CurrentBlue Cross Blue Shield - IowaPolicy 05.05.61

Yorvipath (palopegteriparatide) — Coverage Criteria for Hypoparathyroidism

This policy governs prior authorization, coverage criteria, dosing limits, and documentation requirements for Yorvipath for treatment of chronic hypoparathyroidism in adults for Blue Cross Blue Shield - Iowa members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyYorvipath (palopegteriparatide) — Coverage Criteria for Hypoparathyroidism

Policy CodePolicy 05.05.61

Change TypeNo material change

Effective DateDec 13, 2024

Next Review DateN/A

Key ActionSubmit chart notes and lab results showing current vitamin D and elemental calcium use and albumin-corrected serum calcium ≥7.8 mg/dL for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

2 pens/28dquantity limit

18–30 mcgFDA dosing

postsurgical ≤6moexclusion

Coverage criteria for Yorvipath (palopegteriparatide)

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Medical necessity criteria

Authorization of 12 months may be granted for treatment of hypoparathyroidism in adults when ALL of the following are met

Initial approval criteria: 1. Member has a confirmed diagnosis of chronic hypoparathyroidism for at least 6 months based on hypocalcemia with inappropriately low serum parathyroid hormone (PTH) levels; 2. Member cannot be adequately controlled on conventional therapy alone; 3. Member has an inadequate response to maximally tolerated calcium supplementation and active vitamin D therapy (e.g., calcitriol, alfacalcidol); 4. Member will continue calcium supplementation and active vitamin D therapy while titrating to an appropriate dose of the requested medication; 5. Recent serum 25-hydroxyvitamin D concentration is above the lower limit of normal laboratory range; 6. Recent albumin-corrected serum calcium level is greater than or equal to 7.8 mg/dL prior to initiating therapy with the requested medication; 7. Recent serum magnesium level is within normal laboratory limits.

Continuation (re-authorization) criteria: 1. Member is experiencing benefit from therapy as evidenced by maintenance or normalization of albumin-corrected serum calcium levels compared to baseline; 2. One of the following is met: (A) Member no longer requires active vitamin D or therapeutic doses of elemental calcium (>= 600 mg per day); OR (B) Member has had a significant reduction in required dosages of active vitamin D and elemental calcium and is still actively titrating doses of the requested medication.

Authorization of 12 months may be granted.

Coding and clinical thresholds

Provider billing guidancemixed

No codes listed

inv-05: Albumin-corrected serum calcium — clinical threshold value

Albumin-corrected serum calcium threshold>= 7.8 mg/dL prior to initiating therapy (must be documented on recent labs)

Supporting documentation requiredLab results confirming albumin-corrected serum calcium >= 7.8 mg/dL must be submitted for initial requests

Titration contextTitration scheme was evaluated only in adults who first achieved albumin-corrected serum calcium >= 7.8 mg/dL using calcium and active vitamin D

inv-06: Elemental calcium during titration goal — > 600 mg/day

Elemental calcium goal during titration> 600 mg/day (therapeutic elemental calcium threshold)

Continuation criterion related to calciumFor reauthorization, member no longer requires therapeutic elemental calcium (>=600 mg/day) OR has significant reduction in required doses while titrating

Titration objectiveTitrate medication to maintain serum calcium in normal range without need for active vitamin D or therapeutic calcium (>600 mg/day)

Prior authorization, quantity limits, and documentation

Prior Authorization

Prior authorization requirement — 12 months

Prior authorization may be granted for 12 months when specified initial or continuation clinical criteria and required documentation are provided.

Authorization duration: 12 months
Ensure required documentation submitted with initial and continuation requests

Billing Rule

Quantity limits

Approvals may be subject to quantity limits of 2 pens per 28 days per listed strengths.

Yorvipath 168 mcg/0.56 mL — Standard limit: 2 pens per 28 days
Yorvipath 294 mcg/0.98 mL — Standard limit: 2 pens per 28 days
Yorvipath 420 mcg/1.4 mL — Standard limit: 2 pens per 28 days

Prior Authorization

Concomitant therapy requirement

Inadequate response to maximally tolerated calcium supplementation and active vitamin D therapy is required prior to approval. Continuation approvals require ongoing use of calcium supplementation and active vitamin D therapy while titrating the requested medication, unless the member meets continuation criteria demonstrating reduced or eliminated need for these therapies.

Initial therapy requirement: inadequate response to maximally tolerated calcium supplementation and active vitamin D (e.g., calcitriol, alfacalcidol).
Continuation requirement: member will continue calcium supplementation and active vitamin D while titrating to an appropriate dose; for reauthorization, either no longer requires active vitamin D/therapeutic calcium (≥600 mg/day) OR has significant reduction in required dosages and is actively titrating.

Documentation Required

Required Documentation

Submission of the following documentation is necessary to initiate the prior authorization review. Provide all applicable items for initial and continuation requests to avoid delays or denial.

Initial requests:
• Chart notes, medical record documentation, or claims history supporting current use of a vitamin D metabolite/analog therapy and elemental calcium
• Lab results confirming serum 25-hydroxyvitamin D concentration is above the lower limit of normal laboratory range
• Lab results confirming albumin-corrected serum calcium ≥ 7.8 mg/dL prior to initiating the requested medication
• Lab results confirming serum magnesium level is within normal laboratory limits
Continuation (reauthorization) requests:
• Lab results confirming maintenance or normalization of albumin-corrected serum calcium levels compared to baseline
• Chart notes, medical record documentation, or claims history supporting discontinuation or significant reduction in required dosages of vitamin D metabolite/analog therapy and therapeutic doses of elemental calcium

Denial Risk

Exclusion and Not Medically Necessary

Coverage will not be provided for acute postsurgical hypoparathyroidism within 6 months of surgery and expected recovery from hypoparathyroidism. Therapy is considered not medically necessary for members who do not meet the specified clinical criteria.

Exclusion: Acute postsurgical hypoparathyroidism (within 6 months of surgery) with expected recovery
Not medically necessary when criteria for chronic hypoparathyroidism treatment are not met

OpenPayer

Yorvipath (palopegteriparatide) — Coverage Criteria for Hypoparathyroidism

Coverage criteria for Yorvipath (palopegteriparatide)

Coding and clinical thresholds

Prior authorization, quantity limits, and documentation

Background on Yorvipath and indication

Definitions and diagnostic criteria