1. Category: Threshold

Threshold procedures and therapies are those in which a clinical threshold has been set which needs to be met before funding will be made available for treatment

For patients who DO NOT meet the eligibility criteria, the ICB will only consider funding the treatment if an Individual Funding Request (IFR) detailing the patient’s clinical presentation is submitted to the ICB

2. Background

Surgical mesh is a loosely woven sheet which is used as either a permanent or temporary support for organs and other tissue during surgery. The meshes are available in both inorganic (synthetic) and biological materials and are used in a variety of surgeries

Composite meshes are also available with a synthetic inner and biological outer

Biologic mesh development resulted from a search for a biomaterial that addresses the problems associated with permanent synthetic mesh, including chronic inflammation and foreign body reaction, stiffness and fibrosis, and mesh infection

Biological Mesh is made from human or animal dermis or porcine small intestinal submucosa and there are many different products available

Each product differs in composition, porosity, weave, configuration and material nature, thus making it difficult to directly compare the different products available

The theoretical advantage of biologic mesh over synthetic mesh is appealing and over the last decade biologic mesh has been used in a variety of indications. The presence of contamination limits the applicability of permanent synthetic mesh and biological mesh is being used for this purpose or for placement in open wounds as a staged closure in complex abdominal wall reconstruction

There is limited data across all indications for use and a particular lack of comparable data between products

Biological Mesh is currently excluded from PbR tariff. This is because of the variable and often high cost associated with its use; the product can range in cost from £750 to in excess of £8,500 per patient, depending on intended use, size of wound and product choice

All items listed as PbR exclusions are subject to locally agreed payments taking into consideration existing tariff charges

For a device to be considered as an exclusion from PbR it must meet all 3 of the following criteria:

• High cost and represent a disproportionate cost relative to the relevant HRG
• Used in a subset of cases within an HRG and/or used in a subset of providers delivering services under a specific HRG
• Relatively high cost in terms of volume and cost

University Hospital Coventry and Warwickshire (UHCW) reported use of biological mesh in the following areas and requested funding from Commissioners:

• Reconstructive breast surgery
• eLAPE reconstructive surgical technique for low rectal cancer
• Complex and recurrent hernia repairs
• Stoma creation and closure
• Complex colorectal surgical procedures

3. Commissioning position

Following a review of the evidence and consideration of the local circumstances for use, the Integrated Care Board will separately fund use of biological mesh for the following indications whilst it is listed as an exclusion from Payment by Results (PbR):

• When used as part of eLAPE (extra-Levator AbdominoPerineal Excision of the rectum) reconstructive surgical technique for low rectal cancer to achieve wound closure
• When used in patients with cancer of the breast, ductal carcinoma in situ and those patients identified with the high risk BRCA gene, for single stage skin sparing mastectomy/reconstruction to avoid the need for a 2 stage operation involving mastectomy and reconstruction

The Integrated Care Board will not separately fund as an exclusion from PbR:

• Biological mesh when used for complex abdominal wall hernia repair or closure of laparostomy
• Biological mesh when used for any other indications not listed above
• Synthetic mesh* for any indications
• Synthetic equivalents** to biological mesh
• Any identified new indications for use of biological mesh or synthetic equivalents requiring additional funding will require agreement with the ICB
• Synthetic mesh does not meet the criteria for consideration as an exclusion from PbR; the costs associated with use are therefore contained within tariff rates for given procedures

**This wording included within 2015/16 PbR exclusions is intended to allow for the possibility that there are synthetic materials in use which may represent a similar disproportionate cost as biological mesh

4. Guidance

Faulkner HR, Shikowitz-Behr L, McLeod M, Wright E, Hulsen J, Austen WG Jr. The Use of Absorbable Mesh in Implant-Based Breast Reconstruction: A 7-Year Review. Plast Reconstr Surg. 2020 Dec;146(6):731e-736e. doi: 10.1097/PRS.0000000000007384. PMID: 33234950; PMCID: PMC7676463.

Logan Ellis, H., Asaolu, O., Nebo, V. et al. Biological and synthetic mesh use in breast reconstructive surgery: a literature review . World J Surg Onc 14, 121 (2016). https://doi.org/10.1186/s12957-016-0874-9

Choi YS, You HJ, Lee TY, Kim DW. Comparing Complications of Biologic and Synthetic Mesh in Breast Reconstruction: A Systematic Review and Network Meta-Analysis. Arch Plast Surg. 2023 Feb 6;50(1):3-9. doi: 10.1055/a-1964-8181. PMID: 36755646; PMCID: PMC9902089.

Thomas, P.W., Blackwell, J.E.M., Herrod, P.J.J. et al. Long-term outcomes of biological mesh repair following extra levator abdominoperineal excision of the rectum: an observational study of 100 patients. Tech Coloproctol 23, 761–767 (2019).

Buscail E, Canivet C, Ghouti L, Kirzin S, Carrere N, Molinier L, Rosillo A, Lauwers-Cances V, Costa N; French Research Group of Rectal Cancer Surgery (GRECCAR Group). Randomised clinical trial for the cost-utility evaluation of two strategies of perineal reconstruction after abdomino-perineal resection in the context of anorectal carcinoma: biological mesh repair versus primary perineal wound closure, study protocol for the GRECCAR 9 Study. BMJ Open. 2021 Apr 1;11(4):e043333. doi: 10.1136/bmjopen-2020-043333. PMID: 33795299; PMCID: PMC8021762.

Diab, M.M. et al. (2023) ‘Quality of life measures and cost analysis of biologic versus synthetic mesh for ventral hernia repair: The preventing recurrence in clean and contaminated hernias randomized clinical trial’, Surgery [Preprint]. doi:10.1016/j.surg.2023.11.013.

Harris HW, Primus F, Young C, Carter JT, Lin M, Mukhtar RA, Yeh B, Allen IE, Freise C, Kim E, Sbitany H, Young DM, Hansen S. Preventing Recurrence in Clean and Contaminated Hernias Using Biologic Versus Synthetic Mesh in Ventral Hernia Repair: The PRICE Randomized Clinical Trial. Ann Surg. 2021 Apr 1;273(4):648-655. doi: 10.1097/SLA.0000000000004336. PMID: 33443907.

Bhangu, A. et al. (2020) ‘Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): A multicentre, randomised controlled trial’, The Lancet, 395(10222), pp.417–426. doi:10.1016/s0140-6736(19)32637-6.

Cornille JB, Pathak S, Daniels IR, Smart NJ. Prophylactic mesh use during primary stoma formation to prevent parastomal hernia. Ann R Coll Surg Engl. 2017 Jan;99(1):2-11. doi: 10.1308/rcsann.2016.0186. Epub 2016 Jun 8.

Tzivanakis A, Dayal SP, Arnold SJ, Mohamed F, Cecil TD, Venkatasubramaniam AK, Moran BJ. Biological mesh is a safe and effective method of abdominal wall reconstruction in cytoreductive surgery for peritoneal malignancy. BJS Open. 2018 Aug 2;2(6):464-469. doi: 10.1002/bjs5.93. PMID: 30511047; PMCID: PMC6254008.

Worcestershire ICBs’ Commissioning Policy on Funding Arrangements for Use of Biological and Synthetic Mesh/Equivalents

Thames Valley Priorities Committee Commissioning Policy Statement. Policy No. 255 (TVPC 14) Biological Mesh