“COVID-friendly” Cancer Treatments – What Will Be the Lasting Impact of Interim Access?

January 05, 2021

UK pr brief

Interim access without a formal NICE appraisal has allowed almost 50 cancer treatments to be approved as “swaps” for existing options since August 2020. Our team of healthcare experts discuss “COVID-friendly” cancer treatments and discuss the lasting impact of interim access.

Interim availability has been achieved by demonstrating:

  • Lower immunosuppression, thereby mitigating a patient’s risk of contracting/becoming seriously ill from COVID-19
  • At-home administration feasibility, such as an oral or subcutaneous formulation to keep patients out of healthcare facilities
  • Association with fewer side effects so there is reduced need for hospital admission
  • Lower resource intensity, including less training on services or dosing

Despite neither having UK marketing authorization nor having started the NICE review process, Opdivo (nivolumab) monotherapy has been recommended for interim use in mesothelioma instead of second line chemotherapy, in order to reduce the risk of immunosuppression*. A further example is Xtandi (enzalutamide), the targeted hormone therapy that has been recommended as an alternative to Taxotere (docetaxel) for newly diagnosed metastatic prostate cancer in order to reduce toxicity and potential need for hospital admission. Interim treatment options include:

General

  • Prophylactic daily granulocyte-colony stimulating factor (G-CSF) or a biosimilar PEGylated G-CSF to prevent neutropenic fever and reduce admissions (for example, for patients on chemotherapy regimens with a greater than 10% risk of neutropenic fever)

Acute myeloid leukemia (AML)

  • Venetoclax with either low-dose cytarabine or azacitidine instead of standard induction chemotherapy for newly diagnosed acute myeloid leukemia

Bladder cancer

  • Use atezolizumab as first-line immunotherapy instead of chemotherapy

Breast cancer

  • Consider reducing the duration of adjuvant trastuzumab monotherapy from 12 months to 6 months
  • Consider giving pertuzumab plus trastuzumab for neo-adjuvant therapy, adjuvant therapy, locally recurrent or metastatic disease without chemotherapy
  • Switch to oral capecitabine from intravenous taxanes with anti-HER2 therapies
  • Substitute albumin-bound paclitaxel (Abraxane) for paclitaxel or docetaxel t

Colorectal cancer

  • Give intermittent treatment with chemotherapy regimens that contain cetuximab or panitumumab
  • Give nivolumab as immunotherapy instead of chemotherapy

Endometrial cancer

  • Give nivolumab instead of chemotherapy for microsatellite instability-high tumors

Gestational or placental site trophoblastic tumor

  • Use pembrolizumab first-line or subsequent line instead of combination chemotherapy

Lung cancer (non-small cell)

  • Stop maintenance pemetrexed in combination with pembrolizumab
  • Give pembrolizumab as a single agent as a first-line treatment for squamous or nonsquamous non-small cell lung cancer and a PDL-1 score of less than 50%
  • Allow durvalumab to be given 4-weekly in patients eligible for durvalumab following treatment with chemotherapy

Lymphoma (Hodgkin)

  • Give brentuximab earlier in treatment pathway to replace salvage chemotherapy
  • Give nivolumab earlier in treatment pathway – after brentuximab to replace salvage chemotherapy

Lymphoma (Non-Hodgkin)

  • Consider suspending rituximab maintenance to avoid patients attending hospital
  • Consider suspending obinutuzumab maintenance to avoid patients attending hospital
  • Switch intravenous rituximab to subcutaneous rituximab in follicular lymphoma patients receiving rituximab with lenalidomide
  • Give oral ibrutinib (with or without rituximab) first-line instead of intravenous chemotherapy

Mesothelioma

  • Give nivolumab monotherapy instead of second-line chemotherapy

Myeloma

  • Give oral pomalidomide with dexamethasone as second- or third-line therapy instead of intravenous treatments
  • Give first-line lenalidomide and dexamethasone for transplant eligible myeloma patients in preference to regimens that need more hospital attendances
  • Give lenalidomide as second-line treatment in patients with multiple myeloma
  • Give second-line ixazomib with lenalidomide and dexamethasone for patients who are neither refractory to previous proteasome inhibitor-based treatment nor to lenalidomide-based treatment

Neuroendocrine tumors

  • Give oral temozolomide and capecitabine instead of intravenous streptozocin and 5- fluorouracil t

Prostate cancer

  • Give enzalutamide with androgen deprivation therapy for patients with newly diagnosed metastatic disease instead of docetaxel
  • For patients who are intolerant to enzalutamide, give the option of switching treatment to abiraterone

Renal cell cancer

  • Use nivolumab instead of chemotherapy for microsatellite instability-high tumors

Upper gastrointestinal cancers

  • Use nivolumab instead of chemotherapy for microsatellite instability-high tumors

Source: https://www.nice.org.uk/guidance/ng161/resources/interim-treatment-change-options-during-the-covid19-pandemic-endorsed-by-nhs-england-pdf-8715724381

Next steps: Although the interim treatment options do not have formal NICE guidance in place, and in some cases do not have UK marketing authorisation, they will remain available until April 5th 2021.

What will happen to these interim treatments at the end of this period? Manufacturers already benefit from the clause allowing patients who start a treatment during the pandemic to be allowed to continue until it is appropriate to stop or to switch to a different treatment. However, changes in treatment approach may be longer lasting. Is it possible that UK real-world evidence collected during this period could lead to faster positive NICE appraisals in the future? Will additional clinical experience with the product help drive a positive commissioning decision and early uptake? 

Manufacturers who are not directly impacted by inclusion may still benefit from lasting changes to the UK’s delivery of systemic anticancer care. For example, increased use of easy-to-use subcutaneous/oral treatments, prioritization of shorter treatment regimens, preference for less toxic treatment options which have an increased likelihood of keeping patients out of hospital (i.e., chemotherapy alternatives), and greater openness to using therapies made available under the Early Access to Medicine Scheme (EAMS) before treatments formally receive UK marketing authorisation, etc., are potential lasting changes that could impact the delivery of care. 

*Note: Opdivo (nivolumab) in combination with Yervoy (ipilimumab) is currently in the NICE review process for untreated unresectable malignant pleural mesothelioma with the expected date of August 2021