Published

February 19, 2025

Selpercatinib [SEL3]

Selpercatinib as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) exhibiting a RET gene fusion and who have previously received immunotherapy and/or platinum-based chemotherapy where the following criteria have been met:

  1. This application for selpercatinib 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. The patient has locally advanced or metastatic non-small cell lung cancer.
  3. The patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer. Please mark which type of NSCLC applies to this patient:
  • non-squamous NSCLC or
  • squamous NSCLC
  1. This patient’s NSCLC has been shown to harbour a RET gene fusion as determined on a tumour tissue biopsy or a plasma specimen (liquid biopsy) or both. Please mark which type of specimen was positive for the presence of the RET gene fusion:
  • tumour tissue biopsy or
  • plasma specimen (liquid biopsy) or
  • both tumour tissue and plasma specimen
  1. This patient’s RET fusion partner has been determined to be in one of the categories as set out below:
  • KIF5B
  • CCDC6
  • NCOA4
  • RELCH
  • another fusion partner
  • unknown fusion partner
  1. This patient has previously received immunotherapy and/or platinum-based chemotherapy for this locally advanced or metastatic NSCLC indication. Please mark below which of these 5 scenarios applies to this patient:
  • the only treatment that the patient has received is platinum-based cytotoxic chemotherapy for locally advanced or metastatic NSCLC with or without 2nd line cytotoxic chemotherapy or
  • the only treatment that the patient has received is 1st line immunotherapy monotherapy for locally advanced or metastatic NSCLC or
  • the patient has received 1st line combination treatment of platinum-based chemotherapy with immunotherapy for locally advanced or metastatic NSCLC with or without 2nd line cytotoxic chemotherapy or
  • the patient has received 1st line immunotherapy monotherapy for locally advanced or metastatic NSCLC followed by 2nd line cytotoxic chemotherapy with or without further cytotoxic chemotherapy or
  • the patient has received 1st line platinum-based cytotoxic chemotherapy for locally advanced or metastatic NSCLC followed by 2nd line immunotherapy with or without further cytotoxic chemotherapy
  1. The patient has not previously received selpercatinib or any other TKI which targets the RET receptor unless the patient has received selpercatinib via a company early access scheme and the patient meets all the other criteria listed here.
  2. The patient has an ECOG performance status (PS) score of 0 or 1 or 2. Please mark below the performance status of the patient:
  • ECOG PS 0
  • ECOG PS 1
  • ECOG PS 2
  1. The patient either has no known brain/CNS metastases or if the patient does have brain/CNS metastases then the patient is symptomatically stable before starting selpercatinib. Please mark below the status with respect to known brain/CNS metastases:
  • the patient has never had known brain/CNS metastases
  • the patient has had brain/CNS metastases treated before with surgery/radiotherapy and is currently symptomatically stable
  • the patient has brain secondaries which have not been treated with surgery/radiotherapy and is currently symptomatically stable
  1. Selpercatinib will be used as monotherapy.
  2. 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
  1. The patient will be treated until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment whichever is the sooner.
  2. 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.
  3. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, including as appropriate if the patient has had an extended break on account of Covid-19.
  4. Selpercatinib is to be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 25 November 2021 - anticipated to move to NHS funding: 20 May 2025

Form version:

CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.348 of the CDF list, downloaded from an archive of NHS England’s website on 19 February 2025 at 18:00.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.