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.
Nifedipine–lidocaine for treating chronic anal fissure
Nifedipine-lidocaine has been clinically developed for the treatment of chronic anal fissure. An anal fissure is a tear or open sore (ulcer) that develops in the lining of the large intestine, near the anus. Many fissures heal by themselves, or certain medicines can be prescribed to treat them. However, sometimes a fissure does not heal […]
DownloadPertuzumab biosimilar with trastuzumab and chemotherapy neoadjuvant and adjuvant therapy for early stage and locally advanced HER2-positive breast cancer
Pertuzumab biosimilar is in clinical development for the adjuvant and neoadjuvant treatment of invasive early stage or locally advanced breast cancer (BC) that is human epidermal growth factor 2 (HER2) positive (+). HER2 is a protein found on some cancer cells. Neoadjuvant therapy comes before primary treatment. Adjuvant therapy follows the primary treatment. BC is […]
DownloadPirtobrutinib for previously treated Bruton tyrosine kinase inhibitor naïve mantle cell lymphoma
Pirtobrutinib is in clinical development for the treatment of previously treated Bruton tyrosine kinase (BTK) inhibitor-naïve mantle cell lymphoma (MCL) in adults. MCL is a rare and aggressive blood cancer that starts in white blood cells (B cells) in the outer edge of the lymph nodes. The abnormal white blood cells start to collect in […]
DownloadSelumetinib (granule formulation) for treating neurofibromas type 1-related symptomatic, inoperable plexiform in children
Selumetinib granule formulation is currently in clinical development for the treatment of symptomatic and inoperable plexiform neurofibromas (PN) associated with type 1 neurofibromatosis (NF1) in children. NF1 is a genetic condition that causes tumours to grow along the nerves. The tumours are usually non-cancerous but may cause a range of symptoms. Some children have a […]
DownloadSavolitinib with osimertinib for treating EGFR- mutated, MET-overexpressed advanced non-small-cell lung cancer
Savolitinib in combination with osimertinib is in clinical development for treatment of acquired mesenchymal epithelial transition factor (MET)-mediated osimertinib resistance in epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). NSCLC is the most common form of lung cancers in the UK and at the metastatic stage, the disease has already spread from the […]
DownloadSoticlestat as an adjunctive therapy in patients with Dravet syndrome
Soticlestat is in clinical development as an adjunctive therapy in patients with Dravet syndrome, a rare neurological condition characterized by treatment-resistant epilepsy, intellectual disability, and a spectrum of associated conditions such as behaviour, speech, feeding and mobility difficulties. Typically, Dravet syndrome involves multiple, frequent, and often prolonged seizures that do not respond well to treatment. […]
DownloadPembrolizumab with lenvatinib and chemotherapy for the treatment of metastatic squamous cell oesophageal carcinoma
Lenvatinib in combination with pembrolizumab and chemotherapy is in clinical development as a first line therapy for metastatic squamous cell oesophageal carcinoma (SCOC). SCOC is a type of cancer that originates in the squamous cells that line the oesophagus (sometimes referred to as the food pipe or gullet). Metastatic cancer means the cancer has spread […]
DownloadLenacapavir for preventing HIV infection
Lenacapavir is in clinical development for the prevention of human immunodeficiency virus (HIV) in people who are at risk of HIV infection. HIV is a virus that damages the cells in the immune system and weakens the ability to fight everyday infections and disease. AIDS (acquired immune deficiency syndrome) is the name used to describe […]
DownloadApremilast for the treatment of juvenile psoriatic arthritis
Psoriatic arthritis is an inflammatory arthritis (a condition that causes pain and inflammation in a joint) associated with psoriasis. Psoriasis is a skin condition that causes flaky patches of skin which form scales. When this occurs in children it is referred to as juvenile psoriatic arthritis. Symptoms of juvenile psoriatic arthritis can include swelling of […]
DownloadCendakimab for eosinophilic oesophagitis in people aged 12 years and over
Eosinophilic oesophagitis (EoE) is a chronic disorder of the digestive system in which large numbers of white blood cells called eosinophils are present in the tube that carries food from the mouth to the stomach (oesophagus). Eosinophils play a role in immune regulation. The production and accumulation of eosinophils seen in EoE may be caused […]
DownloadEptinezumab for cluster headache
Eptinezumab is in clinical development for cluster headache. Cluster headaches are excruciating attacks of pain in one side of the head, often felt around the eye. The most common presentation the majority of patients with cluster headache have is the episodic form, in which attacks appear daily lasting for weeks or months, followed by a […]
DownloadSpesolimab for preventing generalised pustular psoriasis flares in adults and adolescents aged 12 years and over
Spesolimab is in development for the prevention of flares in generalised pustular psoriasis in adults and adolescents aged 12 years and over. Generalised pustular psoriasis is a rare dermatological condition characterised by the sudden appearance of multiple small blisters filled with pus (called pustules) on large areas of the skin on the body, arms, and […]
DownloadLomitapide for treating homozygous familial hypercholesterolaemia in children aged 5 to 17 years
Lomitapide is currently in clinical development for the treatment of paediatric patients with homozygous familial hypercholesteraemia (HoFH) receiving stable lipid-lowering therapy. HoFH is a more severe form of familial hypercholesterolaemia, a condition passed down through families, which raises blood low density lipoprotein (LDL) cholesterol to very high levels. Low density lipoprotein cholesterol (LDL-C) is often […]
DownloadRetifanlimab with carboplatin with paclitaxel for treating locally advanced or metastatic squamous cell anal carcinoma
Retifanlimab is in clinical development as a combination therapy, with carboplatin and paclitaxel, for treating inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). SCAC is a rare cancer that starts in the squamous cells in the anal canal. Squamous cells make up the lining of the anal canal which is […]
DownloadSoticlestat as an adjunctive therapy for treatment of Lennox-Gastaut syndrome
Soticlestat is in clinical development as a secondary treatment used together with a primary treatment to enhance its effectiveness for patients with Lennox-Gastaut syndrome (LGS). LGS is a rare and severe form of childhood epilepsy characterized by tonic seizures (sudden stiffening of the body, often causing falls and injuries), atypical absence seizures (brief episodes of […]
DownloadNorucholic acid for treating primary sclerosing cholangitis
Norucholic acid (NCA), (previously known as norursodeoxycholic acid (norUDCA) is in clinical development for treating primary sclerosing cholangitis (PSC). PSC is a rare and progressive chronic liver disease. In PSC the bile ducts (tubes which allow the liquid produced by the liver (bile) to flow from the liver to the small intestine where it helps […]
DownloadTargeted-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 […]
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