FASTER — HIGHER — STRONGER: the global race for a COVID-19 therapy

FASTER — HIGHER — STRONGER: the global race for a COVID-19 therapy

FASTER — HIGHER — STRONGER: the global race for a COVID-19 therapy

FASTER — HIGHER — STRONGER: the global race for a COVID-19 therapy

FASTER — HIGHER — STRONGER: the global race for a COVID-19 therapy

JAYMIN PATEL, RICHARD H. STANFORD & TYLER REINSCH

FASTER — HIGHER — STRONGER: the global race for a COVID-19 therapy

FASTER — HIGHER — STRONGER: the global race for a COVID-19 therapy

It’s the middle of August 2020 and everyone is on the edge of their seat witnessing a great spectacle of competition. Not the quadrennial Olympics but, unexpectedly, the competition amongst the world’s best and brightest clinical researchers searching for anything that may ameliorate the COVID-19 pandemic.

Therapeutics are important, too

If clinical development was the Olympic track and field, vaccine trials would be the 100 meter sprinters attracting all of the attention. Maybe this attention makes sense. If successfully developed, vaccines would have the greatest impact by potentially eliminating all threat of the disease. COVID-19 vaccines are being developed at lightning speed, however even the best vaccine may only be 50% effective and may not have enough safety data in the most at-risk populations, which could lead to lower uptake of the vaccine to control spread. If the vaccines fall short in any of those areas – which they likely will in the short term – we will need therapeutics to treat those that get infected. Relying on vaccines would be like Usain Bolt in a decathlon. Sure, he would win the 100 meter sprint and it would be exciting to watch, but there are 9 other events that he would need to compete in to win the Gold.

Treatments don’t have the benefit of eliminating the spread, but by reducing or eliminating the negative outcomes associated with COVID-19, treatments may be more effective at reducing the negative outcomes and a quicker return to normalcy than just awaiting a vaccine to be developed and relying on a large uptake to reach necessary levels.

59 therapeutics currently under evaluation in clinical trials for the treatment of COVID-19

We’ve assessed clinicaltrials.gov and EudraCT clinical trials registries for medicinal products currently under evaluation for the treatment of COVID-19. For each one, we determined whether the treatment is currently available for an alternative indication and, if treatment has already been approved, if it is available as a generic.

Our review has shown that, as of August 1, 2020, there were approximately three thousand clinical trials registered in the US and EU for the treatment of COVID-19. Of these, 34% are in Phase 3. Focusing on non-vaccine therapeutics, there are 59 molecules being studied.

41 products under investigation for COVID-19 are already approved in other indications, likely with proven safety profiles

Long-term safety in the real-world setting will likely play an important role in the uptake and utilization of treatments shown to be effective against COVID-19. With this, treatments already approved with indications outside of COVID-19 may have an advantage over new molecular entities by leveraging established safety profiles. Of the 59 different therapies being studied, 41 are currently approved with alternative indications.

Value of generic products

An effective new therapy would in principle deliver considerable value even at premium prices, since the burden of COVID-19 has been shown to affect all parts of the global economy – although of course there is an ongoing debate about this, with Wall Street and global NGOs taking mutually exclusive stances on this question. An effective treatment available as a generic, however, could benefit health systems by starting from a lower established price, well-set manufacturing and multi-source production, all of which should improve treatment availability, distribution and access. Currently 11 (27%) of the treatments already approved for other indications are available as generics.

Novel classification of investigational COVID-19 treatments by treatment stage

Therapeutics can be classified into three categories: those that treat 1) at time of diagnosis, 2) at time of hospitalization, and 3) at time of mechanical ventilation.  Of the 59 different treatments, 16.9% are targeted for use at time of diagnosis, 69.5% at the point of hospitalization, and 13.6% after mechanical ventilation has begun. As far as we know, AESARA is the first team to break down COVID-19 treatments into these categories.

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Next Steps
Testing COVID-19 treatment value with payers and HTA bodies

The next stage of our research is to produce sample product profiles using the factors described above and test those products with our global payer and HTA advisor network. This new data will allow us to gain insights into how decision-makers in a cross-section of health systems will assess the value of forthcoming treatments. We will explore how price, access and reimbursement decisions are likely to play out in the key categories – findings which should be of keen interest to any biotech or pharma company competing for medals in this global event.

Download COVID-19 Data

3,042

on-going clinical trials are registered in the US and EU combined.

1,259

studies are designated as
phase I, II, or III-(I,II,III) 

PHASE I

17.9%

PHASE II

48.1%

PHASE III

34.0%

70%

are existing treatments for other indications

0%

of these are available as generic

These treatments are being studied to treat COVID-19 stages

16.9%

10/59

at time of diagnosis

69.5%

41/59

when hospitalized

13.6%

8/59

when ventilators are used

EU Clinical Trials Register. (2020). Retrieved August 18, 2020, from https://www.clinicaltrialsregister.eu/
NIH US National Library of Medicine ClinicalTrials.gov. (2020). Retrieved August 18, 2020, from https://clinicaltrials.gov/
Orphanet. (2020). Retrieved August 18, 2020, from https://www.orpha.net/consor4.01/www/cgi-bin/index.php?lng=EN

Developing the value strategy for a COVID-19 therapy? Talk to us

If you would like to talk to AESARA value & access experts about value evidence and access strategies for your investigational COVID-19 therapy, please contact Richard Stanford:

Researching COVID-19?
Download our data

If you would like to examine our data from this study to see what you can discover, you can download an Excel file here.
Share your findings with us by tweeting @AESARA!

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