, however interventions will not
be funded for purely cosmetic reasons. If the individual has had similar
treatment for the same condition, which was non-beneficial or harmful, this will
also be taken into account. The Exceptional Treatments Group will take into
account additional circumstances, such as mental or psychological factors or
the avoidance of social care through treatment.
6
Cost effectiveness
When choosing between different interventions, the PCT will aim to achieve a
reasonable balance between cost and effect – measured in terms of improved
health and quality of life.
The following should be considered: ƒ Are there alternative, comparable and more cost effective interventions
available?
ƒ Are there comparable but more cost effective providers available?
ƒ Is the treatment comparatively new, such that there may not be information
available with regard to cost per QALY (or similar cost effectiveness
measure)?
Alignment with PCT priorities
Funding decisions will be in line with the PCT’s agreed strategic priorities.
Equity
Where an individual package is not warranted by the healthcare needs of the
patient, the PCT will not support an intervention that enables an individual to
gain advantage in terms of care otherwise denied to the rest of the population
– such as a reduction in waiting time.
The following should be considered: ƒ Is this patient or patient subgroup being treated fairly in relation to
others?
ƒ What precedent for funding is there within the PCT?
ƒ Would funding establish an important precedent?
Unusual clinical circumstances or other ‘exceptional’ circumstances
The group will take account of unusual clinical circumstances, e.g. mental or
psychological factors, or any other circumstances which would make this
application exceptional.
Ethical Framework
The Ethical Framework underpinning the decision making of the ETG is set out
in Appendix 5 of this policy.
Legal framework
The ETG should consider when making their decision, whether there is
existing case law which could guide their decision making. They will also wish
to consider the principles of the Human Rights Act (1998) when making their
decision. This consideration will include consideration of Article 2 of the
Human Rights Act (the right to life) if the condition for which the treatment is
being sought is deemed terminal.
Evidence
When making its determinations the Exceptional Treatments Group may
consider relevant evidence from sources which could include
o Large clinical trials, systematic reviews and meta-analyses
o NICE
o Cochrane reviews
o Scottish Medicines Consortium
7
o Centre for Reviews & Dissemination, University of York
o Prodigy
o The ScHARR Technology Assessment Group
Minute taking
Minutes should be taken of the panel meeting which give as a minimum the
panel’s evaluation and decision making against each of the above headings.
9.
RIGHT OF APPEAL & ETG APPEALS PANEL
If the patient or referrer is unhappy with the decisions of the group, there is the
right of appeal to the ETG Appeals Panel. The procedure for making an appeal
and the terms of reference for the ETG appeals panel form Appendix 4 of this
policy.
The ETG Appeals Panel shall be established with the proviso that no one who
will be present as a member of the Appeals Panel who was also present as a
member of the Exceptional Treatment Group when the decision being
appealed was being discussed. Patients also retain the right to make
complaints through the PCT complaints procedure at any stage of the process.
10.
POLICY IMPLEMENTATION, REVIEW AND MONITORING
10.1
TRAINING ARRANGEMENTS
PCT staff and GPs should be made aware of the recommendations in this
policy with regard to making referrals for treatment. Opportunities should
be identified to raise awareness of the process, including through induction,
Practice Based Commissioning and Continuing Professional Development
events.
Exceptional Treatment Group members should have access to relevant
training in ethical decision making, aspects of law, health economics and
public health skills, to ensure that all members understand the relevance of
human rights, the basics of assessment of clinical and cost effectiveness
and risk and the technical terms used.
Copies of this Policy will be made available to all staff via Policy Files,
which are in all staff bases, and on the PCT’s intranet and internet sites, for
those staff that have access. All staff will be notified of a new or reviewed
policy via the PCT newsletter.
Copies of the Policy will be circulated to all GPs via e-mail.
This document will be included in the PCT Publication Scheme in
compliance with the Freedom of Information Act 2000.
10.2 PROCESS FOR MONITORING IMPLEMENTATION &
EFFECTIVENESS
For this policy, the following monitoring processes are in place.
8
Standard
•
•
Monitoring process
100% of treatments deemed to be
exceptional are dealt with under the
process described in this policy.
Decisions made are assessed to be in
line with the policy.
A clinical external assessor should be
identified to audit the decisions made
under the terms of this policy, on an
annual basis
Because of the confidential, patient
identifiable and sensitive nature of the
work of this committee, an anonymised
report, including the audit report will be
provided by the Chair of the panel to
closed session of the PCT Board.
10.3
The PCT Board will receive the paper
including the audit. Any discussion and
action points will be recorded in the
closed minutes and followed up by the
PCT Board.
KEY PERFORMANCE INDICATORS
Key performance indicators are as described above.
11. DISSEMINATION OF AND ACCESS TO THE POLICY
Once approved, the policy/procedure will be made available on the PCT’s
intranet. The Corporate Affairs policy gatekeeper will keep a record of this.
If the policy/procedure replaces a previous version, the Corporate Affairs
gatekeeper will remove the outdated copy from the intranet and keep a record of
this.
When a new policy/procedure is made available on the intranet, all staff will be
notified of this (e.g., by e-mail, staff newsletter).
12. REVIEW, UPDATING AND ARCHIVING OF THE POLICY
This Policy will be reviewed annually by the Director of Public Health or as and
when significant changes make earlier review necessary.
13. REFERENCES
The following are other PCT policies that relate to or are referenced in this policy:
• Waltham Forest PCT “Commissioning for Effectiveness Policy”
• Waltham Forest PCT Assisted conception policy
• Waltham Forest PCT Bariatric Surgery Policy
• NE London policies / specialist commissioning arrangements
14. DEFINITIONS
Extra Contractual Referral (ECR)
An ECR is any treatment for which there is no existing contractual arrangement
held by the PCT with a care provider, or for which no NHS body has contracted on
behalf of the PCT, such as those commissioned through NHS Specialist
Commissioning arrangements and NHS Risk Sharing agreements.
Service Level Agreement (SLA)
9
This is a contractual arrangement between the PCT and a care provider.
Treatment
for the purposes of this policy ‘treatment’ means any clinical intervention, including
new drug therapies, and usually performed or prescribed by a health care
professional registered with a professional body
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APPENDIX 1 – FLOW CHART OF APPLICATION PROCESS
11
APPENDIX 2 – DECISION MAKING TREE
12
APPENDIX 3 – ETG TERMS OF REFERENCE
1. EXCEPTIONAL TREATMENT GROUP – TERMS OF REFERENCE
1.1.
AIM
The Exceptional Treatment Group exists to make decisions on an individual basis
on requests for access to treatments which are not currently funded by the PCT in
a way that is open, consistent, fair and equitable.
1.2.
OBJECTIVES
1.2.1. To consider applications on an individual basis using the decision
making guiding principles.
1.2.2. To reach a majority decision on whether or not to fund specific
cases. In the event of the group being equally divided, further advice
will be sought from an external expert in the field and the case
reconsidered.
1.2.3. To relay the group’s decision in writing (with reasons) to the
appropriate GP for further discussion (if necessary) with the patient.
1.2.4. To ensure the group’s decisions are recorded and remain available
for scrutiny.
1.2.5. To ensure the members declare any interests in individual cases
and withdraw from the discussion prior to an application being
considered by the group.
1.2.6. To ensure that the wider implications of individual funding decisions
are considered, and relayed to those responsible for managing the
PCT’s service level agreements.
1.2.7. To review the current policy framework and make amendments as
necessary.
1.2.8. To keep the policy framework constantly updated in the light of
changing laws, e.g. the human rights act.
1.2.9. To review the treatments which are included regarding access under
exceptional circumstances.
1.2.10. Unusual or difficult cases should be referred for external expert
advice, e.g. expensive or innovative treatment.
1.2.11. Confidentiality: every reasonable effort should be made to ensure
confidentiality of the individual patient concerned, including
anonymising relevant papers.
1.2.12. To produce an annual report for the board in order to spot trends
and make recommendations.
1.3.
MEMBERSHIP
Voting members
Voting members of the ETG should include the following, and the quorum shall be
no less than three, at least one of whom shall be a medically qualified doctor:
• Director of Public Health / Medical Director
• General Practitioner
• Commissioning Manager
• Head of Medicines Management
13
The Group will elect a Chair, who will hold a casting vote in the event of a tied
decision. Additional (non-voting) members may be co-opted as required for
certain areas of expertise, e.g. dental advisor. Deputies should only be
allowed where the substitute has had the appropriate training and has been
agreed by the Panel.
Non-voting members
Additionally the Exceptional Treatments Group shall include non-voting
members who will not form part of the quorum.
1. A Case Manager, who should lead the process of handling each case
and be an advocate for the applicant patient. The Case Manager is
responsible for ensuring the ETG consider responsiveness of their
decision to the applicant and for advising the ETG of information about:
• Patient choice and his or her views about exceptionality
• Any specific needs of the patient in the submission
• Consistency of decision making, drawing on past and other panel
decisions
• Procedural propriety and human rights considerations.
2. A Public Health Programme manager may support the process at the
request of the Director of Public Health.
3. A finance officer may be invited to attend the meeting ensure the panel
have information about efficiency and financial control in their decision.
1.4. FREQUENCY OF MEETINGS
The ETG will meet monthly.
1.5. URGENT REQUESTS
If a request is deemed urgent and cannot wait until the next scheduled ETG
meeting, then the case may be reviewed by the PCT Medical Director. In the
absence of the PCT Medical Director, advice will be sought from the GP member
and a decision made by any other PCT Executive Director with the exception of
the Director of Finance.
1.6. ACCOUNTABILITY
This group is accountable to the PCT Board. Reports from the ETG will be
provided to the PCT Board in closed session with patient-identifiable information
removed. The reports will be provided on an annual basis.
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APPENDIX 4 – ETG APPEALS PROCESS & TERMS OF REFERENCE
Patients or their representatives who are not satisfied with the outcome of the
request for treatment under the Exceptional Treatments Arrangements have the
right of appeal to the Exceptional Treatments Appeals Panel. The terms of
reference of the Appeals Panel appear later in this appendix. The process for
making an appeal is as described below.
1. Right of Appeal
1.1. The ‘Appeal Period’
There will be a period of 15 working days from the day the ETG decision is
received by the originator of the referral during which an appeal may be made to
the Appeal Panel. The letter from the ETG that accompanies the decision will
state the deadline for any appeal. In calculating the deadline weekends and public
holidays will not be counted.
1.2. Who can appeal?
The Patient may appeal in consultation with the referring party (i.e. the GP and/or
the consultant). However, it is expected that the lead Referrer will lodge the
appeal.
1.3. What is the scope of an appeal?
An appeal may relate to either the decision itself or the way in which the decision
has been reached (the process). Appeal cases which may provide a significantly
disproportionate resource relative to the health needs of the Waltham Forest
population may be rejected at the discretion of the Chief Executive.
1.4. How is an appeal lodged?
An appellant who wishes to appeal should lodge their appeal with the Chief
Executive of Waltham Forest PCT within the appeal period. The documents
lodged by the appellant must include the following information:
• The aspect(s) of the decision being appealed against
• The ground(s) of the appeal.
The Chief Executive may refuse to entertain an appeal that does not include all of
the above information.
1.5. What is the timescale for an appeal?
The Appeal Panel will endeavour to hear an appeal within 28 days of the appeal
being lodged with the PCT. The Appeal Panel will aim to send its decisions to the
Board within 21 days of the hearing, but there may be some instances in which a
longer interval is necessary. The Board will then make the full text of the decision
available to the appellants. The date for hearing any appeal will be confirmed to
appellants in a letter. Should the appellant be of the opinion that a 28 day
timescale does not recognise the medical urgency of the appeal then this should
be reflected in the letter of appeal.
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The Appeal Panel has the restricted role of hearing appeals that fall into one or
more of three strictly limited grounds upon which interested parties may appeal.
An appeal on any other ground will not be considered.
These grounds are:
•
Ground One: The ETG has failed to act fairly and in accordance with
the framework for evidence-based decision making relating to the
commissioning of procedures not normally funded
The ETG is committed to following a fair and equitable procedure
throughout the process. An appellant who believes the have not been
treated fairly by the ETG may appeal on this ground. This ground relates to
the procedure followed and not directly to the decision itself.
•
Ground Two: The ETG has prepared a decision which is perverse in
the light of the evidence submitted
The Appeals Panel will not normally entertain an appeal against the merits
of the decision reached by the ETG. However, the appellant may appeal
where the decision is perverse in light of the evidence submitted. To be
perverse means to be obviously and unarguable wrong; to be in defiance of
logic or so absurd that no reasonable ETG could have reached such
conclusions. The Appeal Panel will not substitute its own judgement for that
of the ETG but will review the decisions of the ETG to see whether or not
they are perverse.
•
1.6.
Ground Three: The PCT has exceeded its powers
The ETG is a constituted committee of the PCT. The PCT is a public body
that carries out its duties in accordance with the Statutory Instruments
under which it was established. An appellant may appeal on the grounds
that the PCT has acted outside its remit or has acted unlawfully in any
other way.
Who will sit on the Appeal Panel?
The Panel will comprise three or more of the following, to include at least one
medically qualified doctor.
• PEC Chair or PCT Chief Executive
• Non-executive PCT Board Member
• PCT Public Health representative
• Local GP or specialist clinician.
The Appeals Panel will inform the appellants(s) of the membership of the Appeal
Panel as soon as possible after an appeal has been lodged. None of the
members of the Appeal Panel will have had any prior involvement in the original
submission or decision. In appointing the members of the Appeal Panel, the PCT
will endeavour to ensure that no member has any interest that may give rise to a
real danger of bias. Once appointed, the Appeal Panel will act impartially and
independently.
16
1.7.
Initial scrutiny by the PCT’S Governance lead
The appeal documents lodged by an appellant will be scrutinised by the PCT’s
Governance lead, who will ensure that the appeals document contains the
necessary information, which shall include:
• The aspect(s) of the decision or process being appealed against
• The ground(s) of the appeal.
If the notice of the appeal does not contain the necessary information or if the
appeal does not appear to the Governance Lead to fall under any of the grounds
of appeal, they contact the appellant to request further information or clarification.
An appeal will only be referred to the Appeal Panel if, after giving the appellant an
opportunity to elaborate or clarify the grounds of the appeal, the Governance lead
is satisfied that the appeal falls under one or more of the grounds upon which the
Appeal Panel can hear the appeal.
2. Can new data be submitted to the Appeal Panel?
New data or evidence that was not presented to the LHB as part of the request for
exemption will almost certainly not be relevant to the grounds of appeal and if this
is the case will not be considered by the Appeal Panel. Appellants have the right
to re-submit, via the request for exemption process, should robust, supporting
evidence become available in the future.
3. After the appeal hearing
The Board will notify appellants of the Appeal Panel’s decision in writing. The
Appeal Panel will aim to send its decisions to the Board within 21 days of the
hearing, but there may be some circumstances where a longer interval may be
necessary.
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ETG APPEALS PANEL TERMS OF REFERENCE
1. EXCEPTIONAL TREATMENT GROUP APPEALS PANEL – TERMS OF
REFERENCE
1.1.
AIM
The Exceptional Treatment Group Appeals Panel exists to hear appeals against
decisions made by the Exceptional Treatment Group under their terms of
reference. The appeal should be handled in a way which is open, consistent, fair
and equitable.
1.2.
OBJECTIVES
1.2.1. To consider appeals on an individual basis using the decision
making guiding principles.
1.2.2. To reach a majority decision on whether or not to overturn or revisit
the existing decision to fund specific cases. In the event of the group
being equally divided, further advice will be sought from an external
expert in the field and the case reconsidered.
1.2.3. To consider the appeal in accordance with the process set out in
Appendix 4 of the Exceptional Treatment Policy, specifically to
assess whether the appeal is in line with any of the three grounds
for appeal.
1.2.4. To relay the group’s decision in writing (with reasons) to the
appropriate GP/referring clinician for further discussion (if
necessary) with the patient.
1.2.5. To ensure the group’s decisions are recorded and remain available
for scrutiny.
1.2.6. To ensure the members declare any interests in individual cases
and withdraw from the discussion prior to an application being
considered by the group should there be an interest.
1.2.7. To ensure that the wider implications of individual funding decisions
are considered, and relayed to those responsible for managing the
PCT’s service level agreements.
1.2.8. To produce an annual report for the board in order to spot trends
and make recommendations.
1.2.9. Unusual or difficult cases should be referred for external expert
advice, e.g. expensive or innovative treatment.
1.2.10. Confidentiality: every reasonable effort should be made to ensure
confidentiality of the individual patient concerned, including
anonymising relevant papers.
1.3.
MEMBERSHIP
Voting members
Voting members of the Exceptional Treatments Appeals Panel should include the
following, and the quorum shall be no less than three, to include at least one
medically qualified doctor:
• Professional Executive Committee Chair or PCT Chief Executive
• Non-executive director of the PCT
18
• Local GP or specialist clinician
• Public Health representative
No person who was present at the Exceptional Treatments Group meeting
when the original request was discussed will be eligible to be a voting member
of the Appeals Panel.
The Group will elect a Chair, who will hold a casting vote in the event of a tied
decision. Additional (non-voting) members may be co-opted as required for
certain areas of expertise, e.g. dental advisor. Members of the Appeals Panel
should undergo the appropriate training.
Non-voting members
Additionally the Exceptional Treatments Group Appeals Panel shall include
two non-voting members who will not form part of the quorum.
• A Case Manager, who should lead the process of handling the appeal.
The Case Manager is responsible for presenting the appeal to the
Appeals Panel along with information about:
o
Patient choice and his or her views about exceptionality
o
Any specific needs of the patient in the submission
o
Consistency of decision making, drawing on past and other panel
decisions
o
Procedural propriety and human rights considerations.
• A finance officer may be invited to attend the meeting ensure the panel
have information about efficiency and financial control in their decision.
• Administrative support may also be provided
1.4. FREQUENCY OF MEETINGS
The Appeals Panel shall meet as required to discuss appeals. The Appeals panel
will be convened within 28 days of an appeal being lodged, or more urgently if
clinical advice is that this is required.
1.5. ACCOUNTABILITY
This Panel is accountable to the PCT Board. Reports from the Appeals Panel will
be provided to the PCT Board in the month following any decision made by the
panel. The report will be in closed session with patient-identifiable information
removed.
19
APPENDIX 5 – ETHICAL FRAMEWORK
Waltham Forest PCT believes that people have equal rights of access to health
care. There may also be times when some categories of care are given priority in
order to address health inequalities in the community. However when making
decisions, the Exceptional Treatment Group will not discriminate on grounds of
personal characteristics, such as age, gender, sexual orientation, race, religion,
lifestyle, social position, family or financial status, intelligence or cognitive
functioning.
The Exceptional Treatment Group will assess patients' health needs according to
their capacity to benefit from health care. In the absence of evidence of health
need, treatment will not generally be given solely because a patient requests it.
Similarly, a treatment of very little benefit will not be provided simply because it is
the only treatment available. This is necessary to ensure that resources are used
to provide the greatest health benefit. When making decision under the
Exceptional Treatment Policy, it is important to do this within the context of an
ethical framework. An ethical framework :
• Provides a coherent structure for discussion, ensuring all important aspects
of each issue are considered
• Promotes fairness and consistency in decision making from meeting to
meeting and with regard to different clinical topics
• Provides a means of expressing the reasons behind the decisions made
• Ensures that people are treated with equal concern and respect and harm
is minimised.
• Promotes consideration of four key ethical principles
ƒ Patient autonomy
ƒ Beneficence
ƒ Non maleficence
ƒ Justice
The Ethical Framework is especially concerned with the following:
EVIDENCE OF CLINICAL EFFECTIVENESS
The Exceptional Treatments Group will seek to obtain the best evidence of
clinical effectiveness when managing requests under the policy. It will promote
treatments for which there is good evidence of clinical effectiveness. It will not
normally recommend treatment that is shown to be ineffective. When assessing
evidence of clinical effectiveness the outcome measures which will be given
greatest importance are those considered important to patients. Reliable evidence
may be available from large-scale randomised clinical trials. Evidence may also
be available from less authoritative sources and this will also be considered.
Patients' evidence of significant clinical benefit is also relevant.
COST OF TREATMENT
Because the PCT is duty-bound not to exceed its budget, the cost of treatment
must be considered. The cost of treatment is significant because investing in one
area of health care inevitably diverts resources from other uses. A single episode
of treatment may be very expensive, or the cost of treating a whole community
20
may be high. The Exceptional Treatment Group will compare the costs of
treatment to its overall benefit, both to the individual and the community. It will
consider technical cost-benefit calculations, but these will not by themselves be
the basis for decisions made.
THE NEED FOR HEALTH CARE
The Exceptional Treatment Group will consider the health needs of patients
according to their capacity to benefit from health care. So far as possible, it will
respect the rights of patients to choose between different treatment options,
subject to the support of the clinical evidence. Urgent and life-saving treatment will
be given a high priority, as will treatment which effectively treats "life time", or
chronic conditions such as arthritis, mental illness, or sensory impairment. When
evidence of clinical effectiveness is equivocal, options for treatment will be given
particular attention.
The Exceptional Treatment Group will not adopt blanket bans on treatment since
there may be cases in which a particular patient has special circumstances which
present an exceptional need for treatment. The Group will aim to identify what
might be or not be exceptional circumstances where appropriate. Each case
considered to be of exceptional circumstances will be considered on its own
merits by the Exceptional Treatment Group.
NEEDS OF THE COMMUNITY
Public health is an important concern of the Exceptional Treatments Group and it
will always seek to make decisions which promote the health of the entire
community. Some of these decisions are promoted by the Department of Health
(such as the guidance from the National Institute for Clinical Excellence and
National Service Frameworks). Others are produced locally. The Exceptional
Treatment Group also supports effective policies to promote preventive medicine
which help stop people becoming ill in the first place.
Sometimes the needs of the community may conflict with the needs of individuals.
Decisions are difficult when expensive treatment produces very little clinical
benefit. For example, it may do little to improve the patient's condition, or to stop,
or slow the progression of disease. Where it has been decided that a treatment
has a low priority and cannot generally be supported, a patient's doctor may seek
to persuade the PCT that there are exceptional circumstances which mean that
the patient should receive the treatment within procedures established by the
PCT.
The PCT recognises that its discretion and decision making may be affected by
National Service Frameworks, NICE technology appraisal guidance and other
NHS directions.
The Human Rights Act has been considered in the formation of this ethical
framework.
21
APPENDIX 6 – COMMISSIONING FOR EFFECTIVENESS POLICY
WALTHAM FOREST PCT COMMISSIONING FOR EFFECTIVENESS POLICY
Purpose:
This document sets out a policy for introducing evidence-based
service access criteria into the commissioning of clinical
interventions.
Policy Statement:
This Policy will ensure that the surgical interventions commissioned
by Waltham Forest Primary Care Trust are based on evidence of
clinical effectiveness and are cost-effective.
Policy Distribution:
Waltham Forest PCT Commissioning and Performance Directorate.
Responsibilities:
Chief Executive, PEC Chair, Director of Commissioning &
Performance, Director of Public Health, staff in Commissioning &
Performance Directorate.
Main Imperatives of the Policy:
Services must be commissioned from both acute and community sector providers, and
primary care in line with this policy.
Policy Profile
Policy Ref. Number
Version
1
Status
Approved
Trust Lead
Director of Commissioning and Performance
Implementation Date
30th May 2007
Last Review Date
Next Formal Review
Annually
Approval Record
Date: 29th May 2007
Status: Approved
Impact on:
Finance:
Equality & Diversity:
The introduction of
this policy should
realise financial
benefits for the PCT.
The PCT recognises the diversity of our
patients & potential patients. Our aim is
to provide a safe environment free from
discrimination, where all patients are
treated fairly, with dignity and
appropriately to their need.
Public Health:
Legal implications:
This policy introduces
access criteria based
on evidence of
effectiveness.
YES – There are precedents for PCT
commissioning decisions to be challenged.
It is important that commissioning
decisions are robust and evidence-based.
Author:
Name
Job Title
Linda Bailey
Head of Health Needs Assessment & Outcomes
22
Waltham Forest Primary Care Trust
Commissioning for Effectiveness Policy
May 2007
23
INDEX
SECTION 1 – PROCEDURES REQUIRING PRIOR APPROVAL ................25
1.1.
1.2
1.3
1.4
1.5
1.6
1.7
COSMETIC PROCEDURES 25
COCHLEAR IMPLANTS 29
MACULAR DEGENERATION
29
NON-MEDICAL CIRCUMCISIONS
30
ALTERNATIVE THERAPIES
30
REVERSAL OF VASECTOMY OR FEMALE STERILISATION 31
FUNCTIONAL ELECTRICAL STIMULATION (FES)
31
SECTION 2 – PROCEDURES NOT REQUIRING PRIOR AGREEMENT.....32
2.1 EXCISION OF OTHER SKIN LESIONS 32
2.2 VARICOSE VEINS 32
2.3 FERTILITY TREATMENTS 34
2.4 DILATION AND CURETTAGE
35
2.5 HYSTERECTOMY FOR HEAVY MENSTRUAL-BLEEDING
(MENORRHAGIA)
35
2.6 FILTERED / COLOURED LENSES 35
2.7 TREATMENT OF GENDER DYSPHORIA 36
2.8 COMMON HAND CONDITIONS 36
2.9 TONSILLECTOMY 37
2.10 GROMMETS 37
2.11 ADENOIDECTOMY FOR OTITIS MEDIA IN CHILDREN
37
All patients requiring a Consultant opinion for diagnostic or symptomatic advice
should continue to be referred by General Practitioners e.g. skin lesions that may be
malignant.
24
SECTION 1 – PROCEDURES REQUIRING PRIOR APPROVAL
Procedures in Section 1 will still require prior approval through the
‘Exceptional Treatments Arrangements Group’ even if the restricted access
criteria outlined are met.
1.1. COSMETIC PROCEDURES
General Remarks
Cosmetic procedures are generally effective but they are considered to be of low
priority by local commissioners and will only be purchased in exceptional
circumstances. They should not be funded for aesthetic / cosmetic reasons.
To qualify under the Exceptional Treatments Policy the patient should be over the
age of 21 and have a severe physical disfigurement with a long standing reactive
psychiatric disorder that should clearly be caused by the relevant physical problem.
The clinician making the referral to the Exceptional Treatments Group will need to
provide evidence confirming that the problem is still ongoing despite being
appropriately addressed by a psychiatric or psychological intervention. Children
and young people aged under 21 should be considered for funding if there is a
problem likely to impair normal emotional development.
Individual Procedures
Detailed exceptions to the general restriction on cosmetic surgery are detailed here:
i)
Aesthetic facial surgery
Funding should be considered for:
• Anatomical abnormalities in children <18, likely to cause impairment of
normal emotional and social development.
• Pathological abnormalities e.g. facial palsy, progeria or cutis laxa.
ii)
Abdominoplasty / apronectomy
This is not ordinarily available, however funding should be considered if there is
intractable intertrigo and/or associated abdominal wall prolapse with urinary
symptoms.
iii)
Body Contouring / sculpting (arm reduction, thigh lift / reduction and buttock
lift / reduction, excision of redundant skin or fat liposuction)
These procedures are not available on cosmetic grounds. An exception may be
made for post-traumatic surgery for contouring at diabetes injection sites or for
Lymphoedema.
iv)
Blepharoplasty (Eyelid Reduction)
This procedure is not available on cosmetic grounds. An exception may be made
if the upper eyelid skin interferes with the visual field or if there is evidence that
eyelids impinge on visual fields reducing field to 120˚ laterally and 40˚ vertically.
v)
Cosmetic Breast Surgery
This does not refer to breast reconstruction following mastectomy or trauma.
25
vi)
Breast Augmentation
This procedure is not available on cosmetic grounds. Funding considered if:
• Aplastic breasts/congenital abnormalities.
• Reconstruction needed after surgery/trauma.
vii)
Breast augmentation or reduction to correct asymmetry.
Funding should be considered if there is a disparity of 2 or more cup sizes in the
lower range (cup size C or below) or 3 or more cup sizes in the upper range (cup
size D and upwards). For some cup sizes (but not all) there are also intermediate
sizes – AA, A, B, C, D, DD, E, EE, G, GG, etc. A difference of B to D would
count as 2 cup sizes; a difference of DD to F would count as 3 cup sizes.
viii)
Breast Reduction
This procedure is not available on cosmetic grounds. An exception may be made
for true virginal hyperplasia when the proposed volume of reduction is greater than
500g preside, gross asymmetry or if the patient has at least one of the following:
•
•
•
•
Unresponsive to treatment for ulceration of the shoulder from the bra
straps.
Unresponsive to treatment for Intertigo between the breasts and the chest
wall.
Lordotic posture (curvature of the spine).
Ulnar pain from the thoracic nerve root compression.
The patient must also meet the following criteria:
•
•
•
body Mass Index (BMI) of 30 or less.
waist to hip ratio of 0.85 or less for women (0.94 for men).
bra cup size of H or more.
ix)
Mastopexy (relocating the nipple and improving the shape of the breast)
This procedure is not available on cosmetic grounds. Breast ptosis is inevitable in
most women due to a combination of maturity, gravity and pregnancy/lactation.
An exception may be made in gross cases when a nipple areola lies below the
infra-mammary fold.
x)
Revision Mammoplasty
This procedure is not available on cosmetic grounds unless the original procedure
was performed locally on the NHS because of health reasons, and the patient now
has a gross deformity.
xi)
Breast Implants
Breast implants and instant replacements are not available on the NHS. Ruptured
breast implants, however, will be removed on the NHS if they are considered to be
of danger to the patient, i.e. if there is a leaking prosthesis. Removal should be
funded if the leak is causing health problems. Replacement should be funded if the
original operation was done under the NHS and the outcome of removal is likely to
be worse than the situation before the original operation. (Removal may result in
severe ptosis.) Replacement should not be funded if the operation was done for
26
cosmetic reasons in the private sector, although it would be acceptable to replace
the leaking prosthesis with prosthesis bought by the patient.
xii)
Gynaecomastia
This procedure is not available on cosmetic grounds. True gynaecomastia that is
mainly caused by an excess of glandular breast tissue will be funded if the normal
medical treatments have failed. The commissioners will also need re-assurance that
the problem is not due to the abuse of drugs with bodybuilding.
Pseudo-gynaecomastia. Where the enlargement of the male breast is due to an
excess of adipose tissue and the BMI is outside the range of what is regarded as
“normal”, funding will not normally be agreed unless there is clear evidence that
the problem has persisted in spite of rigorous dieting and weight loss
xiii)
Correction of Congenital Nipple Inversion
This procedure is not available on cosmetic grounds. Nipple inversion is a
common condition which responds well to conservative treatment, e.g. use of
Niplette device. If the inversion is newly developed then it will require urgent
assessment.
xiv)
Dermabrasion (Chemical Peel)
This procedure is not available for skin rejuvenation. It does have a place in the
treatment of severe scarring following acne or sometimes following trauma.
xv)
Brow or Face lift
This procedure is not available on cosmetic grounds. An exception may be made
for the treatment of facial palsy.
xiii)
Depilation
xiv)
Lipomas/Liposuction
Lipomas should normally be managed in the context of the local general surgical
services. Multiple lipomas or those presenting particular technical difficulties
because of site or size can be referred on a tertiary basis to the plastic surgeons.
Multiple neurofibromatosis – plastic surgery will be funded.
Sebaceous cysts, sebaceous cysts on the face will be funded because of the risk of
recurrent infection. Cysts on the scalp or other body parts should be managed in
the context of the local general surgical or minor operations services. Funding will
be considered for:
• Treatment of diabetic injection sites.
• Pathological lipodystrophy.
xv)
Male Pattern Baldness (Hair Grafting and Flaps with or without Tissue
Expansion)
This procedure is not available on cosmetic grounds. Baldness is a natural
condition.
xvi)
Penile Implants
27
xvii)
Pinnaplasty (correction of prominent or Bat Ears)
This procedure is not available on cosmetic grounds to adults. An exception may
be made for children under the age of 18 at the time of referral.
xviii) Repair of Lobe of External Ear
This procedure is not available on cosmetic grounds. However surgery to repair
split earlobes in children under 18 should be funded.
xix)
Rhinoplasty (Reshaping of the Nose)
This procedure is not available on cosmetic grounds. Rhinoplasty should be
funded as part of reconstructive head and neck surgery, or for serious airway
problems.
xx)
Scar Revision
This procedure is not available on cosmetic grounds. An exception may be made
with certain scars, e.g. those which interfere with function following burns or for
treatment of Keloid and post-surgical scarring. Scars that are resulting in physical
disability due to contractors, or tethering or recurrent breakdown will be treated.
Keloid scars – Keloid is due to an over vigorous reaction in a scar. This is more
common in certain parts of the body, and in certain racial groups.
• Keloid scars that result in physical distress due to significant pain or pruritis
will be funded.
• Keloid scars on the face – the treatment of significant keloid scarring on the
face will be funded.
• Keloid scars on other parts of the body – treatment will not normally be
funded.
• Keloid scars secondary to ear piercing or other body piercing procedures will
not be funded.
Scars secondary to trauma/accidents
• Scars on the face that are ragged, over 2 cm in length, or can otherwise be
regarded as particularly disfiguring will be funded.
• Scars on the rest of the body. Scar revision for cosmetic purposes will not
normally be funded unless the disfigurement can be regarded as particularly
grave. Cases will be judged on an individual basis.
Scars as a result of self-harm
• These are very difficult to treat and usually the only achievable outcome is to
make the scars resemble trauma or burns rather than be obviously due to selfharm. Treatment will only be funded when there has been a minimum period
of 3 years where there has been no self-harm and where there is a supporting
report from a psychiatrist indicating that the behaviour would be unlikely to
recur.
xviii) Tattoo Removal
This procedure is not available on cosmetic grounds, however funding may be
considered for allergy to pigments.
28
xix)
Removal of Birthmarks
Available for children up to the age of 18 for permanent large or prominent lesions
on face or neck. See section 2.1 for Tunable Dye Laser.
xx)
Other Benign Skin Lesions
Other benign skin lesions e.g. skin tags, fibroepithelial polyps, dermatofibromata,
seborrhoeic warts will not be removed on cosmetic grounds. However, if
symptomatic and inflamed at the time of consultation, removal will be considered.
Epidermoid (Sebaceous) cysts are always benign and are not removed in the
Dermatology Department. Some may become infected and symptomatic and
referral to General Surgeons is indicated in these cases.
xxi)
Viral Warts and Molluscum Contagiosum in Children under 16 Years of Age
These are self-limiting viral infections. Warts are appropriately treated in Primary
Care by topical Keratolytics. Cryotherapy is too painful and no other treatment is
offered in Secondary Care for either condition.
xxii)
Viral Warts in Adults
A recent systematic review has shown that properly compliant treatment with
Keratolytics is as effective as Cryotherapy.
1.2
COCHLEAR IMPLANTS
Cochlear implantation is a high cost low volume speciality, with about 300 new
cases each year in England equating to about 6 cases per million. This procedure is
available at specialist centres only and is offered to both adults and children. The
service requires considerable pre-operative counselling and assessment and postoperative support from speech therapy services.
It is proposed that children up to the age of 18 should have first priority on the
allocation of scarce funding. In accordance with their protocols referrals will be
on a tertiary basis from a consultant audiological physician or ENT surgeon and
the service offered to those children whose hearing loss is profound or total and for
whom there has been a clear lack of hearing aid benefit over a period of months.
NICE guidance is expected in May 2008. Referral for Cochlear implants will
require prior approval by the Exceptional Treatments Group.
1.3
MACULAR DEGENERATION
NICE recommends PDT for people with wet Age-related Macular Degeneration
(ARMD) who have a confirmed diagnosis of classic subfoveal choroidal
neovascularisation (CNV), with no sign of occult CNV. People should also have at
least 6/60 vision – this means that they can see (with glasses if they usually wear
them) the same line of test letters 6 metres away that a person with normal vision
can see when 60 metres away.
PDT treatment should be carried out by doctors who specialise in treating
disorders of the retina and who have experience in using PDT. PDT is not
recommended for people who have wet ARMD with mostly classic subfoveal
CNV (that is, at least half is classic but there is also some occult CNV). The
29
exception is where the person is treated as part of a clinical study designed to
provide useful information on the effectiveness of the treatment.
NICE has not made any recommendations about PDT for people who have ARMD
with occult CNV. Referrals for all treatment of Macular degeneration will require
prior approval.
1.4
NON-MEDICAL CIRCUMCISIONS
General Remarks
Circumcision is an effective operative procedure with a range of medical
indications. However some circumcisions are also requested for social, cultural or
religious reasons, these procedures will not be funded on the NHS.
Medical Indications
Circumcisions should continue to be performed for medical indications only, e.g.
• Phimosis seriously interfering with urine flow and/or associated with recurrent
infections.
• Some cases of paraphimosis.
• Suspected cancer or balanitis xerotica obliterans.
• Congenital urological abnormalities when skin is required for grafting.
• Interference with normal sexual activity in adult males.
1.5
ALTERNATIVE THERAPIES
Osteopathy
• Osteopathy remains a low priority treatment due to the limited evidence of
clinical effectiveness.
• Future referral for osteopathy is not available on the NHS.
Acupuncture
• Acupuncture remains a low priority treatment due to the limited evidence of
clinical effectiveness.
• Future referrals for acupuncture should be made in exceptional circumstances
only for cases of dental pain and nausea and vomiting and shall be agreed by
the local Exceptional Treatment Group.
Homeopathy
• Homeopathy should remain a low priority treatment due to the limited
evidence of clinical effectiveness.
• Future referrals for homeopathy should be made in exceptional circumstances
only and shall be agreed by the local Exceptional Treatment Group.
All Other Complementary Therapies
The Primary Care Trust will not purchase these services in the Acute or Primary
Care Sector. Any referrals shall be agreed by the local Exceptional Treatment
Group.
30
1.6
REVERSAL OF VASECTOMY OR FEMALE STERILISATION
The decision to be sterilized is taken by mature adults on the understanding that it
is an irreversible contraceptive choice. Therefore, any reversal or subsequent
fertility treatment should be the responsibility of the individual and will not be
funded by the PCT. Any requests for possible exceptions may be referred to the
Exceptional Treatments Group for consideration. There should be no live children
from either of the partners.
Female
♦ The woman should not be older than 35 years.
♦ The procedure should be done in a Regional Centre by a surgeon performing
sufficient procedures to report a success rate of over 50%.
Male
♦ The reversal of vasectomy should not be performed more than 10 years after
the original sterilization procedure.
♦ The female partner should not be more than 36 years old.
1.7
FUNCTIONAL ELECTRICAL STIMULATION (FES)
FES is a way of producing contractions in muscles, paralysed due to central
nervous system lesions, using electrical stimulation. The electrical stimulation is
applied either by skin surface electrodes or by implanted electrodes. There is
uncertainty about the clinical effectiveness of this procedure and it will not be
commissioned on a routine basis.
31
SECTION 2 – PROCEDURES NOT REQUIRING PRIOR AGREEMENT
The following procedures do not require prior agreement providing the restricted
access criteria are met. An audit of these procedures will be undertaken routinely. If
the restricted access criteria are not met, then referral for treatment should be made
through the PCT Exceptional Treatments Group.
2.1
EXCISION OF OTHER SKIN LESIONS
General Remarks
If a GP or consultant is concerned that any skin lesion may be malignant the
patient should continue to be referred appropriately and treated promptly. The
general remarks about other cosmetic procedures also apply to the excision of
benign skin lesions. Some benign skin lesions will continue to be excised in the
acute sector for differential diagnosis. It will be appropriate to refer some patients
to primary care dermatology clinics.
i)
Pigmented Lesions
Removal of obviously clinically benign moles is not available on cosmetic
grounds. In most cases the distinction between suspicious and purely benign
moles is clear cut but suspicious pigmented lesions should always be subjected to
excision biopsy.
ii)
Tunable Dye Laser
This treatment is offered for the removal of vascular birthmarks (port wine stains)
often present on the neck and face and is the only successful treatment for this type
of birthmark. The criteria for patients requiring this type of treatment will be:
• On the face or neck above the collar line in children up to the age of 18 years
• Chest area on women
Patients above the age of 18 years will be considered on an individual basis taking
into account psychological and psychiatric effects of the birthmarks on the patient.
Referrals should be made on a tertiary basis usually by a Consultant dermatologist.
2.2
VARICOSE VEINS
General Remarks
Scope for prevention of varicose veins is limited. Although treatment for varicose
veins is generally effective, recurrence is estimated at around 50% within five
years. Surgical treatment of asymptomatic or mild varicose veins is not
recommended in the Department of Health’s Healthcare Needs Assessment
document, accessible at http://hcna.radcliffe-oxford.com/vvframe.htm
In view of the lack of evidence for any prophylactic benefit of varicose vein
surgery, high rates of recurrence and the current financial situation, treatment of
moderate varicose veins is also considered to be a low priority. Most patients can
be managed in primary care. Surgical treatment of asymptomatic, mild and
moderate varicose veins will therefore only be purchased in individual exceptional
circumstances.
32
In patients in whom varicosities are present or suspected, referral to a specialist
service is advised as described in the table below. Conservative management of
varicose veins, as detailed in the Department of Health funded Healthcare Needs
Assessment should continue to be offered to all appropriate patients.
NICE Referral advice
ÒÒÒÒ
immediate
ÒÒÒ
urgent
ÒÒ
soon
they are bleeding from a varicosity that has eroded the skin
they have bled from a varicosity and are at risk of bleeding again
they have an ulcer which is progressive and/or painful despite
treatment
taken from National Institute for Clinical Excellence “Referral Advice – a guide to appropriate referral
from general to specialist services” NICE, London, 2001.
i)
Asymptomatic and Mild Varicose Veins
Surgical treatment of asymptomatic and mild varicose veins will not be available
routinely. Asymptomatic varicose veins are those which present as a few isolated,
raised, palpable veins which are not associated with any pain or discomfort or any
skin changes. The main problems with asymptomatic varicose veins are likely to
be cosmetic anxiety.
Mild varicose veins are associated with moderate ankle swelling, feelings of
heaviness, pain and other discomfort, with local or generalised dilation of
subcutaneous veins. Generally, only the superficial veins are involved.
ii)
Moderate Varicose Veins
Surgical treatment of moderate varicose veins will not be available routinely.
Moderate varicose veins are associated with the symptoms described above for
mild varicose veins with prominent local or generalized dilation of subcutaneous
veins. Moderate varicose veins are more likely to be associated with skin changes
but not actual ulceration or pre-ulcerative changes.
iii)
Severe Varicose Veins
Treatment for severe varicose veins is available routinely if:
• associated with obvious skin changes including lipodermatosclerosis,
moderate to severe oedema (itching is insufficient for referral)
• intractable ulceration secondary to venous stasis
• more than one episode of minor haemorrhage from a ruptured
superficial or significant haemorrhage from a ruptured superficial
varicosity, e.g. if serious enough to consider transfusion
• Chronic venous insufficiency assessed by hospital consultant
33
Severe varicose veins are those associated with chronic leg pain, ulcerative
and pre-ulcerative skin conditions, liposclerosis, varicose eczema, history
of phlebitis or haemorrhage and there is generally deep venous
incompetence or obstruction.
Treatment should be in line with the recommendations of the NHS R & D
Health Technology Assessment 2006; 10 (13), (Michaels J.A. et al)
2.3
FERTILITY TREATMENTS
Infertility is a condition that requires investigation, management and treatment in
accordance with national guidance. As part of the provision of prevention,
treatment and care Commissioners are committed to ensuring that access to NHS
fertility services is provided fairly and consistently.
Initial Assessment
It will be the responsibility of the General Practitioners to initially assess that the
person meets the local PCT’s criteria for treatment for NHS funded cycles. Further
support and advice is available from the Pharmaceutical advisor, Public Health
Department and Directorate of Strategy (Commissioning) in implementing this
guidance.
Prescribing of medication
♦ The clinical prescribing of all drugs will be the responsibility of the providing
Trust in line with the North East London Protocol.
♦ If a patient has started a privately funded cycle, the PCT will not fund the
provision of prescribed drugs, which forms part of that treatment.
Timescale for treatment
Couples must be made aware at the time of being placed on the waiting list of the
likely waiting time and the treatment for which the PCT will pay.
ELIGIBILITY CRITERIA
All couples must be registered with a General Practitioner within the boundaries of
the PCT or Care Trust and be eligible for NHS treatment. Patients whose sperm or
eggs have been stored prior to chemotherapy or radiotherapy will be entitled to
NHS funded infertility treatment provided they meet the eligibility criteria.
Where the eligibility criteria are not met but clinicians feel there are exceptional
reasons, a case should be referred to the Exceptional Treatment Arrangements
Group for consideration.
IVF / ICSI / IUI
See additional Waltham Forest PCT Commissioning Guidance on referral for this.
HIV and Other Viral Infections (Sperm Washing)
Chelsea and Westminster Healthcare NHS Trust, the only UK centre able to treat patients
with known viral infection, offer specialist advice to HIV infected individuals and
have developed special treatment programs for men and women who are infected.
34
2.4
DILATION AND CURETTAGE
Effective Health Care Bulletin 9 has recommended that diagnostic Dilation and
Curettage (D&C) should not be performed on women aged under 40 since the
risks of anaesthesia, uterine perforation and cervical laceration outweigh the
minimal potential benefit.
Newer methods of endometrial sampling appear to be at least as accurate as D&C
with high levels of acceptability and lower complication rates.
For women with dysfunctional uterine bleeding, a range of medical interventions is
available (e.g. mefenamic acid with norethisterone etc).
2.5
HYSTERECTOMY FOR HEAVY MENSTRUAL-BLEEDING
(MENORRHAGIA)
Funding for hysterectomy for heavy menstrual-bleeding will be approved only
when:
There has been a prior trial with a levonorgestrel intrauterine system (LNG-IUS)
unless contraindicated, which has not successfully relieved symptoms
AND
Other treatments (such as NSAIDs, Tranexamic Acid, Endometrial ablation,
uterine-artery embolisation) have failed, are not appropriate, or are contraindicated in line with NICE guidelines.
Contraindications to LNG-IUS are:
•
Severe anaemia, unresponsive to transfusion or other treatment whilst a LNGIUS trial is in progress
•
Distorted or small uterine cavity (with proven ultrasound measurements)
•
Genital malignancy
•
Active trophoblastic disease
•
Pelvic inflammatory disease
•
Established or marked immunosuppression
Rationale:
•
The Mirena® device has been shown to be effective in the treatment of heavy
menstrual-bleeding.
•
It is considerably more cost-effective than performing a hysterectomy, even if
required for many years.
A number of effective conservative treatments are available as second line
treatment after failure of Mirena or where Mirena is contra-indicated.
2.6
FILTERED / COLOURED LENSES
These are not offered for specific reading difficulties.
35
2.7
TREATMENT OF GENDER DYSPHORIA
Treatment is covered by specialist commissioning arrangements and Mental
Health.
2.8
COMMON HAND CONDITIONS
♦ Ganglion
Cystic degeneration from joint capsule or tendon sheath. Lesions at the base of
the digits are often small but very tender (Seed Ganglion). Mucoid cysts arise
at the distal interphalangeal joint and may disturb nail growth. Ganglions
arising at the level of the wrist are rarely painful and most will resolve
spontaneously within 5 years. The recurrence rate after excision of wrist
ganglia is between 10-45%. Refer:
•
•
Painful seed ganglia
Mucoid cysts that are disturbing nail growth or have a tendency to
discharge (risk of septic arthritis in distal interphalangeal joint)
There is no indication for the routine excision of simple wrist ganglia. These
should not generally be referred.
♦
Carpal Tunnel Syndrome
Patients typically present with nocturnal dysaesthesia in the hands that wears
off with activity. The presence of a positive Phalen’s (wrist flexion test) or
Tinel’s sign confirms. Nerve conduction studies are NOT generally needed to
confirm the diagnosis. In elderly patients the condition may develop
insidiously. Conservative treatment may include adjustment of activities or
posture with night splintage in neutral wrist position. Non-steroidal antiinflammatory drugs and diuretics are occasionally of benefit. Steroid
injections may be of value in uncomplicated cases (requires clinical
experience). Refer:
•
•
•
♦
Dupuytren’s Disease
Nodular or cord-like thickening of the palmar skin. May tend to cause
tethering of the digits with loss of extension range. Refer:
•
•
♦
Acute severe symptoms (fewer than 5% of patients) uncontrolled
by conservative measures, particularly pregnancy
Mild to moderate symptoms with failure of conservative
management (4 months)
Neurological deficit i.e. sensory blunting or weakness of thenar
abduction (APB)
Loss of extension in one or more joints exceeding 25 degrees
Young patients (under 45 years) with disease affecting 2 or more
digits and loss of extension exceeding 10 degrees)
Trigger Finger
Snapping of the fingers as they are extended from a fully flexed posture,
associated with a tender nodule in flexor tendon at base of finger or thumb.
Conservative treatment may include rest from precipitating activities or
36
NSAIDs. Injection of hydrocortisone into the tissue in front of the tendon at
the level of the distal palmar crease (MCPJ) will often settle early cases
(requires clinical experience). Refer:
• Failure to respond to conservative treatment (maximum 2
injections)
• Fixed flexion deformity that cannot be corrected
2.9
TONSILLECTOMY
Tonsillectomy will not be funded except in cases of suspected malignancy or
significant severe impact on quality of life indicated by at least 7 episodes in the
preceding year or 5 episodes/year in the preceding 2 years, or 3 episodes/year in
the preceding 3 years and documented evidence of absence from school or
attendance at GP or other health care setting.
Rationale
2.10
•
Tonsillectomy offers relatively small clinical-benefit, measured best in
terms of time taken away from school. The benefit in the year after the
operation is roughly 2.8 days less taken away from school.
•
Tonsillectomy carries a risk of mortality estimated to lie between 1 in 8,000
and 1 in 35,000 cases.
GROMMETS
Children with hearing Impairment should have a period of at least 6 months of
watchful waiting from the onset of symptoms. Grommets should only be
considered if glue ear persists, and the child (over 3 years of age) also suffers from
one of the following:
• Recurrent acute otitis media more than 5 times per year
• Delay in speech development
• Educational problems
• Behavioural problems
• A second disability such as Down’s Syndrome
• Severe collapse of the eardrum
Indications 1-5 are similar to the referral guidelines outlined in ‘Prodigy’.
Combine adenoidectomy and grommet insertion if the child has nasal symptoms
on top of otitis media with effusion.
2.11
ADENOIDECTOMY FOR OTITIS MEDIA IN CHILDREN
Adenoidectomy combined with grommets may be considered in children who fulfil the
criteria for grommets (see grommets section 2.10 of ETA).
37
APPENDIX 7 – LIST OF OTHER INTERVENTIONS FOR CONSIDERATION
Below is a list of treatments which are not included in the Waltham Forest PCT
“Commissioning for Effectiveness” Policy, and for which prior approval should also
be requested under this policy. This list is not exhaustive as the policy applies to
any treatment / intervention for which no Service Level Agreement exists.
•
•
•
•
•
•
Balloon infusers
Bariatric Surgery
Botulinum toxin injections.
Chronic Fatigue Syndrome – interventions not covered by existing Service
Level Agreements
CPAP / sleep apnoea interventions
Hyperbaric therapy for wound healing.
38
APPENDIX 8 - EQUALITY IMPACT ASSESSMENT TOOL
To be completed and attached to any policy and procedural document when
submitted to the appropriate committee for consideration and approval.
Yes/No
1.
Comments
Does the policy/guidance affect one group less or
more favourably than another on the basis of:
• Race
No
• Gender
No
• Culture
No
• Religion or belief
No
• Sexual orientation (including lesbian, gay
and bisexual people)
No
• Age
No
• Disability – (learning disabilities, physical
disability, sensory impairment and mental
health problems)
No
2.
Is there any evidence that some groups are
affected differently?
No
3.
If you have identified potential discrimination,
are any exceptions valid, legal and/or justifiable?
Not
applicable
4.
Is the impact of the policy/guidance likely to be
negative?
Yes
Requests dealt with under
Exceptional Treatment Policies
often attract unfavourable press
coverage.
5.
If so can the impact be avoided?
No
By ensuring that this policy is
robust and decisions made under
it are defensible, any impact can
be diminished.
6.
What alternatives are there to achieving the
policy/guidance without the impact?
None
7.
Can we reduce the impact by taking different
action?
No, a policy is needed to cover
this issue.
39
APPENDIX 9 – POLICY APPROVAL FORM
To be completed and attached to any document which guides practice when
submitted to the appropriate committee for consideration and approval.
Yes/No/
Unsure
Title of document being reviewed:
1.
Title
Is the title clear and unambiguous?
Is it clear whether the document is a guideline,
policy, protocol or standard?
2.
Rationale
Are reasons for development of the document
stated?
3.
Development Process
Is the method described in brief?
Are people involved in the development identified?
Do you feel a reasonable attempt has been made to
ensure relevant expertise has been used?
Is there evidence of consultation with stakeholders
and users?
4.
Content
Is the objective of the document clear?
Is the target population clear and unambiguous?
Are the intended outcomes described?
Are the statements clear and unambiguous?
5.
Evidence Base
Is the type of evidence to support the document
identified explicitly?
Are key references cited?
Are the references cited in full?
Are supporting documents referenced?
6.
Approval
Does the document identify which committee/group
will approve it?
If appropriate have the joint Human Resources/staff
side committee (or equivalent) approved the
document?
7.
Dissemination and Implementation
Is there an outline/plan to identify how this will be
40
Comments
Yes/No/
Unsure
Title of document being reviewed:
Comments
done?
Does the plan include the necessary training/support
to ensure compliance?
8.
Document Control
Does the document identify where it will be held?
Have archiving arrangements for superseded
documents been addressed?
9.
Process to Monitor Compliance and
Effectiveness
Are there measurable standards or KPIs to support
the monitoring of compliance with and
effectiveness of the document?
Is there a plan to review or audit compliance with
the document?
10.
Review Date
Is the review date identified?
Is the frequency of review identified? If so is it
acceptable?
11.
Overall Responsibility for the Document
Is it clear who will be responsible for co-ordinating
the dissemination, implementation and review of
the document?
Sub-Committee Approval
If you are happy to approve this document, please sign and date it and forward to the chair of the
committee/group where it will receive final approval.
Name
Date
Signature
(Chair)
Committee Approval
If the committee is happy to approve this document, please sign and date it and forward copies to the person
with responsibility for disseminating and implementing the document and the person who is responsible for
maintaining the organisation’s database of approved documents.
Name
Date
Signature
(chair)
Acknowledgement: Cambridgeshire and Peterborough Mental Health Partnership NHS Trust
41
APPENDIX 10 - VERSION CONTROL SHEET
If revising a policy/procedure summarise the key changes made in the comments
column. Where a policy/procedure replaces a previous version, the old version will
be archived in accordance with the Policy for the Development and Management
of Policies and Procedures.
Version
Date
th
Author(s)
Status
Comment
One
4 April
2008
Linda Bailey
Approved by
ETG
Awaiting further approval
Two
14/05/08
Linda Bailey
Not approved by
HFA Committee
as meeting was
inquorate.
Meeting inquorate
Three
02/07/08
Linda Bailey
Draft to HFA
Committee again.
Not approved.
Amendments requested
Four
29/09/08
Linda Bailey
2nd draft for
agreement sent to
Chair of HFA.
Agreement Pending,
amendments incorporated.
42