Download effective use of resources policy

EFFECTIVE USE OF
RESOURCES POLICY
July 2010
Revised Version: 2
Review Date: July 2011
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INDEX
PAGES
1. Introduction
4
2. Elective referral for treatments not currently covered in contracts
4
3. Low clinical value treatments not normally funded
7
4. Conclusion
7
5. Glossary of terms
8
6. References
9
APPENDIX 1:
Summary of policy decisions for access to funding
i.
Breast procedures
ii.
Facial procedures
iii.
Correction of congenital abnormalities of the face and skull
iv.
Body contouring procedures
v.
Skin and subcutaneous lesions
vi.
Circumcision
vii.
Varicose veins
viii.
ENT
ix.
Neurology
x.
Hair depilation
xi.
Paediatrics
xii.
Dental
xiii.
Botolium toxin
xiv.
Obesity management
10 - 22
APPENDIX 2:
23 - 54
Greater Manchester EUR policy decisions formerly adopted by PCT
i.
Assisted conception
ii.
Tonsillectomy
iii.
Chelation therapy for vascular occlusion
iv.
Endoscopic lumber decompression
v.
CAMs – Complimentary and alternative medicine
vi.
Gender realignment
vii.
Cochlear implants
viii.
PDT for age related macular degeneration
ix.
PDT for advanced bronchial carcinoma
x.
Pulmonary hypertension
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xi.
xii.
Botolium toxin A treatment for cerebral palsy
Caesarean section
INDEX
xiii.
PAGES
Surgical treatment of ottis media
APPENDIX 3:
55
Process for applying for funding for medicines
APPENDIX 4:
56 - 59
Proforma for requesting funding for treatments
APPENDIX 5:
60 - 62
Proforma for requesting funding for bariatric surgery
APPENDIX 6:
63 - 67
Information for patients
APPENDIX 7:
68
Framework for quality assuring new providers of EUR services
i.
ii.
iii.
Assess the risk
Well-worded contracts
Improving performance through contract monitoring
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1.
Introduction
1.1
Ashton, Leigh and Wigan PCT is responsible for commissioning healthcare services
to meet the needs of the local population. At the same time, the PCT has to achieve
this by working within a finite level of resources.
1.2
The most cost-efficient and least bureaucratic way to fund a wide range of
accessible, appropriate and effective health care for the local population is through
service agreements that are agreed in advance, which cover a period of at least one
year.
The PCT’s existing agreements allow access to a comprehensive and
geographically convenient portfolio of services, and the need to seek referral to a
service, which is not covered by a service agreement, should therefore be minimal.
1.3
Even so, there is likely to be a mismatch between patient demand and the level of
service available through these agreements. To gain maximum benefit for the local
population, the PCT needs to focus on treatments with the highest clinical priority.
Consequently, a small number of treatments have been awarded a lower priority,
and are not routinely funded. Prior funding approval is therefore required for
procedures of low clinical priority.
1.4.1
The key aim of the policy is to define a fair and consistent approach to determining
commissioning principles and decisions for funding treatments of low clinical priority
services.
1.5
The Effective Use of Resources Policy provides the PCT with an evidence based
approval process. An evidence basis is considered for all funding requests received
by the PCT (this will include bodies such as the National Institute for Clinical
Excellence (NICE) or its equivalent).
2.
Elective referral for treatments currently not covered in contracts
2.1
Examples of situations in which funding for treatment by other providers may be
considered under this policy include:

Specialities or treatments that are not available in service agreements. Where a
number of alternative providers are available, those who are cost effective will be
given preference over those that are more expensive

Continuation of in-patient treatment packages approved earlier
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
Second opinions for assessment (but not treatment) that are supported by the
patient’s GP and are not available within an existing service agreement

2.2.
Procedures of low clinical value
The PCT will consider applications for funding under this policy if:

The patient is either a temporary or permanent resident within Ashton, Leigh
and Wigan PCT area, eligible for NHS services

The procedure is not covered by service level agreements with local service
providers or collaborative and consortium commissioning arrangements or the
procedure is of a low clinical value

The referrer is the patient’s GP or NHS hospital consultant. However, referrals
from other health professionals will also be accepted, as long as prior agreement
has been obtained from the patient’s GP and the referral process had been
agreed with the PCT through the Professional Executive Committee
2.3
Unless there are compelling reasons or exceptional circumstances identified by the
referring clinician, the PCT will not normally consider referrals for:

3rd or subsequent opinions.

Patients receiving self funded treatment within the private sector wishing to
transfer to NHS outside service agreements, or requiring retrospective or
continuing funding where care has previously been funded privately or by
insurance

Direct referrals from primary care clinicians or their representatives for
procedures that are judged to be highly specialised, although these are available
for tertiary (consultant to consultant) referral.
2.4
The decision-making process for treatments that have unique circumstances or are
of low clinical value will comprise all applications being reviewed by an Effective Use
of Resources Panel ‘EUR Panel’. The panel would be chaired by the Assistant
Director of Commissioning and Partnership, and membership will include the
Director of Public Health (or nominee), the GP with a Special Interest in Effective
Use of Resources, Finance representation and the Patient and Public Involvement
Manager. The panel will review all funding applications monthly using the criteria setout in Appendix 1, but urgent cases may be considered by a minimum of three
members of the panel (to include one lay representative), with the decision being
ratified at the next panel meeting.
2.5
Referring clinicians will be responsible for ensuring that all relevant information is
presented to the panel for each case. All applications will be sent to the Business
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Manager for the Commissioning and Partnership Directorate. Anyone enquiring
about individual funding will be given a copy of the of the EUR policy and asked to
complete the standard proforma. Further action at this stage could include:

Clarification of the needs of the patient, if necessary, through further discussion
with the referring clinician

Consideration of whether the needs of the patient could be met within existing
service agreements, and clarifying the reasons why this might not be
appropriate.

Consideration of the evidence for effectiveness of the treatment, if it is not
offered within an existing service agreement. This could include reviewing
relevant literature and taking opinion from relevant specialists, locally and
elsewhere.

Consideration of other relevant information – for example, previous funding
decisions, existing policy documents etc

Evidence that the patient meets the criteria for low clinical value procedures

Seek further views, if appropriate – for example, from the patient (if this is not
clear from the requesting doctor’s information), relevant patient support or
disorder based organisations (e.g. British Thoracic Society), or professional
associations (e.g. Royal College of Physicians)

In occasional cases, it might be appropriate to suggest that the patient is referred
to a named relevant specialist – usually within a service agreement – for a
second opinion and further advice before formal application is made.
2.6
The EUR panel will follow the terms of reference listed below:

To meet monthly on a date previously agreed – unless no applications are
received

To consider individual applications against the PCT’s criteria for prior approval

To reach a majority decision on whether or not to fund specific cases. In the
event of the panel being equally divided, the chairperson will make the casting
vote

To relay the panel’s decision (with reasons) in writing to the appropriate GP for
further discussion (if necessary) with the patient

To relay the panel’s decision (with reasons – unless this would be harmful) in
writing to the patient for further discussion (if necessary) with their GP

To ensure that the panel’s decisions are recorded and remain available for
scrutiny

To ensure that members declare any interests in individual cases – and withdraw
from the discussion – prior to an application being considered by the panel
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
To ensure that the wider implications of individual funding decisions are
considered, and relayed to those responsible for managing PCT’s service
agreements.
2.7
Evidence for the effectiveness of the proposed treatment will be taken into account
(for instance, some new treatments – and in particular, certain complimentary
therapies – are yet to be established). In these situations, funding decisions will be
guided by advice from public health specialists, and regional and national bodies,
including NICE.
2.8
When choosing 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.
2.9
Should the patient or referring clinician wish to appeal against the decision of
the panel, then the appeal should be made in writing to the chairperson of the panel
within 28 days. The appeal will be managed through the PCT’s appeals process.
3.
Low clinical value treatments not formally funded
3.1
The PCT considers a number of treatments to be of low clinical priority, and not
routinely affordable in secondary or tertiary care within resources currently available
(see Appendix 2). In some cases alternative local schemes to provide these
treatments may exist – or are to be developed.
3.2
It is important to note that the PCT does not impose a blanket ban on these
treatments and recognises that there will be occasional cases where individual
circumstances make such treatments appropriate. However, we expect activity be
low in areas of low clinical value.
Funding of individual cases will therefore be
considered under the guidance described in Appendix 2. Prior funding approval is
required for such cases.
4. Conclusion
4.1
The commissioning policy provides a broad guideline for the PCT’s management of
Effective Use of Resources (EUR).
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4.2
Partners working with the Commissioning and Partnership Directorate will have
clearly defined terms of reference developed for their engagement in commissioning
EUR treatments. Reports on decision outcomes and the process will be provided for
the PCT Board to enable the effects and benefits of the commissioning policy to be
assessed and understood.
6. Glossary of terms
BAPRAS – British Association of Plastic, Reconstructive and Aesthetic Surgeons
(formally BAPS – British Association of Plastic Surgeons)
Body Mass Index (BMI) – This is calculated form a recent accurate height and
weight measurement unsung the formula: weight in Kg / (height in m)2 and that the
normal range is between 18 and 25 kg/m2. It is recognised that rarely a patient with
exceptional muscle mass may exceed a BMI of 25 without being ‘overweight’.
Childhood – Defined as being under the age of 19 years at referral.
Congenital Abnormality – Any abnormality of structure, deficiency of function or
disease that is present at the time of birth.
Gillick Competent – In the health realm, children are considered competent to
make decisions on the own behalf when they are capable of understanding fully the
nature of what is proposed.
A competent child’s refusal should not be overridden, except in exceptional
circumstances.
The decision as to whether a child is Gillick competent (Victoria Gillick v West
Norfolk and Wisbech Health Authority and Department of Health and Social Security,
House of Lords, 1985) will usually be taken by health care professionals involved in
the child’s care, sometimes with input from clinical psychologists, teachers etc.
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The DH issued revised guidance in July 2004 (gateway ref 3382), which did not
change the original advice. Whilst this advice specifically relates to sexual health and
contraception, the general rules can be applied to all health care: A doctor or health
professional is able to provide (contraception, sexual and reproductive) health advice
and treatment without the parental knowledge or consent to a young person under
16, provided that:

She/ he understands the advice provided and its implications

Her / his physical or mental health would otherwise be likely to suffer and so
provision of advice or treatment is in their best interest.
However, even if a decision is taken not to provide treatment, the duty of
confidentiality applies, unless there are exceptional circumstances as to above.
Morbid Obesity – For the purpose of this guidance, people are defined as having
morbid obesity if they have a body mass index (BMI) either equal to or greater than
40 kg/m2, or between 35kg/m2 and 40kg/m2 in the presence of significant co-morbid
conditions that could be improved by weight loss.
NSCAG – National Specialist Commissioning Group
Trauma – An injury to living tissue caused by an extrinsic agent.
7. References
Laser treatment for skin problems
Drugs and Therapeutics Bulletin. 42(10):73-76, 2004
Modernisation Agency ‘Action on Plastic Surgery’
Information for Commissioners of Plastic Surgery Services, 2007
National Standards, Local Action
Health and Social Care Standards and Planning Framework. 2005/06 – 2007/08.
http://www.dh.gov.uk/PublicationsAndStandards/Publications/
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APPENDIX 1
Summary of policy decisions for access to funding
It is essential that we maximise health benefit from the resources available. As new
services become available, demand pressures increase. It is therefore necessary to
prioritise procedures, which give the maximum health benefit.
This document explains in detail how the policy would work in practice in Ashton, Leigh and
Wigan PCT. Specific sections explain the use of eligibility criteria and how procedures may
be requested in exceptional individual circumstances.
i.
Summary of specific procedures
Cosmetic Surgery
Cosmetic surgery (surgery undertaken exclusively to improve appearance) will usually be
excluded from NHS provision in the absence of previous trauma, disease or congenital
deformity. In exceptional circumstances and after special consideration, the PCT’s EUR
Group may allow a referral for cosmetic surgery to proceed. Prior funding approval is
required for such procedures.
Assessment of patients being considered for referral to Plastic Surgery who may have an
underlying genetic, endocrine or psychological condition should have this fully investigated
by the relevant specialist prior to the referral to Plastic Surgery being made.
Referrals within the NHS for the revision of treatments originally performed outside of the
NHS will not usually be permitted. Referrers should be encouraged to re-refer to the
practitioner who carried out the original treatment.
Psychological assessment
Psychological assessment can form an important part of the management of some patients
referred for low priority procedures.
Commissioners may request a psychological
assessment of patients in order to inform a commissioning decision as part of the EUR
process.
Excision of benign skin lesions
Removal of benign skin lesions will only be considered for:



Suspicious or potentially malignant lesions
Impairment of function or significant facial disfigurement, for example large
lymphoma
Treatment of multiple lipomatosis or neurofibromatosis.
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If a General Practitioner or Consultant is concerned that any skin lesion may be malignant,
the patient should continue to be referred under the 2-week rule so that treatment can be
carried out promptly.
Excision of benign skin lesions is generally effective but they are considered to be of low
priority and will only be carried out under exceptional circumstances. Therefore prior
funding approval is required for such procedures.
Non-medical circumcisions
Exceptional individual circumstances only.
Reversal of sterilisation and reversal of vasectomy
Exceptional individual circumstances only.
Varicose Veins
Varicose vein procedures are generally effective, but surgical treatment of symptomatic or
mild varicose veins is considered to be discretionary (NHS Executive Needs Assessment
1992).
Surgical treatment of symptomatic, mild and moderate varicose veins will only be offered in
exceptional individual circumstances. Evidence from recent population surveys indicates
very little relationship between symptoms and varicose veins – substantial numbers of
patients without varicose veins have similar symptoms. Conservative management of
varicose veins should continue to be offered to all appropriate patients.
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ii.
Local commissioning policy for specific procedures (Prior funding
approval required)
Treatment
Category
Cosmetic
procedures –
Breast
procedures
Treatment Procedure
Local Policy
Female breast reduction
(Reduction
mammoplasty)
Breast reduction is not commissioned.
Male breast reduction for
gynaecomastia
Breast augmentation
(enlargement ) for
healthy women that have
not had a mastectomy
and reconstruction
recommended by a
plastic surgeon
Breast enlargement in
healthy women
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have a
breast reduction.
Breast augmentation in healthy women is not
commissioned
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have a
breast augmentation.
Breast enlargement that is not needed because of
an underlying medical condition, trauma or
treatment
for
disease
is
not
routinely
commissioned.
Revision of breast
augmentation
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have a
breast enlargement.
Revision surgery will only be considered if the
NHS commissioned the original surgery.
Breast lift (Mastopexy)
If revisional surgery is being carried out for implant
failure, the decision to replace the implant (s)
rather than simply remove them should be based
upon the clinical need for replacement and
whether the patient meets the policy augmentation
at the time of revision.
Breast lifts are not commissioned
Nipple inversion that is
not due to an underlying
breast carcinoma
Cosmetic
procedures –
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have a
breast reduction.
Male breast reduction is not commissioned.
Face or brow lifts to
improve appearance
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have a
breast reduction.
For cosmetic reasons alone nipple inversion
surgery is not commissioned.
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have
nipple inversion surgery.
Face and brow lift surgery is not commissioned.
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Facial
procedures
(Rhytidectomy)
Upper lid & lower lid
blepharoplasty for
cosmetic reasons
Surgery to lower brow
Rhinoplasty to reshape
the nose
Correction of prominent
ears (Pinnaplasty /
Octoplasty)
Repair of external ear
lobe (lobules)
Cosmetic
procedures –
Correction of
congenital
anomalies of the
face and skull
Correction of bony and
soft tissue deformity of
the face
Hair loss procedures in
both men and women
Correction of male
pattern baldness
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have face
or brow lift surgery.
Upper lid blepharoplasty and lower lid
blepharoplasty is not commissioned.
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have
upper lid blepharoplasty.
This is available on the NHS for correction of
ectropion or entropion or for the removal of lesions
of the eyelid or lid margin.
Rhinoplasty surgery for cosmetic reasons is not
commissioned.
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have a
rhinoplasty.
An otoplasty or pinnaplasty done for cosmetic
reasons is not commissioned.
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have an
Otoplasty or pinnaplasty.
This procedure is only available on the NHS for
the repair of totally split ear lobe as a result of
direct trauma. Prior to surgical correction, patients
should receive pre-operation advice to inform
them of:
 Likely success rates
 The risk keloid and hypertrophic scarring in
this site
 The risks of further trauma with re-piercing of
the ear lobule
Is available on the NHS
Procedures for loss of hair are not commissioned.
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have a
hair loss procedures
Is excluded from treatment by the NHS
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Hair transplantation
Cosmetic
procedures –
Body contouring
procedures
‘Tummy tuck’
(apronectomy or
abdominoplasty)
Other skin excision for
contour e.g. buttock lift,
thigh lift, arm lift
(brachioplasty)
Abdominal lipectomy
(Liposuction)
Cosmetic
procedures –
Skin and
subcutaneous
lesions
Fatty lumps (lipomata)
Excision of noncancerous skin lesions
for cosmetic reasons
Will not be available on the NHS, regardless of
gender – other than in exceptional cases, such as
reconstruction of the eyebrow following cancer or
trauma
Apronectomy or abdmominoplasty is not
commissioned.
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have an
apronectomy or abdmominoplasty.
Body contour surgery is not commissioned.
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have body
contour surgery.
Abdominal lipectomy is usually cosmetic and is
not routinely commissioned.
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have
abdominal lipectomy.
Lipomata of any size should be considered for
treatment by the NHS in the following
circumstances:
 The lipoma (-ta) is / are symptomatic
 There is functional impairment
 The lump is rapidly growing or abnormally
located (e.g. sub-fascial, sub-muscular)
Non-cancerous skin lesions include:
skin tags; warts; corns; comedones (blackheads);
milia (whitish spots which occur on the face);
spider naevi (spider-like capillaries visible below
the skin); sebaceous cysts (sac-like lesions filled
with fatty substance); seborrhoeic keratoses
(brown warts); molluscum contagiosum (dome
shaped, pearly lesions caused by a viral
infection); xanthelasma (yellow plaques which
occur on the eye-lids); lipomata (fatty lumps found
below the skin)
Removing these skin lesions for cosmetic reasons
is not commissioned.
Excision of noncancerous skin lesions
Prior approval for removing these skin lesions can
be obtained from the PCT for certain defined
situations
Non-cancerous skin lesions include:
skin tags; warts; corns; comedones (blackheads);
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milia (whitish spots which occur on the face);
spider naevi (spider-like capillaries visible below
the skin); sebaceous cysts (sac-like lesions filled
with fatty substance); seborrhoeic keratoses
(brown warts); molluscum contagiosum (dome
shaped, pearly lesions caused by a viral
infection); xanthelasma (yellow plaques which
occur on the eye-lids); lipomata (fatty lumps found
below the skin)
Removing these skin lesions for cosmetic reasons
is not funded
For a non-cancerous skin lesion surgical excision
will only be funded if there is recorded evidence
that one of the following criteria are met:


Viral warts
Xanthelasma
Laser treatment or
surgery for removal of
tattoos on both men and
women
Laser treatment for
birthmarks
it is an unidentified lesion requiring biopsy
a lesion displaying unusual behaviour e.g.
bleeding, change in colour
 it is basal cell carcinoma
 it is a lesion causing symptoms such as
persistent itching, bleeding, recurrent
inflammation and pain
 it is a lesion causing restrictions on
movement or activity
 it is a moderate to large facial lesion which
causes disfigurement
 Lesions on a site subjected to recurrent
trauma
 Lesions obstructing an orifice or vision
Most viral warts will clear spontaneously or
following application of tropical treatments.
Painful, persistent or extensive warts (particularly
in the immuno-supporessed patient) may need
specialist assessment, usually by a dermatologist.
For a small proportion surgical removal
(cryotherapy, cautery, laser or excision) may be
appropriate.
Laser treatment or surgery for removal of tattoos
is not commissioned.
Laser treatment or surgery for removal of tattoos
is not commissioned.
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have
tattoo removal
Laser removal of a birthmark is usually cosmetic
and is not routinely commissioned.
- 15 -
Laser treatment or
surgery for the revision
of scars
Skin hypo-pigmentation
Vascular skin lesions
Acne vulgaris
Rhinophyma
Circumcision
Medical circumcision
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have laser
removal of a birthmark.
Laser treatment or surgery for revision of scars is
usually cosmetic and is not routinely
commissioned.
Clinical evidence of exceptional circumstances
must be submitted to the PCT to be considered on
an individual case basis for a patient to have laser
treatment or surgery for the revision of scars.
The recommended NHS suitable treatment for
hypo-pigmentation is Cosmetic Camourflage.
Access to a qualified camourflage beautician
should be available on the NHS for this and other
skin conditions requiring camourflage.
NHS treatment is allowed for all vascular skin
lesions except for small benign, acquired vascular
lesions such as thread veins and spider naevi.
The treatment of active acne vulgaris should be
provided in primary care or through a dermatology
service.
Patients with severe facial post-acne scarring can
benefit from ‘resurfacing’ and other surgical
interventions, which may be available from the
plastic surgery service.
The first line treatment for this disfiguring condition
of the nasal skin is medical. Severe cases or
those that do not respond to medical treatment
may be considered for surgery or laser treatment.
Circumcision is an effective procedure with a
range
of
medical
indications.
Some
circumstances are also requested for social,
cultural or religious reasons; these non-medical
circumcisions do not confer any health gain but do
carry measurable health risks.
Medical Indications
Circumcisions should continue to be performed for
medical indications, including:
 Phimosis seriously interfering with urine flows
and/or associated risks with recurrent
infection.
 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
- 16 -
Varicose veins
Surgical treatment of
mild varicose veins.
adult males.
Surgical treatment of mild varicose veins is not
commissioned.
Mild symptoms, include:
Itching, aching, mild swelling, minor skin changes
of eczema haemosiderosis
Surgical treatment of
Moderate varicose veins
Surgical treatment of
severe varicose veins
when arterial
insufficiency is not
present
Mild symptoms can be managed by compression
and skin care.
Surgical treatment of moderate varicose veins is
not commissioned.
Moderate varicose veins are associated with the
symptoms described for mild varicose veins, with
prominent
local
or
general
dilation
of
subcutaneous veins. Moderate varicose veins are
more likely to be associated with skin changes but
not actual ulceration or pre-ulcerative changes.
The following criteria must be met before surgical
treatment can be considered:


ENT
Myringotomy (with or
without grommets) for
children younger than 12
with glue ear
The patient must have severe symptoms
which include: thrombophlebitis,
haemorrhage, severe swelling, skin change
of atrophie blanche, lipodermatosclerosis,
ulcers.
There is evidence that the patient has had
conservative therapy and has undertaken
compression therapy unless this is contra
indicated.
Note patients with arterial insufficiency should be
referred to a vascular surgeon
There should be evidence that advice has been
given to parents and information about
alternatives. There should be a documented
period of watchful waiting.
The insertion of a ventilation tube into the ear can
be considered for a child that is under 12 and has
the following criteria:
 persistent bilateral OME documented over a
period of 3 months with a hearing level in the
better ear of 25–30 dBHL or worse averaged
at 0.5, 1, 2 and 4 kHz (or equivalent dBA
where dBHL not available)
Once a decision has been taken to offer surgical
intervention for OME in children, the insertion of
ventilation tubes is recommended.
Adjuvant adenoidectomy is not recommended in
- 17 -
the absence of persistent and/or frequent upper
respiratory tract symptoms.
The following treatments are not commissioned
for the management of OME:
 antibiotics
 topical or systemic antihistamines
 topical or systemic decongestants
 topical or systemic steroids
 homeopathy
 cranial osteopathy
 acupuncture
 dietary modification, including probiotics
 immunostimulants
 massage.
Hearing aids should be offered to children with
persistent bilateral OME and hearing loss as an
alternative to surgical intervention where surgery
is contraindicated or not acceptable.
Tonsillectomy for
tonsillitis
Hearing aids should normally be offered to
children with Down’s syndrome and OME with
hearing loss.
 For children with persistent bilateral OME
with a hearing loss less than 25–30 dBHL
clinical evidence of exceptional
circumstances must be submitted to the PCT
to be considered on an individual case basis
There is evidence that the patient has had a six
month period of watchful waiting prior to
tonsillectomy. This is to establish firmly the pattern
of symptoms.
There is evidence that the patient has had options
and risks explained and has considered fully the
implication of the operation.
Once the decision is made for tonsillectomy, this
should be performed as soon as possible to
maximise the period of benefit.
The patient should meet all of the following
criteria:
 Sore throat is due to tonsillitis
 Had five or more documented episodes of
sore throat per year
 Had symptoms for at least one year
 Episodes of sore throat are disabling and
demonstrably prevent normal functioning
Tonsillectomy may be of modest benefit for
- 18 -
children who experience severe recurrent bouts of
tonsillitis, but this benefit may be outweighed by
the risks associated with surgery. The risk-benefit
ratio is less favourable for children who
experience less severe tonsillitis.
Hysterectomy for
Menorrhagia
Hysterectomy for
Menorrhagia
There is evidence that the woman fits the clinical
criteria of heavy menstrual bleeding (HMB). This
is defined as excessive menstrual blood loss
which interferes with the woman’s physical,
emotional, social and material quality of life, and
which can occur alone or in combination with
other symptoms.
Women offered hysterectomy should have a full
discussion of the implications of surgery and the
increased risk of serious complications. Any
interventions should aim to improve quality of life
measures.
For hysterectomy a patient must have
documented evidence of heavy bleeding due to
fibroids greater than 3cm and the following must
apply:
 Other symptoms (e.g. pressure) are present
 There is evidence of severe impact on quality
of life
 Other pharmaceutical options have failed
 Patient has been offered myomectomy and/or
uterine ablation (unless medically contraindicated).
For HMB alone hysterectomy should not be the
first line of treatment.
In line with NICE hysterectomy for HMB should
only be undertaken when there is documented
evidence that there has been an unsuccessful use
of a levonorgestrel intrauterine system (e.g.
Mirena) unless medically contraindicated. And at
least two of the following treatments have failed,
are not appropriate or are contra-indicated:
 Non –steroidal anti-inflammatory agents
 Tranexamic acid
 Injected progesterone’s
 Combined oral contraceptives.
A hysterectomy patient with HMB should meet all
of the following criteria:
- 19 -




Neurology
Video telemetry
Hair depilation
(Hair removal)
Laser and electrolysis
hair removal
Paediatrics
Bobath therapy
Vagal nerve stimulators
for epilepsy
Dental
Extraction of healthy
wisdom teeth
Dental Implants
Botulinum Toxin
Botulinum toxin
There is evidence that all other treatment
options have failed, are contraindicated or
have been offered and declined by the
woman
There is a wish for amenorrhoea
The woman has been fully informed of all
options and requests it
The woman no longer wishes to retain her
uterus and fertility
In women with HMB alone, with uterus no bigger
than a 10-week pregnancy, endometrial ablation
should be considered preferable to hysterectomy
During 2007/08, a video telemetry service was
established at Hope Hospital.
Hair removal will be commissioned on the NHS for
patients who:
 Have undergone reconstructive surgery
leading to abnormally located hair baring skin
 Those who have a proven underlying
endocrine disturbance resulting in Hirsutism
(e.g. polycystic ovary syndrome)
 Are undergoing treatment for pilonidal
sinuses to reduce recurrence
 Hirsutism leading to significant psychological
impairment
The PCT does not currently fund bobath therapy.
This policy will be reviewed by the GM EUR
Group in 2008/09.
This procedure will only be funded by the PCT if
the patient has been assessed as meeting the
NICE criteria for Vagal Nerve Stimulators.
Impacted wisdom teeth that are free from disease
(healthy) should not be operated on and surgery is
not commissioned.
Note NICE guidance states - The practice of
prophylactic removal of pathology-free impacted
third molars should be discontinued in the NHS.
All referrals for dental implants must meet the
Greater Manchester criteria for this procedure.
The PCT’s dentistry advisor will screen all funding
requests for this procedure.
Botulinum toxin has many uses within the NHS. It
is available for pathological conditions by
appropriate specialists in cases such as:
 Frey’s syndrome
 Blepharospasm
 Cerebral palsy
- 20 -

Hyperhidrosis
Botulinum toxin is not available for the treatment
of facial ageing or excessive wrinkles.
Dilation and
Curettage for
menorrhagia
Obesity
Management
Dilation and Curettage
for menorrhagia
This procedure is not commissioned for
menorrhagia.
The risk of anesthesia, uterine perforation and
cervical laceration outweighs the minimum
potential benefit.
Bariatric Surgery
In accordance with NICE guidance, dilation and
curettage should not be used as a therapeutic
treatment or a diagnostic tool (if there is a
suspected endometrial pathology, a hysteroscopy
should be used for diagnosis).
It has been agreed that a common approach
should be used for controlling bariatric surgery. All
PCTs in Greater Manchester are now working to
the priority criteria for adult’s bariatric surgery and
definitions of “serious” co- morbidity for a time
limited period of 12 months prior to it being
reviewed again.
Priority patients to be considered have:
- BMI of 50 kg/m² or greater without obesity
related co-morbidity;
- BMI of 45 kg/m² or greater in the presence of a
serious co-morbidity (see table below) which
may be amenable to treatment if obesity is
modified by surgery, and/or have:




Condition which requires surgery at the
same time as bariatric surgery, based
upon clinical need and urgency for such
surgery, such as cholecystectomy, hernia
repair
Condition which needs surgery or complex
technological intervention as soon as
possible after bariatric surgery, such as hip
or knee replacements.
Condition for which surgery is withheld
until weight loss is achieved e.g. spinal
pathology or awaiting IVF for infertility
Condition that although surgically treatable
is at a high risk of recurrence in the
presence of obesity e.g. incisional hernia.
Prior to surgical referral this group of patients
should:
 Complete the PCT's 6 month intensive
Specialist Weight Management Service to
- 21 -
show a commitment and understanding to
the healthy life style choices they will have
to adhere to after surgery.
 Attend a pre – bariatric surgery education
programme, run by PCT specialist weight
management services (not bariatric
surgery providers) to get a greater
understanding of the commitment they are
making.
 Patients that do not meet these clinical
definitions should be referred into the
PCT’s Specialist Weight Management
Service for treatment
Patients with lower BMIs 35 to 44.9 with comorbidities and BMI 40 to 49.9 without comorbidities are currently not priority patients and
would not progress to surgery. To ensure
implementation of NICE guidance this group of
patients should be offered treatment via the ‘Lose
Weight Feel Great’ care pathway.
iii.
Eligibility criteria
If a General Practitioner considers that a patient might reasonably fulfil the eligibility
criteria for a Procedure of Low Clinical Priority, as detailed in this document (i.e. they
meet the specific criteria listed for each treatment) the patient may be referred to
an NHS provider local hospitals for a Consultant opinion. The referral letter should
include specific information regarding the patient’s eligibility. The Consultant may
request additional information before seeing the patient. The NHS Trust would then
apply to the PCT for prior approval for this procedure.
The notes should clearly reflect exactly how the criteria were fulfilled, to allow routine
service level agreement monitoring. A list of funding requests approved by the PCT
will be monitored monthly through the invoice validation process with providers.
- 22 -
APPENDIX 2
GREATER MANCHESTER EFFECTIVE USE OF RESOURCES (EUR) POLICY
DECISIONS
- 23 -
ASSISTED CONCEPTION GREATER MANCHESTER GUIDELINE
Topic:
Assisted Conception
Issue Date:
Ratified by GM DPHs September 2004
(clinically reviewed/updated and agreed December 2004)
Summary:
In February 2004 the National Institute for Clinical Excellence (NICE) published the first NHS guidelines outlining the types of investigations and
treatments that should be available to people with fertility problems1-5. The intention of the guidelines is to offer best practice advice on the
care of people in the reproductive age group who perceive problems in conceiving. It addresses optimal lower and upper age ranges for
treatment, and offers advice on the management of people with a known condition or reason for their fertility problems, for example, prior
treatment for cancer, HIV or a genetic condition.
The guideline covers the care received in primary, secondary and tertiary healthcare settings and covers the diagnostic, medical and surgical
management of people throughout all stages of their care.
It is expected that full implementation of the fertility treatment guidance will take time and the Department of Health has issued advice to the
NHS confirming its interim expectations of PCT’s to:
 Offer all women aged 23-39 who meet the NICE clinical criteria a minimum of one full cycle of IVF from April 2005;
 Give priority to couples that do not already have a child living with them.
Recommendations:
Key recommendations in the guideline include:
 Screening all women for Chlamydia before they undergo procedures to check if their fallopian tubes are blocked;
 Offering women who do not have any history of problems with their fallopian tubes an x-ray to see if their tubes are blocked, rather than
an invasive procedure;
 Offering six cycles of intra-uterine insemination (IUI) to couples with: unexplained fertility problems, or slightly abnormal sperm count, or
mild endometriosis;
 Offering three cycles of stimulated IVF with two embryo transferred or six cycles with one embryo transferred each time with to couples
in which the woman is aged between 23-39 who have an identified cause of their fertility problems or unexplained fertility of at least
three years.
The finding that the rate of neurological sequelae and cerebral palsy was not higher amongst twins born after assisted conception compared to
- 25 -
naturally compared twins is reassuring. It suggests that assisted conception does not lead to a higher rate of neurological sequelae per se.
The rate of neurological sequelae and cerebral palsy amongst singletons after assisted conception may not be a good guide as how many eggs
should be transferred. Although the paper by Pinborg et al (1) does not give information on how many embryos were transferred to the mothers
in their study, it is reasonable to assume that it was usual for at least two embryos to be transferred. The women who gave birth to singletons
will be different from those women who gave birth to twins in that only one embryo developed. It may well be that the chances of only having a
singleton rather than twins is sometimes a reflection of the health of the woman or that one of the twins died early. This could well explain the
higher rate in singletons resulting from assisted conception, compared to naturally conceived singletons, of neurological sequelae and cerebral
palsy as naturally conceived singletons are likely to be usually the result of only one egg being fertilised.
Studies show that there is a higher rate of cerebral palsy in twins compared to singletons (2-3). The comparisons given, by Pinborg et al, for the
crude rates of cerebral palsy in all births are higher than the rates for singletons. For example, the rate of cerebral palsy amongst singletons in
a European multicentre study, which included East Denmark, was 1.8 per 1,000 live births in 1984-90(4).
The epidemiological evidence indicates that it is safest to transfer only one embryo. A randomised controlled trial, comparing one versus twoembryo transfer, could provide a more definitive answer but this would need to recruit tens of thousands of couples to have sufficient statistical
power. In the absence of such a trial, it will be necessary to make a judgement using all the evidence available.
N.B. Ashton, Leigh and Wigan PCT offers one cycle of IVF with a maximum of 2 embryos transferred at a time where a cycle includes
the use of any suitable fresh or frozen embryos.
Reference:
1.
National Institute for Clinical Excellence, Fertility: assessment and treatment for people with fertility problems: clinical guideline 11. NICE,
February 2004.
2.
National Institute for Clinical Excellence, Assessment and treatment for people with fertility problems: understanding the NICE guidance –
information for people with fertility problems, their partners and the public. NICE February 2004.
3.
National Institute for Clinical Excellence, Scope: assessment and treatment for people with fertility problems, 18 February 2002.
4.
Department of Health, Health Secretary welcomes new fertility guidance, Press release issued Wednesday 25 February 2004, Ref. no:
2004/0069.
5.
National Institute for Clinical Excellence, New NHS guidelines on fertility treatment, Press release issued Wednesday 25 February 2004.
6.
Pinborg A, Loft A, Schmidt L, Griesen G, Rasmussen S, Andersen AN, Neurological sequaelae in twins born after assisted
conception: Controlled national cohort study, BMJ, 2004; 329: 311-7
- 26 -
7.
8.
9.
Luke B, Keith LG, The contribution of singletons, twins and triplets to low birth weight, infant mortality and handicap in the United States. J
Reprod Med 1992: 37: 661-6
Petterson B, Nelson KB, Watson L, Stanley F, Twins, triplets and cerebral palsy in births in Western Australia in the 1980s, BMJ, 1993,
307: 1239-43
Topp M, Huusom LD, Langhoff-Roos J, Delhumeau C, Hutton JL, Dolk H on behalf of the SCPE Collaborative Group, Multiple birth and
cerebral palsy in Europe: a multicenter study, Acta Obstet Gynecol Scand, 2004; 83: 548-53
TONSILLECTOMY GREATER MANCHESTER GUIDELINE
Topic:
Tonsillectomy
Issue Date:
Ratified by GM DPHs September 2004
(subject to agreement by clinicians and incorporation of any amendments)
Summary:
Tonsillectomy procedures are used to treat recurrent or chronic tonsillar infection, tonsillar hypertrophy (increase in bulk or size), abcess in the
tonsillar area and middle ear infections where tonsillar hypertrophy is believed to be an exacerbating factor. Life-threatening complications of
these conditions are rare and the main aim of surgery is to relieve symptoms. About 45,000 people had a tonsillectomy in 2000/01 and about
60% of these were children under the age of 15.
A Cochrane systematic review (search date 1998) concluded that the effectiveness of tonsillectomy (regardless of technique) has not been
adequately or systematically evaluated1. However, the Scottish Intercollegiate Guidelines Network (SIGN) produced a comprehensive
guideline presenting evidence-based recommendations for the management of acute and recurring sore throat and indications for tonsillectomy
in 19992.
NICE issued Interventional Procedures Guidance on coblation tonsillectomy issued in September 2003 that is still current3. Coblation
tonsillectomy may be more effective in reducing post-operative pain, reducing tissue-damage and improving healing, when compared with other
surgical procedures. This technique uses a bipolar probe and a radiofrequency electrical current to dissect out the tonsil, a procedure that
heats the surrounding tissue less than standard diathermy. However, the guidance emphasises the important of adequate training in coblation
tonsillectomy.
- 27 -
In March 2004 NICE issued further interim guidance concerning tonsillectomies that involve diathermy, following early results from
the National Prospective Tonsillectomy Audit4,5. Initial results from the audit suggest that patients who have tonsillectomies that
involve using heat are more likely to have bleeding (haemorrhage) after the operation, requiring readmission to hospital and return to
theater, than patients operated on without heat (the ‘cold steel’ technique). This interim guidance recommends the use of the least
possible diathermy and that surgeons should consider alternative procedures. It also recommends that surgical instruments are
reused, in preference to the use of disposable instruments.
NICE will go on to develop definitive guidance on tonsillectomies that involve diathermy, and the best techniques for reducing any possible risks
of variant Creuzfeldt-Jakob Disease (vCJD) transmission whilst ensuring that tonsillectomies are as safe as possible.
Recommendations:
It is recommended that the guidelines issued by NICE on coblation tonsillectomy and tonsillectomies that involve diathermy are adopted.
Adoption of the SIGN indications for tonsillectomy is also recommended:
i)
Patients should meet all the following criteria:
 Sore throats are due to tonsillitis
 Five or more episodes of sore throat per year
 Symptoms for at least a year
 Episodes of sore throat are disabling and prevent normal functioning
ii)
Following specialist referral, a six month period of watchful waiting is recommended to establish the pattern of symptoms and allow the
patient to consider the implications of the operation
iii)
Once a decision is made for tonsillectomy, this should be performed as soon as possible to maximise the period of benefit.
Reference:
1. Burton MJ, Towler B, Glasziou P. (2004) Tonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis (Cochrane
Review). In: The Cochrane Library, Chichester, UK: Issue 2.
2. Scottish Intercollegiate Guidelines Network, Management of sore throat and indications for tonsillectomy: a national clinical guideline,
January 1999.
- 28 -
3. NICE (2004), Interventional procedures guidance number: IPG0009 coblation tonsillectomy, 24 September.
4. NICE (2004), NICE issues interim guidance for NHS surgeons and the public on the use of diathermy in tonsillectomy, 24 March.
5. National Prospective Tonsillectomy Audit: www.tonsil-audit.org.
CHELATION THERAPY FOR VASCULAR OCCULSIONS GREATER MANCHESTER GUIDELINE
Topic: Chelation therapy for vascular occlusions.
Issue Date:
Ratified by GM DPHs September 2004
Summary:
The effectiveness of chelation therapy in the treatment of cardiovascular disease is unproven by Randomised Control Trial or other high-quality
evidence.
The Department of Health does not recommend that the NHS offers chelation therapy for the treatment of vascular complications associated
with cardiovascular disease and other diseases, such as diabetes.
Chelating drugs are not licensed under the Medicines Act 1968 for use in treating patients with heart and arterial disease and cannot therefore
be used except where such use is part of a clinical trial, or in accordance with the provision of the Act.
Recommendations:
This intervention should not be commissioned based on current evidence.
Reference:
DOH communication reference: DE1059047, Friday July 16, 2004.
- 29 -
ENDOSCOPIC LUMBAR DECOMPRESSION GREATER MANCHESTER GUIDELINE
Topic:
Endoscopic lumbar decompression
Issue Date:
Ratified by GM DPHs September 2004
(clinically reviewed and agreed December 2004)
Summary:
Based on the epidemiological literature1, about 3,000 - 5,000 people in Greater Manchester will require surgery for back pain, sometimes with
neurological problems each year. The issue facing PCTs is whether the only surgery for back pain that they should fund is lumbar fusion or
whether to give patients a choice between lumbar fusion and endoscopic lumbar decompression.
There are two randomised controlled trials of lumbar fusion. The Swedish Lumbar Spine Study2 compared fusion in 222 patients with physical
therapy in 72 patients. It showed, that pain was reduced by 33% in the surgical group compared to 7% in the controls (p=0.0002) and disability
was reduced by 25% compared to 6% in controls ((p=0.015) according to the Oswestry Low Back Pain Questionnaire at two year follow up.
Another study of 64 patients comparing lumbar fusion with cognitive intervention and exercises failed to find any difference in pain or disability
after
one
year3.
4
For degenerative lumbar spondylosis the Cochrane Review concluded that, "there is no scientific evidence about the effectiveness of any form
of surgical decompression or fusion for degenerative lumbar spondylosis compared with natural history, placebo, or conservative treatment."
NICE guidance states about endoscopic laser foraminoplasty that "the research on efficacy undertaken to date is based on case series only
and has been led by a single clinician. In general, pain was decreased after the procedure." Although the review of endoscopic laser
foraminoplasty found greater reductions in pain and disability than in the intervention groups in the randomised controlled trials, the review did
not have any controls for comparison. This leads to NICE's conclusion that "the efficacy of the procedure is unproven" but "further research into
safety and efficacy will be useful in reducing the current uncertainty." In view of the Government's policy that "by 2008, independent sector
providers will provide up to 15% of procedures on behalf of the NHS.", it is vital to identify cost effective procedures that can be provided by
independent sector providers such as the Spinal Foundation.
Recommendations:
Endoscopic lumbar decompression should not be commissioned routinely but PCTs should fund endoscopic lumbar decompression as part of
peer reviewed randomised controlled trial(s) which compare endoscopic laser foraminoplasty to either conservative therapy or to conventional
surgery such as spinal fusion.
- 30 -
Reference:
1.
Knight MTN, Goswami, A, Patko JT, Buxton N, Endoscopic foraminoplasty: a prospective study on 250 consecutive patients with
independent evaluation, J Clin Laser Med & Surg 2001;19, 73-81
2.
Hagg FP, Hagg O, Wessberg P, Nordwall A; 2001 Volvo award winner in clinical studies: lumbar fusion versus nonsurgical treatment for
chronic low back pain: a multicenter randomised controlled trial from the Swedish Lumbar Spine Study Group, Swedish Lumbar Spine
Study Group, Spine 2001; 26; 2521-32
3.
Ivar Brox J, Sorensen R, Friis A, Nygaard O, Indahl A, Keller A, Ingebrigtsen T, Eriksen HR, Holm I, Koller AK, Riise R, Reikeras O,
Randomised clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and
disc degeneration, Spine 2003; 28;1913-21
4.
Gibson JNA, Waddell G, Grant IC Surgery for degenerative lumbar spondylosis (Cochrane Review). In: The Cochrane Library, Issue 3,
2004. Chichester, UK: John Wiley & Sons, Ltd
COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAMs) GREATER MANCHESTER GUIDELINE
Topic: Complementary and alternative medicine (CAMs)
Issue Date: 4/10/06
Summary:
CAMs are controversial because some lack evidence for their effectiveness and some lack regulation of their therapists and therefore have the
potential to cause harm, e.g. through delayed diagnosis or through the therapeutic intervention. However, there may be scope for expansion of
CAMs which have been demonstrated to be effective and offer the possibility of cost savings over conventional therapies.
Several health care professionals use CAM as part of their practice e.g. physiotherapists use spinal manipulation, some GPs use homeopathy,
anaesthetists use acupuncture etc. A number of reviews of complementary and alternative therapies have been published however no national
policy exists [1,2]. In Greater Manchester some Primary Care Trusts have developed local policies [3]. An evidence based systematic review of
69 CAMs and 46 conditions which are frequently treated with CAM has recently been updated [4]. A national review commissioned by the
Prince of Wales recommended that the National Institute for Health and Clinical Excellence should undertake a full assessment of the cost
- 31 -
effectiveness of specific CAMs and their potential role within the NHS [4].
The House of Lords Select Committee undertook a review and divided CAMs into three broad groups [5]:
1) Those regarded as the principle disciplines or “Big 5” of the CAM world and which have an individual diagnostic approach; osteopathy,
chiropractic, acupuncture, herbal medicine and homeopathy. The first two of these are regulated in their professional activity and
education by Acts of Parliament.
2) Therapies which are most often used to complement conventional medicine and do not purport to embrace diagnostic skills. It includes
aromatherapy, the Alexander technique, bodywork therapies, including massage; counselling; stress therapy; hypnotherapy; reflexology
and probably shiatsu; meditation and healing.
3) Therapies which “purport to offer diagnostic information as well as treatment and which, in general, favour a philosophical approach and
are indifferent to the scientific principles of conventional medicine”. This group can be further divided:
3a) Long established and traditional systems of healthcare such as Ayurvedic medicine and Traditional Chinese medicine.
3b) Alternative disciplines which “lack any credible evidence base” such as crystal therapy, iridology, radionics, dowsing and
kinesiology.
The principle disciplines are considered here, further analysis of the evidence can be found in [4]:
Spinal manipulation
The use of spinal manipulation (osteopathy or chiropractic) for back pain by physiotherapists, osteopaths or chiropractics can be considered as
a treatment option for back pain.
Osteopathy and chiropractic both use techniques of manipulation and are therefore referred to as the manipulative therapies. Osteopathy and
chiropractic are the only CAM therapies at present regulated by statutory bodies: the General Chiropractic Council (GCC) and the General
Osteopathic Council (GOC). The Royal College of General Practitioners and the Europe wide guidelines support manipulation as having a
place in the treatment of back pain; there is some evidence to support this [6,7]. However, a recent Cochrane review found that spinal
manipulation is only better than sham or detrimental treatments but not superior to conventional therapies for back pain [8]. Considering that
spinal manipulation is neither free of risks [9] nor inexpensive, it may not be the best possible approach. For all other indications, the evidence
fails to show efficacy [4].
- 32 -
Acupuncture
The use of acupuncture for pain and nausea does have some evidence to support it (specifically for chronic back pain, dental pain,
fibromyalgia, gastrointestinal endoscopy, idiopathic headache, nausea and vomiting, pain relief after oocyte retrieval, and knee osteoarthritis)
and might be supported when provided within NHS settings [1, 4]. Existing services, which use acupuncture in stroke or substance abuse
services, will need to demonstrate evidence of their effectiveness to be supported.
The acupuncture profession is moving towards statutory regulation and legislation is expected by 2007.There is conflicting evidence for the use
in a number of conditions including some forms of chronic pain, stroke and substance abuse whilst there is no evidence of use for rheumatoid
arthritis, smoking cessation or weight reduction. In the hands of well-trained clinicians, acupuncture is relatively safe.
Herbal medicine and nutritional supplements
Evidence exists for the use of a number of herbal remedies e.g. St Johns Wort for the treatment of mild to moderate depression [10].
Glucosamine is a natural component of cartilage and has synthetically been produced as a nutritional supplement. There is evidence to support
its use in knee osteoarthritis to reduce symptoms [11]. Traditional, individualized approaches as practised by the vast majority of UK herbalists,
is not supported by good evidence.
Concerns have been raised about the training and regulation of non-medical herbalists. Single herbal medicines, which have clear evidence of
their effectiveness, should be supported when herbalists are statutorily regulated. The profession of medical herbalism is moving towards
statutory regulation and legislation is expected by 2007. Extension of the use of herbal medicines in the NHS should be re-considered once this
has occurred.
Homeopathy
The use of homeopathy should only be supported when prescribed by an NHS professional; there should be no expansion of this service until
there is greater evidence of its effectiveness.
The evidence for homeopathy is controversial. There is some evidence that it offers benefits in terms of outcomes and costs (probably due to
the therapeutic nature of the consultation rather than the therapeutic intervention). The data from rigorous clinical trials, however, tends to fail to
show efficacy [12]. Therefore, there is not thought sufficient evidence to warrant its expansion [2]. Homeopaths are not moving towards
statutory regulation and at present have only voluntary self-regulation.
- 33 -
Recommendations:
Reference:
[1] NHS Centre for Reviews and Dissemination. Effective Health Care: Acupuncture. York; Royal Society of Medicine Press, 2001.
[2] NHS Centre for Reviews and Dissemination. Effective Health Care: Homeopathy. York; Royal Society of Medicine Press, 2002.
[3] Verma A. A draft policy on the uses of complementary therapies in the NHS in Trafford. Trafford PCTs; 2004.
[4] Ernst E, Pittler MH, Wider B. The desktop guide to complementary and alternative medicine. Mosby Elsevier, 2006.
[4] Smallwood C. The role of complementary and alternative medicine in the NHS.
[5] Complementary and alternative medicine. Report of the House of Lords Select Committee on Science and Technology; Session 1992000:HL Paper 1232. London: the Stationery Office;2000.
[6] Royal College of General Practitioners. Clinical guidelines for the management of acute low back pain. London: RCGP,1999.
[7] www.backpaineurope.org
[8] Assendelft WJJ, Morton SC, Yu E.I., Suttorp MK, Shekelle PG. Spinal manipulative therapy for low back pain. A meta-analysis of
effectiveness relative to other therapies. Ann Intern Med 2003;138:871-81.
[9] Stevinson C, Ernst E. Risks associated with spinal manipulation. Am J Med 2002;112:566-570.
[10] Gaster B, Holroyd J. St Johns wort for depression: a systematic review. Arch Intern Med 2000;160(2):152-6.
[11] Poolsup N, Suthisisang C, Channark P, Kittikulsuth W. Glucosamine long term treatment and the progression of knee osteoarthritis:
systematic review of randomized controlled trials. Ann Phrmacother 2005;39:1080-1087.
[12] Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol 2002;54:577-582.
- 34 -
GENDER REALIGNMENT GREATER MANCHESTER GUIDELINE
Topic:
Gender Realignment
Issue Date: December 2006
Summary:
No national guidance exists. The Harry Benjamin International Gender Dysphoria Association’s Standards of Care for Gender Identity
Disorders (HBSOC) are the internationally recognised standards Specialist Gender Identity Clinics should adhere to.
There is a lack of available evidence to support the cost effectiveness of gender reassignment surgery, however a recent assessment of the
evidence associated with the key points on the treatment pathway, focusing on Gender Reassignment Surgery highlighted improvements in
patients across most studies. PCTs are legally obliged to make treatment available following the decision in North West Lancashire Health
Authority v A, D & G.
The HBSOC set out the eligibility and readiness criteria for patients to receive hormone treatment, breast surgery and gender reassignment
surgery. Requests for hormone treatment or breast surgery will require one letter from a mental health professional in support. Genital surgery
requires two letters. The HBSOC specify what the mental health professional(s) documentation letter(s) should include.
The patient pathway in broad outline is as follows:
 A patient sees their GP who refers them to a local psychiatrist.
 Patient sees local psychiatrist and a decision to refer to specialist services is made.
 Psychiatrist refers patient to the specialist mental health services.
 Patient is assessed by the specialist services and a diagnosis made.
 If the patient is to continue, a treatment plan is agreed.
 Patient commences reversible treatment including speech therapy if required. Male-to-female patients may require facial hair removal at
this stage prior to commencing Real Life Experience (RLE).
 Patient commences RLE.
 After meeting eligibility and readiness criteria, patient commences irreversible treatments: hormone therapy and/or other treatments
including mastectomy for female-to-male patients.
 Patient completes RLE. If to proceed for genital surgery, a second mental health opinion is obtained.
- 35 -







Patient assessed for surgery.
Patient undergoes gender reassignment surgery (GRS).
Patient is monitored for ongoing hormone therapy and receives local counselling and support as appropriate.
Patient receives specialist services as appropriate, e.g. revision surgery.
At all stages of the pathway, information and advice to be available to patients, GPs, families, carers and other interested bodies.
At all stages of the pathway, patient remains under the care of local services as appropriate.
Patients may exit at any stage on the pathway.
A referral to local psychiatric services is required to eliminate any co-morbid psychiatric problems. In addition the specialist gender
identity clinics operate as tertiary centres and consequently only accept referral from secondary mental health services. In practice
this stage of the pathway is problematic due to the pressures it creates on local mental health services. However all patients must
undergo a comprehensive mental health assessment as well as receiving a specialist diagnosis of gender dysphoria prior to
progressing to hormonal and surgical stages of the pathway. The HBSOC recommend only mental health professionals who meet
certain set competencies should diagnose gender identity disorder. They list a number of other responsibilities of these
professionals including diagnosis and arranging treatment of co-morbid psychiatric problems, making formal recommendations to
medical and surgical colleagues in relation to hormonal and surgical treatment, being available for follow-up and being part of a
team with a special interest in gender identity disorders.
It should be noted that patients may exit at any stage of the pathway, or take a break from the pathway for many years and then
seek to rejoin and undergo further gender realignment. PCTs can assume any individual who received surgery at a recognised
NHS centre had previsouly received the appropriate mental health assessment and specialist diagnosis, however this should be
checked for individuals who have used another pathway (e.g. overseas surgery.)
Currently specialist mental health services are collaboratively commissioned for the North West from Leeds GIC and The Claybrook Centre
(Charing Cross). Male to female surgery is collaboratively commissioned from Hammersmith Hospitals who will only accept referrals from the
Claybrook Centre. Female to male surgery is collaboratively commissioned from UCLH and St Peter’s Andrology Centre. Funding requests
may therefore be received for male to female genital surgery for patients who have attended Leeds GIC. Funding should be granted, in the
absence of any clinical contra-indications, if the patient has complied with the pathway and has the necessary psychiatric reports to support
readiness for surgery in accordance with the HBSOC.
- 36 -
Only the genital surgery is commissioned on a collaborative basis. PCTs may therefore receive requests to fund any of the following
procedures:
Breast augmentation
Breast removal
Hysterectomy*
Hair removal
Speech therapy
Thyroid Chondroplasty
Compliance with the approved pathway and whether an appropriate mental health professional supports the treatment at this point in the
patient’s transition should be considered when making the decision to fund the treatment. Such requests should also be considered in the light
of any other EUR policies that may be relevant such as the policy for plastic surgery.
* Hysterectomy is included as part of the surgical package for female to male patients, however some patients may only wish to undergo a bilateral mastectomy and a hysterectomy to complete their transition.
Recommendations:
Intervention approved according to certain criteria i.e. adherence to approved patient pathway and The Harry Benjamin International Gender
Dysphoria Association’s Standards of Care for Gender Identity Disorders.
Reference:
1.
Gender Report; Trent Research and Development Support Unit, Sutcliffe et al, 2005
(http://www.trentrdsu.org.uk/cms/uploads/EBCC%20Gender%20reassignment%20Final%20report%20240406.pdf)
2.
The Harry Benjamin International Gender Dysphoria Association’s Standards of Care for Gender Identity Disorders, Sixth Version,
February 2001
3.
Salford PCT Commissioning Team: Development of Commissioning Arrangements for Gender Identity Services for North West
Patients, Harry Golby & Hilary Rothwell, May 2006.
- 37 -
COCHLEAR IMPLANTS GREATER MANCHESTER GUIDELINE
Topic:
Cochlear Implants
Issue Date:
Ratified by GM DPHs September 2004
(subject to agreement by clinicians and incorporation of any amendments)
Summary:
No national guidance exists. The Royal National Institute for the Deaf would like to see a national framework that gives equal access to all
those people who would like to have a cochlear implant and who would benefit more from a cochlear implant than from hearing aids.
The appropriateness of cochlear implantation for an individual is assessed by the cochlear implant team at Central Manchester and Manchester
Children’s University Hospitals, which have a set of referral guidelines.
Cochlear implants are included within each Greater Manchester PCT’s contract with Central Manchester and Manchester Children’s University
Hospitals, however the number included in the baseline contract and how additional activity is funded differs between PCTs.
Cochlear implants are effective and cost effective for selected groups of adults and deaf children1,2. Cochlear implants are a developing
technology and changes in their use e.g. bilateral implantation and the criteria for who they should be offered to, will occur over time3. The
population prevalence of hearing impairment may change4. In Greater Manchester acceptability to different ethnic groups and equitable
provision may also need to be considered5,6.
Recommendations:
This intervention is approved according to current referral guidelines and individual assessment.
It is suggested that the evidence base for the commissioning of cochlear implants is reviewed in collaboration with the Central Manchester
cochlear implant team.
Reference:
1.
Summerfield AQ, Marshall DH. Cochlear implantation in the UK 1990-1994. London: HMSO 1995.
2.
Cheng AK, Niparko JK. Cost-utility of the cochlear implant in adults: A Meta-analysis. Arch Otolaryngol Head Neck Surg 1999;11:1214-18.
- 38 -
3.
Summerfield AQ, Marshall D, Barton G, Bloor K. A cost-utility scenario analysis of bilateral cochlear implantation. Arch Otolaryngol
Head Neck Surgery;Nov 2002;128:1255-62.
4.
Fortnum H, Summerfield AQ, Marshall DH, Davis AC. Prevalence of permanent childhood hearing impairment in the United Kingdom
and implications for universal neonatal hearing screening:questionnaire based ascertainment study. BMJ 2001;323:536-41.
5.
Mawman DJ, Bhatt M, Green KMJ, O Driscoll MP, Saeed SR, Ramsden RT. Trends and outcomes in the Manchester adult cochlear
implant series. Clinical Otolaryngology and Allied Sciences 2004;29:331-339.
6.
Kubba H, MacAndie C, Ritchie K, MacFarlane M. Is deafness a disease of poverty? The association between socio-economic
deprivation and congenital hearing impairment. Int J Audiol 2004;43(3):123-5.
PHOTODYNAMIC THERAPY FOR AGE RELATED MACULAR DEGENERATION GREATER MANCHESTER GUIDELINE
Topic: Photodynamic Therapy for Age
Related Macular Degeneration
Issue Date:
Ratified by GM DPHs September 2004
(clinically reviewed and agreed subject to minor amendment November 2004)
Summary:
PDT involves the intravenous administration of a light-activated drug, followed by activation by a laser. This treatment can prevent further
damage to the eye, but is not a curative procedure and there is a limited window of opportunity during which the treatment is effective.
In September 2003 NICE published guidance on the use of photodynamic therapy (PDT) for age-related macular degeneration (ARMD) within
the NHS in England and Wales1-3.
The Greater Manchester Collaborative Commissioning Programme has developed proposals for the provision of this treatment across the
Greater Manchester Strategic Health Authority area, in accordance with NICE guidance4.
Recommendations:
NICE has recommended the use of PDT as follows:
 For all patients with “wet” ARMD who have a confirmed diagnosis of classic subfoveal CNV, with no sign of occult CNV and at least 6/60
- 39 -

vision;
Existing patients with predominantly classic (at least 50% classic) but with some occult CNV, who were already receiving PDT when the
NICE guidance was published, must be offered continued treatment until their clinical condition indicates that it is appropriate to stop.
For a second group of people, with predominantly classic but some occult sub-foveal CNV, the evidence of benefit from PDT proved
inconclusive. The independent advisory committee that advises NICE recommends that these people should access treatment through clinical
studies which will help to provide evidence as to the outcome and effectiveness of such treatment. The Department of Health has agreed to
fund a nationwide clinical study and NICE will take results from the study into account when reviewing its guidance on PDT in 2006. Greater
Manchester patients will be part of this nationwide clinical study.
PDT should only be administered by retinal specialists with experience of the technology.
Reference:
1.
NICE, Full guidance on the use of photodynamic therapy for age-related macular degeneration, Technology Appraisal Guidance 68, 24
September 2004
2.
NICE, Press release: NICE guidance sets recommendations on photodynamic therapy for age-related macular degeneration, 22
September 2004
3.
NICE, Photodynamic therapy for age related macular degeneration – some common questions and answers, 24 September 2004
4.
Charles S J, Doherty G. Photodynamic therapy for age-related macular degeneration: proposal for provision in Greater Manchester.
Greater Manchester Collaborative Commissioning Programme, 15 April 2004.
- 40 -
PHOTODYNAMIC THERAPY FOR ADVANCED BRONCHIAL CARCINOMA GREATER MANCHESTER GUIDELINE
Topic: Photodynamic Therapy for
Advanced Bronchial Carcinoma
Issue Date:
Ratified by GM DPHs September 2004
(clinically reviewed and agreed with minor amendment November 2004)
Summary:
Photodynamic therapy (PDT) is a procedure that can be used to treat advanced, inoperable non-small cell lung cancer, which has a poor
prognosis1. It is a minimally invasive treatment, involving intravenous injection of a photosensitizing agent, followed a few days later by
photoradiation to the affected area through a broncoscope. This is intended to reduce the bulk of a tumour, thereby reducing symptoms
caused by bronchial obstruction. Alternative treatments include debulking with biopsy forceps, intraluminal and external beam radiotherapy and
laser reduction.
In August 2004 NICE issued interventional procedures guidance on the use of photodynamic therapy for advanced bronchial carcinoma in the
NHS in England, Wales and Scotland, based on available evidence from three small but good quality RCTs and one case series study1-6.
Photodynamic therapy for early bronchial carcinoma is being considered separately by the Institute.
Specialist Advisors generally considered the procedures to be safe, and listed the main potential adverse events as: skin photosensitivity;
bleeding; necrosis/obstruction; late strictures; oesophago-bronchial fistula formation, and airway occlusion by exudates. The role of this
procedure in conjunction with other techniques remains uncertain.
NICE has proposed that further research and audits would be useful to allow ongoing examination of the clinical and quality of life data, and
has produced information describing its guidance on this procedure for patients and carers, written with patient consent in mind7.
Recommendations:
NICE consider that the current evidence on the safety and efficacy of photodynamic therapy for bronchial carcinoma appears adequate to
support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.
Specialist Advisors noted that it was unclear whether tumour bulk reduction in a palliative setting was associated with gains in quality of life or
survival, and that careful patient selection is needed.
- 41 -
Reference:
1.
National Institute for Clinical Excellence (2004), Interventional procedure guidance 87, NICE: August.
2.
National Institute for Clinical Excellence (2003), Interventional procedures programme: interventional procedures overview of
photodynamic therapy for bronchial carcinoma, NICE: March. Available at: www.nice.org.uk.
3.
Moghissi K, Dixon K, Parsons RJ. (1993), A controlled trial of Nd-YAG laser vs photodynamic therapy for advanced malignant bronchial
obstruction. Laser Med Science; 8: 269-73.
4.
Diaz-Jimenez JP, Martinez-Ballarin JE, Llunell A, et al. (1999), Efficacy and safety of photodynamic therapy versus Nd-YAG laser
resection in NSCLC with airway obstruction. Eur Resp J; 14: 800-5.
5.
Lam S, Kostashuk EC, Coy EP, Laukkanen E, et al. (1987), A randomized comparative study of the safety and efficacy of photodynamic
therapy using Photofrin II compared with palliative radiotherapy versus palliative radiotherapy alone in patients with inoperable obstructive
non-small cell bronchogenic carcinoma. Photochem Photobiol; 46: 893-7.
6.
McCaughan JS Jr, Williams TE. (1997), Photodynamic therapy for endobronchial malignant disease: a prospective fourteen-year study.
J Thoracic Cardovasc Surg;114:940-6.
7.
NICE (2004), Photodynamic therapy for advanced bronchial carcinoma: understanding NICE guidance – information for people
considering the procedure, and for the public, NICE. Available at: www.nice.org.uk.
- 42 -
PULMONARY (ARTERIAL) HYPERTENSION GREATER MANCHESTER GUIDELINE
Topic: Pulmonary (Arterial) Hypertension
Issue Date:
Ratified by GM DPHs September 2004
(subject to agreement by clinicians and incorporation of any amendments)
Summary:
The literature indicates that primary pulmonary hypertension (PPH) is a rare lung disorder of unknown cause, with an incidence rate of 1-2
cases per million per year 1. Secondary pulmonary hypertension (SPH) has a known cause, and is relatively common but under-diagnosed2.
This paper considers the treatment of pulmonary hypertension but does not cover standard supportive care that includes anticoagulant therapy,
diuretics, digoxin and oxygen therapy.
Patients should be tested for acute vasoreactivity, during cardiac catheterisation, to a short-term agent such as nitric oxide. Those who
demonstrate acute vasoreactivity should be treated with a high dose of an oral calcium channel blocker3.
Those patients who do not have acute vasoreactivity or do not respond to a high dose of an oral calcium channel blocker, should be treated
with sildenafil4.
Recommendations:
Only patients who do not respond to sildenafil should be considered for treatment with an endothelian receptor antagonist (bosentan5) or a
prostacyclin (epoprostenol6 treprostinil7). As all these drugs have been shown to have some degree of effectiveness but have not been directly
compared, the choice of drug should therefore be based on whichever is least expensive.
Requests to change to the more expensive option should only be considered after there has been a trial of treatment of the initial drug for
twelve weeks as this is the time used for the assessment of benefit in most of the trials.
Reference:
1.
Rich S, Dantzker DR, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Koerner SK, et al.
Primary pulmonary hypertension. A national prospective study. Ann Intern Med. 1987,107:216-23.
2.
Nauser DT, Stites S. Diagnosis and treatment of pulmonary hypertension. American Family Physician. 2001. Available:
www.aafp.org/afp/200110501/1789.html
- 43 -
3.
Rich S, Kaufmann E, Levy PS, The effect of high doses of calcium-channel blockers on survival in primary pulmonary hypertension: N
Engl J Med 1192,327:76-81
4.
Sastry BK, Narasimhan C, Reddy NK, Raju BS, Clinical efficacy of sildenafil in pulmonary hypertension. A randomised, placebocontrolled, double-blind, crossover study. Am Coll Cardiol 2004,43:1149-53
5.
Channick RN, Sitbon O, Barst RJ, Manes A, Rubin LJ, Endothelin receptor antagonists in pulmonary arterial hypertension, J Am Coll
Cardiol. 2004,43:62S-67S
6.
McLaughlin VV, Shillington A, Rich S, Survival in primary pulmonary hypertension: the impact of epoprostenol therapy, Circulation “002,
106:1477-82
7.
Simonneau G, Barst RJ, Galie N, Naeije R, Rich S, Bourge RC, Keogh A, Oudiz R, Frost A, Blackburn SD, Crow JW, Rubin LJ;
Treprostinil Study Group, Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial
hypertension: a double-blind, randomized, placebo-controlled trial, Am J Respir Crit Care Med. 2002 Mar 15;165(6):800-4.
BOTULINUM TOXIN A (BTA) – CHILDREN WITH CEREBRAL PALSY BOTOX AND DYSPORT GREATER MANCHESTER GUIDELINE
Topic:
Botulinum Toxin A (BTA) – Children with Cerebral Palsy Botox and
Dysport
Issue Date:
Ratified by GM DPHs September 2004
(subject to agreement by clinicians and incorporation of any
amendments)
Summary:
NATIONAL/LOCAL GUIDANCE:
Botulinum Toxin A [BTA] is a muscle relaxant derived from the bacterium Clostridium Botulinum. This bacteria has associations with botulism, a
rare form of food poisoning, but can, like many toxic substances when used in small, controlled doses, provide safe, effective relief from a
number of conditions. Currently BTA, under the brand name Botox™, is perhaps more commonly associated with face-lifts.
In 2000, two BTA products, Botox™ and Dysport™, were licensed for use in the treatment of children with cerebral palsy in the UK. (However,
- 44 -
this is not a new treatment. BTA has been used therapeutically for over 20 years, mainly with adults, to treat a variety of conditions
characterised by muscle hyperactivity).
Botulinum Toxin A (BTA) is licensed in the UK to treat pes equinus in children with cerebral palsy. Pes equinus, often referred to as tip-toe
walking, is very common in children with cerebral palsy, and results from spasticity in surrounding muscles which makes it difficult, or
impossible, to place the foot flat on the floor. When injected into the calf muscle[s] [gastrocnemius and/or tibialis], BTA can relax these muscles,
making walking easier and more comfortable, as well as generally improving balance and reducing the frequency of falls.
Usually a full assessment will be carried out by a hospital medical team, comprising a consultant [either a paediatrician or orthopaedic surgeon]
and a physiotherapist. An orthotist or occupational therapist may also be present. This assessment will involve a detailed movement study,
which is often videoed, probably lasting around an hour. A decision will then be made as to whether the treatment is appropriate and which
muscle, or range of muscles will be injected. A clear indication should also be given as to what the end result is likely to be.
Skeletal muscles tighten, or contract, in response to the release from nerve endings of a chemical called acetylcholine [also known as a
neurotransmitter]. The production of too much acetylcholine leads to increased muscle tone, which results in spasticity. When BTA is injected
into the muscle[s] the release of acetylcholine is blocked, resulting in a relaxation of overactive muscles. The injection[s] take effect within a few
days and last until new nerve endings grow back and the affected muscle[s] recover, which usually takes around 12-16 weeks. Functional
benefits, however, usually last longer than this.
BTA is diluted in a saline solution and injected directly into the muscle[s]. An anaesthetic cream may be applied to the skin to reduce any
discomfort from the injection. Oral sedation is frequently used, or sometimes a local or general anaesthetic, especially if the individual is very
young and/or anxious, or where the area to be injected is difficult to access. The muscles to be injected are identified by manual palpation,
ultrasound, EMG [electromyography] or stimulation of the nerve.
The amount of BTA used is determined by the size and number of muscle[s] to be treated, the degree of spasticity and the weight of the
patient, up to a maximum recommended dose. Multi-level injections, where a number of sites are injected during the one treatment, are now
becoming commonplace.
Following the injection[s], advice and direction should be given as to how to maximise the effects of BTA. This may involve more intensive
physiotherapy, increased use of walking aids or splinting or some discreet changes to the daily routine to incorporate greater involvement of the
treated muscles. Sometimes BTA may be used in conjunction with casting to maximise muscle stretch.
A follow-up appointment will be made to assess how successful the injection[s] have been and the treatment repeated as necessary. On
average the interval between injections varies from between three to six months: re-injection will usually be recommended when muscle tone
- 45 -
begins to interfere with function rather than when it returns to pre-injection levels. There is no absolute limit to the number of re-injections.
In the main, reported side-effects are mild and short-lived. These include:









Post-injection pain requiring simple analgesia
Increased frequency of falls within first two weeks of injection
Mild, cold- or 'flu-like symptoms
Temporary incontinence
Positive effect on constipation
Difficulty with swallowing, especially where upper limb or neck injected
Mood swings/irritability
Fatigue
Anaphylaxis [severe allergic reaction], but this is rare
Recommendations:
A considerable body of medical research shows BTA to be a safe and effectiv treatment for spasticity in selected patients. However, BTA
injections are not suitable for all children with cerebral palsy and patient selection is very important. It is also important to have clear, realistic
expectations as to what the end results of the treatment are likely to be.
Following the injection[s], advice and direction should be given as to how to maximise the effects of BTA. This may involve more intensive
physiotherapy, increased use of walking aids or splinting or some discreet changes to the daily routine to incorporate greater involvement of
the treated muscles. Sometimes BTA may be used in conjunction with casting to maximise muscle stretch.
Availability and commissioning of support services should be considered prior to approval of treatment with Botulinum Toxin A.
Reference:
1.
Bakheit AM. Botulinum toxin in the management of childhood muscle spasticity: comparison of clinical practice of 17 treatment centres.
Eur J Neurol. 2003 Jul;10(4):415-9.
2.
Hodgkinson I, Sindou M. Neurosurgical treatment of spasticity: indications in children. Neurochirurgie. 2003 May;49(2-3 Pt 2):408-12.
- 46 -
3.
Reddihough DS, King JA, Coleman GJ, Fosang A, McCoy AT, Thomason P, Graham HK. Functional outcome of botulinum toxin A
injections to the lower limbs in cerebral palsy. Dev Med Child Neurol. 2002 Dec;44(12):820-7.
4
Polak F, Morton R, Ward C, Wallace WA, Doderlein L, Siebel A. Double-blind comparison study of two doses of botulinum toxin A
injected into calf muscles in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2002 Aug;44(8):551-5.
5.
Love SC, Valentine JP, Blair EM, Price CJ, Cole JH, Chauvel PJ. The effect of botulinum toxin type A on the functional ability of the
child with spastic hemiplegia a randomized controlled trial. Eur J Neurol. 2001 Nov;8 Suppl 5:50-8.
6.
Ubhi T, Bhakta BB, Ives HL, Allgar V, Roussounis SH. Randomised double blind placebo controlled trial of the effect of botulinum toxin
on walking in cerebral palsy. Arch Dis Child. 2000 Dec;83(6):481-7.
CAESAREAN SECTION GREATER MANCHESTER GUIDELINE
Topic:
Caesarean Section
Issue Date:
Ratified by GM DPHs September 2004
(clinically reviewed and agreed with amendments November 2004)
Summary:
In April 2004 NICE issued guidelines setting out the best care for women and babies on caesarean section1-4, in conjunction with the National
Collaborating Centre for Women’s and Children’s Health .
Published data indicates that caesarean section rates in England and Wales are rising. In 1989-90 they were 11.3%, in 1994-95 they were
15.5% and in 1997-98 they were 18%5. Demographic transitions have contributed to but do not wholly explain the observed increase in
caesarean section rates. Variations in caesarean section rates may not be accounted for by differences in hospital populations and case-mix
alone.
- 47 -
Recommendations:
Caesarean section (CS) is indicated when it is agreed that the fetus or mother will benefit from a higher probability of a healthy outcome than if
vaginal birth were attempted. Maternal request is not on its own an indication for caesarean section. Pregnant women should be given
evidence-based information on caesarean section, including what the procedure involves, risks and benefits, and the implications for future
pregnancies.
Planned caesarean section should only be routinely offered to women with:
 a term singleton breech (if external cephalic version is contraindicated or has failed)
 a twin pregnancy with breech first twin
 HIV (only if recommended by a HIV consultant)
 both HIV and hepatitis C (as above, there is no evidence that CS should be performed for hepatitis C alone)
 primary genital herpes in the third trimester (acive genital herpes at the onset of labour)
 Grade 3 and 4 placenta praevia
 Two previous caesarean sections or more
 Previous upper segment caesarean section or type unknown
 Previous significant uterine perforation/surgery breaching the cavity.
Reference:
1. National Collaborating Centre for Women’s and Children’s Health, Caesarean section clinical guideline/NICE Clinical Guideline 13,
Royal College of Obstetricians and Gynaecologists, London, April 2004.
2. NICE, Press release: new NHS guidelines on caesarean sections set out best care for women and babies, Wednesday 28 April 2004.
3. NICE, Quick reference guide: caesarean section, Clinical guideline 13.
4. NICE (2004), Caesarean section: understanding NICE guidance – information for pregnant women, their partners and the public, NICE,
London.
5. NICE (2001), Scope for the development of a clinical guideline on caesarean section, NICE 17 October 2001, London.
- 48 -
SURGICAL TREATMENT OF OTITIS MEDIA WITH EFFUSION (OME) GREATER MANCHESTER GUIDELINE
Topic:
Surgical Treatment of Otitis Media with Effusion (OME)
Issue Date:
Ratified by GM DPHs September 2004
(subject to agreement by clinicians and incorporation of any
amendments)
Summary:
NHS guidance has been issued covering the diagnosis and management of OME in children in primary care1,2. Primary care practitioners have
a key role in the detection, diagnosis, observation (watchful waiting) and management of persistent OME and appropriate referral to specialist
services.
Incidence of OME in young children is high, but prevalence is significantly lower due to the short duration of episodes. Most episodes of OME
resolve spontaneously: around 50% of affected ears resolve spontaneously after three months and only 5% of children will have OME for a
period of a year or more3,4. The usual presenting feature is hearing loss and/or concern regarding speech and language, social interaction or
behaviour. Evidence that OME adversely affects speech, language development and behaviour is inconsistent and suggests that for most
children any adverse effect is temporary5.
The long-term benefits of surgical treatment of OME are uncertain and the benefits have to be balanced against possible harms6.
Published RCT studies suggest that surgical intervention may resolve OME but that the gains in hearing improvement are modest and there is
uncertainty about long-term outcomes. There is also a large variation in outcomes between children and risk of complications3,7.
Surgical intervention to insert grommets combined with adenoidectomy has been shown to be more effective at maintaining improvement than
grommet insertion alone8. Over a third of children who had grommet insertion alone required further surgery within the year, compared with
less than 10% of those treated with both adenoidectomy and grommet insertion.
There continues to be debate about how best to select children for surgery. Persistent bi-lateral hearing impairment of 25-30 dB HL is
sometimes thought sufficient to justify surgery. Introducing a period of ‘watchful waiting’ is recommended for children with persistent OME and
a hearing loss of 25dB HL or more, as this is likely to decrease surgical activity because of natural spontaneous resolution8. Studies are being
undertaken to audit the outcome of watchful waiting through use of a provisional waiting list, accompanied by audiological retesting immediately
prior to surgery (to prevent ‘dry taps’, where no OME is found at surgery)6.
- 49 -
Recommendations:
Surgery should only be considered in children with OME and a hearing loss of 25dB HL after a period of watchful waiting (to establish that the
condition is persistent), managed through a provisional waiting list system and audiological retesting immediately prior to surgery.
Reference:
1.
Prodigy Guidance (2004), Glue ear, available at: www.prodigy.nhs.uk.
2.
NICE (2001) Persistent otitis media with effusion (glue ear) in young children. In: GP referral practice: a guide to appropriate referral from
general practice to specialist services. National Institute for Clinical Excellence. www.nice.org.uk.
3.
Freemantle N, Long A, Mason J et al (1992), The treatment of persistent glue ear in children, Effective Health Care Bulletin, No. 4,1-15.
4.
Zielhuis GA, Rach GH, Broek PV (1989), Screening for otitis media with effusion in preschool children. Lancet, 1:311-4.
5.
SIGN (2003) Diagnosis and management of childhood otitis media in primary care. Report No. 66. Scottish Intercollegiate Guidelines
Network, www.sign.ac.uk.
6.
Bandolier (1994), Glue ear – a sticky problem, February,1-3.
7.
Fiellua-Nikolajsen M. (1980) Tympanometry in three year old children. Prevalence and spontaneous course of MEE. Ann Otol Phinol
Laryngol, 89 Suppl 68:223-7.
8.
Maw R, and Bawden R. (1993), Spontaneous resolution of severe chronic glue ear in children and the effect of adenoidectomy,
tonsillectomy, and insertion of ventilation tubes (grommets). British Medical Journal 306(6880), 756-760.
- 50 -
OBESITY MANAGEMENT GREATER MANCHESTER GUIDELINE
Topic Obesity Management
Summary:


Issue Date: (Review in 12 months)
Ratified by Greater Manchester Directors of Commissioning and
Directors of Finance
Throughout 2009 the Association of Greater Manchester Primary Care Trusts have been reviewing the obesity and bariatric
surgery contract and a common approach to controlling the bariatric surgery contract has been agreed.
PCT’s have been asked to accelerate the development and implementation of care pathways for adult obesity that include a
range of upstream services to divert activity away from end stage surgery.
NHS Ashton Leigh and Wigan has invested in developing a comprehensive, fully integrated care pathway for managing excess weight in
adults,’ Lose Weight Feel Great’, providing approximately 11,000 treatment places per annum.
Overview of the ‘Specialist Weight Management Service’ element of the pathway: For full details of the pathway go to www.lwfg.co.uk.
Recommendations:
Bariatric Surgery
It has been agreed that a common approach should be used for controlling bariatric surgery. All PCTs in Greater Manchester are now working
to the priority criteria for adult’s bariatric surgery and definitions of “serious” co- morbidity for a time limited period of 12 months prior to it being
reviewed again.
Priority patients to be considered have:
-
BMI of 50 kg/m² or greater without obesity related co-morbidity;
-
BMI of 45 kg/m² or greater in the presence of a serious co-morbidity (see table below) which may be amenable to treatment if obesity is
modified by surgery, and/or have:

Condition which requires surgery at the same time as bariatric surgery, based upon clinical need and urgency for such surgery,
- 51 -
such as cholecystectomy, hernia repair

Condition which needs surgery or complex technological intervention as soon as possible after bariatric surgery, such as hip or
knee replacements.

Condition for which surgery is withheld until weight loss is achieved e.g. spinal pathology or awaiting IVF for infertility

Condition that although surgically treatable is at a high risk of recurrence in the presence of obesity e.g. incisional hernia.
Prior to surgical referral this group of patients should:

Complete the PCT's 6 month intensive Specialist Weight Management Service to show a commitment and understanding to the
healthy life style choices they will have to adhere to after surgery.

Attend a pre – bariatric surgery education programme, run by PCT specialist weight management services (not bariatric surgery
providers) to get a greater understanding of the commitment they are making.

Patients that do not meet these clinical definitions should be referred into the PCT’s Specialist Weight Management Service for
treatment
Patients with lower BMIs 35 to 44.9 with co- morbidities and BMI 40 to 49.9 without co- morbidities are currently not priority patients and would
not progress to surgery. To ensure implementation of NICE guidance this group of patients should be offered treatment via the ‘Lose Weight
Feel Great’ care pathway.
Co morbidity identification table
For the purposes of assessments for bariatric surgery a patient will be defined as having a serious co-morbidity associated with their obesity if
they meet at least 1 of the major definitions below and / or 2 minors
Major
-
Type II diabetes, requiring the use of 2 or more agents
-
Established coronary heart disease, TIA or stroke (if good functional recovery)
-
Severe obstructive sleep apnoea and obesity hypoventilation syndrome
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Minor
-
Hypertension requiring the use of 3 or more drugs
-
Benign intracranial hypertension
-
Obesity related cardiomyopathy or pulmonary hypertension
-
Osteoarthritis - severe lower limb major joint disease requiring orthopaedic intervention which is precluded on
safety grounds due to patient’s BMI
-
Severe dismobility due to obesity sufficient to affect essential activities of daily living, e.g. bathing, toileting,
dressing, cooking, shopping, that is likely to be improved with weight loss.
-
Other co-morbid conditions which have been agreed by the PCT as exceptional, for example Pickwickian
syndrome, on an individual patient basis
-
Infertility where weight loss is required prior to IVF, where the couple meet all other IVF criteria other than BMI of
the woman, and the woman is less than 38 years old
-
Polycystic ovary syndrome
-
Diabetes requiring only one drug agent or diet control, OR Impaired fasting glucose, OR impaired glucose
tolerance
-
Back pain interfering with daily life lasting more than 6 months
-
Severe depression where confirmed by psychiatrist or psychologist that obesity is major causal factor, and, there
is no other major life event e.g. relationship breakdown or bereavement in the last 12 months that might be
impacting on the depressive illness.
Reference:
Association of Greater Manchester Primary Care Trusts
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SPECIALISED WEIGHT MANAGEMENT PATHWAY
Referral route A
BMI 35 – 44.9
With serious co morbidities
BMI 40 – 49.9
Phase 1
Intensive S W M S
Programme
6 months
Phase 2 S W M S Programme
18 Months
Discharge
Back to GP
care
Review
Phase 1
Intensive S W M S
Programme
6 months
Pre bariatric surgery
education programme
Surgery
2 years follow-up
with surgical
provider
Discharge
back to GP
care
BMI 50+
BMI 45+
With serious co morbidities
Referral route B
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APPENDIX 3
PROCESS FOR APPLYING FOR EUR PROCEDURES
Although there are some restrictions:
Any patient who needs emergency treatment will always be treated
No treatment is completely ruled out if an individual patient’s circumstances are
exceptional.
All patients requiring a consultant opinion for diagnostic or symptomatic advice
should continue to be referred by General Practitioner e.g. skin lesions, which may
be malignant.
The Primary Care Trusts and the Hospital Trust recognise that in some
circumstances, a Procedure of Limited Clinical priority may be the most clinically
appropriate intervention for a patient. In these circumstances, agreed eligibility
criteria have been established for example, varicose veins and cosmetic surgery.
Patients should not be formally placed on the Waiting List until the Effective Use of
Resources Group have approved their case.
Requests for funding EUR procedures should be directed to:
Susan Baron
EUR Manager
Bryan House
Ashton, Leigh and Wigan PCT
61 Standishgate,
Wigan, WN1 1AH.
Tel: 01942 482876
Fax: 01942 772785
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APPENDIX 4
Proforma for requesting funding for treatments
PCT Patient Ref No:
EUR/SPECIALIST DRUGS/PBR EXCLUSIONS
PRIOR AUTHORISATION FUNDING PROFORMA
1.
Patient Details
NHS No. . . . . . . . . . . . . . . . . . . . . .
Date of Birth: . . . . . . . . . . . . . . . . .
Gender . . . . . . . . . . . . . . . . . . . . .
Drug / procedure requested . . . . . . . . . . . . . . .
(Please circle)
2.
Treatment

Does the treatment fall within NICE guidance
Yes
No

If not within NICE guidance, does the treatment use
national guidance, which the PCT agrees to
What is this specific guidance?
Yes
No
Yes
No

2a.
If not covered in NICE and there is no national
guidance to support this treatment, has the PCT been
involved in the development of the treatment protocol
Drug/funding request
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3.
Patient treatments

.
Please provide a summary of the patient’s clinical history:
ALWPCT USE ONLY
Agreeing medicines management/ Commissioning name:
Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Please provide a summary of the patient’s treatment history, including
treatment failures.

Please attach a summary of the patient’s care pathway
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4. Treatment Costs and start date of treatment

Please provide a breakdown of costs for the treatment:

Please document the length of the treatment and the treatment review date:

Please document any additional support costs:

Please document anticipated outcomes:

Please document anticipated consequences for withdrawing treatment:

Please provide the contact name, telephone number and email address for
the lead manager coordinating this request on behalf of your Trust:
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Estimated start date for procedure/ treatment: . . . . . . . . . . . . . . . . . . . . . . . . . .
Proposed method of funding (i.e. invoiced to PCT or directly charged from SLA)
..................................................................
Please return this form to Susan Baron, EUR Manager, Commissioning and
Partnership Directorate, Ashton, Leigh and Wigan PCT, Bryan House, 61
Standishgate, Wigan, WN1 1AH. Tel: 01942 482876, Fax: 01942 772785
Email: [email protected]
Additional page for Wet AMD requests only.
The PCT medicines management committee on 13th June 2007 agreed to follow the
recommendation of the Greater Manchester Effective Use of Resources committee.
This is an interim decision by MMC until final guidance is available from NICE. AntiVEGF treatments will only be considered as a treatment option where the individual
has:




been diagnosed as having wet AMD in any presenting eye
best-corrected visual acuity of 6/60 or better
lesion types that are not eligible for treatment with Photodynamic
Therapy (PDT), that is, minimally classic and occult only subfoveal
choroidal neovascularisation (CNV), or
Other CNV type where treatment by PDT has been or is clinically problematic.
Please can you confirm that the patient above matches each of the criteria listed
above.
Once the PCT has the required information we will be able to make a funding
decision for the individual patient.
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APPENDIX 5
Proforma for requesting funding for bariatric surgery
RMC Dept, Regency Hospital, West Street, Macclesfield Cheshire, SK11 8DW
Tel: 01625 501150 ext 308 / 529 Fax: 01625 505433
E-mail: [email protected]
REFERRAL TO CLASSIC HOSPITAL
Referral Forms to be completed and authorised by referring PCT
Please use BLOCK CAPITALS and complete in full in black ink (any incomplete or inappropriate
referrals will be returned)
Patient Details:
Surname:
First Name(s):
Address:
Tel Number:
Date of Birth:
NHS Number:
GP Name/Practice:
GP Telephone Number:
GP Fax Number:
Date:
Measurements
Height (cm)
Weight (kg)
BMI (kg/m2)
Waist Circumference (cm)
Date of Most Recent Measurements: ………………………………………………
Diagnosis & Clinical Details:
Diabetes
Stroke
Osteoporosis
Sleep Apnoea
MI
Cancer
Chronic Joint Pain
Epilepsy
Angina
Renal
Thyroid Dysfunction
Psychiatric Illness
PCOS
COPD
Anxiety/Depression
Post Surgery
Weight Related Infertility
History of Eating
Disorder
Others:
Biochemistry
Cholesterol
mmol/L
TG
LDL
mmol/L
FBS
Blood Pressure
Mm/HG
mmol/L
mol/L
HDL
HbA1c
(diabetes only)
mmol/L
%
Others
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Medication:
Special Requirements:
Continuation Page - Patient Name: _________________________________ DOB:
________________
Weight Management History:
Dietary Information:
Lifestyle Management:
Has your patient attended lifestyle & or weight management service for intervention in the last 12 months:
YES
NO
If yes Details:
Have non-surgical measures been tried:
YES
NO
Details:
Anti-Obesity Drug Therapy – Copy of Prescribing Record Needed
Drug Name
Drug Name
Date Prescribed
Date Discontinued
Reason Discontinued
Dosage
Weight Loss Outcomes (loss/gain)
Other Measures (if applicable)
Mental Health:
Are there any diagnosed psychological illnesses?
(Details Attaches Separately)
YES
Are there any specific clinical/psychological contraindication for this type of surgery?
YES
NO
NO
Does the patient understand the need for follow up and long term compliance with
altered lifestyle and dietary habit post-operatively?
YES
Referrer Signature:
NO
Date:
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Please attach any relevant medical history
Referrer Signature:
Date:
Print Name:
PCT:
- 62 -
APPENDIX 6
INFORMATION FOR PATIENTS
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Draft letter to patients
Dear
Request for (insert procedure, treatment or therapy)
We have recently received a letter from your GP, Dr (insert clinician), about your
request for (insert procedure, treatment or therapy).
Although the NHS does not usually offer this treatment, we do consider every request
on its merits. I am enclosing a leaflet which explains how the NHS makes decisions
on whether to provide treatment in cases such as yours, what you need to do next,
and how long this process should take.
As we are going to consider your case further, we need to have your written
agreement that we can ask for more information about you. This information, for
example, could be medical records from your GP.
I have also enclosed with this letter a ‘consent form’ for you to fill in and send back to
me that will enable us to ask for the information we need. When you send this form
back to me, you can also, if you so wish, send a written statement explaining why
you think you need this treatment. You can ask someone else, such as a friend,
relative or advisor, to help you with this, or to provide it on your behalf, if you prefer.
I hope you find the enclosed information helpful, but please do contact me if you
need any further help, or if you would like to ask any other questions. You can also
ask for advice and information from Susan Baron.
Yours sincerely
Susan Baron
EUR Manager
Ashton, Leigh and Wigan PCT
Bryan House
61 Standishgate
Wigan
WN1 1AH
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Patient Consent Form
Please fill in this form to show you have agreed that we can ask for information about
you from the Doctors who are caring for you, which will help us to consider your
request for treatment.
Information we receive about you will be treated in the strictest confidence and the
Data Protection Act will govern its use. You can also enclose a brief written
statement explaining why you think you need this treatment and any exceptional
circumstances. You can ask a friend, relative or advisor to help you write this, if you
prefer. Please tick the relevant box below if you are enclosing a statement.
I understand that Ashton, Leigh and Wigan Primary Care Trust may need to request
information about me for the purposes of making a decision about providing
treatment under its Effective Use of Resources Policy.
By signing this form, I am giving my consent to this process.
Your name:
Date of birth:
Sex (M/F):
Address:
Postcode:
Telephone:
 I am enclosing a brief written statement outlining the relevant exceptional
circumstances of my case
Your signature:
Date:
Please return this form and your statement (if you are providing one) to:
Susan Baron
EUR Manager
Ashton, Leigh and Wigan PCT
Bryan House
61 Standishgate
Wigan
WN1 1AH
THANK YOU
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Effective Use of Resources Policy
How do we make decisions about providing treatments that are
not normally available through the National Health Service? Can I
get this treatment on the NHS?
Please read through this leaflet carefully. It will explain how
this process works and how you will be involved
What happens if my doctor refers me for one of these treatments?
If we receive a letter from your doctor asking us to provide
treatment for you, we will set up a special panel to consider your
case called the Effective Use of Resources Panel. The Panel will
include a medical advisor, a public health advisor and a director of
the Primary Care Trust.
The EUR Panel members will decide if your case meets the
criteria set out in our ‘Effective Use of Resources Policy’ (we can
provide you with a copy of this document if you wish or you can
see it on our website www.alwpct.nhs.uk
To help the panel make a decision, they will also need to request
more information about you – such as medical records. To do
this they will need your written consent and we will send you a
form to complete. Information we receive about you will be
treated in the strictest confidence and its use will comply with the
Data Protection Act. You can also provide a written statement to
the Panel explaining in more detail why you think you need this
treatment. You can send this statement in with your consent
form.
- 66 -
How long will it take to make a decision?
When we write to you, in the first instance you have two weeks in which
to return your consent form and written statement. We will also ask for
statements from the doctors involved in your care. We cannot
guarantee how long this will take but we will keep you informed of
progress. Once the Effective Use of Resources Panel has received all
the necessary information, they will make a decision within 30 working
days. Kim Godsman, Assistant Director - Business Management will
write to you to tell you what the EUR Panel have decided.
We also have a Process Review Panel to help us make sure the correct
procedures have been followed. When the Panel write to you with their
decision, they will also send you details of how to request a Review,
should you wish to do so. However, it is important to remember that the
Process Review is not intended to look at the merits of the case again,
but only at the way that the Effective Use of Resources Policy was
applied in assessing your case.
Why are certain treatments not available through the NHS?
Like any other organization, the NHS has limited resources and we
have a duty to manage them carefully.
This means we have to look at the evidence for how safe and effective
any particular treatment is, and ensure that services we plan and
provide will give patients the greatest health gains from the resources
available.
For more information, please contact
Susan Baron
EUR Manager
Ashton, Leigh and Wigan PCT
Bryan House
61 Standishgate
Wigan
WN1 1AH
- 67 -
APPENDIX 7
FRAMEWORK FOR QUALITY ASSURING NEW PROVIDERS OF EUR
COMMISSIONED SERVICES
This involves developing strong partnerships with providers and engaging them in
needs assessments, transparent and fair procurement, and outcome-based
commissioning that leads to more innovative provision, tailored to the needs of
individuals and supplied by a wider range of providers.
i.
Assess the risk
All providers of services will be asked to provide the commissioner with the following
information prior to the PCT commissioning services with them:
- Their latest Health Care Commission (or other related inspectorate) report
- Declaration of compliance with Standards for Better Health
- Audit data on procedure
- Patient feedback reports
- Details of patient complaints linked to service
- Benchmark report on procedure within facility against national data
- Surgeon’s critical mass of cases
- Assurance that the provider will be willing to sign the PCT contract for EUR
ii.
Well-worded contracts
Well-worded and agreed clauses in contracts can facilitate good working
relationships between commissioners and providers of social care, while protecting
service users.
The EUR panel has generated two types of contracts for their providers. 1 is the
NHS contract for high risk clinical procedures that can be used for all secondary care,
private sector and third sector providers of acute services. The second contract is a
bespoke contract for use in non-invasive procedures. Both contracts have relevant
clauses surrounding Standards for Better Health, Information Governance, Insurance
and liability etc.
iii.
Improving performance through contract monitoring
All contractors of EUR will be asked to provide performance data on outcomes for
our patients care.
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