Table 1, Reimbursement Conditions and Reasons - Mogamulizumab (Poteligeo)

Reimbursement condition	Reason	Implementation guidance
Initiation
1. Mogamulizumab should be reimbursed for adult patients who have all of the following: 1.1. Histologically confirmed MF or SS 1.2. Stage IB, IIA, IIB, III or IV disease 1.3. Failed at least one prior course of systemic therapy	Evidence from the MAVORIC trial demonstrated that mogamulizumab resulted in improvements in PFS, and ORR in adult patients who have histologically confirmed MF or SS of stage IB-IV disease and have failed at least one prior systemic therapy.	pERC noted that brentuximab vedotin is available in some jurisdictions and that patients with MF are required to have CD30+ immunohistochemical expression for treatment with brentuximab vedotin. As a result, pERC agreed with the clinical experts that brentuximab vedotin would be sequenced ahead of mogamulizumab in patients with CD30+ MF in jurisdictions where brentuximab vedotin is available for patients with CD30+ MF.
2. Patients should have a good performance status	The MAVORIC trial included patients with ECOG performance status of 0 to 1. Patients with an ECOG performance status of 2 were not eligible for inclusion in MAVORIC trial. The CADTH review identified no evidence to demonstrate the benefit of MF or SS with mogamulizumab in patients with ECOG performance status greater than 1. pERC agreed with the clinical experts that treatment of mogamulizumab in these patients should be left to the discretion of the treating clinician.	—
3. Treatment with mogamulizumab should not be used in patients with active or untreated CNS metastases	Patients with clinical evidence of CNS metastasis were excluded from the MAVORIC trial. The CADTH review did not identify any evidence to demonstrate the safety and potential benefits in patients with active or untreated CNS metastases.	—
Renewal
4. To be eligible for renewal of mogamulizumab, patients should be assessed by the treating physician for all of the following: 4.1. disease progression with: #4.1.1.# skin and blood assessment conducted every 4 weeks #4.1.2.# lymph nodes and visceral involvement imaging conducted every 3 to 4 months 4.2. acceptable toxicity.	In the MAVORIC trial, response in skin and blood was evaluated every 4 weeks during treatment. In the first year of treatment, response in lymph nodes and viscera was documented 4 weeks after the start of study treatment (end of cycle 1) and every 8 weeks thereafter. After the first year, response in the lymph nodes and viscera was documented every 16 weeks.	—
Prescribing
5. Mogamulizumab should only be prescribed by a clinician with experience and expertise in treating MF or SS. The treatment should be supervised and delivered in outpatient specialized oncology clinics or infusion centers with expertise in systemic therapy delivery.	To ensure that mogamulizumab is prescribed only for appropriate patients and adverse effects are managed in an optimized and timely manner.	—
Pricing
6. A reduction in price	The cost-effectiveness of mogamulizumab is unknown. Based on the sponsor’s submitted pharmacoeconomic model at least a 51% reduction in price is required to achieve an ICER of $50,000 per QALY; the true price reduction required is likely greater.	—

Reimbursement condition

Reason

Implementation guidance

Initiation

1. Mogamulizumab should be reimbursed for adult patients who have all of the following:

1.1. Histologically confirmed MF or SS

1.2. Stage IB, IIA, IIB, III or IV disease

1.3. Failed at least one prior course of systemic therapy

Evidence from the MAVORIC trial demonstrated that mogamulizumab resulted in improvements in PFS, and ORR in adult patients who have histologically confirmed MF or SS of stage IB-IV disease and have failed at least one prior systemic therapy.

pERC noted that brentuximab vedotin is available in some jurisdictions and that patients with MF are required to have CD30+ immunohistochemical expression for treatment with brentuximab vedotin. As a result, pERC agreed with the clinical experts that brentuximab vedotin would be sequenced ahead of mogamulizumab in patients with CD30+ MF in jurisdictions where brentuximab vedotin is available for patients with CD30+ MF.

2. Patients should have a good performance status

The MAVORIC trial included patients with ECOG performance status of 0 to 1. Patients with an ECOG performance status of 2 were not eligible for inclusion in MAVORIC trial. The CADTH review identified no evidence to demonstrate the benefit of MF or SS with mogamulizumab in patients with ECOG performance status greater than 1. pERC agreed with the clinical experts that treatment of mogamulizumab in these patients should be left to the discretion of the treating clinician.

—

3. Treatment with mogamulizumab should not be used in patients with active or untreated CNS metastases

Patients with clinical evidence of CNS metastasis were excluded from the MAVORIC trial. The CADTH review did not identify any evidence to demonstrate the safety and potential benefits in patients with active or untreated CNS metastases.

—

Renewal

4. To be eligible for renewal of mogamulizumab, patients should be assessed by the treating physician for all of the following:

4.1. disease progression with:

#4.1.1.# skin and blood assessment conducted every 4 weeks

#4.1.2.# lymph nodes and visceral involvement imaging conducted every 3 to 4 months

4.2. acceptable toxicity.

In the MAVORIC trial, response in skin and blood was evaluated every 4 weeks during treatment. In the first year of treatment, response in lymph nodes and viscera was documented 4 weeks after the start of study treatment (end of cycle 1) and every 8 weeks thereafter. After the first year, response in the lymph nodes and viscera was documented every 16 weeks.

—

Prescribing

5. Mogamulizumab should only be prescribed by a clinician with experience and expertise in treating MF or SS. The treatment should be supervised and delivered in outpatient specialized oncology clinics or infusion centers with expertise in systemic therapy delivery.

To ensure that mogamulizumab is prescribed only for appropriate patients and adverse effects are managed in an optimized and timely manner.

—

Pricing

6. A reduction in price

The cost-effectiveness of mogamulizumab is unknown.

Based on the sponsor’s submitted pharmacoeconomic model at least a 51% reduction in price is required to achieve an ICER of $50,000 per QALY; the true price reduction required is likely greater.

—

From: Mogamulizumab (Poteligeo)

Mogamulizumab (Poteligeo): CADTH Reimbursement Recommendation: Indication: Relapsed or refractory mycosis fungoides or Sézary syndrome after at least 1 prior systemic therapy [Internet].

Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2022 Aug.

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Table 1Reimbursement Conditions and Reasons