Macrogol 3350
chronic constipation or faecal impaction not adequately controlled with first line interventions such as bulk-forming agents; patients with malignant neoplasia, paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function
Decisions on record
- Meeting Mar 2010 Recommended Constipation no PSD
- Meeting Nov 2008 Recommended Laxative no PSD
- Meeting Nov 2007 Recommended Constipation
- Meeting Mar 2007 Recommended Laxative
Access path
- Nov 2005Not recommended
inadequate clinical evidence (single-arm, open-label studies with small sample size and short duration; selection and…
- Nov 2005Not recommended
inadequate clinical evidence (single-arm, open-label studies only), potential for inappropriate use if listed as…
- ↻ resubmittedMar 2007Recommended · restricted
Comparator changed: conventional therapy (repeated enemas and suppositories, lavage…
- Mar 2007Recommended · restricted
Comparator changed: conventional therapy (repeated enemas and suppositories, lavage…
- Nov 2007Recommended · restricted
- PBS listing · Restricted
Cost-effectiveness
No economic evaluation generated by the sponsor was presented. Five published pharmacoeconomic studies were cited but no ICER values are stated in the document.
The PBAC considered that the evidence presented in the submission to be poor and unconvincing and acknowledged the difficulties associated with collecting data in this patient group. PBAC · 2007
Decision context
Populationpatients with chronic constipation or faecal impaction not adequately controlled with first line interventions such as bulk-forming agents; patients with malignant neoplasia, paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2007 | Recommended · restricted | — | — | RCT · QoL |
| Mar 2007 | Recommended · restricted | rectal interventions such as suppositories and enemas | — | RCT, non-comparative studies, before-and-after study · null |
| Mar 2007 | Recommended · restricted | rectal interventions (suppositories and enemas) | — | RCT |
| Nov 2005 | Not recommended | conventional therapy (hospital admission with repeated enemas and suppositories, lavage solutions or manual disimpaction | — | Single-arm | Registry |
| Nov 2005 | Not recommended | conventional therapy (repeated enemas and suppositories, lavage solutions, manual disimpaction, and hospital admission) | — | Single-arm |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to chronic constipation/faecal impaction inadequately controlled by first-line agents, plus specific neurological conditions.