NICE says yes to treatment for asthma in final draft guidance

In final draft guidance published today (7 March), NICE has recommended omalizumab (Xolair, Novartis Pharmaceuticals UK) as an option for treating severe, persistent allergic asthma in adults, adolescents and children following additional analyses and submission of a patient access scheme (PAS) by the manufacturer. In previous draft recommendations published for consultation in November 2012, NICE did not recommend the treatment.

Omalizumab is recommended as an option for treating severe, persistent confirmed allergic IgE-mediated asthma in people aged 6 years and older as an add-on to optimised standard therapy for those people who need continuous or frequent treatment with oral corticosteroids (defined as 4 or more courses in the previous year), only if the manufacturer makes omalizumab available with the agreed patient access scheme.

Omalizumab has a UK marketing authorisation as an add-on therapy to standard care to improve control of asthma in adults and adolescents (12 years and over) and children aged 6 to 11 years with severe persistent allergic asthma. It is currently only offered to those whose asthma remains poorly controlled despite receiving optimised standard therapy. Standard therapies for asthma include high-dose inhaled corticosteroids (which NICE has recommended), long-acting beta-2 agonists and, where appropriate, oral corticosteroids.

This appraisal of omalizumab is a review of NICE technology appraisal guidance 133 (omalizumab for severe persistent allergic asthma in adults, 2007) and NICE technology appraisal guidance 201 (omalizumab for the treatment of severe persistent allergic asthma in children aged 6 to 11 years, 2011). TA 133 recommended omalizumab for adults, and TA 201 did not recommend it for use in children.

The Committee concluded that applying the Assessment Group's corrections to the manufacturer's analysis resulted in a most plausible ICER of £23,200 per QALY (including the patient access scheme) gained for the combined population of adults, adolescents and children on maintenance or frequent courses of oral corticosteroids, defined as 4 or more courses in the year before receiving omalizumab.

The Committee also acknowledged the health-related quality of life benefits (which were not quantifiable) of reducing dependence on oral corticosteroids and was persuaded that the inclusion of these additional benefits would be sufficient to make omalizumab a cost effective option for treating severe, persistent allergic asthma in adults, adolescents and children.

Omalizumab works by blocking immunoglobulin E (IgE) antibodies from attaching to allergens. When IgE attaches to an allergen, it sets off a process that eventually leads to an allergic reaction.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: "NICE is aware that severe, persistent allergic asthma can have a significant effect on a person's life. We are therefore pleased to now be able to recommend omalizumab as an effective therapy for adults, adolescents and children with this condition in final draft guidance, with the discount agreed in the patient access scheme submitted by the manufacturer."

The final draft guidance (final appraisal determination / FAD) can be found from Thursday 7 March on theNICE website.

NICE has not yet issued final guidance to the NHS; these decisions may change in the event of an appeal.

Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.

Final guidance is expected to be published in April 2013.

Ends

Notes to editors

About the guidance

1. The final draft guidance (final appraisal determination / FAD) can be found fromThursday 7 March on theNICE website.

2. Closing date for appeals is Thursday 21 March.

3. Final guidance is expected to be published in April 2013.

4. This appraisal on omalizumab for treating severe, persistent allergic asthma is a review of NICE technology appraisal guidance 133 (omalizumab for severe persistent allergic asthma in adults, 2007) and NICE technology appraisal guidance 201 (omalizumab for the treatment of severe persistent allergic asthma in children aged 6 to 11 years, 2011).

5. Following publication of TA 201, NICE recognised that it would be preferable to have a single piece of guidance covering recommendations for omalizumab for all age groups.

6. Omalizumab (Xolair, Novartis) is a monoclonal (derived from a single cloned cell) antibody that binds to IgE. It has a UK marketing authorisation as add-on therapy to improve control of asthma in adults and adolescents (12 years and over) and children aged 6 to 11 years with severe persistent allergic asthma who have:

  • a positive skin test or in vitro reactivity to a perennial aeroallergen
  • reduced lung function (forced expiratory volume at 1 second [FEV1] less than 80% (in adults and adolescents aged 12 years and over)
  • frequent daytime symptoms or night-time awakenings
  • multiple documented severe exacerbations despite daily high-dose inhaled corticosteroids plus a long-acting inhaled beta2 agonist.

7. The marketing authorisation states that omalizumab treatment "should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma". It also specifies that, 16 weeks after the start of omalizumab, physicians should assess how effective the treatment is, and should continue omalizumab only in patients whose asthma has markedly improved.

8. Omalizumab is given by injection every 2 or 4 weeks. The dose is determined by a person's body weight and IgE level.

9. The summary of product characteristics lists injection site pain, swelling, erythema and pruritus, and headaches as the most commonly reported adverse reactions for omalizumab treatment in people aged 12 years and over. The most commonly reported adverse reactions for omalizumab treatment in children under 12 years are headaches, pyrexia and upper abdominal pain. For full details of adverse reactions and contraindications, see the summary of product characteristics.

10. The price of omalizumab is £256.15 for a 150-mg vial and £128.07 for a 75-mg vial (excluding VAT; 'British national formulary' [BNF] edition 63). The dosage administered is 75-600 mg every 2 or 4 weeks, up to a maximum dosage of 600 mg every 2 weeks. The cost of omalizumab ranges from approximately £1665 per patient per year (excluding VAT) for a 75 mg dose administered every 4 weeks to approximately £26,640 per patient per year (excluding VAT) for a 600 mg dose (the maximum recommended dose in the summary of product characteristics) administered every 2 weeks. Costs may vary in different settings because of negotiated procurement discounts.

11. The manufacturer has agreed a patient access scheme with the Department of Health, including a discount on the list price of omalizumab.

12.Omalizumab is accepted for restricted use within NHS Scotland.

13. Asthma is a long-term, inflammatory disorder affecting the airways. It is characterised by symptoms including breathlessness, wheezing and coughing, particularly at night. Allergic asthma is the most common type of asthma and is triggered by immunoglobulin E (IgE) antibodies produced in response to environmental allergens such as pollen, dust mites, or moulds.

14. There are currently more than 5.2 million people in the UK being treated for asthma; about 1.1 million of these are children. In its development of the appraisal, the Committee heard from clinical specialists and patient experts that, in current UK clinical practice, the population for which omalizumab would be considered was smaller than that covered by the marketing authorisation. One clinical specialist noted that the number of people currently being offered omalizumab in his practice accounts for approximately 1 in 200 people. The Committee concluded that only people with the most severe persistent allergic asthma despite optimised treatment would currently be offered omalizumab.

15. Until final guidance is published, the current guidance on omalizumab, TA133 and TA 201, is applicable.

Related NICE guidance

Published

1. Omalizumab for the treatment of severe persistent allergic asthma in children aged 6 to 11 years. NICE technology appraisal guidance 201 (2011).

2. Omalizumab for severe persistent allergic asthma. NICE technology appraisal guidance 133 (2007). Available from

3. Corticosteroids for the treatment of chronic asthma in adults and children aged 12 years and over. NICE technology appraisal guidance 138 (2008).

4. Corticosteroids for the treatment of chronic asthma in children under the age of 12 years. NICE technology appraisal guidance 131 (2007).

5. Bronchial thermoplasty for severe asthma. NICE interventional procedure guidance 419 (2012).

About NICE

1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

2. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS
  • social care - the Health and Social Care Act (2012) sets out a new responsibility for NICE to develop guidance and quality standards for social care. To reflect this new role, from 1 April 2013 NICE will be called the National Institute for Health and Care Excellence (NICE) and it will become a Non-Departmental Public Body.

3. NICE produces standards for patient care:

  • quality standards - these describe high-priority areas for quality improvement in a defined care or service area
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
  • CCG Outcomes Indicator Set(formerly known as COF) - NICE develops the potential clinical health improvement indicators to ensure quality of care for patients and communities served by the clinical commissioning groups (CCGs).

4. NICE provides advice and support on putting NICE guidance and standards into practice throughitsimplementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

Suggested Articles

J&J's talc woes deepened Friday after the FDA turned up "sub-trace" levels of asbestos one bottle of the company's baby powder,…

Another major drugmaker is recalling in the U.K. 10 batches of its Zantac generics because they contain a possible carcinogen.

With diagnosis rates on the rise, Pfizer's Vyndaqel franchise could collect $157 million in 2019 U.S. sales, well above consensus, SVB Leerink says.