Natpara- Yorvipath - NC Standard

Restricted Product(s):

• Natpara® (parathyroid hormone) for injection
• Yorvipath® (palopegteriparatide)

FDA Approved Use Natpara:

• Indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
• Limitations of Use:
  • Because of the potential risk of osteosarcoma, Natpara is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone.
  • Natpara was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations.
  • Natpara was not studied in patients with acute post-surgical hypoparathyroidism.

FDA Approved Use Yorvipath:

• Indicated for the treatment of hypoparathyroidism in adults.
• Limitations of Use:
  • Not studied for acute post-surgical hypoparathyroidism.
  • 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.

Criteria for Approval of Restricted Product(s):

1. The patient is 18 years of age or older; AND
2. The patient has a confirmed diagnosis of hypocalcemia with hypoparathyroidism (medical record documentation required); AND
3. The patient has failed to respond to calcium and vitamin D alone to control hypocalcemia associated with hypoparathyroidism; AND
4. If the request is for Yorvipath;
   1. The patient has achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment (medical record documentation required); AND
5. If the request is for Natpara;
   1. The patient does not have hypoparathyroidism caused by calcium sensing receptor mutations; AND
6. The patient does not have acute post-surgical hypoparathyroidism (i.e. hypoparathyroidism <6 months); AND
7. The patient is being managed by or in consultation with an endocrinologist; AND
8. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval:

365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below

Policy Implementation/Update Information:

September 2024: Criteria change: Added new to market Yorvipath to policy. Changed name of policy to include Yorvipath in title. Added limitations of use to FDA section.

March 2023: Criteria change: Criteria review and formatting changes. Decreased the initial duration of approval to 365 days. Added patient is being managed by or in consultation with an endocrinologist. Added medical record documentation for diagnosis.

May 2020: Criteria update: Reformatted criteria.

April 2015: Original utilization management criteria issued.