Opdivo

Drug - Opdivo® (nivolumab) [E.R.Squibb & Sons, L.L.C.]

January 2018

Therapeutic area - Oncology

Approval criteria - Melanoma

• Patient must be 18 years of age or older AND
• Nivolumab will be used as monotherapy for the treatment of BRAF V600 wild-type unresectable or metastatic melanoma OR
• Nivolumab will be used as monotherapy for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma OR
• Nivolumab will be used in combination with impilimumab for the treatment of unresectable or metastatic melanoma

Provide documentation of diagnosis from patient’s medical records at time of request.

Approval criteria - Non-small cell lung cancer

• Patient must be 18 years of age or older AND
• Patient is diagnosed with metastatic non-small cell lung cancer AND
• Disease has progressed on or after treatment with platinum-based chemotherapy AND
• If EGFR or ALK genomic tumor aberration, had disease progression on FDA-approved therapy

Provide documentation of diagnosis from patient’s medical records at time of request.

Approval criteria – Renal cell carcinoma

• Patient must be 18 years of age or older AND
• Have received prior anti-angiogenic therapy

Provide documentation of diagnosis from patient’s medical records at time of request.

Approval criteria – Classical Hodgkin lymphoma

• Patient must be 18 years of age or older AND
• Disease has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) AND
• Disease has relapsed or progressed after post-transplant brentuximab vedotin regimen

Provide documentation of diagnosis from patient’s medical records at time of request.

Approval criteria – Head and neck squamous cell carcinoma (HNSCC)

• Patient must be 18 years of age or older AND
• Patient is diagnosed with recurrent or metastatic HNSCC AND
• Disease has progressed on or after a platinum-based therapy

Provide documentation of diagnosis from patient’s medical records at time of request.

Approval criteria – Urothelial carcinoma

• Patient must be 18 years of age or older AND
• Patient is diagnosed with locally advanced or metastatic urothelial carcinoma
• Disease has progressed during or following platinum-containing chemotherapy OR
• Disease has progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Provide documentation of diagnosis from patient’s medical records at time of request.

Approval criteria – Colorectal cancer  

• Patient must be 12 years of age or older AND
• Patient is diagnosed with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer
• Disease has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan

Provide documentation of diagnosis from patient’s medical records at time of request.

Quantity limit – Melanoma

• Monotherapy: Maximum of 240 mg every 2 weeks
• Combination therapy with ipilimumab: 
  • Maximum of 1mg/kg every 3 weeks for 4 doses, then
  • 240 mg every 2 weeks until disease progression
• Must use appropriate vial size to minimize waste

Quantity limit – Non-small cell lung cancer, Renal cell carcinoma

• Maximum of 240 mg every 2 weeks until disease progression
• Must use appropriate vial size to minimize waste

Quantity limit – Classical Hodgkin lymphoma

• Maximum of 3mg/kg every 2 weeks until disease progression
• Must use appropriate vial size to minimize waste

Quantity limit – Head and neck squamous cell carcinoma

• Maximum of 3mg/kg every 2 weeks until disease progression
• Must use appropriate vial size to minimize waste

Quantity limit – Urothelial carcinoma  

• Maximum of 240 mg every 2 weeks until disease progression
• Must use appropriate vial size to minimize waste

Quantity limit – Colorectal cancer  

• Maximum of 240 mg every 2 weeks until disease progression
• Must use appropriate vial size to minimize waste

Approvals

• Initial approval will be limited to 6 months in duration
• Renewal approval will be limited to 6 months in durations - Documentation must be supplied at time of request showing patient is responsive to treatment AND absence of unacceptable toxicities, including:
  • Severe pneumonitis
  • Severe colitis
  • Severe transaminase or total bilirubin elevation
  • Severe hyperglycemia
  • Life-threatening serum creatinine elevation
  • Life-threatening rash
  • Immune-mediated encephalitis

Background information

• Opdivo’s indication for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma, as a single agent, is approved under accelerated approval based on progression-free survival.  Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
• Opdivo’s indication for the treatment of unresectable or metastatic melanoma, in combination with ipilimumab,is approved under accelerated approval based on progression-free survival.  Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
• Opdivo’s indication for classical Hodgkin lymphoma is approved under accelerated approval based on overall response rate.  Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
• Opdivo’s indication for the treatment of patients with locally advanced or metastatic urothelial carcinoma is approved based on tumor response rate and duration of response.  Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
• Opdivo’s indication for the treatment of patients with MSI-H or dMMR metastatic colorectal cancer is approved based on overall response rate and duration of response.  Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411