|
Initiation
|
|---|
| 1. Adults with all of the following: 1.1. newly diagnosed, supratentorial GBM 1.2. received maximal debulking surgery and RT concomitant with temozolomide (45 Gy to 70 Gy) 1.3. completion of RT. | Evidence from the EF-14 trial demonstrated a clinical benefit in adults with newly diagnosed, supratentorial GBM following maximal debulking surgery and completion of RT. | — |
| 2. Patients should have good performance status. | KPS is a measure of overall health status with scores ranging from 0 to 100. Higher KPS scores postoperatively are associated with better survival. Patients in the EF-14 trial were included if they had a KPS score of 70% or higher. | Treating patients with a KPS score of 60 and below could be at the discretion of the treating clinician. |
|
Discontinuation
|
|---|
| 3. Reimbursement of Optune and temozolomide should be discontinued upon any of the following: 3.1. clinical disease deterioration 3.2. unacceptable device-related serious adverse events 3.3. intolerance to treatment with Optune. | Patients from the EF-14 trial did not continue treatment upon clinical disease deterioration or after 24 months or second progression, whichever occurred first; unacceptable device-related serious adverse events; or intolerance to treatment with Optune. | — |
|
Prescribing
|
|---|
| 4. Optune with temozolomide should be initiated and supervised by a clinician certified by Novocure Canada Inc. who specializes in oncology and the use of anticancer treatment. | Optune can only be prescribed by a clinician who has completed the required certification training provided by Novocure Canada Inc. | — |
|
Pricing
|
|---|
| 5. A reduction in price of 97% | The ICER for Optune + temozolomide vs. temozolomide alone was $899,470 per QALY gained. A price reduction of between 91% and 97% is required for Optune + temozolomide to be considered cost-effective at a willingness-to-pay threshold between $50,000 and $100,000 per QALY gained. | — |
|
Feasibility of adoption
|
|---|
| 6. The feasibility of adoption of Optune and temozolomide must be addressed. | HTERP noted that, at the submitted price, the uncertainty in the budget impact must be addressed to ensure the feasibility of adoption, given the difference between the sponsor’s estimate and CADTH’s estimate. HTERP noted uncertainties with identifying the appropriate public health care payer for Optune and whether the monthly fee structure is implementable. | Implementation considerations should be addressed meaningfully, including providing more clarity as to who the appropriate payer would be for Optune, whether the subscription model and full set of included services indicated by the sponsor is implementable by the payer, ensuring sufficient support to facilitate device uptake to increase the ability to adhere to treatment, and ensuring the privacy, confidentiality, and security of patient data. |
| 7. Patients who lack caregiver support must be accommodated. | Ensuring equitable access to, and effective use of, Optune for eligible patients may require offering additional resources for people who require support with the use of Optune but lack a caregiver. | Formal, funded supportive resources should be offered for patients who require help to use Optune (e.g., with product placement and/or head shaving). Supportive resources should be reliable (to ensure continuity of treatment) and accessible (e.g., to avoid exacerbating inequities for those with limited mobility). |
