Olaparib in combination with hormone therapy [OLAP6]

As adjuvant treatment of high-risk HORMONE RECEPOR POSITIVE HER 2 NEGATIVE early breast cancer treated with neoadjuvant or adjuvant chemotherapy and definitive local therapy in patients with a deleterious or suspected deleterious germline BRCA mutation where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with olaparib 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 diagnosis of hormone receptor positive and HER 2 negative breast cancer.
  3. This patient has early breast cancer. Note: olaparib for the treatment of recurrent or metastatic breast cancer is not funded.
  4. This patient HAS a documented germline deleterious or suspected deleterious BRCA 1 or BRCA 2 mutation(s). Please enter below as to which deleterious or suspected deleterious BRCA mutation(s) the patient has:
  • BRCA 1 mutation or
  • BRCA 2 mutation or
  • both BRCA1 and BRCA 2 mutations
  1. The patient has recently completed either neoadjuvant chemotherapy or adjuvant chemotherapy. Please enter below as to whether the patient was treated with a neoadjuvant cytotoxic chemotherapy-containing regimen or an adjuvant cytotoxic chemotherapy-containing chemotherapy regimen:
  • the patient was treated with a neoadjuvant cytotoxic chemotherapy-containing regimen or
  • the patient was treated with an adjuvant cytotoxic chemotherapy-containing regimen Note: adjuvant olaparib without the use of prior neoadjuvant or adjuvant cytotoxic chemotherapy is not funded.
  1. The patient was treated with at least 6 cycles of an anthracycline-containing regimen or at least 6 cycles of a taxane-containing regimen or at least a total of 6 cycles of anthracycline-containing and taxane-containing regimens. Please mark below which option applies to this patient:
  • the patient received at least 6 cycles of an anthracycline-containing regimen or
  • the patient received at least 6 cycles of a taxane-containing regimen or
  • the patient received at least a total of 6 cycles of anthracycline-containing and taxane-containing regimens
  1. Which definition of high-risk early breast cancer applies to this patient noting that this depends on whether the patient had neoadjuvant or adjuvant chemotherapy. Please mark below which of these 2 options applies to this patient:
  • the patient received neoadjuvant chemotherapy as above and the post-surgical pathology revealed residual invasive breast carcinoma in the breast and/or resected lymph nodes and the CPS&EG score was at least 3 (see below for calculation of the CPS&EG score) Or
  • the patient received adjuvant chemotherapy as above with a pre-chemotherapy pathological demonstration of at least 4 involved axillary lymph nodes whatever the T stage The CPS&EG scoring system is made up as follows to a maximum score of 6:
  • clinical stage: 0 for stage 0-IIA, 1 for stages IIB and IIIA, 2 for stages IIIB and IIIC (AJCC staging)
  • pathological stage: 0 for stages 0 and I, 1 for stages IIA-IIIB, 2 for stage IIIC (AJCC staging)
  • receptor status: 0 for ER positive, 1 for ER negative
  • nuclear grade (Bloom and Richardson expected but if not available use regular histological grade): 0 for nuclear grade 1-2, 1 for nuclear grade 3
  1. The patient has completed definitive local treatment for the breast cancer (this includes any radiotherapy).
  2. The patient is ideally 8 weeks or less but no more than 12 weeks from the date of the last treatment (surgery, chemotherapy, radiotherapy). Note: patients must be a minimum of 2 weeks after completion of radiotherapy and a minimum of 3 weeks since the chemotherapy. last olaparib will or 10. Adjuvant be prescribed in combination with adjuvant hormone therapy (an aromatase inhibitor an anti-oestrogen or a LHRH agonist). Note: adjuvant olaparib in combination with adjuvant abemaciclib are NOT to be prescribed together. If a patient is eligible for both of these adjuvant indications, the patient and the clinician can choose one of the options but not both.
  3. The patient has not previously received any PARP inhibitor unless the patient has received olaparib as part of a company early access scheme for this adjuvant indication and the patient meets all the other criteria set out in this form, in particular the definition of high-risk disease in criterion 7. NHS England will not fund the use of adjuvant olaparib in patients who have accessed olaparib via a company early access scheme unless ALL the treatment criteria on this form are fulfilled. Please mark below which scenario applies to this patient:
  • the patient has never previously received a PARP inhibitor or
  • the patient has received olaparib as part of a company early access scheme for this adjuvant indication and all the other criteria set out in this form are fulfilled
  1. The patient has an ECOG performance status of either 0 or 1. Note: a patient with a performance status of 2 or more is not eligible for Olaparib.
  2. Adjuvant olaparib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment or for a total treatment duration of 1 calendar year as measured from the date of commencing adjuvant olaparib.
  3. A formal medical review as to whether adjuvant olaparib should continue or not will be scheduled to occur at least by the start of the third 4-weekly cycle of treatment.
  4. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
  5. Olaparib is to be otherwise used as set out in its Summary of Product Characteristics.

[NHS funded]{.badge .rounded-pill .bg-success} From: 08 August 2023

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CDF Managed Access: NA

NICE Technology Appraisal: TA886 (10 May 2023)

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