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Medicine Industry's Gateway to NICE

The National Institute for Health and Care Excellence (NICE) TA programme provides UK healthcare guidance through Technology Appraisals and Highly Specialised Technologies assessments. A NICE recommendation is crucial for market access to the NHS in England and Wales. The Innovation Observatory is the first step in the process and we work closely with our pharmaceutical industry partners. 

We provide the 'gateway' to NICE by submitting potential topics that meet the NICE Topic Selection criteria for medicines as set out in the NICE Topic Selection Manual. We follow the development of new and repurposed medicines from at least two years before estimated UK licence to provide a timely notification to NICE. This early notification triggers the NICE TA process and allows NICE to provide new guidelines as close to the licence date as possible. 

The Innovation Observatory has a strict confidentiality agreement which means we only share confidential information with selected policymakers. 

Latest Technology Briefings

Urological Cancer

Pembrolizumab adjuvant for urothelial carcinoma and/or localised muscle invasive bladder cancer

Pembrolizumab is currently in clinical development for patients with localised muscle-invasive bladder cancer (MIBC) (where the cancer has grown into, but not through the muscle layer of the bladder) or and/or urothelial cancer (UC) which has spread from where it started to nearby tissue or lymph nodes (locally advanced), who are ineligible or refuse cisplatin […]

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Neurology

Eszopiclone for treating insomnia

Eszopiclone has been developed for the treatment of insomnia in adults. Insomnia is difficulty getting to sleep or staying asleep for long enough to feel refreshed the next morning. It is a common problem thought to regularly affect around one in every three people in the UK and is particularly common in elderly people. Insomnia […]

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Respiratory System

Mepolizumab add-on therapy for chronic obstructive pulmonary disease with eosinophil-associated exacerbations

Mepolizumab is in clinical development as an add-on therapy for chronic obstructive pulmonary disease (COPD) with eosinophilic disease. COPD is the name for a group of lung conditions that cause breathing difficulties. COPD is a long-term condition that is characterised by periods of acute exacerbations (worsening of respiratory symptoms) such as shortness of breath, cough […]

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Ear Nose and Throat (ENT)

Depemokimab for treating chronic rhinosinusitis withnasal polyps

Depemokimab is in clinical development for the treatment of chronic rhinosinusitis with nasalpolyps (CRSwNP) in adults. CRSwNP is a combination of two conditions: chronic rhinosinusitisand nasal polyps. Chronic rhinosinusitis is a condition in which the sinuses (air-filled spaces in thebones around the nose) are inflamed causing difficulty in breathing due to nasal blockage. Nasalpolyps are […]

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Respiratory System

Depemokimab as adjunctive therapy for severe asthma with an eosinophilic phenotype in patients aged 12 years and older

Severe asthma is the most serious type of asthma where symptoms are hard to control, even with high doses of medicine. Severe asthma with an eosinophilic phenotype makes up approximately 50% of all severe asthmatic cases. It is characterised by tissue and sputum eosinophilia, which is when there are unusually high levels of eosinophils (a […]

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Respiratory System

Budesonide-glycopyrronium-formoterol fumarate for the treatment of severe and inadequately controlled asthma

Budesonide-glycopyrronium-formoterol fumarate is in development for the treatment of severe asthma. Asthma is a common lung condition that causes occasional breathing difficulties. It affects people of all ages and often starts in childhood, although it can also develop for the first time in adults. Asthma is caused by swelling (inflammation) of the breathing tubes that […]

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Respiratory System

BI 1015550 for treating idiopathic pulmonary fibrosis or progressive pulmonary fibrosis

BI 1015550 is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in people aged 18 years and over. IPF is a long-term disease of the lungs characterised by the progressive deposition of collagen and fibrous tissue in the lungs. This causes the lung tissue to become inflamed […]

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Dermatology

Dupilumab for treating bullous pemphigoid

Dupilumab is currently in phase II/III development for adult patients with bullous pemphigoid (BP). BP is the most common form of blistering disorders of the skin. The first symptom of BP is usually redness and itching of the skin. BP primarily affects older people, with an average age around 80 years old. The burden of […]

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Cardiovascular System

Eplontersen for treating transthyretin amyloid cardiomyopathy

Eplontersen is in clinical development for the treatment of adults with transthyretin amyloid cardiomyopathy (ATTR-CM). ATTR-CM occurs due to a build-up of abnormal proteins in the heart. These protein deposits can cause thickening and stiffening of the heart muscle, leading to heart failure. There are two types of ATTR, namely the hereditary and wild-type forms. […]

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Dermatology

IgPro20 for treating dermatomyositis

IgPro20 is in clinical development for the treatment of dermatomyositis (DM). DM is an inflammatory disease of the muscles and the skin which causes muscle weakness and severe skin rash. Although skeletal muscle and skin problems are the most frequent signs of the disease, inflammation may also affect the muscles of the oesophagus (the food […]

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Genetic Disorders

Troriluzole for spinocerebellar ataxia

Troriluzole is in development for the treatment of adults with spinocerebellar ataxia (SCA). SCAs are a group of ataxias (lack of muscular control) which are inherited from parents. SCAs do not usually begin until adulthood and can affect people from the age of 25 up to 80, depending on the type of SCA. The symptoms […]

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Neurology

Inebilizumab for neuromyelitis optica spectrum disorders

Inebilizumab is in clinical development for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare autoimmune condition in which the immune system attacks and damages one’s own spinal cord and optic nerves (nerves in the eyes). Autoantibodies (proteins that attacks own cells) against a cell surface protein found in neural […]

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Haematological Cancer and Lymphomas

Brentuximab vedotin with cyclophosphamide, prednisone and doxorubicin for treating peripheral Tcell lymphoma

Brentuximab vedotin in combination with cyclophosphamide, prednisone and doxorubicin is in clinical development for the treatment of peripheral T-cell lymphoma (PTCL). Peripheral T-cell lymphomas (PTCLs) are a group of rare blood cancers. They develop in T-cells and affect the lymphatic system. PTCLs happen when the T-cells mutate and become cancerous cells that multiply uncontrollably. PTCL […]

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Gastroenterology

Linaclotide acetate for treating Chronic idiopathic constipation

Linaclotide acetate is currently in clinical development for the treatment of adults with chronic idiopathic constipation (CIC). Constipation is defecation that is problematic because of infrequent and/or hard stools, difficulty passing stools (often involving straining), or the sensation of incomplete emptying or anorectal blockage. Chronic is when the symptoms are present for at least three […]

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Breast Cancer

Datopotamab deruxtecan for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer

Datopotamab deruxtecan is in development for the treatment of patients with previously untreated, locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), who are not suitable candidates for PD-1/PD-L1 inhibitor therapy. TNBC is a subtype of breast cancer which lacks hormone receptor expression. The risk factors for TNBC include a history of breast disease […]

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Infectious Disease

Sarconeos for treating severe COVID-19 in people aged 45 years and over

Sarconeos is currently in clinical development for treating adults aged 45 or over who are hospitalised with COVID-19. COVID-19 is an infectious respiratory disease caused by the severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). The main symptoms of COVID-19 are fever, a new continuous cough, and loss of taste or smell. In some patients, COVID-19 may […]

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Male Reproductive Cancer

Talazoparib with enzalutamide for previously untreated homologous recombination repair-mutated metastatic hormonal-sensitive prostate cancer

Talazoparib in combination with enzalutamide is in clinical development for the treatment of homologous recombination repair (HRR)-mutated metastatic hormonal-sensitive prostate cancer (mHSPC). Prostate cancer is a cancer of the prostate gland and is the most common type of cancer in men in the UK. The cancer is called metastatic when it has spread to other […]

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Renal Cancer

Nivolumab for treating advanced clear cell renal cell carcinoma after systemic treatment

Subcutaneous (SC) Nivolumab is currently in clinical development for treating advanced or metastatic clear cell renal cell carcinoma (ccRCC) in adult patients who previously received systemic treatment. Metastatic cancer is when cancer cells have spread to other parts of the body and advanced cancer is when the cancer cannot be cured. ccRCC is the most […]

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Immunology

Teprotumumab for thyroid eye disease

Teprotumumab is currently in development for treatment of thyroid eye disease (TED). TED, also known as Graves’ orbitopathy or ophthalmopathy, is an autoimmune condition. It occurs when the body’s immune system attacks the tissue surrounding the eye causing inflammation in eye muscles, eyelids, tear glands and fatty tissues behind the eye. This can cause the […]

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Breast Cancer

Retifanlimab with chemotherapy for previously untreated metastatic non-small-cell lung cancer

Retifanlimab is currently in clinical development for previously untreated metastatic non-small-cell lung cancer (NSCLC). NSCLC is the most common lung cancer. There are three main types: adenocarcinoma, squamous cell carcinoma and large-cell lung cancer. Stage IV NSCLC is also called metastatic (the most advanced stage) lung cancer. Smoking tobacco is the cause of most lung […]

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Dermatology

Secukinumab biosimilar for treating plaque psoriasis

Secukinumab biosimilar is in clinical development for the treatment of moderate to severe plaque psoriasis in adults. Plaque psoriasis is a long-lasting autoimmune disease that causes skin cells to reproduce very quickly. Plaque psoriasis is characterised by thick, scaly patches called plaques on the skin. These plaques most commonly effect elbows, the back, knees, and […]

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Endocrine Nutritional and Metabolic Disorders

Olezarsen for treating familial chylomicronaemia syndrome

Olezarsen is in clinical development for the treatment of patients with familial chylomicronaemia syndrome (FCS). FCS is a rare genetic disorder that causes very high levels of triglycerides, which is a kind of fat, in the blood. This can lead to serious health problems, including acute and chronic pancreatitis and type 3c diabetes. Symptoms of […]

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Hepatology

Odevixibat for treating biliary atresia in children following Kasai hepatoportoenterostomy

Odevixibat is in clinical development for the treatment of children with biliary atresia (BA) following a Kasai hepatoportoenterostomy (HPE). BA is a rare gastrointestinal disorder where either all or a portion of the bile duct on the outside of the liver is absent or destroyed. As a result, bile acids accumulate in the liver causing […]

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Endocrine Nutritional and Metabolic Disorders

Ferric maltol for treating iron deficiency anaemia in children and adolescents aged 1 month to 17 years

Ferric maltol is in clinical development for the treatment of children and adolescents with iron deficiency anaemia. Iron deficiency anaemia is diminished red blood cell production due to low iron stores in the body, and can develop because of malnutrition, malabsorption, or blood loss. Iron deficiency, with or without anaemia, adversely affects overall health and […]

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Breast Cancer

Inavolisib with palbociclib and fulvestrant for treating HR+/HER2-, PIK3CA mutated locally advanced or metastatic breast cancer

Inavolisib in combination with palbociclib and fulvestrant is in clinical development for the treatment of patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA-mutated locally advanced or metastatic breast cancer. Breast cancer occurs when abnormal cells in the breast begin to grow and divide in an uncontrolled way and […]

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Haematological Cancer and Lymphomas

Brentuximab vedotin with chemotherapy (BrECADD) for previously untreated advanced classical Hodgkin lymphoma

Hodgkin lymphoma (HL) is an uncommon cancer that develops in the lymphatic system, which is a network of vessels and glands spread throughout the body. About 95% of all HL cases are classical HL. Lymphomas are cancers that occur if white blood cells of the immune system start to multiply uncontrollably. Symptoms of classical HL […]

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Haematological Cancer and Lymphomas

Elranatamab monotherapy or with daratumumab for previously treated relapsed or refractory multiple myeloma

Elranatamab, alone or in combination with daratumumab, is in clinical development for the treatment of relapsed or refractory multiple myeloma (MM). MM is a type of bone marrow cancer that is characterised by an abundance of abnormal immune cells, known as plasma cells, in the bone marrow. In the early stages, MM may not cause […]

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Cardiovascular System

Inhaled treprostinil for treating pulmonary hypertension with interstitial lung disease including combined pulmonary fibrosis and emphysema

Pulmonary hypertension is a rare and serious condition that occurs when blood pressure within the lungs becomes abnormally high. It can be caused by thickening of the pulmonary artery walls, heart failure, lung disease and clots within the lungs' blood vessels. Symptoms of pulmonary hypertension include shortness of breath, tiredness, feeling faint or dizzy, chest […]

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Urological Cancer

Durvalumab and enfortumab vedotin with or without tremelimumab for muscle-invasive bladder cancer

Durvalumab and enfortumab vedotin with or without tremelimumab is currently in clinical development for patients with muscle invasive bladder cancer (MIBC), who are ineligible or refuse cisplatin therapy (a type of chemotherapy) and are receiving a radical cystectomy (removal of bladder and surrounding lymph nodes). MIBC is a cancer that spreads into the muscle layer […]

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Neurology

Zavegepant for treating acute migraine

Zavegepant is in clinical development for the acute treatment of migraine. Migraines is a headache that is usually characterised by throbbing in one side of the head. In addition to this, other symptoms include sensitivity to light and sound, nausea and vomiting. The cause of migraines is not known but some triggers include tiredness, anxiety […]

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