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Biol Ther. 2013;3:35-43. Epub 2013 May 28.

Switching From Originator to Biosimilar Human Growth Hormone Using Dialogue Teamwork: Single-Center Experience From Sweden.

Author information

1
Childhood Obesity Unit, Barn-och Ungdomsmedicinska Kliniken, Skånes Universitetssjukhus, Malmö, Sweden ; Department of Pediatrics, Skåne University Hospital, Malmö, Sweden.
2
Department of Medicines Management and Informatics, County of Skåne, Malmö, Sweden.
3
Biostatistics, HEXAL AG, Sandoz Biopharmaceuticals, Holzkirchen, Germany.
4
Department of Pediatrics, Skåne University Hospital, Malmö, Sweden.

Abstract

INTRODUCTION:

A new treatment plan was implemented at Skåne University Hospital, on economic grounds, for children requiring recombinant human growth hormone (rhGH) treatment. This involved switching patients from treatment with originator rhGHs to treatment with a biosimilar rhGH, somatropin (Omnitrope®), using a Dialogue Teamwork approach. The feasibility of using this approach to implement the switch of treatment was assessed, as well as the impact of the switch on treatment efficacy and cost of therapy.

METHODS:

As part of the Dialogue Teamwork approach, patients/parents received several opportunities for dialogue and sources of information, including discussions with the Head of Department, the responsible physician and a specialized endocrinology nurse. Height and height standard deviation score (HSDS) data were plotted for each individual patient (N = 98). A modeling approach was also used, to predict growth after switching to biosimilar rhGH; the predictions were then compared to the actual observed height after the switch. Costs to the clinic of rhGH therapy were calculated between May-August 2009 and May-August 2012.

RESULTS:

Of the 102 patients offered the switch, 98 accepted. Height and HSDS data indicated there was no negative impact on growth velocity after the switch to biosimilar rhGH. Modeling demonstrated that observed growth following the switch was consistent with predicted growth based on data before patients were switched. There were no reports of serious or unexpected adverse drug reactions following the switch to biosimilar rhGH. Following the switch, the cost to the clinic of rhGH treatment decreased from approximately 6 million SEK (May-August 2009) to approximately 4 million SEK (May-August 2012). This corresponds to an annual saving of 6 million SEK (€650,000).

CONCLUSION:

Patients were successfully switched from originator to biosimilar rhGH (somatropin), with no negative impact on growth, and no serious or unexpected adverse drug reactions. The switch from originator to biosimilar rhGH is associated with substantial cost savings.

KEYWORDS:

Biosimilar; Cost savings; Growth disturbances; Human growth hormone; Omnitrope; Pediatric; Switch

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