Policy Application
All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.
Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Mirikizumab-mrkz (Omvoh) IV
Mirikizumab-mrkz (Omvoh) IV may be considered medically necessary when an individual meets the following criteria:
Ulcerative Colitis (UC)
- The individual is at least 18 years of age; and
- ONE of the following:
- BOTH of the following:
- The individual has tried and had an inadequate response to infliximab or an infliximab biosimilar; and
- The individual has tried and had an inadequate response to Skyrizi (Risankizumab-rzaa), Entyvio (vedolizumab), or Stelara (ustekinumab); or
- The individual has an intolerance or hypersensitivity to infliximab or an infliximab biosimilar AND Skyrizi (Risankizumab-rzaa), Entyvio (vedolizumab), or Stelara (ustekinumab); or
- The individual has an FDA labeled contraindication to infliximab or an infliximab biosimilar, Skyrizi (Risankizumab-rzaa), Entyvio (vedolizumab), and Stelara (ustekinumab); and
- The physician has assessed baseline disease severity utilizing an objective measure/tool; and
- The individual is up to date with all age-appropriate vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; and
- Baseline liver enzymes and bilirubin levels have been obtained prior to initiating therapy; and
- The individual has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for the presence of TB during treatment; and
- The individual does not have an active infection, including clinically important localized infections; and
- The individual will not receive live vaccines during therapy; and
- There is documentation of moderate to severe active disease; and
- ONE of the following:
- The individual has tried and had an inadequate response to one (1) conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) used in the treatment of UC for at least three (3)-months; or
- The individual has severely active ulcerative colitis; or
- The individual has an intolerance or hypersensitivity to one (1) of the conventional agents used in the treatment of UC; or
- The individual has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC; or
- The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence, or NCCN compendium recommended use of 1 or 2a for the treatment of UC; and
- ONE of the following:
- The individual will NOT be using mirikizumab-mrkz (Omvoh) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using mirikizumab-mrkz (Omvoh) IV in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for mirikizumab-mrkz (Omvoh) IV does NOT limit the use with another immunomodulatory agent; and
- The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).
Other
- The individual has another FDA labeled indication for mirikizumab-mrkz (Omvoh) IV; or
- The individual has another indication supported in compendia for the requested agent and route of administration; and
- If the individual has an FDA approved diagnosis, ONE of the following:
- The individual's age is within FDA labeling for the requested indication for mirikizumab-mrkz (Omvoh) IV; or
- The prescriber has provided information in support of using mirikizumab-mrkz (Omvoh) IV for the individual's age for the requested indication; and
- The prescriber is a specialist in the area of the individual's diagnosis or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
- ONE of the following:
- The prescribing information for mirikizumab-mrkz (Omvoh) IV does NOT limit the use with another immunomodulatory agent; and
- The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).
- The individual will NOT be using mirikizumab-mrkz (Omvoh) IV in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; or
- The individual will be using mirikizumab-mrkz (Omvoh) IV in combination with another immunomodulatory agent AND BOTH of the following:
- The prescribing information for mirikizumab-mrkz (Omvoh) IV does NOT limit the use with another immunomodulatory agent; and
- The prescriber has provided information in support of combination therapy (submitted copy required, e.g., clinical trials, phase III studies, guidelines required).
Length of Approval: 300mg at week 0, week 4 and week 8 for induction.
The use of mirikizumab-mrkz (Omvoh) IV for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
