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Persistence With Growth Hormone Therapy in Pediatric Patients
Bradley S. Miller, MD, PhD; Deborah Rotenstein, MD; Larry C. Deeb, MD; John Germak, MD; and Tami Wisniewski, MPH

Persistence With Growth Hormone Therapy in Pediatric Patients

Bradley S. Miller, MD, PhD; Deborah Rotenstein, MD; Larry C. Deeb, MD; John Germak, MD; and Tami Wisniewski, MPH
Height outcomes in growth hormone“deficient patients may be adversely affected by lack of persistence with growth hormone therapy, possibly associated with changes in insurance coverage
Changes in insurance coverage for GH therapy can be due to a change of carriers, an insurance company switch to approval through a pharmacy benefit manager, a change in the insurance criteria for GH approval, a retrospective review of previously approved cases with new approval criteria, or a change in insurance criteria for stopping therapy. When an insurance carrier changes, a new coverage application is required and the child may no longer qualify based on the new carrier’s coverage criteria. If an insurance company rejects a patient’s treatment, physicians and family members may then need to become involved in a time-consuming appeals process; this may cause a lack of persistence or early termination of therapy, leading to worse growth outcomes.

A lack of follow-up data and a lack of height-outcomes comparisons for patients who discontinued therapy with somatropin injection after receiving GH treatment for the same length of time are limitations of this analysis. Individuals may have continued therapy on another GH drug and achieved comparable height outcomes; currently, however, there is no way to track patients who are enrolled in different manufacturer-based registries. Future research is needed to explore the impact of therapy discontinuation on long-term height outcomes in children treated with GH. Improving payer processes so that GH therapy will continue to be approved, while minimizing mandated switches to a different GH product, may help ensure adherence and persistence with GH therapy and optimize growth outcomes.26 Improvements in the approval and formulary-change processes could include notifying patients and providers about impending formulary changes and changes in coverage criteria, educating patients and families about the importance of persistence in order to achieve ultimate height outcomes, developing industrywide insurance guidelines for the approval and continuation of GH therapy, and creating similar application forms and appeals processes among insurers.

Author Affiliations: From Department of Pediatrics (BSM), University of Minnesota, Minneapolis, MN; Pediatric Alliance (DR), Pittsburgh, PA; Department of Medical Humanities and Social Sciences, Florida State University (LCD), Tallahassee, FL; Novo Nordisk Inc (JG, TW), Princeton, NJ.

Funding Source: Novo Nordisk Inc, Princeton, NJ.

Author Disclosures: Dr Bradley reports attending a paid scientific advisory board meeting at Novo Nordisk, receiving phase 4 safety and efficacy registry grants from Novo Nordisk, and presenting data from this paper at an Academy of Managed Care Pharmacies meeting in 2011; Dr Rotenstein reports receiving payment from Novo Nordisk for speaking engagements. Ms Wisniewski and Dr Germak report employment at Novo Nordisk and ownership of Novo Nordisk stock.

Authorship Information: Concept and design (BSM, LCD, DR, TW, JG); acquisition of data (BSM, JG); analysis and interpretation of data (BSM, LCD, DR, TW, JG); drafting of the manuscript (BSM, LCD, DR, TW, JG); critical revision of the manuscript for important intellectual content (BSM, LCD, JG); statistical analysis (JG); provision of study materials or patients (BSM).

Address correspondence to: Bradley S. Miller, MD, PhD, Department of Pediatrics, University of Minnesota Amplatz Children’s Hospital, MMC 8952D, E Bldg MB671, 2450 Riverside Ave, Minneapolis, MN 55454. E-mail: mille685@umn.edu.
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