National Institute for Health and Care Excellence (NICE) Guidance (Table 1) DECEMBER 2017 – JANUARY 2018
No. / Title(click link) / Findings/ Recommendations/Conclusions / Implications/For Discussion / CommissionersTA492
(Dec 2017) / Atezolizumab for untreated locally advanced or metastatic urothelial cancer when cisplatin is unsuitable / Recommended for use within the Cancer drugs fund (CDF). / Managed by the CDF / NHS England
TA493 (Dec 2017) / Cladribine tablets for treating relapsing–remitting multiple sclerosis / Recommended as an option in either rapidly evolving, severe relapsing – remitting multiple sclerosis (2 relapses in the previous year with MRI confirmation), or relapsing – remitting which has had inadequate response to disease modifying therapy.
Dose is 10 mg – 20 mg daily over 4 days for 2 weeks per annum. Maximum treatment is for 2 years. / Cost for each 10 mg tablet is around £2000. NICE do not expect this to have a significant cost impact because cladribine is similar to other available products. However, the commissioners will require assurances that the strict dosing schedule is being adhered to. / NHS England
TA494
(Dec 2017) / Naltrexone–bupropion for managing overweight and obesity / Not recommended as an option to manage overweight and obesity in adults alongside a reduced calorie diet and increased physical activity. / Long-term effectiveness is unknown.
Commissioners (which may include those in local authorities) will require assurances that combination is not being prescribed. / CCGs
TA495
(Dec 2017) / Palbociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer / Recommended as an option in combination with an aromatase inhibitor (e.g. letrozole). Taken orally, an approximate cost is around £3000 per month (excluding NHS discount). / Confidential discount has been negotiated and this can be used in the costing template to calculate local costs when available. / NHS England
TA496
(Dec 2017) / Ribociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer / Recommended as an option in combination with an aromatase inhibitor (e.g. letrozole). Also taken orally with the cost similar to above. / Confidential discount has been negotiated and this can be used in the costing template to calculate local costs when available. / NHS England
TA497
(Jan 2018) / Golimumab for treating non-radiographic axial spondyloarthritis / Recommended as an option in adults whose disease hasn’t responded to NSAIDs. Treatment should be continued after 12 weeks only if there is clear evidence of response.This is one of the first of NICE’s “fast track appraisals”. / Cost neutral as this product is one of many, currently available, similarly priced items. Commissioners will require assurances that golimumab isn’t continued beyond 12 weeks in non-responders. Because this is a “fast track” appraisal, funding must be available within 30 days (as opposed to the usual 3 months). / CCGs
TA498
(Jan 2018) / Lenvatinib with everolimus for previously treated advanced renal cell carcinoma / Recommended as an option in patients who have received at least one vascular endothelial growth factor (VEGF) targeted therapy and current “performance status” is reasonably good. / Not expected to be a significant cost pressure as similar price to currently available agents. / NHS England
TA499
(Jan 2018) / Glecaprevir–pibrentasvir for treating chronic hepatitis C / Recommended as an option. Prescribing decisions should be made by a multidisciplinary team put in place by NHS England to prioritise treatment for people with the highest unmet clinical need. / Expected to be cost neutral because product is a similar price to existing agents. / NHS England
TA500
(Jan 2018) / Ceritinib for untreated ALK-positive non-small-cell lung cancer / Recommended as an option in adults. / Local costs to be calculated using template because price is confidential. However, nationally, there are only around 400 people per annum expected to receive this treatment. / NHS England
CG128
(Dec 2017) / Autism spectrum disorder in under 19s: recognition, referral and diagnosis / UPDATED: First published 2011. Minor amendments which included a review of the factors associated with prevalence.
NG82
(Jan 2018) / Age-related macular degeneration / Recommendations on classification, information and support, risk factors and diagnosis, treatment and referral. There should be a clear pathway in place between primary and secondary care. Recommended treatments include anti-vascular endothelial growth factor (anti-– VEGF). / Crucially, NICE commented they found no clinically significant differences in effectiveness and safety between the different anti— VEGF treatments. Thus, although ranibizumab (Lucentis) is the subject of a technology appraisal, the inference is that bevacizumab (Avastin), which is much cheaper, is a suitable alternative. / CCGs
NG83
(Jan 2018) / Oesophago-gastric cancer: assessment and management in adults / Recommendations include:-information and support, specialist multidisciplinary teams, assessment and treatment. / Expected to be cost neutral. / NHS England
DG14 / Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point of care coagulometers (the CoaguChek XS system) / Systems are point-of-care monitors for coagulation status. System is recommended if patient is suitable and prefers this form of testing.
IPG599 / Transvaginal mesh repair of anterior or posterior vaginal wall prolapse / Serious but well-recognised adverse effects. / Should only be used in the context of research.
IPG600 / Endobronchial valve insertion to reduce lung volume in emphysema / Data on safety and efficacy are adequate. / Standard arrangements for clinical governance, consent and audit.
IPG601 / Transcutaneous microwave ablation for severe primary axillary hyperhidrosis / Current evidence on safety and efficacy is inadequate / Special arrangements for clinical governance, consent and audit or research.
IPG602 / Artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure / Data on safety and efficacy are limited in quality and quantity. / Special arrangements for clinical governance, consent and audit or research.
IPG603 / Subcutaneous implantable cardioverter defibrillator insertion for preventing sudden cardiac death / Current evidence on safety and efficacy is adequate. / Standard arrangements for clinical governance, consent and audit.
MIB132 / Point-of-care and home faecal calprotectin tests for monitoring treatment response in inflammatory bowel disease / Tests for inflammatory markers to measure response to treatment for inflammatory bowel disease. Limited research shows that these point-of-care tests have comparable accuracy to existing laboratory tests but with greater patient satisfaction. / Key uncertainties around lack of a standard NHS pathway and limited evidence on the long-term clinical outcomes.
MIB133 / Next-generation sequencing panel for solid tumour cancers in children / Potential use is in addition to standard care to expand the level of genomic analysis in children with solid tumour cancers. / Technology is still in early development and so the evidence base is not fully established.
MIB134 / TYM smartphone otoscope for imaging and videoing the external ear canal and eardrum / Images can be stored and shared between healthcare professionals. / Evidence based on 1 small non-UK study.
MIB135 / MammaTyper in vitro diagnostic test for determining breast cancer subtypes / System determines different molecular subtypes of breast cancer to decide on systemic therapy. / Further studies on clinical outcomes are required.
MIB136 / Point-of-care creatinine tests before contrast-enhanced imaging / Result is available in about 9 minutes. / No published evidence of effectiveness.
MIB137 / Plasma EGFR mutation tests for adults with locally advanced or metastatic non-small-cell lung cancer / Measures circulating tumour DNA in a blood sample rather than standard histological assessment. / Tests for these mutations are rapidly evolving and there is no established gold standard to compare.
IPG = Interventional Procedure Guidance CG = Clinical Guideline TA= Technology Appraisal PHG = Public Health Guidance PSG = Patient Safety Guidance
MIB: Medtech Innovation Briefing MTG= Medical Technology Guidance DG = Diagnostics GuidanceSSG = Safe Staffing Guideline HST = Highly Specialised Technology Guidance
NG = NICE guideline
Table 2: QUALITY STANDARDS
Title / Publication date / DescriptionQS 124:Suspected cancer / December 2017 / UPDATED: First published in 2016. Minor amendments included revision of the definitions and source guidance for testing of blood and faeces.
1
J.P. Hampson Public Health Specialist 2018