NHS Dudley Health Economy Medicines Formulary
Home > 3 Respiratory system > 3.3 Cromoglicate and related therapy, leukotriene receptor antagonists, and phosphodiesterase type-4 inhibitors > 3.3.3 Phosphodiesterase type-4 inhibitors

3.3.3 Phosphodiesterase type-4 inhibitors

Chronic obstructive pulmonary disease - roflumilast - NICE TAG TA244

1.1 Roflumilast is recommended only in the context of research as part of a clinical trial for adults with severe chronic obstructive pulmonary disease (COPD) (for the purposes of this guidance defined as forced expiratory volume in 1 second [FEV1] post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of frequent exacerbations as an add-on to bronchodilator treatment.

1.2 Such research should be designed to generate robust evidence about the benefits of roflumilast as an add-on to long-acting muscarinic antagonists (LAMA) plus long-acting beta2 agonists (LABA) plus inhaled corticosteroids (ICS), or LAMA plus LABA for people who are intolerant to ICS.

1.3 People receiving roflumilast should have the option to continue treatment until they and their clinicians consider it appropriate to stop.



Roflumilast for treating chronic obstructive pulmonary disease - NICE TAG TA461

1.1 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, defined as a forced expiratory volume in 1 second (FEV1) after a bronchodilator of less than 50% of predicted normal, and

  • the person has had 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.

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

1.3 These recommendations are not intended to affect treatment with roflumilast that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.


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