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Melanoma

About

What is covered

This pathway covers suspected or newly diagnosed cutaneous melanoma (including vulval and penile melanoma) in children, young people and adults. However, there was insufficient high-quality evidence on which to make specific recommendations for vulval and penile melanoma. It does not cover primary ocular melanoma or melanoma arising in mucosal sites.
The pathway addresses areas where there is uncertainty or variation in practice. It contains recommendations on:
  • assessing and staging melanoma, including the use of sentinel lymph node biopsy
  • treating stages 0–IV melanoma, including adjuvant chemotherapy and immunotherapy
  • treating in-transit melanoma metastases
  • treating metastatic melanoma
  • follow-up after treatment for melanoma.
It also includes advice on managing vitamin D levels and drug therapy for intercurrent conditions in people diagnosed with melanoma.

Updates

Updates to this pathway

25 October 2016 Cobimetinib in combination with vemurafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma (NICE technology appraisal guidance 414) added to targeted therapy for BRAF V600-positive melanoma.
27 September 2016 Talimogene laherparepvec for treating unresectable metastatic melanoma (NICE technology appraisal guidance 410) added to stage III melanoma and intralesional treatment.
20 September 2016 Skin cancer (NICE quality standard 130) added.
26 July 2016 Nivolumab in combination with ipilimumab for treating advanced melanoma (NICE technology appraisal guidance 400) added to immunotherapy.
21 June 2016 Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma (NICE technology appraisal guidance 396) added to targeted therapy.
17 February 2016 Nivolumab for treating advanced (unresectable or metastatic) melanoma (NICE technology appraisal guidance 384) added to immunotherapy.
24 November 2015 Pembrolizumab for advanced melanoma not previously treated with ipilimumab (NICE technology appraisal guidance 366) added to immunotherapy.
10 November 2015 VivaScope 1500 and 3000 imaging systems for detecting skin cancer lesions (NICE diagnostic guidance 19) added to visualisation, photography and imaging.
06 October 2015 Pembrolizumab for treating advanced melanoma after disease progression with ipilimumab (NICE technology appraisal guidance 357) added to immunotherapy.

Professional responsibilities

The recommendations in this pathway represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients or service users. Applying the recommendations in this pathway is at the discretion of health and care professionals and their individual patients or service users and does not override the responsibility of health and care professionals to make decisions appropriate to the circumstances of the individual, in consultation with them and/or their carer or guardian.
Commissioners and/or providers have a responsibility to enable the recommendations to be applied (and to provide funding required for technology appraisal guidance) when individual health and care professionals and their patients or service users wish to use them. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this pathway should be interpreted in a way that would be inconsistent with compliance with those duties.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Short Text

Everything NICE has said on the assessment and management of melanoma in an interactive flowchart

What is covered

This pathway covers suspected or newly diagnosed cutaneous melanoma (including vulval and penile melanoma) in children, young people and adults. However, there was insufficient high-quality evidence on which to make specific recommendations for vulval and penile melanoma. It does not cover primary ocular melanoma or melanoma arising in mucosal sites.
The pathway addresses areas where there is uncertainty or variation in practice. It contains recommendations on:
  • assessing and staging melanoma, including the use of sentinel lymph node biopsy
  • treating stages 0–IV melanoma, including adjuvant chemotherapy and immunotherapy
  • treating in-transit melanoma metastases
  • treating metastatic melanoma
  • follow-up after treatment for melanoma.
It also includes advice on managing vitamin D levels and drug therapy for intercurrent conditions in people diagnosed with melanoma.

Updates

Updates to this pathway

25 October 2016 Cobimetinib in combination with vemurafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma (NICE technology appraisal guidance 414) added to targeted therapy for BRAF V600-positive melanoma.
27 September 2016 Talimogene laherparepvec for treating unresectable metastatic melanoma (NICE technology appraisal guidance 410) added to stage III melanoma and intralesional treatment.
20 September 2016 Skin cancer (NICE quality standard 130) added.
26 July 2016 Nivolumab in combination with ipilimumab for treating advanced melanoma (NICE technology appraisal guidance 400) added to immunotherapy.
21 June 2016 Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma (NICE technology appraisal guidance 396) added to targeted therapy.
17 February 2016 Nivolumab for treating advanced (unresectable or metastatic) melanoma (NICE technology appraisal guidance 384) added to immunotherapy.
24 November 2015 Pembrolizumab for advanced melanoma not previously treated with ipilimumab (NICE technology appraisal guidance 366) added to immunotherapy.
10 November 2015 VivaScope 1500 and 3000 imaging systems for detecting skin cancer lesions (NICE diagnostic guidance 19) added to visualisation, photography and imaging.
06 October 2015 Pembrolizumab for treating advanced melanoma after disease progression with ipilimumab (NICE technology appraisal guidance 357) added to immunotherapy.

Sources

NICE guidance and other sources used to create this pathway.
Melanoma: assessment and management (2015) NICE guideline NG14
Improving outcomes for people with skin tumours including melanoma (2006 updated 2010) NICE cancer service guidance 8
Nivolumab for treating advanced (unresectable or metastatic) melanoma (2016) NICE technology appraisal guidance 384
Endoscopic radical inguinal lymphadenectomy (2011) NICE interventional procedure guidance 398
Skin cancer (2016) NICE quality standard 130

Quality standards

Quality statements

Local health promotion activities

This quality statement is taken from the skin cancer quality standard. The quality standard defines clinical best practice in skin cancer and should be read in full.

Quality statement

Local authority health promotion activities on preventing skin cancer and recognising early signs are consistent with the messages in any national campaigns.

Rationale

Skin cancer is the most common form of cancer and, even though most types are preventable, its incidence has been increasing. People can recognise changes to their skin in early stages of the disease but some are still seeking help too late. Local health promotion activities, with messages consistent with any national campaigns, should minimise public confusion and increase the likelihood of behaviour change.

Quality measures

Structure
Evidence that the local authority health promotion activities on preventing skin cancer and recognising early signs are consistent with the messages in any national campaigns.
Data source: Local data collection.
Outcome
a) Incidence of skin cancer.
Data source: Public Health England National Cancer Registration and Analysis Service.
b) Proportion of melanoma diagnosed at stage 1 or 2.
Data source: Public Health England National Cancer Registration and Analysis Service.
c) Proportion of non-melanoma skin cancer diagnosed at stage 1 or 2.
Data source: Local data collection.

What the quality statement means for public health practitioners and commissioners

Public health practitioners ensure that they implement local authority health promotion activities on preventing skin cancer and recognising early signs using messages consistent with those in any national campaigns.
Commissioners (local authorities) ensure that local authority health promotion activities on preventing skin cancer and recognising early signs are consistent with the messages in any national campaigns.

What the quality statement means for people in the community

People in the community are given advice about how to prevent skin cancer, and how to recognise early signs, through local authority health promotion activities that reinforce the messages in any national skin cancer campaigns.

Source guidance

GPs managing low-risk basal cell carcinoma

This quality statement is taken from the skin cancer quality standard. The quality standard defines clinical best practice in skin cancer and should be read in full.

Quality statement

GPs who manage low risk basal cell carcinoma, including GPs with a special interest (GPwSI), maintain and audit records of their caseload.

Rationale

Low-risk basal cell carcinoma can sometimes be managed by GPs in the community, which can be more convenient for patients. Treatment in the community can also frequently be provided at a lower cost and free up capacity in hospitals. However, it is essential that this is balanced with ensuring that care offered in the community is as safe and effective as that in hospital. Maintaining and auditing records of their caseload can help in demonstrating competence.

Quality measures

Structure
Evidence of local arrangements to ensure that GPs who manage low risk basal cell carcinoma, including GPwSI, maintain and audit records of their caseload.
Data source: Local data collection.
Process
Proportion of GPs managing low risk basal cell carcinoma, including GPwSI, who audited their caseload within the past 12 months.
Numerator – number in the denominator who audited their caseload within the past 12 months.
Denominator – number of GPs managing low risk basal cell carcinoma, including GPwSI.
Data source: Local data collection.
Outcome
a) Proportion of skin lesions excised by GPs and GPwSI in dermatology and skin surgery that are subsequently confirmed as low risk basal cell carcinomas.
Data source: Local data collection.
b) Patient safety incidents reported related to removal of basal cell carcinomas in primary care.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (GP practices) ensure that GPs managing low risk basal cell carcinoma, including GPwSI, maintain and audit records of their caseload.
Healthcare professionals (GPs and GPwSI) managing low risk basal cell carcinoma maintain and audit records of their caseload.
Commissioners (NHS England and clinical commissioning groups) ensure that GPs who manage low risk basal cell carcinoma, including GPwSI, maintain and audit records of their caseload.

What the quality statement means for patients and carers

People who are having treatment from a GP for a type of skin cancer called low risk basal cell carcinoma receive treatment that is safe and effective.

Source guidance

Definitions of terms used in this quality statement

Low-risk basal cell carcinoma
Low-risk basal cell carcinoma is defined as set out in ‘Models of care’ in NICE’s guidance on improving outcomes for people with skin tumours including melanoma.
Competence in managing low-risk basal cell carcinoma
NICE’s guidance on improving outcomes for people with skin tumours including melanoma outlines criteria for assessing competence and accrediting practitioners.

Suspected cancer pathway referrals

This quality statement is taken from the skin cancer quality standard. The quality standard defines clinical best practice in skin cancer and should be read in full.

Quality statement

People with suspected malignant melanoma are referred using a suspected cancer pathway for an appointment within 2 weeks.

Rationale

Timely referral to a specialist is important for a quick and accurate diagnosis of skin cancer. The specialist will usually be working as part of the local hospital skin cancer multidisciplinary team and can provide rapid diagnosis, treatment, management and follow up for most people with skin cancer. Some squamous cell carcinomas, basal cell carcinomas and less common skin cancers may also need urgent referrals, in line with clinical judgement.

Quality measures

Structure
Evidence of local arrangements and clinical protocols ensuring that a suspected cancer pathway is in place for suspected malignant melanoma.
Data source: Local data collection.
Process
Proportion of confirmed malignant melanomas that were referred using a suspected cancer pathway for an appointment within 2 weeks.
Numerator – number in the denominator that were referred using a suspected cancer pathway for an appointment within 2 weeks.
Denominator – number of confirmed malignant melanomas.
Data source: NHS England Cancer waiting times.
Outcome
a) Time between GP referral for suspected skin cancer and specialist assessment.
Data source: NHS England Cancer waiting times.
b) Time from GP referral for suspected skin cancer to first definitive treatment.
Data source: NHS England Cancer waiting times.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (GP practices and secondary care providers) ensure that systems are in place for people presenting with suspected malignant melanoma to be referred using a suspected cancer pathway for an appointment within 2 weeks.
Healthcare professionals (such as GPs or secondary care clinicians) ensure that they refer people with suspected malignant melanoma using a suspected cancer pathway for an appointment within 2 weeks.
Commissioners (NHS England, clinical commissioning groups) ensure that services they commission refer people with suspected malignant melanoma using a suspected cancer pathway for an appointment within 2 weeks.

What the quality statement means for patients and carers

People who have skin lesions, such as damaged or injured patches of skin or new, large, changing or unusual looking moles, and whose GP thinks it is a type of skin cancer called malignant melanoma, are referred for an appointment to see a specialist within 2 weeks.

Source guidance

Definitions of terms used in this quality statement

Suspected cancer pathway referral
The patient is seen within the national target for cancer referrals. This was 2 weeks at the time of publication of the NICE guideline on suspected cancer: recognition and referral.

Dermoscopy

This quality statement is taken from the skin cancer quality standard. The quality standard defines clinical best practice in skin cancer and should be read in full.

Quality statement

People with pigmented skin lesions undergoing a specialist assessment have the lesions examined using dermoscopy.

Rationale

Dermoscopy performed by suitably trained specialists is more sensitive and more specific in classifying skin lesions than clinical examination with the naked eye. It lessens the chance of missing a diagnosis of melanoma and reduces the number of unnecessary surgical procedures to remove benign lesions.

Quality measures

Structure
Evidence of local arrangements and clinical protocols to ensure that people undergoing specialist assessment of pigmented skin lesions are examined using dermoscopy.
Data source: Local data collection.
Process
Proportion of pigmented skin lesions undergoing specialist assessment that are examined using dermoscopy.
Numerator – number in the denominator examined using dermoscopy.
Denominator – number of pigmented skin lesions undergoing specialist assessment.
Data source: Local data collection.
Outcome
a) Pigmented skin lesions not selected for biopsy that are subsequently confirmed as melanoma
Data source: Public Health England Cancer stats tool and local data collection.
b) Proportion of melanoma diagnosed at stage 1 or 2.
Data source: Public Health England, National Cancer Registration and Analysis Service.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (local hospital skin cancer multidisciplinary teams and specialist skin cancer multidisciplinary teams) ensure that systems are in place for using dermoscopy during specialist assessment of pigmented skin lesions. Service providers should also ensure that those using dermoscopy have formal training.
Healthcare professionals (members of local hospital skin cancer multidisciplinary teams or specialist skin cancer multidisciplinary teams) undertaking specialist assessment of pigmented skin lesions ensure that they examine the lesions using dermoscopy. They should include formal training as part of their continuing professional development.
Commissioners (clinical commissioning groups and NHS England) ensure that the specialist services they commission have trained specialists who use dermoscopy to examine pigmented skin lesions.

What the quality statement means for patients and carers

People with skin lesions (such as damaged or injured patches of skin or new, large, changing or unusual looking moles) that are being assessed by a specialist have the lesions examined using a magnifying tool called a dermatoscope, which gives a more accurate view of the lesion.

Source guidance

Definitions of terms used in this quality statement

Specialist assessment
An assessment carried out by a doctor trained in the diagnosis of skin malignancy, normally a dermatologist, who is a member of either a local hospital skin cancer multidisciplinary team or a specialist skin cancer multidisciplinary team.
[Adapted from NICE’s guideline on improving outcomes for people with skin tumours including melanoma, key recommendations (page 8).]

Skin cancer clinical nurse specialist

This quality statement is taken from the skin cancer quality standard. The quality standard defines clinical best practice in skin cancer and should be read in full.

Quality statement

People with malignant melanoma or squamous cell carcinoma have access to a skin cancer clinical nurse specialist.

Rationale

Skin cancer clinical nurse specialists can provide specialist guidance and support at all stages of care and treatment, including follow up. They can act as a source of information (including about local support groups), psychological support and palliative care if needed. People with other forms of skin cancer may also need support from a skin cancer clinical nurse specialist, depending on their individual needs and the impact of their disease.

Quality measures

Structure
Evidence of local arrangements and clinical protocols to ensure that skin cancer clinical nurse specialists are available for people with malignant melanoma or squamous cell carcinoma.
Data source: Local data collection.
Process
Proportion of people with malignant melanoma or squamous cell carcinoma who have a skin cancer clinical nurse specialist.
Numerator – number in the denominator who have a skin cancer clinical nurse specialist.
Denominator – number of people with malignant melanoma or squamous cell carcinoma.
Data source: (Quality Health National Cancer Patient Experience Survey and National Cancer Intelligence Network Cancer Outcomes and Services Dataset.
Outcome
a) Quality of life among people with malignant melanoma or squamous cell carcinoma.
Data source: Quality Health National Cancer Patient Experience Survey.
b) Satisfaction with support received from skin cancer clinical nurse specialist, reported by people with skin cancer.
Data source: Quality Health National Cancer Patient Experience Survey.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (secondary and tertiary care) ensure that skin cancer multidisciplinary teams have a skin cancer clinical nurse specialist to support people with malignant melanoma or squamous cell carcinoma under their care.
Healthcare professionals (members of local hospital skin cancer multidisciplinary teams or specialist skin cancer multidisciplinary teams) ensure that people with malignant melanoma or squamous cell carcinoma have access to a skin cancer clinical nurse specialist.
Commissioners (clinical commissioning groups and NHS England) ensure that there are enough skin cancer clinical nurse specialists to support all people with malignant melanoma or squamous cell carcinoma.

What the quality statement means for patients and carers

People with a type of skin cancer called malignant melanoma or squamous cell carcinoma have a skin cancer nurse specialist who can provide information, advice and support.

Source guidance

Sentinel lymph node biopsy

This quality statement is taken from the skin cancer quality standard. The quality standard defines clinical best practice in skin cancer and should be read in full.

Quality statement

People with stage IB–IIC melanoma with a Breslow thickness of more than 1 mm have a discussion about the advantages and disadvantages of sentinel lymph node biopsy as a staging procedure.

Rationale

Sentinel lymph node biopsy helps to find out whether cancer has spread to the lymph nodes. It is better than ultrasound scans at finding very small deposits of cancers in the lymph nodes. However, it is not a form of treatment and, as with all invasive procedures, it has associated risks and complications that should be discussed with the person to enable shared decision making.

Quality measures

Structure
Evidence of local arrangements and clinical protocols to ensure that the advantages and disadvantages of sentinel lymph node biopsy as a staging procedure are discussed with people with stage IB–IIC melanoma with a Breslow thickness of more than 1 mm.
Data source: Local data collection.
Process
Proportion of people with stage IB–IIC melanoma with a Breslow thickness of more than 1 mm who have a discussion about the advantages and disadvantages of sentinel lymph node biopsy as a staging procedure.
Numerator – number in the denominator who have a discussion about the advantages and disadvantages of sentinel lymph node biopsy as a staging procedure.
Denominator – number of people with stage IB–IIC melanoma with a Breslow thickness of more than 1 mm.
Data source: Local data collection.
Outcome
Satisfaction with support received when deciding the best treatment, reported by people with skin cancer.
Data source: Quality Health National Cancer Patient Experience Survey.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (secondary and tertiary care) ensure that systems are in place for people with stage IB–IIC melanoma with a Breslow thickness of more than 1 mm to have a discussion about the advantages and disadvantages of sentinel lymph node biopsy as a staging procedure.
Healthcare professionals (members of local hospital skin cancer multidisciplinary teams or specialist skin cancer multidisciplinary teams) discuss the advantages and disadvantages of sentinel lymph node biopsy as a staging procedure with people who have stage IB–IIC melanoma with a Breslow thickness of more than 1 mm.
Commissioners (clinical commissioning groups and NHS England) ensure that in the services they commission the advantages and disadvantages of sentinel lymph node biopsy as a staging procedure are discussed with people who have stage IB–IIC melanoma with a Breslow thickness of more than 1 mm.

What the quality statement means for patients and carers

People with a type of skin cancer called malignant melanoma that is classified as stage 1B or stage 2 discuss the pros and cons of a procedure called sentinel lymph node biopsy with their healthcare professional. In this procedure, 1 or 2 lymph nodes near the cancer are removed and checked to see whether there is melanoma in them. Sentinel lymph node biopsy does not cure melanoma, but it can help to find out whether it has spread and may lead to other treatment options.

Source guidance

Genetic testing

This quality statement is taken from the skin cancer quality standard. The quality standard defines clinical best practice in skin cancer and should be read in full.

Quality statement

People with unresectable or metastatic melanoma are offered genetic testing of the tumour.

Rationale

Genetic testing of tumour tissue can help with choosing more targeted and effective treatment for people with unresectable or metastatic melanoma.

Quality measures

Structure
Evidence of local arrangements and clinical protocols to provide genetic testing of the tumours for people with unresectable or metastatic melanoma.
Data source: Local data collection.
Process
Proportion of people with unresectable or metastatic melanoma who receive genetic testing of the tumour.
Numerator – number in the denominator who receive genetic testing of the tumour.
Denominator – number of people with unresectable or metastatic melanoma.
Data source: Local data collection.
Outcome
1-year survival rates in people with diagnosed with unresectable or metastatic melanoma.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (secondary and tertiary care) ensure that systems are in place to provide genetic testing of the tumour for people with unresectable or metastatic melanoma.
Healthcare professionals (specialist skin cancer multidisciplinary teams) offer people with unresectable or metastatic melanoma genetic testing of the tumour.
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services that offer genetic testing of the tumour to people with unresectable or metastatic melanoma.

What the quality statement means for patients and carers

People with a type of skin cancer called unresectable or metastatic melanoma are offered genetic testing of their tumour to help find out whether a type of drug treatment called targeted systemic therapy might be suitable for them.

Source guidance

Effective interventions library

Effective interventions library

Successful effective interventions library details

Implementation

Information for the public

NICE produces information for the public that summarises, in plain English, the recommendations that NICE makes to healthcare and other professionals.
NICE has written information for the public explaining its guidance on each of the following topics.

Pathway information

Professional responsibilities

The recommendations in this pathway represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients or service users. Applying the recommendations in this pathway is at the discretion of health and care professionals and their individual patients or service users and does not override the responsibility of health and care professionals to make decisions appropriate to the circumstances of the individual, in consultation with them and/or their carer or guardian.
Commissioners and/or providers have a responsibility to enable the recommendations to be applied (and to provide funding required for technology appraisal guidance) when individual health and care professionals and their patients or service users wish to use them. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this pathway should be interpreted in a way that would be inconsistent with compliance with those duties.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Supporting information

Possible advantages of surveillance imaging (having regular scans)
Possible disadvantages of surveillance imaging (having regular scans)
If the melanoma comes back (recurrent melanoma), it is more likely to be detected sooner. It is possible that this could lead to a better outcome by allowing treatment with drugs (such as immunotherapy drugs) to start earlier.
Although early drug treatment of recurrent melanoma might improve survival, there is currently no evidence showing this.
Some people find it reassuring to have regular scans.
Some people find that having regular scans increases their anxiety.
Scans expose the body to radiation, which can increase the risk of cancer in the future.
Scans of the brain and neck increase the risk of developing cataracts.
Scans of the chest cause a very small increase in the risk of thyroid cancer.
Scans may show abnormalities that are later found to be harmless, causing unnecessary investigations and anxiety.
The following recommendations are from NICE technology appraisal guidance on talimogene laherparepvec for treating unresectable metastatic melanoma.
Talimogene laherparepvec is recommended, in adults, as an option for treating unresectable, regionally or distantly metastatic (Stage IIIB, IIIC or IVM1a) melanoma that has not spread to bone, brain, lung or other internal organs, only if:
  • treatment with systemically administered immunotherapies is not suitable and
  • the company provides talimogene laherparepvec with the discount agreed in the patient access scheme.
This guidance is not intended to affect the position of patients whose treatment with talimogene laherparepvec was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
NICE has written information for the public explaining its guidance on talimogene laherparepvec.

Glossary

Paths in this pathway

Pathway created: July 2015 Last updated: October 2016

© NICE 2016

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