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Constipation Agents Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1015

 

This prior authorization program applies to Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies.

TARGET PREFERRED AGENT(S)

Movantik® (naloxegol)

Symproic® (naldemedine)

Trulance® (plecanatide)

TARGET NON-PREFERRED AGENT(S)

Amitiza® (lubiprostone)

Ibsrela® (tenapanor)

Linzess® (linaclotide)

Lubiprostone

Motegrity® (prucalopride)

Relistor® (methylnaltrexone)

Zelnorm™ (tegaserod)

Brand (generic)

GPI (NDC)

Multisource Code

Quantity Limit

(per day or as listed)

Amitiza, Lubiprostone

8 mcg capsule

52450045000110

M, N, O, or Y

4 capsules

24 mcg capsule

52450045000120

M, N, O, or Y

2 capsules

Ibsrela (tenapanor)

50 mg tablet

52558580100320

M, N, O, or Y

2 tablets

Linzess (linaclotide)

72 mcg capsule

52557050000110

M, N, O, or Y

1 capsule

145 mcg capsule

52557050000120

M, N, O, or Y

1 capsule

290 mcg capsule

52557050000140

M, N, O, or Y

1 capsule

Motegrity (prucalopride)

1 mg tablet

52560060200320

M, N, O, or Y

1 tablet

2 mg tablet

52560060200330

M, N, O, or Y

1 tablet

Movantik (naloxegol)

12.5 mg tablet

52580060300320

M, N, O, or Y

1 tablet

25 mg tablet

52580060300330

M, N, O, or Y

1 tablet

Relistor (methylnaltrexone)

12 mg/0.6 mL (20 mg/mL) injection syringe kit

52580050106420

M, N, O, or Y

1 syringe

8 mg/0.4 mL (20 mg/mL) injection syringe

52580050102015

M, N, O, or Y

1 syringe (0.4 mL)

12 mg/0.6 mL (20 mg/mL) injection syringe

52580050102020

(65649-0551-03

65649-0551-07)

M, N, O, or Y

1 syringe (0.6 mL)

12 mg/0.6 mL (20 mg/mL) injection vial

52580050102020

(65649-0551-02)

M, N, O, or Y

2 vials (1.2 mL)a

150 mg tablet

52580050100320

M, N, O, or Y

3 tablets

Symproic (naldemedine)

0.2 mg tablet

52580057200320

M, N, O, or Y

1 tablet

Trulance (plecanatide)

3 mg tablet

52543060000320

M, N, O, or Y

1 tablet

Zelnorm (tegaserod)

6 mg tablet

52555060200320

M, N, O, or Y

2 tablets

  1. Quantity Limit allows for dosing for individuals at least 90th percentile weight

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. ONE of the following:
    1. The patient has a diagnosis of irritable bowel syndrome with constipation (IBS-C) AND ALL of the following:
      1. The patient has had IBS-C symptoms for ≥3 months

AND

      1. ONE of the following:
        1. The requested agent is Trulance (plecanatide), Linzess (linaclotide) OR Ibsrela (tenapanor)

OR

        1. The requested agent is Amitiza, Lubiprostone OR Zelnorm (tegaserod) AND ONE of the following:
          1. The patient’s sex is female

OR

          1. The prescriber has provided information that the requested agent is medically appropriate for the patient’s sex and the intended diagnosis

AND

      1. ONE of the following:
        1. The patient has tried and had an inadequate response to at least 2 standard laxative therapy classes (e.g., bulk-forming, stimulant, enema, osmotic, or stool softener)

OR

        1. The patient has an intolerance or hypersensitivity to at least 2 standard laxative therapy classes

OR

        1. The patient has an FDA labeled contraindication to ALL standard laxative therapy classes

OR

    1. The patient has a diagnosis of chronic idiopathic constipation (CIC) AND ALL of the following:
      1. The patient has had CIC symptoms for ≥3 months

AND

      1. The requested agent is Amitiza, Lubiprostone, Linzess, Motegrity, or Trulance

AND

      1. ONE of the following:
        1. The patient has tried and had an inadequate response to at least 2 standard laxative therapy classes (e.g., bulk-forming, stimulant, enema, osmotic, or stool softener)

OR

        1. The patient has an intolerance or hypersensitivity to at least 2 standard laxative therapy classes

OR

        1. The patient has an FDA labeled contraindication to ALL standard laxative therapy classes

OR

    1. The patient has a diagnosis of opioid-induced constipation (OIC) AND ALL of the following:
      1. ONE of the following:
        1. BOTH of the following:
          1. ONE of the following:
            1. The requested agent is Symproic (naldemedine), Movantik (naloxegol), OR Relistor (methylnaltrexone) tablet

OR

            1. The requested agent is Amitiza OR Lubiprostone, AND the patient is not currently receiving a diphenylheptane opioid (e.g., methadone)

AND

          1. ONE of the following:
            1. The patient has chronic non-cancer pain

OR

            1. The patient has chronic pain related to prior cancer or its treatment

OR

            1. The patient has active cancer pain

OR

        1. The requested agent is Linzess (linaclotide) AND the patient has active cancer pain

OR

        1. The request is for Relistor (methylnaltrexone) injection and the patient is receiving palliative care AND ONE of the following:
          1. The patient has advanced illness

OR

          1. The patient has pain caused by active cancer

AND

      1. The patient has chronic use of an opioid agent in the past 30 days

AND

      1. ONE of the following:
        1. The patient has tried and had an inadequate response to at least 2 standard laxative therapy classes (e.g., stimulant, enema, osmotic, or stool softener, but not including fiber or bulking agents)

OR

        1. The patient has an intolerance or hypersensitivity to at least 2 standard laxative therapy classes

OR

        1. The patient has an FDA labeled contraindication to ALL standard laxative therapy classes

AND

  1. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent

OR

    1. The prescriber has provided information in support of using the requested agent for the patient’s age

AND

  1. ONE of the following:
    1. The request is for Symproic (naldemedine), Trulance (plecanatide), Movantik (naloxegol), OR Relistor (methylnaltrexone) injection

OR

    1. The requested agent is for use in IBS-C or CIC AND ONE of the following:
      1. The patient has tried and had an inadequate response to Trulance (plecanatide)

OR

      1. The patient has an intolerance or hypersensitivity to Trulance (plecanatide) that is not expected to occur with the requested agent

OR

      1. The patient has an FDA labeled contraindication to Trulance (plecanatide) that is not expected to occur with the requested agent

OR

    1. The requested agent is for use in OIC AND ONE of the following:
      1. The patient has tried and had an inadequate response to Symproic (naldemedine) and Movantik (naloxegol)

OR

      1. The patient has an intolerance or hypersensitivity to Symproic (naldemedine) and Movantik (naloxegol) that is not expected to occur with the requested agent

OR

      1. The patient has an FDA labeled contraindication to Symproic (naldemedine) and Movantik (naloxegol) that is not expected to occur with the requested agent

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. The patient will NOT be using the requested agent in combination with another constipation agent in this program for the requested indication

AND

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

      1. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process

AND

  1. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent

OR

    1. The prescriber has provided information in support of using the requested agent for the patient’s age

AND

  1. The patient has had clinical benefit with the requested agent

AND

  1. The patient will NOT be using the requested agent in combination with another constipation agent in this program for the requested indication

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
  1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

  1. ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

  1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

  1. ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

  1. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

FDA APPROVED INDICATIONS AND DOSAGE1,3,9,11,13-15,18,20

Agent(s)

Indication(s)

Dosage

Amitiza®,

Lubiprostonea

Capsules

Treatment of chronic idiopathic constipation (CIC) in adults.

Treatment of opioid-induced constipation (OIC) in adults with chronic, non-cancer pain including patients with chronic pain related to prior cancer of its treatment who do not require frequent (e.g. weekly) opioid dosage escalation.

Limitation of Use: Effectiveness of Amitiza in the treatment of OIC in patients taking diphenylheptane opioids

(e.g. methadone) has not been established.

Treatment of irritable bowel syndrome with constipation

(IBS-C) in women ≥ 18 years old.

CIC, OIC: 24 mcg taken twice daily orally.

IBS-C: 8 mcg taken twice daily orally.

Ibsrela®

(tenapanor)

Tablets

Treatment of irritable bowel syndrome with constipation (IBS-C) in adults

IBS-C: The recommended dosage in adults is 50 mg, orally twice daily

Linzess®

(linaclotide)

Capsules

Treatment of irritable bowel syndrome with constipation

(IBS-C) in adults.

Treatment of chronic idiopathic constipation (CIC) in adults.

IBS-C: 290 mcg taken once daily orally.

CIC: 145 mcg orally once daily or 72 mcg orally once daily based on individual presentation or tolerability.

Motegrity®

(prucalopride)ab

Tablets

Treatment of chronic idiopathic constipation (CIC) in adults.

Adults: 2 mg once daily

Movantik®

(naloxegol)

Tablets

Treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation

25 mg once daily; if not tolerated, reduce to 12.5 mg once daily

Discontinue maintenance laxative therapy before starting naloxegol; may resume laxatives if patients have OIC symptoms after taking naloxegol for 3 days

Patients receiving opioids for less than 4 weeks may be less responsive

to Movantik

Discontinue if treatment with the opioid pain medication is also discontinued

Relistor®

(methylnaltrexone)

Subcutaneous injection (SC)*

Tablets

Injection/Tablet:

Treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation

SC: 12 mg once daily

Tablet: 450 mg orally once daily

Patients receiving opioids for less than 4 weeks may be less responsive to Relistor

Discontinue maintenance laxative therapy before starting Relistor; may resume laxatives if patients have OIC symptoms after taking Relistor for 3 days

Discontinue if treatment with opioid pain medication is also discontinued

Injection:

Treatment of OIC in adult patients with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care

Once daily weight-based administration every other day, as needed, but no more frequently than one dose in a 24 hour period

Adult Patient Weight±

SQ dose

<38 kg

0.15 mg/kg

38 kg to <62 kg

8 mg

62 kg to 114 kg

12 mg

>114 kg

0.15 mg/kg

Symproic®

(naldemedine)

Tablets

Treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

0.2 mg once daily

Patients receiving opioids for less than 4 weeks may be less responsive to Symproic

Discontinue Symproic if treatment with the opioid pain medication is also discontinued

Trulance®

(plecanatide)

Tablets

Treatment of chronic idiopathic constipation (CIC) in adults.

Treatment of irritable bowel syndrome with constipation (IBS-C) in adults

3 mg taken orally once daily

Zelnorm™

(tegaserod)

Tablets

Treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C)

Limitations of Use: The safety and effectiveness of Zelnorm in men with IBS-C have not been established.

6 mg taken twice daily orally

Discontinue Zelnorm in patients who have not had adequate control of symptoms after

4 to 6 weeks of treatment

a – effectiveness has not been established in a trial of pediatric patients 6 years and over

b – clinical studies included individuals 17 years of age and greater

* - The pre-filled syringe is only for patients who require a Relistor injection dose of 8 mg or 12 mg. Use the vial for patients who require other doses of Relistor injection

± - CDC 90th percentile weight for adult males 20 years of age and over is 113.3 kg22

CLINICAL RATIONALE

Irritable Bowel Syndrome with Constipation (IBS-C)

IBS is a chronic functional disorder of the gastrointestinal system. Patients experience abdominal pain and altered bowel habit, with either predominantly diarrhea (IBS-D), constipation (IBS-C), or both (IBS-M). There is no definitive investigation as no biomarker has been found, so IBS is diagnosed clinically. The Rome criteria were developed by a panel of international experts in the field of functional gastrointestinal disorders. Although initially developed to guide researchers, these criteria have undergone several revisions with the intent of making them clinically useful whereas the criteria can be applied to diagnose IBS.19

Rome IV defines IBS as recurrent abdominal pain, on average, at least one day per week in the last three months associated with two or more of the following:19

  • Related to defecation
  • Associated with a change in stool frequency
  • Associated with a change in stool form (appearance)

The goal of treatment of IBS-C is to improve symptoms such as abdominal bloating, discomfort, and constipation. The American College of Gastroenterology (ACG) updated (2021) guidelines suggest that soluble (e.g., psyllium, oat bran, barley, and beans), but not insoluble (e.g., wheat bran, whole grains, and some vegetables), fiber be used to treat IBS especially when the predominant symptom is constipation. Updated guidelines recommend against the use of polyethylene glycol (PEG), probiotics and antispasmodics. However, the authors do recognize that clinicians may use PEG as a first-line treatment for constipation in IBS, given its low cost and availability.5

Tricyclic antidepressants (TCAs) are also recommended for use with global symptoms of IBS, such as patients who report abnormal bowel habits of constipation, diarrhea, or both. TCAs are believed to improve visceral pain and central pain by acting on norepinephrine, and dopaminergic receptors, thus making them attractive candidates for the treatment of IBS-related abdominal pain. A recent systematic review and meta-analysis evaluated 7 RCTs that evaluated the effect of antidepressant therapy on abdominal pain. Antidepressants were more likely to improve symptoms of abdominal pain than placebo; however, the beneficial effects were due to TCA therapy, not serotonin reuptake inhibitors (SSRIs).

2021 AGA guidelines recommend lubiprostone with a strong recommendation, and with moderate quality of evidence; in addition to guanylate cyclase activators (linaclotide and plecanatide) with a strong recommendation, high quality of evidence to treat global IBS- C symptoms. Lubiprostone exhibits an appropriate safety profile and efficacy with the most common adverse events being gastrointestinal (i.e., nausea) in nature. Although there may be a delay in initial response, improvement in global symptoms is maintained or increases over time. Guanylate cyclase-C (GC-C) agonists target GC-C receptors residing in the apical membranes of intestinal epithelial cells. There are currently 2 US FDA-approved agents for the treatment of IBS-C—linaclotide 290 μg and plecanatide 3 mg. Recent comparative analyses suggest that both are comparably effective, safe, and well-tolerated. Responses develop quickly and are maintained over time. Diarrhea is the most common adverse event experienced, but discontinuation rates due to diarrhea are low and both are well-tolerated. The 5-HT4 agonist tegaserod is also suggested to be used to treat IBS-C symptoms in women younger than 65 years with ≤1 cardiovascular risk factors who have not adequately responded to secretagogues, but the recommendation is conditional (weak) with a low quality of evidence.

Chronic Idiopathic Constipation (CIC)

Rome IV diagnostic criteria for functional constipation requires the presence of the following for at least 3 months:12

  • Must include two or more of the following:
    • Straining during more than 25 percent of defecations
    • Lumpy or hard stools (Bristol Stool Scale Form 1-2) in more than 25 percent of defecations
    • Sensation of incomplete evacuation for more than 25 percent of defecations
    • Manual maneuvers to facilitate more than 25 percent of defecations (e.g., digital evacuation, support of the pelvic floor)
    • Fewer than three spontaneous bowel movements per week
  • Loose stools are rarely present without the use of laxatives
  • There are insufficient criteria for Irritable Bowel Syndrome (IBS)

According to 2021 American College of Gastroenterology (ACG) guidelines, polyethylene glycol (PEG) is a relatively inexpensive, widely available, nonprescription osmotic laxative that is US FDA-approved for occasional constipation based on several RCT studies. Four trials in chronic idiopathic constipation have yielded improvement in stool frequency and stool consistency. American Gastroenterology Association recommends a gradual increase in fiber intake, as both foods included in the diet and as supplements and/or an inexpensive osmotic agent (e.g., milk of magnesia or polyethylene glycol (PEG)). Depending on stool consistency, the next step may be to supplement the osmotic agent with a stimulant laxative (e.g., bisacodyl or glycerol suppositories), preferably administered 30 minutes after a meal to synergize the pharmacologic agent with the gastrocolonic response. A newer agent (e.g., linaclotide, lubiprostone) should be considered when symptoms do not respond to other laxatives.10

Although linaclotide and lubiprostone are effective in CIC and are well tolerated, there have been no comparative studies. As both were evaluated in comparison with placebo rather than “standard therapy,” a recommendation regarding their precise position in a CIC treatment algorithm (i.e., for those who have failed fiber, osmotic, or stimulant laxatives, or as primary therapy) cannot be made at this time.5

Opioid-Induced Constipation (OIC)

In anticipation of potential OIC development with long-term opioid use, treatment guidelines recommend initiation of a prophylactic bowel regimen that may involve increased fluid and fiber intake, stool softeners, and/or laxatives. When a diagnosis of OIC is suspected despite prophylactic treatment, clinicians should confirm that initiation of opioid therapy has led to a change from baseline in the patient’s typical bowel habits, before consideration of further or alternative interventions. First line approaches to intervention also include dietary changes, OTC treatments, and exercise. 6

National Comprehensive Cancer Network (NCCN) guidelines on adult cancer pain include the following recommendations on OIC. Preventative measures include prophylactic medications such as a stimulant laxative (e.g., senna and polyethylene glycol) in addition to maintaining adequate fluid intake, maintaining adequate dietary fiber, and exercise if feasible. Supplemental medicinal fiber (e.g., psyllium) is unlikely to control OIC and may worsen constipation. Docusate does not provide benefit. If constipation develops, pharmacological recommendations include titrating stool softeners/laxatives as needed to achieve one non-forced bowel movement every 1-2 days. Consider adjuvant analgesics to allow reduction of opioid dose. If constipation persists, pharmacological recommendations include the consideration of adding another agent (magnesium hydroxide, bisacodyl, rectal suppository, lactulose, sorbitol, magnesium citrate, or polyethylene glycol). When response to laxative therapy has not been sufficient for OIC in patients with advanced illness, then consider peripherally acting mu opioid receptor antagonists such as methylnaltrexone or naloxegol; other second line agents include lubiprostone and linaclotide.4

The American Gastroenterological Association Institute 2019 guideline for OIC recommends that patients with OIC, first line agents are traditional laxatives which include osmotic, stimulant, detergent/surfactant stool softener, and lubricant agents. In patients with laxative refractory OIC, naldemedine, naloxegol, and methylnaltrexone are recommended over no therapy. No recommendations are made on lubiprostone or prucalopride.  Fiber or bulk-forming agents have limited role in OIC. Enemas may occasionally be prescribed as rescue therapy, but are not used regularly due to inconvenience, patient preference, and safety concerns.16

Safety1,3,9,11,13-15,18,20

Contraindications

Amitiza carries the following contraindications:

  • Known or suspected mechanical gastrointestinal obstruction

Ibsrela carries the following contraindications:

  • Pediatric patients less than 6 years of age
  • Patients with known of suspected mechanical gastrointestinal obstruction

Linzess carries the following contraindications:

  • Known or suspected mechanical gastrointestinal obstruction
  • Patients under 6 years of age

Movantik carries the following contraindications:

  • Patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction
  • Concomitant use with strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole)
  • Known serious or severe hypersensitivity reaction to naloxegol or any of its excipients

Motegrity carries the following contraindications:

  • A history of hypersensitivity to Motegrity. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed
  • Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease, ulcerative colitis, and toxic megacolon/megarectum

Relistor carries the following contraindications:

  • Patients with known or suspected mechanical gastrointestinal obstruction and at increased risk of recurrent obstruction

Symproic carries the following contraindications:

  • Patients with known or suspected gastrointestinal obstruction at increased risk of recurrent obstruction
  • Patients with a history of a hypersensitivity reaction to naldemedine

Trulance carries the following contraindications:

  • Patients less than 6 years of age due to the risk of serious dehydration.
  • Patients with known or suspected mechanical gastrointestinal obstruction

Zelnorm carries the following contraindications:

  • A history of myocardial infarction, stroke, transient ischemic attack, or angina
  • A history of ischemic colitis or other forms of intestinal ischemia.
  • Severe renal impairment (eGFR< 15 mL/min/1.73 m2 ) or end-stage renal disease
  • Moderate or severe hepatic impairment (Child-Pugh B or C)
  • A history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions
  • Hypersensitivity to tegaserod

For additional clinical information see the Prime Therapeutics Formulary Chapters 7.1: Laxatives and 7.7E: Irritable Bowel Syndrome Agents

REFERENCES

  1. Amitiza Prescribing Information. Sucampo Pharmaceuticals, Inc. November 2020.
  2. Brandt LJ, Chey WD, Foxx-Orenstein AE, et al. American College of Gastroenterology task force on irritable bowel syndrome 2009.
  3. Linzess Prescribing Information. Forest Pharmaceuticals, Inc. September 2020.
  4. National Comprehensive Cancer Network (NCCN) Clinical Practice guidelines in oncology. Adult Cancer Pain. Version 3.2019. Accessed 4/8/2020.
  5. Weinberg DS, Smalley W, et al. American Gastroenterological Association Institute Guideline on the Pharmacological Management of Irritable Bowel Syndrome. Gastroenterology. 2021;116:17-44.
  6. Argoff C, Brennan M, Camilleri M, et al. Review Article: Consensus recommendations on initiating prescription therapies for opioid-induced constipation. Pain Med. 2015;16(12):2324-2337.
  7. Thomas R, Luthin D. Current and emerging treatments for irritable bowel syndrome with constipation and chronic idiopathic constipation: Focus on prosecretory agents. Pharmacotherapy 2015;35(6):613–630.
  8. World Gastroenterology Organization Global Guidelines. IBS: a Global Perspective Update September 2015. Available at: http://www.worldgastroenterology.org/UserFiles/file/guidelines/irritable-bowel-syndrome-english-2015.pdf. Accessed 4/11/2021
  9. Trulance prescribing information. Synergy Pharms, Inc. July 2018.
  10. American Gastroenterological Association Medical Position Statement on Constipation. Gastroenterology. 2013;144:211–217. 
  11. Motegrity prescribing information. Shire US, Inc. December 2018.
  12. Crockett SD, Greer KB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation. Gastroenterology 2019;156:218-226. 
  13. Relistor prescribing information. Salix Pharmaceuticals. March 2018.  
  14. Movantik prescribing information.  Astra Zeneca Pharmaceutical LP. April 2020.  
  15. Symproic prescribing information. Purdue Pharma LP. January 2018.  
  16. American College of Gastroenterology monograph on management of irritable bowel syndrome. American Journal of Gastroenterology. 2018; 113:1–18. https://doi.org/10.1038/s41395-018-0084-x  
  17. Anthropometric Reference Data for Children and Adults: United States, 2011–2014. Center for Disease Control and Prevention. Available at: https://www.cdc.gov/nchs/data/series/sr_03/sr03_039.pdf.  Accessed 5/22/19
  18. Zelnorm prescribing information. US WorldMeds LLC. July 2019. 
  19. Lacy BE, Patel NK. Rome Criteria and a Diagnostic Approach to Irritable Bowel Syndrome. Journal of Clinical Medicine. 2017; 6(11):99. https://doi.org/10.3390/jcm6110099. Accessed 4/5/2021.
  20. Ibsrela prescribing information. Ardelyx, Inc. May 2021.

 

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment

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