Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual
Policy #:	2015011
Category:	Pharmacy
Initiated:	May 2015
Last Review:	November 2023

Vedolizumab (e.g., Entyvio) for Inflammatory Bowel Disease

Description:

Vedolizumab (e.g., Entyvio) is a humanized monoclonal antibody that inhibits adhesion and migration of leukocytes into the gastrointestinal tract by preventing the alpha4beta7 integrin subunit from binding to mucosal addressing cell adhesion molecule-1 (MAdCAM-1). It was developed as a treatment for individuals with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD) who have failed at least one conventional therapy, including tumor necrosis factor (TNF) antagonists. The interaction of the α4β7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn’s disease (Takeda Pharmaceutical, 2014).

Regulatory Status

On May 20, 2014, the U.S. Food and Drug Administration approved vedolizumab injection to treat adult individuals with moderate to severe ulcerative colitis and adult individuals with moderate to severe Crohn‘s disease (FDA , 2014).

On September 28, 2023, the U.S. Food and Drug Administration approved vedolizumab injection, for subcutaneous use, for the treatment of adults with moderately to severely active ulcerative colitis.

Coding

See CPT/HCPCS Code section below.

Policy/
Coverage:

Effective April 01, 2022 Prior Approval is required for Vedolizumab.

The use of vedolizumab subcutaneous injection is not covered under the medical benefit. Please check the member’s pharmacy benefit for coverage.

The use of vedolizumab intravenous injection is covered under the medical benefit.

The Step Therapy Medication Act is applicable to fully-insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.

Effective December 2023

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Vedolizumab (e.g., Entyvio) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:

ULCERATIVE COLITIS

INITIAL APPROVAL STANDARD REVIEW for up to 12 months:

1. Individual is ≥ 18 years of age; AND

2. Individual has a diagnosis of moderate to severe ulcerative colitis supported by the submitted medical records; AND

3. Individual has an active disease with documented inadequate response (trial of ≥3 months) to at least one conventional therapy option (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide, betamethasone, prednisone, prednisolone, methylprednisolone, triamcinolone, hydrocortisone, budesonide, corticotropin) (ECCO 2022); OR

4. Individual has an active disease with intolerance or contraindication to at least one conventional therapy option (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide, betamethasone, prednisone, prednisolone, methylprednisolone, triamcinolone, hydrocortisone, budesonide, corticotropin) (ECCO 2022); OR

5. Individual has previously received a biologic (e.g., adalimumab, infliximab, golimumab, ustekinumab, vedolizumab, mirikizumab) or targeted synthetic drug (e.g., tofacitinib, upadacitinib, ozanimod, etrasimod) indicated for ulcerative colitis; AND

6. Individual is not using the medication in combination with other biologic intended for treatment of ulcerative colitis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND

7. Indiviual does not have latent tuberculosis or serious active infection ; AND

8. Must be dosed in accordance with the FDA label.  

 

CONTINUED APPROVAL for up to 1 year:

1. Individual has met initial criteria for a diagnosis of ulcerative colitis; AND

2. Individual has experienced a documented positive clinical response; AND

3. Individual is not using the medication in combination with other biologic intended for treatment of ulcerative colitis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND

4. Must be dosed in accordance with the FDA label.

CROHN’S DISEASE

INITIAL APPROVAL STANDARD REVIEW for up to 12 months: 

1. Individual is ≥ 18 years of age; AND

2. Individual has a diagnosis of moderate to severe Crohn’s disease supported by the submitted medical records; AND

3. Individual has an active disease with documented inadequate response (trial of ≥3 months) to at least one conventional therapy option (e.g., betamethasone, methylprednisolone, prednisolone, prednisone, budesonide, hydrocortisone, azathioprine, mercaptopurine, sulfasalazine, mesalamine, methotrexate) (Lichtenstein, 2018); OR

4. Individual has an active disease with intolerance or contraindication to at least one conventional therapy option (e.g., betamethasone, methylprednisolone, prednisolone, prednisone, budesonide, hydrocortisone, azathioprine, mercaptopurine, sulfasalazine, mesalamine, methotrexate) (Van Rheenen, 2021); OR

5. Individual has previously received a biologic (e.g., adalimumab, infliximab, certolizumab pegol, risankizumab, ustekinumab, natalizumab, vedolizumab) or Janus Kinase Inhibitor (e.g., updatacitinib) indicated for Crohn’s disease; OR

6. Individual has fistulizing disease (Feuerstein, 2021); AND

7. Individual is not using the medication in combination with other biologic intended for treatment of Crohn’s disease, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND

8. Individual does not have latent tuberculosis or serious active infection ; AND

9. Must be dosed in accordance with the FDA label.  

 

CONTINUED APPROVAL for up to 1 year:

1. Individual has met initial criteria for a diagnosis of Crohn’s disease; AND

2. Individual has experienced a documented positive clinical response; AND

3. Individual is not using the medication in combination with other biologic intended for treatment of Crohn’s disease, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND

4. Must be dosed in accordance with the FDA label.

Dosage and Administration

Dosing per FDA Guidelines

The recommended dosage in UC and CD: 300 mg infused intravenously at week 0, 2 weeks , 6 weeks, then every 8 weeks thereafter.

Discontinue vedolizumab in individuals who do not show evidence of therapeutic benefit by Week 14.

Bring individuals up to date with all immunizations (according to current immunization guidelines) before initiating treatment with vedolizumab.

Vedolizumab is available as 300 mg in a single-dose vial.

Vedolizumab should be administered by as an intravenous by a healthcare professional.

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Vedolizumab, for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For individuals with contracts without primary coverage criteria, the use of vedolizumab for any indication or circumstance not described above is considered investigational. Investigational services are exclusions in most member benefit certificates of coverage.

Effective August 2023 - November 2023

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

INITIAL APPROVAL STANDARD REVIEW for up to 12 months for the following indications:

Ulcerative Colitis

The use of vedolizumab meets member benefit primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for adult individuals with moderately to severely active ulcerative colitis who have had an inadequate response with lost response to, or were intolerant to a tumor necrosis factor (TNF) inhibitor or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroid. Indications for vedolizumab use in ulcerative colitis include (FDA, Entyvio, 2014):

Inducing and maintaining clinical response,
Inducing and maintaining clinical remission,
Achieving corticosteroid-free remission,
Must be dosed in accordance with FDA label.

Crohn’s Disease

The use of vedolizumab meets member benefit primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of adult individuals with moderate to severe active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids (FDA, Entyvio, 2014):

Achieving clinical response
Achieving clinical remission
Achieving corticosteroid-free remission
Must be dosed in accordance with FDA label.

CONTINUATION OF THERAPY for 12 months (FDA, Entyvio, 2014):

Individual meets criteria for initial approval based on indication.
Individual has experienced a positive clinical response to vedolizumab.
Individual is not taking vedolizumab concomitantly with any other biologic DMARD (e.g., adalimumab, golimumab, ustekinumab, or certolizumab) or targeted synthetic DMARD (e.g., Tofacitinib).
Must be dosed in accordance with FDA label.

Dosage and Administration

Dosing per FDA Guidelines

The recommended dosage in UC and CD: 300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter.

Discontinue vedolizumab in individuals who do not show evidence of therapeutic benefit by Week 14.

Reconstitute vedolizumab lyophilized powder with Sterile Water for Injection and dilute in 250 mL of sterile 0.9% Sodium Chloride Injection or sterile Lactated Ringer’s Injection prior to administration. See Full Prescribing Information for complete reconstitution, dilution, and storage instructions.

Bring individuals up to date with all immunizations (according to current immunization guidelines) before initiating treatment with vedolizumab.

Vedolizumab is available as 300 mg in a single-dose vial.

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of vedolizumab does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness of improving health outcomes for any indication or circumstance not described above.

For individuals with contracts without primary coverage criteria, the use of vedolizumab for any indication or circumstance not described above is considered investigational.

Investigational services are exclusions in most member benefit certificates of coverage.

EffectiveAugust 2022 to July 2023

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

INITIAL APPROVAL STANDARD REVIEW for up to 12 months for the following indications:

Ulcerative Colitis

The use of vedolizumab meets member benefit primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for adult individuals with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) inhibitor or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroid. Indications for vedolizumab use in ulcerative colitis include (FDA, Entyvio, 2014):

inducing and maintaining clinical response,
inducing and maintaining clinical remission,
achieving corticosteroid-free remission

Crohn’s Disease

Achieving clinical response
Achieving clinical remission
Achieving corticosteroid-free remission
Must be doesed in accordance with FDA label unless otherwise specified.

CONTINUATION OF THERAPY for 12 months (FDA, Entyvio, 2014):

1. Individual meets criteria for initial approval based on indication.

2. Individual has experienced a positive clinical response to vedolizumab.

3. Individual is not taking vedolizumab concomitantly with any other biologic DMARD (e.g., adalimumab, golimumab, ustekinumab, or certolizumab) or targeted synthetic DMARD (e.g. Tofacitinib).

4. Must be dosed in accordance with FDA label unless otherwise specified.

Dosage and Administration

Must be dosed in accordance with FDA label unless otherwise specified.
Recommended dosage in UC and CD: 300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter.
Discontinue Vedolizumab in patients who do not show evidence of therapeutic benefit by Week 14.
Reconstitute Vedolizumab lyophilized powder with Sterile Water for Injection and dilute in 250 mL of sterile 0.9% Sodium Chloride Injection or sterile Lactated Ringer’s Injection prior to administration. See Full Prescribing Information for complete reconstitution, dilution and storage instructions.
Bring individuals up to date with all immunizations (according to current immunization guidelines) before initiating treatment with Vedolizumab.

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of vedolizumab for any indication or circumstance not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness of improving health outcomes.

For individuals with contracts without primary coverage criteria, the use of vedolizumabfor any indication or circumstance not described above is considered investigational.

lnvestigational services are exclusions in most member benefit certificates of coverage.

Effective April 1, 2022 to July 2022

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

INITIAL APPROVAL STANDARD REVIEW for up to 12 months for the following indications:

Ulcerative Colitis

The use of vedolizumab meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) inhibitor or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroid. Indications for vedolizumab use in ulcerative colitis include (FDA, Entyvio, 2014):

inducing and maintaining clinical response,
inducing and maintaining clinical remission,
achieving corticosteroid-free remission

Crohn’s Disease

The use of vedolizumab for the treatment of adult patients with moderate to severe active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids (FDA, Entyvio, 2014):

achieving clinical response
achieving clinical remission
achieving corticosteroid-free remission

CONTINUATION OF THERAPY for 12 monhts (FDA, Entyvio, 2014):

1. Member meets criteria for initial approval based on indication.

2.Member has experienced a positive clinical resposne to bedolizumab.

3. Member is not taking vedolizumab concomitantly with any other biologic DMARD (e.g., adalimumab, golimumab, ustekinumab, or certolizumab) or targeted synthetic DMARD (e.g. Tofacitinib).

4. Dosed in accordance with FDA labeling.

Dosage and Administration

Recommended dosage in UC and CD: 300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter.
Discontinue Vedolizumab in patients who do not show evidence of therapeutic benefit by Week 14.
Reconstitute Vedolizumab lyophilized powder with Sterile Water for Injection and dilute in 250 mL of sterile 0.9% Sodium Chloride Injection or sterile Lactated Ringer’s Injection prior to administration. See Full Prescribing Information for complete reconstitution, dilution and storage instructions.
Bring patients up to date with all immunizations (according to current immunization guidelines) before initiating treatment with Vedolizumab.

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of vedolizumab does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness of improving health outcomes in any circumstance other than those listed as meeting primary coverage criteria above.

For members with contracts without primary coverage criteria, the use of vedolizumab is considered investigational in any circumstance other than those listed above as covered.

lnvestigational services are exclusions in most member benefit certificates of coverage.

Effective August 2019 to March 31, 2022

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Ulcerative Colitis

inducing and maintaining clinical response,
inducing and maintaining clinical remission,
achieving corticosteroid-free remission

Crohn’s Disease

achieving clinical response
achieving clinical remission
achieving corticosteroid-free remission

Dosage and Administration

Recommended dosage in UC and CD: 300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter.
Discontinue Vedolizumab in patients who do not show evidence of therapeutic benefit by Week 14.
Reconstitute Vedolizumab lyophilized powder with Sterile Water for Injection and dilute in 250 mL of sterile 0.9% Sodium Chloride Injection or sterile Lactated Ringer’s Injection prior to administration. See Full Prescribing Information for complete reconstitution, dilution and storage instructions.
Bring patients up to date with all immunizations (according to current immunization guidelines) before initiating treatment with Vedolizumab.

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

For members with contracts without primary coverage criteria, the use of vedolizumab is considered investigational in any circumstance other than those listed above as covered.

lnvestigational services are exclusions in most member benefit certificates of coverage.

Effective September 2015 to July 2019

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Ulcerative Colitis

inducing and maintaining clinical response,
inducing and maintaining clinical remission,
achieving corticosteroid-free remission

Crohn’s Disease

The use of vedolizumab for the treatment of adult patients with moderate to severe Crohn’s disease who have failed to respond (no response or inadequate response) to treatment with TNF inhibitor medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

For members with contracts without primary coverage criteria, the use of vedolizumab is considered investigational in any circumstance other than those listed above as covered. lnvestigational services are exclusions in most member benefit certificates of coverage.

Effective Prior to September 2015

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

The use of vedolizumab meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroid. Indications for vedolizumab use in ulcerative colitis include:

inducing and maintaining clinical response,
inducing and maintaining clinical remission,
achieving corticosteroid-free remission

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of vedolizumab does not meet member benefit certificate primary coverage criteria in that there be scientific evidence of effectiveness of improving health outcomes in adult patients with Crohn’s Disease.

For members with contracts without primary coverage criteria, the use of vedolizumab is considered investigational for Crohn’s Disease. Investigational services are exclusions in the member benefit contract.

Rationale:

This policy was enacted with searches of the MEDLINE database with literature reviewed through April 2015. Following is a summary of the key literature.

The safety and effectiveness of Vedolizumab (VDZ) for ulcerative colitis (UC) was established in two induction and maintenance clinical trials (GEMINI I) conducted by Feagan et al (2013) involving 895 patients who had not responded adequately to corticosteroids, immunomodulators, or tumor necrosis factor blocker medications. The 2 trials were integrated randomized, double-blind, placebo-controlled trials of VDZ in patients with active UC.

In the trial of induction therapy, 374 patients (cohort 1) received VDZ (at a dose of 300 mg) or placebo intravenously at weeks 0 and 2, and 521 patients (cohort 2) received open-label VDZ at weeks 0 and 2, with disease evaluation at week 6. In the trial of maintenance therapy, patients in either cohort who had a response to VDZ at week 6 were randomly assigned to continue receiving VDZ every 8 or 4 weeks or to switch to placebo for up to 52 weeks. A response was defined as a reduction in the Mayo Clinic score of at least 3 points and a decrease of at least 30 % from baseline, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo clinic score is an evaluation and measurement of stool frequency, rectal bleeding, endoscopic findings and a physician‘s overall assessment. Score ranges from 0 to 12, with higher scores indicating more active disease. Response rates at week 6 were 47.1 % and 25.5 % among patients in the VDZ group and placebo group, respectively (difference with adjustment for stratification factors, 21.7 percentage points; 95 % confidence interval [CI]: 11.6 to 31.7; p < 0.001). At week 52, 41.8 % of patients who continued to receive VDZ every 8 weeks and 44.8 % of patients who continued to receive VDZ every 4 weeks were in clinical remission (Mayo Clinic score less than or equal to 2 and no subscore greater than 1), as compared with 15.9 % of patients who switched to placebo (adjusted difference, 26.1 percentage points for VDZ every 8 weeks versus placebo [95 % CI: 14.9 to 37.2; p < 0.001] and 29.1 percentage points for VDZ every 4 weeks versus placebo [95 % CI: 17.9 to 40.4; p < 0.001]). The frequency of adverse events was similar in the VDZ and placebo groups (Feagan et al, 2013).

Findings from GEMINI I showed that VDZ met primary endpoints for improvements in clinical response at six weeks and clinical remission at 52 weeks. A statistically significant number of UC patients achieved corticosteroid-free clinical remission and showed mucosal healing (Mayo endoscopic subscore of 0 or 1) compared with placebo. Therefore, the authors concluded that VDZ was more effective than placebo as induction and maintenance therapy for UC (Feagan et al, 2013 and FDA, 2014).

The safety and effectiveness of Vedolizumab (VDZ) for Crohn‘s (CD) disease was established in three induction and maintenance clinical trials (GEMINI II) conducted by Sandborn et al (2013) involving 1,576 patients who had not responded adequately to corticosteroids, immunomodulators, or tumor necrosis factor blocker medications. The study was integrated with separate induction and maintenance trials that assessed intravenous VDZ therapy (300 mg) in adults with active Crohn’s disease.

In the induction trial, 368 patients were randomly assigned to receive VDZ or placebo at weeks 0 and 2 (cohort 1), and 747 patients received open-label VDZ at weeks 0 and 2 (cohort 2); disease status was assessed at week 6. In the maintenance trial, 461 patients who had had a response to VDZ were randomly assigned to receive placebo or VDZ every 8 or 4 weeks until week 52. At week 6, a total of 14.5 % of the patients in cohort 1 who received VDZ and 6.8 % who received placebo were in clinical remission (i.e., had a score on the Crohn’s Disease Activity Index (CDAI) of less than or equal to 150) (p = 0.02); a total of 31.4 % and 25.7 % of the patients, respectively, had a CDAI-100 response (greater than or equal to 100-point decrease in the CDAI score) (p = 0.23). CDAI scores range from 0 to 600, with higher scores indicating greater disease activity. Among VDZ patients in cohorts 1 and 2 who had a response to induction therapy, 39.0 % and 36.4 % of those assigned to VDZ every 8 weeks and every 4 weeks, respectively, were in clinical remission at week 52, as compared with 21.6 % assigned to placebo (p < 0.001 and p = 0.004 for the 2 VDZ groups, respectively, versus placebo). Antibodies against VDZ developed in 4.0 % of the patients. Naso-pharyngitis occurred more frequently, and headache and abdominal pain less frequently, in patients receiving VDZ than in patients receiving placebo. VDZ, as compared with placebo, was associated with a higher rate of serious adverse events (24.4 % versus 15.3 %), infections (44.1 % versus 40.2 %), and serious infections (5.5 % versus 3.0 %).

The authors concluded that VDZ-treated patients with active Crohn’s disease were more likely than patients receiving placebo to have a remission, but not a CDAI-100 response, at week 6; patients with a response to induction therapy who continued to receive VDZ (rather than switching to placebo) were more likely to be in remission at week 52. Adverse events were more common with VDZ (Sandborn, 2013).

In a Mayo Clinic article (2013), gastroenterologist Dr. Edward V. Loftus, interpreted the Gemini I and II results to indicate that VDZ is better for treating UC than Crohn’s. Loftus stated that VDZ met its primary endpoint for Crohn's disease but not all of its secondary endpoints and that, “the induction data are not as robust as the maintenance data. So it's possible these drugs--the lymphocyte trafficking blockers-- have a slower onset of action in Crohn's. The efficacy-to-safety ratio may also not be as good for Crohn's as for UC."

In 2015, Garnock-Jones published the results of a study on the pharmacological properties of intravenous infusions of VDZ and its clinical efficacy in adult patients with UC and Crohn’s. In phase III clinical trials, patients with UC had significantly higher rates of clinical response and clinical remission when treated with VDZ than when receiving placebo at both 6 and 52 weeks. However, outcomes with VDZ in patients with Crohn's disease were mixed. In a study that evaluated both clinical remission rate and CDAI-100 response rate as primary endpoints, only the clinical remission rate at 6 weeks was significantly higher with vedolizumab than placebo. In another trial, there was no significant between-group difference in the clinical remission rate in TNF-antagonist failure patients at 6 weeks (primary endpoint), although there was a significant difference at 10 weeks. In the Crohn's disease study that included maintenance treatment, VDZ was significantly more effective at 52 weeks than placebo in both endpoints (clinical remission was the only primary endpoint in the maintenance study). VDZ was generally well tolerated in these trials. Also, vedolizumab is a specific α4β7 integrin antagonist, with gut-specific effects, and is unlikely to be associated with the development of progressive multifocal leukoencephalopathy, a risk observed with the less selective α4β7/α4β1 integrin antagonist natalizumab. Overall, current research supports vedolizumab as a useful treatment option for patients with moderately to severely active ulcerative colitis. The evidence for use of vedolizumab as a cost effective treatment option for Crohn’s disease is insufficient.

In 2023, Pannacione et al have published a Bayesian Network Meta-Analysis evaluation efficacy and safety of advanced therapies for moderately to severely active ulcerative colitis. Vedolizumab maintenance 300 mg every 8 weeks had a slightly better clinical response rate (absolute rate 55%, range 30-79%) than vedolizumab 300 mg every 4 weeks (absolute rate 52%, range 24-79%) with identical rate of clinical remission (45% absolute rate for both). Vedolizumab 300 mg every 4 weeks was also more frequently discontinued due to adverse events.

Updated Prescribing Insert states that vedolizumab every four-week dosing regimen did not demonstrate additional clinical benefit over every eight-week dosing regimen. Manufacturer states that every four-week dosing regimen is not recommended.

Mechanistically, the α4β7 binding saturation studies that evaluated serum inhibition of MAdCAM-1-Fc binding to α4β7 revealed that maximum (100%) α4β7 binding saturation was achieved within an hour after the first dose, at all doses over a range of 2-10 mg/kg. This level of inhibition was sustained for a substantial period of time: 84, 126 and 112 days for 2 mg/kg, 6 mg/kg, and 10 mg/kg dose cohorts, respectively. The serum concentration associated with dropping below 100% ranged 2-6 micrograms/mL. Based on this, every 8-week dosing schedule (every 56 days) is expected to result in sustained maximum binding of vedolizumab to α4β7.

2016 Update

A literature search conducted through August 2016 did not reveal any new information that would prompt a change in the coverage statement.

2017 Update

A literature search conducted through August 2017 did not reveal any new information that would prompt a change in the coverage statement.

2018 Update

A literature search conducted through August 2018 did not reveal any new information that would prompt a change in the coverage statement.

2019 Update

A literature search conducted through July 2019 did not reveal any new information that would prompt a change in the coverage statement.

2020 Update

Annual policy review completed with a literature search using the MEDLINE database through August 2020. No new literature was identified that would prompt a change in the coverage statement.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through August 2021. No new literature was identified that would prompt a change in the coverage statement.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through August 2022. No new literature was identified that would prompt a change in the coverage statement.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through August 2023. No new literature was identified that would prompt a change in the coverage statement.

March 2024 Update

Rationale has been updated based on the Pannacione (2023) meta-analysis and updated package insert.

CPT/HCPCS:

References:

Bressler B, Marshall JK, Bernstein CN , Bitton A, Jones J, Leontiadis GI, Panaccione R, Steinhart AH, Tse F, Feagan B , Toronto Ulcerative Colitis Consensus Group.(2015) Clinical Practice Guidelines for the Medical Management of Nonhospitalized Ulcerative Colitis: The Toronto Consensus Gastroenterology. 2015 May;148(5):1035-1058.

Feagan BG, et al(2013) GEMINI 1 Study Group Vedolizumab as induction and maintenance therapy for ulcerative colitis. New England Journal of Medicine. 2013;369:699.

Garnock-Jones KP.(2015) Vedolizumab: a review of its use in adult patients with moderately to severely active ulcerative colitis or Crohn's disease. BioDrugs. 2015 Feb;29(1):57-67. PMID: 25502899

Hazlewood GS, Rezaie A, Borman M., et al.(2015) Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn's disease: a network meta-analysis. Gastroenterology. 2015 Feb;148(2):344-54.

Loftus, EV.(2015) Vedolizumab better for UC than Crohn’s disease in trials. Mayo Clinic Website at http://www.mayoclinic.org/medical-professionals/clinical-updates/digestive-diseases/vedolizumab-better-for-uc-than-crohns-disease-in-trials.

Mosli MH, MacDonald JK, Bickston SJ, et al.(2015) Vedolizumab for Induction and Maintenance of Remission in Ulcerative Colitis: A Cochrane Systematic Review and Meta-analysis. . Inflamm Bowel Dis. 2015 Apr 3. [Epub ahead of print].

Sandborn WJ, et al.(2013) GEMINI 2 Study Group: Vedolizumab as induction and maintenance therapy for Crohn's disease. New England Journal of Medicine. 2013;369:711.

Takeda Pharmaceuticals America Inc.(2014) Entyvio (vedolizumab) for injection, for intravenous use. Prescribing Information. Deerfield, IL: Takeda Pharmaceuticals America; 2014.

U.S. Food and Drug Administration (FDA).(2014) FDA approves Entyvio to treat ulcerative colitis and Crohn's disease. FDA News. Silver Spring, MD: FDA; May 20. 2014.

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association.