Xifaxan, Lotronex and Viberzi Prior Authorization and Quantity Limit Program Summary

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1 Xifaxan, Lotronex and Viberzi Prior Authorization and Quantity Limit Program Summary FDA APPROVED INDICATIONS DOSAGE 1,2 Lotronex (alosetron) a Indication For women with severe diarrheapredominant irritable bowel syndrome (IBS) who have: chronic IBS symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded and not responded adequately to conventional therapy. Dosage & Administration mg twice daily Discontinue alosetron in patients who have not had adequate control of IBS symptoms after 4 weeks of treatment with 1 mg twice a day Viberzi (eluxadoline) Severe IBS includes diarrhea and 1 or more of the following: frequent and severe abdominal pain/discomfort frequent bowel urgency or fecal incontinence disability or restriction of daily activities due to IBS Treatment of irritable bowel syndrome with diarrhea in adults The recommended dosage in adults is 100 mg twice daily taken with food. The recommended dosage is 75 mg twice daily taken with food in patients who: Do not have a gallbladder Are unable to tolerate the 100 mg dose Are receiving concomitant OATP1B1 inhibitors Have mild or moderate hepatic impairment Discontinue eluxadoline in patients who develop severe constipation for more than 4 days. FL_CS_Xifaxan_Viberzi_Lotronex_PAQL_ProgSum_AR0716_r1116 Page 1 of 9

2 Xifaxan (rifaximin) Indication Treatment of travelers diarrhea (TD) caused by noninvasive strains of Escherichia coli in adult and pediatric patients 12 years of age and older Reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults Dosage & Administration TD: One 200 mg tablet 3 times a day for 3 days. HE: One 550 mg tablet 2 times a day. a generic available Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults Limitations of Use: TD - Do not use in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli IBS-D: One 550 mg tablet 3 times a day for 14 days. Patients who experience recurrence can be retreated up to two times with the same regimen. CLINICAL RATIONALE Guidelines Irritable Bowel Syndrome (IBS) is defined on the basis of the presence of recurrent abdominal pain or discomfort at least 3 days/month in the past 3 months associated with two or more of the following: 3 Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool These criteria should be fulfilled for the past 3 months with symptom onset at least 6 months before diagnosis. 3 IBS is subtyped according to predominant bowel habit as IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), mixed type (IBS-M), and unclassified (IBS-U). 3 The American College of Gastroenterology lists the following in the management of IBS: 4 Intervention Statement Recommendation Quality of Evidence Patient Population Specialized diets may improve symptoms in individual IBS patients Weak Very Low Likely to relate to only some IBS patients Fiber provides overall symptom relief in IBS Psyllium, but not bran, provides overall symptom relief in IBS There is insufficient evidence to recommend prebiotics or synbiotics in IBS Weak Moderate May only relate to IBS-C, most trials did not state type of IBS patients Weak Moderate May only relate to IBS-C, most trials did not state type of IBS patients Weak Very Low Likely that only some patients will respond FL_CS_Xifaxan_Viberzi_Lotronex_PAQL_ProgSum_AR0716_r1116 Page 2 of 9

3 Intervention Statement Recommendation Quality of Evidence Patient Population Taken as a whole, probiotics improve global symptoms, bloating, and flatulence in IBS Weak Low Likely that only some patients will respond Rifaximin is effective in reducing total IBS symptoms and bloating in IBS-D Certain antispasmodics provide symptomatic short-term relief in IBS Peppermint oil is superior to placebo in improving IBS symptoms There is insufficient evidence to recommend loperamide for use in IBS As a class, antidepressants are effective in symptom relief in IBS A variety of psychological interventions are effective in improving IBS symptoms Alosteron is effective in females with IBS-D Mixed 5-HT 4 agonists / 5-HT 3 antagonists are not more effective than placebo at improving symptoms of IBS-C Linaclotide is superior to placebo for the treatment of IBS-C Lubiprostone is superior to placebo for the treatment of IBS-C There is no evidence that polyethylene glycol improves overall symptoms and pain in patients with IBS Weak Moderate Likely that only some patients will respond Weak Low All patients Weak Moderate All patients Strong Very Low All patients Weak High All patients Weak Very Low All patients Weak Moderate All patients Strong Low All patients Strong High All patients Strong Moderate All patients Weak Low Not clear whether this intervention is effective Efficacy Alosetron was studied in women with IBS in five 12-week US multicenter, randomized, double-blind, placebo-controlled clinical studies. Studies 1 and 2 were conducted in nonconstipated women with irritable bowel syndrome (IBS). About two thirds of the women had diarrhea-predominant IBS. Compared with placebo, 10% to 19% more women with diarrhea-predominant IBS who received alosetron had adequate relief of IBS abdominal pain and discomfort during each month of the study. Studies 3 and 4 were conducted in women with diarrhea-predominant IBS and bowel urgency on at least 50% of days at entry. Women receiving alosetron had significant increases over placebo (13% to 16%) in the median percentage of days with urgency control. Study 5 was conducted in women with severe diarrhea-predominant IBS and 1 or more of the following: frequent and severe abdominal pain or discomfort, frequent bowel urgency or fecal incontinence, disability or restriction of daily activities due to IBS. At Week 12, all three groups receiving alosetron had significantly FL_CS_Xifaxan_Viberzi_Lotronex_PAQL_ProgSum_AR0716_r1116 Page 3 of 9

4 greater percentages of Global Improvement Scale responders compared to the placebo group (43% to 51% vs. 31%) using a Last Observation Carried Forward (LOCF) analysis. At each of the 4 week intervals of the treatment phase, all three dosages of alosetron provided improvement in the average adequate relief rate of IBS pain and discomfort, stool consistency, stool frequency, and sense of urgency compared with placebo. 5 Eluxadoline was studied in two 26 week double blind, placebo-controlled trials. During the double-blind treatment phase and the single-blinded placebo withdrawal phase, patients were allowed to take loperamide rescue medication for the acute treatment of uncontrolled diarrhea, but were not allowed to take any other anti-diarrheal, antispasmodic agent or rifaximin for their diarrhea. 1 Rifaximin s efficacy given as 200 mg orally taken three times a day for 3 days was evaluated in 2 randomized, multi-center, double-blind, placebo-controlled studies in adult subjects with travelers diarrhea. The efficacy of rifaximin 550 mg taken orally two times a day was evaluated in a randomized, placebo-controlled, double-blind, multi-center 6-month trial of adult subjects. The efficacy of rifaximin for the treatment of IBS-D was established in 3 randomized, multicenter, double-blind, placebo-controlled trials in adult patients. 2 Safety Alosetron carries the following contraindications: 5 Do not initiate in patients with constipation History of chronic or severe constipation or sequelae from constipation; intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions; ischemic colitis; impaired intestinal circulation, thrombophlebitis, or hypercoagulable state; Crohn s disease or ulcerative colitis; diverticulitis; severe hepatic impairment Concomitant use of fluvoxamine Alosetron also carries the following black box warnings: 5 Infrequent but serious gastrointestinal adverse reactions have been reported with the use of alosetron. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and, rarely, blood transfusion, surgery, and death. Alosetron is indicated only for women with severe diarrhea predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy. Discontinue alosetron immediately in patients who develop constipation or symptoms of ischemic colitis. Do not resume alosetron in patients who develop ischemic colitis Eluxadoline carries the following contraindications: 1 Known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction Alcoholism, alcohol abuse, alcohol addiction, or drink more than 3 alcoholic beverages/day a history of pancreatitis; structural diseases of the pancreas, including known or suspected pancreatic duct obstruction Severe hepatic impairment (Child-Pugh Class C) Severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction Rifaximin carries the following contraindications: 2 History of hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components of rifaximin REFERENCES FL_CS_Xifaxan_Viberzi_Lotronex_PAQL_ProgSum_AR0716_r1116 Page 4 of 9

5 1. Viberzi prescribing information. Forest Pharmaceuticals, Inc. Februrary Xifaxan prescribing information. Salix Pharmaceuticals, Inc. May Longstreth GF, Thompson WG, Chey WD et al. Functional bowel disorders. Gastroenterology. 2006; 130: Ford, AC, et. al. American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation. The American Journal of Gastroenterology. August :1, S2-S Lotronex prescribing information. Sebela Pharmaceuticals, Inc. January FL_CS_Xifaxan_Viberzi_Lotronex_PAQL_ProgSum_AR0716_r1116 Page 5 of 9

6 Xifaxan Lotronex and Viberzi Prior Authorization with Quantity Limit OBJECTIVE The intent of the Xifaxan, Lotronex and Viberzi Prior Authorization (PA) program is to ensure appropriate selection of patients for treatment according to product labeling and/or clinical studies and/or clinical guidelines. TARGET DRUG Lotronex (alosetron) a Xifaxan (rifaximin) Viberzi (eluxadoline) a generic available and included as target PROGRAM PRI AUTHIZATION QUANTITY LIMIT Brand (generic) GPI Multisource Quantity Limit Per Day Code Lotronex (alosetron) 0.5 mg tablet tablets per day M, N, O, Y 0 1 mg tablet tablets per day M, N, O, Y 0 Viberzi (eluxadoline) 75 mg tablet M, N, O, Y 2 tablets 100 mg tablet M, N, O, Y 2 tablets Xifaxan (rifaximin) 200 mg tablet M, N, O, Y Traveler s diarrhea: 3 tablets for 3 days 550 mg tablet M, N, O, Y Risk of Recurrent Hepatic Encephalopathy: 2 tablets IBS-D: 3 tablets PRI AUTHIZATION CRITERIA F APPROVAL- SUMMARY (For full criteria, refer to question set) Rifaximin (Xifaxan) tablet meets the definition of medical necessity for members meeting ONE of the following indications for use when ALL associated criteria are met: 1. Traveler s diarrhea a. Traveler s diarrhea is due to a noninvasive strain of Escherichia coli b. Member has failed an adequate trial (i.e., 3-5 days) of a fluoroquinolone (e.g., ciprofloxacin, levofloxacin) or has a documented contraindication that would prevent use c. Dose does not exceed 200 mg three times daily for three days d. Member is 12 years of age or older Duration of approval: One 3-day treatment course 2. Prophylaxis of hepatic encephalopathy a. Member has failed an adequate trial of lactulose (dose: ml every 8-12 hours) or has a documented contraindication or intolerance that would prevent FL_CS_Xifaxan_Viberzi_Lotronex_PAQL_ProgSum_AR0716_r1116 Page 6 of 9

7 use NOTE: Three or fewer soft stools per day is not considered an intolerance to lactulose b. Dose does not exceed 550 mg twice daily c. Member is 18 years of age or older Duration of approval: 1 year 3. Irritable bowel syndrome with diarrhea (IBS-D) Initiation Criteria: a. Member has failed an adequate trial of an antispasmodic agent (e.g., dicyclomine, hyoscine) in the past 12 months b. Member has failed an adequate trial of either a tricyclic antidepressant a selective serotonin reuptake inhibitor (SSRI) for IBS-D in the past 12 months c. Dose does not exceed 550 mg three times daily for 14 days d. Member is 18 years of age or older Duration of approval: 3 months (Quantity limit of 42 tablets/3 months) Continuation Criteria: a. Member was previously approved for use in IBS-D meets all initiation criteria b. Member has demonstrated a beneficial response to treatment with Xifaxan Duration of approval: 1 year (Quantity limit of 126 tablets/year) Eluxadoline (Viberzi) meets the definition of medical necessity for members meeting ONE of the following indications for use when ALL associated criteria are met: 1. Irritable bowel syndrome with diarrhea (IBS-D) Initiation Criteria: a. Member has failed an adequate trial of an antispasmodic agent (e.g., dicyclomine, hyoscine) in the past 12 months b. Member has failed an adequate trial of either a tricyclic antidepressant a selective serotonin reuptake inhibitor (SSRI) for IBS-D in the past 12 months c. Dose does not exceed 100mg twice daily (2 tablets daily) d. Member is 18 years of age or older Duration of approval: 3 months Continuation Criteria: a. Member was previously approved for use in IBS-D meets all initiation criteria b. Member has demonstrated a beneficial response to treatment with Viberzi c. Dose does not exceed 100mg twice daily (2 tablets daily) Duration of approval: 1 year Lotronex will be approved when ALL of the following are met: 1. ONE of the following diagnoses: a. ALL of the following: i. The patient has a diagnosis of irritable bowel syndrome with severe diarrhea (IBS-D), with documentation of symptoms for 6 months 1. BOTH of the following: FL_CS_Xifaxan_Viberzi_Lotronex_PAQL_ProgSum_AR0716_r1116 Page 7 of 9

8 a. The patient exhibits at least ONE of the following: i. Frequent and severe abdominal pain/discomfort ii. Frequent bowel urgency or fecal incontinence iii. Disability or restriction of daily activities due to IBS b. ONE of the following: i. The patient is not currently taking Viberzi (eluxadoline) or Xifaxan (rifaximin) for treating IBS- D ii. The Viberzi (eluxadoline) or Xifaxan (rifaximin) for treating IBS-D will be discontinued prior to starting Lotronex ii. ONE of the following: 1. The patient is female 2. The prescriber has provided documentation that the requested agent is medically appropriate for the patient s gender iii. The patient has had anatomic or biochemical abnormalities of the gastrointestinal tract excluded iv. The patient has not responded adequately to conventional therapy b. The patient has another FDA approved indication 2. The patient does not have any FDA labeled contraindications to the requested agent 3. ONE of the following: a. The requested quantity (dose) is NOT greater than the program quantity limit b. ALL of the following: i. The requested quantity (dose) is greater than the program quantity limit ii. The requested quantity (dose) is less than or equal to the FDA labeled dose iii. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the limit Length of Approval: 3 months FL_CS_Xifaxan_Viberzi_Lotronex_PAQL_ProgSum_AR0716_r1116 Page 8 of 9

9 Xifaxan, Lotronex and Viberzi Quantity Limit OBJECTIVE The intent of the Xifaxan, Lotronex and Viberzi quantity limit is to encourage appropriate prescribing quantities as recommended by FDA approved product labeling and to encourage cost-effective prescribing when lower quantities of a higher strength are equivalent to the prescribed dose. TARGET DRUGS (brands and generics) Lotronex (alosetron) Xifaxan (rifaximin) Viberzi (eluxadoline) PRI AUTHIZATION CRITERIA F APPROVAL- SUMMARY (For full criteria, refer to question set) Xifaxan, Lotronex and Viberzi will be approved for quantities above the program set limit when ONE of the following is met: 1. The quantity (dose) requested is within FDA approved labeling and the prescribed dose cannot be achieved using a lesser quantity of a higher strength Length of approval: Drug Indication Initial approval length Renewal approval length Xifaxan 200mg traveler's diarrhea 1 treatment course per 180 days 1 treatment course per 180 days Xifaxan 550 mg Hepatic encephalopathy 12 months 12 months Xifaxan 550mg IBS-Diarrhea 1 treament course per 3 moths 3 treatment courses per 12 months Viberzi 75 and 100mg IBS-Diarrhea 3 months 12 months Lotronex IBS-Diarrhea 3 months 3 months FL_CS_Xifaxan_Viberzi_Lotronex_PAQL_ProgSum_AR0716_r1116 Page 9 of 9

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