NICE Marks 20 Years of Treatment Appraisals

Peter Russell

April 05, 2019

The National Institute for Health and Care Excellence (NICE) marked its 20th birthday this week.

The organisation, launched in 1999 as the National Institute for Clinical Excellence, developed a reputation for its independent appraisal of treatments, and replacing so-called 'postcode prescribing' with more joined up appraisals of what worked and was cost-effective.-

Professor Sir Munir Pirmohamed, president-elect of the British Pharmacological Society commented that NICE had "pioneered a new way to achieve consistency in the availability and quality of public health treatment and care" with a model that had "since been adopted in many countries".

Some of NICE's decisions over the past two decades have proved controversial, such as its conclusion within months of being set up not to recommend the antiviral flu treatment zanamivir (Relenza, GlaxoSmithKline, then Glaxo Wellcome) for routine NHS use on cost-effectiveness grounds.

This anniversary week also saw controversy for NICE with campaigners opposed to the use of surgical mesh to treat stress urinary incontinence or pelvic organ prolapse in women, angry that it was prepared to contemplate re-introduction of the procedure if certain conditions were met in the future.

We round up this week's major announcements from NICE, and a decision by the Government to impose tighter controls on two anticonvulsant drugs to help prevent their misuse.

Breast Cancer Treatment for CDF

Abemaciclib (Verzenio, Eli Lilly) in combination with fulvestrant (Faslodex, AstraZeneca) was recommended for use within England's Cancer Drugs Fund (CDF) as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in patients who have had endocrine therapy.

In final draft guidance, NICE said the CDK4/6 inhibitor would be an option for up to 4800 women where exemestane (Aromasin, Pfizer) plus everolimus (Afinitor, Novartis) would be the most appropriate alternative treatment.

An appraisal committee said that clinical trial evidence from the MONARCH2 study suggested that compared with fulvestrant alone, abemaciclib with fulvestrant increased the length of time before the disease progressed.

Uncertainties around the overall survival benefit and the drug's cost-effectiveness meant it was not currently possible to recommend it for routine NHS use. Inclusion within the CDF would allow patient access while more data was collected, NICE said.

A review of the guidance will follow final analysis of data from MONARCH 2, expected in February 2020.

Meindert Boysen, director of the Centre for Health Technology Assessment at NICE, said: "The committee heard from patients that a treatment which could postpone or avoid the need for chemotherapy is important because chemotherapy has the potential to substantially reduce quality of life.

"They also highlighted the importance of people remaining in better health longer, without the disease progressing."

Baroness Delyth Morgan, chief executive at Breast Cancer Care and Breast Cancer Now, commented: "We are really encouraged that Lilly UK, NHS England and NICE have worked together to ensure patients can access this important new option whilst further data on its full benefits are collected.

"We hope NICE will be able to approve this combination for routine use following its time on the Cancer Drugs Fund, and look forward to further results to understand whether this combination will also extend patients' lives overall."

Kidney Carcinoma Treatment

Also recommended for CDF use this week was nivolumab (Opdivo, Bristol-Myers Squibb) with ipilimumab (Yervoy, Bristol-Myers Squibb) as an option for adults with untreated advanced renal cell carcinoma.

Patients would be eligible for treatment when their condition was intermediate or poor-risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria, NICE said in a final draft appraisal.

An appraisal committee said that for people with untreated advanced renal cell carcinoma that was at intermediate or high risk of getting worse, results from the CheckMate 214 clinical trial, showed that nivolumab with ipilimumab was more effective than one of the alternative treatments, sunitinib (Sutent, Pfizer), in the short term, but that its long-term effects were uncertain.

Nivolumab with ipilimumab had the potential to be cost effective, NICE said, and that inclusion on the CDF would allow access for patients while more data was gathered to address the clinical uncertainties.

Final guidance is expected on 15th May 2019.

'No' to Prostate Cancer Drug

NICE gave a negative assessment of enzalutamide (Xtandi, Astellas) for treating high-risk hormone-relapsed non-metastatic prostate cancer in adults.

Treatment with enzalutamide is intended for patients where their prostate cancer no longer responds to hormone treatment (androgen deprivation therapy), but has not yet spread beyond the prostate, and where the only option is to continue hormone treatment.

In draft guidance, NICE said that clinical trial evidence, including data from the double-blind randomised placebo-controlled PROSPER trial, showed that adding in enzalutamide extended the time until the cancer started spreading to other parts of the body. However, it said there was no evidence that it increased how long patients lived.

The list price of enzalutamide is £2734.67 per 112 capsules, with a daily dose of 4 capsules costing £97.67.

A commercial arrangement would apply if the technology was recommended but NICE said it did not consider the treatment to be a cost-effective use of NHS resources.

Final guidance is expected on 15th May 2019.

Surgical Mesh

A suggestion that surgical mesh to treat stress urinary incontinence or pelvic organ prolapse in women aged 18 and older could be used again in England subject to certain conditions being met proved controversial.

The use of vaginal mesh implants to treat complications after childbirth was paused in NHS hospitals in England last year after hundreds of women reported disabling complications as a result of the procedure.

The new NICE guidance recommended that non-surgical options should be considered before surgery was contemplated.

It acknowledged "limited evidence on the long-term adverse effects" of using surgical mesh to treat these conditions but said there was "evidence of benefit" for mesh procedures.

However, a committee's decision that "women should not be denied effective surgical options" prompted expressions of dismay from campaigners opposed to the procedure.

Baroness Julia Cumberlege, chair of The Independent Medicines and Medical Devices Safety Review, which is examining the use of surgical mesh, pointed out that the conditions it set to permit the procedure to be re-introduced had not been met. "This means that now and for the foreseeable future mesh should not be used to treat stress urinary incontinence either in the NHS or the independent sector," she said.

Consultation on Eye Inflammation Treatment

NICE announced a consultation on fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences) as an option for preventing relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye in adults.

It said that at this stage it was minded not to recommend the implant for routine NHS use.

Appraisers said the manufacturer should be asked for further evidence, including a revised cost-effectiveness model. It also wanted to compare the fluocinolone acetonide implant with the dexamethasone intravitreal implant (Ozurdex, Allergan), both as single and repeated implants.

The closing date for comments by clinical and patient experts and other interested parties is 24th April 2019.

Preterm Respiratory Care Guidance

NICE updated its clinical guideline for specialist neonatal respiratory care for babies born preterm.

The guideline covered specific aspects of respiratory support, including oxygen supplementation, assisted ventilation, treatment of some respiratory disorders, and aspects of monitoring for preterm babies in hospital.

It also included a visual timeline of interventions and support.

Tighter Controls on Two Anticonvulsant Drugs

Anticonvulsant drugs gabapentin and pregabalin, both generic with several branded formulations also have been reclassified as class C controlled substances, the Home Office announced this week.

The drugs have been placed under Schedule 3 of the 2001 Misuse of Drugs Regulations, although they are exempted from safe custody requirements.

Acting on advice from the Advisory Council on the Misuse of Drugs (ACMD), the Home Office said both pregabalin and gabapentin had been increasingly reported as drugs that presented a risk of addiction and a potential for illegal use.

In January this year, the ACMD noted particular concern about the misuse and abuse of pregabalin in Northern Ireland, where 10 cases of abuse were recorded at one A&E department in Belfast during 2012-13.

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