Confidential draft – Not for circulation, citation or quotation

Kent and Medway Policy Recommendation and Guidance Committee Policy Recommendation

Policy: PR 2016-22: augmentation

Issue date: September 2016

Review date: September 2019

This policy recommendation replaces PR2013-10

The Kent and Medway Policy Recommendation and Guidance Committee (PRGC) considered national guidelines, the baseline position (with respect to activity, costs and expenditure), other CCG policies, evidence relating to the impact of living with conditions for which breast augmentation may be indicated and the safety, clinical- and cost-effectiveness of treatment, and the views and opinions of local stakeholders. All decisions were made with reference to the Ethical Framework. Taking these into account, the PRGC recommends that:  Breast augmentation is not routinely funded within the local NHS for any patient group  This recommendation does not apply to patients undergoing breast reconstruction as part of treatment for breast cancer or its prevention

See overleaf for background information and supporting rationale. This policy recommendation will be reviewed in light of new evidence or guidance from NICE. Clinical Commissioning Groups in Kent and Medway will always consider appropriate individual funding requests (IFRs) through their IFR process.

Supporting documents South East CSU Health Care Intervention Appraisal and Guidance (HCiAG) team (2016) Breast augmentation, revision of breast augmentation and mastopexy – Scoping report Equality Analysis Screening Tool – Breast augmentation (2016)

PR2016-22 September 2016 Confidential draft – Not for circulation, citation or quotation

Key points and rationale What is breast augmentation? Breast augmentation (augmentation mammoplasty) involves accessing and creating a pocket for an implant, which is usually inserted through incisions in the inframammary fold. Alternatively, the incision may be made around the areola or in the armpit. Implants may be inserted either directly behind the breast tissue (subglandular placement), or behind the breast and chest wall/ muscle (submuscular placement). Some patients may require tissue expansion surgery prior to augmentation. The NHS cost of breast augmentation is likely to be between £2,900 and £3,300 per patient; the cost will be higher if tissue expansion is required. What are the potential indications for breast augmentation? Breast augmentation may be considered an option for patients with breast asymmetry, (absence of breast tissue, and areola), amazia (absence of breast tissue) or tuberous (herniation of breast tissue through the -areola complex). The prevalence of these conditions is unknown. Breast augmentation may also be requested by patients with gender dysphoria undergoing transition from Male-to-Female and those who perceive their breasts to be too small. What is the impact of living with a condition for which breast augmentation may be indicated? No studies comparing the impact of living with a condition for which breast augmentation may be indicated to population norms were identified; it has therefore not been possible to determine the impact of living with these conditions. What national guidelines are available? The NHS Modernisation Agency (2005) Information for Commissioners of Plastic Surgery Services sets out recommended eligibility criteria for breast augmentation. No supporting evidence is referenced and the methods used to determine individual recommendations are not disclosed. What does local guidance say? Currently, Kent and Medway CCGs do not routinely fund breast augmentation for any patient group. This recommendation does not apply to patients undergoing breast reconstruction as part of treatment for breast cancer or patients undergoing gender reassignment surgery. What is the evidence base for breast augmentation? The evidence relating to the effectiveness of breast augmentation is limited to one systematic review and four small case series. The impact of breast augmentation on quality of life is inconsistent. Single studies found improvements following surgery in sexual and psychosocial well-being, self- esteem and depression. One study found that four months after breast augmentation trans women rated their quality of life, and psychological and sexual well-being significantly higher than three weeks before the surgery, however there was no significant change for physical well-being. One systematic review of 3 observational studies found women who underwent breast augmentation are less likely to exclusively breast feed. No studies assessing the cost-effectiveness of breast augmentation in the NHS were identified. Overall complication rates of 13.1% and 16.6% have been reported in the literature for breast augmentation. Common complications include , poor scarring, capsular contracture, post- operative seroma and haematoma, malrotation or asymmetry, and infection. Reoperation rates ranged from 6% to 21%. The main reasons for reoperation were inadequate cosmetic result, desire to change implant type and capsular contracture. Why is breast augmentation not funded on the NHS in Kent and Medway? The evidence base relating to the impact of potential indications for breast augmentation on quality of life and the clinical-effectiveness of breast augmentation is poor and equivocal. In addition, there is no evidence that funding breast augmentation is cost-effective for the NHS. In the context of the resources available and the health needs of the population, funding this procedure is not currently a priority for Kent and Medway CCGs. Will implementation of PR2016-22 lead to a change in activity or expenditure? No. Currently breast augmentation is not routinely funded for any patient group in Kent and Medway.

PR2016-22 September 2016 Confidential draft – Not for circulation, citation or quotation

Change sheet Reason for review: The current local policy on breast augmentation (PR2013-10) is due for routine review. Changes made to current policy: The table below highlights the changes made to the existing policy on this topic.

Current policy (PR2013-10) PRGC policy recommendation  Breast augmentation is not funded within the  Breast augmentation is not funded within the local NHS for any patient group local NHS for any patient group  This recommendation does not apply to patients  This recommendation does not apply to patients undergoing breast reconstruction as part of undergoing breast reconstruction as part of treatment for breast cancer or patients treatment for breast cancer or its prevention undergoing gender reassignment surgery Note: Green = addition; red = deletion

Rationale for changes to policy (as per table above):  Patients undergoing gender reassignment surgery are no longer excluded from the policies on breast augmentation and revision of breast augmentation. NHS England consider breast augmentation a non-core procedure for patients with gender dysphoria who undergo transition from Male-to-Female. Core procedures are the commissioning responsibility of NHS England; non-core procedures the commissioning responsibility of CCGs. No evidence was identified to suggest that gender reassignment patients should be treated differently to other patients seeking breast augmentation.  Clarification that patients undergoing prophylactic mastectomy as part of preventative treatment for breast cancer are also excluded from this policy Estimated cost impact of implementing the new policy: None. Currently breast augmentation is not routinely funded for any patient group in Kent and Medway.

PR2016-22 September 2016