NUCALA (mepolizumab), anti-IL5 monoclonal antibody

RESPIRATORY MEDICINE - New medicinal product
Opinions on drugs - Posted on Oct 12 2016

Reason for request

Inclusion

Minor improvement in the management of severe refractory eosinophilic asthma

  • NUCALA has Marketing Authorisation as additional treatment, in severe refractory eosinophilic asthma
  • It must be prescribed by a physician experienced in the diagnosis and management of severe refractory eosinophilic asthma.
  • It is reserved for adults with severe refractory eosinophilic asthma defined by a blood eosinophil level ≥ 300/µL in the last twelve months

AND at least one of the 2 following criteria:

- > 2 episodes of asthmatic exacerbations having required treatment with oral corticosteroids (> 3 days each) in the last 12 months despite a basic treatment combining high-dose inhaled corticosteroids and a long-acting bronchodilator (LABA) (step 4/5 GINA);

- a treatment with oral corticosteroid therapy for at least 6 months during the last 12 months.




Clinical Benefit

Substantial

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Clinical Added Value

minor

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