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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 Leukotriene 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 licensed
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
 
Mepolizumab  -NICE TA431 
Mepolizumab, as an add-on to optimised standard therapy, is recommended as an option for treating severe refractory
eosinophilic asthma in adults only if:
  > the blood eosinophil count is 300 cells/microlite or more in the previous 12 months AND
  > the person has agreed to and followed the optimised standard treatment  plan AND
  > has had 4 or more asthma 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 AND
  > the company provides the drug with the discount agreed in the patient access scheme.
 
At 12 months of treatment:
  >  stop mepoliizumab if the asthma has not responded adequately or
  >  continue treatment if the asthma has responded adequately and assess response each year.
 
An adequate response is defined as:
  >  at least 50% fewer asthma exacerbations needing systemic corticosteroids in those  people with 4 or more exacerbations in 
      the previous 12 months or
  >  a clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma control.
 For further guidance see NICE TA431  
 
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▼)
 
 

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% 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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