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New anti-cancer drugs and new cancer diagnostic tests have been added to the list of essential drugs and essential diagnostic tests of the World Health Organization (WHO).
"Worldwide, more than 150 countries use WHO's list of essential medicines to guide decisions on the most cost-effective drugs, based on evidence-based evidence and impact on health" said the Director General of the WHO, Tedros Adhanom Ghebreyesus.
"The inclusion in this list of some of the latest and most advanced cancer drugs is a strong statement that everyone deserves to have access to these life-saving drugs, not just those who have them." the means, "he added.
The new Essential Medicines List (EML) includes several more expensive products, such as immunotherapies with melanoma inhibitors and targeted therapies for lung cancer, among others.
Essential drugs
WHO defines essential drugs as those that meet the priority health care needs of the population. The drugs are selected based on the burden of disease, evidence of efficacy and safety, and cost-effectiveness.
The WHO Model Essential Medicines Lists began in 1977. The list of general drugs is updated every two years, but updates to the cancer-specific list have been more sporadic. The most important examinations of anticancer drugs were performed in 1984, 1994 and 1999. The last exam was performed in 2015, with the addition of 16 new oncology treatments.
For this last review, the Committee of Experts endorsed the recommendations of the LEM Cancer Working Group recommending that WHO adopt a threshold for a survival benefit of at least 4 years. 6 months for a drug to be considered for inclusion in the list.
The committee recognized ESMO's Magnitude of Clinical Benefit Scale (ESMO – MCBS) as a screening tool to identify cancer treatments of potential therapeutic value. He recommended that candidates for the inclusion of anti-cancer drugs in the MEA generally have an ESMO-MCBS A or B score in the curative setting and 4 or 5 in the non-curative context.
The panel of experts recommended adding the following new anti-cancer drugs to the SCI:
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Nivolumab (Opdivo, Bristol-Myers Squibb) as first-line monotherapy for patients with unresectable and metastatic melanoma. (pembrolizumab[[[[Keytruda, Merck]is listed as a therapeutically equivalent alternative.) This is the first time that LEM has listed treatments for metastatic melanoma.
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Bortezomib (Velcade, Millennium), lenalidomide (Revlimid, Celgene), thalidomide (Thalomid, Celgene) and melphalan (multiple markings) are indicated in patients with newly diagnosed multiple myeloma, in eligible / available settings for transplants and transplants. These are the first multiple myeloma drugs to appear on the SCI.
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Erlotinib (Tarceva, Genentech) is indicated for first line therapy EGFR advanced non-small-cell lung cancer with mutation (with afatinib)[[[[Gilotrif, Boehringer Ingelheim Pharmaceuticals]and gefitinib[[[[Iressa, AstraZeneca Pharmaceuticals LP]listed as therapeutically equivalent alternatives).
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Abiraterone (Zytiga, Janssen) is indicated in patients with metastatic prostate cancer resistant to castration. (enzalutamide[[[[XtandiAstellas]was not listed.)
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Arsenic (Trisenox, Cephalon) (oral and intravenous preparations) is indicated for patients with acute promyelocytic leukemia. (Arsenic is also on the list of essential drugs for children's medicines) [EMLc]).
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Pegaspargase (Oncaspar, Sigma Tau) has been recommended for the treatment of patients with acute lymphoblastic leukemia.
For many of the current cancer treatments on the SCI, it has been recommended to extend the indications to cervical cancer and multiple myeloma. In addition, it was recommended that indications for 10 drugs currently on the SCI be extended to the LEMC. The indications were extended for 11 agents currently included in the LEMC.
The expert committee also reviewed several new cancer treatments, but decided not to recommend them for inclusion in the SCI. Among those rejected were the following:
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Nivolumab, pembrolizumab and atezolizumab (Tecentriq, Genentech) for the treatment of non-small cell lung cancer. The committee felt that their place in the treatment of this disease was still evolving and that more data was needed with longer follow-up to better estimate the extent of benefit.
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Pertuzumab (Perjeta, Genentech / Roche) for HER2-positive bad cancer. The evidence does not demonstrate clinically significant benefit for survival in the early stages of the disease. A single trial in the treatment of metastatic disease has demonstrated significant benefits in terms of overall survival, but similar results have not been observed in other trials. The committee recommended that further independent badysis of data from existing and ongoing trials be undertaken to inform future reflections for inclusion in the SCI.
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Trastuzumab emtansine (Kadcyla, Roche) for HER2-positive bad cancer. Although it provides a benefit in terms of survival, its use as a second-line treatment for metastatic disease is not considered a priority for the treatment of bad cancer. Alternative medicines are listed on the EML list.
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Subcutaneous formulations of rituximab (TruximaCelltrion) and trastuzumab (several brands). The Committee was concerned that the listing of these drugs, for which biosimilars are not yet available, could limit competition and, consequently, patient access.
Essential (in vitro) Diagnostics
The first list of essential diagnostics published by WHO, published last year, included tests to diagnose the most common conditions as well as a limited number of priority diseases such as HIV, malaria, tuberculosis and tuberculosis. 'hepatitis. This year's list has been expanded to include more noncommunicable and communicable diseases.
"The list of essential diagnoses has been introduced in 2018 to guide test supply and improve treatment outcomes," said Mariângela Simão, MD, WHO's Deputy Director General for Drugs and Products. in a statement. "As countries move towards universal health coverage and medicines become more available, it will be crucial to have the appropriate diagnostic tools in place to ensure appropriate treatment."
Twelve new tests added to the 2019 diagnostic list are used to detect a wide range of solid tumors, including colorectal, hepatic, cervical, prostate, bad and germ cell cancers, as well as leukemia and lymphoma.
These cancer diagnostic tests are as follows:
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Test of the activity of lactate dehydrogenase, used to help the prognosis and monitoring of hematological malignancies (lymphomas) and germ cell tumors.
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Estrogen and progesterone receptor tests, used in the diagnosis, prognosis and treatment of bad cancer.
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Tyrosine protein kinase receptor or human epidermal growth factor receptor 2 (HER2) overexpression tests, used in the diagnosis, prognosis and treatment of bad cancer.
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Papanicolaou test, used for screening for cervical cancer.
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Prostate-specific antigen test, used to facilitate the diagnosis and monitoring of prostate cancer.
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Fecal immunochemical test, used for screening for colorectal cancer.
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Human chorionic gonadotropin (hCG) plus betahCG, used for the diagnosis and monitoring of germ cell tumors and gestational trophoblastic disease.
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The immunobaday of alpha-fetoproteins, used in conjunction with an ultrasound, for the detection of hepatocellular carcinoma in high-risk individuals with cirrhosis of the liver and those with a family history. It is also used for staging and monitoring of germ cell tumors.
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Basic panel for immunohistochemical tests, used for the diagnosis of lymphoma, as well as for subclbadification, prognosis and treatment.
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Basic panel of immunohistochemical markers, used for the diagnosis of solid tumors.
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BCR-ABL1 and ABL1 transcription tests, used for the diagnosis and monitoring of chronic myeloid leukemia (CML) and its variants (neutrophilic CML) and for the prognosis of patients with acute lymphoblastic leukemia.
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An essential panel of antibodies for leukemia, flow cytometry, used to facilitate the diagnosis of acute leukemia.
Overall, the updated model list of essential in vitro diagnostics includes 46 general tests and 69 tests for the detection, diagnosis and monitoring of specific diseases. The list is divided into two sections, one for community testing (including self-testing), and one for testing in clinical laboratories.
WHO. Executive summary, full text; Second Model List of Essential In Vitro Diagnostics Established by WHO, Full text
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