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Natpara (parathyroid hormone) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1059
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
1/1/2023 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Natpara® (parathyroid hormone) Subcutaneous injection |
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. |
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1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Hypoparathyroidism |
Hypoparathyroidism is a rare disorder of mineral metabolism characterized by hypocalcemia and absent or deficient production of parathyroid hormone (PTH). PTH is one of the major hormones that regulates calcium along with vitamin D via direct effects on the bone and kidney and indirect effects on the gastrointestinal tract. Hypoparathyroidism occurs when there is destruction of the parathyroid glands (e.g., autoimmune, surgical), abnormal parathyroid gland development, altered regulation of PTH production, or impaired PTH action. When PTH secretion is insufficient, hypocalcemia develops. Hypocalcemia can affect the function of most organs, but in hypoparathyroidism the most obvious organ systems that become dysfunctional are neurological, cognitive, muscular, and cardiac.(2,3,5)
The diagnostic biochemical hallmarks of hypoparathyroidism are hypocalcemia in association with deficient production of PTH. It is thus readily distinguished from pseudohypoparathyroidism, a genetic disorder of PTH resistance in which the circulating PTH concentration is elevated.(2,3) The diagnosis of hypoparathyroidism is also readily distinguished from secondary causes of hypocalcemia (e.g., vitamin D deficiency) in which the PTH level is also high. In hypoparathyroidism, circulating concentrations of active vitamin D is usually in the lower normal range.(2,3,5)
Treatment with oral calcium supplements and active forms of vitamin D (e.g., calcitriol, cholecalciferol, ergocalciferol) are the current standard of care. Monitoring of urinary and serum calcium and serum phosphate is required weekly initially, until a stable serum calcium concentration is achieved. Thereafter, monitoring levels at 3- to 6-month intervals is sufficient. Some patients may require the addition of thiazide diuretics with or without dietary sodium restrictions to decrease urinary calcium excretion. Some patients, despite very high amounts of calcium and active vitamin D, are subject to wide swings in their serum calcium and associated symptomology. Second line therapy is recombinant human parathyroid hormone (rhPTH), which provides an additional useful therapeutic option in the management of hypoparathyroidism. Goals of therapy with rhPTH are to minimize or eliminate the use of active vitamin D, to reduce supplemental calcium to 500 mg daily, and to maintain the serum calcium in the lower range of normal.(2,3,5) |
Efficacy (1,4) |
Efficacy of recombinant human PTH (rhPTH) was evaluated in a 24-week, randomized, double-blind, placebo-controlled, multicenter trial (REPLACE). In this trial, patients with established hypoparathyroidism receiving calcium and active forms of vitamin D (vitamin D metabolite or analogs) were randomized to PTH (n=84) or placebo (n=40). For the efficacy analysis, patients that fulfilled three components of a three-part response criterion were considered responders. A responder was defined as an individual who had: greater than or equal to 50% reduction from baseline in the dose of active vitamin D, greater than or equal to 50% reduction from baseline in the dose of oral calcium supplementation, and an albumin-corrected total serum calcium concentration between 7.5 mg/dL and 10.6 mg/dL. At the end of treatment, significantly more subjects treated with Natpara compared to placebo met the response criteria (54.8% and 2.5%, respectively). |
Safety (1) |
Natpara carries a boxed warning for potential risk of osteosarcoma. In male and female rats, rhPTH caused an increase in incidence of osteosarcoma, with occurrence dependent on rhPTH dose and treatment duration. This effect was observed at rhPTH levels from 3 to 71 times the exposure levels in humans receiving a 100 mcg dose of rhPTH. Data could not exclude a risk to humans. Due to risk of osteosarcoma, rhPTH should be used only in patients who cannot be well-controlled on calcium and active vitamin D alone and for whom potential benefits outweigh risks. Avoid use in patients at increased baseline risk for osteosarcoma (e.g., Paget’s disease of bone, elevated alkaline phosphatase, pediatric and young adult patients with open epiphyses, hereditary disorders predisposing to osteosarcoma, or history of external beam or implant radiation therapy involving the skeleton). Because of this risk, rhPTH is available only through the Natpara REMS Program.
Natpara is contraindicated in patients with a known hypersensitivity to any component of the product.
Co-administration of alendronate and Natpara leads to reduction in the calcium-sparing effect, which can interfere with the normalization of serum calcium. Concomitant use of Natpara with alendronate is not recommended. |
REFERENCES
Number |
Reference |
1 |
Natpara prescribing information. Shire-NPS Pharmaceuticals, Inc. April 2022. |
2 |
Brandi ML, Bilezikian JP, Shoback D, et al. Management of Hypoparathyroidism: Summary Statement and Guidelines. J Clin Endocrinol Metab 2016;101(6):2273-2283. |
3 |
Sinnott BP. Hypoparathyroidism – Review of the Literature. J Rare Disord Diagn Ther 2018;4(3):1-7. |
4 |
Clarke BL, Vokes TJ, Bilezikian JP, et al. Effects of Parathyroid Hormone rhPTH(1-84) on Phosphate Homeostasis and Vitamin D Metabolism in Hypoparathyroidism: REPLACE Phase 3 Study. Endocrine 2017;55(1):273-282. |
5 |
Bilezikian JP. Hypoparathyroidism: Mini Review. J Clin Endocrinol Metab 2020;105(6):1-15. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Agent Names |
Strength |
Targeted MSC |
Available MSC |
Preferred Status |
Effective Date |
|
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NATPARA*parathyroid hormone (recombinant) for inj cartridge |
100 MCG ; 25 MCG ; 50 MCG ; 75 MCG |
M ; N ; O ; Y |
N |
|
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POLICY AGENT SUMMARY QUANTITY LIMIT
Target Agent GPI |
Agent Names |
Strength |
QL Amount |
Dose Form |
Days Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
Effective Date |
|
||||||||||
3004405510E1 |
NATPARA*parathyroid hormone (recombinant) for inj cartridge |
100 MCG ; 25 MCG ; 50 MCG ; 75 MCG |
1.0 |
KIT |
28 |
Days |
|
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Agent Names |
Strength |
Client Formulary |
NATPARA*parathyroid hormone (recombinant) for inj cartridge |
100 MCG ; 25 MCG ; 50 MCG ; 75 MCG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Agent Names |
Strength |
Client Formulary |
NATPARA*parathyroid hormone (recombinant) for inj cartridge |
100 MCG ; 25 MCG ; 50 MCG ; 75 MCG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Initial Evaluation Target Agent will be approved when ALL of the following are met:
Length of Approval: 6 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Renewal Evaluation Target Agent will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL with PA |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: Initial: 6 months; Renewal: 12 months |
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ Natpara (parathyroid hormone) Prior Authorization with Quantity Limit _ProgSum_ 1/1/2023