3.3 CromoglIcate and related therapy and leukotriene receptor antagonists, and omalizumab

3.3 Cromoglicate and related therapy and leukotriene receptor antagonists, and omalizumab

3.3.2 Leoukotriene receptor antagonists and omalizumab

The leukotriene receptor antagonists block the effects of the cysteinyl leukotrienes in the airways. They are relatively

expensive agents and BTS guidelines recommend their addition to therapy only at Step 3 for both adults and children.

GREEN Montelukast

tablets 10mg (for patients over 15 years of age)

chewable tablets 5mg (for patients 6 to14 years of age)

granules 4mg (for patients 6 months to 5 years of age)

Omalizumab - NICE TA278 (review of NICE TA133 and TA201)

Omalizumab should be initiated and prescribed only by a specialist in the treatment of asthma, and used strictly within its

indications. Omalizumab is licensed as add-on therapy to improve control of asthma control 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 and who have reduced lung function (FEV1<80%) as well as frequent

daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite

daily high-dose inhaled corticosteroids, plus a long-acting inhaled β2-agonist. Treatment should only be considered for

patients with convincing IgE mediated asthma.

Only patients with an IgE level of >30 – 700 IU/ml, and body weight of >20 – 150kg are eligible for treatment. The dose is

determined from the baseline IgE level, see the SPC for details. It is given subcutaneously, at 2-4 weekly intervals, and

response to treatment is measured at 16 weeks. Only patients who have shown an adequate response to treatment will

continue therapy. The manufacturer in the USA has been asked by the FDA to add a boxed warning stating that there is a

possibility of a patient developing anaphylaxis after any dose, even if there was no reaction to the first dose. In addition,

anaphylaxis after administration of the drug may be delayed for up to 24 hours after the dose is given.

Therefore, health care professionals should:

> be prepared to manage life-threatening anaphylaxis following administration of the drug

> observe patients for at least two hours after an injection

Patients should be offered and know how to initiate emergency self-treatment for anaphylaxis (Where this is prescribed

& patients should know how and when to administer an adrenaline/epinephrine autojector (Epipen®) with their first

prescription. Anaphylaxis was reported in clinical trials at a frequency of approximately one in a thousand patients (0.1%);

usually these reactions occurred within 2 hours of an injection. However the agency has received new reports of delayed

anaphylaxis (within 2 to 24 hours or even longer) after treatment.

Please note that for children under the age of 6 omalizumab has a BLACK traffic light.

RED Omalizumab injection 150mg

Risk of anaphylaxis (up to 24hrs after dose) see advice above

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Mepolizumab - NICE TA671 [update to and replaces NICE TA431]

Mepolizumab, as an add-on therapy, is recommended as an option for treating severe refractory

eosinophilic asthma in adults only if:

> it is used for adults who have agreed to and followed the optimised standard treatment plan and

> the blood eosinophil count has been recorded as 300 cells/microlite or more and the person has has at least 4

exacerbations needing systemic corticosteroids in the previous 12 months, or has had continuous oral

corticosteroids of at least the equivalent of prednisolone 5mg per day over the previous 6 months or

> the blood eosinophil count has been recorded as 400 cells per microlitre or more and the person has had at least 3

exacerbations needing systemic corticosteroids in the previous 12 months (so they are also eligible for either

benralizumab or reslizumab).

> the company provides the drug with the discount agreed in the patient access scheme.

If mepolizumab, benralizumab or reslizumab are equally suitable, start treatment with the least expensive option (taking

into account drug and administration costs)

At 12 months of treatment:

> stop mepolizumab if the asthma has not responded adequately or

> continue treatment if the asthma has responded adequately and assess response each year.

For further guidance see NICE TA671

RED Mepolizumab 100mg powder for solution for injection

Reslizumab - NICE TA479

1. Reslizumab, as an add-on therapy, is recommended as an option for the treatment of severe eosinophilic asthma that is

inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids plus another drug,

only if:

> the blood eosinophil count has been recorded as 400 cells per microlitre or more

> the person has had 3 or more severe asthma exacerbations needing systemic corticosteroids in the past 12

months and

> the company provides reslizumab with the discount agreed in the patient access scheme.

1.2. At 12 months:

> stop reslizumab if the asthma has not responded adequately or

> continue reslizumab if the asthma has responded adequately and assess response each year.

An adequate response is defined as:

> a clinically meaningful reduction in the number of severe exacerbations needing systemic corticosteroids or

> a clinically significant reduction in continuous oral cortiscosteroid use while maintaining or improving asthma

control.

RED Reslizumab 100mg/10ml concentration for solution for infusion (Cinqaero®) NHS England Commissioned

Benralizumab - NICE TA565 - updated September 2019

Benralizumab, as and add-on therapy, is recommended as an option for treating severe eosinophilic asthma that is

inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids and long-acting beta-

agonists, only if:

> and person has agreed to and followed the optimised standard treatment plan and

> and blood eosinophil count has been recorded as 300 cells per microlitre or more and the person has had 4 or more

exacerbations needing systemic corticosteroids in the previous 12 months, or has had continuous oral

corticosteroids of at least the equivalent of prednisolone 5 mg per day over the previous 6 months (that is, the

person is eligible for mepolizumab) or

> the blood eosinophil count has been recorded as 400 cells per microlitre or more with 3 or more exacerbations

needing systemic corticosteroids in the past 12 months (that is, the person is eligible for reslizumab).

Benralizumab is recommended only if the company provides it according to the commercial arrangement.

RED Benralizumab 30mg/1mL solution for injection pre-filled syringes (Fasenra▼)

Tezepelumab - NICE TA880 NHS England Commissioned

Tezepelumab as an add-on maintenance treatment is recommended as an option for severe asthma in people 12 years and

when treatment with high-dose inhaled corticosteroids plus another maintenance treatment has not worked well enough.

It is recommended only if people:

> have had 3 or more exacerbations in the previous year, or

> are having maintenance oral corticosteroids/

Tezepelumab is recommended only if the company provides it according to the commercial arrangement.

RED Tezepelumab (Tezspire solution for injection pre-filled syringes 210mg/1.91mL)

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3.3.3 Phophodiesterase type-4 inhibitors

NICE guidance TA461 (update to TA244)

Roflumilast, as an add-on to bronchodilator therapy, is recommended as an option for treating severe chronic obstructive

pulmonary disease in adults with chronic bronchitis, only if:

> the disease is severe, defines as a forced expiratory volume in 1 second FEV¹ after a bronchodilator of less than 50% o

of predicted normal, and

> the person has ja 2 or more exacerbations in the previous 12 months despite triple inhaled therapy with a long-

acting muscarinic antagonist, a long-acting beta-2 agonist and an inhaled corticosteroid.

Treatment with roflumilast should be started by a specialist in respiratory medicine.

AMBER Roflumilast tablets 500mcg (Daxas®)

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All material in this section is aimed at health care professionals, but is information currently held in the public domain,

members of the public seeking advice on medicine-related matters are advised

to speak with their GP, pharmacist, nurse or contact NHS111 Service

Email: info.elmmb@nhs.net