Published

May 11, 2025

Olaparib [OLAP5]

Olaparib monotherapy as adjuvant treatment of high-risk TRIPLE 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 triple negative breast cancer (hormone receptor negative and HER 2 negative).
  3. This patient has early breast cancer.
  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. Whether the patient received pembrolizumab as part of neoadjuvant chemotherapy or not. Please mark below which option applies to this patient as regards the receipt of neoadjuvant pembrolizumab as part of the neoadjuvant regimen:
  • no pembrolizumab because the patient received adjuvant chemotherapy or
  • no, the patient did not receive pembrolizumab as part of the neoadjuvant regimen or
  • yes, the patient received pembrolizumab as part of the neoadjuvant treatment regimen
  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 3 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 Or
  • the patient received adjuvant chemotherapy as above with a pre-chemotherapy pathological demonstration of axillary lymph node positive disease (at least pN1) whatever the T stage Or
  • the patient received adjuvant chemotherapy as above with a pre-chemotherapy pathological demonstration of axillary lymph node negative disease (pN0) and an invasive primary tumour diameter of >2cm (pT2 or greater)
  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 last chemotherapy.
  3. Adjuvant olaparib will be prescribed as monotherapy. Note: Olaparib and pembrolizumab are not to be prescribed together in the adjuvant phase of treatment. 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.
  4. 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 8. 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. is disease 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 14. Adjuvant olaparib to be continued until progression or unacceptable olaparib.
  2. 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.
  3. 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.
  4. Olaparib is to be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 08 August 2023

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA886 (10 May 2023)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

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.

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