Diagnosis: Crohn's disease.
Treatment: Entyvio 300mg (milligrams) every 4 weeks under the medical benefit (Code J3380).
The insurer denied Entyvio 300mg every 4 weeks under the medical benefit (Code J3380).
The determination is overturned.

This is a female patient with ileocolonic Crohn's Disease and primary sclerosing cholangitis. The patient has failed numerous previous anti-inflammatory, immune modulator, and biologic drugs. The patient is maintained on Entyvio 300 milligrams (mg) every (Q) 8 weeks. The patient underwent a colonoscopy which showed persistent but improved inflammatory changes in the right colon. The patient continues to endorse diarrhea, right lower quadrant (RLQ) pain and nausea.
The patient's provider has recommended increasing Entyvio to 300 mg every 4 weeks. The rationale is that the standard dose is only partially beneficial, and the patient has ongoing active inflammation with symptoms.
At issue is whether the proposed health service or treatment Entyvio 300mg every 4 weeks is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The best data comes from a systematic review of real-world literature [1]. This systematic literature review (SLR) of real-world studies was conducted to assess the effectiveness of dose escalation from Vedolizumab every 8 weeks (Q8W) during maintenance treatment to achieve a response in patients who were either Vedolizumab responders experiencing secondary loss of response or non-responders. Overall, 196/395 (49.6 percent [%]) patients with inflammatory bowel disease (IBD) had a response within 54 weeks of Vedolizumab maintenance dose escalation. Clinical response rates after escalated Vedolizumab Q8W maintenance dosing ranged from 40.0% to 73.3% (9 studies) and from 30.0% to 55.8% for remission (4 studies) over a range of 8 to less than (<) 58 weeks' follow-up.
Expert consensus is that before abandoning Vedolizumab, if the patient is having a partial response, is to dose escalate to Q 4 weeks and assess the response. This is based on the fact that trough drug levels for Vedolizumab do correlate with efficacy. This patient may need a higher trough to achieve benefit. As a practical matter, the patient does not have much in the way of remaining choices to treat her disease.