Medical Policy

Effective Date:01/01/2016 Title:Natpara (Parathyroid Hormone)
Revision Date: Document:BI490:00
CPT Code(s):None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Natpara (parathyroid hormone) requires prior authorization.

2)    Natpara is used to treat hypocalcemia due to chronic hypoparathyroidism.

3)    Natpara is covered under the pharmacy benefit as a specialty drug.

Medical Statement

Natpara (parathyroid hormone) is considered medically necessary for an initial coverage period of 4 months when the following criteria are met:

 

1)    Diagnosis of hypocalcemia (E83.51) due to chronic hypoparathyroidism (E89.2) AND

2)    Natpara is not being used in the setting of acute post-surgical hypoparathyroidism (E89.2) AND

3)    Patient does not have a known calcium-sensing receptor mutation AND

4)    Patient has a documented parathyroid hormone concentration that is inappropriately low for the level of calcium, recorded on at least two occasions within the previous 12 months  AND

5)    Natpara is prescribed by or in consultation with an endocrinologist AND

6)    Patient has been optimized on adequate doses of oral calcium (>2,000mg daily) and vitamin D (calcitriol >0.25ug/day or alfacalcidol >0.5ug/day) supplementation AND

7)    Patient has normal thyroid-stimulating hormone concentrations if not on thyroid hormone replacement therapy (or if on therapy, the dose had to have been stable for >3 months) AND

8)    Patient has normal magnesium and serum 25-hydroxyvitamin D concentrations AND

9)    Creatinine clearance is at least 30ml/min on two separate measurements, or greater than 60ml/min (one measurement) with an accompanying serum creatinine concentration of less than1.5mg/dL  AND

10) Natpara will be used as an adjunct to calcium and vitamin D AND

11) Prescriber is certified in the Natpara REMS program

Natpara is considered medically necessary for continued coverage (12 month period) when the following criteria are met:

1)    Patient has achieved and maintained serum calcium levels in the normal range (8-10.6 mg/dL)  OR

2)    Patient has experienced a 50% or greater reduction in oral calcium intake OR

3)    Patient has experienced a 50% or greater reduction in oral vitamin D intake  AND

4)    Prescriber is certified in the Natpara REMS program

Limits

Natpara is subject to a quantity limit of 2 cartridges per 28 days.

Reference

1.    Natpara Prescribing Information.  NPS Pharmaceuticals, Inc. Bedminster, NJ. January 2015.

2.    Clinical Pharmacology. Accessed online 9/11/2015.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.