ENTYVIO (vedolizumab)

ENTYVIO (vedolizumab)

Office-Administration – intravenous (IV) infusion

Self-Administration – subcutaneous (SC) injection

Indications for Prior Authorization:

ENTYVIO (vedolizumab) – IV infusion

• Crohn's Disease (CD): Indicated in adults for the treatment of moderately to severely active Crohn's disease.
• Ulcerative Colitis (UC): Indicated in adults for the treatment of moderately to severely active ulcerative colitis.

ENTYVIO (vedolizumab) – SC injection

• Ulcerative Colitis (UC): Indicated in adults for the treatment of moderately to severely active ulcerative colitis.

Coverage Criteria:

For diagnosis of Crohn's Disease (CD):

• Documented diagnosis of moderately to severely active Crohn's disease; AND
• One of the following:
  • Frequent diarrhea and abdominal pain
  • At least 10% weight loss
  • Complications such as obstruction, fever, abdominal mass
  • Abnormal lab values (e.g., C-reactive protein [CRP])
  • CD Activity Index (CDAI) greater than 220; AND
• Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies:
  • 6-mercaptopurine
  • azathioprine
  • corticosteroids (e.g., prednisone, methylprednisolone, budesonide)
  • methotrexate; AND
• One of the following:
  • Trial and failure, contraindication, or intolerance to TWO of the following:
    • Cimzia (certolizumab pegol)
    • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
    • Rinvoq (upadacitinib)
    • Stelara (ustekinumab)
    • Skyrizi (risankizumab-rzaa)
  • For continuation of prior Entyvio therapy, defined as no more than a 45-day gap in therapy; AND
• Prescribed by or in consultation with a gastroenterologist

For diagnosis of Ulcerative Colitis (UC):

• Documented diagnosis of moderately to severely active ulcerative colitis; AND
• One of the following:
  • Greater than 6 stools per day
  • Frequent blood in the stools
  • Frequent urgency
  • Presence of ulcers
  • Abnormal lab values (e.g., hemoglobin, ESR, CRP)
  • Dependent on, or refractory to, corticosteroids; AND
• Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies:
  • 6-mercaptopurine
  • Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
  • azathioprine
  • corticosteroids (e.g., prednisone, methylprednisolone, budesonide); AND
• One of the following:
  • Trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*:
    • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
    • Simponi (golimumab)
    • Skyrizi (risankizumab-rzaa) 
    • Stelara (ustekinumab)
    • Rinvoq (upadacitinib)
    • Xeljanz/XR (tofacitinib/ER)
  • For continuation of prior Entyvio therapy, defined as no more than a 45-day gap in therapy; AND
• Prescribed by or in consultation with a gastroenterologist; AND
• For Subcutaneous (SC) Injection only: 
  • One of the following:
    • Will be used as a maintenance dose following two doses of Entyvio IV for induction
    • Patient is currently established on Entyvio IV

* Includes attestation that the patient has failed to respond to the TNF inhibitor mechanism of action in the past and should not be made to try a second TNF inhibitor. In this case, only a single step through a preferred agent is required.

Reauthorization Criteria:

For diagnosis of CD, UC:

• Documentation of positive clinical response to therapy as evidenced by at least one of the following:
  • Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
  • Reversal of high fecal output state

Dosing:

For diagnosis of CD (adults):

• Intravenous (IV) infusion:
  • Initial: 300 mg given as IV infusion at week 0, 2, 6, and 14.
  • Maintenance: 300 mg given as IV infusion every 8 weeks thereafter.

For diagnosis of UC (adults):

• Intravenous (IV) infusion
  • Initial: 300 mg given as IV infusion at week 0, 2, 6, and 14.
  • Maintenance: 300 mg given as IV infusion every 8 weeks thereafter.
• Subcutaneous (SC) injection
  • 108 mg/0.68 mL given every 2 weeks.
    • Entyvio may be switched from IV infusion to SC injection, for patients in clinical response or remission beyond Week 6.
    • To switch patients to Entyvio SC injection, administer the first SC dose in place of the next scheduled IV infusion and every 2 weeks thereafter.

Coverage Duration:

IV or SC:

• Initial: 14 weeks (to provide first 4 doses)
  • Full response is usually observed by 6 weeks; patients who do not respond by week 14 are unlikely to respond with continued treatment and consideration should be given to discontinuing therapy in these patients.
• Reauthorization: 1 year

Authorization is not covered for the following:

• The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee:
  • Use of Entyvio in combination with other targeted biologic or immunotherapy agents to treat the condition (e.g. TNF blockers, JAK inhibitors, interleukin inhibitors, integrin antagonists, PDE4 inhibitors, etc.).
  • Patients who have a history of progressive multifocal leukoencephalopathy (PML).

Additional Information:

• Intravenous (IV) Administration: Entyvio should be administered intravenously by a healthcare provider.
• Subcutaneous (SC) Injection: Entyvio prefilled syringe and Entyvio pen are intended for subcutaneous use. A patient may self-inject or caregiver may inject after proper training on correct subcutaneous injection technique.
• Discontinue Entyvio in patients who do not show evidence of therapeutic benefit by Week 14.

Policy Updates:

• 09/08/2020 – Criteria reviewed.
• 11/15/2022 – Added symptom requirement for coverage; added prerequisite agents for UC; added reauthorization criteria for UC, CD.
• 11/14/2023 – Addition of Entyvio SC formulation for self-administration for UC. Addition of Rinvoq as another preferred step option for CD. Addition of preferred adalimumab agents as other preferred step options for CD and UC. PA reinstated for IV formulation. (P&T 11/14/2023)
• 10/01/2024 – Addition of Skyrizi as an additional trial option for UC indication.

References:

1. Entyvio Prescribing Information. Takeda Pharmaceuticals of America, Inc. Deerfield, IL. April 2024.
2. Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG clinical guideline: management of Crohn’s disease in adults. Am J Gastroenterol. 2018;113:481-517.
3. 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(7):2496-2508.
4. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413.
5. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterol. 2020;158:1450-1461.