NICE unlocks use of Amarin’s Vazkepa in 425k NHS patients
Health technology assessment (HTA) agency NICE has finalised its guidance on Amarin’s Vazkepa, clearing the path for GPs to start prescribing the drug in up […]
HEOR
NICE backs two new breast cancer drugs for NHS use
Cost-effectiveness watchdog NICE has recommended routine NHS use of two new therapies for women with advanced breast cancer – Gilead’s Trodelvy and Novartis’ Piqray – […]
NICE makes J&J’s Tremfya more accessible in England and Wales
NICE has updated its recommendations for NHS use of Johnson & Johnson’s IL-23 inhibitor Tremfya in the treatment of psoriatic arthritis (PsA), expanding the pool […]
BMS’ Opdivo gets NHS use as adjuvant bladder cancer therapy
NICE has recommended routine use of Bristol-Myers Squibb’s Opdivo for the adjuvant treatment of some patients with urothelial carcinoma (UC), the most common form of […]
Lilly’s Verzenios gets NICE blessing for early-stage breast cancer
Thousands more people with breast cancer in England look set to be eligible for routine treatment with Eli Lilly’s Verzenios, after new guidance from NICE […]
NICE backs Astellas’ oral therapy Evrenzo for anaemia in kidney disease
Astellas’ oral HIF-PH inhibitor Evrenzo has become the first drug in the class to be recommended for routine NHS use as a treatment for anaemia […]
NICE backs NHS use of Amarin’s Vazkepa for cardiovascular risk reduction
Around 425,000 in England and Wales with cardiovascular disease who are at risk of a secondary stroke or heart attack, could be eligible for treatment […]
MHRA gives Alnylam ‘innovation passport’ for hypertension drug zilebesiran
The UK medicines regulator has awarded Alnylam’s RNAi-based therapy zilebesiran for hypertension an ‘innovation passport‘, a designation designed to speed up NHS access to promising […]
NICE finds solution to making Keytruda available for TNBC
Around 100 patients in England and Wales with triple negative breast cancer (TNBC) that has spread to other parts of the body could soon access […]
Gedeon Richter gets NICE nod for uterine fibroids drug Ryeqo
Around 4,500 women in the UK will be eligible for treatment with Gedeon Richter’s once-daily oral therapy Ryeqo, after NICE backed the GnRH antagonist to […]
ICER says bluebird bio’s $2.1m gene therapy is cost-effective
US cost-effectiveness watchdog ICER has handed bluebird bio some good news ahead of its FDA advisory committee meeting for rare blood disorder gene therapy beti-cel […]
NICE verdict on Trodelvy threatens unequal access to drug in UK
In draft guidance, NICE has said it cannot recommend Gilead Sciences’ Trodelvy in triple-negative breast cancer (TNBC), setting up a disparity in access to the […]
NICE ends UK access disparity to osteoporosis drug Evenity
NICE has reversed its stance on UCB and Amgen’s severe osteoporosis therapy Evenity, saying out can be prescribed on the NHS for women with the […]
NICE says no to Keytruda in triple-negative breast cancer
There isn’t enough evidence to support the use of Merck & Co/MSD’s Keytruda in combination with chemotherapy as a first-line treatment for advanced triple negative […]
Fishawack Health acquires HEOR consultancy PAI
March 3, 2022, London, UK—Fishawack Health (FH), a leading commercialization partner for biopharmaceutical, medical technology, and wellness companies, today welcomes the US-based health economics and […]
Novo Nordisk gets NICE okay for obesity drug Wegovy
Novo Nordisk’s new obesity therapy Wegovy has been recommended for routine NHS use by UK cost-effectiveness watchdog NICE, but in a narrower group of patients […]
NHS signs deal with Orchard for pricey Libmeldy gene therapy
NHS England has agreed a confidential deal with Orchard Therapeutics that will allow access to Libmeldy – a gene therapy for a rare childhood disease […]
NICE expands cover for AZ’s high potassium drug Lokelma
NICE has recommended extending funding via the NHS for AstraZeneca’s elevated potassium therapy Lokelma in new guidance, making it easier to receive the drug outside […]
After a Scottish aye, NICE says no to Lynparza for prostate cancer
AstraZeneca’s PARP inhibitor Lynparza should not be made available routinely on the NHS n England and Wales as a treatment for prostate cancer, according to […]
NICE backs Aimmune’s peanut allergy drug Palforzia for children
Children in England with peanut allergies could be among the first in Europe to get access to Aimmune’s oral immunotherapy Palforzia, after the drugmaker agreed […]
Samantha Roberts to replace Gillian Leng as CEO of NICE
Prof Gillian Leng’s replacement as chief executive of the National Institute for Health and Care Excellence (NICE) has been named as Dr Samantha Roberts, currently […]
NICE gives Keytruda parity with Opdivo for adjuvant melanoma
After three years of availability via the Cancer Drugs Fund (CDF), MSD’s checkpoint inhibitor Keytruda has now been approved for routine NHS use after surgery […]
Wales is first UK country to fund GW’s Epidyolex for tuberous sclerosis
Patients in Wales with a rare disease that causes epilepsy will be the first in the UK to get access to GW Pharma’s cannabis-based medicine […]
After Scotland says no, NICE backs Lilly’s Retsevmo for lung cancer
Eli Lilly’s RET inhibitor Retsevmo can now be prescribed on the NHS for people with RET fusion-positive advanced non-small cell lung cancer (NSCLC) in England […]
NICE backs ViiV/J&J’s six-per-year injection for HIV
People living with HIV in England and Wales now have an alternative to daily oral tablets, after NICE backed NHS use of two long-acting injectable […]
Drug-resistant epilepsy drug Ontozry backed by NICE
NHS patients in England and Wales with drug-resistant epilepsy are in line for access to another treatment option, after NICE recommended routine use of Angelini […]
NICE changes tack on ‘game changer’ rare cancer therapy Poteligeo
NICE has reversed an earlier decision not to recommend NHS use of Kyowa Kirin’s Poteligeo for two rare blood cancers, ending the threat of a […]
Cautious welcome as NICE backs Forxiga for chronic kidney disease
Tens of thousands of people with chronic kidney disease in England could be eligible for treatment with AstraZeneca’s SGLT2 inhibitor Forxiga, after NICE backed NHS […]
NICE uncertain on insomnia app Sleepio in draft guidance
Big Health’s Sleepio app for insomnia has been cautiously backed by NICE in preliminary guidance, although the cost-effectiveness agency says more data on longer-term use […]
Seagen’s breast cancer drug Tukysa turned down by NICE
NICE has decided not to recommend Seagen’s orally-active HER2 inhibitor Tukysa for advanced breast cancer in draft guidance, saying it isn’t a cost-effective use of […]
Alnylam gets NICE backing for porphyria therapy Givlaari
UK cost-effectiveness watchdog NICE is set to recommend NHS use of Alnylam’s gene-silencing therapy Givlaari in England and Wales for the rare disease acute hepatic […]
NICE changes stance on Sanofi’s Dupixent for severe asthma
18 months after saying “no” to regular NHS funding for Sanofi and Regeneron’s Dupixent (dupilumab) for severe asthma in initial guidance, NICE has now backed […]
Scotland backs Cabometyx combo for kidney cancer, amid stalled NICE review
Patients in Scotland with newly-diagnosed advanced kidney cancer can now access a therapy combining Bristol-Myers Squibb’s immunotherapy Opdivo with Ipsen’s targeted drug Cabometyx, ahead of […]
Consternation as NICE rejects Janssen MS drug Ponvory
NICE has delivered its first verdict on NHS funding of Janssen’s oral multiple sclerosis drug Ponvory, and it’s not good news for patients with the […]
Joy as sickle cell patients get access to Novartis’ Adakveo after NICE ruling
People living with sickle cell disease (SCD) in England and Wales will be able to get access to treatment with Novartis’ Adakveo, thanks to a […]
NICE clears NHS use of Roche’s Tecentriq in bladder cancer
NICE has recommended routine NHS access to Roche’s cancer immunotherapy Tecentriq for some bladder cancer patients, four years after it was first made available via […]
Keytruda backed by NICE for late-stage oesophageal cancer
MSD’s Keytruda has become the first immunotherapy cleared by NICE for previously-untreated patients with advanced oesophageal cancer, making it an option for routine NHS treatment. […]
NICE backs BioCryst’s Orladeyo for hereditary angioedema
BioCryst Pharma’s Orladeyo has been recommended by NICE as a treatment for the rare disease hereditary angioedema (HAE) in England, Wales and Northern Ireland. Orladeyo […]
NICE backs Cosentyx’ use in thousands of children with psoriasis
NICE has recommended broadening NHS use of Novartis’ IL-17 inhibitor Cosentyx to include children aged six to 17 with severe plaque psoriasis. The cost-effectiveness agency […]
NICE backs NHS use of Novartis’ cholesterol drug Leqvio
Novartis’ cholesterol-lowering drug Leqvio will be made available on the NHS in England and Wales, and could help to prevent up to 30,000 deaths, according […]
NICE rejects J&J’ Darzalex regimen for multiple myeloma
New guidance from NICE has rejected a combination regimen based on Johnson & Johnson’s Darzalex for a group of previously-untreated patients with multiple myeloma, a […]
NICE says yes to Novartis’ Rydapt for rare blood disorder
Novartis’ Rydapt has become the first and only licensed treatment for rare and life-threatening blood disorder systemic mastocytosis (SM) to be cleared for routine NHS […]
UCB’s bimekizumab ‘pre-approved’ using NICE fast-track scheme
UCB’s bimekizumab hasn’t been approved for marketing in Europe yet, but has already been given the nod for NHS use in England and Wales under […]
NICE changes its mind on rare bile duct cancer drug from Incyte
Incyte’s Pemazyre has become the first targeted therapy available for NHS patients with cholangiocarcinoma or bile duct cancer, after NICE concluded it provided value for […]
NICE rejects Orchard’s gene therapy for rare childhood disease MLD
Orchard Therapeutics’ gene therapy for rare childhood disease metachromatic leukodystrophy (MLD) Libmeldy has been rejected for NHS use by NICE in draft guidance. The agency […]
NICE backs Novartis’ Cosentyx for underdiagnosed back condition
NICE has extended the range of indications that Novartis’ Cosentyx can be prescribed for by the NHS in England, giving a green light for its […]
NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group
NICE has rejected routine NHS funding for Roche’s Evrysdi (risdiplam) for spinal muscular atrophy drug in draft guidance, a decision which doesn’t come as a […]
Scotland backs NHS use of Alexion’s Ultomiris for rare disease aHUS
NHS patients in Scotland with the rare disease atypical haemolytic uremic syndrome (aHUS) will now be able to access treatment with Alexion’s Ultomiris, ahead of […]
NICE says no to Merck Serono’s Bavencio in bladder cancer
Merck Serono’s Bavencio is the only checkpoint inhibitor to be approved for first-line maintenance treatment of bladder cancer in Europe, but UK cost-effectiveness agency NICE […]
Scotland opens door to Translarna for Duchenne muscular dystrophy
A disparity in UK access to a medicine for Duchenne muscular dystrophy (DMD) has been addressed, after Scotland gave a green light to use of […]
NICE backs Sobi’s Kineret for rare inflammatory disease
The UK’s cost-effectiveness agency NICE has recommended that Sobi’s Kineret can be used to treat NHS patients with Still’s disease, a rare form of arthritis […]
Double first for Scotland as it backs Roche’s Rozlytrek, Novartis’ Zolgensma
The Scottish Medicines Consortium (SMC) has said Roche’s Rozlytrek can be used by NHS Scotland for the treatment of solid tumours with NTRK gene fusion […]
NICE says no to AZ’s Lynparza for prostate cancer
NHS patients in England will not be able to get access to AstraZeneca’s PARP inhibitor Lynparza if they have BRCA-positive advance prostate cancer, according to […]
NICE backs broad use for Gilead/Galapagos arthritis pill Jyseleca
Patients with rheumatoid arthritis (RA) in England will be able to get treatment with Gilead Sciences and Galapagos’ JAK inhibitor Jyseleca, after it was backed […]
Scotland backs Roche’s Rozlytrek for ROS1 lung cancer
The Scottish Medicines Consortium (SMC) has given a green light to Roche’s Rozlytrek for a rare form of lung cancer, almost seven months after NICE […]
NICE backs AZ’s Forxiga for heart failure
Just a few weeks after its EU approval for heart failure, AstraZeneca’s Forxiga has been backed by NICE for this use by the NHS in […]
Okra says AI-based drug price predictor is 90% accurate
UK artificial intelligence startup Okra Technologies has launched a new software platform that it claims can take the guesswork out of the price that can […]
Gene Therapy Medical Affairs
The inaugural Gene Therapy Medical Affairs Summit is dedicated to exploring the pivotal internal and external role that Medical Affairs plays in delivering gene therapies to patients. Industry pioneers […]
