CDF Approval for Immunotherapy Drug

Peter Russell

November 23, 2018

In two separate announcements this week, the National Institute for Health and Care Excellence (NICE) recommended pembrolizumab (Keytruda, Merck Sharpe & Dohme) as a treatment option for certain types of lung cancer, as well as for some patients with melanoma.

There was also an announcement on widening eligibility of stroke patients to undergo thrombectomy, which may improve quality of life and reduce the risk of disability.

Pembrolizumab for Lung Cancer

Immunotherapy drug pembrolizumab with pemetrexed and platinum chemotherapy should be made available on the Cancer Drugs Fund (CDF) for people with lung cancer, NICE announced in draft guidance.

The treatment was recommended as an option for adults with untreated non-small-cell lung cancer, whose tumours have no epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-positive mutations.

NICE said it was unable to recommend the treatment for routine NHS use in England and Wales because of a lack of clinical evidence. However, it accepted that manufacturer-reported results from a clinical trial, suggesting that this pembrolizumab combination therapy gave patients nearly four additional months without their cancer progressing, compared with standard treatment of pemetrexed with platinum chemotherapy, made it suitable for inclusion on the CDF.

Pembrolizumab is administered every 3 weeks by intravenous infusion. The 200 mg infusion has a list price of £5,260, but the company offered the NHS a confidential discount.

The treatment will be available to NHS patients in England immediately, and final guidance is expected in January 2019.

NICE said it estimated that more than 3000 people in England may be eligible for the treatment.

Professor Charles Swanton, Cancer Research UK's chief clinician, commented: "This drug combination has shown significant benefits for some patients in clinical trials, helping them to survive their cancer for longer.

"This also shows the value of the Cancer Drugs Fund, which gives NICE the option to approve promising treatments while more data is collected on their long-term benefits. Lung cancer is the biggest cancer killer in the UK so it’s vital that innovations like this reach patients as quickly as possible."

Paula Chadwick, chief executive of the Roy Castle Lung Cancer Foundation, said: "We welcome this decision by NICE as it opens up access to immunotherapy to a group of lung cancer patients who were not previously eligible."

Pembrolizumab for Melanoma

NICE said it was also developing guidance on pembrolizumab for various other indications, including a CDF recommendation for it to be made an available option for some people with melanoma, which was also published this week.

The recommendation applied to adults who have disease that has spread to the lymph nodes and who have already had surgery to remove the tumour and associated lymph glands.

NICE said that clinical evidence suggested that pembrolizumab was likely to extend the time people remained cancer free, with nearly three-quarters of people having no recurrence of the disease at 18 months, compared with just over half of the people who received a placebo.

Pembrolizumab is administered by an IV drip every 3 weeks.

The treatment has been offered by Merck Sharp & Dohme at a confidential discounted price.

Meindert Boysen, director for NICE's Centre for Health Technology Evaluation, said: "There are currently no adjuvant immunotherapies recommended by NICE for people who have had surgery to remove their melanoma, a disease which even after surgical removal has a high risk of recurrence."

Pembrolizumab will be available to patients once its marketing authorisation has been received, which is expected to be in early December 2018.

Thrombectomy Following Stroke

Patients with acute ischaemic stroke should be offered thrombectomy up to 24 hours after the onset of symptoms, NICE said in a draft guideline.

Currently, thrombectomy is only offered to people with stroke up to 12 hours after onset.

Paul Chrisp, director for the centre for guidelines at NICE, explained: "New evidence shows that extending the eligibility period of thrombectomy to up to 24 hours can be very cost-effective.

"There is also a potential benefit for improved quality of life by reducing the level of disability people can experience as a result of a stroke."

NICE said the speed at which these recommendations were adopted by local NHS services would depend on available resources and other priorities. However, Dr Chrisp said the additional cost should be balanced against "the positive effects for other aspects of stroke care, such as a decrease in demand for in-patient rehabilitation and a reduction in the need for long-term social care."

Commenting on the draft guideline, Alexis Kolodziej from the Stroke Association said: "A bigger window for treatment means it could be a viable option for more patients, helping more people to make a better recovery."

However, she said that as the treatment was currently only offered to 1% of eligible patients, "We urgently need more trained professionals and services organised so they can deliver it."

NICE said it expected to publish a final guideline on May 01, 2019.

Prostate Cancer Drug Rejected

An appraisal committee rejected padeliporfin (Tookad, Steba Biotech) as a treatment for unilateral, low-risk prostate cancer in adults.

The manufacturer promoted the treatment as an option for patients with low-risk disease who chose not to have active surveillance and so would otherwise have radical therapies.

In final guidance, NICE said there was a lack of clinical evidence to show whether people having the treatment lived longer, and said there were concerns about long-term side-effects.

Antimicrobial Prescribing

An antimicrobial prescribing strategy for catheter-associated urinary tract infection in children, young people and adults was published.

NICE said it aimed to optimise antibiotic use and reduce antibiotic resistance.

The guideline included recommendations on treatment, advice when an antibiotic was given, choice of antibiotic, and prevention.

Surgical Infections

NICE invited comments on updated draft guidance on preventing and treating surgical site infections.

Changes to advice on the effectiveness of nasal decontamination, the effectiveness of skin antiseptics, the application of intraoperative topical antiseptics and antibiotics before wound closure, and the effectiveness of closure materials and techniques are out for consultation.

Final guidance is scheduled for April 2019.


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