Selpercatinib [SEL5]

For the treatment of adults and adolescents aged 12 years and older with RET fusion positive non-medullary thyroid cancer previously UNTREATED with any kinase inhibitor therapy where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with selpercatinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. This patient has a proven histological or cytological diagnosis of non-medullary thyroid cancer (there is a separate form SEL6 for selpercatinib in medullary thyroid cancer previously untreated with any kinase inhibitor therapy). Please enter below as to which type of thyroid cancer this patient has:

• papillary thyroid cancer or
• follicular thyroid cancer or
• Hurtle cell thyroid cancer or
• anaplastic thyroid cancer

3. This patient’s thyroid cancer has been documented as having a RET fusion as determined by a validated genomic test. Please enter below as to which is the RET fusion partner in this patient’s thyroid cancer:

• CCDC6 or
• NCOA4 or
• another fusion partner

4. The patient is either an adult or an adolescent aged 12 years and older. Please enter below as to which applies to this patient:

• the patient is an adult or
• the patient is an adolescent aged 12 years and older Note: if the patient is an adolescent, open growth plates should be monitored.

5. The patient’s disease is either refractory to radioactive iodine or that treatment with radioactive iodine is inappropriate.
6. The patient is previously untreated with any kinase inhibitor unless the patient has received selpercatinib via a company early access scheme and the patient meets all the treatment criteria on this form.
7. The patient has an ECOG performance status (PS) of 0 or 1 or 2.
8. Selpercatinib is being given as monotherapy.
9. Selpercatinib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment.
10. The prescribing clinician is aware of the following issues as regards the administration of selpercatinib as detailed in its Summary of Product Characteristics (SPC):

• the dosage of selpercatinib is according to body weight
• selpercatinib has reduced solubility at a higher pH and hence precautions are necessary with the co-administration of proton pump inhibitors or H2 antagonists
• selpercatinib has clinically important interactions with CYP3A inhibitors or CYP3A inducers

11. A formal medical review as to how selpercatinib is being tolerated and whether treatment with selpercatinib should continue or not will be scheduled to occur at least by the start of the third 4-weekly cycle of treatment.
12. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment.
13. Selpercatinib is to be otherwise used as set out in its Summary of Product Characteristics.

CDF funded From: 05 September 2024 - anticipated to move to NHS funding: 13 May 2025

Additional information

Form version:

CDF Managed Access: No

NICE Technology Appraisal: NA (NA)

Current Form Version

Important

This is an older version of the form. To view the most up to date form follow this link

Older Form Versions

There are previous versions of this form. These may not all be available on this site.