Methylnaltrexone BromideRELISTOR
treatment of opioid-induced constipation in palliative care patients who have failed to respond to, or are unable to tolerate, laxative therapies
Decisions on record
- Meeting Jul 2009 Recommended Constipation
- Meeting Mar 2009 Not recommended Laxative agent
Access path
- TGA registered · RELISTOR
TGA label narrower than the PBS population
- Mar 2009Not recommended
high and uncertain cost-effectiveness, significant uncertainty in utility weights and their derivation from Schmier et…
- ↻ resubmittedJul 2009Recommended · restricted
ICER rose $45,000 → $75,000 (+67%)
- PBS listing · Authority Required
Cost-effectiveness
Two ICER ranges presented: $15,000–$45,000 (original utility study) and $45,000–$75,000 (Van den Haak utility weights). PBAC considered true ICER likely between these ranges. Primary reliance on $45,000–$75,000 range.
The PBAC considered that the proposed restriction for methylnaltrexone did not define those patients at highest risk and that any future submission should consider restricting use to a subgroup of patients with high clinical need, such as end stage palliative care patients. The PBAC also considered that treatment should be limited to a maximum period of 4 months, given that the evidence supporting the efficacy and safety of methylnaltrexone is limited to a time horizon of 4 months. Pre-filled syringes should also be available in preference to the vials as this would facilitate ease of use for carers managing patients at home and potentially reduce wastage. PBAC · 2009
Decision context
Populationpalliative care patients with opioid-induced constipation who have failed to respond to, or are unable to tolerate, laxative therapies
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2009 | Recommended · restricted | placebo | $45k–75k | RCT |
| Mar 2009 | Not recommended | placebo | $15k–45k | RCT · laxation within 4 hours and 24 hours of a single subcutaneous administration |
Consumer voice
The PBAC noted comments from consumers acknowledging that opioid-induced constipation is a significant problem and that methylnaltrexone is an effective medication for this condition.
The PBAC noted comments from consumers and acknowledged that opioid-induced constipation (OIC) is a significant problem. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients who failed or cannot tolerate laxatives; TGA label requires only insufficient laxative response.