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The 2019 WHO essential medicine list: Narrowing the access gap to innovative cancer treatments

The essential medicine list (EML) contains treatments considered to be the most effective and safe in targeting global health concerns. On 9 July 2019, the World Health Organization (WHO) published the 21st edition of the EML, recommending the inclusion of 28 new medicines.

The new additions were selected through an evidence-based process which assesses the quality, safety, efficacy and cost-effectiveness of candidate treatments. For the 2019 update, the Expert Committee evaluated a total of 65 applications, including proposals to add new medicines, extend the indication of listed treatments and remove medicines from the list.

The criteria

In 2018, The WHO Cancer Medicines Working Group (CMWG) adopted the European Society for Medical Oncology‒Magnitude of Clinical Benefit Scale (ESMO–MCBS) as a screening tool to identify cancer treatments that demonstrate therapeutic value. The CMWG indicated that for therapies to become eligible for inclusion in the EML, they need to show an ESMO score equal to 4, 5 or A–B, provided that the clinical benefits meet or exceed the 4–6-month survival interval.

Cancer treatments recommended for listing:

International nonproprietary name (INN)

Brand name

Manufacturer

Indication

Notes

Nivolumab

Opdivo®

Bristol-Myers Squibb

Front-line monotherapy in patients with unresectable and metastatic melanoma

Merck’s Keytruda (pembrolizumab) was indicated as a therapeutically equivalent alternative

Bortezomib

Velcade®

Millennium

Treatment of patients with

newly diagnosed multiple myeloma in both non-transplant and transplant eligible/available settings

 

Lenalidomide

Revlimid®

Celgene

Thalidomide

Thalomid®

Celgene

Melphalan

Multiple brands

-

Erlotinib

Tarceva®

Genentech

Front-line treatment of EGFR mutation positive advanced non-small cell lung cancer

Boehringer Ingelheim’s Gilotrif (afatinib) and AstraZeneca’s Iressa (gefitinib) were indicated as a therapeutically equivalent alternative

Abiraterone

Zytiga®

Janssen

Treatment of patients with metastatic castration-resistant prostate cancer

 

Arsenic

Trisenox®

Cephalon

Treatment of patients with

acute promyelocytic leukaemia

 

Pegaspargase

Oncaspar®

Sigma Tau

  

A number of high-profile rejections were also reported in the latest WHO EML, including:

  • Non-small cell lung cancer treatments, due to their still-evolving place in therapy:
  • Bristol-Myers Squibb’s Opdivo® (nivolumab)
  • Merck’s Keytruda® (pembrolizumab)
  • Genentech’s Tecentriq (atezolizumab)
  • HER-2 positive breast cancer treatments:
    • Genentech’s Perjeta® (pertuzumab)
      due to lack of sufficient evidence to demonstrate a clinically meaningful overall survival benefit in early-stage disease.
    • Roche’s Kadcyla® (trastuzumab emtansine)
      the Committee stated that while it demonstrates relevant survival benefit, its use as second-line treatment of metastatic disease was considered not to be a priority in the context of treatment of breast cancer.

Narrowing the gap to effective treatment access

The inclusion of innovative medicines in the WHO EML is an important step to help patients gain access to effective treatments. The WHO EML influences other essential medicines lists at the national and regional level, and, therefore, which medicines are kept in stock and available by the government. According to the WHO, more than 150 countries use the EML to guide decisions about which medicines represent the best value for money.

To read the rest of the blog visit: https://www.validinsight.com/who-essential-medicine-list/

22nd October 2019

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