Major Finding: Ninety percent of respondents reported switching a pediatric patient from one growth hormone brand to another, with 50% experiencing repeated switches.
Data Source: Survey of 231 active members of the Lawson Wilkins Pediatric Endocrine Society.
Disclosures: The study was commissioned by the Food and Drug Administration. Dr. Grimberg had no disclosures.
VANCOUVER, B.C. — Switching children from one brand of growth hormone to another, a common occurrence, acan negatively impact overall treatment efficacy and safety, according to a survey of 231 active members of the Lawson Wilkins Pediatric Endocrine Society.
Of 182 respondents, 8% said they observed growth deceleration after a switch. The majority said they thought the reduction was due to lapses in treatment, patient confusion, and dosing errors.
Of 185 respondents, 13% had safety concerns about switches, citing dosing errors and patient confusion. There are different recombinant human growth hormone (rhGH) concentrations, storage requirements and injection devices, with different reconstitution procedures and dosing increments.
Brand switches during pediatric growth hormone treatment are becoming more prevalent now that multiple brands are commercially available and insurance carriers are increasingly adopting formulary preference coverage strategies, Dr. Adda Grimberg, scientific director of the Diagnostic and Research Growth Center at Children's Hospital of Philadelphia, said at the meeting..
“The same child can be started on one brand, be switched to another brand, and be switched again because the growth hormone companies and insurance carriers renegotiate their contracts every 1-2 years,” she said. “It's an ongoing process.”
Ninety percent of all respondents reported switching a pediatric patient from one rhGH product to another, with 50% of these experiencing repeated switches.
At roughly $20,000 a year, the cost of rhGH is and will continue to be a factor behind the brand-switching phenomenon. “Because growth hormone is expensive and used for years, financial pressures are pushing more and more for cost-containing measures like formulary preference strategies and that's created this environment of multiple brand switches, and there are potential downsides that need to be addressed,” she said.
Brand switches also caused patient-family issues, two-thirds of the respondents said. Patients and families are concerned that there may be lapses in treatment, distrust that the new product will be as good as their current brand, and are anxious about being denied coverage and their ability to learn how to use a new device, she said. Physicians reported that two children were unable to use their new device and 10 experienced burning, pain, or stinging with a particular brand.
Physicians and their staff are also feeling the effects of brand switching: More than half of all respondents reported that when a patient is switched from one rhGH brand to another they spend at least 1 hour on device instruction, paperwork, and other activities such as telephone reassurance and follow-up, appeals, and changing rhGH registries.
Concerns have been raised that frequent brand switches may be contributing to an increased incidence of growth hormone immunogenicity. Only three respondents routinely measured anti–growth hormone antibodies, and all three found negative titers both before and after the switch, Dr. Grimberg said.
At roughly $20,000 a year, the cost of rhGH is a major factor behind the brand-switching phenomenon.
Source DR. GRIMBERG