South, Central and West NICE UPDATE FOR COMMISSIONERS April 2019

This NICE Update for Commissioners includes:

 At-a-glance summary Headline update: what’s been published?

 Guidance and quality standards published by NICE in March 2019 What’s new for CCGs?

 Horizon scanning What’s coming out from NICE in the next six months?

 For your reference, a summary of the types of NICE guidance Reference – a guide to NICE products

The next (May 2019) NICE Update for Commissioners will be issued at the beginning of June 2019.

For further information about NICE guidance and its implementation contact:

 Tiina Korhonen, Clinical Effectiveness Lead  Kathryn Markey, Clinical Effectiveness Manager  Kate Forbes, Clinical Effectiveness Manager  Rebecca Hodge, Clinical Effectiveness Manager  Gill Barlow, Clinical Effectiveness Manager  Katie Newens, Clinical Effectiveness Researcher  Rachel Finch, Clinical Effectiveness Administrator [email protected]

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At-a-glance summary

The table below shows ALL NICE guidance published in April2019. Those likely to have significant impact for CCG commissioners are discussed further in the ‘What’s new for Clinical Commissioning Groups’ section (link to relevant section provided within guidance reference). Guidance type and Title Commissioner(s) Main providers(s) Impact for CCG commissioners (financial /public reference interest/quality of care)

Technology Appraisal – Daratumumab with NHS England Secondary care - TA573 bortezomib and acute and dexamethasone for Tertiary care previously treated multiple myeloma

Technology Appraisal – Certolizumab pegol for CCGs Primary care, NICE does not expect this guidance to have a TA574 treating moderate to severe secondary care - significant impact on resources; that is, it will be plaque psoriasis acute and tertiary less than £5 million per year in England (or care £9,100 per 100,000 population) because the technology is an option alongside current standard treatment options and is available at a similar price. Technology Appraisal – Tildrakizumab for treating CCGs Primary care, NICE does not expect this guidance to have a TA575 moderate to severe plaque secondary care - significant impact on resources; that is, it will be psoriasis acute and tertiary less than £5 million per year in England (or care £9,100 per 100,000 population) because the technology is an option alongside current standard treatment options and is available at a similar price Technology Appraisal- Bosutinib for untreated Terminated appraisal TA576 chronic myeloid leukaemia NICE is unable to make a recommendation about the use in the NHS of bosutinib (Bosulif) for untreated chronic myeloid leukaemia in adults because no evidence submission was received from Pfizer. Technology Appraisal- Brentuximab vedotin for NHS England Secondary care- TA577 treating CD30-positive acute 2 | p a g e

Guidance type and Title Commissioner(s) Main providers(s) Impact for CCG commissioners (financial /public reference interest/quality of care)

cutaneous T-cell lymphoma

NICE guideline NG121- Intrapartum care for women CCGs Secondary care - Recommendations on continuous update with existing medical acute cardiotocography for women with a previous conditions or obstetric caesarean section have been replaced with links complications and their to advice in the NICE guideline on caesarean babies section. No additional impact on resources is anticipated. NICE guideline - CG132 Caesarean section CCGs Secondary care - This guidance has been updated to reflect the update acute recommendations in NG125 Surgical site infections: prevention and treatment. New recommendation: ‘Consider using sutures rather than staples to close the skin after caesarean section to reduce the risk of superficial wound dehiscence’. No additional impact on resources is anticipated. NICE guideline -NG123 Urinary incontinence and CCGs Primary care and The resource impact report focuses on yearly pelvic organ prolapse in secondary care - reviews for women who use absorbent women: management acute containment products for management of long term urinary incontinence. NICE recommends that the resource impact is assessed locally as there is uncertainty around the number of women who are currently using these products and who attend an annual review. NICE guideline- NG124 Specialist neonatal NHS England Secondary care - NICE does not anticipate that this guideline will respiratory care for babies acute have significant impact in resources. born preterm

NICE guideline –NG125 Surgical site infections: NHS England and Secondary care - NICE does not anticipate that this guideline will prevention and treatment CCGs acute have significant impact in resources. This is because practice is not expected to change significantly as a result of implementing the 3 | p a g e

Guidance type and Title Commissioner(s) Main providers(s) Impact for CCG commissioners (financial /public reference interest/quality of care)

guidance. NICE guideline -NG126 Ectopic pregnancy and CCGs Primary care and NICE does not anticipate that this guideline will miscarriage: diagnosis and secondary care – have significant impact in resources. initial management acute

Interventional Procedure Guidelines:

Type of Title Recommendation Guidance and reference Interventional Endoscopic ablation for an anal Current evidence on endoscopic ablation for an anal fistula raises no major safety concerns procedure fistula and the evidence on efficacy is adequate in quality and quantity. Therefore, this procedure guidance – can be used provided that standard arrangements are in place for clinical governance, IPG645 consent and audit. Interventional Endoscopic ablation for a Current evidence on endoscopic ablation for a pilonidal sinus raises no major safety procedure pilonidal sinus concerns and the evidence on efficacy is adequate in quality and quantity. Therefore, this guidance – procedure can be used provided that standard arrangements are in place for clinical IPG646 governance, consent and audit.

What’s new for Clinical Commissioning Groups?

Technology Appraisal

 Certolizumab pegol for treating moderate to severe plaque psoriasis (TA574) https://www.nice.org.uk/guidance/ta574

Certolizumab pegol (Cimzia; UCB Pharma) is a recombinant, humanised antibody Fab' fragment against tumour necrosis factor alpha (TNFα). It is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Certolizumab pegol is recommended as an option for treating plaque psoriasis in adults, only if:

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 the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and  the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and  the lowest maintenance dosage of certolizumab pegol is used (200 mg every 2 weeks) after the loading dosage and  the company provides the drug according to the commercial arrangement.

Stop certolizumab pegol at 16 weeks if the psoriasis has not responded adequately. An adequate response is defined as:  a 75% reduction in the PASI score (PASI 75) from when treatment started or  a 50% reduction in the PASI score (PASI 50) and a 5-point reduction in DLQI from when treatment started.

The recommended starting dosage of certolizumab pegol for adults is 400 mg (given as 2 subcutaneous injections of 200 mg each) at weeks 0, 2 and 4. The maintenance dosage of certolizumab pegol for adults is 200 mg every 2 weeks. A dosage of 400 mg every 2 weeks can be considered when there is an insufficient response. The cost of Certolizumab pegol is £357.50 per 200 mg pre-filled pen or syringe.

Impact: This guideline is commissioned by CCGs. The resource impact statement indicates that no significant impact on resources is anticipated.

 Tildrakizumab for treating moderate to severe plaque psoriasis (TA575) https://www.nice.org.uk/guidance/ta575

Tildrakizumab is a humanised IgG1/k monoclonal antibody. It has a marketing authorisation for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Tildrakizumab is recommended as an option for treating plaque psoriasis in adults, only if:  the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and  the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and  the company provides the drug according to the commercial arrangement.

Consider stopping tildrakizumab between 12 weeks and 28 weeks if there has not been at least a 50% reduction in the PASI score from when treatment started.

Stop tildrakizumab at 28 weeks if the psoriasis has not responded adequately. An adequate response is defined as:  a 75% reduction in the PASI score (PASI 75) from when treatment started or

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 a 50% reduction in the PASI score (PASI 50) and a 5-point reduction in DLQI from when treatment started.

Tildrakizumab is administered by subcutaneous injection at a dose of 100 mg at weeks 0 and 4 and every 12 weeks thereafter. In patients with certain characteristics (for example, high disease burden, body weight of 90 kg or more), a 200 mg dose may provide greater efficacy.

Impact: This guideline is commissioned by CCGs. The resource impact statement indicates that no significant impact on resources is anticipated.

Clinical Guidelines

 Urinary incontinence and pelvic organ prolapse in women: management (NG123) https://www.nice.org.uk/guidance/ng123

This guideline updates and replaces NICE guideline CG171 (September 2013), NICE guideline CG40 (October 2006), NICE technology appraisal guidance 56 (February 2003), NICE interventional procedures guidance 154 (2006) and NICE advice ESNM2 (September 2012).This guideline covers assessing and managing urinary incontinence and pelvic organ prolapse in women aged 18 and over. It also covers complications associated with mesh surgery for these conditions.

This guideline includes new and updated recommendations on:

 organisation of specialist services includes the function and members of local and regional multidisciplinary teams  collecting data on surgery and surgical complications. This recommendation states what data should be recorded in a national registry of surgery for urinary incontinence and pelvic organ prolapse in women. The national registry of surgery for urinary incontinence and pelvic organ prolapse in women must ensure that follow‑up data are collected on key short- and long-term (at least 5 years) outcomes  urodynamic testing to assess urinary incontinence. This includes guidance on: history taking and physical examination; assessing pelvic floor muscles; urine testing; assessing residual urine; symptom scoring and quality-of-life assessment; bladder diaries; indications for referral to a specialist service  pelvic floor muscle training and absorbent containment products for urinary incontinence  medicines and botulinum toxin type A injections for overactive bladder  surgical management of stress urinary incontinence. Surgery is an option for whose symptoms have not improved or women who decline non surgical treatment. For all of the procedures recommended in this section, including mesh procedures, there is evidence of benefit but limited evidence on the long-term adverse effects. The use of the NICE patient decision aid on surgery for stress urinary incontinence to promote informed preference and shared decision making, is recommended.  assessing pelvic organ prolapse  non-surgical and surgical management of pelvic organ prolapse includes advice on lifestyle modification, topical oestrogen, pelvic floor muscle training, vaginal pessaries. 6 | p a g e

 surgery for women with both stress urinary incontinence and pelvic organ prolapse  assessing and managing complications associated with mesh surgery

In July 2018, the Government announced a period of ‘high vigilance restriction’ on the use of a group of procedures, including vaginally inserted mesh and tape to treat stress urinary incontinence and pelvic organ prolapse, in England. This followed a recommendation by Baroness Cumberlege, who is chairing an independent review of surgical mesh procedures and has heard from women and families affected by them. At the time of publication of this updated NICE guideline, the high vigilance restriction period had been extended and, until it ends, professionals should continue to follow its requirements. The letter sent to medical directors can be found here

Impact: Services for urinary incontinence and pelvic organ prolapse in women are commissioned by CCGs and NHS England. NHS England are responsible for commissioning specialist surgeries and the mesh involved in surgery. CCGs are responsible for all other services such as surgery and outpatient appointments. The recommendation in this guideline that is likely to have the biggest impact is offering a review at least once a year to women who are using absorbent containment products for long-term management of urinary incontinence (UI). There is uncertainty around the number of women who are currently using absorbent containment products and who attend an annual review. The resource impact report models 3 different scenarios with the number of women who currently attend an annual review ranging from 20% to 60%. Costs of annual review could range up to £1.4 million per year for the population of England. Currently continence services are commissioned through block contracts and therefore a significant increase in activity may require providers to employ additional staff and to re-negotiate the block payment for the service with CCGs. Ensuring that all women have at least one annual review may lead to a reduction in the use of absorbent containment products in some women and this may result in a cost saving. NICE recommends the use of the resource impact template to assess impact locally.

 Surgical site infections: prevention and treatment (NG125) https://www.nice.org.uk/guidance/ng125

This guideline covers preventing and treating surgical site infections in adults, young people and children who are having a surgical procedure involving a cut through the skin. It focuses on methods used before, during and after surgery to minimise the risk of infection. It includes recommendations on the following:  Information for patients and carers. Patients and carers should be offered advice throughout all stages of their care. This should include the risks of surgical site infections; how to recognise surgical site infection; how to care for their wound after discharge; the use of antibiotics  Preoperative phase. This includes advice on preoperative showering, nasal decolonisation, hair removal, patient and staff theatre wear, antibiotic prophylaxis.  Intraoperative phase.  Postoperative phase. This includes advice on: changing dressings; postoperative cleansing; dressings; antibiotic treatment; specialist wound care services.

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Impact: Surgical services are commissioned by NHS England and CCGs. The resource impact statement indicates that no significant impact on resources is anticipated; that is, the resource impact of implementing any single guideline recommendation will be less than £1 million per year in England (or £1,800 per 100,000 population) and the resource impact of implementing the whole guideline in England will be less than £5 million per year (or £9,100 per 100,000 population).

 Ectopic pregnancy and miscarriage: diagnosis and initial management (NG126) https://www.nice.org.uk/guidance/ng126

This guideline covers diagnosing and managing ectopic pregnancy and miscarriage in women with complications, such as pain and bleeding, in early pregnancy (up to 13 completed weeks of pregnancy). It aims to improve how early pregnancy loss is diagnosed, and the support women are given, to limit the psychological impact of their loss. It includes recommendations on the following:  Support and information giving  Early pregnancy assessment services  Symptoms and signs of ectopic pregnancy and initial assessment  Diagnosis of viable intrauterine pregnancy and of tubal ectopic pregnancy  Management of miscarriage  Management of tubal ectopic pregnancy  Anti-D rhesus prophylaxis

Impact: Services for ectopic pregnancy and miscarriage are commissioned by CCGs. The resource impact statement for this guideline indicates that no significant impact on resources is anticipated; the resource impact of implementing any single guideline recommendation will be less than £1 million per year in England (or £1,800 per 100,000 population) and the resource impact of implementing the whole guideline in England will be less than £5 million per year (or £9,100 per 100,000 population).

What’s coming out from NICE in the next six months?

The following were due to be published in April 2019. NICE has confirmed this guidance will now be published in May and June 2019

April 2019 Title Type of Funding considerations and other comments guidance Patient and service user experience: No additional resource impact is expected on top of the impact associated with refresh of QS14 and QS15 (QS183) Quality Standard implementing the underpinning guideline.

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Physical activity: encouraging No additional resource impact is expected on top of the impact associated with Quality Standard activity in the general population implementing the underpinning guideline. The draft guideline has been out for consultation. The recommendations that may have a resource impact are around using multiparametric MRI (mpMRI) as a first line Prostate cancer: diagnosis and Clinical Guideline investigation for people with suspected clinically localised prostate cancer and management (update) discussing the option of docetaxel chemotherapy to people who have a newly diagnosed non-metastatic prostate cancer.

May 2019 Title Type of Funding considerations and other comments guidance Patient and service user Quality Standard No additional resource impact is expected on top of the impact associated with experience: refresh of QS14 and implementing the underpinning guideline. QS15 (QS183) Suspected neurological conditions Clinical Guideline This guideline is not expected to have a significant impact on resources. Where clinical (NG127) practice changes as a result of this guideline, there will not be a significant change in resource use. Prostate cancer: diagnosis and Clinical Guideline The draft guideline has been out for consultation. The recommendations that may management (update) have a resource imapct are around using multiparametric MRI as a first line investigation for people with suspected clinically localised prostate cancer and discussing the option of docetaxel chemotherapy to people who have a newly diagnosed non-metastatic prostate cancer. Stroke and transient ischaemic Clinical Guideline A number of recommendations in this guideline are expected to result in a significant attack in over 16s: diagnosis and resource impact. The estimated financial impact of implementing this guideline for initial management (update) England in the next 5 years is a cost of around £1.7 million in 2019/20 rising to a cost (NG128) of around £2.4 million in 2023/24. The guideline is supported by a resource impact report and template. Durvalumab for treating locally Single NICE has recommended durvalumab monotherapy for use within the Cancer Drugs advanced unresectable non-small- Technology Fund for treating locally advanced unresectable non-small-cell lung cancer in adults cell lung cancer after platinum- Appraisal whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has based chemoradiation (TA578) not progressed after concurrent platinum-based chemoradiation therapy. Durvalumab will be available to the NHS in line with the managed access agreement with NHS England. As part of this, NHS England and Astra Zeneca have a commercial access agreement that makes durvalumab available to the NHS at a reduced cost.

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The financial terms of the agreement are commercial in confidence. Ulcerative Colitis (update) (CG166) Clinical Guideline This update to the existing guideline CG166 Ulcerative disease: management, is not expected to have a significant impact on resources. The updated guideline reviewed the evidence on inducing remission in people with ulcerative colitis. Where clinical practice does change as a result of this update, there will not be a significant change in resource use.

Crohns Disease Management Clinical Guideline This update to the existing guideline CG152 Crohn’s disease: management, is not (update CG152) expected to have a significant impact on resources. The updated guideline reviewed the evidence on maintaining remission after surgery and now reflects current clinical practice more closely. Where clinical practice does change as a result of this update, there will not be a significant change in resource use.

Lead-I electrocardiogram (ECG) Diagnostic Draft guidance states that there is not enough evidence to recommend the routine devices for detecting atrial Technology adoption of lead-I ECG devices (imPulse, Kardia Mobile, MyDiagnostick, RhythmPad fibrillation using single-time point GP and Zenicor-ECG) to detect atrial fibrillation when used for single time point testing testing in primary care in primary care for people with signs or symptoms of the condition and an irregular pulse. Abemaciclib with fulvestrant for Single Final appraisal document (FAD) produced. Draft guidance states that Abemaciclib with treating advanced hormone- Technology fulvestrant is recommended for use within the Cancer Drugs Fund as an option for receptor positive, HER2-negative Appraisal treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)- breast cancer after endocrine negative locally advanced or metastatic breast cancer in people who have had therapy endocrine therapy only if: • exemestane plus everolimus would be the most appropriate alternative and • the conditions in the managed access agreement for abemaciclib with fulvestrant are followed. PICO negative pressure wound Medical Cost modelling suggests that PICO negative pressure wound dressings provide extra dressings for closed surgical Technology clinical benefits at a similar overall cost compared with standard wound dressings. incisions The guidance may have resource implications at a local level because of variation in clinical practice across the country. Therefore, organisations are encouraged to evaluate their own practices against the recommendations in the NICE guidance and assess resource impact locally. Curos for preventing infections Medical Draft guidance states that curos disinfecting cap shows promise for preventing when using needleless connectors Technology infections when using needleless connectors, but there is currently insufficient

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evidence to support the case for routine adoption in the NHS. Cerliponase alfa for treating Single FAD produced. Draft guidance states that cerliponase alfa is not recommended, within neuronal ceroid lipofuscinosis type2 Technology its marketing authorisation, for treating neuronal ceroid lipofuscinosis type 2, also Appraisal known as tripeptidyl peptidase 1 deficiency. Enzalutamide for treating non- Single FAD published. Draft guidance states that enzalutamide is not recommended, within metastatic hormone-relapsed Technology its marketing authorisation, for treating high-risk hormone-relapsed non-metastatic prostate cancer Appraisal prostate cancer in adults.

Nivolumab with ipilimumab for Single FAD published. Guidance states that nivolumab with ipilimumab is recommended for untreated metastatic renal cell Technology use within the Cancer Drugs Fund as an option for adults with untreated advanced carcinoma Appraisal renal cell carcinoma that is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria. Hyperparathyroidism (primary): Clinical Guideline The draft guideline has been out for consultation, it is not anticipated that there will be diagnosis, assessment and initial a significant resource impact as a result of this guideline. management

June 2019 Title Type of Funding considerations and other comments guidance Atezolizumab in combination for Single Appraisal consultation document (ACD) produced. Draft guidance states that treating advanced non-squamous Technology atezolizumab plus bevacizumab, carboplatin and paclitaxel is not recommended, non-small-cell lung cancer Appraisal within its anticipated marketing authorisation, for untreated metastatic non-squamous non-small-cell lung (NSCLC) cancer or for previously treated (with targeted therapy) epidermal growth factor receptor positive or anaplastic lymphoma kinase positive NSCLC in adults. Physical activity: encouraging Quality Standard No additional resource impact is expected on top of the impact associated with activity in the general population implementing the underpinning guideline. Endocuff Vision for endoscopic Medical The guidance is not expected to result in a significant resource impact because the investigation Technology unit cost of Endocuff is small. Ocrelizumab for treating primary Single Guidance development is ongoing. More information will be provided as the progressive multiple sclerosis Technology development of the guidance progresses. Appraisal Hypertension in pregnancy: Clinical Guideline The draft guideline has been out for consultation. More information will be provided as diagnosis and management the development of the guideline progresses.

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(Update) Ertugliflozin in a triple therapy Single FAD produced. Draft guidance states that ertugliflozin with metformin and a dipeptidyl regimen for treating type 2 diabetes Technology peptidase-4 (DPP-4) inhibitor is recommended as an option for treating type 2 diabetes Appraisal in adults when diet and exercise alone do not provide adequate glycaemic control, only if: • the disease is uncontrolled with metformin and a DPP-4 inhibitor, and • a sulfonylurea or pioglitazone is not appropriate. Dementia (update) Quality Standard No additional resource impact is expected on top of the impact associated with implementing the underpinning guideline.

July 2019 Title Type of Funding considerations and other comments guidance Abdominal aortic aneurysm: Clinical Guideline The draft guideline has been out for consultation. Resource impact work is ongoing, diagnosis and management however it is anticipated that the guideline will result in a cost saving. Erenumab for preventing migraine Single Guidance development is ongoing. More information will be provided as the Technology development of the guidance progresses. Appraisal Cemiplimab for treating cutaneous Single Guidance is still in early development stage. More information will be provided as the squamous cell carcinoma Technology development of the guidance progresses. Appraisal Pembrolizumab with carboplatin Single Guidance is still in early development stage. More information will be provided as the and paclitaxel for untreated Technology development of the guidance progresses. squamous non-small-cell lung Appraisal cancer Lyme disease Quality Standard No additional resource impact is expected on top of the impact associated with implementing the underpinning guideline.

Human alpha1-proteinase inhibitor Highly Guidance development is ongoing. More information will be provided as the for treating emphysema Specialised development of the guidance progresses Technology Evaluation

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Hearing loss Quality Standard No additional resource impact is expected on top of the impact associated with implementing the underpinning guideline.

Therapeutic monitoring of TNF- Diagnostic Draft guidance states that enzyme-linked immunosorbent assay (ELISA) tests for alpha inhibitors in rheumatoid Technology therapeutic monitoring of tumour necrosis factor (TNF)-alpha inhibitors (drug serum arthritis levels and antidrug antibodies) show promise but there is currently insufficient evidence to recommend their routine adoption in rheumatoid arthritis. The ELISA tests covered by this guidance are Promonitor, IDKmonitor, LISA-TRACKER, RIDASCREEN, MabTrack, and tests used by Sanquin Diagnostic Services. Service model for people with Quality Standard No additional resource impact is expected on top of the impact associated with learning disabilities and challenging implementing the underpinning guideline. behaviour Care and support of people growing Quality Standard No additional resource impact is expected on top of the impact associated with older with learning disabilities implementing the underpinning guideline. Chronic obstructive pulmonary Clinical Guideline Draft guideline has been out for consultation. More information will be provided as the disease in over 16s: diagnosis and development of the guideline progresses. management (2019 update) Olaparib for maintenance treatment Single Guidance is still in early development stage. More information will be provided as the of ovarian, fallopian tube or Technology development of the guidance progresses. peritoneal cancer that has a BRCA Appraisal germline mutation after response to first-line platinum-based chemotherapy Letermovir prophylaxis for Single Guidance development is ongoing. More information will be provided as the cytomegalovirus disease after Technology development of the guidance progresses. allogeneic stem cell transplant Appraisal Ribociclib in combination with Single Guidance is still in early development stage. More information will be provided as the fulvestrant for treating advanced Technology development of the guidance progresses. hormone-receptor positive, HER2- Appraisal negative breast cancer

August 2019 Title Type of Funding considerations and other comments guidance

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Osimertinib for untreated EGFR- Single ACD produced. Draft guidance states that osimertinib is not recommended, within its positive non-small-cell lung cancer Technology marketing authorisation, for untreated locally advanced or metastatic epidermal growth Appraisal factor receptor mutation-positive non-small-cell lung cancer in adults. Alcohol: school-based interventions Public Health The draft guideline has been out for consultation. More information will be provided as Guideline the development of the guideline progresses. Coexisting severe mental illness Quality Standard No additional resource impact is expected on top of the impact associated with and substance misuse implementing the underpinning guideline. Dapagliflozin, in combination with Single ACD produced. Draft guidance states that the committee was minded not to insulin, for treating type 1 diabetes Technology recommend dapagliflozin with insulin as an option for treating type 1 diabetes in adults Appraisal with a BMI of at least 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy. Lanadelumab for preventing Single Guidance is still in early development stage. More information will be provided as the recurrent attacks of hereditary Technology development of the guidance progresses. angioedema Appraisal Risankizumab for treating moderate Fast Track Guidance is still in early development stage. This appraisal is being considered as a to severe plaque psoriasis Appraisal Fast Track Appraisal (FTA). If a positive recommendation is made through the FTA process, NHS England/commissioners have committed to providing funding for the technologies within 30 days of final guidance publication. For further information please refer to the process guide addendum. Sodium zirconium cyclosilicate for Single ACD produced. Sodium zirconium cyclosilicate is recommended as an option for treating hyperkalaemia Technology treating hyperkalaemia in adults only if: Appraisal • it needs treating in an emergency care setting • the drug is stopped after 28 days of maintenance treatment, or earlier if the hyperkalaemia resolves. Hypertension in adults: diagnosis Clinical Guideline The draft guideline has been out for consultation. The potential resource impact is still and management being assessed. However, the recommendation to offer antihypertensive drug treatment in addition to lifestyle advice to adults aged under 80 with persistent stage 1 hypertension who have 1 or more of the following: • target organ damage • established cardiovascular disease (CVD) • renal disease • diabetes • an estimated 10-year risk of cardiovascular disease of 10% or more, may result in more people being eligible for drug treatments because of the lowering of the 10-year risk of CVD from 20% or more to 10% or more. 14 | p a g e

Treatments would however, help avoid CVD events associated with no treatments. Dacomitinib for untreated EGFR- Single ACD produced. Draft guidance states that dacomitinib is not recommended, within its positive non-small-cell lung cancer Technology marketing authorisation, for untreated locally advanced or metastatic epidermal growth Appraisal factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults. Rivaroxaban for preventing major Single Guidance is still in early development stage. More information will be provided as the cardiovascular events in people with Technology development of the guidance progresses. coronary or peripheral artery Appraisal disease

September 2019 Title Type of Funding considerations and other comments guidance Maternal health Quality Standard No additional resource impact is expected on top of the impact associated with implementing the underpinning guideline. Twin and triplet pregnancy (update) Clinical Guideline The draft guideline is out for consultation. More information will be provided as the development of the guideline progresses. Pentosan polysulfate sodium for Single Guidance is still in early development stage. More information will be provided as the treating interstitial cystitis Technology development of the guidance progresses. Appraisal Suicide prevention Quality Standard No additional resource impact is expected on top of the impact associated with implementing the underpinning guideline. Implantable cardiac monitors Diagnostic Guidance is still in early development stage. More information will be provided as the (BioMonitor 2-AF, Confirm Rx Technology development of the guidance progresses. insertable cardiac monitor and Reveal LINQ Insertable Cardiac Monitoring System) to detect atrial fibrillation after cryptogenic stroke Pneumonia (community-acquired): Antimicrobial Guideline is still in early development stage. More information will be provided as the antimicrobial prescribing prescribing development of the guideline progresses. guideline Pneumonia (hospital-acquired): Antimicrobial Guideline is still in early development stage. More information will be provided as the antimicrobial prescribing prescribing development of the guideline progresses. guideline

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Non-bisphosphonates for treating Multiple Guidance is still in early development stage. More information will be provided as the osteoporosis Technology development of the guidance progresses. Appraisal Termination of pregnancy Clinical Guideline The draft guideline is out for consultation. More information will be provided as the development of the guideline progresses. Cellulitis and erysipelas: Antimicrobial Guideline is still in early development stage. More information will be provided as the antimicrobial prescribing prescribing development of the guideline progresses. guideline

October 2019 Title Type of Funding considerations and other comments guidance Neratinib for treating early HER2- Single Guidance is still in early development stage. More information will be provided as the positive breast cancer after adjuvant Technology development of the guidance progresses. trastuzumab Appraisal Rucaparib for maintenance Single Guidance is still in early development stage. More information will be provided as the treatment of recurrent platinum- Technology development of the guidance progresses. sensitive epithelial ovarian, fallopian Appraisal tube and peritoneal cancer that has responded to platinum-based chemotherapy Clostridium botulinum neurotoxin Single Guidance is still in early development stage. More information will be provided as the type A for treating hypersalivation Technology development of the guidance progresses. associated with neurological Appraisal conditions Diabetic foot infection: antimicrobial Antimicrobial The draft guideline is out for consultation. More information will be provided as the prescribing prescribing development of the guideline progresses. guideline End of life care – service delivery Clinical Guideline The draft guideline is out for consultation. More information will be provided as the development of the guideline progresses. Diverticular Disease Clinical Guideline Guideline is still in early development stage. More information will be provided as the development of the guideline progresses. Cannabis-based products for Clinical Guideline Guideline is still in early development stage. More information will be provided as the medicinal use development of the guideline progresses.

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NBTXR-3 for treating soft tissue Single NICE has been asked to consider an appraisal of NBTXR-3 for treating soft tissue sarcoma Technology sarcoma ID1050. At this stage there is no information advising whether this technology Appraisal should be formally referred to NICE for appraisal. Leg ulcer infection: antimicrobial Antimicrobial Guideline is still in early development stage. More information will be provided as the prescribing prescribing development of the guideline progresses. guideline Budesonide for treating active Single Guidance is still in early development stage. More information will be provided as the eosinophilic oesophagitis Technology development of the guidance progresses. Appraisal

What NICE guidance is in consultation?

To review and comment in a consultation, please register as a stakeholder with NICE.

Title Consultation Type Consultation end date Osimertinib for untreated EGFR-positive non-small-cell lung Appraisal consultation Technology appraisal 09 May 2019 cancer guidance

Cellulitis and erysipelas: antimicrobial prescribing Draft guidance Antimicrobial 10 May 2019 consultation prescribing guideline Diabetic foot infection: antimicrobial prescribing Draft guidance Antimicrobial 16 May 2019 consultation prescribing guideline Dapagliflozin, in combination with insulin, for treating type 1 Appraisal consultation Technology appraisal 17 May 2019 diabetes guidance Sodium zirconium cyclosilicate for treating hyperkalaemia Appraisal consultation: 2 Technology appraisal 20 May 2019 guidance Suicide prevention Quality standard Quality standard 23 May 2019 consultation Low energy contact x-ray brachytherapy (the Papillon technique) Interventional procedure Interventional 23 May 2019 for locally advanced rectal cancer consultation procedures guidance Endovascular insertion of an intrasaccular wire-mesh blood-flow Interventional procedure Interventional 23 May 2019 disruption device for intracranial aneurysm consultation procedures guidance Bioprosthetic plug insertion for anal fistula Interventional procedure Interventional 23 May 2019

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consultation procedures guidance Social and emotional wellbeing in primary and secondary Draft scope consultation NICE guideline 28 May 2019 education

Reference – a guide to NICE Products

NICE guidance (NG) - Clinical Guidelines CGs provide the NHS with advice on the management of specific health conditions, and are developed in association with National Collaborating Centres (NCCs) using the expertise of the royal medical colleges, professional bodies and patient/carer organisations. They are systematically-developed statements to assist professional and patient decisions about appropriate care in specific clinical circumstances. Status NICE guidance (NG) relates to a whole pathway of care and consequently makes a number of recommendations spanning all stages of care from diagnosis to treatment. In view of their complexity, NICE guidance are not subject to statutory funding directions, and their implementation is at the discretion of local commissioners of NHS care. NICE guidance (NG) - Public Health Guidelines Public Health guidance covers disease prevention, health improvement and health protection and seeks to influence policy and practice in the NHS and local government on issues of great importance to health and health service utilisation. NICE guidance (NG) - Social Care Guidelines SCG make evidence-based recommendations on "what works" in terms of both the effectiveness and cost-effectiveness of social care interventions and services. NICE guidance (NG) - Medicines Practice Guidelines MPG provide recommendations for good practice for those individuals and organisations involved in governing, commissioning, prescribing and decision-making about medicines. The outputs have a wide range of audiences across both health and social care environments. NICE guidance (NG) - Safe Staffing Guidelines SSG is a new work programme for NICE to develop evidence-based guidelines on safe staffing levels in NHS care settings. From June 2015 NHS England will take forward staffing work as part of a wider programme of service improvement. Interventional Procedures Guidance (IPG) IPGs recommend whether interventional procedures are effective and safe enough for use in the NHS. IPGs do not consider cost effectiveness. Status IPGs are not subject to a mandatory requirement regarding funding but health care organisations should protect patients by following IPGs as outlined in the Department of Health's 'Standards for better health' (2004). Diagnostics guidance (DG)

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DGs focus on the evaluation of innovative medical diagnostic technologies in order to ensure that the NHS is able to adopt clinically and cost effective technologies rapidly and consistently. Medical Technologies Guidance and Diagnostic Technologies Guidance (MDG and DTG) MTGs and DTGs help facilitate rapid and consistent access to, and use of, potentially cost saving technologies in the NHS. Status Implementation is at the discretion of local commissioners of NHS care. Quality Standards (QS) QSs are concise statements, with accompanying metrics, designed to drive and measure priority quality improvements within a particular area of care. Status The NHS is expected to use QS to plan and deliver services as part of a general duty to secure continuous improvement in quality. Clinical Commissioning Groups might wish to use selected indicators to monitor provider performance. Technology Appraisal Guidance (TAG) TAGs assess the clinical and cost effectiveness of health technologies, such as new pharmaceutical and biopharmaceutical products. Status TAGs aim to ensure that all NHS patients have equitable access to the most clinically and cost-effective treatments that are available, and NHS commissioners are mandated to make funding available for the implementation of TAG recommendations within 3 months of the issue of guidance. If the product has received approval for the Early Access to Medicines Scheme (EAMS), CCGs and Trusts will be expected to implement the NICE TA within a 30 day period. The funding requirement is set out in the NHS Constitution, and compliance is monitored through the national provider contracts. Highly Specialised Technology Guidance (HST) HST evaluations are recommendations on the use of new and existing highly specialised medicines and treatments within the NHS in England. Status HSTs aim to notify the Department of Health and Social Care of key, new and emerging healthcare technologies that might need to be referred to NICE against the following timeframes: new drugs, in development, at 20 months to marketing authorisation and new indications, at 15 months to marketing authorisation.

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