Criteria for Prior Authorization — Anti-Constipation Agents
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Defines prior authorization requirements for linaclotide, plecanatide, prucalopride, and tenapanor for Kansas Department of Health and Environment beneficiaries, including clinical prerequisites and dosing/age limits.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial prior authorization criteria
Covered when ALL of the following are met:
Length of approval (initial and renewal) is 12 months. Requests for uses/doses not listed in Table 1 will be reviewed using package insert information.
Uses or dosing outside those listed in Table 1 will not be automatically approved. Such requests will be reviewed on a case-by-case basis using the drug’s package insert for the submitted indication, age, dose, and any prerequisite treatment requirements; prior authorization approval requires that the request meet those package-insert–based criteria.
Use of these agents in the presence of a known or suspected mechanical gastrointestinal obstruction is contraindicated and does not meet medical necessity for prior authorization.
Drug Codes and Coding Rules
| Linaclotide (Linzess®) | All dosage forms require prior authorization |
| Plecanatide (Trulance®) | All dosage forms require prior authorization |
| Prucalopride (Motegrity®) | All dosage forms require prior authorization |
| Tenapanor (Ibsrela®) | All dosage forms require prior authorization |
Provider Actions and Requirements
Prior authorization required for listed agents
Prior authorization is required for all listed anti-constipation agents. Initial approvals require that the request meet the general criteria: indication/age/dose limits per Table 1, preferred PDL tried when applicable (or non-preferred criteria met), prerequisite laxative trial or documented intolerance/contraindication, and absence of mechanical GI obstruction.
- Linaclotide (Linzess®)
- Plecanatide (Trulance®)
- Prucalopride (Motegrity®)
- Tenapanor (Ibsrela®)
Step therapy: trial of standard laxatives required
Patient must have failed, or be intolerant/contraindicated to, a 14-day trial of soluble fiber, lactulose, or polyethylene glycol (PEG-3350) at a maximum tolerated dose before approval of the listed agents.
- 14-day trial of soluble fiber, lactulose, or PEG-3350 at maximum tolerated dose
- Documented intolerance or contraindication to both lactulose and PEG-3350 satisfies the step requirement
Required clinical documentation
Document a trial and inadequate response to at least 14 days of soluble fiber, lactulose, or PEG-3350 (or documented intolerance/contraindication to both lactulose and PEG-3350); include diagnosis/indication, patient age, and that the requested dose does not exceed Table 1 limits. Length of approval and renewal should reflect a 12-month approval period.
- Record dates and doses of laxative trial (≥14 days) and maximum tolerated dose
- Document intolerance/contraindication when applicable
- Include diagnosis, indication, patient age, and requested dose relative to Table 1
Denial risk: insufficient prior laxative trial
Prior authorization may be denied if the patient has not had an inadequate response after a 14-day trial of soluble fiber, lactulose, or PEG-3350 at a maximum tolerated dose and lacks documented intolerance or contraindication to both lactulose and PEG-3350.
- Failure to document a ≥14-day inadequate response to the specified laxatives may result in denial
Denial risk: mechanical gastrointestinal obstruction
Prior authorization may be denied if the patient has a known or suspected mechanical gastrointestinal obstruction; use in the presence of mechanical GI obstruction is contraindicated and would not meet medical necessity for PA.
- Confirm absence of known or suspected mechanical gastrointestinal obstruction before approval
Background
These agents — including Guanylate Cyclase‑C (GC‑C) agonists such as linaclotide and plecanatide, the 5‑HT4 receptor agonist prucalopride, and the NHE3 inhibitor tenapanor — are used to treat chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS‑C). Prior authorization is required for all listed anti‑constipation agents to ensure appropriate use after standard laxative measures and to confirm indication, age, and dosing limits are consistent with Table 1.
Drug Class Definitions
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