Medical Policy

Effective Date:12/01/2012 Title:Relistor (Methylnaltrexone)
Revision Date:09/01/2018 Document:BI380:00
CPT Code(s):None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Relistor (Methylnaltrexone) injection requires prior authorization.

2)    Relistor tablets are not covered.

3)    Relistor injection is used to treat opioid-induced constipation.

4)    Relistor injection is covered under the pharmacy benefit as a specialty drug.

Medical Statement

Relistor (Methylnaltrexone) injection is considered medically necessary for patients who meet all the following criteria.  Initial approval will be for 6 months, as longer term use has not been studied.  Continued use will require documentation of effectiveness.

1)    Diagnosis of opioid-induced constipation (F11.288), F11.988) AND

2)    Diagnosis of an advanced terminal illness   AND

3)    Concomitant use of opioid therapy   AND

4)    Tried and failed at least 3 laxatives at their maximally recommended doses  AND

5)    Tried and failed at least 60 days of Movantik at recommended dose AND

6)    Patient is 18 years of age or older.


Relistor is subject to the following quantity limits:

·         Relistor vials – 15/30 days (30/30 days if greater than 114kg)

·         Relistor kits – 2 kits/30 days (4 kits/30 days if greater than 114kg)


Dosing is limited to no more than one dose per 24 hours.


1)    Relistor Product Information.  Wyeth Pharmaceuticals, Inc.  September 2010.

2)    Clinical Pharmacology.  Relistor.  Accessed online October 2012.

3)    Thomas J, Karver S, Cooney G, et al.  Methylnaltrexone for opioid-induced constipation in advanced illness.  N Eng J Med 2008; 358:  2332-2343.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.