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This revision (Policy 2025 P 2358-2, effective 2026-03-01) defines specific, prescriptive authorization criteria for Yorvipath (a parathyroid hormone analog, PTH(1-34)) for treatment of hypoparathyroidism in adults. The document explicitly sets both initial authorization and reauthorization requirements, detailing diagnostic laboratory thresholds, exclusions, required concomitant therapy, and prescriber specialty. The policy formalizes laboratory cutoffs for pretreatment serum calcium and intact parathyroid hormone (PTH) concentrations, clarifies that the product is not indicated for acute post-surgical hypoparathyroidism, and delineates which specialists may prescribe.

The policy limits initial approval to adults with a documented diagnosis of hypoparathyroidism and requires objective biochemical confirmation. Pretreatment albumin-corrected serum calcium must be ≤ 8.5 mg/dL on at least two occasions separated by a minimum of 2 weeks. In addition, pretreatment intact PTH must be undetectable or inappropriately low (< 20 pg/mL) measured by a second- or third-generation immunoassay on at least two occasions. These paired laboratory requirements emphasize chronic biochemical hypocalcemia with inadequate PTH as prerequisites for therapy initiation.

The policy contains several treatment-context and prescriber restrictions. Yorvipath must not be used for acute post-surgical hypoparathyroidism. Prior to initiation, the patient must be on "adequate" supplemental calcium and active vitamin D (e.g., calcitriol), with evidence defined by albumin-corrected serum calcium in the range 7.8–10.6 mg/dL and serum 25(OH) vitamin D between 20–80 ng/mL. Additionally, initial prescriptions must come from an endocrinologist or a nephrologist, restricting prescribing to these specialties.

Reauthorization is tied to documented clinical benefit and reduction of conventional therapy dependence. Continued approval requires evidence of a positive clinical response, exemplified by albumin-corrected serum calcium in the normal range (approximately 8.3–10.6 mg/dL) and independence from conventional therapy—defined in the policy as requiring no active vitamin D and calcium intake of ≤ 600 mg/day. The reauthorization criteria thus emphasize both biochemical stabilization and decreased need for supplemental calcium or active vitamin D.