Skip Navigation
PrintDownload PDFGet Adobe ReaderDownload to WordDownload as HTMLDownload as XMLCitation Manager
Save to Favorites
Guideline Summary
Guideline Title
Human growth hormone (somatropin) for the treatment of growth failure in children.
Bibliographic Source(s)
National Institute for Health and Clinical Excellence (NICE). Human growth hormone (somatropin) for the treatment of growth failure in children. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 May. 49 p. (Technology appraisal guidance; no. 188). 
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)
  • Growth hormone deficiency
  • Turner syndrome
  • Prader-Willi syndrome
  • Chronic renal insufficiency
  • Born small for gestational age with subsequent growth failure at 4 years of age or later
  • Short stature homeobox-containing gene (SHOX) deficiency
Guideline Category
Assessment of Therapeutic Effectiveness
Treatment
Clinical Specialty
Endocrinology
Family Practice
Medical Genetics
Pediatrics
Intended Users
Advanced Practice Nurses
Nurses
Physician Assistants
Physicians
Guideline Objective(s)

To assess the clinical- and cost-effectiveness of recombinant human growth hormone for children with growth hormone deficiency, Turner syndrome, Prader-Willi syndrome, chronic renal insufficiency, short stature homeobox-containing gene-deficiency, and those born short for gestational age

Target Population

Children with growth failure associated with any of the following conditions:

  • Growth hormone deficiency
  • Turner syndrome
  • Prader-Willi syndrome
  • Chronic renal insufficiency
  • Born small for gestational age with subsequent growth failure at 4 years of age or later
  • Short stature homeobox-containing gene (SHOX) deficiency
Interventions and Practices Considered

Recombinant human growth hormone (somatropin)

Major Outcomes Considered
  • Clinical effectiveness
    • Final height gained
    • Height standard deviation score (height relative to the distribution of height in children of the same chronological age)
    • Growth velocity
    • Growth velocity standard deviation score (growth velocity relative to the distribution of growth in children of the same chronological age or bone age)
    • Body composition
    • Biochemical and metabolic markers
    • Adverse effects of treatment
    • Health-related quality of life
  • Cost-effectiveness

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Searches of Unpublished Data
Description of Methods Used to Collect/Select the Evidence

Note from the National Guideline Clearinghouse (NGC): The National Institute for Health and Clinical Excellence (NICE) commissioned an independent academic centre to perform a systematic literature review on the technology considered in this appraisal and prepare an assessment report. The assessment report for this technology appraisal was prepared by the Southampton Health Technology Assessments Centre (see the "Availability of Companion Documents" field).

Clinical Effectiveness

Search Strategy

An experienced information specialist developed and tested search strategies for this review. Separate searches were carried out to identify studies reporting clinical-effectiveness, cost-effectiveness, health-related quality of life (QoL), resource use and costs, and epidemiology/natural history of the conditions. The search strategy for Medline, shown in Appendix 2 of the assessment report (see the "Availability of Companion Documents" field), was adapted as appropriate for a number of other electronic databases. The assessment group searched: The Cochrane Database of Systematic Reviews (CDSR); The Cochrane Central Register of Controlled Trials; National Health Service Center for Reviews and Dissemination (NHS CRD, University of York); Database of Abstracts of Reviews of Effectiveness (DARE) and the NHS Economic Evaluation Database (NHS EED); Medline (Ovid); EMBASE (Ovid); National Research Register; Current Controlled Trials; Institute for Scientific Information (ISI) Proceedings; Web of Science; and BIOSIS. For all disease areas the assessment group searched the databases from their inception to June 2009. This meant there was some duplication of earlier work for the previous review, but was necessary since the present review required searches for additional outcomes, such as biochemical and metabolic markers. Searches were limited to the English language.

Relevant conferences (European Society for Paediatric Endocrinology, The Endocrine Society, American Association of Endocrinologists, Paediatric Academic Societies) were searched for recent abstracts (up to June 2009) to assess against the inclusion criteria. Bibliographies of related papers were screened for relevant studies, and the group contacted experts to identify any additional published or unpublished references. The manufacturers' submissions to NICE were also assessed for any additional studies which met the inclusion criteria.

Inclusion and Data Extraction Process

Titles and abstracts of studies identified by the search strategy were assessed for potential eligibility by two reviewers. The full text of relevant papers was then obtained, and inclusion criteria were applied by two independent reviewers. At both stages of the screening process, any differences in opinion on inclusion of a particular study were resolved through discussion. Data from included studies were extracted by one reviewer using a standard data extraction form and checked by a second reviewer. Any discrepancies were identified and resolved through discussion.

Inclusion Criteria

Patients

The inclusion criteria required the patient group to be children with growth disturbance due to one of the following conditions:

  • Insufficient secretion of growth hormone (growth hormone deficiency)
  • Turner syndrome
  • Prader-Willi syndrome, confirmed by genetic testing
  • Chronic renal insufficiency (prepubertal children only)
  • Short stature homeobox-containing gene deficiency (SHOX-D)
  • Small for gestational age

Studies which included adolescents and young adults who have completed linear growth were excluded from the systematic review of effectiveness.

Interventions

Recombinant human growth hormone (somatropin)

Comparators

Management strategies without somatropin.

Outcomes

The following outcomes were included in the review, where data were available:

  • Final height gained
  • Height standard deviation score (height relative to the distribution of height in children of the same chronological age)
  • Growth velocity
  • Growth velocity standard deviation score (growth velocity relative to the distribution of growth in children of the same chronological age or bone age)
  • Body composition
  • Biochemical and metabolic markers
  • Adverse effects of treatment
  • Health-related QoL

Types of Studies

  • Fully published randomised controlled trials (RCTs) were included in the review, and systematic reviews of RCTs were included as sources of information. Indicators of a systematic review include: explicit search strategy, inclusion criteria, data extraction and assessment of quality.
  • Studies published only as abstracts or conference presentations were included in the primary analysis of clinical and cost-effectiveness if sufficient details were presented to allow an appraisal of the methodology and assessment of results.
  • Non-English language studies were excluded.
  • In an effort to capture all randomised evidence, all identified RCTs were included with no restriction on length of treatment, size of study population, or design (parallel group or cross-over design). Cross-over studies could potentially be problematic as children's growth continues without treatment, making comparisons between the different arms less straightforward than in a parallel-group trial. However, the assessment group has attempted to include discussion of this in the quality assessment of studies.

Cost-Effectiveness

Systematic Review of Existing Cost-Effectiveness Evidence

Methods for the Systematic Review of Cost-Effectiveness

A systematic literature search was undertaken to identify economic evaluations for recombinant human growth hormone (rhGH) in children. The details of the search strategy for the cost effectiveness studies are in Appendix 2 in the assessment report (see the "Availability of Companion Documents" field). The manufacturers' submissions were reviewed for any additional studies. Titles and abstracts of studies identified by the search strategy were assessed for potential eligibility by two health economists. Full text versions of relevant papers were retrieved and checked by two health economists. Any differences in judgement were resolved through discussion. The quality of the cost effectiveness studies was assessed using a critical appraisal checklist based on that by Drummond and Jefferson, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) checklist, and the NICE reference case.

Review of Research on Quality of Life

Systematic Review of Health Related Quality of Life (HRQoL) Studies

A systematic review was undertaken to identify HRQoL studies for rhGH for children. The HRQoL searches were undertaken to populate a lifetime economic model with utilities to calculate quality-adjusted life years (QALYs), so studies with adults and children were eligible for inclusion. Titles and abstracts of studies identified by the search strategy were assessed for potential eligibility by two health economists. Full text versions of relevant papers were retrieved and checked by two health economists. Any differences in judgement were resolved through discussion. The details of the search strategy for QoL are in Appendix 2 in the assessment report (see the "Availability of Companion Documents" field).

The titles and abstract of the studies identified by the search strategy were assessed on the basis of the following criteria:

  • Disease condition as defined in Table 2 in Section 3 of the assessment report (see the "Availability of Companion Documents" field).
  • Primary research using a preference/utility based measure for the conditions of interest.
  • Primary research using a generic measure (i.e., short form 36 questionnaire [SF-36]) that can be translated into a utility-based estimate.
  • Primary research using a condition/disease specific QoL measure and an algorithm that allowed disease specific QoL to be converted into utility values.

Exclusion criteria for the systematic literature search:

  • Primary research reporting QoL that could not be converted into utility values using a validated mapping algorithm.
  • Background or discussion papers that do not report a QoL measure for the conditions of interest.
  • Papers reported in language other than English.
Number of Source Documents

Clinical Effectiveness

A total of 37 studies were included.

  • Systematic reviews n=3 (one of the systematic reviews was the previous Health Technology Assessment [HTA] report written for National Institute for Health and Clinical Excellence [NICE], so this was not data extracted)
  • Randomised controlled trials (RCTs) n=28 in 34 publications

Cost-Effectiveness

  • Five full papers were retrieved with only two economic evaluations meeting the inclusion criteria.
  • Six papers met the inclusion criteria on quality of life (QoL). An additional targeted search for QoL in relation to height identified an additional study.
  • Five manufacturers submitted cost-effectiveness models.
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus
Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Note from the National Guideline Clearinghouse (NGC): The National Institute for Health and Clinical Excellence (NICE) commissioned an independent academic centre to perform a systematic literature review on the technology considered in this appraisal and prepare an assessment report. The assessment report for this technology appraisal was prepared by the Southampton Health Technology Assessments Centre (see the "Availability of Companion Documents" field).

Clinical Effectiveness

Quality Assessment

The quality of included studies was assessed using National Health Service Center for Reviews and Dissemination (NHS CRD) (University of York) criteria. Quality criteria were applied by one reviewer and checked by a second reviewer, with differences in opinion resolved by discussion and involvement of a third reviewer where necessary. The criteria used are shown in Appendix 3 in the assessment report (see the "Availability of Companion Documents" field).

Data Synthesis

  • Clinical-effectiveness studies were synthesised through a narrative review with tabulation of results of included studies. Key outcome measures are reported in tables in the text, and other outcomes are shown in the full data extraction forms in Appendix 4 in the assessment report (see the "Availability of Companion Documents" field). For conciseness, where a study reported outcome measures after one and two years, only the final year's outcomes are included in the table since these show the longest duration of treatment effect.
  • Where data were of sufficient quality and homogeneity, a meta-analysis of the clinical effectiveness studies was considered using Review Manager 5.0 software.
  • Quality of life studies were synthesised using the same methods as above, i.e., narrative review and meta-analysis only if feasible.

Cost-Effectiveness

Evaluation of Uncertainty

The evaluation of the cost-effectiveness of growth hormone treatment is based on uncertain information about variables such as clinical effect, health related quality of life (QoL) and resource use. This uncertainty was evaluated using deterministic and probabilistic sensitivity analyses. One-way deterministic sensitivity analyses were conducted to evaluate the influence of individual parameters on the model results and test the robustness of the cost-effectiveness results to variations in the structural assumptions and parameter inputs. Multi-parameter uncertainty in the model was addressed using probabilistic sensitivity analysis (PSA). In PSA probability distributions are assigned to the point estimates used in the base case analysis. The model is run for 1000 iterations, with a different set of parameter values for each iteration, by sampling parameter values at random from their probability distributions. The uncertainty surrounding the cost-effectiveness of the growth hormone treatment is represented on a cost-effectiveness acceptability curve (CEAC) according to the probability that the intervention will be cost effective at a particular willingness to pay threshold. Appendix 12 of the assessment report (see the "Availability of Companion Documents" field) reports the parameters included in the PSA, the form of distribution used for sampling each parameter, and the upper and lower limits assumed for each variable.

Model Validation

The Southampton Health Technology Assessment Centre (SHTAC) model was validated by checking the model structure, calculations and data inputs for technical correctness. The completed cost-effectiveness model was verified by another health economist. The SHTAC model was checked for internal consistency against the manufacturer's submission (MS) economic models by running the SHTAC model with the inputs used in MS models to ensure similar results. The robustness of the model to changes in input values was tested using sensitivity analyses to ensure that any changes to the input values produced changes to the results of the expected direction and magnitude. Finally, the model results were compared with those from previous studies including the previous Health Technology Assessment (HTA) report and this is discussed in more detail in Section 6 of the assessment report (see the "Availability of Companion Documents" field).

Refer to section 4 of the assessment report (see the "Availability of Companion Documents" field) for more information on cost-effectiveness analysis.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Considerations

Technology appraisal recommendations are based on a review of clinical and economic evidence.

Technology Appraisal Process

The National Institute for Health and Clinical Excellence (NICE) invites 'consultee' and 'commentator' organisations to take part in the appraisal process. Consultee organisations include national groups representing patients and carers, the bodies representing health professionals, and the manufacturers of the technology under review. Consultees are invited to submit evidence during the appraisal and to comment on the appraisal documents.

Commentator organisations include manufacturers of the products with which the technology is being compared, the National Health Service (NHS) Quality Improvement Scotland and research groups working in the area. They can comment on the evidence and other documents but are not asked to submit evidence themselves.

NICE then commissions an independent academic centre to review published evidence on the technology and prepare an 'assessment report'. Consultees and commentators are invited to comment on the report. The assessment report and the comments on it are then drawn together in a document called the evaluation report.

An independent Appraisal Committee then considers the evaluation report. It holds a meeting where it hears direct, spoken evidence from nominated clinical experts, patients and carers. The Committee uses all the evidence to make its first recommendations, in a document called the 'appraisal consultation document' (ACD). NICE sends all the consultees and commentators a copy of this document and posts it on the NICE website. Further comments are invited from everyone taking part.

When the Committee meets again it considers any comments submitted on the ACD; then it prepares its final recommendations in a document called the 'final appraisal determination' (FAD). This is submitted to NICE for approval.

Consultees have a chance to appeal against the final recommendations in the FAD. If there are no appeals, the final recommendations become the basis of the guidance that NICE issues.

Who Is on the Appraisal Committee?

NICE technology appraisal recommendations are prepared by an independent committee. This includes health professionals working in the NHS and people who are familiar with the issues affecting patients and carers. Although the Appraisal Committee seeks the views of organisations representing health professionals, patients, carers, manufacturers and government, its advice is independent of any vested interests.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

Manufacturers' Core Economic Model

The manufacturers developed a Markov cohort model for the economic evaluation containing two health states: 'alive' and 'dead'. The manufacturers estimated the transition probabilities between states using UK-specific mortality rates observed in the general population. The economic model considered a 1-year cycle length. Two alternative model structures were also presented. One allowed for a reduction in the risk of osteoporosis in children with growth hormone deficiency treated with somatropin and assumed that some children with growth hormone deficiency would continue treatment until they reached 25 years of age. A second model incorporated a cost-effectiveness analysis of somatropin in Prader-Willi syndrome. This model assumed that people with Prader–Willi syndrome and diabetes would have a 10% lower quality of life than those without diabetes.

The incremental cost effectiveness ratios (ICERs) for the base case ranged from: 15,730 to 17,522 pounds per quality-adjusted life year (QALY) gained for growth hormone deficiency; 18,721 to 20,881 pounds per QALY gained for growth hormone deficiency with somatropin continued through the transition years from age 18 to 25; 26,630 to 29,757 pounds per QALY gained for Turner syndrome; 12,498 to 15,962 pounds per QALY gained for chronic renal insufficiency (CRI) and from 14,221 to 18,655 pounds per QALY gained for small for gestational age. The base-case analyses for Prader-Willi syndrome and short stature homeobox-containing gene (SHOX) deficiency produced ICERs of 32,540 and 23,237 pounds per QALY gained respectively.

The ICERs were most sensitive to the choice of utility values, time horizon, discount rates, treatment duration, doses during the transition phase for those with growth hormone deficiency, the proportion of people achieving final height, and drug price.

Assessment Group's Model

The Assessment Group developed a state transition Markov model based on the model developed for National Institute for Health and Clinical Excellence (NICE) technology appraisal guidance 42. The modelled health states were 'alive' and 'dead'. The economic model considered a cycle length of 1 year and a life time horizon of 100 years. The mortality rates for the population in England and Wales were applied in each cycle and the rates were adjusted upward using the standard mortality rates for each of the conditions. The Assessment Group presented an additional scenario for growth hormone deficiency in which it assumed that 34% of people with growth hormone deficiency continued treatment until age 25 years at a dosage of 40 micrograms/day. The model assumes that this group does not receive additional benefits from somatropin beyond those associated with attaining final height.

The ICERs (cost per QALY gained) for the base case were 23,196 pounds per QALY gained for growth hormone deficiency; 28,244 pounds per QALY gained for growth hormone deficiency with treatment continued through the transition phase of early adulthood; 39,460 pounds per QALY gained for Turner syndrome; 135,311 pounds per QALY gained for Prader-Willi syndrome; 39,273 pounds per QALY gained for CRI; 33,079 pounds per QALY gained for small for gestation age and 40,531 pounds per QALY gained for SHOX deficiency.

The discount rates used for the analyses had a large effect on the results. Using discount rates that were used in the model for NICE technology appraisal guidance 42 (that is costs 6% and benefits 1.5%), the costs per QALY gained were less than 30,000 pounds for all the conditions except Prader-Willi syndrome. In addition, for all conditions, the results of the model were most sensitive to age at the start of treatment, length of treatment, adherence and utility gain.

Consideration of the Evidence

The Appraisal Committee concluded that within its marketing authorisation somatropin represents a cost-effective treatment for children with growth failure associated with all the conditions under consideration. The Committee also concluded that in light of the apparent equivalence of the clinical effectiveness of the different somatropin products, the least costly product that, after discussion between the responsible clinician and the patient and/or their carer, has been agreed to meet the needs of the individual child and to maximise the likelihood of adherence to treatment should be chosen.

Refer to Sections 4.2 and 4.3 in the original guideline document for details of the economic analyses provided by the manufacturers, the Assessment Group comments, and the Appraisal Committee considerations.

Method of Guideline Validation
External Peer Review
Description of Method of Guideline Validation

Consultee organisations from the following groups were invited to comment on the draft scope, Assessment Report, and the Appraisal Consultation Document (ACD) and were provided with the opportunity to appeal against the Final Appraisal Determination.

  • Manufacturer/sponsors
  • Professional/specialist and patient/carer groups
  • Commentator organisations (without the right of appeal)

In addition, individuals selected from clinical expert and patient advocate nominations from the professional/specialist and patient/carer groups were also invited to comment on the ACD.

Recommendations

Major Recommendations

Note from the National Institute for Health and Clinical Excellence (NICE): This guidance replaces 'NICE technology appraisal guidance 42' issued in May 2002. The review and re-appraisal of human growth hormone (somatropin) for the treatment of growth failure in children has resulted in a change in the guidance. Human growth hormone (somatropin) is still recommended for the treatment of growth failure in children with growth hormone deficiency, Turner syndrome, Prader-Willi syndrome and chronic renal insufficiency, but there has been an extension of the guidance to include growth failure associated with either of the two following conditions: born small for gestational age with subsequent growth failure at 4 years of age or later short stature homeobox-containing gene (SHOX) deficiency.

Guidance

Somatropin (recombinant human growth hormone) is recommended as a treatment option for children with growth failure associated with any of the following conditions:

  • Growth hormone deficiency
  • Turner syndrome
  • Prader-Willi syndrome
  • Chronic renal insufficiency
  • Born small for gestational age with subsequent growth failure at 4 years of age or later
  • Short stature homeobox-containing gene (SHOX) deficiency.

Treatment with somatropin should always be initiated and monitored by a paediatrician with specialist expertise in managing growth hormone disorders in children. The choice of product should be made on an individual basis after informed discussion between the responsible clinician and the patient and/or their carer about the advantages and disadvantages of the products available, taking into consideration therapeutic need and the likelihood of adherence to treatment. If, after that discussion, more than one product is suitable, the least costly product should be chosen.

Treatment with somatropin should be discontinued if any of the following apply:

  • Growth velocity increases less than 50% from baseline in the first year of treatment
  • Final height is approached and growth velocity is less than 2 cm total growth in 1 year
  • There are insurmountable problems with adherence
  • Final height is attained

In Prader-Willi syndrome evaluation of response to therapy should also consider body composition.

Treatment should not be discontinued by default. The decision to stop treatment should be made in consultation with the patient and/or carers either by:

  • A paediatrician with specialist expertise in managing growth hormone disorders in children
  • An adult endocrinologist, if care of the patient has been transferred from paediatric to adult services
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of evidence supporting the recommendations is not specifically stated.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate use of human growth hormone (somatropin) for the treatment of growth failure in children

Potential Harms

The summary of product characteristics (SPC) for somatropin states that side effects include headache, visual problems, nausea and vomiting, fluid retention (peripheral oedema), arthralgia, myalgia, carpal tunnel syndrome, paraesthesia, antibody formation, hypothyroidism and reactions at injection site. Paediatricians should pay particular attention when giving somatropin to children with diabetes mellitus or its risk factors, slipped capital epiphyses, idiopathic intracranial hypertension, or malignancies.

For full details of side effects and contraindications, see the SPC.

Contraindications

Contraindications

For full details of side effects and contraindications, see the summary of product characteristics.

Qualifying Statements

Qualifying Statements
  • This guidance represents the view of National Institute for Health and Clinical Excellence (NICE), which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
  • Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.

Implementation of the Guideline

Description of Implementation Strategy

The Secretary of State and the Welsh Assembly Minister for Health and Social Services have issued directions to the National Health Service (NHS) on implementing National Institute for Health and Clinical Excellence (NICE) technology appraisal guidance. When a NICE technology appraisal recommends use of a drug or treatment or other technology, the NHS must provide funding and resources for it within 3 months of the guidance being published. If the Department of Health issues a variation to the 3-month funding direction, details will be available on the NICE website. The NHS is not required to fund treatments that are not recommended by NICE.

NICE has developed tools to help organisations put this guidance into practice (listed below). These are available on NICE website (http://guidance.nice.org.uk/TA188 External Web Site Policy).

  • Costing report and costing template to estimate the savings and costs associated with implementation.
  • Audit support for monitoring local practice.
Implementation Tools
Audit Criteria/Indicators
Foreign Language Translations
Patient Resources
Quick Reference Guides/Physician Guides
Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
National Institute for Health and Clinical Excellence (NICE). Human growth hormone (somatropin) for the treatment of growth failure in children. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 May. 49 p. (Technology appraisal guidance; no. 188). 
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 May
Guideline Developer(s)
National Institute for Health and Care Excellence (NICE) - National Government Agency [Non-U.S.]
Source(s) of Funding

National Institute for Health and Clinical Excellence (NICE)

Guideline Committee

Appraisal Committee

Composition of Group That Authored the Guideline

Committee Members: Dr Amanda Adler (Chair), Consultant Physician, Addenbrooke's Hospital, Cambridge; Professor Keith Abrams, Professor of Medical Statistics, University of Leicester; Dr Ray Armstrong, Consultant Rheumatologist, Southampton General Hospital; Dr Jeff Aronson, Reader in Clinical Pharmacology, University Department of Primary Health Care, University of Oxford; Dr Peter Barry, Consultant in Paediatric Intensive Care, Leicester Royal Infirmary; Dr Michael Boscoe, Consultant Cardiothoracic Anaesthetist, Royal Brompton and Harefield NHS Foundation Trust; Professor John Cairns, Professor of Health Economics, Public Health and Policy, London School of Hygiene and Tropical Medicine; Dr Mark Chakravarty, External Relations Director – Pharmaceuticals & Personal Health, Oral Care Europe; Ms Sally Gooch, Independent Nursing and Healthcare Consultant; Mrs Eleanor Grey, Lay member; Mr Sanjay Gupta, YPD Service Case Manager, Southwark Health and Social Care, Southwark Primary Care Trust; Dr Neil Iosson, General Practitioner, West Sussex; Mr Terence Lewis, Lay member; Dr Ruairidh Milne, Director of Strategy and Development, and Director for Public Health Research at the NIHR Evaluation, Trials and Studies Coordinating Centre, University of Southampton; Dr Rubin Minhas, General Practitioner, Kent, Clinical Director, BMJ Evidence Centre; Mr Stephen Palmer, Senior Research Fellow, Centre for Health Economics, University of York; Dr Sanjeev Patel, Consultant Physician and Senior Lecturer in Rheumatology, St Helier University Hospital and St George's University of London; Mr Philip Pugh, Strategic Development Lead for Healthcare Associated Infection and Antimicrobial Resistance, Health Protection Agency, London; Dr Florian Alexander Ruths, Consultant Psychiatrist and Cognitive Therapist, Maudsley Hospital, London; Mr Navin Sewak, Primary Care Pharmacist, NHS Trust – Hammersmith and Fulham; Dr Lindsay Smith, General Practitioner, East Somerset Research Consortium; Mr Roderick Smith, Finance Director, West Kent Primary Care Trust; Mr Cliff Snelling, Lay member; Professor Ken Stein (Vice Chair), Professor of Public Health, Peninsula Technology Assessment Group (PenTAG), University of Exeter; Professor Andrew Stevens, Professor of Public Health, Department of Public Health and Epidemiology, University of Birmingham; Dr Rod Taylor, Associate Professor in Health Services Research, Peninsula Medical School, Universities of Exeter and Plymouth; Ms Nathalie Verin, Health Economics Manager, Boston Scientific UK and Ireland; Dr Colin Watts, Consultant Neurosurgeon, Addenbrooke's Hospital, Cambridge; Mr Tom Wilson, Director of Contracting and Performance, NHS Tameside and Glossop

Financial Disclosures/Conflicts of Interest

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) format from the National Institute for Health and Clinical Excellence (NICE) Web site External Web Site Policy.

Availability of Companion Documents

The following are available:

  • Human growth hormone (somatropin) for the treatment of growth failure in children: quick reference guide. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 May. 2 p. (Technology appraisal 188). Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site External Web Site Policy.
  • Human growth hormone (somatropin) for the treatment of growth failure in children. Costing template and report. Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 May. (Technology appraisal 188). Available in PDF from the NICE Web site External Web Site Policy.
  • Human growth hormone (somatropin) for the treatment of growth failure in children. Audit support. Implementing NICE guidance. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 May. 10 p. (Technology appraisal 188). Available in PDF from NICE Web site External Web Site Policy.
  • Recombinant human growth hormone for the treatment of growth disorders in children: a systematic review and economic evaluation. Assessment report. Southampton Health Technology Assessments Centre; 2009. 271 p. Available in PDF from NICE Web site External Web Site Policy.
Patient Resources

The following is available:

  • Human growth hormone (somatropin) for the treatment of growth failure in children. Understanding NICE guidance. Information for people who use NHS services. London (UK): National Institute for Health and Clinical Excellence (NICE); 2010 May. 2 p. (Technology appraisal 188). Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site External Web Site Policy. Also available in Welsh from the NICE Web site External Web Site Policy.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on December 20, 2010.

The National Institute for Health and Clinical Excellence (NICE) has granted the National Guideline Clearinghouse (NGC) permission to include summaries of their Technology Appraisal guidance with the intention of disseminating and facilitating the implementation of that guidance. NICE has not verified this content to confirm that it accurately reflects the original NICE guidance and therefore no guarantees are given by NICE in this regard. All NICE technology appraisal guidance is prepared in relation to the National Health Service in England and Wales. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. The full versions of all NICE guidance can be found at www.nice.org.uk External Web Site Policy.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouseâ„¢ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

Read full disclaimer...