National Cancer Drugs Fund List (Including list of NICE approved and baseline funded drugs/indications from 1st April 2016 with criteria for use) ver1.165 27-May-20 National Cancer Drugs Fund (CDF) List NHS England INFORMATION READER BOX Directorate Medical Operations and Information Specialised Commissioning Nursing Trans. & Corp. Ops. Commissioning Strategy Finance Publications Gateway Reference: 05605 Document Purpose Policy Document Name National Cancer Drug Fund List Author NHS England Cancer Drugs Fund Team Publication Date 29 July 2016 Target Audience Foundation Trust CEs , Medical Directors, NHS England Regional Directors, NHS England Directors of Commissioning Operations, Directors of Finance, NHS Trust CEs, Patients; Patient Groups; Charities; Pharmaceutical Industry Additional Circulation #VALUE! List Description 0 Cross Reference National Cancer Drug Fund decision summaries Superseded Docs National Cancer Drug Fund List (as updated July 2015) (if applicable) Action Required N/A Timing / Deadlines N/A (if applicable) Contact Details for NHS England Cancer Drugs Fund Team further information Skipton House 80 London Road London SE1 6LH 0 [email protected] Document Status This is a controlled document. Whilst this document may be printed, the electronic version posted on the intranet is the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from the intranet. v1.165 2 of 160 27 May 2020 National Cancer Drugs Fund (CDF) List A. National CDF List Notes: This list should be read in conjunction with 'Appraisal and Funding of Cancer Drugs from July 2016 (including the new Cancer Drugs Fund) A new deal for patients, taxpayers and industry' published by NHS England on 8 July 2016 at www.england.nhs.uk/ourwork/cancer/cdf Interim Funding CDF Available to new patients Transition Eligible for agreed by Managed Expected Entry Transition Funding agreed Interim manufacturer Access into Baseline Drug (Old by Funding (Yes, (Agreed, Scheme Commissioning Blueteq Form Drug Indication Criteria for use Yes (but CDF) manufacturer No, Not Rejected, (Yes, No, (Date if known ref: notice of Yes No Indication (Agreed, currently Pending, Not Not or Not currently removal (Yes or No) Rejected, applicable currently currently applicable served) Pending) (NCA)) applicable applicable (NCA)) (NCA)) (NCA)) 1. This application for abemaciclib in combination with fulvestrant is made by and the first cycle of abemaciclib plus fulvestrant will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. The patient has histologically or cytologically documented oestrogen receptor positive and HER-2 negative breast cancer 3. The patient has metastatic breast cancer or locally advanced breast cancer which is not amenable to curative treatment 4. The patient is male or is female and if female is either post-menopausal or if pre- or peri- menopausal has undergone ovarian ablation or suppression with LHRH agonist treatment 5. The patient has an ECOG performance status of 0 or 1 or 2 6. The patient has received previous endocrine therapy according to one of the three populations as set out below as these are the only groups for which there was evidence submitted to NICE for the use of abemaciclib plus fulvestrant. Please record which population the patient falls into: - has progressive disease whilst still receiving adjuvant or neoadjuvant endocrine therapy for early breast cancer with no subsequent endocrine therapy received following disease progression or The treatment of hormone receptor- Abemaciclib - has progressive disease within 12 or less months of completing adjuvant endocrine therapy for positive, HER2-negative, locally advanced ABEM2_v1.1 (in combination with early breast cancer with no subsequent endocrine therapy received following disease From 02-Apr-19 No n/a Yes Agreed Yes nca or metastatic breast cancer where the fulvestrant) progression or following criteria have been met: - has progressive disease on 1st line endocrine therapy for advanced/metastatic breast cancer with no subsequent endocrine therapy received following disease progression 7. The patient has had no prior treatment with a CDK 4/6 inhibitor unless either palbociclib (in combination with fulvestrant) or ribociclib (in combination with fulvestrant) has had to be stopped within 6 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression or abemaciclib has been received as part of any early access scheme for the combination of abemaciclib plus fulvestrant and the patient meets all the other criteria set out here. 8. The patient has had no prior treatment with fulvestrant 9. The patient has had no prior treatment with everolimus 10. Abemaciclib will only be given in combination with fulvestrant 11. Treatment will continue until there is progressive disease or excessive toxicity or until the patient chooses to discontinue treatment, whichever is the sooner 12. Treatment breaks of up to 6 weeks are allowed, but solely to allow toxicities to settle 13. Abemaciclib and fulvestrant will be otherwise used as set out in its Summary of Product Characteristics (SPC) v1.165 3 of 160 27 May 2020 National Cancer Drugs Fund (CDF) List Interim Funding CDF Available to new patients Transition Eligible for agreed by Managed Expected Entry Transition Funding agreed Interim manufacturer Access into Baseline Drug (Old by Funding (Yes, (Agreed, Scheme Commissioning Blueteq Form Drug Indication Criteria for use Yes (but CDF) manufacturer No, Not Rejected, (Yes, No, (Date if known ref: notice of Yes No Indication (Agreed, currently Pending, Not Not or Not currently removal (Yes or No) Rejected, applicable currently currently applicable served) Pending) (NCA)) applicable applicable (NCA)) (NCA)) (NCA)) 1. An application has been made by and the first cycle of systemic anti -cancer therapy with atezolizumab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy. 2. The prescribing clinician is fully aware of the management of and the treatment modifications that may be required for immune-related adverse reactions due to anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies and hepatitis. 3. The patient has histologically or cytologically documented transitional cell carcinoma of the urothelial tract 4. The patient has disease that is either locally advanced (ie T4b any N or any T N2-3 disease) or metastatic (any T any N M1 disease) 5. The patient has not received previous chemotherapy for inoperable locally advanced or metastatic urothelial cancer 6. The patient has EITHER not received previous adjuvant chemotherapy, neoadjuvant chemotherapy or chemo- radiotherapy OR, if previously treated with platinum-based chemotherapy whether as adjuvant chemotherapy or as neoadjuvant chemotherapy or with chemo-radiotherapy, has relapsed more than 12 months since completing the platinum-based chemotherapy* * Patients meeting this criterion are eligible to be considered as treatment naïve for locally advanced/ metastatic disease but must satisfy all other criteria 7. The patient has an ECOG performance status (PS) of 0, 1 or 2. Note: treatment of patients of performance status 2 should only proceed with caution as there is limited safety data on PS 2 patients with urothelial cancer treated with atezolizumab. The first line treatment of locally advanced or metastatic urothelial cancer in patients 8. The patient is ineligible for platinum-based chemotherapy, due to one or more of the following: ATE1_v1.3 Atezolizumab who are ineligible for cisplatin-based * impaired renal function (EDTA-assessed glomerular filtration rate >30 and <60mls/min) From 01-Nov-17 No n/a nca nca Yes nca * hearing loss of 25dB as assessed by formal audiometry chemotherapy where all the following * NCI CTCAE grade 2 or worse peripheral neuropathy criteria are met: * ECOG PS 2 9. The patient’s urothelial tumour has undergone PD-L1 testing 10. A PD-L1 expression of ≥5% has been recorded and the measurement used for PD-L1 testing is defined as the presence of discernible PD-L1 staining of any intensity in tumour infiltrating immune cells covering ≥5% of tumour area occupied by tumour cells, associated intra-tumoural and contiguous peri-tumoural desmoplastic stroma 11. The patient has not received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti- Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody 12. The patient has no symptomatically active brain metastases or leptomeningeal metastases 13. Atezolizumab is being given as monotherapy and will commence at a fixed dose of 1200mg every 3 weeks or 1680mg every 4 weeks 14. A formal medical review as to whether treatment with atezolizumab should continue or not will be scheduled to occur at least by the end of the third cycle of treatment 15. The patient is to be treated until disease progression and loss of clinical benefit or excessive toxicity or patient choice, whichever is the sooner 16. Treatment breaks of up to 12 weeks beyond the expected cycle length are allowed but solely to allow immune toxicities to settle. Where treatment is interrupted any restart and continuation of drug must be in line with the treatment break policy outlined in Specialised Services Circular (SSC) 1918. 17. Atezolizumab