Subject: Entyvio 2004-A SGM P2021
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that all the
approval criteria are met and the member has no exclusions to the
prescribed therapy.
A. FDA-Approved Indications
1. Adult patients with moderately to severely active ulcerative
colitis (UC)
2. Adult patients with moderately to severely active Crohn’s disease
(CD)
B. Compendial Uses
Immune checkpoint inhibitor-related toxicity
All other indications are considered experimental/investigational and
not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior
authorization review:
A. Ulcerative colitis
1. Initial requests
i. Chart notes, medical record documentation, or claims history
supporting previous medications tried (if applicable), including
response to therapy. If therapy is not advisable,
documentation of clinical reason to avoid therapy.
ii. Chart notes or medical record documentation of
hospitalization due to acute, severe ulcerative colitis (if
applicable)
2. Continuation requests: Chart notes or medical record
documentation supporting positive clinical response to therapy or
remission.
B. Crohn’s disease
1. Initial requests
i. Chart notes, medical record documentation, or claims history
supporting previous medications tried (if applicable), including
response to therapy. If therapy is not advisable,
documentation of clinical reason to avoid therapy.
ii. Chart notes or medical record documentation supporting
diagnosis of fistulizing Crohn’s disease (if applicable)
2. Continuation requests: Chart notes or medical record
documentation supporting positive clinical response to therapy
or remission.
C. Immune checkpoint inhibitor-related toxicity
Chart notes, medical record documentation, or claims history
supporting previous medications tried, including response to therapy
or intolerance to therapy. If therapy is not advisable, documentation
of clinical reason to avoid therapy.
III. CRITERIA FOR INITIAL APPROVAL
A. Moderately to severely active ulcerative colitis (UC)
1. Authorization of 12 months may be granted for members who
have previously received a biologic or targeted synthetic drug
(e.g., Xeljanz) indicated for moderately to severely active
ulcerative colitis.
2. Authorization of 12 months may be granted for the treatment of
moderately to severely active UC for members who had an
inadequate response, intolerance or contraindication to at least
one conventional therapy option (See Appendix A).
3. Authorization of 12 months may be granted for members who
have been hospitalized for acute, severe UC (e.g., continuous
bleeding, severe toxic symptoms, including fever and anorexia).
B. Moderately to severely active Crohn’s disease (CD)
1. Authorization of 12 months may be granted for members who
have previously received a biologic indicated for the treatment of
moderately to severely active Crohn’s disease.
2. Authorization of 12 months may be granted for the treatment of
moderately to severely active CD in members who had an
inadequate response, intolerance or contraindication to at least
one conventional therapy option (See Appendix B).
3. Authorization of 12 months may be granted for the treatment of
fistulizing CD.
C. Immune checkpoint inhibitor-related toxicity
Authorization of 1 month may be granted for the treatment of
immune checkpoint inhibitor-related diarrhea or colitis when the
member has experienced an inadequate response, intolerance, or
contraindication to systemic corticosteroids.
IV. CONTINUATION OF THERAPY
A. Moderately to severely active ulcerative colitis
1. Authorization of 12 months may be granted for all
members (including new members) who are using the requested
medication for moderately to severely active ulcerative colitis
and who achieve or maintain remission.
2. Authorization of 12 months may be granted for all members
(including new members) who are using the requested
medication for moderately to severely active ulcerative colitis
and who achieve or maintain a positive clinical response as
evidenced by low disease activity or improvement in signs and
symptoms of the condition when there is improvement in any of
the following from baseline:
i. Stool frequency
ii. Rectal bleeding
iii. Urgency of defecation
iv. C-reactive protein (CRP)
v. Fecal calprotectin (FC)
vi. Endoscopic appearance of the mucosa
vii. Improvement on a disease activity scoring tool (e.g.,
Ulcerative Colitis Endoscopic Index of Severity [UCEIS],
Mayo score)
B. Moderately to severely active Crohn’s disease
1. Authorization of 12 months may be granted for all members
(including new members) who are using the requested
medication for moderately to severely active Crohn’s disease and
who achieve or maintain remission.
2. Authorization of 12 months may be granted for all members
(including new members) who are using the requested
medication for moderately to severely active Crohn’s disease and
who achieve or maintain a positive clinical response as evidenced
by low disease activity or improvement in signs and symptoms of
the condition when there is improvement in any of the following
from baseline:
i. Abdominal pain or tenderness
ii. Diarrhea
iii. Body weight
iv. Abdominal mass
v. Hematocrit
vi. Endoscopic appearance of the mucosa
viii. Improvement on a disease activity scoring tool (e.g., Crohn’s
Disease Activity Index [CDAI] score)
C. Immune checkpoint inhibitor-related toxicity
All members (including new members) requesting authorization for
continuation of therapy must meet all initial authorization criteria.
V. OTHER
For all indications: Member cannot use the requested medication
concomitantly with any other biologic drug or targeted synthetic drug.
VI. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-
approved labeling, accepted compendia, and/or evidence-based practice
guidelines.
VII. APPENDICES
Appendix A: Examples of Conventional Therapy Options for UC
1. Mild to moderate disease – induction of remission:
a. Oral mesalamine (e.g., Asacol, Asacol HD, Lialda, Pentasa),
balsalazide, olsalazine
b. Rectal mesalamine (e.g., Canasa, Rowasa)
c. Rectal hydrocortisone (e.g., Colocort, Cortifoam)
d. Alternatives: prednisone, azathioprine, mercaptopurine,
sulfasalazine
2. Mild to moderate disease – maintenance of remission:
a. Oral mesalamine, balsalazide, olsalazine, rectal mesalamine
b. Alternatives: azathioprine, mercaptopurine, sulfasalazine
3. Severe disease – induction of remission:
a. Prednisone, hydrocortisone IV, methylprednisolone IV
b. Alternatives: cyclosporine IV, tacrolimus, sulfasalazine
4. Severe disease – maintenance of remission:
a. Azathioprine, mercaptopurine
b. Alternative: sulfasalazine
Appendix B: Examples of Conventional Therapy Options for CD
1. Mild to moderate disease – induction of remission:
a. Oral budesonide
b. Alternatives: metronidazole, ciprofloxacin, rifaximin
2. Mild to moderate disease – maintenance of remission:
a. Azathioprine, mercaptopurine
b. Alternatives: oral budesonide, methotrexate intramuscular (IM) or
subcutaneous (SC), sulfasalazine
3. Moderate to severe disease – induction of remission:
a. Prednisone, methylprednisolone intravenously (IV)
b. Alternatives: methotrexate IM or SC
4. Moderate to severe disease – maintenance of remission:
a. Azathioprine, mercaptopurine
b. Alternative: methotrexate IM or SC
5. Perianal and fistulizing disease – induction of remission
a. Metronidazole ± ciprofloxacin, tacrolimus
6. Perianal and fistulizing disease – maintenance of remission
a. Azathioprine, mercaptopurine
b. Alternative: methotrexate IM or SC
Place of Service:
Outpatient
The above policy is based on the following references:
- Entyvio [package insert]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; March 2020.
- Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25.
- Lichtenstein GR, Loftus Jr EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2018;113:481-517.
- Rubin DT, Ananthakrishnan AN, et al. 2019 ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroentrol. 2019;114:384-413.
- The NCCN Drugs & Biologics Compendium® © 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed June 04, 2021.
- NCCN Clinical Practice Guidelines in Oncology® (NCCN Guidelines®). Management of Immunotherapy-Related Toxicities. Version 3.2021. Available at: www.nccn.org. Accessed June 04, 2021.
- Brahmer JR, Lacchetti C, Schneider BJ, et al. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol 2018; 36:1714.
- Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology 2020; 158:1450-1461.
- Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease. Gastroenterology 2021; 160: 2496- 2508.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
January 01, 2022
