Gattex Teduglutide Rdna Origin
Total Page：16
File Type：pdf, Size：1020Kb
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. Page 1 of 12 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 Page 2 of 12 ¶ 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 ¶ 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. 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 Page 3 of 12 ß Member’s current body mass index (must have a BMI 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. ¶ 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 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]