Yorvipath®

Drug - Yorvipath® (palopegteriparatide injection) [Ascendis Pharma Endocrinology, Inc.]

June 2025

Therapeutic Area - Hyperparathyroid Agents

Initial approval criteria

Patient is ≥ 18 years of age; AND
Patient has a diagnosis of hypoparathyroidism; AND
Patient does NOT have acute post-surgical hypoparathyroidism; AND
Patient does NOT have pseudohypoparathyroidism; AND
Patient has baseline (prior to therapy with the requested agent) albumin-corrected serum calcium of ≥ 7.8 mg/dL using calcium and active vitamin D treatment; AND
Patient does NOT have severe hypersensitivity to palopegteriparatide or to any of its excipients; AND
Patient has baseline (prior to therapy with the requested agent) vitamin D levels above the lower limit of normal; AND
Patient has tried and had an inadequate response to maximally tolerated calcium AND vitamin D supplements (e.g., calcitriol,
ergocalciferol, cholecalciferol); AND
Patient will continue calcium and vitamin D supplementation while titrating to an appropriate dose of the requested agent; AND
The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, nephrologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis.
Initial approval is for 6 months

Patient must continue to meet the above criteria; AND
Patient has had clinical benefit with the requested agent; AND
Patient has an albumin-corrected total serum calcium concentration between 8.3 to 10.6 mg/dL; AND
Patient has NOT experienced any treatment-restricting adverse effects (e.g., osteosarcoma).
Renewal approval is for 12 months

2 pens per 28 days. Max dose of 30 mcg once daily.

Limitations of Use:

Yorvipath was not studied for acute post-surgical hypoparathyroidism.
Yorvipath's titration scheme was only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment

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