Medicine Industry's Gateway to NICE
The Innovation Observatory is the gateway to the NICE Technology Assessment (TA) Programme for industry, preventing delays in bringing new and repurposed medicines to the UK market through the early identification and tracking of new and repurposed medicines and health technologies.
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.
Targeted-release budesonide for treating primary IgA nephropathy
Targeted-release budesonide is in clinical development for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN). IgAN is one of the most common causes of chronic kidney disease and kidney failure and is caused by the immune system (the body's natural defences) producing a faulty version of an antibody, which is a protein, called IgA. […]
DownloadMosunetuzumab (subcutaneous injection) for treating relapsed or refractory follicular lymphoma
Mosunetuzumab is in clinical development for the treatment of relapsed or refractory follicular lymphoma (FL). FL is a type of blood cancer originating in the lymph nodes of the immune system, and it is the most common type of low-grade Non-Hodgkin’s Lymphoma in the UK. A relapsed or refractory cancer is one that has come […]
DownloadResminostat for maintenance treatment of patients with advanced stage mycosis fungoides or Sézary syndrome
Resminostat is in clinical development for the maintenance treatment of adults with mycosis fungoides (MF) and Sézary syndrome (SS) which are the most common types of cutaneous T-cell lymphoma (CTCL), a rare type of non-Hodgkin lymphoma affecting the skin. CTCL can develop when T-cells become abnormal. T-cells are one of the important types of white […]
DownloadSomapacitan for treating idiopathic short stature or Noonan syndrome or small for gestational age in people aged 2 to 18 years
Somapacitan is in clinical development for the treatment of small for gestational age or Noonan syndrome or idiopathic short stature in patients aged 2 to 18 years. Idiopathic short stature is defined as shortness in childhood without a specific cause. This condition may be familial (run in families) or nonfamilial and may be associated with […]
DownloadGovorestat for treating galactosemia in people aged 2-65 years
Govorestat is in clinical development for treating classic galactosemia. Classic galactosemia is a rare disorder affecting the body’s ability to break down (metabolise) the sugar present in milk (galactose) into another type of sugar called glucose. Glucose provides a source of energy for body cells. Classic galactosemia is caused by a faulty (mutated) gene, meaning […]
DownloadCamlipixant for treating refractory or unexplained chronic cough
Camlipixant is in clinical development for the treatment of adults with refractory or unexplained chronic cough. Cough is a normal reflex response to airway irritation, triggered by stimulation of airway cough receptors, which protect against choking and enhance airway clearance. Chronic cough is a persistent cough that lasts for eight weeks or longer. Refractory cough […]
DownloadBaloxavir marboxil for reducing direct transmission of influenza
Baloxavir marboxil is in clinical development for reducing direct transmission of influenza.Influenza commonly known as flu is an infection of the nose, throat, and lungs, which are a partof the respiratory system. There are three types of viruses that cause influenza; type A, B and C.Type A and B influenza viruses cause the main outbreaks […]
DownloadBemarituzumab with chemotherapy for previously untreated advanced gastric or gastroesophageal junction cancer
Bemarituzumab in combination with chemotherapy is in clinical development for the treatment of previously untreated locally advanced, or metastatic gastric or gastroesophageal junction (GEJ) cancer. Gastric (or stomach) cancer is when abnormal cells in the stomach start to grow and divide in an uncontrolled way. GEJ cancer starts in the junction where the food pipe […]
DownloadVimseltinib for treating Tenosynovial Giant Cell Tumour
Vimseltinib is in development to treat tenosynovial giant cell tumour (TGCT) in adults. TGCTs are rare but non-cancerous tumours that develop in tissues around joints. TGCTs can be diffuse, meaning the tumour affects most of a large joint (e.g., knee), or localised, meaning the tumour is limited to a specific area of the joint (normally […]
DownloadIclepertin for treating cognitive impairment associated with schizophrenia in people aged 18 to 80 years
Iclepertin is in clinical development for treating cognitive (thinking) impairment associated with schizophrenia (CIAS). Schizophrenia is a long-term mental health condition, which can be triggered by many different biological, social and psychological factors. The symptoms of schizophrenia are usually divided into positive symptoms (such as hallucinations and delusions), negative symptoms (such as emotional apathy, lack […]
DownloadImetelstat for treating relapsed or refractory intermediate-2 or high-risk myelofibrosis after janus kinase inhibitor treatment
Imetelstat is in clinical development for the treatment of intermediate-2 or high-risk myelofibrosis (MF) in patients who are relapsed (the disease has come back) or refractory (the disease has stopped responding to a treatment) to Janus-Kinase (JAK) inhibitor treatment. MF is a rare blood cancer that causes scarring of the bone marrow which makes it […]
DownloadSumatriptan-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 […]
DownloadEpcoritamab 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 […]
DownloadOsmertinib 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 […]
DownloadAtezolizumab-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 […]
DownloadNivolumab-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 […]
DownloadSQ 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 […]
DownloadDiclofenac-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 […]
DownloadPatritumab 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 […]
DownloadBelzutifan 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% […]
DownloadPridopidine 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, […]
DownloadCapivasertib 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 […]
DownloadFinerenone 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 […]
DownloadPembrolizumab 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, […]
DownloadGlycopyrronium 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 […]
DownloadVenetoclax 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 […]
DownloadAcarizax 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 […]
DownloadIrinotecan 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 […]
DownloadNeuro-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 […]
DownloadPegcetacoplan 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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