Independent Market Access and Reimbursement Risk Assessment.

Built by former payers, HTA reviewers, and Industry Experts. 

Remdesivir / veklury for treating COVID-19

As of May 2024, MARA’s assessment finds Remdesivir / Veklury’s reimbursement risk concentrated in patient population and subgroups, with care pathway integration a strength; the current MARA Rating and full rationale are available in the report.

The assessment also weighs quality of life: whether the trial benefit shows up in patients’ daily lives, not only in the clinical endpoints. The strength recorded in care pathway integration carries weight because that domain asks how the drug fits into the way care is organised today; a treatment that demands new infrastructure or displaces an established pathway faces extra scrutiny.

Infectious Diseases

This rating sits within MARA’s Infectious Diseases coverage, alongside 12 other independently assessed treatments in the same area.

What payers will ask

Is the clinical benefit the kind payers reward? — Clinical effectiveness

The clinical evidence for remdesivir indicates it can increase survival for adults needing low-flow supplemental oxygen compared to standard care, but the evidence is highly uncertain due to the changing nature of COVID-19 and the predominance of the Omicron variant. The committee noted that most evidence comes from studies conducted before the Omicron variant, leading to significant uncertainty in its effectiveness in the current context.

Does the economic case hold at the expected price? — Cost effectiveness

The cost-effectiveness estimates for remdesivir are uncertain and depend heavily on the mortality rates and hospitalisation rates, which are variable. The committee concluded that remdesivir is likely to be cost-effective for certain high-risk groups, but overall, the ICERs are above NICE’s acceptable threshold for many populations.

Is there quality-of-life evidence payers weigh? — Quality of life

There is limited evidence regarding the impact of remdesivir on HRQoL, particularly in children and immunocompromised populations. The committee acknowledged that while remdesivir may have some benefits, the overall impact on quality of life remains uncertain and not well documented.

Does the safety profile hold up for payers? — Safety and Adverse Effects

Remdesivir has an acceptable safety profile with manageable adverse effects. The evidence suggests that it is well tolerated, particularly in the populations studied, although the committee noted that the safety data is less robust for children and immunocompromised individuals.

Was the drug compared against what payers expect? — Comparator Selection

The evidence for remdesivir was compared against standard care, which has evolved over time. However, the committee noted that the comparators used in the trials may not fully reflect current clinical practice, particularly with the emergence of new variants.

Is the population defined the way payers need it? — Patient Population and Subgroups

The patient populations studied include adults and children, but the evidence for children is particularly limited. The committee recognized that while remdesivir is the only licensed treatment for children under 12, the small number of cases limits generalizability.

Does the drug fit how care is delivered and paid for? — Care Pathway Integration

Remdesivir can be integrated into existing care pathways with minor adjustments. The committee noted that it fits well within the current treatment protocols for COVID-19, particularly for high-risk patients.

Are the wider system costs understood? — Resource Use and Cost Implications

The resource implications of remdesivir are significant, particularly in terms of hospitalisation costs. The committee acknowledged that while it may be cost-effective for certain populations, the overall budget impact raises concerns.

Would the evidence survive payer scrutiny? — Evidence Quality and Robustness

The evidence base for remdesivir includes several studies, but there are notable gaps and uncertainties, particularly regarding its effectiveness against current variants. The committee highlighted the need for more robust data to support its use.

How exposed is the case to uncertainty? — Uncertainty, Sensitivity, and Broader Impacts

There is considerable uncertainty surrounding the effectiveness of remdesivir in the current COVID-19 landscape, particularly with the emergence of new variants. The committee noted that this uncertainty could impact its broader applicability and acceptance.

Be alerted when this rating changes:

Sample two-page MARA Rating report for the fictional drug Samplinib: the rating with its decision record, and the ten graded payer questions with the reasoning behind each
Every MARA rating is delivered as a two-page reasoned report (sample, fictional product) — see it in full
Full Legal Disclaimer and Usage Terms

The MARA Rating® is an independent opinion of a drug’s market access pharma risk profile and is provided for informational purposes only—not as investment, medical, legal or any other type of advice. See our full disclaimer here.