Patiromer
Initial treatment of adult patients with chronic kidney disease (CKD) Stage 3-4, with chronic hyperkalaemia (at least two episodes of serum potassium 6.0 mmol/L or higher in the previous 12 months), who are receiving at least one renin angiotensin aldosterone system inhibitor (RAASi) medicine or are indicated for a RAASi medicine but are unable to tolerate it due to prior occurrence of hyperkalaemia.
Decisions on record
- Meeting Mar 2023 Recommended Hyperkalaemia; chronic hyperkalaemia in CKD Stage 3-4 patients
- Meeting Nov 2022 Not recommended Chronic hyperkalaemia in chronic kidney disease Stage 3 or 4
- Meeting Nov 2020 Not recommended Patiromer is indicated for the treatment of hyperkalaemia in adults.
Access path
- Nov 2019Not recommended
unclear clinical criteria and eligibility definition for hyperkalaemia requiring pharmacological intervention…
- Nov 2020Not recommended
Comparator changed: placebo → standard care (low K+ diet and RAASi therapy)
- Nov 2022Not recommended
Comparator changed: standard care (low K+ diet and RAASi therapy) → standard care (RAASi…
- ↻ resubmittedMar 2023Recommended
Comparator changed: standard care (RAASi reduction or withdrawal with or without dietary…
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the listing of patiromer for the treatment of adult patients with chronic kidney disease (CKD) Stage 3-4, with chronic hyperkalaemia (at least two episodes of serum potassium ≥ 6.0 mmol/L in the previous 12 months), who are receiving at least one renin angiotensin aldosterone system inhibitor (RAASi) or are indicated for a RAASi but are unable to tolerate it due to prior occurrence of hyperkalaemia.PSD · Mar 2023
5.2 The PBAC acknowledged the consumer comments relating to patiromer which described the benefits of treatment and highlighted the need for safe, effective, and palatable therapies in this setting. The comments also highlighted the issues with the existing therapies such as gastrointestinal adverse events and lack of palatability.PSD · Mar 2023
4.5 In November 2022, the PBAC considered ‘it would be appropriate for any future resubmission to be based solely on the cost minimisation approach versus SPS/CPS resins presented by the evaluators in chronic hyperkalaemia patients (per Table 16, which resulted in a cost per pack of patiromer of $ in the submission and $ in the Pre- Sub-Committee Response (PSCR) (as the gastrointestinal adverse event costs were removed)).PSD · Mar 2023
4.6 The resubmission based the proposed price of patiromer solely on a cost minimisation approach (CMA), consistent with the PBAC’s previous advice. However, compared with the CMA presented in the November 2022 submission, the key difference was that the average daily dose of SPS and CPS resins was based on the dose recommended in the Product Information of 15 g three to four times a day, with the resubmission applying a daily dose of 45 g (this had been …PSD · Mar 2023
4.3 The resubmission described patiromer as non-inferior in terms of effectiveness and safety compared to SPS/CPS resins, noting patiromer is associated with fewer gastrointestinal adverse events (AEs) and improved tolerability. This was consistent with the PBAC’s previous advice in November 2022, in which the PBAC considered that patiromer was:PSD · Mar 2023
• non-inferior compared to SPS/CPS resins in terms of reducing potassium levels (paragraph 6.48, patiromer PSD, November 2022 PBAC Meeting).PSD · Mar 2023
4.2 The PBAC noted and welcomed the input from health care professionals (10) via the Consumer Comments facility on the PBS website. The comments described the benefits of treatment with patiromer including the improved tolerability and palatability compared to currently available therapies.PSD · Mar 2023
4.24 The resubmission did not propose an RSA. The PBAC previously advised that a resubmission should include ‘an RSA based on the revised financial impact estimates with expenditure caps, beyond which a rebate of % would be applied’ (paragraph 7.14, patiromer PSD, November 2022 PBAC Meeting). For more detail on PBAC’s view, see section 5 PBAC outcome.PSD · Mar 2023
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. PBAC advised that cost-utility analysis was unreliable and a cost-minimisation approach versus SPS/CPS resins was appropriate.
The PBAC considered that the claim of superior comparative effectiveness compared to placebo was unclear. PBAC · 2019
Decision context
PopulationAdults with chronic kidney disease Stage 3-4, chronic hyperkalaemia (at least 2 episodes of serum potassium ≥6.0 mmol/L in previous 12 months), receiving or indicated for RAASi but unable to tolerate due to prior hyperkalaemia.
Risk sharingRisk sharing arrangement presented based on revised financial estimates with expenditure caps beyond which a rebate of % was applied.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2023 | Recommended | sodium polystyrene sulfonate (SPS) and calcium polystyrene sulfonate (CPS) | — | Cost-minimisation · Cost-minimisation |
| Nov 2022 | Not recommended | standard care (RAASi reduction or withdrawal with or without dietary modification) and sodium polystyrene sulfonate (SPS | — | RCT · Serum potassium reduction |
| Nov 2020 | Not recommended | standard care (low K+ diet and RAASi therapy) | — | RCT · Other |
| Nov 2019 | Not recommended | placebo | — | RCT · Other |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| OPAL-HK | Ph 3 | 243 | Change in Serum Potassium From Part A Baseline to Part A Week 4 | completed |
| AMETHYST-DN | Ph 2 | 324 | Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titr… | completed |
| TOURMALINE | Ph 4 | 114 | Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Eithe… | completed |
| DIAMOND | Ph 3 | 1,195 | Changes in Serum K+ Levels From Baseline | completed |
| PEARL-HF | Ph 2 | 120 | Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period. | completed |
| AMBER | Ph 2 | 295 | Number of Participants Remaining on Spironolactone at Week 12 | completed |
Consumer voice
Healthcare professionals provided input via the PBS website describing the benefits of patiromer treatment, particularly its improved tolerability and palatability compared to currently available therapies including SPS/CPS resins.
The comments described the benefits of treatment with patiromer including the improved tolerability and palatability compared to currently available therapies. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to CKD Stage 3-4, chronic hyperkalaemia with specific potassium thresholds and RAASi indication/intolerance; TGA label is all adults with hyperkalaemia.