Erdafitinib for treating unresectable or metastatic urothelial cancer with FGFR3 alterations after a PD-1 or PD-L1 inhibitor

Recommendation

NICE has recommended erdafitinib for use, within its marketing authorisation, as an option for treating unresectable or metastatic urothelial cancer with susceptible FGFR3 genetic alterations in adults after at least 1 line of treatment for unresectable or metastatic cancer that included a PD‑1 or PD‑L1 inhibitor. Erdafitinib is only recommended if the company provides it according to the commercial arrangement.

Eligible population for erdafitinib

Table 1 shows the population who are eligible for erdafitinib and the number of people who are expected to have erdafitinib in each of the next 5 years, including forecast population growth.

Table 1 Population expected to be eligible for and have erdafitinib in England

The following assumptions have been used to calculate the eligible population:

The uptake for erdafitinib is based on NICE estimates combining the company and NHS England estimates.

Treatment options for the eligible population

The comparator treatments for the eligible population are paclitaxel monotherapy, paclitaxel with carboplatin and best supportive care.

Erdafitinib is administered orally while the comparator paclitaxel with or without carboplatin is administered intravenously.

For more information about the treatments, such as dose and average treatment duration, see the resource impact template.

Financial resource impact (cash items)

The company has a commercial arrangement. This makes erdafitinib available to the NHS with a discount.

Users can input the confidential price of erdafitinib and amend other variables in the resource impact template.

The payment mechanism for erdafitinib is determined by the responsible commissioner and depends on erdafitinib being classified as high cost.

We expect the resource impact of implementing the recommendations in England will be less than £5 million per year (or approximately £8,800 per 100,000 population, based on a population for England of 57.16 million people). This is because population size is small.

For further analysis or to calculate the financial impact of cash items, see the resource impact template.

Capacity impact

The NICE committee agreed with the company that people having erdafitinib would need less frequent outpatient visits, in part because erdafitinib is administered orally.

Erdafitinib is associated with potential opthalmology side effects. To ensure that any side effects are detected as soon as possible, and that subsequent regimen adjustments could be made, testing is assumed. When using erdafitinib, patients are assumed to require monthly ophthalmological examinations during the first 4 months of treatment and every 3 months afterwards.

Adverse event rates for the comparators are provided in the resource impact template. But because of erdafitinib's adverse event rates being commercial in confidence, these will need to be input locally.

Table 2 shows the estimated impact on capacity activity in each of the next 5 years.

For further analysis or to calculate the financial capacity impact from a commissioner (national) and provider (local) perspective, see the resource impact template.

Key information

About this resource impact summary report

This resource impact summary report accompanies the NICE technology appraisal guidance on erdafitinib for treating unresectable or metastatic urothelial cancer with FGFR3 alterations after a PD-1 or PD-L1 inhibitor and should be read with it. See terms and conditions on the NICE website.

ISBN: 978-1-4731-7014-8