|Highmark Commercial Medical Policy - Pennsylvania|
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Primary Non-responders to adalimumab (Humira) or infliximab (Remicade) or its biosimilars, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis), or infliximab-qbtx (Ixifi).
Vedolizumab (Entyvio) may be considered medically necessary when ANY ONE of the following criteria is met:
Primary Responders to adalimumab (Humira) now relapsing
An exception to the requirement for infliximab (Remicade) or an infliximab biosimilar failure in order to receive approval for vedolizumab (Entyvio) for this group of “primary responders to adalimumab (Humira) now relapsing” may be considered if the treating physician chooses to independently obtain therapeutic drug monitoring and the tests show strong levels of adalimumab with no antibodies.
Note: Therapeutic monitoring of drug levels for infliximab (Anser IFX) and adalimumab (Anser ADA) are considered experimental/investigational and therefore non-covered.
Primary Responders to infliximab (Remicade) now relapsing
Contraindications for adalimumab (Humira) or infliximab (Remicade)
Vedolizumab (Entyvio) is considered not medically necessary for an individual with ANY of the following:
Vedolizumab (Entyvio) for any other indication is considered experimental/investigational and therefore non-covered.
Non-Preferred Intravenous Injectable Product(s)
In order for a request for the non-preferred product, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis) to be approved for Crohn's disease, Fistulizing Crohn's disease or Ulcerative colitis, the individual must have had an adequate therapeutic trial and experienced a documented drug therapy failure or intolerance to infliximab, cA2 (Remicade).
Experimental/Investigational (E/I) services are not covered regardless of place of service.
Intravenous Vedolizumab (Entyvio) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
12/2017, Criteria Revised for Vedolizumab (Entyvio)
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.