Xifaxan (rifaximin) and Viberzi (eluxadoline) Prior Authorization and Quantity Limit Program Summary

Transcription

1 Xifaxan (rifaximin) and Viberzi (eluxadoline) Prior Authorization and Quantity Limit Program Summary FDA APPROVED INDICATIONS AND DOSAGE 1,2 Indication Viberzi Treatment of irritable bowel (eluxadoline) syndrome with diarrhea in adults Dosage & Administration The recommended dosage in adults is 100 mg twice daily taken with food. Xifaxan (rifaximin) 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 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 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. TD: One 200 mg tablet 3 times a day for 3 days. HE: One 550 mg tablet 2 times a day. 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. FL_CS_Xifaxan_Viberzi_PAQL_ProgSum_AR0716 Page 1 of 7

2 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 Taken as a whole, probiotics improve global symptoms, bloating, and flatulence in IBS 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 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 Weak Low Likely that only some patients will respond 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 FL_CS_Xifaxan_Viberzi_PAQL_ProgSum_AR0716 Page 2 of 7

3 Intervention Statement Recommendation Quality of Evidence Patient Population Mixed 5-HT 4 agonists / 5-HT 3 Strong Low All patients antagonists are not more effective than placebo at improving symptoms of IBS-C Linaclotide is superior to placebo Strong High All patients for the treatment of IBS-C Lubiprostone is superior to Strong Moderate All patients placebo for the treatment of IBS-C There is no evidence that polyethylene glycol improves overall symptoms and pain in patients with IBS Weak Low Not clear whether this intervention is effective Efficacy 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. Safety 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 1. Viberzi prescribing information. Forest Pharmaceuticals, Inc. February Xifaxan prescribing information. Salix Pharmaceuticals, Inc. May Longstreth GF, Thompson WG, Chey WD et al. Functional bowel disorders. Gastroenterology. 2006; 130: FL_CS_Xifaxan_Viberzi_PAQL_ProgSum_AR0716 Page 3 of 7

4 4. 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-S26. FL_CS_Xifaxan_Viberzi_PAQL_ProgSum_AR0716 Page 4 of 7

5 Xifaxan and Viberzi Prior Authorization with Quantity Limit OBJECTIVE The intent of the Xifaxan 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 Xifaxan (rifaximin) Viberzi (eluxadoline) PROGRAM PRIOR AUTHORIZATION AND QUANTITY LIMIT Brand (generic) GPI Multisource Quantity Limit Per Day Code 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 PRIOR AUTHORIZATION CRITERIA FOR 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 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 FL_CS_Xifaxan_Viberzi_PAQL_ProgSum_AR0716 Page 5 of 7

6 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 OR 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 OR 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 OR 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 OR 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 FL_CS_Xifaxan_Viberzi_PAQL_ProgSum_AR0716 Page 6 of 7

7 Xifaxan and Viberzi Quantity Limit OBJECTIVE The intent of the Xifaxan 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) Xifaxan (rifaximin) Viberzi (eluxadoline) PRIOR AUTHORIZATION CRITERIA FOR APPROVAL- SUMMARY (For full criteria, refer to question set) Xifaxan 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 FL_CS_Xifaxan_Viberzi_PAQL_ProgSum_AR0716 Page 7 of 7