PalopegteriparatideYORVIPATH
Treatment of adult patients with chronic hypoparathyroidism who are inadequately controlled on conventional therapy (consisting of active vitamin D and calcium supplements).
Decisions on record
- Meeting Jul 2025 Not recommended Chronic hypoparathyroidism inadequately controlled on conventional therapy
- Meeting Mar 2025 Not recommended Chronic hypoparathyroidism, inadequately controlled on conventional therapy
Access path
- TGA registered · YORVIPATH
TGA label narrower than the PBS population
- Mar 2025Not recommended
vs conventional therapy (active vitamin D and calcium…
- Jul 2025Not recommended
From the public summary
5.1 The PBAC did not recommend palopegteriparatide for the treatment of patients with chronic hypoparathyroidism (HPT) who are inadequately controlled on conventional therapy (i.e. active vitamin D and calcium supplements). The PBAC reaffirmed that it considered that palopegteriparatide provided a benefit over conventional therapy in terms of efficacy.PSD · Jul 2025
5.2 The primary reason for this outcome was due to the economic evaluation.PSD · Jul 2025
4.6 At the March 2025 meeting, the PBAC considered that a more reasonable base case would: • reduce the time horizon from 51 years to 30 years;PSD · Jul 2025
• halve the utility increment/decrement applied from Cycle 2 to both the palopegteriparatide and conventional therapy arms; andPSD · Jul 2025
4.4 No new clinical evidence was presented in the early re-entry resubmission.PSD · Jul 2025
4.5 The PBAC had previously considered that palopegteriparatide was superior compared to the nominated comparator of conventional therapy in terms of efficacy and likely comparable in terms of safety (paragraph 7.1, palopegteriparatide minutes, March 2025).PSD · Jul 2025
4.3 The PBAC recalled that the consumer inputs received in relation to the March 2025 submission were supportive of the listing for palopegteriparatide for chronic HPT. The PBAC valued the consumer inputs received for palopegteriparatide as it provided important patient and health care provider perspective for this condition.PSD · Jul 2025
4.30 In March 2025, the PBAC considered that an RSA, with a rebate of % for use above the expenditure caps would be required to mitigate the risk of usage in the first line HPT population who are adequately controlled on conventional therapy (paragraph 7.19, palopegteriparatide minutes, March 2025).PSD · Jul 2025
Cost-effectiveness
The resubmission base case resulted in an ICER of $75,000 to <$95,000 per QALY. The PBAC previously (March 2025) considered cost-effective at $45,000 to <$55,000 per QALY; the sponsor did not fully implement PBAC's requested model revisions.
Decision context
PopulationAdult patients with chronic hypoparathyroidism (postsurgical, auto-immune, genetic, or idiopathic) who have been inadequately controlled on conventional therapy (calcitriol ≥0.5 mcg/day plus elemental calcium ≥800 mg/day for ≥12 weeks) and have evidence of inadequate control (serum calcium <2.0 mmol/L, or serum phosphate >1.5 mmol/L, or prior ER/urgent visits or hospitalisations for HPT in previous 6 months, or 24-hour urinary calcium >7 mmol/24 hours, or history of nephrolithiasis/nephrocalcinosis or eGFR <60 mL/min/1.73m²), with eGFR >30 mL/min/1.73m².
Risk sharingRisk sharing arrangement with a rebate for use above the expenditure caps.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Not recommended | conventional therapy (active vitamin D and calcium supplements) | $75k–95k | RCT · Surrogate |
| Mar 2025 | Not recommended | conventional therapy (active vitamin D and calcium supplements) | — | RCT · Other |
Consumer voice
An individual with surgically induced hypoparathyroidism described the debilitating nature of the condition, including symptoms of hypocalcaemia and the burden of managing calcium and magnesium supplementation, expressing that palopegteriparatide listing could be life-changing.
patients experiencing this rare condition are frequently ignored or misunderstood, as there are limited endocrinologists or general practitioners who can manage the debilitating symptoms, and feel like they are in a permanent state of 'flight or fight' Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients inadequately controlled on conventional therapy with specific biomarkers and renal function thresholds; TGA label covers all adults with chronic hypoparathyroidism.