Amitiza (Lubiprostone)
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- Nigel Warner
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1 Texas Prior Authorization Program Clinical Edit Criteria Drug/Drug Class Clinical Edit Information Included in this Document Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical edit Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical edit criteria rules Logic diagram: a visual depiction of the clinical edit criteria logic Supporting tables: a collection of information associated with the steps within the criteria (diagnosis codes, procedure codes, and therapy codes) References: clinical publications and sources relevant to this clinical edit te: Click the hyperlink to navigate directly to that section. Revision tes Revised step 4 of clinical edit criteria logic to include diagnosis of chronic idiopathic constipation or opioid-induced constipation with chronic, noncancer pain May 24, 2013 Copyright Health Information Designs, LLC 1
2 Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name GCN AMITIZA (LUBIPROSTONE) 8 MCG AMITIZA (LUBIPROSTONE) 24MCG CAPSULES May 24, 2013 Copyright Health Information Designs, LLC 2
3 Clinical Edit Criteria Logic 1. Is the client greater than or equal to ( ) 18 years of age? [ ] (Go to #2) [ ] (Deny) 2. Does the client have a diagnosis of irritable bowel syndrome in the last 365 days? [ ] (Go to #3) [ ] (Go to #4) 3. Is the client a female? [ ] (Go to #5) [ ] (Deny) 4. Does the client have a diagnosis of chronic idiopathic constipation or opioidinduced constipation with chronic, non-cancer pain in the last 365 days? [ ] (Go to #5) [ ] (Deny) 5. Does the client have a history of a GI obstruction in the last 730 days? [ ] (Deny) [ ] (Go to #6) 6. Does the client have a history of lubiprostone in the past 45 days? [ ] (Approve 365 days) [ ] (Go to #7) 7. Is the quantity being requested less than or equal to ( ) 2 caps/day? [ ] (Approve 365 days) [ ] (Deny) May 24, 2013 Copyright Health Information Designs, LLC 3
4 Clinical Edit Criteria Logic Diagram Step 4 Step 1 Is the client 18 years of age? Step 2 Does the client have a diagnosis of irritable bowel syndrome in the last 365 days? Does the client have a diagnosis of chronic idiopathic constipation or opioid-induced constipation with chronic, non-cancer pain in the last 365 days? Deny Request Step 3 Step 5 Deny Request Is the client a female? Does the client have a history of a GI obstruction in the last 730 days? Deny Request Deny Request Step 7 Is the quantity being requested to 2 caps/day? Step 6 Does the client have a history of lubiprostone in the past 45 days? Approve Request (365 days) Approve Request (365 days) May 24, 2013 Copyright Health Information Designs, LLC 4
5 Clinical Edit Criteria Supporting Tables Step 2 (diagnosis of irritable bowel syndrome) Required quantity: 1 Look back timeframe: 365 days ICD-9 Code Description 5641 IRRITABLE BOWEL SYNDROME Step 4 (diagnosis of constipation) Required diagnosis: 1 Look back timeframe: 365 days ICD-9 Code Description 5640 CONSTIPATION CONSTIPATION, UNSPECIFIED SLOW TRANSIT CONSTIPATION OUTLET DYSFUNCTION CONSTIPATION Step 5 (history of GI obstruction) Required quantity: 1 Look back timeframe: 730 days ICD-9 Code Description 5600 INTUSSUSCEPTION 5601 PARALYTIC ILEUS 5602 VOLVULUS OF INTESTINE GALLSTONE ILEUS INTESTINAL ADHES W OBSTR INTESTINAL OBSTRUCT NEC 5609 INTESTINAL OBSTRUCT NOS May 24, 2013 Copyright Health Information Designs, LLC 5
6 Step 6 (history of lubiprostone) Required quantity: 1 Look back timeframe: 45 days Label Name AMITIZA (LUBIPROSTONE) 8MCG CAPSULES AMITIZA (LUBIPROSTONE) 24MCG CAPSULES GCN May 24, 2013 Copyright Health Information Designs, LLC 6
7 Clinical Edit Criteria References 1. Amitiza [package insert]. Deerfield, IL: Takeda Pharmaceuticals rth America. Available at Accessed on July 7, Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc., updated January Available at ICD-9-CM Diagnosis Codes, Volume 1, Available at Accessed on August 14, May 24, 2013 Copyright Health Information Designs, LLC 7
8 Publication History The Publication History records the publication iterations and revisions to this document. Publication Date tes 04/12/2012 Initial publication and posting to website 05/24/2013 Revised step 4 to include diagnosis of chronic idiopathic constipation or opioid-induced constipation with chronic, non-cancer pain May 24, 2013 Copyright Health Information Designs, LLC 8
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