Pharmacy Prior Authorization Criteria

Yorvipath (palopegteriparatide)

For diagnosis of Hypoparathyroidism
Indicated for the treatment of hypoparathyroidism in adults. Limitations of Use: (1) Not studied for acute post-surgical hypoparathyroidism; (2) Titration scheme 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

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [A-C, 1-4]

AND

Requested drug is not being used in the setting of acute post-surgical hypoparathyroidism [1]

AND

Patient has achieved albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D (e.g., calcitriol) treatment [D-F, 1, 2, 5]

AND

Prior Authorization (Reauthorization)

Length of Approval: 12 Months [3,4]

Patient demonstrates positive clinical response to therapy as evidenced by maintenance of normalized calcium levels compared to baseline

2024-11-21, 2024-11-12

Yorvipath Prescribing Information. Ascendis Pharma. Princeton, NJ. August 2024.
Khan AA, Rubin MR, Schwarz P, et al. Efficacy and safety of parathyroid hormone replacement with TransCon PTH in hypoparathyroidism: 26-week results from the phase 3 PaTHway trial. Journal of Bone and Mineral Research. 2023;38:14-25.
Khan AA, Bilezikian JP, Brandi ML, et al. Evaluation and management of hypoparathyroidism summary statement and guidelines from the Second International Workshop. Journal of Bone and Mineral Research. 2022;37(12):2568-85.
Brandi ML, Bilezikian JP, Shoback D, et al. Management of hypoparathyroidism: summary statement and guidelines. Journal of Clinical Endocrinology and Metabolism. 2016;101(6):2273-83.
FDA Review: Yorvipath. Food and Drug Administration Web Site. 2024. http://www.accessdata.fda.gov. Accessed September 9, 2024.

Patients randomized to Yorvipath therapy in the PaTHway pivotal trial were given therapy for 26-week duration. [1, 2]
An international systematic current practice survey of expert panelists recommends monitoring patients every 6 to 12 months as the optimal strategy for stable patients with chronic hypoparathyroidism. For patients with changes in therapy, such as treatment initiation or dosage titration, monitoring should be done more frequently than the 1 to 2 times per year for well-controlled patients. [3, 4]
In the PaTHway pivotal trial, patients were monitored within 1 to 2 weeks after any dosage adjustments. [2]
Patients eligible for inclusion in the PaTHway trial must have been treated with conventional therapy for at least 12 weeks prior to screening. [2]
Serum calcium concentration should be measured within 7 to 10 days of Yorvipath initiation. Doses of active vitamin D or calcium supplement or both should be adjusted based on serum calcium value and clinical assessment (i.e., signs and symptoms of hypocalcemia or hypercalcemia). [1]
Throughout the trial, most patients treated with Yorvipath maintained serum calcium levels in normal range upon discontinuation of active vitamin D and calcium therapies. [5]