Breast Cancer Drug Available on CDF

Peter Russell

July 12, 2018

Announcements on breast cancer, lung cancer, and a single-use sterile elastic tourniquet for limb surgery feature in the latest announcements from NICE.

Advanced Breast Cancer

A potentially life-extending drug combination for some people with advanced breast cancer will be made available on England's Cancer Drugs Fund (CDF) following a recommendation by the National Institute for Health and Care Excellence (NICE).

The draft guidance recommended ribociclib (Kisqali, Novartis) with fulvestrant (Faslodex, AstraZenica) as an option for people with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer who have had previous endocrine therapy.

Clinical trial evidence suggested that compared with fulvestrant alone, the cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor with fulvestrant increased the length of time before the disease progressed. However, it was not known whether ribociclib increased the length of time people lived because final trial results were not yet available.

The committee said it recognised that ribociclib with fulvestrant had the potential to be cost-effective, and CDF listing would allow time until the end of 2020 when uncertainties around survival and cost-effectiveness were likely to be resolved.

Ribociclib is given as 3 x 200 mg tablets once daily for 21 consecutive days, followed by 7 days off treatment. A pack of 63 tablets has a list price of £2950. However, the manufacturer agreed to provide the drug at a confidential discount.

Meindert Boysen, director of the NICE Centre for Health Technology Evaluation, said: "Treatments that can postpone disease progression are important because they can reduce the number of people who are exposed to the often unpleasant side-effects of chemotherapy, and delay the need for its use in others.

"We are pleased therefore that the company has agreed a commercial arrangement for ribociclib that will allow it to be made available to people with this type of breast cancer." 

Subject to appeal, NICE’s final guidance will be published in August.

NICE had already approved abemaciclib (Verzenios, Eli Lilly) (also a CDK4/6 inhibitor) in combination with fulvestrant for the same indication within the CDF.

Access to Psychological Therapies

NICE issued guidance on a digital therapy for managing social anxiety disorder, panic disorder, and general anxiety disorder in adults under its Improving Access to Psychological Therapies (IAPT) programme.

It decided that the online programme, Velibra (Gaia Group) did not meet the criteria for the evaluation in practice phase of the NICE and NHS England IAPT assessment programme.

The programme, which uses the principles of cognitive behavioural therapy, was developed as an alternative to guided or unguided self-help.

The estimated cost of Velibra was £343 per person.

IAPT services provide evidence-based psychological therapies to people with anxiety disorders and depression.

A panel of experts assess digitally enabled therapies for anxiety, depression, and medically unexplained symptoms which offer the potential to expand these services further.

Lung Cancer

NICE updated its 2012 guidelines on diagnosing and managing lung cancer in adults.

Among the main changes in the draft quality standard were:

  • Adults with suspected or confirmed lung cancer who smoke should be referred to an evidence-based stop smoking service

  • Adults with lung cancer should have investigations to complete diagnostic staging and assess lung function before starting treatment with curative intent

  • Adults with non-small cell lung cancer stage I or II and good performance status should have treatment with curative intent

A consultation on the draft text runs until 23rd August, with a final version due to be published on 13th December 2019.

HemaClear for Bloodless Surgical Field During Limb Surgery

NICE issued a medtech innovation briefing (MIB) on HemaClear (Oneg HaKarmel Limited) for bloodless surgical field during limb surgery.

It described the innovative aspects of the single-use sterile elastic tourniquet, which the manufacturer claimed provided better limb exsanguination, and fewer side effects, such as tourniquet-induced skin damage, neuropraxia, and pain, compared with pneumatic tourniquet devices.

It could also be used outside the operating theatre, such as in a procedure room or accident and emergency, for minor cases.

The device comes in a variety of models for different limb circumferences (14 cm to 85 cm), and different systolic blood pressure limits.

The NICE briefing said that studies suggested that the device could be as effective as pneumatic tourniquets in providing a bloodless field in adult patients. However, uncertainties remained over outcomes such as pain, complications, and a lack of evidence over medium- to long-term follow up.

The cost of HemaClear was between £15.95 and £41.80 per unit. The cost impact could be reduced if the device shortened surgery time or was found to reduce the number of adverse events, the briefing concluded.

HermaClear was previously marketed as S-MART.

Drug Safety Updates

Febuxostat: The Medicines and Healthcare products Regulatory Agency (MHRA) issued a drug safety update on febuxostat (Adenuric, Ipsen) because of an increased risk of cardiovascular death and all-cause mortality in a clinical trial in patients with a history of major cardiovascular disease.

It said findings from the phase 4 CARES clinical study in patients with gout and a history of major cardiovascular disease showed a higher risk for cardiovascular-related death and for all-cause mortality in patients given febuxostat than in those receiving allopurinol.

Health professionals should avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease unless no other therapy options were appropriate, the MHRA said.

Tocilizumab: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be measured before starting treatment with tocilizumab (RoActemra, Roche), the MHRA advised.

It followed reports of serious liver injury involving treatment with tocilizumab from 2 weeks to more than 5 years after initiation.

ALT and AST levels should be monitored every 4 to 8 weeks for the first 6 months of treatment, followed by every 12 weeks thereafter, the agency said.

Rivaroxaban: The MHRA issued a reminder that 15 mg or 20 mg tablets of rivaroxaban (Xarelto, Bayer HealthCare) should be taken with food.

It said it had received reports suggesting a lack of efficacy in patients taking the medication on an empty stomach.


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