Beclometasone dipropionate with formoterol fumarate dihydrate and glycopyrronium bromide

PBAC's latest decision on Beclometasone dipropionate with formoterol fumarate dihydrate and glycopyrronium bromide: Recommended with restriction (2020). Considered for Maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD) in adult patients who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA) or a combination of a LABA and a long-acting muscarinic antagonist (LAMA).

Eligible population

Adult patients with moderate to severe COPD who have experienced at least one severe exacerbation requiring hospitalisation or two or more moderate exacerbations in the previous 12 months despite regular dual or triple therapy, or have been stabilised on triple therapy (LAMA, LABA, and ICS).

Therapy area

Respiratory

Line of therapy

Later-line

Evidence base

RCT

Primary endpoint

COPD exacerbations

Pivotal trial size

2,529 patients

Key trials

TRILOGY, TRINITY, TRIBUTE, FULFIL, IMPACT

Comparator

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol)

Economic model

Cost-minimisation

ICER note

Cost-minimisation analysis conducted; no ICER calculated as the submission assumed therapeutic equivalence.

Similar precedents

• Beclometasone dipropionate with formoterol fumarate dihydrate and glycopyrronium
  similarity 0.83
• Budesonide / glycopyrronium / formoterol
  similarity 0.79
• Fluticasone furoate / umeclidinium / vilanterol
  similarity 0.76
• Beclometasone dipropionate with formoterol fumarate dihydrate
  similarity 0.74
• Budesonide with glycopyrronium and formoterol
  similarity 0.74
• Aclidinium bromide plus eformoterol fumarate dihydrate
  similarity 0.72