Growth hormone (GH) plays a role in the regulation of protein, lipid, and carbohydrate metabolism during adult life. About three-quarters of adult growth hormone deficiency (GHD) cases are associated with pituitary tumours and subsequent surgery and radiotherapy. Clinical manifestations of GHD in adults include decreased lean body and muscle mass, increased fat mass, reduced bone mineral density, lipid profile changes, and psychiatric symptoms. Diagnosis of adult GHD is usually based on a medical history (childhood-onset GHD, hypothalamic–pituitary disease or surgery, cranial irradiation or traumatic brain injury) and biochemical tests (GH stimulation tests). In a European study, the prevalence of hypopituitarism was estimated to be 29 to 45 per 100,000, and the incidence 4.2 cases per 100,000. There are no data on prevalence or incidence of GHD in Canada.

Once diagnosed, patients with GHD may receive replacement therapy with somatropin, which is identical in amino acid sequence to endogenous GH and synthesized through recombinant DNA technology. The goals of replacement therapy are to correct the metabolic, functional, and psychological abnormalities associated with adult GHD. A number of somatropin products are available in Canada for replacement of endogenous growth hormone in adults with GHD, including Genotropin. The approved dose of Genotropin in this population is 0.15 mg to 0.3 mg per day, administered subcutaneously.

Contents

• Clinical Review Report
  • ABBREVIATIONS
  • EXECUTIVE SUMMARY
    • Introduction
    • Results and Interpretation
    • Summary of Systematic Reviews of Somatropin
    • Efficacy
    • Harms
    • Comparison of Somatropin Products Available in Canada
    • Summary of Manufacturer-Submitted Placebo-Controlled Trials
    • Pharmacoeconomic Summary
    • Conclusions
  • 1. INTRODUCTION
    • 1.1 Disease Prevalence and Incidence
    • 1.2 Standards of Therapy
    • 1.3 Drug
  • 2. OBJECTIVES AND METHODS
    • 2.1 Objectives
    • 2.2 Methods
  • 3. RESULTS
    • 1.1 Findings from the Literature
    • 1.2 Included Studies
    • 1.3 Key Clinical Issues
  • 4. DISCUSSION
    • 1.4 Summary of Available Evidence
    • 1.5 Interpretation of Results
  • 5. CONCLUSIONS
  • APPENDIX 1 PATIENT INPUT SUMMARY
  • APPENDIX 2 LITERATURE SEARCH STRATEGY
  • APPENDIX 3 EXCLUDED STUDIES
  • REFERENCE
• Pharmacoeconomic Review Report
  • ABBREVIATIONS
  • SUMMARY
  • 1. INTRODUCTION
    • 1.1 Cost Comparison Table
  • 2. SUMMARY OF PHARMACOECONOMIC SUBMISSION
  • 3. INTERPRETATIONS AND KEY LIMITATIONS
    • 3.1 Lack of Evidence to Support Equivalent Efficacy and Safety
  • 4. ISSUES FOR CONSIDERATION
  • 5. CONCLUSIONS
  • APPENDIX 1 UTILIZATION ANALYSIS
  • REFERENCE
• CDEC Final Recommendation
  • Recommendation
  • Condition
  • Reasons for the Recommendation
  • Of Note
  • Background
  • Summary of CDEC Considerations
  • Other Discussion Points
  • Research Gaps

This report was prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). Through the Common Drug Review (CDR) process, CADTH undertakes reviews of drug submissions, resubmissions, and requests for advice, and provides formulary listing recommendations to all Canadian publicly funded federal, provincial, and territorial drug plans, with the exception of Quebec.

The report contains an evidence-based clinical and/or pharmacoeconomic drug review, based on published and unpublished material, including manufacturer submissions; studies identified through independent, systematic literature searches; and patient-group submissions. In accordance with CDR Update — Issue 87, manufacturers may request that confidential information be redacted from the CDR Clinical and Pharmacoeconomic Review Reports.

The information in this report is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a substitute for the application of clinical judgment with respect to the care of a particular patient or other professional judgment in any decision-making process, nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of this document to ensure that its contents are accurate, complete, and up-to-date as of the date of publication, CADTH does not make any guarantee to that effect. CADTH is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in the source documentation. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the information in this document or in any of the source documentation.

This document is intended for use in the context of the Canadian health care system. Other health care systems are different; the issues and information related to the subject matter of this document may be different in other jurisdictions and, if used outside of Canada, it is at the user’s risk. This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada.

CADTH takes sole responsibility for the final form and content of this document, subject to the limitations noted above. The statements and conclusions in this document are those of CADTH and not of its advisory committees and reviewers. The statements, conclusions, and views expressed herein do not necessarily represent the views of Health Canada or any Canadian provincial or territorial government. Production of this document is made possible by financial contributions from Health Canada and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Prince Edward Island, Saskatchewan, and Yukon.