NICE has published final draft guidance recommending cemiplimab (Libtayo, Regeneron) for adults whose cancer has worsened during or after platinum-based chemotherapy, and who have not previously had immunotherapy.

Key points

• Around 90 adults a year are expected to be eligible.

• NICE said the treatment can prolong the time before disease progression and improve overall survival versus standard chemotherapy.

• Trial data from EMPOWER Cervical-1 showed average survival of 11.7 months with cemiplimab, compared with 8.5 months with single-agent chemotherapy.

• At 24 months, more than twice as many patients treated with cemiplimab were still alive.

• The treatment will be available immediately via the Cancer Drugs Fund before moving to routine NHS commissioning 90 days after final guidance is published.

Read more at https://www.nice.org.uk/news/articles/new-treatment-option-recommended-for-recurrent-or-metastatic-cervical-cancer

Indlægget NICE recommends cemiplimab for recurrent or metastatic cervical cancer blev først udgivet på NHTA.

NICE has recommended mirvetuximab soravtansine (Elahere, AbbVie) for adults with folate receptor-alpha-positive platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer after 1 to 3 previous treatments.

Key points:

• It is the first new NHS treatment for this patient group in over 20 years.

• In the MIRASOL study, overall survival was 16.9 months versus 13 months with chemotherapy.

• Time before disease worsened was 5.6 months versus 4 months with chemotherapy.

• The treatment is available now through the Cancer Drugs Fund and will later move to routine commissioning.

NICE said the treatment represents good use of NHS resources, taking into account the severity of the condition.

Read more at https://www.nice.org.uk/news/articles/nice-recommends-new-treatment-for-resistant-ovarian-cancer

Indlægget NICE recommends first new NHS treatment in over 20 years for women with resistant ovarian cancer blev først udgivet på NHTA.

NICE has published final draft guidance recommending nusinersen and risdiplam for certain people with spinal muscular atrophy (SMA) in England.

Key points:

• The medicines were previously available through managed access agreements while additional evidence was collected.

• NICE says the treatments can improve survival, slow disease progression and help patients maintain independence and quality of life.

• Data from the managed access period also reported fewer emergency hospital admissions and benefits for carers.

• The guidance supports access to both therapies, allowing clinicians, patients and families to choose the option best suited to individual needs.

SMA is a rare inherited condition that can cause progressive muscle weakness and, in its most serious forms, early death.

Read more at https://www.nice.org.uk/news/articles/nice-recommends-routine-nhs-access-to-sma-treatments-offering-new-hope-for-patients-and-families

Indlægget NICE opens routine NHS access to SMA treatments blev først udgivet på NHTA.

• Around 530 people in England are expected to benefit.

• The medicine will be funded immediately through the Innovative Medicines Fund.

• NICE says givinostat, also called Duvyzat and made by ITF Pharma, is the third recommended treatment for the condition.

The guidance notes that evidence from clinical trials suggests givinostat may extend the time people can walk by around five years on average compared with established clinical management, although the full benefit remains uncertain because of evidence limitations.

Read more at https://www.nice.org.uk/news/articles/nice-approves-duchenne-muscular-dystrophy-treatment-givinostat-after-commercial-deal-sealed

Indlægget NICE approves givinostat for Duchenne muscular dystrophy blev først udgivet på NHTA.

NICE has recommended rozanolixizumab (Rystiggo, UCB Pharma) for some adults with generalised myasthenia gravis (gMG) whose symptoms are not controlled by existing treatments. The recommendation was published on 29 April 2026.

Who is eligible (per draft guidance)

• Adults with gMG who test positive for AChR or MuSK antibodies.

• People who still have poorly controlled symptoms after trying standard treatments, which can include steroids.

What the evidence showed (as described by NICE)

• Adding rozanolixizumab to existing treatments reduced symptom severity.

• It helped people manage everyday activities more easily.

Access
NICE says the treatment could help around 800 adults in England and will be available on the NHS straight away through interim funding from the Innovative Medicines Fund. It is given as a short course of injections under the skin and can be supported by a homecare service.

Read more at https://www.nice.org.uk/news/articles/first-nice-recommended-treatment-for-uncontrolled-generalised-myasthenia-gravis

Indlægget NICE greenlights Rystiggo for uncontrolled gMG via interim NHS funding blev først udgivet på NHTA.

NICE has issued final draft guidance recommending zanidatamab (also known as Ziihera, from Jazz Pharmaceuticals) for routine use on the NHS in England for adults with HER2-positive advanced biliary tract cancer who have already had at least one treatment.

Key facts from the announcement:

• Eligible population: adults with HER2-positive advanced biliary tract cancer after ≥1 line of treatment.

• Expected uptake: around 65 people per year in England.

• Administration: intravenous infusion once every two weeks.

• Mechanism: binds to the HER2 protein on cancer cells to slow or stop tumour growth.

• Reported outcomes: clinical trial data showed an average survival of 18 months after taking zanidatamab vs around six months with standard chemotherapy.

• Comparator note: unlike FOLFOX, zanidatamab does not require a surgically implanted device, which can cause side effects including pain, exhaustion, and nerve damage.

Read more at https://www.nice.org.uk/news/articles/new-life-extending-treatment-given-the-green-light-for-people-with-rare-form-of-bile-duct-cancer

Indlægget NICE recommends zanidatamab for HER2-positive advanced biliary tract cancer blev først udgivet på NHTA.

**NICE** has published draft guidance recommending **pirtobrutinib** (also known as **Jaypirca**, made by **Eli Lilly**) for some adults with relapsed or refractory **chronic lymphocytic leukaemia (CLL)**.

Key points from the article:
– Around 200 people in England whose CLL has returned after treatment are expected to benefit from a new option.
– The draft recommendation is for people who have previously had a **Bruton’s tyrosine kinase (BTK) inhibitor**, and for whom further BTK inhibitor treatment is not suitable.
– Patient and clinical experts noted that taking pirtobrutinib as a tablet at home could reduce the need for frequent hospital visits and help people maintain independence.
– Experts also highlighted potential value for older people and those with other health conditions, including impaired kidney function.

The draft recommendations are open for public consultation until 5 pm on Monday, 11 May.

Read more at https://www.nice.org.uk/news/articles/new-take-at-home-drug-recommended-for-people-with-chronic-lymphocytic-leukaemia

Indlægget NICE backs Jaypirca in draft guidance for relapsed CLL blev først udgivet på NHTA.

In final draft guidance, NICE recommends belantamab mafodotin (also known as blenrep, gsk) in combination with bortezomib and dexamethasone for people in England whose multiple myeloma has relapsed after previous therapy. NICE says around 1,600 people a year could benefit, and the treatment can be offered by the NHS from today.

How it works
Belantamab mafodotin is described as a ‘trojan horse’ approach: an antibody carries the drug to myeloma cells and delivers a toxic agent directly to the target.

Evidence summary (as reported by NICE)

• Extends time before the disease progresses versus daratumumab + bortezomib + dexamethasone.

• Early results suggest people may live longer, but the trial is ongoing and uncertainty remains.

NICE notes the recommendation is broader than the previous draft, now covering anyone who has had 1 previous line of treatment (whether or not it included lenalidomide). Interim funding will be available immediately via the Cancer Drugs Fund, with final guidance expected later this month.

Read more at https://www.nice.org.uk/news/articles/trojan-horse-treatment-recommended-for-people-with-multiple-myeloma

Indlægget NICE recommends Blenrep for relapsed multiple myeloma blev først udgivet på NHTA.

NICE has launched a public consultation on the proposed adoption of the new EQ-5D-5L value set. According to NICE, the new value set will help it make more accurate assessments of how treatments improve health-related quality of life.

Scope

The current consultation includes proposed updates to NICE’s methods manuals, along with the results of 3 impact assessments examining how the EQ-5D-5L could affect: 

• cost-effectiveness calculations, including QALY estimates and incremental cost-effectiveness ratios 

• the number of decisions qualifying for the severity modifier and how it changes QALY shortfall estimates 

• equalities and health inequalities.

The consultation is open from Wednesday 15 April to Wednesday 13 May.

Read more at https://www.nice.org.uk/news/articles/have-your-say-on-nices-adoption-of-the-new-eq-5d-5l-value-set

Indlægget NICE seeks feedback on new EQ-5D-5L value set blev først udgivet på NHTA.

NICE has updated its fertility guideline to include a new, dedicated section for people with endometriosis who are struggling to conceive. NICE says this change followed feedback during public consultation from patients, patient groups, clinicians and professional bodies.

What changed

• Dedicated endometriosis pathway: endometriosis is treated as a distinct, diagnosed cause of fertility problems rather than being grouped with unexplained infertility.
• Terminology update: the terms “mild” and “severe” endometriosis were removed after consultation responses described them as clinically ambiguous.
• Personalised discussions: clinicians should consider factors such as time trying to conceive, symptom severity, age, ovarian reserve and male fertility factors.

Treatment pathway outlined
Where appropriate, expectant management or surgery (aligned with NICE endometriosis guideline NG73) may be offered. If these are not suitable or successful after 2 years, fertility treatments including IUI or IVF will be discussed.

Read more at https://www.nice.org.uk/news/articles/nice-recommends-new-dedicated-fertility-treatment-pathway-for-endometriosis

Indlægget NICE sets a dedicated fertility pathway for endometriosis blev først udgivet på NHTA.