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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

Neurology

Sumatriptan-Naproxen for the treatment of acute migraine

Sumatriptan-naproxen is for the acute treatment of migraine. Migraine is a headache that is usually characterised by throbbing in one side of the head and other symptoms including sensitivity to light and sound, nausea and vomiting. The cause of migraines is not known but triggers include tiredness, anxiety and caffeine. Migraines are also thought to […]

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Haematological Cancer and Lymphomas

Epcoritamab for treating relapsed or refractory diffuse large B-cell lymphoma previously treated with at least one line of systemic therapy

Epcoritamab is in clinical development for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after one or more lines of therapy. DLBCL is a cancer of B cells, a type of immune cell, and the most common type of fast-growing non-Hodgkin’s lymphoma - a disease in which cancer cells […]

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Lung and Respiratory Cancer

Osmertinib neoadjuvant for treating EGFR mutation positive resectable non-squamous non- small cell lung cancer

Osimertinib is in phase III clinical development as a neoadjuvant treatment for epidermal growth factor receptor mutation (EGFRm) positive, resectable (stage II -IIIB), non-squamous, non-small cell lung cancer (NSCLC). Lung cancer is one of the most common and serious types of cancer and NSCLC is the most common type of lung cancer. A neoadjuvant treatment […]

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Lung and Respiratory Cancer

Atezolizumab-tiragolumab for locally advanced, recurrent, or metastatic PD-L1 selected solid tumours

Atezolizumab-tiragolumab is currently in clinical development for treating adults with Programmed death ligand 1 (PD-L1)-selected solid tumours whose disease is locally advanced, recurrent or metastatic. Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. These cancerous cells can invade and destroy healthy tissue, including organs. One in […]

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Skin Cancer

Nivolumab-relatlimab adjuvant therapy for stage III-IV resected melanoma

Nivolumab-relatlimab is currently clinical development for the adjuvant treatment of patients with resected stage III-IV melanoma. Melanoma is a type of skin cancer. The stage of a cancer tells how big it is and how far it has spread. Stage III melanomas are regional, meaning the cancer has spread beyond the primary tumour (local) to […]

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Ear Nose and Throat (ENT)

SQ tree sublingual immunotherapy tablet for treating moderate to severe allergic rhinitis and/or conjunctivitis in children and adolescents

The SQ tree sublingual immunotherapy (SLIT)–tablet is currently in clinical development for the treatment of tree pollen–induced allergic rhinitis (AR) and/or conjunctivitis, a highly prevalent respiratory condition. Globally, it is estimated that more than 10 million children have uncontrolled respiratory allergies. Pollen allergies are a major cause of allergic rhinoconjunctivitis, and birch pollen is one […]

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Gynaecology and Obstetrics

Diclofenac-clotrimazole for treating recurrent vulvovaginal candidiasis

Diclofenac-clotrimazole is in clinical development for the treatment of recurrent vulvovaginal candidiasis (RVVC). Vulvovaginal candidiasis (genital thrush) is an inflammation of the vagina and/or vulva caused by a superficial fungal infection (usually yeast). Symptoms of RVVC include vulval or vaginal itch and irritation, a non-offensive vaginal discharge, painful intercourse, and painful urination. Recurrent RVVC refers […]

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Lung and Respiratory Cancer

Patritumab deruxtecan for previously treated metastatic or locally advanced EGFR mutated non-small-cell lung cancer

Patritumab deruxtecan is currently in clinical development for treatment of metastatic or locally advanced epidermal growth factor receptor-mutated (EGFRm) non-squamous non-small cell lung cancer (NSCLC) after failure of several therapy options. NSCLC is the most common type of lung cancer. EGFR is protein involved in the growth and division of healthy cells. For some NSCLC […]

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Renal Cancer

Belzutifan with Lenvatinib in Patients with Advanced Renal Cell Carcinoma

Belzutifan in combination with lenvatinib are in clinical development for the treatment of adults with advanced clear cell renal cell carcinoma (RCC) after previous treatment. Clear cell RCC is the most common type of kidney cancer and is named after how the tumour looks under the microscope. Because early-stage RCC often goes undetected, approximately 16% […]

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Genetic Disorders

Pridopidine for treating Huntington’s disease in adults

Pridopidine is in clinical development for the treatment of adult patients with Huntington’s disease (HD). HD is a hereditary neurodegenerative disorder (disease of the nervous system) caused by a genetic mutation in the Huntingtin gene (HTT) that leads to the progressive loss of nerve cells in the brain. This results in movement dysfunction, cognitive decline, […]

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Male Reproductive Cancer

Capivasertib with abiraterone acetate for treating metastatic PTEN deficient hormone-sensitive prostate cancer

Capivasertib with abiraterone acetate is in clinical development for the treatment of prostate cancer which is metastatic (has spread to other parts of the body) and hormone-sensitive, meaning the cancer can be controlled by keeping the testosterone level as low as would be expected if the testicles were removed. Specifically, capivasertib with abiraterone acetate is […]

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Cardiovascular System

Finerenone for treating heart failure

Finerenone is currently in clinical development for treating heart failure in adults. Heart failure is a combination of symptoms and signs that indicate that the heart is pumping blood around the body less efficiently. Left ventricular ejection fraction is calculated as the percentage of how much blood in a part of the heart called the […]

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Head and Neck Cancer

Pembrolizumab neoadjuvant therapy and as adjuvant therapy with radiotherapy for previously untreated stage III/IVA head and neck squamous cell carcinoma

Pembrolizumab is in clinical development as neoadjuvant therapy (given before surgery to shrink a tumour) and in combination with standard of care radiotherapy as adjuvant therapy (given after surgery) for the treatment of locally advanced head and neck squamous cell carcinoma (HNSCC). HNSCC is a cancer that develops in the mucous membranes of the mouth, […]

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Endocrine Nutritional and Metabolic Disorders

Glycopyrronium bromide cream for treating severe primary axillary hyperhidrosis

One percent glycopyrronium bromide (GPB) cream has been developed for the treatment of severe primary axillary hyperhidrosis (severe underarm sweating, which has no obvious cause). Patients with primary axillary hyperhidrosis (PAHH), suffer from an excessive amount of sweat production in the armpits when the body does not need to cool down. Severe PAHH strongly affects […]

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Haematological Cancer and Lymphomas

Venetoclax with azacitidine for treating acute myeloid leukaemia following allogeneic stem cell transplantation

Venetoclax in combination with azacitidine is currently in clinical development for the treatment of acute myeloid leukaemia (AML) following allogeneic stem cell transplantation in children and adults. AML is a rare form of blood cancer that affects the white blood cells resulting in frequent infections for patients. AML also affects red blood cells resulting in […]

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Immunology

Acarizax for treating allergic rhinitis or allergic rhinoconjunctivitis in children aged 5 to 11 years old

Acarizax is in development for the treatment of house dust mite (HDM) allergic rhinitis or rhinoconjunctivitis in children aged 5 to 11 years old with or without asthma. HDM allergic rhinitis is caused by an allergic reaction to HDM and leads to symptoms similar to a cold, including sneezing, a runny or blocked nose and […]

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Gastrointestinal Cancer

Irinotecan liposome injection with oxaliplatin, 5-fluorouracil and leucovorin for previously untreated metastatic pancreatic cancer

Irinotecan liposome injection with oxaliplatin, 5-fluorouracil and leucovorin is in development for the treatment of metastatic pancreatic cancer. Pancreatic cancer occurs when abnormal cells in the pancreas divide and grow in an uncontrolled way, forming a growth (tumour). Cells from the tumour can spread to other parts of the body (metastases). Metastatic pancreatic cancer has […]

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Musculoskeletal System

Neuro-Cells for treating traumatic spinal cord injury

Neuro-Cells are in development for the treatment of patients with traumatic spinal cord injury (TSCI). The spinal cord can be injured through accidents or by internal causes such as tumours or bleeding within the spine putting pressure on the spinal cord. The resulting damage to the nerves that run through the cord and that branch […]

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Immunology

Pegcetacoplan for treating C3 glomerulopathy or immune-complex membranoproliferative glomerulonephritis

Pegcetacoplan is in clinical development for treating C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). C3G and primary IC-MPGN are both subtypes of membranoproliferative glomerulonephritis (MPGN). They result from an immune system disorder that causes antibodies and a substance called complement (C3) to be deposited in the kidneys, with evidence of immune complex deposition […]

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Skin Cancer

Pembrolizumab adjuvant therapy for locally advanced cutaneous squamous cell carcinoma

Pembrolizumab is in development for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) following surgery and radiotherapy. cSCC is a type of skin cancer that develops in the outermost layer of the skin. Certain factors can increase an individual’s risk of developing cSCC, such as exposure to the sun, […]

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Genetic Disorders

Doxecitine and doxribtimine for treating thymidine kinase 2 deficiency

Doxecitine and doxribtimine is in development for the treatment of thymidine kinase 2 deficiency (TK2d). Thymidine kinase 2 (TK2) is a protein involved in the normal function of mitochondria. Mitochondria produce energy in the cells of the body. TK2d leads to abnormally low amounts of DNA in mitochondria and because of this defect, the mitochondria […]

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Neurology

Human immunoglobulin with recombinant human hyaluronidase maintenance therapy for treating multifocal motor neuropathy

Human immunoglobulin with recombinant human hyaluronidase is currently in development for the maintenance treatment of patients with multifocal motor neuropathy (MMN). MMN is a rare disease that causes damage to the nerves in the arms and legs. The nerve damage is progressive and worsens over time. The cause of MMN is unknown, but it is […]

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Male Reproductive Cancer

Darolutamide with androgen deprivation therapy for metastatic hormone sensitive prostate cancer

Darolutamide with androgen deprivation therapy (ADT) is in clinical development to treat prostate cancer that is metastatic (has spread to another part of the body) and hormone-sensitive, where the cancer is controlled by lowering levels of the hormone testosterone. Prostate cancer affects the prostate (a small gland only found in men), but symptoms generally do […]

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Male Reproductive Cancer

Niraparib with abiraterone acetate and prednisone for treating homologous recombination repair-mutated metastatic castration-sensitive prostate cancer

Niraparib with abiraterone acetate and prednisone is in clinical development for patients with prostate cancer which is metastatic (has spread to other parts of the body) and hormone-sensitive, meaning the cancer is being controlled by keeping the testosterone level as low as would be expected if the testicles were removed. Prostate cancer is the most […]

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Haematological Cancer and Lymphomas

Human normal immunoglobulin for preventing primary infection in chronic lymphocytic leukaemia

Human normal immunoglobulin (IVIG) is in development for preventing primary infection in patients with chronic lymphocytic leukaemia (CLL). CLL is the most common type of leukaemia, which is a cancer that affects blood cells in the bone marrow and progresses slowly over time. In CLL, the bone marrow makes too many unusual white blood cells […]

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Cardiovascular System

Telmisartan-amlodipine-indapamide for treating hypertension

Telmisartan-amlodipine-indapamide is in development for the treatment of Hypertension. Hypertension is characterised by persistently high blood pressure. When a person’s blood pressure is too high, it puts extra strain on the blood vessels, heart and other organs, such as the brain, kidneys and eyes. The causes of high blood pressure are not always clear, but […]

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Infectious Disease

Cefepime-enmetazobactam for treating hospital-acquired pneumonia including ventilator-associated pneumonia

Cefepime-enmetazobactam is in clinical development for the treatment of adults with hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Pneumonia is a type of chest infection where tiny air sacs in lungs (alveoli) fill with fluid, making it harder to breathe. Symptoms include coughing, feeling tired, a high temperature, difficulty breathing, chest pain and loss […]

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Immunology

Alpha-1 antitrypsin for treating high risk, acute graft versus host disease in people aged ≥ 12 years

Alpha-1 antitrypsin is currently in development for the treatment of high risk, acute graft versus host disease (aGvHD) in people aged ≥ 12 years following an allogeneic haematopoietic stem cell transplant (HSCT) for any indication. A stem cell transplant replaces damaged blood cells with healthy ones from another person (a donor). GvHD is a frequent […]

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Urological Cancer

Sasanlimab with Bacillus Calmette-Guérin for treating high-risk non-muscle invasive bladder cancer

Sasanlimab in combination with Bacillus Calmette-Guérin (BCG) is in clinical development for BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). Bladder cancer is when cancerous cells develop in the lining of the bladder. NMIBC is the most common type of bladder cancer and is categorised by risk (low, medium and high). High-risk NMIBC is when cancerous […]

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Cardiovascular System

Vutrisiran for treating transthyretin amyloidosis with cardiomyopathy

Vutrisiran is a medicinal product that is in development for the treatment of adults with transthyretin amyloidosis with cardiomyopathy (ATTR-CM). ATTR-CM is classified as either wildtype transthyretin (wtATTR) amyloidosis with cardiomyopathy (wtATTR-CM) or hereditary transthyretin (hATTR) amyloidosis with cardiomyopathy (hATTR-CM). ATTR-CM occurs when a protein called transthyretin (TTR) becomes defective and aggregates, forming amyloid deposits […]

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