Subject: Growth Hormone, insulin-like growth factor

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
Growth Hormones
P	Humatrope®  (somatropin)	X
P	Nutropin®  (somatropin)	X
P	Nutropin AQ®  (somatropin)	X
P	Saizen®  (somatropin)	X
P	Tev-tropin®  (somatropin)	X
NP	Genotropin®  (somatropin)	X			X	X
NP	Norditropin®  (somatropin)	X			X	X
NP	Omnitrope®  (somatropin)	X
NP	Serostim®  (somarelin)	X
NP	Zorbtive®  (somatropin)	X
Growth Hormone Antagonists
NP	Somavert®  (pegvisomant)
Note: Reference :Aetna Medical Clinical Policy #0170: Growth Hormone (GH), Growth Hormone Releasing Hormone (GHRH), and Growth Hormone Antagonists; http://www.aetna.com/cpb/medical/data/100_199/0170.html

Policy:

 

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Genotropin, Humatrope,  Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin and Zorbtive are subject to precertification. If precertification requirements apply Aetna considers Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin and Zorbtive to be medically necessary for those members who meet the following precertification criteria:

For Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin and Zorbtive 

A documented diagnosis of:

1. Growth hormone deficiency in children and adolescents AND

a. Idiopathic growth hormone deficiency (GHD) OR
b. Chronic renal insufficiency OR
c. Turner's syndrome OR
d. Prader Willi syndrome OR
e. Small for gestational age (SGA) children OR
f. Noonan syndrome OR
g. Children with Short Stature Homeobox-Containing Gene (SHOX) Deficiency


OR

2. Growth hormone deficiency in adults AND

a. Destructive lesions of the pituitary OR
b. Adults who were growth hormone deficient as children or adolescents OR
c. Adults who develop growth hormone deficiency in early adulthood OR
d. AIDS-related wasting OR

3.  Growth Hormone for Short Bowel Syndrome

Continued Authorization:
The continued medical necessity of growth hormone therapy is reviewed at least annually to determine whether growth hormone therapy continues to be medically necessary. The annual medical necessity review focuses on response to therapy, whether discontinuation criteria are met, whether there are any major changes in clinical status affecting the medical necessity of growth hormone supplementation, and verification that the person continues to follow up with the provider and receive appropriate reevaluations and care.

Other Indications: Idiopathic Short Stature
Note: Aetna does not consider idiopathic short stature a disease or injury. Accordingly, coverage would not be available under most plans, which provide coverage only for treatment of injury or disease. If the benefit plan only covers treatment for disease or injury and the diagnosis is idiopathic short stature, growth hormone is not a covered plan benefit. When growth hormone is not a covered plan benefit, medical necessity language should not be included within the review determination rationale. This is a contract denial and not based upon medical necessity.

Growth Hormone Antagonists: Pegvisomant (Somavert):
Aetna considers pegvisomant (Somavert) medically necessary for the treatment of acromegaly in members who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are inappropriate.


2. Step Therapy Criteria

Under some plans, including plans that use an open or closed formulary, Genotropin and Norditropin is subject to step-therapy.  Aetna considers Genotropin and Norditropin to be medically necessary for those members who meet the following step-therapy criterion:

A documented trial of six (6) months each of two (2) of the following preferred products – Humatrope, Nutropin, Nutropin AQ, Saizen or Tev-tropin

If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member’s treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below.)


3. Medical Exception Criteria

Genotropin and Norditropin is currently listed on the Aetna Step Therapy list. If it is medically necessary for a member to be treated initially with one of these medications subject to step-therapy, Aetna considers Genotropin and Norditropin to be medically necessary for those members who meet the criteria specified below:

(1 OR 2 OR 3) AND 4

 A documented diagnosis of:

1. Growth hormone deficiency in children and adolescents AND

a. Idiopathic growth hormone deficiency (GHD) OR
b. Chronic renal insufficiency OR
c. Turner's syndrome OR
d. Prader Willi syndrome OR
e. Small for gestational age (SGA) children OR
f. Noonan syndrome OR
g. Children with Short Stature Homeobox-Containing Gene (SHOX) Deficiency

OR

2. Growth hormone deficiency in adults AND

a. Destructive lesions of the pituitary OR
b. Adults who were growth hormone deficient as children or adolescents OR
c. Adults who develop growth hormone deficiency in early adulthood OR
d. AIDS-related wasting

OR

3. Growth Hormone for Short Bowel Syndrome

AND

4. A documented trial of six months each of two of the preferred alternatives - Humatrope, Nutropin, Nutropin AQ, Saizen or Tev-tropin

Special Notes:

Growth Hormone Brands and FDA-Approved Indications

FDA-Approved Indication - Brands

Growth failure associated with chronic renal insufficiency – Nutropin, Nutropin AQ

Growth failure associated with Noonan syndrome – Norditropin

Growth failure associated with Prader-Willi syndrome – Genotropin

Growth failure associated with Turner syndrome – Accretropin, Genotropin,
Humatrope, Norditropin, Nutropin, and Nutropin AQ

Growth failure in children due to inadequate secretion of endogenous growth hormone –
Accretropin, Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin

Children born small for gestational age (SGA) who fail to manifest catch-up growth –
Genotropin, Norditropin

Growth hormone deficiency in adults – Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, and Saizen

Idiopathic short stature – Humatrope, Nutropin, and Nutropin AQ

Short bowel syndrome – Zorbtive

Short stature homeobox–containing gene deficiency – Humatrope

Wasting or cachexia associated with HIV – Serostim

(Preferred brands bolded)

Source: Adapted from Drug Facts & Comparisons, 2009

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. National Institute for Clinical Excellence (NICE). Appraisal consultation document: Human growth hormone (somatropin) in adults with growth hormone deficiency. London, UK: NICE; May 2003. Available at: http://www.nice.org.uk/. Accessed August 26, 2003.
7. National Institute for Clinical Excellence (NICE). Human growth hormone (somatropin) in adults with growth hormone deficiency. Technology Appraisal 64. London, UK: NICE; August 2003. Available at: http://www.nice.org.uk/. Accessed August 28, 2003.
8. Van Pareren Y, Mulder P, Houdijk M, et al. Adult height after long-term, continuous growth hormone (GH) treatment in short children born small for gestational age: Results of a randomized, double-blind, dose-response GH trial. J Clin Endocrinol Metab. 2003;88(8):3584-3590.
9. Rapaport R. Growth hormone treatment in short children born SGA - FDA approved and recommended. Clinical Controversies: Growth Hormone for Short Children Born SGA. American Academyof Pediatrics Section on Endocrinology Newsletter. 2002;10:3-4. Available at: http://www.aap.org/sections/endocrinology/. Accessed August 26, 2003.
10. Root AW. Growth hormone should not be administered routinely to children with short stature due to intrauterine growth retardation who are not classically growth hormone deficient. Clinical Controversies: Growth Hormone for Short Children Born SGA. American Academy of PediatricsSection on Endocrinology Newsletter 2002; 10:3-4. Available at: http://www.aap.org/sections/endocrinology/. Accessed August 26, 2003.
11. Arwert LI, Deijen JB, Witlox J, Drent ML. The influence of growth hormone (GH) substitution on patient-reported outcomes and cognitive functions in GH-deficient patients: a meta-analysis. Growth Horm IGF Res. 2005;15(1):47-54.
12. Gravholt CH. Clinical practice in Turner syndrome. Nat Clin Pract Endocrinol Metab. 2005;1(1):41-52.
13. Molitch ME, Clemmons DR, Malozowski S, Merriam GR, Shalet SM, Vance ML; Endocrine Society's Clinical Guidelines Subcommittee; Stephens PA. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2006;91(5):1621-34.
14. Reiter EO, Price DA, Wilton P, Albertsson-Wikland K, Ranke MB. Effect of growth hormone (GH) treatment on the near-final height of 1258 patients with idiopathic GH deficiency: analysis of a large international database. J Clin Endocrinol Metab. 2006;91(6):2047-54.
15. Lindgren AC. Somatropin Therapy for Children with Prader-Willi Syndrome : Guidelines for Use. Treat Endocrinol. 2006;5(4):223-228.
16. Lee MM. Clinical practice. Idiopathic short stature. N Engl J Med. 2006;354(24):2576-82
17. Mahan JD, Warady BA; the Consensus Committee. Assessment and treatment of short stature in pediatric patients with chronic kidney disease: a consensus statement. Pediatr Nephrol. 2006;21(7):917-30.
18. Molitch ME, Clemmons DR, Malozowski S, Merriam GR, Shalet SM, Vance ML; Endocrine Society's Clinical Guidelines Subcommittee; Stephens PA. Evaluation and treatment of adult growth hormone deficiency: and Endocrine Society Clinical Practice Guideline. Clin Endocrinol Metab. 2006;91(5):1621-34.
19. Aetna Medical Clinical Policy CPB 170-Growth Hormone (GH), Growth Hormone Releasing Hormone (GHRH) and Growth Hormone Antagonists: http://www.aetna.com/cpb/medical/data/100_199/0170.html
    

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

September 25, 2009