Laxatives – Enhanced & Essential

Restricted Product(s)

Restriction applies to brand and generic products

• Amitiza (lubiprostone) 
• Ibsrela (tenapanor) 
• Linzess (linaclotide)
• Motegrity (prucalopride) 
• Movantik (naloxegol oxalate) 
• Symproic (naldemedine) 
• Trulance (plecanatide) 
• Relistor (methylnaltrexone bromide)

FDA Approved Use

• Amitiza 
  • For chronic idiopathic constipation (CIC) in adults. 
  • For opioid-induced constipation (OIC) in adult patients with chronic, noncancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. 
    • Limitations of Use: Effectiveness of Amitiza in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. 
  • For irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old
• Ibsrela 
  • For irritable bowel syndrome with constipation (IBS-C) in adults 
• Linzess 
  • For irritable bowel syndrome with constipation (IBS-C) in adults 
  • For chronic idiopathic constipation (CIC) in adults 
  • For functional constipation (FC) in pediatric patients 6 to 17 years of age
• Movantik 
  • For the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. 
• Motegrity 
  • For treatment of chronic idiopathic constipation (CIC) in adults. 
• Symproic
  • For the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
• Trulance 
  • For the treatment of chronic idiopathic constipation in adults. 
  • For the treatment of irritable bowel syndrome with constipation (IBS-C) 
• Relistor 
  • For treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, and 
  • For treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. 
    • Limitation of Use: Use beyond four months has not been studied. 
  • For the 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. 

Criteria for Approval of Restricted Product(s)

Initial Coverage

1. The patient requires laxative to regularly achieve loose stools; AND 
2. The patient has tried a minimum of two standard laxative therapy classes listed below: 
   1. Stimulant laxatives (i.e., senna, bisacodyl) 
   2. Stool softeners (i.e., docusate) 
   3. Enemas (i.e., sodium phosphate) 
   4. Osmotic agents (i.e., polyethylene glycol, lactulose, sorbitol); AND 
3. ONE of the following: 
   1. The patient is 6 to 17 years of age; AND 
      1. The patient has a diagnosis of functional constipation; AND 
         1. The requested drug is Linzess; OR 
   2. The patient is 18 years of age or older; AND 
      1. The patient has a diagnosis of Chronic Idiopathic Constipation; AND 
         1. The requested drug is Trulance; OR 
         2. The requested drug is Amitiza, Lubiprostone (generic Amitiza), Linzess, Motegrity, or Prucalopride (generic Motegrity); AND 
            1. The patient has tried and failed or has a clinical contraindication/intolerance to Trulance; OR 
      2. The patient has a diagnosis of Irritable bowel syndrome with constipation; AND
         1. The requested drug is Trulance; OR 
         2. The requested drug is Amitiza or Lubiprostone (generic Amitiza), Ibsrela, or Linzess; AND 
            1. The patient has tried and failed or has a clinical contraindication/intolerance to Trulance; OR 
      3. The patient has a diagnosis of opioid induced constipation; AND 
         1. The requested drug is Symproic or Movantik; OR
         2. The requested drug is Amitiza, Lubiprostone (generic Amitiza) or Relistor; AND 
            1. The patient has tried and failed or has a clinical contraindication/intolerance to Symproic and Movantik; AND
4. The patient will NOT be using the requested agent in combination with another constipation agent in this program for the requested indication; AND 
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Continuation Coverage

1. The patient was approved through Blue Cross NC initial criteria for approval; OR 
   1. The patient would have met initial criteria for approval at the time they started therapy; AND 
2. The patient has demonstrated a positive clinical response while using the medication; AND 
3. The patient will NOT be using the requested agent in combination with another constipation agent in this program for the requested indication.

Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Ford A., Moayyedi P., Lacy B., Lembo A., Saito Y., Schiller L., et al. (2014a) American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation. Am J Gastroenterol 109 Suppl 1: S2–S26.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

January 2025: Criteria update: Added Prucalopride (generic Motegrity) to policy.

September 2024: Criteria change: Added continuation criteria. Removed strength and requirement that patient does not have pediatric IBSC or fecal impaction from pediatric functional constipation indication. 

July 2023: Criteria change (Linzess): Added new indication for Linzess to include functional constipation in pediatric patients 6 to 17 years of age.

April 2023: Criteria change: Added quantity limits to all targets. The patient will not utilize the requested agent in combination with another constipation agent in the program for the same indication.

January 2023: Criteria update: Added Lubiprostone (generic Amitiza) to policy. Removed authorized generic Amitiza from the policy.

March 2022: Criteria update: Added new to market Ibsrela to the policy.

October 2021: Criteria change: Step through Symproic removed on Movantik. Require step through Movantik for Amitiza, Relistor requests for OIC.

July 2021: Criteria update: Created separate Enhanced & Essential policy.

Jan 2021: Criteria update: Added Lubiprostone (authorized generic Amitiza) to the policy.

Additional historical revisions available upon request from Corporate Pharmacy