Gattex Teduglutide Rdna Origin

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Subject: Gattex (teduglutide [rDNA origin]) Original Effective Date: 5/30/2014 Policy Number: MCP-176 Revision Date(s): Review Date(s): 12/16/15; 9/15/2016; 6/22/2017

DISCLAIMER This Medical Policy is intended to facilitate the Utilization Management process. It expresses Molina's determination as to whether certain services or supplies are medically necessary, experimental, investigational, or cosmetic for purposes of determining appropriateness of payment. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Molina) for a particular member. The member's benefit plan determines coverage. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusion(s) or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the CMS website. The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or Local Coverage Determination (LCD) will supersede the contents of this Molina medical coverage policy (MCP) document and provide the directive for all Medicare members.

FDA INDICATIONS � ∑ Short bowel syndrome: For the treatment of adult patients with short bowel syndrome who are dependent on parenteral support.

Available as: Gattex comes as a single-use vial kit (containing 5mg of teduglutide) and a kit containing 30 single-use vials

Approved by the FDA: December 21, 2012

RECOMMENDATIONS/COVERAGE CRITERIA

Initiation of therapy with Gattex (teduglutide [rDNA origin]) may be authorized for members who meet ALL of the following criteria [ALL]

1. � Prescriber specialty [ONE]

ß Board-certified gastroenterologist who is a certified REMS provider

2. � Diagnosis/Indication [ALL]

¶ Diagnosis of short bowel syndrome defined by clinical documentation of less than 200cm of remnant functional intestine.3 Documentation of confirmed diagnosis required (which may include, but not be limited to, test reports, chart notes from provider’s office, or hospital admission notes) ‹ Short bowel syndrome occurs when, following surgical resection of some or the entire small and large intestine, a patient is left with < 200cm of functional intestine causing significant malabsorption of both macro and micro-nutrients.3

¶ An initial nutritional assessment has been completed by a registered dietitian who has determined that oral/enteral nutrition is not sufficient to meet nutritional goals. Prescriber to submit completed nutritional assessment.

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ß Dependence on parenteral nutrition documented by BOTH of the following: [BOTH]

û Dependent on parenteral nutrition (PN) and/or intravenous (IV) fluids at least 12 consecutive months continuously ‹ The efficacy and safety of teduglutide in adult patients with SBS due to intestinal resection dependent on parenteral support (at least 3 times per week for at least 12 months) was studied in two randomized, double-blind, placebo-controlled, Phase 3 trials. In both clinical trials by Jeppesen et al., patients were required to be dependent on parenteral support (fluids, electrolytes or nutrients) at least three times per week for a period of at least 12 months prior to the start of the studies.1,2

û Three (3) or more days per week of parenteral nutrition support (fluids, electrolytes and/or nutrients) ‹ Evidence for teduglutide effectiveness is limited to patients who required at least three days per week of parenteral nutrition support to meet their energy requirements. 1,2

3. � Age/Gender/Other restrictions [ALL]

ß 18 years of age or oldera-f

ß Member has a body mass index of 15 kg/m2 or more1,2

ß For members with his/her large intestine intact: A colonoscopy must be completed within 6 months before starting Gattex. Clinical documentation of colonoscopy within six months prior to initiation of teduglutide to confirm absence of gastrointestinal malignancy. ‹ Teduglutide is associated with several significant concerns including, acceleration of neoplastic growth, intestinal obstruction, and biliary and pancreatic disease. Due to this risk, the FDA recommends colonoscopy of the entire colon with removal of polyps 6 months prior to initiating treatment with teduglutide and after one year of treatment. Subsequent colonoscopies should be performed as needed, but no less than every five years.a,I,1,2

4. � Step/Conservative Therapy/Other condition Requirements [ALL]

¶ Documented clinically significant failure/intolerance/contraindication to ALL of the following therapy. Prescriber submit documentation and dates of failed therapy [ALL] û An antimotility agent (e.g. loperamide [Imodium], diphenoxylate/atropine [Lomotil]) û An antisecretory agent (i.e. PPI, H2 blocker, octreotide [Sandostatin]) û Somatropin (Humatrope®, Norditropin®, Zorbtive®) or NutreStore (L-glutamine) ‹ Recommended dose: 0.1 mg/kg SC QD. Maximum dose/limit: 8 mg per day for 4 weeks

¶ The following laboratory results must be assessed within 6 months before starting Gattex and every 6 months for the duration of therapy: [ALL] 1,2 û Alkaline phosphatase û Amylase û Bilirubin û Lipase

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¶ Absence of the following conditions: [BOTH] û Gastrointestinal malignancy û Intestinal or stomal obstruction

¶ The following must NOT be applicable to member: [AS APPLICABLE] û History of colorectal or other GI malignancy û Received biologic treatment for Crohn’s disease or immunosuppressant drugs within 3 months before starting Gattex û Used a biologic drug within 6 months before starting Gattex

5. � Contraindications/Exclusions/Discontinuations to Gattex (teduglutide [rDNA origin]) therapy Authorization will not be granted if ANY of the following conditions apply [ANY] ¶ Non-FDA approved indications ¶ Hypersensitivity to teduglutide or any of its components ¶ Less than 18 years of age ¶ Active gastrointestinal malignancy (gastrointestinal tract, hepatobiliary, pancreatic), colorectal cancer, or small bowel cancer ¶ Cardiac disease and congestive failure ¶ Radiation enteritis

6. � Labs/Reports/Documentation required [ALL] Prescriber has submitted ALL documentation (lab reports, medical records, chart notes) demonstrating above criteria are met. NO EXCEPTIONS [ALL]

¶ Documentation of confirmed diagnosis of short bowel syndrome defined by clinical documentation of less than 200cm of remnant functional intestine (which may include, but not be limited to, test reports, chart notes from provider’s office, or hospital admission notes) ‹ Short bowel syndrome occurs when, following surgical resection of some or the entire small and large intestine, a patient is left with < 200cm of functional intestine causing significant malabsorption of both macro and micro-nutrients.3

ß Dependence on parenteral nutrition documented by BOTH of the following: [BOTH]

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ß Member’s current body mass index (must have a BMI of 15 kg/m2 or more1,2)

¶ The following laboratory results dated within 6 months before starting Gattex: [ALL] 1,2 û Alkaline phosphatase û Amylase û Bilirubin û Lipase

¶ Absence of the following conditions: [BOTH] û Gastrointestinal malignancy û Intestinal or stomal obstruction

¶ Documentation that the following conditions are NOT applicable to member: [AS APPLICABLE] û History of colorectal or other GI malignancy û Received biologic treatment for Crohn’s disease or immunosuppressant drugs within 3 months before starting Gattex û Used a biologic drug within 6 months before starting Gattex

ADMINISTRATION, QUANTITY LIMITATIONS, AND AUTHORIZATION PERIOD

7. � Recommended Dosing Regimen The recommended teduglutide dose is 0.05 mg/kg administered as a daily subcutaneous injection. Injection sites should be alternated and can include the abdomen, arms, or thighs. The dose should be reduced 50% in patients with moderate or severe renal impairment (creatinine clearance less than 50 mL/min) or end-stage renal disease.

¶ 0.05mg/kg subcutaneously once daily

8. � Authorization Limit [ALL]

¶ Initial authorization may be authorized up to 4 months (16 weeks) ‹ In the study by Jeppesen et al., the primary efficacy endpoint using the graded response score (GRS) criteria was not significantly different from placebo when compared to Gattex 0.10 mg/kg/day (8/32 vs. 1/16, p=0.16). The GRS criteria relied on the timing and reduction from baseline in weekly parenteral volumes. The protocol- defined reduction was set a minimum of 20% and a maximum of 100%. The duration of response was considered the response at weeks 16, 20 and 24.1,2

¶ Quantity and dispensing limit: Thirty (30) vials per 30 days. A maximum supply of 30 days will be dispensed at a time

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¶ Re-authorization for continuation of treatment is required every 3 months to determine continued need based � on documented positive clinical response

ß TOTAL DURATION OF TREATMENT: Treatment is limited to 24 weeks; extensions to be determined on case-by-case basis by a Molina Medical Director ‹ Both pivotal trials evaluated treatment up to 24 weeks, after which time patients could be enrolled in an extension study.1,2,a,9, ‹ Long-term safety and efficacy is not available past 12 to 18 months of treatment. There is also inadequate information on treatment with teduglutide and the potential impact of reduction in parenteral support volume, or number of days of parenteral support required, on quality of life. There are no direct comparison trials with other approved therapies (e.g., recombinant human growth hormone and glutamine).

9. � Route of Administration [ALL]

ß Teduglutide Injection (Gattex) is considered to be self-administered by subcutaneous injection (the drug should not be administered IV or IM) until information from the manufacturer, scientific literature, practice standards, or governing State or Federal agency indicates otherwise.

ß If member meets all criteria and approval for therapy is granted, medication will be dispensed by a specialty pharmacy vendor at the discretion of Molina Healthcare. Self-administered medications may not be dispensed for self-administration and billed through the medical benefit by a provider; they must be dispensed through a participating pharmacy.

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CONTINUATION OF THERAPY

Continuation of therapy with Gattex (teduglutide [rDNA origin]) may be authorized for members who meet ALL of the following criteria [ALL]

1. � Initial Coverage Criteria

ß Member currently meets ALL initial coverage criteria

2. Compliance

ß Adherence to therapy at least 85% of the time as verified by Prescriber and member’s medication fill history (review Rx history for compliance), including: û Compliance in taking the medication as prescribed û No intolerable adverse effects or drug toxicity

NOTE: Therapy may be discontinued due to poor adherence upon recommendation of the Molina Medical Director when adherence < 85% has been demonstrated in at least two months during the course of therapy

ß Documentation by Molina Internal Staff: History of non-compliance or non-adherence as verified by member’s medication fill history or prescription drug profile [MOLINA MEDICAL/PHARMACY REVIEWER TO VERIFY]

3. � Labs/Reports/Documentation required [ALL APPLICABLE] Teduglutide Injection (Gattex) maintenance therapy may be authorized when therapy has demonstrated efficacy as evidenced by an improvement in disease activity after initial therapy. Documentation of disease stabilization or improvement is required for continuation of therapy.

ß Positive response or demonstrated efficacy to therapy as evidenced by an improvement as measured by a standardized disease activity tool: [ANY]

û Documentation of a 20% or more decrease in parenteral support (i.e. parenteral nutrition and/or intravenous fluids) decreased in volume (ml) from baseline weekly requirement (prior to initiation of Gattex therapy) ‹ In the study by Jeppesen et al., the primary efficacy endpoint using the graded response score (GRS) criteria was not significantly different from placebo when compared to Gattex 0.10 mg/kg/day (8/32 vs. 1/16, p=0.16). The GRS criteria relied on the timing and reduction from baseline in weekly parenteral volumes. The protocol-defined reduction was set a minimum of 20% and a maximum of 100%. The duration of response was considered the response at weeks 16, 20 and 24.1,2

û Documentation of reduction in the numbers of days of required parenteral nutrition support

NOTE: This specific member criterion is a specific Molina requirement for authorization of coverage and the continued use of teduglutide (Gattex) will not be authorized when there is no documentation of decreased parenteral support volume and number of days of required parenteral nutrition support from baseline. Copy of pertinent lab results and/or the current clinical progress notes required.

ß With continued treatment, Prescriber has a reasonable expectation that this member can be removed from parenteral support within the next 6 months

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ß Follow-up lab values every 6 months for the duration of therapy indicating the following are within a normal range: bilirubin, alkaline phosphatase, lipase, and amylase ‹ Cholecystitis, cholangitis, cholelithiasis, and pancreatitis have been reported. If clinically meaningful changes are seen, further evaluation is recommended including imaging, and continued treatment with Gattex should be reassessed. a-f

4. � Discontinuation of Treatment [ANY]

ß Poor response to treatment as evidenced by physical findings and/or clinical symptoms following the initial 16 weeks approval for coverage

ß Intolerable adverse effects or drug toxicity

ß Persistent and uncorrectable problems with adherence to treatment

ß Follow-up lab values every 6 months for the duration of therapy indicating the following are not within normal range: bilirubin, alkaline phosphatase, lipase, and amylase

ß Contraindications/Exclusions to Gattex (teduglutide [rDNA origin]) therapy � Authorization will not be granted if ANY of the following conditions applya,b [ANY] � û Non-FDA approved indications û Hypersensitivity to teduglutide or GLP-2 or any of its components û Less than 18 years of age û Active gastrointestinal malignancy (gastrointestinal tract, hepatobiliary, pancreatic), colorectal cancer, or small bowel cancer û Cardiac disease and congestive failure û Radiation enteritis

ADMINISTRATION, QUANTITY LIMITATIONS, AND AUTHORIZATION PERIOD

5. � Recommended Dosing Regimen [AS APPLICABLE] The recommended teduglutide dose is 0.05 mg/kg administered as a daily subcutaneous injection. Injection sites should be alternated and can include the abdomen, arms, or thighs. The dose should be reduced 50% in patients with moderate or severe renal impairment (creatinine clearance less than 50 mL/min) or end-stage renal disease.

¶ 0.05mg/kg subcutaneously once daily

6. � Authorization Limit [ALL]

¶ Quantity and dispensing limit: Thirty (30) vials per 30 days. A maximum supply of 30 days will be dispensed at a time

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¶ Re-authorization for continuation of treatment is required every 3 months to determine continued need based � on documented positive clinical response

7. � Route of Administration [ALL]

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COVERAGE EXCLUSIONS All other uses of the mentioned drugs that are not an FDA-approved indication or included in ‘Coverage Criteria’ section above are considered experimental/investigational and is not a covered benefit. The following list is not all-inclusive and is subject to change based on research and medical literature: ¶ Chemotherapy-induced enteritis ¶ Gastro-intestinal mucositis ¶ Gastro-intestinal stromal tumors ¶ Inflammatory bowel disease (Crohn's disease and ulcerative colitis) ¶ Necrotizing enterocolitis ¶ Post-operative ileus ¶ Radiation-induced enteritis

SUMMARY OF EVIDENCE/POSITION STATEMENTS

Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. Endogenous GLP-2 is a 33-amino peptide gastrointestinal, trophic hormone involved in the structural and functional repair and regeneration of intestinal cells. Gattex (teduglutide [rDNA origin]) differs from GLP-2 through the substitution of one amino acid. However, endogenous GLP-2 is rapidly degraded by dipeptidyl peptidase-IV (DDP- IV) resulting in a half-life of only 7 minutes. Teduglutide is created in Escherichia coli, and differs from human GLP-2 by the substitution of glycine for alanine at position 2. As a result, teduglutide is resistant to DDPIV degradation, thereby increasing the half-life and allowing for once daily subcutaneous administration. Teduglutide improves bowel function by enhancing absorption of nutrients and fluids, and decreases dependence on parenteral nutrition.

Gattex (teduglutide) is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Gattex received Orphan Drug designation on June 29, 2000 and subsequently submitted a new drug application (NDA) to the Food and Drug Administration (FDA) on 30 November 2011, seeking approval for the treatment of adult patients with Short Bowel Syndrome (SBS) to improve intestinal absorption of fluid and nutrients. Gattex (teduglutide) is the first in its class with this mechanism of action.

Short Bowel Syndrome Short bowel syndrome (SBS) is often defined as that symptom complex which occurs in adults who have less than 200 centimeters of combined jejunum-ileum following small bowel resection.A,8-10 SBS is a disorder clinically defined by malabsorption, diarrhea, steatorrhea, fluid and electrolyte disturbances, and malnutrition. Short bowel syndrome may be a congenital or acquired condition. Infants may be born with congenital jejunal or ileal atresia. Otherwise, short bowel syndrome results from surgical resection of bowel. The final common etiologic factor in all causes of short-bowel syndrome is the functional or anatomic loss of extensive segments of small intestine so that absorptive capacity is severely compromised. Although resection of the colon alone typically does not result in short-bowel syndrome, the condition's presence can be a critical factor in the management of patients who lose significant amounts of small intestine. Due to the reduction in surface area, sub-optimized GI function occurs directly leading to reduced absorption of macronutrients, water, and electrolytes, leaving many at risk for malnutrition, diarrhea, dehydration, and weight loss. The extent of nutrition and fluid needs in SBS patients is dependent upon multiple factors including the amount of residual intestine and colon, presence of an ileal segment, and degree of spontaneous intestinal adaptation following resection.8-10

Conventional treatments include dietary manipulations, oral rehydration solutions, antidiarrheal and antisecretory treatments. Pharmacologic management of SBS may include use of anti-motility agents (e.g. loperamide and diphenoxylate), or antisecretory agents that reduce gastric acid secretion (e.g., H2 receptor antagonists, proton pump inhibitors, somatostatin analog).8-10 Recombinant growth hormone (somatropin, ZORBTIVE™) is approved for the treatment of SBS (for up to 4 weeks) in patients receiving specialized nutritional support, based on reductions in caloric content and frequency of administration of parenteral nutrition with treatment compared to placebo.j Glutamine (NUTRESTORE™) is also approved for the treatment of SBS (for up to 16 weeks) in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication.k Comparator trials with Gattex (teduglutide) were not found.

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Based on a Cochrane systematic review of treatment with human growth hormone with or without glutamine in patients with SBS, it was noted that treatment increased weight and energy absorption.A The authors noted the limitation that the benefits returned to baseline after discontinuation of therapy and conclusive evidence is not available to recommend this treatment. Further studies that evaluate human growth hormone treatment during the immediate phase of bowel adaptation are needed.

The current AGA guidelines (2003) did not recommend glutamine or growth hormone for the management of SBS since these agents do not lead to morphological changes in the intestine but may cause significant peripheral edema.B GLP-2 analogs [Gattex (teduglutide)] were not addressed since it was investigational at the time of the writing of these guidelines.B

Clinical Efficacy: Short Bowel Syndrome1,2,g Teduglutide, when compared to placebo, demonstrated an ability to reduce the requirement for parenteral nutrition volume. However, there is no evidence that teduglutide is safer or more effective than other options and its effect is reversible. ‹ The safety and efficacy of teduglutide were evaluated in two clinical trials and two extension studies of patients randomly assigned to receive teduglutide or placebo: Study 1 (Placebo-controlled) and Study 2 (Open-label extension of Study 1) and Study 3 (Placebo-controlled) and Study 4 (Blinded uncontrolled extension of Study 3). ‹ Clinical response was measured by the number of patients who achieved ≥ 20% reduction in volume of weekly PN at treatment weeks 20 and 24. ‹ The pivotal randomized controlled trial evaluated teduglutide versus placebo over 24 weeks to establish the proportion of patients who had a reduction of 20% to 100% in parenteral nutrition volume at week 24 when compared to baseline. • 63% of teduglutide patients met the primary endpoint compared to 30% of placebo patients, a statistically significant difference. ° In the two clinical trials, 63% and 46% of teduglutide-treated patients achieved clinical response, versus 6% and 30% of placebo patients. • After 24 weeks, teduglutide patients had mean PN reductions of 2.5 L/week and 4.4 L/week, compared with 0.9 L/week and 2.3 L/week in placebo patients. However, No patients in either treatment arm were weaned completely from parenteral nutrition support during the trial • The extension studies followed patients who received teduglutide in the initial trials for an additional 28 weeks. These patients experienced mean PN reductions of 4.9 L/week and 5.2 L/week after 1 year of continuous teduglutide treatment, and six patients were weaned off PN while taking teduglutide for an additional 28 weeks. These patients experienced mean PN reductions of 4.9 L/week and 5.2 L/week after 1 year of continuous teduglutide treatment, and six patients were weaned off PN while taking teduglutide.

CODING INFORMATION CPT Description 96372 Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular HCPCS Description J3490 Gattex (teduglutide) ICD-9 Description [For dates of service prior to 10/01/2015] 579.3 Other and unspecified postsurgical nonabsorption [for the treatment of adults with short bowel syndrome who are dependent on parenteral support when selection criteria are met] ICD-10 Description [For dates of service on or after 10/01/2015] K91.2 Postsurgical malabsorption, not elsewhere classified

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REFERENCES Package Insert, FDA, Drug Compendia a. � Gattex [Package Insert]. Bedminster, NJ: NPS Pharmaceuticals, Inc.; December 2012. b. � Gattex® (teduglutide [rDNA origin]) for injection, for subcutaneous use. Prescribing information. McPherson, KS: Hospira, Inc.; 2012 Dec. c. � AHFS Drug Information® with AHFS®. (www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically. d. � DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically. e. � Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically. f. � Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2012. URL: http://www.clinicalpharmacology.com. g. � Kusiak V. NDA approval letter: Gattex (teduglutide [rNDA origin] NDA 203441). Food and Drug Administration website. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203441Orig1s000ltr.pdf. Published December 21, 2012. Accessed May 28, 2014 h. � Food and Drug Administration. Gattex Risk Evaluation and Mitegation Strategy (REMS). December 21, 2012. Accessed January 3, 2013. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/UCM333243.pdf Accessed May 28, 2014 i. � Teduglutide (Gattex) Medical Review. Accessed May 28, 2014; Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203441Orig1s000MedR.pdf j. � Zorbtive® for injection [prescribing information]. Rockland, MA: EMD Serono, Inc.; January 2012. k. � Nutrestore® powder for oral solution [prescribing information]. Torrance, CA. Emmaus Medical, Inc.; March, 2011.

Clinical Trials, Definitions, Peer-Reviewed Publications 1. � Jeppesen PB, Pertikiewicz M, Messing B, et al. Teduglutide Reduces Need for Parenteral Support Among Patients With Short Bowel Syndrome With Intestinal Failure. Gastroenter 2012;143:1374-1481. 2. � Jeppesen PB, Gilroy R, Pertkiewicz M, et al. Randomized placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut 2011;60:902- 914. 3. � Vanderhoof, JA. Management of the short bowel syndrome in adults. In: UpToDate, LaMont, JT (Ed), UpToDate, Waltham, MA, 2012. 4. � Schwartz LK, Fujioka K, Jeppeson PB, et al. Continued improvement and maintenance of parenteral nutrition and/or intravenous fluid support volume reduction in patients with long-term teduglutide treatment: results of an ongoing open-label study [Abstract P47]. Presented at: The American Society for Parenteral and Enteral Nutrition Clinical Nutrition Week 2013; Phoenix, AZ; February 9-13, 2013. 5. � O'keefe SJ, Jeppesen PB, Gilroy R, et al. Safety and Efficacy of Teduglutide After 52 Weeks of Treatment in Patients With Short Bowel Syndrome Intestinal Failure. Clin Gastroenterol Hepatol. 2013 Jan 17. [Epub ahead of print] 6. � Compher C, Gilroy R, Pertkiewicz M, et al. Maintenance of parenteral nutrition volume reduction, without weight loss, after stopping teduglutide in a subset of patients with short bowel syndrome. JPEN J Parenter Enteral Nutr. 2011;35(5):603-609. 7. � Buchman AL, Katz S, Fang JC, et al. Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP- 2) for the treatment of moderate to severe Crohn's disease. Inflamm Bowel Dis. 2010;16(6):962-973. 8. � Nightingale J, Woodward JM on behalf of the Small Bowel and Nutrition Committee of the British Society of Gastroenterology. Guidelines for the management of patients with a short bowel. Gut 2006;55(Suppl IV):iv1-iv12. doi: 10.1136/gut/2006.091108 9. � Burness CB, McCormack PL. Teduglutide: a review of its use in the treatment of patients with short bowel syndrome. Drugs 2013;73:935-47. 10. � O'Keefe SJ, Buchman AL, Fishbein TM, et al. Short bowel syndrome and intestinal failure: consensus definitions and overview. Clin Gastroenterol Hepatol 2006;4:6-10.

Government Agencies, Professional Societies, and Other Authoritative Publications

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A. � Wales PW, Nasr A, deSilva N et al. Human growth hormone and glutamine for patients with short bowel syndrome. Cochrane Database Syst Rev. 2010; (6):CD006321. B. � American Gastroenterological Association. American Gastroenterological Association Medical Position Statement: Short Bowel Syndrome and Intestinal Transplantation. Gastroenterology. 2003;124:1105–1110.

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