Table 1, Reimbursement Conditions and Reasons - Lutetium (177Lu) Oxodotreotide (Lutathera)

Reimbursement condition	Reason	Implementation guidance
Initiation
1. Treatment with ¹⁷⁷Lu oxodotreotide should be reimbursed when initiated in patients with pNETs who meet all of the following criteria: 1.1. adult patients with unresectable or metastatic, well-differentiated, SSR-positive pNETs 1.2. disease has progressed after treatment with an SSA or patient has a contraindication or intolerance to SSAs.	Patients enrolled in the NETTER-R study had SSR-positive pNETs that were well differentiated at the time of diagnosis and had unresectable or metastatic progressive disease.	—
Discontinuation
2. Treatment with ¹⁷⁷Lu oxodotreotide should be discontinued upon occurrence of any of the following: 2.1. unacceptable toxicity 2.2. disease progression assessed by clinical examination, imaging, or biomarker assessment as appropriate.	Clinical experts indicated that treatment with ¹⁷⁷Lu oxodotreotide would be stopped if patients experienced these criteria.	Serious toxicities that could lead to treatment discontinuation include, but are not limited to, permanent renal toxicities and myelotoxicity (e.g., transformation to MDS or AML).
Prescribing
3. Prescribing of ¹⁷⁷Lu oxodotreotide should be restricted to specialized centres that have the infrastructure to handle, prepare, administer, and dispose of radiopharmaceuticals in a safe manner.	As per clinical expert opinion and the NETTER-R study. In the NETTER-R study, patients could have been treated with ¹⁷⁷Lu oxodotreotide under the Advanced Accelerator Applications Lutathera Compassionate Use Program.	The clinical experts stated that administration of ¹⁷⁷Lu oxodotreotide will require a tertiary referral centre with dedicated nuclear medicine and/or radiation oncology. Access to ⁶⁸Ga-PET scan or FDG PET scan is needed.
4. ¹⁷⁷Lu oxodotreotide should be prescribed by clinicians with expertise in the use of radiopharmaceuticals.	To ensure that ¹⁷⁷Lu oxodotreotide is prescribed only for appropriate patients and adverse effects are managed in an optimized and timely manner.	—
Pricing
5. A reduction in price	The ICER for ¹⁷⁷Lu oxodotreotide is $120,931 per QALY and $466,632 per QALY when compared with everolimus and sunitinib, respectively. A price reduction of at least 41% to 63% would be required for ¹⁷⁷Lu oxodotreotide to be able to achieve an ICER of $50,000 per QALY compared with everolimus and sunitinib, respectively.	—
Feasibility of adoption
6. Organizational feasibility must be addressed so that jurisdictions have the infrastructure in place to implement treatment with ¹⁷⁷Lu oxodotreotide.	Administration of ¹⁷⁷Lu oxodotreotide, a radiopharmaceutical, is resource-intensive due to its limited shelf life and complex preparation and administration. There are a limited number of specialized centres in Canada that have the infrastructure in place to prepare, administer, and dispose of ¹⁷⁷Lu oxodotreotide in a safe manner.	Jurisdictions will need to consider the significant impacts of additional resources, including nursing, pharmacy, and nuclear medicine staff when considering the feasibility of adoption.

Reimbursement condition

Reason

Implementation guidance

Initiation

1. Treatment with ¹⁷⁷Lu oxodotreotide should be reimbursed when initiated in patients with pNETs who meet all of the following criteria:

1.1. adult patients with unresectable or metastatic, well-differentiated, SSR-positive pNETs

1.2. disease has progressed after treatment with an SSA or patient has a contraindication or intolerance to SSAs.

Patients enrolled in the NETTER-R study had SSR-positive pNETs that were well differentiated at the time of diagnosis and had unresectable or metastatic progressive disease.

—

Discontinuation

2. Treatment with ¹⁷⁷Lu oxodotreotide should be discontinued upon occurrence of any of the following:

2.1. unacceptable toxicity

2.2. disease progression assessed by clinical examination, imaging, or biomarker assessment as appropriate.

Clinical experts indicated that treatment with ¹⁷⁷Lu oxodotreotide would be stopped if patients experienced these criteria.

Serious toxicities that could lead to treatment discontinuation include, but are not limited to, permanent renal toxicities and myelotoxicity (e.g., transformation to MDS or AML).

Prescribing

3. Prescribing of ¹⁷⁷Lu oxodotreotide should be restricted to specialized centres that have the infrastructure to handle, prepare, administer, and dispose of radiopharmaceuticals in a safe manner.

As per clinical expert opinion and the NETTER-R study. In the NETTER-R study, patients could have been treated with ¹⁷⁷Lu oxodotreotide under the Advanced Accelerator Applications Lutathera Compassionate Use Program.

The clinical experts stated that administration of ¹⁷⁷Lu oxodotreotide will require a tertiary referral centre with dedicated nuclear medicine and/or radiation oncology. Access to ⁶⁸Ga-PET scan or FDG PET scan is needed.

4. ¹⁷⁷Lu oxodotreotide should be prescribed by clinicians with expertise in the use of radiopharmaceuticals.

To ensure that ¹⁷⁷Lu oxodotreotide is prescribed only for appropriate patients and adverse effects are managed in an optimized and timely manner.

—

Pricing

5. A reduction in price

The ICER for ¹⁷⁷Lu oxodotreotide is $120,931 per QALY and $466,632 per QALY when compared with everolimus and sunitinib, respectively.

A price reduction of at least 41% to 63% would be required for ¹⁷⁷Lu oxodotreotide to be able to achieve an ICER of $50,000 per QALY compared with everolimus and sunitinib, respectively.

—

Feasibility of adoption

6. Organizational feasibility must be addressed so that jurisdictions have the infrastructure in place to implement treatment with ¹⁷⁷Lu oxodotreotide.

Administration of ¹⁷⁷Lu oxodotreotide, a radiopharmaceutical, is resource-intensive due to its limited shelf life and complex preparation and administration. There are a limited number of specialized centres in Canada that have the infrastructure in place to prepare, administer, and dispose of ¹⁷⁷Lu oxodotreotide in a safe manner.

Jurisdictions will need to consider the significant impacts of additional resources, including nursing, pharmacy, and nuclear medicine staff when considering the feasibility of adoption.

From: Lutetium (¹⁷⁷Lu) Oxodotreotide (Lutathera)

Cover of Lutetium (177Lu) Oxodotreotide (Lutathera)

Lutetium (¹⁷⁷Lu) Oxodotreotide (Lutathera): CADTH Reimbursement Recommendation: Indication: For the treatment of unresectable or metastatic, well-differentiated, somatostatin receptor (SSR)–positive pancreatic neuroendocrine tumours (pNETs) in adults whose disease has progressed after treatment with a somatostatin analogue (SSA), unless there is a contraindication or intolerance [Internet].

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

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Table 1Reimbursement Conditions and Reasons