NICE

Sanofi’s Dupixent (dupilumab) Receives NICE Recommendation for the Treatment of Severe Asthma

Shots: The NICE has issued a final appraisal determination (FAD) which recommends Dupixent (dupilumab) as an add-on maintenance treatment for severe asthma The NICE recommendation is based on a LIBERTY ASTHMA QUEST trial evaluating Dupixent vs PBO in patients with severe asthma with high exacerbation rates and high biomarkers indicating type 2 inflammation The results …

Sanofi’s Dupixent (dupilumab) Receives NICE Recommendation for the Treatment of Severe Asthma Read More »

A test of NICE’s resolve: clinical guidelines for Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

The work of the UK’s HTA body, the National Institute for Health and Care Excellence (NICE), is often heatedly debated, and this time it’s for holding back a clinical guideline. Leela Barham looks into the controversy. Updating a previous clinical guideline NICE began their work to update a 2007 clinical guideline on Myalgic encephalomyelitis/chronic fatigue …

A test of NICE’s resolve: clinical guidelines for Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) Read More »

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 the drug. The final appraisal document for Dupixent (dupilumab) has given the green light to use of the drug as an add-on maintenance therapy for people aged over 12 with …

NICE changes stance on Sanofi’s Dupixent for severe asthma Read More »

What does the future of European healthcare look like?

After the “stress test” of COVID, how can the sector create resilient, sustainable healthcare systems for the long term? COVID has taught us that future proofing healthcare systems has to be everyone’s main priority in the coming years. That’s according to the speakers at a roundtable session, held as part of the Reuters Events: Pharma …

What does the future of European healthcare look like? Read More »

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 disease waiting for new treatment options. In a provisional decision, NICE has said Ponvory (ponesimod) should not be available routinely on the NHS in England and Wales for relapsing forms …

Consternation as NICE rejects Janssen MS drug Ponvory Read More »

Novartis’s Adakveo (crizanlizumab) Receives NICE Recommendation as a New Therapy for Sickle Cell Disease

Shots: The NICE has recommended Novartis’ Adakveo (crizanlizumab) as a new treatment option to prevent recurrent sickle cell crises in patients aged ≥16 Additionally, patients will now have access to this treatment option on the NHS. The clinical evidence demonstrated that the people treated with crizanlizumab have significantly fewer sickle cell crises in a year …

Novartis’s Adakveo (crizanlizumab) Receives NICE Recommendation as a New Therapy for Sickle Cell Disease Read More »

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 special arrangement between the drugmaker and NICE. The decision makes Adakveo (crizanlizumab) the first new treatment for SCD available via the NHS for 20 years, according to the cost-effectiveness agency, …

Joy as sickle cell patients get access to Novartis’ Adakveo after NICE ruling Read More »

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 the Cancer Drugs Fund (CDF). The PD-L1 inhibitor was initially turned down by NICE for a form of bladder cancer called urothelial carcinoma (UC), but Roche was encouraged to make …

NICE clears NHS use of Roche’s Tecentriq in bladder cancer Read More »

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. Keytruda (pembrolizumab) has been given the green light for use alongside platinum- and fluoropyrimidine-based chemotherapy in patients with locally advanced or metastatic oesophageal cancer that cannot be treated with surgery. …

Keytruda backed by NICE for late-stage oesophageal cancer Read More »

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 (berotralstat) – which was approved by the EMA and MHRA in April and May, respectively – is set to become the first oral, once-daily therapy that can be used to …

NICE backs BioCryst’s Orladeyo for hereditary angioedema Read More »

NICE changes its mind on J&J’s Erleada in prostate cancer

NICE has reversed its position on Johnson & Johnson’s oral prostate cancer therapy Erleada in patients with hormone-relapsed or hormone sensitive tumours, backing NHS use of the drug. The change of heart comes after J&J’s Janssen pharma unit offered an improved discount on Erleada (apalutamide), according to the cost-effectiveness watchdog in its final appraisal determination, …

NICE changes its mind on J&J’s Erleada in prostate cancer Read More »

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 says in draft guidance that Cosentyx (secukinumab) should be offered as an option to patients in this age bracket who either don’t respond to or cannot tolerate other systemic treatments. …

NICE backs Cosentyx’ use in thousands of children with psoriasis Read More »

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 to NICE. The PCSK9-targeting oligonucleotide – which is already available in Scotland – requires dosing just twice a year and has been approved by the health technology assessment (HTA) agency …

NICE backs NHS use of Novartis’ cholesterol drug Leqvio Read More »

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 type of bone marrow cancer. The draft document covers the use of Darzalex (daratumumab) as an add-on to standard induction treatment with Takeda’s Velcade (bortezomib) plus thalidomide and dexamethasone given …

NICE rejects J&J’ Darzalex regimen for multiple myeloma Read More »

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 use, after getting a green light from NICE. The decision means around 170 people with advanced SM in England and Wales will be eligible for  treatment with oral, twice-daily drug, …

NICE says yes to Novartis’ Rydapt for rare blood disorder Read More »

A problem combination?

Leela Barham takes stock of past NICE decisions for combinations to explore the scale of the reimbursement challenge for combination therapies. Combination therapies are now common in therapy areas like cancer. There have been cases where even if a new treatment used in combination were offered at zero cost to the NHS that it would …

A problem combination? Read More »

NICE changes stance on Lilly’s breast cancer dug Verzenio

After rejecting Eli Lilly’s Verzenio for breast cancer therapy earlier this year, NICE has relented, recommending the drug for routine NHS use alongside hormonal therapy fulvestrant. A final appraisal document from the health technology assessment (HTA) agency backs the use of Verzenio (abemaciclib) alongside fulvestrant for the treatment of women with hormone receptor-positive, HER2-negative breast …

NICE changes stance on Lilly’s breast cancer dug Verzenio Read More »

Scotland backs Bavencio for bladder cancer after NICE says no

Patients with bladder cancer in Scotland will be the first in the UK to claim access to maintenance treatment with Merck Serono and Pfizer’s Bavencio, ahead of their counterparts in England and Wales. The Scottish Medicines Consortium (SMC) has cleared NHS funding for Bavencio (avelumab) as a first-line maintenance therapy for people with advanced urothelial …

Scotland backs Bavencio for bladder cancer after NICE says no Read More »

How to balance the patient voice atop the shifting plates of HTA

The tectonic plates of healthcare technology assessment (HTA) have shifted – but where does the patient voice fit within this new evaluation paradigm? Recent advances in medical science, from genomics and gene therapies to artificial intelligence (AI), have transformed the healthcare landscape, and triggered a review of NICE’s methods and processes. Consultation on the proposals …

How to balance the patient voice atop the shifting plates of HTA Read More »

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 a new fast-track scheme introduced by NICE. The IL-17 inhibitor is the first to go through a new process aimed at accelerating appraisals for drugs deemed to be low-risk, which …

UCB’s bimekizumab ‘pre-approved’ using NICE fast-track scheme Read More »

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 money. The green light for Pemazyre (pemigatinib) has been hailed by cholangiocarcinoma charity AMMF, which said it was a “major milestone” in the fight against the “Cinderella” cancer, which for …

NICE changes its mind on rare bile duct cancer drug from Incyte Read More »

NICE second Zytiga rejection ‘shows need for flexible pricing models’

NICE has stuck with its original decision to reject NHS funding for Johnson & Johnson’s Zytiga as a treatment for men with newly diagnosed advanced prostate cancer, drawing criticism from the Institute of Cancer Research (ICR).  The UK cost-effectiveness body first turned down Zytiga (abiraterone acetate) for this use in June 2020, but said four …

NICE second Zytiga rejection ‘shows need for flexible pricing models’ Read More »

NICE feedback?

The National Institute for Health and Care Excellence (NICE) is quite far along a NICE-led process to review its methods and processes for evaluating technologies. As part of that work, NICE is engaging widely with stakeholders, including patient organisations. Leela Barham provides an independent view of patient organisations responses to a NICE online survey and …

NICE feedback? Read More »

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 said that while there was evidence of a short-term benefit with Libmeldy (atidarsagene autotemcel or OTL-200), assumptions about its long-term effects are uncertain, making it unclear whether it will offer …

NICE rejects Orchard’s gene therapy for rare childhood disease MLD Read More »

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 use in non-radiographic axial spondyloarthritis (nr-axSpA), a form of arthritis affecting the joints of the spine. IL-17 inhibitor Cosentyx (secukinumab) is already approved by NICE to treat ankylosing spondylitis or …

NICE backs Novartis’ Cosentyx for underdiagnosed back condition Read More »

Artificial pancreas will be piloted in 1,000 diabetics, says NHS CEO

NHS England will provide artificial pancreas devices to 1,000 type 1 diabetes patients as part of a pilot study of the technology, according to chief executive Sir Simon Stevens. The diabetics will be offered the closed-loop systems, which continually monitor glucose levels in the blood and uses the data to automatically adjust the dose of …

Artificial pancreas will be piloted in 1,000 diabetics, says NHS CEO Read More »

How the patient voice is becoming vital for drug approval

Rebecca Sanders from Lipodystrophy UK tells us how the patient voice helped convince NICE to approve a much-needed drug for this rare disease, and explores how regulators and pharma companies can help make patient involvement in HTA more impactful. This article appears in our free digital magazine Deep Dive: Market Access 2021. Read below for …

How the patient voice is becoming vital for drug approval Read More »

Time for a NICE change

The National Institute for Health and Care Excellence (NICE) is world-renowned for their work assessing the clinical and cost-effectiveness of new treatments. In recognition of how the world has changed over its history, NICE is coming to the end of a period of review and consultation on their processes and methods. Leela Barham takes stock. …

Time for a NICE change Read More »

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 surprise to patient association SMA UK. The cost-effectiveness agency’s initial assessment is that Evrysdi is simply too expensive at its current price to be provided to the roughly 1,500 people …

NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group Read More »

NICE rejects J&J’s prostate cancer drug Erleada in initial guidance

NICE has rejected Johnson & Johnson’s oral prostate cancer drug Erleada (apalutamide) in patients with hormone-relapsed or hormone sensitive disease in first draft guidance. The cost-effectiveness body is assessing Erleada, plus androgen deprivation therapy (ADT), for prostate cancer in adults who have hormone-relapsed non-metastatic disease at high risk of metastasising and hormone-sensitive metastatic disease. Hormone …

NICE rejects J&J’s prostate cancer drug Erleada in initial guidance Read More »

How will NICE fare in a post-Brexit world?

NICE has a global reputation as a pioneering HTA – but is that influence at risk now that the UK has left the EU? Experts from ICON give us their views on the past, present and future of NICE’s standing on the world stage. This article appears in our digital magazine, Deep Dive: Market Access …

How will NICE fare in a post-Brexit world? Read More »

NICE says final ‘no’ to BMS’ Zeposia for multiple sclerosis

NICE has issued a final “no” to Bristol-Myers Squibb’s oral MS drug Zeposia (ozanimod), in a decision that prevents access for patients in England and Wales. This ruling means that there will be a divide in access to Zeposia in the UK, after the Scottish Medicines Consortium allowed funding in February for the drug in …

NICE says final ‘no’ to BMS’ Zeposia for multiple sclerosis Read More »

NICE says ‘no’ to Pfizer’s Vyndaqel for rare heart condition

NICE has rejected regular NHS funding for Pfizer’s Vyndaqel (tafamidis) for a rare heart condition, although it has left the door open for negotiations if the pharma decides to drop its price. Pfizer had appealed against draft guidance from NICE that rejected Vyndaqel for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) on cost grounds. The pharma unsuccessfully …

NICE says ‘no’ to Pfizer’s Vyndaqel for rare heart condition Read More »

NICE’s Office for Digital Health opens its doors

UK cost-effectiveness agency NICE has this week officially opened the Office for Digital Health, one of the pillars of its five-year strategy out to 2026.  The in-house team of advisors has been set up by the health technology assessment (HTA) agency to spearhead its policy on digital health technologies (DHTs) – including apps, programmes and …

NICE’s Office for Digital Health opens its doors Read More »

Patients in England get fast access to AZ’s Tagrisso in early lung cancer

The UK’s drugs regulator has swiftly granted a licence extension for AstraZeneca’s Tagrisso in certain patients with early stage lung cancer, with NICE allowing fast access to patients on England’s NHS. The arrangements under Project Orbis, a global project run by the FDA that the Medicines and Healthcare products Regulatory Authority is supporting, aim to …

Patients in England get fast access to AZ’s Tagrisso in early lung cancer Read More »

Deep Dive: Market Access

It’s fair to say this is the most interesting time ever for market access. Not only has COVID forced companies, governments and healthcare systems to work towards approving drugs and vaccines in record times, the sector is also facing an influx of digital therapeutics and advanced drugs that don’t fit neatly into existing access frameworks. …

Deep Dive: Market Access Read More »

The next five years of NICE: Challenges, opportunities, and the future of technology assessment

If NICE is to remain a “beacon of evidence-based medicine”, it must become more agile, more flexible, and more ready to adapt – and COVID-19 has proved that it is more than capable of doing so. NICE is about to undergo a complete transformation in a bid to get ready – and stay ready – …

The next five years of NICE: Challenges, opportunities, and the future of technology assessment Read More »

Enhertu cleared for NHS use via Cancer Drugs Fund

NICE has recommended the use of AstraZeneca and Daiichi Sankyo’s Enhertu in draft guidance, the first time the drug has been commissioned in any European country.  The UK health technology assessment (HTA) agency has backed Enhertu (trastuzumab deruxtecan) as a therapy for HER2 positive breast cancer which can’t be surgically removed or which has spread …

Enhertu cleared for NHS use via Cancer Drugs Fund Read More »

NICE unveils five year plan promising faster access to medicines

NICE has included proposals to speed up evaluations and focus on new technology such as digital health in a new strategy to provide faster access to new medical treatments and innovations. The cost-effectiveness body has produced a new vision for the next five years, after reflecting on lessons learned during the COVID-19 pandemic. NICE said …

NICE unveils five year plan promising faster access to medicines Read More »

NICE unveils five year plan promising faster access to medicines

NICE has included proposals to speed up evaluations and focus on new technology such as digital health in a new strategy to provide faster access to new medical treatments and innovations.  The cost-effectiveness body has produced a new vision for the next five years, after reflecting on lessons learned during the COVID-19 pandemic. NICE said …

NICE unveils five year plan promising faster access to medicines Read More »

NICE recommends Alexion’s long-acting Ultomiris for PNH

NICE has recommended Alexion’s long-acting Ultomiris (ravulizumab) for the rare disease paroxysmal nocturnal haemoglobinuria (PNH) in final draft guidance. Ultomiris is Alexion’s follow-up to its rare diseases blockbuster Soliris (eculizumab), which allows for  an eight-week dosing schedule after a loading phase. This is more patient-friendly than Soliris, which requires infusions every two weeks, a considerable …

NICE recommends Alexion’s long-acting Ultomiris for PNH Read More »

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 affecting children and adults. The final guidance concludes that interleukin-1 receptor antagonist Kineret (anakinra) can be used as a treatment for two forms of Still’s, namely systemic juvenile idiopathic arthritis …

NICE backs Sobi’s Kineret for rare inflammatory disease Read More »

NICE methods and process review aims to create fertile ground for innovation

The way NICE reviews new medicines is about to go through its biggest change in years – but what do the proposals mean for the future of drug development in the UK? Amanda Barrell spoke to Dr Paul Catchpole, director of value and access policy at the ABPI, to find out. From COVID-19 and Brexit, …

NICE methods and process review aims to create fertile ground for innovation Read More »

NICE backs ovarian cancer and multiple myeloma combination drugs

NICE has recommended funding for two cancer drug combinations for ovarian cancer and multiple myeloma. In final draft guidance that applies to England, NICE said AstraZeneca/MSD’s Lynparza (olaparib) plus Roche’s Avastin (bevacizumab) should be reimbursed by the Cancer Drugs Fund in people with ovarian cancer that have responded to platinum chemotherapy. Early results from the …

NICE backs ovarian cancer and multiple myeloma combination drugs Read More »

NICE backs ovarian cancer and multiple myeloma combination drugs

NICE has recommended funding for two cancer drug combinations for ovarian cancer and multiple myeloma. In final draft guidance that applies to England, NICE said AstraZeneca/MSD’s Lynparza (olaparib) plus Roche’s Avastin (bevacizumab) should be reimbursed by the Cancer Drugs Fund in people with ovarian cancer that have responded to platinum chemotherapy. Early results from the …

NICE backs ovarian cancer and multiple myeloma combination drugs Read More »

NICE says NHS should fund Novartis’ £1.79m SMA gene therapy

The NHS should pay for Novartis’ £1.79 million one-off gene therapy for Spinal Muscular Atrophy (SMA) NICE has said, the most expensive treatment ever approved for funding. In first draft guidance NICE said Zolgensma (onasemnogene abeparvovec) should be made available for babies up to 12 months with type 1 SMA, although the age restriction is …

NICE says NHS should fund Novartis’ £1.79m SMA gene therapy Read More »

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 draft guidance from NICE. The cost-effectiveness agency is assessing use of Lynparza (olaparib) in patients with tumours that carry BRCA1 or BRCA2 mutations who have previously been treated with the …

NICE says no to AZ’s Lynparza for prostate cancer Read More »

Lilly’s Olumiant is first JAK drug backed by NICE for eczema

Eli Lilly’s JAK inhibitor Olumiant has become the first drug in the JAK inhibitor class to be recommended for NHS use in England and Wales as a treatment for atopic dermatitis, also known as eczema. Olumiant (baricitinib) has been backed by cost-effectiveness agency NICE  to treat moderate to severe atopic dermatitis in adults who haven’t …

Lilly’s Olumiant is first JAK drug backed by NICE for eczema Read More »

NICE okays regular NHS funding for Novartis’ breast cancer drug Kisqali

NICE has recommended moving Novartis’ Kisqali (ribociclib) from interim funding arrangements to regular NHS reimbursement for certain previously treated breast cancer patients. In the final draft guidance, NICE recommended Kiskali be taken out of the Cancer Drugs Fund, which has been providing interim reimbursement since 2019 until further trial data emerged addressing uncertainties about overall …

NICE okays regular NHS funding for Novartis’ breast cancer drug Kisqali Read More »

bluebird bio ‘baffled’ after NICE rejects beta-thalassaemia gene therapy

It’s back to the drawing board for bluebird bio and its discussions with NICE, which has rejected its beta thalassaemia gene therapy Zynteglo for regular NHS use in first draft guidance. NICE is assessing Zynteglo (betibeglogene autotemcel), a one-off gene therapy for the condition, which can have life-threatening consequences and is associated with a curtailed …

bluebird bio ‘baffled’ after NICE rejects beta-thalassaemia gene therapy Read More »

NICE backs NHS funding for MSD’s Keytruda combination in lung cancer

NICE has backed regular NHS funding England and Wales for Merck, Sharp and Dohme’s Keytruda in combination with pemetrexed and platinum chemotherapy in certain lung cancer patients. In draft guidance NICE said the Keytruda (pembrolizumab) and chemo combination can now be reimbursed by the NHS in adults with untreated non-squamous non-small cell lung cancer (NSCLC) …

NICE backs NHS funding for MSD’s Keytruda combination in lung cancer Read More »

UK patient group warns COVID could limit access to Novartis’ new eye drug

NICE has recommended regular NHS funding for Novartis’ long-acting eye drug Beovu (brolucizumab) in England and Wales – but a patient group warned that access could be limited until the pandemic recedes because of disruption to ophthalmology clinics. In final guidance NICE said trials have shown Novartis’ Beovu has similar efficacy in wet advanced macular …

UK patient group warns COVID could limit access to Novartis’ new eye drug Read More »

NICE reverses stance on Celgene’s Revlimid for myeloma maintenance

NHS patients in England with newly-diagnosed multiple myeloma can be treated with Celgene’s Revlimid as maintenance therapy after a stem cell transplant, after new guidance from NICE. The cost-effectiveness agency has backed interim funding for Revlimid (lenalidomide) in this setting via the Cancer Drugs Fund (CDF), which provides temporary reimbursement for medicines until further data …

NICE reverses stance on Celgene’s Revlimid for myeloma maintenance Read More »

Unlocking health data to improve oncology outcomes

As the largest single-payer healthcare system in Europe, the UK’s National Health Service (NHS) has a uniquely beneficial health data and real-world evidence (RWE) environment. It’s one that has global potential to improve patient outcomes but efforts to harness the true potential of these information flows are only just beginning. The foundation for this is …

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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 by cost-effectiveness agency NICE. Jyseleca (filgotinib) has been recommended for moderate and severe active RA in patients who have responded inadequately to intensive therapy with two or more conventional disease-modifying …

NICE backs broad use for Gilead/Galapagos arthritis pill Jyseleca Read More »

NHS and Kite sign access deal for Kite’s cancer cell therapy Tecartus

NHS patients in England will be among the first in the world to receive Gilead’s Tecartus cancer cell therapy for certain types of lymphoma, after the company’s specialist Kite unit struck a deal with NICE.  Marketed as Tecartus (autologous anti-CD19-transduced CD3+) in Europe, the drug was approved in the EU in December for adults with …

NHS and Kite sign access deal for Kite’s cancer cell therapy Tecartus Read More »

NICE recommends interim funding for GSK’s Zejula in ovarian cancer

Women with newly-diagnosed advanced ovarian cancer have a new treatment option in England after NICE recommend interim funding for GlaxoSmithKline’s Zejula (niraparib) in final guidance. Zejula competes with AstraZeneca/Merck & Co’s PARP inhibitor class rival Lynparza (olaparib) but in this case it has an advantage in this maintenance therapy use as it can be used …

NICE recommends interim funding for GSK’s Zejula in ovarian cancer Read More »

2021 – UK market access prospects

With a new year comes the opportunity to think ahead for the market access landscape for the coming year. 2020 was a big year for market access initiatives in the UK, many of which are only just starting, and their impact will come through in 2021 and beyond. Looking back at key market access news …

2021 – UK market access prospects Read More »

Unconvinced by NHS test run, NICE rejects BMS’ Opdivo in head and neck cancer

NICE has rejected Bristol Myers Squibb’s immunotherapy Opdivo as a second-line treatment for head and neck cancer in first draft guidance, unconvinced by evidence unearthed during a three-year NHS trial period. In its latest guidance, NICE said that clinical trial data gathered so far and real-world evidence did not convince about the cost-effectiveness of Opdivo …

Unconvinced by NHS test run, NICE rejects BMS’ Opdivo in head and neck cancer Read More »

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 England and Wales. Forxiga (dapagliflozin) – originally developed as a type 2 diabetes drug – is the first SGLT2 inhibitor to be approved for the treatment of symptomatic chronic heart …

NICE backs AZ’s Forxiga for heart failure Read More »

CLL patients in England to get AZ’s Calquence after okay from NICE

NHS England is to grant immediate access to AstraZeneca’s cancer drug Calquence (acalabrutinib) for certain patients with chronic lymphocytic leukaemia (CLL) after NICE backed it in first draft recommendations. NICE recommended regular NHS funding for Calquence in CLL who are considered high-risk due to 17p deletion or TP53 mutations. It is also recommended for adults …

CLL patients in England to get AZ’s Calquence after okay from NICE Read More »

iRhythm digital heart monitoring service backed by NICE

A heart monitor developed by iRhythm has become the first product to be endorsed by NICE in a pilot project covering digital health technologies. In new guidance, the health technology assessment (HTA) agency has recommended iRhythm’s Zio XT service for detecting abnormal heart rhythms – provided NHS organisations that deploy it collect evidence of its …

iRhythm digital heart monitoring service backed by NICE Read More »

NICE says yes to Braftovi combination for colorectal cancer

Two months after rejecting Pierre Fabre’s Braftovi for a rare form of metastatic colorectal cancer (mCRC), NICE has changed its mind, and now says the drug can be funded by the NHS in England, Wales and Northern Ireland. The cost-effectiveness agency has backed the combination of Braftovi (encorafenib) and Eli Lilly’s Erbitux (cetuximab) as a …

NICE says yes to Braftovi combination for colorectal cancer Read More »

NICE backs Lilly’s Emgality for migraine, adding pressure on Novartis rival

UK cost-effectiveness agency NICE has said that Eli Lilly’s Emgality can be made available through the NHS for migraine prevention, the second drug in the CGRP inhibitor class to achieve that milestone. The decision means that with two CGRP antibodies now cleared for migraine prevention, the first drug in the class to be approved in …

NICE backs Lilly’s Emgality for migraine, adding pressure on Novartis rival Read More »

Vertex Pharma’s vision for reimbursement innovation

As regional vice president for Northern Europe & Australia, Simon Lem led the digital launch of Vertex Pharma’s novel cystic fibrosis drug Kaftrio. He tells pharmaphorum about embracing digital change and the need for innovative reimbursement solutions. For Vertex, COVID-19 accelerated a digital transformation much needed for the patients they serve. As the leading developer …

Vertex Pharma’s vision for reimbursement innovation Read More »

NICE okays Roche liver cancer immunotherapy, Sanofi’s rare disease drug

Previously-untreated patients with hepatocellular carcinoma (HCC), a common form of liver cancer, will have an immunotherapy-based treatment option after NICE gave the nod to NHS funding of Roche’s Tecentriq and Avastin combination therapy. The decision by NICE comes shortly after Tecentriq (atezolizumab) and Avastin (bevacizumab) was approved by the European Commission as a first-line treatment …

NICE okays Roche liver cancer immunotherapy, Sanofi’s rare disease drug Read More »

After two decades, NICE begins consultation on drug assessment methods

The UK’s drug cost-effectiveness body NICE has launched a public consultation, presenting the case for change about how it assesses medicines, medical devices and diagnostics. NICE has been assessing medicines for 21 years using the Quality Adjusted Life Year (QALY) – the cost to ‘buy’ a patient a year of quality life – as its …

After two decades, NICE begins consultation on drug assessment methods Read More »

Price cut leads NICE to back Novo Nordisk’s obesity drug Saxenda

Novo Nordisk’s Saxenda has been recommended by NICE as a treatment for obesity, ending a 10-year drought in new drug therapies for weight management. The cost-effectiveness agency for England and Wales has recommended Saxenda (liraglutide) as a treatment option for people with a body mass index (BMI) of 35 or more, and who are also …

Price cut leads NICE to back Novo Nordisk’s obesity drug Saxenda Read More »

NICE talking to you: Trends in early HTA engagement

With exclusive data from Freedom of Information (FOI) requests sent to the National Institute for Health and are Excellence (NICE), Leela Barham takes a look at the trend in early engagement with the UK’s HTA body. In 2009, NICE was one of the first health technology assessment (HTA) agencies to offer the opportunity for early …

NICE talking to you: Trends in early HTA engagement Read More »

NICE changes stance on Keytruda for first-line head and neck cancer

As recently as June, NICE was minded not to back routine NHS of MSD’s Keytruda as a first-line treatment for advanced head and neck cancer, but it has had a partial change of heart on the drug after the company submitted new data. Just-published draft final guidance from the cost-effectiveness agency gives a green light …

NICE changes stance on Keytruda for first-line head and neck cancer Read More »

Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma

Shots: The NICE has issued FAD which is based on the P-III ICARIA-MM trial assessing isatuximab + pom-dex vs pom-dex in patients prior treated with 3L treatment and at least 2L therapies including lenalidomide and a proteasome inhibitor with RRMM in 307 patients with RRMM The study demonstrated that the combination regimen demonstrated a reduction …

Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma Read More »

Lilly to buy private biotech Disarm Therapeutics for up to $1.36bn

Eli Lilly is to buy the private biotech Disarm Therapeutics, which is working on a new class of disease-modifying drugs for neurological diseases, in a deal worth up to $1.36 billion. Massachusetts-based Disarm is focused on treatments for diseases caused by axonal degeneration, such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis. Disarm has discovered …

Lilly to buy private biotech Disarm Therapeutics for up to $1.36bn Read More »

NICE changes its mind on Novartis’ progressive MS drug Mayzent

UK cost-effectiveness agency NICE has backed Novartis’ Mayzent for secondary progressive multiple sclerosis (SPMS), after turning it down earlier this year in draft guidance. The change of heart means Mayzent (siponimod) becomes the first oral disease-modifying therapy to be recommended for NHS use in SPMS patients with active disease, defined as relapses or evidence of …

NICE changes its mind on Novartis’ progressive MS drug Mayzent Read More »

NICE recommends regular NHS funding for Roche’s lymphoma drug Polivy

NICE has recommended regular NHS funding for Roche’s Polivy in certain lymphoma patients in final draft guidance, overturning a previous rejection. The new guidance recommends Polivy (polatuzumab vedotin) in combination with rituximab and bendamustine, for adults with diffuse large B-cell lymphoma (DLBCL), in second line when patients cannot have a stem cell transplant. Around 4,800 …

NICE recommends regular NHS funding for Roche’s lymphoma drug Polivy Read More »

How does HTA for orphan drugs differ across europe?

New research looks at the factors that speed up and slow down HTA appraisals for rare disease medicines across Europe. Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier. Several factors make it difficult for HTA …

How does HTA for orphan drugs differ across europe? Read More »

NICE backs kidney cancer combination from Merck KGaA and Pfizer

NICE has said a combination of Merck KGaA’s Bavencio and Pfizer’s Inlyta should be available as a first line option for kidney cancer patients for NHS patients in England. The cost-effectiveness body okayed interim reimbursement from the Cancer Drugs Fund (CDF) in final guidance for adults with advanced renal cell carcinoma. NICE said that the …

NICE backs kidney cancer combination from Merck KGaA and Pfizer Read More »