Shawview Consulting’s Brendan Shaw examines the WHO’s recently released updated Essential Medicines List. Shaw highlights some of the key trends and new inclusions in the List, why pricing and transparency are hotter topics than ever, and how pharma can incorporate this important document and its implications into their strategies for their own benefit, as well as that of health policy practitioners and patients.
Last week, the World Health Organization (WHO) released the latest 2021 Model List of Essential Medicines. This regular biennial review is often an occasion when global health issues and debates about the pharmaceutical industry get some attention.
The WHO’s Essential Medicines List (EML) is a guide the WHO provides to assist countries and international organisations to inform their own decisions on which medicines they should include in their formularies. The WHO also prepares a Model List of Essential Medicines for Children (EMLc).
The EML has undergone substantial change over the years. Where once upon a time it was comprised largely of older, generic, cheaper medicines, in recent years an increasing number of newer, patented medicines in a range of disease areas have been added. In part, this is a testament to the work of the pharmaceutical industry in developing innovative, new treatments that the world needs.
Since its first iteration in 1977 when the EML started with just 204 unique molecules, the List has expanded to reach 479 such medicines with the release last week of the 22nd edition of the EML for 2021.
This is the highest number of medicines ever included on the List. It means that as a result of scientific progress and investment by the pharmaceutical industry, the WHO has seen a more than doubling of the number of medicines it deems as ‘essential’ over the last 45 years or so.
That’s a pretty good achievement for everyone in health care, the WHO and the pharmaceutical industry alike.
It is important to note, though, that just because a medicine is not listed on the EML does not mean that it is not essential or vital. The EML has a specific purpose in providing health policy advice and ultimately each country must make its own decisions about what medicines its people need. The EML should only act as a guide for countries to develop their own formularies and, indeed, studies have shown that is exactly how countries use it. The WHO itself acknowledges that these 479 medicines are only a fraction of the total number of medicines available on the market.
The 2021 EML
As with previous years, there are some important stories buried in the sometimes arcane clinical assessment undertaken by the WHO’s Expert Committee on the Selection and Use of Essential Medicines. Some of the key development this year include:
- The updated EML adds 20 additional new medicines and 17 added to the EMLc after the Expert Committee reviewed 88 applications.
- A big focus in this year’s update was on diabetes medicines, particularly insulin. The inclusion of analogue insulins (insulin degludec, detemir and glargine) on the EML comes after many years of debate and a review coming out of the previous 2019 update. Insulin analogues had been rejected in previous updates, but this year the Expert Committee has finally decided to include them given their clinical benefits. The Committee has taken an each-way bet, though, by highlighting that human insulin still offers good alternative treatment options for countries depending on their circumstances.
- Oral diabetes medicines, the SGLT2 inhibitors – empagliflozin, canagliflozin and dapagliflozin – have been added and, in an interesting example of how the EML can influence policy – the Committee suggests the WHO work with the Medicines Patent Pool and manufacturers to find ways to license these to generic manufacturers.
- The initiatives on diabetes treatments comes as this year is the 100th anniversary of the development of the first, early insulins in 1921 and coincides with the WHO’s Global Diabetes Compact to improve global treatment and management of diabetes.
- Four cancer medicines were added to the list, including some for children, including enzalutamide for prostate cancer, everolimus for a type of brain tumour in children, ibrutinib for chronic lymphocytic leukaemia, and rasburicase, for tumour lysis syndrome. New children’s indications were also added to 16 existing cancer medicines.
- Several cancer medicines were examined but rejected by the Expert Committee, including PD-1 / PD-L1 immune-checkpoint inhibitors for lung cancers, osimertinib for lung cancer, daratumumab for multiple myeloma, and three types of treatment (CDK4/6 inhibitors, fulvestrant and pertuzumab) for breast cancer. The reasons given by the Expert Committee for rejection were combinations of what they saw as their relative additional clinical benefit against their price and, interestingly, acknowledging the health system management problems present in low-resource settings.
- A handful of new antibiotics and antifungals were added to the list and 81 antibiotics were classified under the AWaRe framework supporting antimicrobial stewardship and surveillance of antibiotic use worldwide. This framework was introduced to the EML in 2017.
- Monoclonal antibodies for rabies prevention were added to the List, the first monoclonal antibodies against an infectious disease to be included on the EML.
- More smoking cessation therapies were added to increase treatment options and supporting WHO’s efforts to eliminate smoking worldwide.
The Expert Committee’s Executive Summary provides a good overview of its thinking and results. In total the Committee rejected 17 of the 38 applications for new medicines or medicine classes and did not consider any COVID-19 treatments given their rapidly evolving situation in terms of scientific evidence and use in the context of the current pandemic.
Broader issues coming out of the EML
Another change in EML reviews and the commentary around them over time has been a stronger focus on pricing and access issues in addition to regulatory and scientific issues. As newer, patented medicines have been added and as health policy has become more globalised, each EML review has increasingly become a focus for debates on the price and transparency of medicines, health system funding and the role of the pharmaceutical industry.
This year, for example, pricing issues were a focus of the WHO when releasing the 2021 EML. Even the first lines of WHO Director General Dr Tedros’ comments on the EML were about pricing and access.
The WHO is going to have to tread carefully here; not to avoid offending the pharmaceutical industry – that hasn’t stopped it before – but to be sure it doesn’t kill the goose that lays the golden eggs
In fact, the debate about medicines prices and the EML reached something of a climax this year, with the Expert Committee recommending the WHO establish a Working Group to provide advice on approaches to make highly priced essential medicines more affordable. The proposed workplan of the Working Group continues to draw the EML into the broader global discussions on medicine pricing policy. It is a debate we have seen building around the EML for some years, but this is a new development.
The WHO is going to have to tread carefully here; not to avoid offending the pharmaceutical industry – that hasn’t stopped it before – but to be sure it doesn’t kill the goose that lays the golden eggs. Pricing policy is one of those topics where less rhetoric and more analysis and considered dialogue is the best recipe for success. If you get it wrong, the pipeline of new medicines dries up and patients miss out on treatments altogether.
In an example of how complicated the pricing argument is, the WHO’s concerns about insulin prices, market concentration and supposed a lack of competition sit at odds with a recent report by analysis firm, IQVIA, which suggests that the situation is more complicated than that. This only reinforces the need for more dialogue, collaboration and out-of-the-box thinking to identify issues and find sustainable business models to fix the gaps in patient access that are obviously there.
Implications for pharmaceutical companies
What happens around the WHO EML is important for the pharmaceutical industry. According to the 2021 Access to Medicines Index almost all of the top 20 pharmaceutical companies in the world have at least one medicine listed on the EML.
For pharmaceutical companies, the EML raises some important pricing and policy issues and different companies have approached these in different ways. Some companies see having their medicines listed on the EML as a positive, both in terms of endorsement but also as an accompaniment to their own access to medicines strategies.
Other companies are perhaps more wary of engaging in the process. This wariness has some justification given the palaver and histrionics from people that sometimes accompanies the process of listing a medicine on the EML.
That said, the smart companies consider how the EML affects their business, and the even smarter ones include the EML in their access strategy.
Companies already use a range of strategies to promote access to medicines for EML-listed medicines, particularly for lower-income countries, such as differential pricing, voluntary licensing to generic manufacturers, deals through the Medicines Patent Pool or non-enforcement of patents in these countries. This comes on top of existing international legal exemptions on patents for the poorest countries in the world.
In classic leadership-speak, companies’ approach to the EML may represent an example of turning a challenge into an opportunity. Given the growing markets in low- and middle-income countries, the EML and company access strategies around it might actually turn out to be a good business opportunity over and above the basic objective to do the right thing as far as global health.
Pharmaceutical companies should include the EML and the resultant policy implications and strategies around it as part of their broader commercial plans. Obviously, companies will have different strategies given their different corporate approaches, pipelines, product lists and disease areas.
For this to happen, though, there’s going to have to be some constructive engagement and support from external stakeholders in global health. The pharmaceutical companies that engage in the process should be acknowledged, rather than penalised or criticised for doing so.
It could prove to be a classic win-win for companies, health policy practitioners and ultimately patients if we can get it right.