Get high-end drugs for high-risk Covid-19 patients

Significantly expand current emergency healthcare expenses and future budgets for potentially life-saving innovative drugs. At the end of the day, prices are numbers. Lives are not.

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Published in Asia News Today & SARAWAKVOICE, image by Asia News Today.

The National Recovery Plan (NRP) phase transition indicators of daily hospital admissions in category 3 and above and utilisation capacity of intensive care units (ICUs) highlights the importance of preventing disease progression.

Even though vaccines have thus far proven effective in reducing severe symptoms (though breakthrough cases and variants will always present a threat), even one life can mean the world to someone – what more a few hundred lives (daily)?

If we can prevent many infected people from ending up in ICUs or dying from Covid-19, wouldn’t that be worth the price?
No vaccines are 100% effective, and there appears to be growing evidence that current vaccines may not be sufficient in stifling transmission of Delta variant. This could explain current observations of seemingly increasing infection rates but lowering rate of hospitalisation.

Therefore, there will always be room for high-end, low-volume market (relatively) of high-risk patients who are more likely to develop severe symptoms.
While next-generation vaccines are being developed, there are other potential therapeutic drugs out there that appear effective in reducing Covid-19 related hospitalisations and deaths such as monoclonal antibodies (mAbs).

Clinical data from double-blinded randomised controlled trials on mAbs compiled by the US National Institutes of Health indicated highly significant relative risk reduction (with results ranging from 70% to 85% between studies) in hospitalisations and deaths related to Covid-19.

Most importantly, laboratory experiments [1],[2] showed that some of these potent mAbs are effective against most variants, including Delta. This is possible as some of the mAbs (or mAbs cocktails) are either targeting multiple regions of the virus, or targeting a region on the virus that is highly conserved (resistant) to mutations.

One particularly promising mAb is sotrovimab. It has been shown to target a highly conserved area present in SARS-CoV-1 and SARS-CoV-2 viruses, and clinical data showed reduction in the chances of hospitalisation or death by up to 85%. Additionally, it has been reported with the potential to be given via intramuscular injection, which is preferred over intravenous routes due to ease of administration and costs.

Affiliate of Berkeley Lab, a US Department of Energy Office of Science lab managed by the University of California, mentioned that “This antibody, which binds to a previously unknown site on the coronavirus spike protein, appears to neutralize all known sarbecoviruses – the genus of coronaviruses that cause respiratory infections in mammals”.

The discovery of the highly conserved sites should also inspire researchers experimenting on potential vaccine targets.
Other promising mAbs include the combination of casirivimab and imdevimab. The cocktail made headlines as it was used to treat former US president Donald Trump.
However, these new therapies are expensive and not available in large quantities, limiting their reach as a global intervention.

According to a recent report dated August 10 by Wellcome, a London-based charitable foundation, and the International AIDS Vaccine Initiative (IAVI), the median price for mAb therapies in the US is around the range of US$15,000 to US$200,000 per annual treatment.

However, unlike other non-communicable diseases such as cancer that may require multiple doses over a long treatment course, clinical trials on sotrovimab indicated only a single dose (500mg) may be needed to prevent disease progression.

Online pharmaceutical portal Fierce Pharma reported (based on an interview with the executives of sotrovimab producers) that the US wholesale cost is about US$2,100 per dose, which has been said to be within the ballpark figure of other antibody therapies.

Despite its high price, the Wellcome-IAVI report mentioned mAbs as the biggest segment of biologic molecules with growing demand due to its potential.

Code Blue reported that only a mere RM6 million on biologics treatment was allocated during Budget 2021 tabling, which is vastly insufficient for the various types of promising biologics out there.
Say there are 10% high-risk cases out of 10,000 daily cases over 60 days, the 30,000 doses of sotrovimab may cost approximately RM529 million. However, keep in mind that the number of cases and percentage of high-risk SARS-CoV-2 positive patients is expected to drop with widespread vaccination (assuming current and future vaccines work well against emerging variants) so, the figure could be lower.
For example, 2,000 daily cases over 60 days (at the same 10% high-risk patients) would mean 12,000 doses at the cost of RM105.8 million. The numbers may be lower as time goes by.
As a comparison, the Australian government announced on August 8 that it had secured 7,700 doses of sotrovimab with an estimate of 8% to 15% high-risk SARS-CoV-2 positive patients.

No doubt this is a relatively hefty price, but it may be worthwhile to consider having these novel therapies at hand for the relatively few high-risk individuals that may exhibit worsening disease progression based on their risk profile such as age group and comorbidities, and help prevent disease progression and deaths.

Assuming we can allocate such a budget, global production capacity remains a bottleneck. The Wellcome-IAVI report showed that nearly 80% of the mAbs global market is concentrated in the US, Canada and Europe.

High prices and relatively low availability mean this is out of reach for most low- and middle-income countries (LMICs), which the Wellcome-IAVI report mentioned as making up 85 per cent of the global population and representing most non-communicable disease mortalities.

Therefore, at current constraints, Big Pharma may not have the economic appetite to negotiate smaller volumes for lower prices in LMICs.

While businesses find ways to increase production capacity and reduce costs, LMICs should consider purchasing such therapies as a bloc while local governments should explore pooled procurement across ministries to increase purchasing power and the size of the order – which would incentivise production scale-up to meet significant demand.

Of course, bloc purchase is not as easy as it sounds. Malaysia’s former Minister of Foreign Affairs initially called for the Association of Southeast Asian Nations (ASEAN) to purchase Covid-19 vaccines as a bloc, which did not appear to gain traction.

Different countries have their own regulations, methods of assessment, pricing mechanisms, and geopolitical considerations. Perhaps Asean needs its own version of Covax, or perhaps the Covax facility should expand beyond vaccines.

That said, Asean countries can learn from the initial mistake by European Union (EU) nations that didn’t show solidarity in vaccine procurement, as well as Covax’s initial failure due to acts of wealthy nations getting in the way of Covax’s objectives.

Even if Asean can get their act together, the historical lesson has shown that in most cases it falls back to the respective countries’ financial and diplomatic strengths to secure scarce health interventions.

With projected vaccination success and increasing ability to identify high-risk patients, and in the absence of biosimilars or generics for these novel therapies, it makes sense to significantly increase current emergency expenditures and future healthcare budget allocations for innovative drugs that could potentially save many lives.

At the end of the day, in emergency settings, prices are numbers. Lives are not.

Ameen Kamal is the Head of Science & Technology at EMIR Research, an independent think tank focused on strategic policy recommendations based on rigorous research.

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