[Ip-health] WHO expands the list of essential medicines and proposes a new working group to address ways to make highly priced essential medicines more affordable and accessible

James Love james.love at keionline.org
Fri Oct 1 06:34:33 PDT 2021


For KEI’s earlier calls for reforms of the WHO EML list, see:

   - 2021, June 21. KEI statement: 23rd meeting of the WHO Expert Committee
   on the Selection and Use of Essential Medicines (link
   <https://www.keionline.org/36362>)
   - 2019, April 1. KEI statement: 22nd meeting of the WHO Expert Committee
   on the Selection and Use of Essential Medicines (Link
   <https://www.keionline.org/30248>)
   - 2017, March 27. KEI statement: 21st meeting of the WHO Expert
   Committee on the Selection and Use of Essential Medicines (Link
   <https://www.keionline.org/23316>)
   - 2017, October 13. KEI Comments on the Draft Concept Note Concerning
   the WHO General Programme of Work. (Link
   <https://www.keionline.org/23450>)
   - 2015, April 17. KEI statement to WHO 20th Expert Committee on the
   Selection and Use of Essential Medicines. (Link
   <https://www.keionline.org/22732>)
   - 2011, August 4. Paul Miano. Cancer: Approval, ownership, market
   structure, and placement on WHO Model Essential Medicines List, for 100 new
   molecular entities (NMEs) on the NCI alpha list of cancer drugs and
   vaccines, KEI Research Note 2011:1. (Link
   <https://www.keionline.org/wp-content/uploads/kei_rn2011-1_cancer_alpha_NMEs_4August2011.pdf>
   )
   - 2007, March 2. : Request for changes in the WHO Model EML. (Link
   <https://www.keionline.org/misc-docs/eml2March2007.pdf>)


On Thu, Sep 30, 2021 at 9:22 PM Claire Cassedy <claire.cassedy at keionline.org>
wrote:

> https://www.keionline.org/36588
>
> WHO expands the list of essential medicines and proposes a new working
> group to address ways to make highly priced essential medicines more
> affordable and accessible
>
> Posted on September 30, 2021 by Staff
>
> On October 1, 2021, the WHO published the new edition of its Model Lists
> of Essential Medicines and Essential Medicines for Children.
>
> WHO Documents:
>
> -Press Release [1]
> -Executive Summary [2]
> -World Health Organization model list of essential medicines: 22nd list
> (2021) [3]
> -World Health Organization model list of essential medicines for children:
> 8th list (2021) [4]
>
> The 22nd Model EML includes “new treatments for various cancers, insulin
> analogues and new oral medicines for diabetes, new medicines to assist
> people who want to stop smoking, and new antimicrobials to treat serious
> bacterial and fungal infections.”
>
> Potentially more consequential, the WHO Report “recommended establishing a
> standing EML Working Group to support the Expert Committee to provide
> advice to WHO on policies and rules to make highly priced essential
> medicines more affordable and accessible.”
>
> KEI has long advocated the creation of a category of products that are
> essential if available at affordable prices, and has called for a new
> approach to the EML list, which was created in the 1970s when developing
> countries confronted different challenges in managing drug supplies.
>
> The new working group is tasked with:
>
> --exploration of thresholds at which specific essential medicines become
> affordable in relation to countries and patients’ ability to pay;
> --identification of prices that represent “fair value”for the benefits
> expected from essential medicines;
> --identification of interventions by policy makers and other actors that
> could facilitate relevant and rapid decreases in prices to reach universal
> access to these treatments;
> --development of a strategy to monitor price and availability trends of
> essential but unaffordable medicines, to be proposed as part of the next
> WHO General Programme of Work.
>
> The WHO press release [5] accompanying the release of the new EML
> highlights a new focus on new products for diabetes including long-acting
> insulin analogues (insulin degludec, detemir and glargine) and their
> biosimilars. Among the four new cancer drugs approved is enzalutamide, a
> drug to treat prostate cancer, invented at UCLA, and marketed globally by
> Astellas under the trade name Xtandi. KEI was the applicant for listing
> enzalutamide.
>
> This was the second time that KEI has sought a listing for enzalutamide. A
> January 2019 application [6] proposed the listing of two drugs,
> enzalutamide and abiraterone acetate for metastatic prostate cancer on the
> EML. However, the 21st WHO EML [7] only listed abiraterone. In December
> 2020, KEI submitted a new proposal for the inclusion of enzalutamide [8],
> which was approved.
>
> Enzalutamide is still under patent in the United States (till 2027) and in
> several other countries, but a number of companies in India sell generic
> versions. Enzalutamide is also the subject of a compulsory licensing
> request currently pending before the U.S. Department of Defense, which
> provided funding for the relevant patented inventions.
>
> The WHO executive summary provided this commentary on the inclusion of
> enzalutamide:
>
> "Inclusion of enzalutamide on the complementary list of the EML, as a
> therapeutic alternative to abiraterone, for treatment of metastatic
> castration-resistant prostate cancer. Enzalutamide appears to demonstrate
> comparable efficacy to abiraterone, has a different mechanism of action and
> a different toxicity profile, and may be an option for patients unable to
> be treated with abiraterone. Enzalutamide and abiraterone are both oral
> treatments but enzalutamide is administered as monotherapy, while
> abiraterone is co-administered with corticosteroids to reduce toxicity and
> requires regular monitoring of liver enzymes.The availability of different
> treatment options with similar efficacy may provide opportunities for
> countries to negotiate better prices as part of their national procurement
> processes."
>
> The WHO press release explained that a number of other effective
> treatments for cancer were considered, but rejected because the drugs are
> too expensive.
>
> "A group of antibodies that enhance the immune response to tumour cells,
> called PD-1 / PD-L1 immune-checkpoint inhibitors, were not recommended for
> listing for the treatment of a number of lung cancers, despite being
> effective, mainly because of their exceedingly high price and concerns that
> they are difficult to manage in low-resourced health systems. Other cancer
> medicines were not recommended for listing due to uncertain additional
> clinical benefit compared with already listed medicines, high price, and
> management issues in low-resource settings. These included osimertinib for
> lung cancer, daratumumab for multiple myeloma, and three types of treatment
> (CDK4/6 inhibitors, fulvestrant and pertuzumab) for breast cancer."
>
> KEI’s Director James Love participated in the WHO’s EML Cancer Working
> Group, and offers this comment:
>
> “The WHO is in the process of rethinking the Essential Medicines List
> (EML), and the new list illustrates the challenges it faces. Inclusion on
> the WHO EML is influential in determining the drugs reimbursed in many
> countries, including in particular those with lower incomes. The list has
> been very conservative when it comes to newer products that don’t have low
> cost generic or biosimilar alternatives. The fact that this excludes many
> important drugs was made explicit in the new report. The encouraging news
> is that the WHO is now proposing a significant review of policies to
> address the effective but expensive category of drugs, including policy
> interventions that can make products more affordable. WHO members need to
> support the WHO in this new effort, because it will certainly face
> opposition.”
>
>
> Links:
> [1]
> https://www.who.int/news/item/01-10-2021-who-prioritizes-access-to-diabetes-and-cancer-treatments-in-new-essential-medicines-lists
> [2]
> https://apps.who.int/iris/bitstream/handle/10665/345554/WHO-MHP-HPS-EML-2021.01-eng.pdf
> [3]
> https://apps.who.int/iris/bitstream/handle/10665/345533/WHO-MHP-HPS-EML-2021.02-eng.pdf
> [4]
> https://apps.who.int/iris/bitstream/handle/10665/345534/WHO-MHP-HPS-EML-2021.03-eng.pdf
> [5]
> https://www.who.int/news/item/01-10-2021-who-prioritizes-access-to-diabetes-and-cancer-treatments-in-new-essential-medicines-lists
> [6]
> https://www.who.int/selection_medicines/committees/expert/22/applications/8.3_enzalutamide-abiraterone.pdf
> [7] https://apps.who.int/iris/rest/bitstreams/1237479/retrieve
> [8]
> https://www.keionline.org/wp-content/uploads/KEI.WHO_.EML_.Enzalutamide.2020.pdf
>


-- 
James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
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