NICE UPDATE FOR COMMISSIONERS June 2018

This NICE Update for Commissioners includes:

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

 Guidance and quality standards published by NICE in June 2018 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 (July 2018) NICE Update for Commissioners will be issued at the beginning of August 2018.

For further information about NICE guidance and its implementation contact:  Tiina Korhonen, Clinical Effectiveness Lead  Kathryn Markey, Clinical Effectiveness Manager  Katherine 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 June 2018. Those likely to have significant impact for CCG commissioners are noted below and further details are discussed in the ‘What’s new for Clinical Commissioning Groups’ section (link to relevant section provided within guidance reference).

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

Technology Beta interferons and glatiramer NHS England Secondary care – Appraisal – TA527 acetate for treating multiple acute and tertiary sclerosis care Technology Guselkumab for treating CCGs Primary care, No significant resource impact is anticipated Appraisal – TA521 moderate to severe plaque secondary care - Guselkumab has been recommended psoriasis acute and Tertiary through the fast track appraisal process. care CCGs must provide funding to implement this guidance 30 days after publication. Technology Pembrolizumab for untreated NHS England Secondary care - Appraisal – TA522 locally advanced or metastatic acute urothelial cancer when is unsuitable Technology Midostaurin for untreated acute NHS England Secondary care - Appraisal – TA523 myeloid leukaemia acute

Technology Brentuximab vedotin for NHS England Secondary care - Appraisal – TA524 treating CD30-positive Hodgkin acute lymphoma Technology Atezolizumab for treating locally NHS England Secondary care - Appraisal – TA525 advanced or metastatic acute and Tertiary urothelial carcinoma after care platinum-containing

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

Technology for treating NHS England Secondary care - Appraisal – TA526 acute promyelocytic leukaemia acute

NICE guideline - Dementia: assessment, CCGs and LAs Various No significant resource impact is anticipated. NG97 management and support for people living with dementia and their carers NICE guideline - Hearing loss in adults: CCGs Community health The resource impact of implementing the NG98 assessment and management care and secondary guideline is expected to be at the lower end care - acute of the 'high cost' band, but will depend on the speed of implementation and uptake of the recommendations. Quality Standard Spondyloarthritis CCGs Secondary care No significant resource impact is anticipated. – QS170 acute

Updates

The following guidelines have been updated:

 Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease (TA217). https://www.nice.org.uk/guidance/ta217

Recommendations have been amended to clarify that they refer to monotherapy i.e. the three acetylcholinesterase (AChE) inhibitors donepezil, galantamine and rivastigmine as monotherapies are recommended as options for managing mild to moderate Alzheimer's disease under all of the conditions specified. Memantine monotherapy is recommended as an option for managing Alzheimer's disease for people with: moderate Alzheimer's disease who are intolerant of or have a contraindication to AChE inhibitors or severe Alzheimer's disease.

Recommendation 1.3 has been updated and replaced by recommendation 1.5.5 in the NICE guideline on dementia: Treatment should be under the following conditions:

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For people who are not taking an AChE inhibitor or memantine, prescribers should only start treatment with these on the advice of a clinician who has the necessary knowledge and skills. This could include:  secondary care medical specialists such as psychiatrists, geriatricians and neurologists  other healthcare professionals (such as GPs, nurse consultants and advanced nurse practitioners), if they have specialist expertise in diagnosing and treating Alzheimer's disease.

Once a decision has been made to start an AChE inhibitor or memantine, the first prescription may be made in primary care.

For people with an established diagnosis of Alzheimer's disease who are already taking an AChE inhibitor, primary care prescribers may start treatment with memantine without taking advice from a specialist clinician.

Ensure that local arrangements for prescribing, supply and treatment review follow the NICE guideline on medicines optimisation.

Do not stop AChE inhibitors in people with Alzheimer's disease because of disease severity alone.

Impact: NICE does not expect this guideline update to have a significant impact on resources.

 Cancer of the upper aerodigestive tract: assessment and management in people aged 16 and over (NG 36) https://www.nice.org.uk/guidance/ng36

Evidence on response assessment after chemoradiotherapy has been reviewed. New recommendations and recommendations for research have been added. Recommendations added:

Response assessment after chemoradiotherapy: o Offer FDG PET-CT to guide management for people treated with radical chemoradiotherapy[1] who have: 2 or more positive nodes in the neck, all of which are less than 6 cm across o Consider FDG PET-CT to guide management for people treated with radical chemoradiotherapy who have: a hypopharyngeal or laryngeal primary site with 1 or more positive nodes in the neck. o For people having an FDG PET-CT scan after chemoradiotherapy, perform the scan 3 to 6 months after chemoradiotherapy has finished. o Do not offer neck dissection to people with no abnormal FDG uptake or residual soft tissue mass on an FDG PET-CT scan.

Impact: NICE does not expect this guideline update to have a significant impact on resources.

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Interventional Procedure Guidelines:

Type of Title Recommendation Guidance and reference Interventional Intranasal phototherapy for Current evidence on the efficacy and safety of intranasal phototherapy for allergic rhinitis is procedure allergic rhinitis limited in quantity and quality. Therefore, this procedure should only be used in the context of guidance – research. IPG616 Interventional Unilateral MRI-guided focused The evidence on the safety of unilateral MRI-guided focused ultrasound thalamotomy for procedure ultrasound thalamotomy for treatment-resistant essential tremor raises no major safety concerns. However, current guidance – treatment-resistant essential evidence on its efficacy is limited in quantity. Therefore, this procedure should not be used IPG617 tremor unless there are special arrangements for clinical governance, consent, and audit or research. Interventional Laparoscopic ventral mesh Current evidence on the safety of laparoscopic ventral mesh rectopexy for internal rectal procedure rectopexy for internal rectal prolapse shows there are well‑recognised, serious but infrequent complications. The guidance – prolapse evidence on efficacy and safety is limited in quality. Therefore, this procedure should only be IPG618 used with special arrangements for clinical governance, consent and audit or research.

What’s new for Clinical Commissioning Groups?

Technology Appraisals

 Guselkumab for treating moderate to severe plaque psoriasis (TA521) https://www.nice.org.uk/guidance/ta521

Guselkumab 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 therapies, including ciclosporin, and PUVA (psoralen and long-wave ultraviolet A radiation), or these options are contraindicated or not tolerated and  the company provides the drug according to the commercial arrangement.

Stop guselkumab treatment at 16 weeks if the psoriasis has not responded adequately. An adequate response is defined as: 5 | p a g e

 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.

Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ) monoclonal antibody (mAb) to the interleukin (IL)-23 protein. The recommended dosage of guselkumab is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a 100 mg maintenance dose every 8 weeks. The list price of guselkumab is £2,250 per prefilled syringe.

Impact: This technology is commissioned by CCGs. Guselkumab has been recommended through the fast track appraisal process. CCGs must therefore provide funding to implement this guidance 30 days after publication. NICE does not anticipate any significant resource impact. This is because the technology is an option alongside current standard treatment options and is available at a similar price. The list price of guselkumab has a discount that is commercial in confidence.

Clinical Guidelines

 Dementia: assessment, management and support for people living with dementia and their carers NG97 https://www.nice.org.uk/guidance/ng97

This guideline is an update of the original NICE clinical guideline (Dementia: supporting people with dementia and their carers in health and social care) which was first published in November 2006 and was last updated in September 2016. It covers diagnosing and managing dementia (including Alzheimer’s disease). It aims to improve care by making recommendations on training staff and helping carers to support people living with dementia.

This guideline includes recommendations on:  Involving people living with dementia in decisions about their care  Diagnosis  Care coordination  Interventions to promote cognition, independence and wellbeing  Pharmacological interventions for dementia  Medicines that may cause cognitive impairment  Managing non-cognitive symptoms  Assessing and managing other long-term conditions in people living with dementia  Risks during hospital admission  Palliative care

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 Supporting carers  Moving to different care settings  Staff training and education

Impact: Dementia services are commissioned by CCGs and local authorities. Organisations are encouraged to evaluate their own practices against the recommendations in the NICE guideline and assess costs and savings locally. NICE provides a resource impact report and resource impact template. The recommendations have been updated, but do not include any changes that have a substantial resource impact. According to uptake of the original guidance reported on the NICE website however some recommendations may not have been been fully implemented. These are:  Provide people living with dementia with a single named health or social care professional who is responsible for coordinating their care  Offer group cognitive stimulation therapy to people living with mild to moderate dementia  Offer carers of people living with dementia psychoeducation and skills training

A key cost driver is the staff cost of appointing care coordinators. This may be achieved either using existing staff differently or appointing additional staff. The cost of each additional named health or social care professional could be around £38,200. The potential benefits of may include:  reduced hospital admissions  reduced contact with healthcare professionals including GPs, psychiatrists, specialist mental health services and social workers  delayed admission to care homes  help to access services and support available  improved wellbeing of carer’s for people with dementia

A key cost driver is staff time to deliver cognitive stimulation therapy. This is estimated to be £50 - £80 per session (45 minutes). Cognitive stimulation therapy has been shown to improve cognition, which would be expected to then improve quality of life. This may delay admission into residential care.

 Hearing loss in adults: assessment and management (NG98) https://www.nice.org.uk/guidance/ng98

This guideline covers some aspects of assessing and managing hearing loss in primary, community and secondary care. It aims to improve the quality of life for adults with hearing loss by advising healthcare staff on assessing hearing difficulties, managing earwax and referring people for audiological or specialist assessment and management

This guideline includes recommendations on:  assessment and referral  removing earwax 7 | p a g e

 investigation using MRI  treating idiopathic sudden sensorineural hearing loss  assessment and management in audiology services  hearing aids and assistive listening devices, including follow-up in audiology services  information and support.

Impact: Services for people with hearing loss are commissioned by CCGs. NICE provides a resource impact report and resource impact template to support organisations in assessing costs locally. The recommendation that is likely to require the most additional resources is: refer adults who present with hearing difficulties for a hearing assessment. Additional costs will arise from:  Hearing assessments, for people not currently referred to audiology.  Additional hearing aids, including fitting and follow up The cost of implementing the guideline per 100,000 population, by 2023, is estimated to be £37,702. Research suggests that use of hearing aids reduces the risks of developing depression, anxiety and other mental health problems. Hearing aids can improve communication, improve cognitive performance people. They may reduce the number of audiology appointments that patients need.

Quality Standards

 Spondyloarthritis (QS170) https://www.nice.org.uk/guidance/qs170

This quality standard covers diagnosing and managing spondyloarthritis in adults aged 16 and over. It describes high-quality care in priority areas for improvement.

Quality statements Statement 1: Adults with suspected axial or peripheral spondyloarthritis are referred to a rheumatologist. Statement 2: Adults with suspected axial spondyloarthritis and an X‑ray that does not show sacroiliitis have an MRI using an inflammatory back pain protocol. Statement 3: Adults with axial spondyloarthritis are referred to a specialist physiotherapist for a structured exercise programme. Statement 4: Adults with spondyloarthritis are given information about their condition, which healthcare professionals will be involved with their care, and how and when to get in touch with them.

This quality standard is expected to contribute to improvements in the following outcomes for people with spondyloarthritis :  Functional capacity  Mobility  Work productivity  Health-related quality of life 8 | p a g e

 Pain  Fatigue  Mortality rates from cardiovascular disease  Joint replacement surgery  Disease activity.

Impact: Services for patients with spondyloarthritis are commissioned by CCGs. Organisations are encouraged to evaluate their own practices and assess costs and savings locally. NICE provides a resource impact report for the associated guideline: Spondyloarthritis in over 16s: diagnosis and management (NG65). The guideline and the quality standard may lead to a much earlier diagnosis of axial spondyloarthritis. Implementation may improve people’s quality of life, reduce disease progression and disability, reduce inappropriate investigations and treatments and reduce unnecessary appointments with GPs and non-specialist physios.

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

The following were due to be published in June. NICE has not yet confirmed a publication date.

Title Type of Funding considerations and other comments guidance Highly Final evaluation document published. Draft guidance states that afamelanotide is not Afamelanotide for treating Specialised recommended, within its marketing authorisation, for preventing phototoxicity in adults erythropoietic protoporphyria Technology with erythropoietic protoporphyria (EPP). Evaluation Medicines management for people Quality Standard No additional resource impact is expected on top of the impact associated with receiving social care in the implementing the underpinning guideline. community

July 2018 Title Type of Funding considerations and other comments guidance Diagnostic Guidance states that there is currently insufficient evidence to recommend the routine Biomarker tests to help diagnose Technology adoption of the Rapid fFN (fetal fibronectin) 10Q Cassette Kit (at thresholds other than preterm labour in women with intact 50 ng/ml), Actim Partus and PartoSure biomarker tests to help diagnose preterm membranes labour in women with intact membranes when transvaginal ultrasound measurement of cervical length is not available or not acceptable.

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Single Final Appraisal Document (FAD) produced. Draft guidance states that Crizotinib is Crizotinib for treating ROS1-positive Technology recommended for use within the Cancer Drugs Fund as an option for treating ROS1- advanced non-small-cell lung Appraisal positive advanced non-small-cell lung cancer in adults, only if the conditions in the cancer managed access agreement are followed. Single FAD produced. is recommended for use within the Cancer Drugs Fund as an Technology option for treating relapsed, platinum-sensitive high-grade serous epithelial ovarian, Appraisal fallopian tube or primary peritoneal cancer that has responded to the most recent course of platinum-based chemotherapy in adults, only if: Niraparib for ovarian cancer • they have a germline BRCA mutation and have had 2 courses of platinum-based chemotherapy or • they do not have a germline BRCA mutation and have had 2 or more courses of platinum-based chemotherapy and • the conditions in the managed access agreement for niraparib are followed. Nivolumab for treating metastatic or Single FAD published. In the FAD, nivolumab is not recommended, within its marketing unresectable urothelial cancer after Technology authorisation, as an option for treating locally advanced unresectable or metastatic platinum-based chemotherapy Appraisal urothelial carcinoma in adults who have had platinum-containing therapy. Brain tumours (primary) and brain Clinical Guideline Draft guidance is available. Offering 5-ala guided resection for malignant gliomas may metastases in adults cause an increase in NHS resource use. Clinical Guideline Draft guidance is available. NICE does not expect this guideline update to have a Rheumatoid arthritis (update) significant impact on resources. Quality Standard No additional resource impact is expected on top of the impact associated with Endometriosis implementing the underpinning guideline. Early and locally advanced breast Clinical Guideline The cost of implementing this guidance is not expected to be significant. cancer (update) End of life care for adults in the last Clinical Guideline Guideline development ongoing. More information will be provided as the development year of life: service delivery of the guideline progresses. Single FAD produced. Draft guidance states that pembrolizumab is recommended as an Technology option for untreated PD-L1-positive metastatic non-small-cell lung cancer in adults Appraisal whose tumours express PD-L1 (with at least a 50% tumour proportion score) and have Pembrolizumab for untreated PD- no epidermal growth factor receptor- or anaplastic lymphoma kinase-positive L1 positive metastatic non-small- mutations, only if: cell lung cancer (CDF Review of • pembrolizumab is stopped at 2 years of uninterrupted treatment, or earlier in the TA447) event of disease progression and • the company provides pembrolizumab according to the commercial access agreement. 10 | p a g e

Single FAD produced. Draft guidance states that cenegermin is not recommended within its Cenegermin for treating Technology marketing authorisation, for treating moderate or severe neurotrophic keratitis in neurotrophic keratitis Appraisal adults. Single FAD produced. Based on the FAD we do not expect this guidance to have a significant Technology impact on resources; that is, it will be less than £5 million per year in England (or Ocrelizumab for treating relapsing Appraisal £9,100 per 100,000 population). multiple sclerosis This is because the technology is an option alongside current standard treatment options and the population is small. The list price of ocrelizumab has a discount that is commercial in confidence.

August 2018 Title Type of Funding considerations and other comments guidance Dupilumab for treating moderate to Single FAD produced. It is estimated that around 7,500 adults with moderate to severe atopic severe atopic dermatitis after Technology dermatitis are eligible for treatment with dupilumab and around 3,000 people will have topical treatments Appraisal dupilumab from year 2022/23 onwards, once uptake has reached 40%. Community pharmacy to promote Clinical Guideline Consultation on the draft guideline is complete and the guideline is being reviewed in health and wellbeing the light of comments received. Resource impact work is still in development, but initial indications are that costs could be incurred through helping people to manage their weight by offering behavioural support programmes in line with NICE’s guidelines on: • obesity: identification, assessment and management and • weight management: lifestyle services for overweight or obese adults preventing excess weight gain and obesity prevention. Decision making and mental Clinical Guideline The majority of recommendations for this guideline are around reinforcing the Mental capacity Capacity Act and are therefore unlikely to result in a significant additional resource impact. There may be a resource impact from activities required to raise awareness to health professionals but it is anticipated that implementing the recommendations may be mostly achieved from using existing resources differently. Lenvatinib and sorafenib for treating Multiple Second Appraisal Consultation Document (ACD) produced. Draft guidance states that differentiated thyroid cancer after Technology lenvatinib and sorafenib are recommended as options for treating progressive, locally radioactive iodine Appraisal advanced or metastatic differentiated thyroid cancer (papillary, follicular or Hürthle cell) in adults whose disease does not respond to radioactive iodine, only if: • they have not had a tyrosine kinase inhibitor before and • the companies provide: • lenvatinib with the discount agreed in the patient access scheme and 11 | p a g e

• sorafenib with the discount agreed in the commercial access agreement. Alectinib for untreated anaplastic Single FAD produced. Draft guidance states that alectinib is recommended, within its lymphoma kinase-positive Technology marketing authorisation, as an option for untreated anaplastic lymphoma kinase- advanced non-small-cell lung Appraisal positive advanced non-small-cell lung cancer in adults. cancer Intermediate care including Quality Standard No additional resource impact is expected on top of the impact associated with reablement implementing the underpinning guideline. Pembrolizumab for classical Single ACD produced. Draft guidance states that the committee is minded not to recommend Hodgkin lymphoma Technology pembrolizumab as an option for treating relapsed or refractory classical Hodgkin Appraisal lymphoma in adults who have had autologous stem cell transplant and brentuximab vedotin.

September 2018 Title Type of Funding considerations and other comments guidance Draft guideline is available. Significant costs may be incurred locally for the updated recommendations relating to cardiac rehabilitation provision and heart failure MDTs. Chronic heart failure in adults: Clinical Guideline Investment in these areas is expected to lead to savings further down the patient diagnosis and management pathway. Costs and savings will depend on the extent to which the original guideline has been implemented and should be assessed locally. Draft guideline is available. There may be a resource impact as a result of several Pancreatitis: diagnosis and recommendations (potentially additional dietetic staff, reduced parenteral nutrition, Clinical Guideline management improved diabetes identification). Costs and savings will depend on current local circumstances and should be assessed locally. Emergency and acute medical care No additional resource impact is expected on top of the impact associated with Quality Standard in over 16s implementing the underpinning guideline. Revised draft guidance states that EndoPredict, Oncotype DX Breast Recurrence Tumour profiling tests to guide Score and Prosigna are recommended as options for guiding adjuvant chemotherapy adjuvant chemotherapy decisions in Diagnostic decisions for people with oestrogen receptor (ER)-positive, human epidermal growth people with breast cancer (update of Technology factor receptor 2 (HER2)-negative and lymph node (LN)-negative early breast cancer,

DG10) only if certain conditions are met. There may be additional costs from the introduction of additional tests.

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Initial resource impact work suggests the guideline is unlikely to have a significant Preventing suicide in community Public Health resource impact. The guideline recommendations reinforces existing national

and custodial settings Guidance polices/strategies on suicide prevention. Therefore any potential costs are not considered as a direct result of the guideline. Draft guidance states that the case for adopting Senza spinal cord stimulation (SCS) Senza for delivering high frequency as a treatment option for chronic back and leg pain after failed back surgery is Medical spinal cord stimulation to treat supported by the evidence. Senza SCS is as effective as low-frequency SCS in Technology chronic neuropathic pain reducing pain and functional disability, but avoids the experience of tingling sensations (paraesthesia). ACD produced. In draft guidance, gemtuzumab ozogamicin, with and , is recommended as an option for treating newly diagnosed de novo CD33- Single Gemtuzumab ozogamicin for positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia, in Technology untreated acute myeloid leukaemia people 15 years and over, only if the disease has: Appraisal • favourable cytogenetics or • unknown cytogenetics because cytogenetic analysis was unsuccessful. ACD produced. In draft guidance, benralizumab is not recommended, within its Single Benralizumab for treating severe marketing authorisation, for treating severe eosinophilic asthma that is inadequately Technology asthma controlled in adults despite maintenance therapy with high-dose inhaled Appraisal corticosteroids and long-acting beta-agonists. No additional resource impact is expected on top of the impact associated with

Asthma (update) Quality Standard implementing the underpinning guideline. Highly Specialised Guidance still in early development stage. More information will be provided as the

Metreleptin for treating lipodystrophy Technology development of the guidance progresses. Evaluation Highly Evaluation consultation document produced. In draft guidance, velmanase alfa is not Velmanase alfa for treating alpha- Specialised recommended, within its marketing authorisation, for treating the non-neurological mannosidosis Technology signs and symptoms of mild-to-moderate alpha-mannosidosis. Evaluation

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October 2018 Title Type of Funding considerations and other comments guidance Draft guidance states that the case for adopting the iFuse implant system to treat iFuse for treating chronic sacroiliac Medical chronic sacroiliac joint pain is supported by the evidence. Cost modelling indicates joint pain Technology that after 9 years, using iFuse instead of non-surgical management will save the NHS around £495 per patient from fewer steroid injections and less pain relief medication. Abiraterone for treating newly Single ACD published. The draft guidance states that Abiraterone plus androgen deprivation diagnosed metastatic hormone- Technology therapy is not recommended, within its marketing authorisation, for untreated high-risk naive prostate cancer Appraisal hormone-sensitive metastatic prostate cancer in adults. ACD published. The draft guidance states that cabozantinib is not recommended, Cabozantinib for untreated locally Single within its marketing authorisation, for adults with untreated advanced renal cell advanced or metastatic renal cell Technology carcinoma that is intermediate- or poor-risk as defined in the International Metastatic carcinoma Appraisal Renal Cell Carcinoma Database Consortium criteria. Nivolumab with ipilimumab for Single Guidance still in early development stage. More information will be provided as the untreated metastatic renal cell Technology development of the guidance progresses. carcinoma Appraisal The draft guideline has been published for consultation on NICE's website. Initial Renal replacement therapy Clinical Guideline resource impact assessment work is still on-going. Draft guidance states that the case for adopting the IN.PACT drug-coated balloon for the treatment of intermittent claudication in people with peripheral arterial disease is supported by the evidence. Using IN.PACT improves medium-term vessel patency The IN.PACT drug-coated balloon and reduces the need for repeat interventions compared with percutaneous Medical for femoro-popliteal peripheral transluminal angioplasty alone. Technology arterial disease Cost modelling indicates that, assuming a target lesion revascularisation rate over 1 year of 30%, IN.PACT is cost saving after 5 years when the acquisition cost is no more than £519. FAD produced. Draft guidance states that ixekizumab alone, or with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults, only if: Single Ixekizumab for treating active • it is used as described in NICE’s technology appraisal guidance on etanercept, Technology psoriatic arthritis after DMARDs infliximab and adalimumab for the treatment of psoriatic arthritis or Appraisal • the person has had a tumour necrosis factor (TNF)-alpha inhibitor but their disease has stopped responding after the first 12 weeks.

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Ixekizumab is only recommended if the company provides it according to the commercial arrangement. Daratumumab with for Single Guidance still in early development stage. More information will be provided as the treating relapsed or refractory Technology development of the guidance progresses. multiple myeloma Appraisal Single Prostate cancer (localised) - Guidance still in early development stage. More information will be provided as the Technology padeliporfin development of the guidance progresses. Appraisal ACD produced. Draft guidance states that pertuzumab is not recommended, within its Pertuzumab for adjuvant treatment Single marketing authorisation, for the adjuvant treatment of early stage human epidermal of early HER2-positive breast Technology growth factor receptor 2 (HER2)-positive breast cancer in adults with high risk of cancer Appraisal disease recurrence. Single ACD produced. Draft guidance states that ocrelizumab is not recommended, within its Ocrelizumab for treating primary Technology marketing authorisation, for treating early primary progressive multiple sclerosis with progressive multiple sclerosis Appraisal imaging features characteristic of inflammatory activity in adults. Lenvatinib for advanced, Single Guidance still in early development stage. More information will be provided as the unresectable, untreated Technology development of the guidance progresses. hepatocellular carcinoma Appraisal

November 2018 Title Type of Funding considerations and other comments guidance Abdominal aortic aneurysm: Clinical Guideline The draft guideline is currently out for consultation. Resource impact work is on-going, diagnosis and management however it is anticipated that the guideline will result is a cost saving. Letermovir prophylaxis for Single Guidance still in early development stage. More information will be provided as the cytomegalovirus disease after Technology development of the guidance progresses. allogeneic stem cell transplant Appraisal Nusinersen for treating spinal Single Guidance still in early development stage. More information will be provided as the muscular atrophy Technology development of the guidance progresses. Appraisal

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December 2018 Title Type of Funding considerations and other comments guidance Mepilex Border Heel and Sacrum Medical Guidance still in early development stage. More information will be provided as the dressings for preventing pressure Technology development of the guidance progresses. ulcers Chronic obstructive pulmonary Clinical Guideline Guideline still in early development stage. More information will be provided as the disease in over 16s: diagnosis and development of the guideline progresses. management (update) Post-traumatic stress disorder Clinical Guideline The guideline is a partial update of NICE guideline CG26 (published March 2005) and (update) replaces it. The updates and changes are not expected to have a significant impact on NHS resources. However, expert opinion suggests that the previous guideline has not been fully implemented. To fully implement the new guideline may have a resource impact on NHS resources in some areas. Areas that have not fully implemented CG26 may need additional resources to: • promote access to care • provide psychological and psychosocial interventions for the prevention and treatment of PTSD.

Implementing NICE’s guideline may result in the following benefits and savings: • awareness of the condition and improved coordination of care • improved quality of life by reducing symptoms of PTSD. Renal and ureteric stones: Clinical Guideline Guideline still in early development stage. More information will be provided as the assessment and management development of the guideline progresses. Oesophago-gastric cancer Quality Standard No additional resource impact is expected on top of the impact associated with implementing the underpinning guideline. Tofacitinib for treating active Single Guidance still in early development stage. More information will be provided as the psoriatic arthritis after DMARDs Technology development of the guidance progresses. Appraisal Pembrolizumab for untreated Single The Department of Health has asked NICE to carry out a Single Technology Appraisal recurrent or metastatic squamous Technology of pembrolizumab for untreated recurrent or metastatic squamous cell carcinoma of cell carcinoma of the head and Appraisal the head and neck. Following on from advice received from the company, the timelines neck for this appraisal are currently to be confirmed. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties when the situation changes. 16 | p a g e

People's experience using adult Quality Standard No additional resource impact is expected on top of the impact associated with social care services implementing the underpinning guideline. Pancreatic cancer Quality Standard No additional resource impact is expected on top of the impact associated with implementing the underpinning guideline. Cx601 for treating perianal fistula in Single Guidance is still in early development stage. More information will be provided as the Crohn’s disease Technology development of the guidance progresses. Appraisal Chronic obstructive pulmonary Antimicrobial Guideline still in early development stage. More information will be provided as the disease (acute exacerbation): prescribing development of the guideline progresses. antimicrobial prescribing guideline Dabrafenib in combination with Single Guidance is still in early development stage. More information will be provided as the trametinib for adjuvant treatment of Technology development of the guidance progresses. resected BRAF V600 positive Appraisal malignant melanoma

What NICE guidance is in consultation?

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Title Consultation Type Consultation end date Atrial fibrillation: management Draft scope consultation NICE guideline 11 July 2018 Pregnancy and complex social factors: a model for service Surveillance consultation NICE guideline 12 July 2018 provision for pregnant women with complex social factors Ex-vivo machine perfusion for extracorporeal preservation of livers Interventional procedure Interventional 19 July 2018 for transplantation consultation procedures guidance Subcutaneous automated low-flow pump implantation for refractory Interventional procedure Interventional 19 July 2018 ascites caused by cirrhosis consultation procedures guidance Ocrelizumab for treating primary progressive multiple sclerosis Appraisal consultation Technology appraisal 19 July 2018 guidance Post-traumatic stress disorder (update) Draft guidance NICE guideline 23 July 2018 consultation Behaviour change: technology-based interventions Draft scope consultation NICE guideline 24 July 2018 Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue Draft scope consultation NICE guideline 26 July 2018 syndrome: diagnosis and management 17 | p a g e

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). 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)

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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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