WHO Releases 2019 Essential Medicines List: What Was Added, Missed in Oncology?

The World Health Organization (WHO) released its biannual Essential Medicines List, adding 28 new drugs. The list includes treatments that WHO regards as global standards that should be available everywhere and aims to help governments make the best choices for their health systems.

WHO defines essential medicines as those that satisfy the priority healthcare needs of the population. The drugs are selected based on disease burden, efficacy and safety data, and comparative cost-effectiveness.

The newly added oncology treatments are:

  • Opdivo® (nivolumab) as frontline monotherapy for the treatment of unresectable and metastatic melanoma
  • Velcade® (bortezomib), Revlimid® (lenalidomide), Thalomid® (thalidomide), and melphalan for newly diagnosed multiple myeloma in both the transplant-eligible and -ineligible setting
  • Tarceva® (erlotinib) for the frontline treatment of EGFR-mutated advanced non-small cell lung cancer (NSCLC; with Gilotrif® [afatinib])
  • Zytiga® (abiraterone) for metastatic castration-resistant prostate cancer
  • Trisenox® (arsenic) oral and intravenous formulations for acute promyelocytic leukemia
  • Oncaspar® (pegasparagase) for acute lymphocytic leukemia (ALL)

The experts also considered the following but did not recommend them for inclusion:

  • Nivolumab, pembrolizumab, and atezolizumab (Tecentriq®) for the treatment of NSCLC
  • Perjeta® (pertuzumab) for human epidermal growth factor receptor 2 (HER2)-positive breast cancer
  • Kadcyla® (trastuzumab) for HER2-positive breast cancer
  • Truxima® (subcutaneous rituximab) and trastuzumab

Several cancer-related diagnostic tests were also added, including:

  • Lactate dehydrogenase activity test, which is used for the prognosis and monitoring of hematologic malignancies and germ cell tumors
  • Estrogen and progesterone receptor tests, which are used for the diagnosis, prognosis, and treatment of breast cancer
  • Tyrosine protein kinase receptor or HER2 overexpression tests, which used for the diagnosis, prognosis, and treatment of breast cancer
  • Papanicolaou test, which is used for cervical cancer screening
  • Prostate-specific antigen test, which is used for the diagnosis and monitoring of prostate cancer
  • Fecal immunochemical test, which is used for colorectal cancer screening
  • Human chorionic gonadotrophin (hCG) plus betahCG, which is used for the diagnosis and surveillance of germ cell tumors and gestational trophoblastic disease
  • Alphafetoprotein immunoassay, which is used in conjunction with ultrasound for screening for hepatocellular carcinoma in high-risk individuals with liver cirrhosis and those who have a family history; it is also used for the staging and monitoring of germ cell tumors
  • Basic panel for immunohistochemical testing, which is used for the diagnosis of lymphoma, as well as for subclassification, prognosis, and treatment
  • Basic panel of immunohistochemical markers, which are used for the diagnosis of solid tumors
  • BCR-ABL1and ABL1 transcript tests, which are used for the diagnosis and monitoring of chronic myelocytic leukemia (CML) and CML variants (neutrophilic CML) and for the prognosis of ALL
  • Essential flow cytometry panel of antibodies for leukemia, which is used in the diagnosis of acute leukemias