70.Growth Hormone Treatment in Children

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70.Growth Hormone Treatment in Children

 

 

 

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Syllabus

Content

List of abbreviations …………………………… vii

Executive summary ……………………………. xi

1 Background ……………………………………….. 1

Description of health problem ………………. 1

Place of the intervention in the treatment

pathway ………………………………………….. 7

Current usage in the NHS ……………………. 9

2 Definition of the decision problem ……… 11

Decision problem …………………………………. 11

Overall aims and objectives of assessment . 11

3 Assessment of clinical effectiveness ……. 13

Methodology ……………………………………….. 13

Results ………………………………………………… 14

Growth hormone deficiency ………………….. 17

Turner syndrome …………………………………. 18

Prader–Willi syndrome …………………………. 25

Chronic renal insufficiency …………………… 33

Children born SGA ………………………………. 39

SHOX deficiency …………………………………. 45

Transition phase in GHD ……………………… 47

Summary of previous systematic reviews … 48

4 Assessment of cost-effectiveness ……….. 49

Introduction ……………………………………….. 49

Systematic review of existing costeffectiveness

evidence ………………………. 49

Review of research on QoL …………………… 53

Review of the manufacturers’

submissions ……………………………………… 58

SHTAC independent economic

evaluation ……………………………………….. 62

Estimation of cost-effectiveness ……………… 68

Sensitivity analyses ………………………………. 68

Summary of cost-effectiveness ……………….. 76

5 Assessment of factors relevant to the

NHS and other parties ……………………….. 79

6 Discussion ………………………………………….. 81

Statement of principal findings ……………… 81

General discussion ……………………………….. 84

7 Conclusions ……………………………………….. 89

Implications for service provision ………….. 89

Suggested research priorities ………………… 89

Acknowledgements ……………………………. 91

References …………………………………………. 93

Appendix 1 Protocol methods ……………… 101

Appendix 2 Literature search strategies .. 103

Appendix 3 Quality assessment ……………. 107

Appendix 4 Data extraction tables ……….. 109

Appendix 5 List of excluded studies ……… 183

Appendix 6 List of eligible abstracts …….. 189

Appendix 7 List of ongoing studies ………. 191

Appendix 8 Critique of industry

submissions (clinical effectiveness) …………. 193

Appendix 9 Critical appraisal of

manufacturers’ economic evaluation ……… 199

Appendix 10 Critical appraisal of

Sandoz MS (cost-effectiveness) ……………….. 201

Appendix 11 Quality of life from

HSE 2003 ……………………………………………. 203

Appendix 12 Input parameters for

probabilistic sensitivity analysis. …………….. 205

Appendix 13 Weight tables for males and

females by age (Western Europe KIGS) ….. 209

Health Technology Assessment

reports published to date …………………… 211

Health Technology Assessment

Programme ……………………………………….. 233

 

Growth Hormone Treatment in Children


When is it appropriate to treat short children with growth hormone? The answer is not always clear-cut, as many parents and physicians have discovered over the past three decades.


Social, medical and ethical concerns complicate the issue. Short stature itself is not a disease, although it may result from underlying disease. But diagnosis can be challenging and treatment decisions may be controversial. Some short but healthy children receive expensive nightly injections of recombinant growth hormone. As with any medicine, there may be side effects — and possibly unknown long-term risks.
A group of medical experts has weighed existing evidence and issued a new set of clinical guidelines for managing children and adolescents with growth failure. Written on behalf of the Pediatric Endocrine Society, the guidelines are the society’s first update since 2003. For children with certain clearly diagnosed medical conditions, the experts recommend hormonal treatments. When the cause of growth failure is unknown, they advise against routine growth hormone use and recommend a more measured decision-making approach.
“The nuances of this issue leave much room for open questions and differences of interpretation,” said study leader Adda Grimberg, MD, a pediatric endocrinologist at Children’s Hospital of Philadelphia (CHOP). “In developing these guidelines, we analyzed not only the results, but the strengths, limitations and potential biases of studies in a large evidence base that continues to evolve.”


Grimberg and colleagues issued their guidelines through two committees of the Pediatric Endocrine Society — the Drug and Therapeutics Committee and the Ethics Committee. The guidelines appeared online Nov. 25 in Hormone Research in Paediatrics, and in the January 2017 print issue.


The co-authors included seven pediatric endocrinologists from different centers in the U.S. and Canada, plus a pediatric bioethicist and a consultant for the group’s methodological approach. Using that method, called GRADE (Grading of Recommendations, Assessment, Development and Evaluation), the co-authors generated a series of strong recommendations, conditional recommendations and ungraded good practice statements.


The authors focused on three diagnoses: growth hormone deficiency (GHD), primary IGF-I deficiency (PIGFD) and idiopathic short stature (ISS). In GHD, a child does not produce enough growth hormone, and the authors strongly recommend the standard treatment with recombinant growth hormone.
Human growth hormone normally acts along a signaling pathway that stimulates production of IGF-I growth factor, which then affects body tissues such as the growth plates in bones. Therefore, growth hormone deficiency often causes IGF deficiency downstream. However, in PIGFD, a patient has sufficient growth hormone but has a biological defect that reduces the production or action of IGF-I growth factor. Because under-nutrition is a common cause of low IGF-I levels, physicians must first rule out a nutritional problem before diagnosing IGF deficiency. For true PIGFD, the authors endorse treating children with recombinant IGF-I growth factor.


In ISS, the cause of short stature is unknown. The U.S. Food and Drug Administration has defined ISS as height that is more than 2.25 standard deviations below the mean height for a patient’s age and gender, without evidence of underlying disease. This statistical definition corresponds to the shortest 1.2 percent of the U.S. population: adult heights below 5 feet, 3 inches for men, and below 4 feet, 11 inches for women.
For children with ISS, the authors offer a conditional recommendation, advising against routinely using growth hormone treatment. Instead, they recommend that parents and clinicians take a shared decision-making approach, weighing physical and psychological burdens for the child, along with a discussion of risks and benefits.


“Growth hormone treatment for patients with growth hormone deficiency offers health benefits beyond height,” said Grimberg, “but growth hormone treatment for ISS is solely about height. Another important difference is that, unlike patients with growth hormone deficiency, not all patients with ISS increase their height in response to growth hormone treatment. So a decision for treating ISS is more of a subjective judgment call than for growth hormone deficiency.”


Much of the controversy in growth hormone treatment involves ISS. The authors note that, in practice, families of many children who are short but do not meet the FDA definition for ISS have sought growth hormone treatment to make them taller. Grimberg previously showed in national research that gender bias influences both referral and treatment patterns for short children. Short boys are three times more likely than short girls to be treated with growth hormone for ISS, even though equal proportions of both genders fall under the ISS height threshold. One consequence is that short girls with underlying disease may be overlooked, while short, healthy boys may receive unnecessary treatments.


Moreover, short-term gains in height do not always translate into adult height differences. A full study of long-term results would require many years to complete, and thus is often expensive and unfeasible to perform.


“We found large gaps in our knowledge of growth hormone treatment,” said Grimberg. “For instance, we know little about the long-term risks of nightly hormone injections given for years. We don’t even really know the relationship between adult height and adult quality of life.”


Other research gaps exist in diagnosing growth hormone deficiency. Because diagnostic tests have evolved over time, different tests can provide different results for the same sample — making it harder to understand the scientific literature over time.


Given the current state of knowledge, there are ethical questions in addition to medical questions surrounding growth hormone treatment for short children who don’t have a disease. “Administering growth hormone treatment may help very short children gain a few inches in height, but it also exposes them to a powerful hormone when we do not fully know the long-term implications,” said co-author Chris Feudtner, MD, PhD, a CHOP pediatrician and director of the Hospital’s Department of Medical Ethics.


While endorsing further research to address the many unanswered questions in the field, the authors recommend that only pediatric endocrinologists manage evaluation and treatment for growth hormone deficiency, ISS and PIGFD in children. “The rigorous methods were designed to create recommendations at the group level,” Grimberg added. “However, due to inter-individual variability, it is important for clinicians to weigh the potential benefits and risks of treatment for each individual patient in the context of the evolving evidence base.”


Fast Facts About Growth Hormone (GH) Treatment
• Growth hormone injection treatment is prescribed for children who have been diagnosed with growth hormone (GH) deficiency and other conditions causing short stature.
• A number of other tests must be conducted first to confirm GH deficiency, Turner Syndrome, or other conditions for which GH therapy is indicated. These tests may include stimulation tests, MRIs, and x-rays.
• GH treatment has few side effects.
• GH treatment is a safe, effective way to treat growth hormone deficiency, Turner Syndrome, and a few other conditions associated with short stature.


How Growth Works
In order for a child to grow, a gland deep inside the brain, called the pituitary, must release enough growth hormone (GH). Natural growth hormone is released during deep sleep. Many factors influence the release of GH, including nutrition, sleep, exercise, stress, medications, blood sugar levels, and other hormones present in the body.


When a child’s body does not produce or release enough GH, he or she may have several symptoms, the most noticeable being slow or no growth or facial features that make the child look a lot younger than his or her peers. Although being small has no effect on a child’s intelligence, it may cause self-esteem issues and interfere with the development of mature social skills. For that reason, GH treatment may be prescribed to help a child reach his or her fullest growth potential—both in height and in personal development.

How Growth Hormone Treatment Works
Once a child has been diagnosed with GH deficiency, Turner Syndrome, or other conditions treatable with GH therapy, the pediatric endocrinologist will discuss the pros and cons of, and usually recommend, GH therapy. The GH used in treatment is manufactured in the laboratory to be identical to that produced by the pituitary gland, so it is safe and effective. GH is given through a subcutaneous (sub-Q-TAIN-ee-us) injection, which means that it goes into the fatty tissue just beneath the surface of the skin. GH can be given by a special injection device that looks like a pen. Because it is such a shallow injection, the needle is very small and does not hurt much at all.


What To Expect With Growth Hormone Treatment
The main thing to expect is growth! Although it takes about 3 to 6 months to realize any height differences, the important thing is that your child will grow — probably 1 to 2 inches within the first 6 months of starting treatment. There may be a few other things you notice:
• Your child may outgrow his or her shoes quickly. Foot growth may occur within 6 to 8 weeks, so you may have to buy new shoes more often.
• Your child may want to eat more. An increase in appetite is common, especially if he or she had a poor appetite before treatment.
• Your child may look skinnier for a while once height growth starts. An increase in lean body mass and decrease of fat mass are common with GH treatment.
It may take a number of years for your child to reach his or her adult height, so you should be aware that GH treatment is often a long-term commitment. Routine visits with the pediatric endocrinologist will be needed, as will periodic blood tests and x-rays to monitor your child’s progress on the treatment. Although the length of treatment varies, your child probably will have to stay on GH treatment until he or she has:
• Reached his or her full adult height
• Reached full bone maturity
• Grown less than 2 cm in the last year
Getting and Giving GH Injections
GH injections are quick and almost pain-free, so children ages 10 and up may be able to and often prefer to give themselves their own injections. It is important that a parent supervises the injection to make sure the child gives the correct dosage each day. Parents should give the injections to younger children. Because natural growth hormone is released mainly during sleep in children, GH treatment is more effective when taken at bedtime.


Learning how to give GH injections may sound intimidating at first, but once you and your child get used to it, it becomes just another daily habit. There are, however, some tips that you should know when you start GH therapy:


Storage
• GH must be refrigerated at 36 to 42° F; letting it get too hot or too cold will decrease its effectiveness.
• If left out overnight, you may place it back into refrigerator and continue to use it.
• When traveling, keep it in the cooler provided in the starter kit for up to 10 hours, then put on ice after 10 hours. Be careful not to place GH pens directly in ice — keep them
separate by placing pen in a Ziploc bag.
Time of Day
• Give GH at night, preferably within an hour of sleep. Try to give it consistently within an hour timeframe, for example between 9 and 10 p.m. every night.
• You may change the time occasionally, by a few hours earlier or later, but do not give before 5 p.m, except under unusual circumstances (such as leaving for a trip, a sleep-over, etc.)
• Do not make up missed injections.
• For best results, try not to miss more than once per month.

Injection Sites
• Use 4 of the 8 possible injection sites, and rotate them each time. The sites are back of arms, top or outside of thighs, sides of belly, and outer quadrant of buttocks.
• Document the site used nightly on a calendar.
• Document when you open a new cartridge to keep track of expiration dates and how many injections have been used out of each cartridge.

Finishing A Cartridge
Because GH is very expensive, you should use up all of the medication in every cartridge.
• Pens will only allow you to dial to what is left of the medication. Use up the last of it, and start a new cartridge by doing a second injection with the amount missing.
• You may have to use up cartridges about once a week or so. If there is less than 0.2 mg left in the old cartridge, or if you are missing less than 0.2 mg of the last injection, do not give an additional injection.

Other Medications
Since GH does not interfere with other medications, it can be taken even if your child is mildly ill (colds, flu), unless your PCP tells you to stop.
• If your child becomes seriously ill or is hospitalized, call the Endocrinology Clinic for further instructions.

Possible Side Effects
Although infrequent, there are some possible side effects that you should be aware of. They are:
• Allergic reaction, including swelling at the injection site, rash, or hives
• Hip, knee, or other joint pain
• Headache
• Progression of spine curvature in patients with scoliosis
• Temporary increase in blood sugar levels, which stops when the GH treatment stops
If the headache is persistent or severe, however, call the Endocrinology Fellow on call immediately. If you have questions about a reaction, or your child is experiencing a reaction, call the Endocrinology Clinic or office.

Insurance Coverage
GH is sold under a number of different prescription brand names, but all of them contain the same medication. Which brand name your child will use, and the shape and color of the pen that delivers the
medication, will depend upon your medical insurance.


Because GH is very expensive, Children’s Hospital works with insurance reimbursement specialists to determine which brand will be covered under your medical insurance. Within 2 to 4 weeks after your child has been prescribed HG treatment, an insurance reimbursement specialist will call your home. It is very important that you speak with the specialist — please pick up or return the call! Your child’s prescription will not be filled until you have spoken with the reimbursement specialist. You should receive your child’s GH with 2 to 4 weeks after approval; if you haven’t heard from the reimbursement specialist after 4 weeks, call the Endocrinology Clinic.


If your insurance changes during the course of GH treatment, please notify the Endocrinology Clinic as soon as possible or the continuity of your child’s treatment could be interrupted.

GH Injection Training
As soon as your child’s GH starter kit arrives, call the Endocrinology Clinic to schedule your family’s GH injection training session. Your child and both parents or guardians should attend the training sessions before your child can begin GH treatment. At the training session, the nurse consultant will teach you and your child how to:
• Care for the medication
• Recognize the side effects
• Practice with the demonstration model of your child’s brand of pen and
• Give a real GH injection

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