Morphine Sulfate PentahydrateANAMORPH
Treatment of severe pain, cancer pain, and severe disabling pain. The drug is for short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated, or are otherwise inappropriate.
Decisions on record
- Meeting Nov 2010 Recommended Pain relief no PSD
- Meeting Mar 2003 Recommended Narcotic analgesic no PSD
Access path
- TGA registered · ANAMORPH
TGA label narrower than the PBS population
- Mar 2019Recommended · restricted
vs placebo
- Jul 2024Recommended · restricted
Evidence: RCT → Other
- PBS listing · Restricted
From the public summary
5.1 The PBAC recommended the General Schedule Restricted Benefit listing of morphine sulfate pentahydrate tablet 30 mg (Anamorph®) for the treatment of severe pain and cancer pain, and a Palliative Care Authority Required (Telephone/Online) listing for the treatment of severe disabling pain.PSD · Jul 2024
5.2 The PBAC noted the unmet clinical need caused by recent morphine discontinuations and that Anamorph remains the only solid oral IR form of morphine registered on the ARTG.PSD · Jul 2024
4.6 The submission justified the higher requested price by noting the clinical need for an IR morphine formulation, particularly for concession card holders and patients in palliative care; noting the advantages of a permanent PBS listing over a section 19A listing; and providing calculations of their cost of goods and profit margins.PSD · Jul 2024
4.7 The submission stated that an analysis of PBS codes for both Anamorph and Sevredol from July 2021 to June 2022 revealed that 91% of processed PBS scripts were supplied to concession holders. The submission stated that the reintroduction of Anamorph into the PBS would alleviate financial burdens for these patients, stating that non-PBS products often result in significantly higher expenses for patients and particularly concession holders.PSD · Jul 2024
5.5 Efficacy results for all patients showed no statistically significant difference in primary endpoint of breathlessness (VAS Now Intensity Breathlessness) between baseline and days 5-7 between groups. Another measure of breathlessness (VAS Worst Intensity Breathlessness) showed a trend toward statistical significance (Least Squares mean difference morphine minus placebo = -4.88, 95%CI -10.73, 0.98, p=0.105).PSD · Mar 2019
5.6 The subgroup of mMRC >3 or 4 and patients with COPD experienced statistically greater improvement.PSD · Mar 2019
Cost-effectiveness
Not modelled. This is a relisting of a previously delisted product (delisted August 2023) with no new economic evaluation required.
As a minor submission, there was no economic comparison presented. PSD · 2019
Decision context
PopulationAdults requiring treatment of severe pain, cancer pain, or severe disabling pain, who have had inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics, or are unable to use these due to contraindications or intolerance.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2024 | Recommended · restricted | — | — | Other |
| Mar 2019 | Recommended · restricted | placebo | — | RCT · Breathlessness (VAS Now Intensity Breathlessness) |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with inadequate management on maximum tolerated doses of prior analgesics or unable to use them.