NICE Roundup: Approval for MS Drug

Peter Russell

May 14, 2019

A multiple sclerosis (MS) drug was approved for routine NHS use in England and Wales after the manufacturer agreed a new price discount.

In final draft guidance, NICE said it would approve ocrelizumab (Ocrevus, Roche) for treating early primary progressive MS (PPMS) with imaging features characteristic of inflammatory activity in adults.

It said the confidential agreement between the company and NHS England would make ocrelizumab the first disease-modifying treatment for PPMS, available at a lower price.

An appraisal committee said there was an unmet clinical need for people with this particular type of MS. Ocrelizumab had been shown to slow the advance of PPMS, although it was unclear by how much and for how long, it said.

Roche has estimated that around 2700 people could be eligible for treatment with ocrelizumab.

It is given as an infusion during an outpatient appointment once every 6 months.

The average cost per patient per year is £19,160 at its list price, based on twice yearly 600 mg infusions.

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: "Our earlier draft guidance acknowledged that ocrelizumab represents an important development in the treatment of a condition for which there is a large unmet need. Unfortunately we couldnt recommend it at the price offered at that time because it did not represent a cost-effective use of limited NHS resources.

"We are therefore pleased that NHS England and the company have been able to reach an agreement that will see this important new treatment made available to thousands of people with this form of MS."

The MS Trust welcomed the decision. David Martin, chief executive officer, said: "We commend the willingness of all three parties to find a solution which enables people with early, inflammatory primary progressive MS to access a treatment which will allow them to continue working and remain independent for longer."

Atrial Fibrillation

NICE rejected the routine adoption of lead-I electrocardiogram (ECG) devices (imPulse, Kardia Mobile, MyDiagnostick, Zenicor-ECG) for detecting atrial fibrillation when used for single time point testing in primary care for people with signs or symptoms of the condition and an irregular pulse.

It said there was not enough evidence to give a positive recommendation.

Further research should be undertaken to assess the number of people with atrial fibrillation that would be detected, and how ECGs generated by the device would be interpreted in practice, NICE said in final guidance.

Breast Cancer Drug for CDF

Abemaciclib (Verzenios, Eli Lilly) 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 people who have had endocrine therapy.

The therapy would be appropriate only if exemestane (Aromasin, Pfizer and others) plus everolimus (Certican, Novartis) would be the most appropriate alternative, and the conditions in the managed access agreement for abemaciclib with fulvestrant were followed, NICE said in final guidance.

Clinical trial evidence suggested that compared with fulvestrant alone, abemaciclib with fulvestrant increased the length of time before the disease progressed, appraisers said. Inclusion in the CDF is expected to yield further data to eliminate some of the uncertainties surrounding how much longer patients might live as a result of the treatment.

PICO Negative Pressure Wound Dressing Approval

PICO (Smith & Nephew) negative pressure wound dressings were recommended as an option for closed surgical incisions in people who were at high risk of developing surgical site infections.

In final guidance, NICE said clinical evidence showed that PICO dressings could lead to fewer surgical site infections, and that they reduced rates of seromas compared with standard wound dressings.

A cost analysis also showed that PICO dressings did not add to the overall costs of treatment.

PICO dressings are available in eight different sizes. Each pack includes a single-use pump and two dressings. The list prices for PICO dressings range from £127.06 to £145.68.

Curos for Preventing Infections

Research was needed to address uncertainties about the clinical benefits of using the Curos disinfecting cap (3M), NICE said in final practice guidelines.

The single-use device which is placed over the needleless connector of vascular access lines, showed promise in preventing infections, an appraisal committee said.

In order to assess whether the device should be adopted for routine NHS use, NICE said research should focus on whether Curos "adds value to the standard bundle of care", was suitable for patients at high risk of infection, and for which patient groups the device would be most appropriate.

Prostate Cancer Guidelines

NICE updated its guidance on diagnosing and managing prostate cancer.

An appraisal committee said it saw no new evidence to suggest that any changes were needed to the recommendations on imaging in people who were not going to have radical treatment.

Among the updates, it said there was good evidence to show that multiparametric MRI was useful in identifying lesions before biopsy, and that the combination of MRI with prostate biopsy led to better identification of clinically significant prostate cancer than systematic prostate biopsy alone.

Technology to Relieve Cluster Headaches

More than 3000 people in the UK could benefit from new technology designed to tackle cluster headaches after the NHS said it would fund a handheld gadget to help relieve the pain.

The device is placed on the neck where it stimulates the vagus nerve using low levels of electric current in order to disrupt pain signals.

It is thought that the technology could benefit 1 in 20 people with cluster headaches who do not respond to traditional treatments such as prescription triptans, oxygen, or anticonvulsants.

NHS England (NHSE), which has contributed to funding, said the Government's long-term plan for the NHS put cutting-edge treatments at the heart of people's care and showed its commitment to speedy adoption of proven and affordable innovations.

Simon Stevens, chief executive of NHSE, said: "Innovative technologies like this could not only alleviate painful symptoms but could empower patients to claim back their ordinary daily lives."

Fit Notes Regional Data

New figures show for the first time regional disparities in the proportion of fit notes issued by GPs in England.

Between April and December 2018, 6.9 million fit notes were issued in England, with 3.9m issued to women (56.7%), and 3.0 million issued to men (43.3%). Of these, 93.1% were declared 'not fit for work' and 6.9% were declared 'maybe fit for work'.

The latest statistics from NHS Digital show that in December 2018, Knowsley Clinical Commissioning Group (CCG) issued the highest number of fit notes (3125 per 100,000 population) and Westminster CCG issued the lowest number (688 per 100,000 population).

During this month, 'mental health and behavioural disorders' was the largest reason for a fit note to be issued, accounting for 32.9% of known diagnoses. This was followed by 'diseases of musculoskeletal system and connective tissue', which accounted for 16.7% of fit notes issued.

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