The impact of COVID-19 on the cell and gene therapies industry: Disruptions, opportunities, and future prospects

Qiu, Tingting; Wang, Yitong; Liang, Shuyao; Han, Ru; Toumi, Mondher

doi:10.1016/j.drudis.2021.04.020

Cited by 14 publications

(12 citation statements)

References 62 publications

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“…services is given to reimburse the costs of COVID-19 services and cases of follow-up events after COVID-19 vaccination. Before providing COVID-19 services, hospitals must obtain prior approval from the Director-General of Health Services (Qiu et al, 2021).…”

Section: Resultsmentioning

confidence: 99%

Claim Analysis of Cost Reimbursement COVID-19 Patient Service to Badan Penyelenggara Jaminan Sosial (BPJS) in health by Hospital

Sugiarto

Ilyas

2022

J. Sci. n.a

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The BPJS COVID-19 fee claim is the government's support in accelerating the handling of COVID-19 in Indonesia. BPJS Health data from January to October 2021, the submission of claims for COVID-19 reached 1,345,970 cases with a cost value of 72.3 trillion IDR. Of the claims submitted by the hospital, only 79.07% were following BPJS claim verification or equivalent to 64.1 trillion IDR. There are still 21% of COVID-19 cost claims that require clarification on dispute resolution. Therefore, it is necessary to study the COVID-19 cost claim according to the provisions and find out the obstacles that occur in submitting BPJS claims by hospitals. The method used is descriptive-analytic by using literature searches, reading materials, and scientific journals. The results obtained are that the claim for COVID-19 costs uses the provisions of the tariff per day/cost per day which is regulated in the technical instructions for claiming reimbursement of costs for COVID-19 patient services number HK.01.07/MENKES/5673/2021. The conclusion obtained is that there are still problems with COVID-19 cost claims in the administrative aspect, the limitations of the verifier team, and the integration of the claim submission system.

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Section: Resultsmentioning

confidence: 99%

Claim Analysis of Cost Reimbursement COVID-19 Patient Service to Badan Penyelenggara Jaminan Sosial (BPJS) in health by Hospital

Sugiarto

Ilyas

2022

J. Sci. n.a

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“…The COVID-19 pandemic caused by the SARS-CoV-2 virus has forced many industries to adapt their way of working, having also had a great impact on the ATMP field [ 73 ]. As shown in this article, different cell types present highly distinct susceptibilities to SARS-CoV-2 infection.…”

Section: Discussionmentioning

confidence: 99%

A Risk Assessment Study of SARS-CoV-2 Propagation in the Manufacturing of Cellular Products

Monte¹,

O’Neill²,

Abitorabi³

2022

Regen. Med.

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The potential infection of cellular therapies by SARS-CoV-2 present high risks, as the target patients for these treatments are often immunocompromised or have chronic diseases associated with a higher risk of serious illness and death by COVID-19. The multicellular tropism of this virus presents challenges for the manufacturing of cell therapies, whereby the material could potentially become infected at the source or during cell processing. In this review we assess the risk of a SARS-CoV-2 propagation in cell types used to date in cellular therapies. Altogether, the risk of SARS-CoV-2 contamination of cellular products remains low. This risk should be evaluated on an individual basis, considering ACE2 and TMPRSS2 expression, existing literature regarding the susceptibility to infection, and single cell RNA sequencing data of COVID-19 patients. This analysis should ideally be performed for both the cells being manufactured and the cells used to produce the vector to ensure patient safety.

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“…In addition, HTA bodies are more likely to accept indirect comparisons for demonstrating non-inferiority but are cautious to accept such evidence for demonstrating superiority (28). Payer uncertainties have been further fueled by the recent challenges of when data were collected in terms of the coronavirus disease 2019 (COVID- 19) pandemic, which has added other confounding issues (29). Therefore, synthetic controls with high patient and outcome similarity may be more appropriate than historical controls with retrospective observational studies (30).…”

Section: Single-arm Trialsmentioning

confidence: 99%

Gene Therapy Evidence Generation and Economic Analysis: Pragmatic Considerations to Facilitate Fit-for-Purpose Health Technology Assessment

Qiu

Pochopien²,

Liang

et al. 2022

Front. Public Health

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Gene therapies (GTs) are considered to be a paradigm-shifting class of treatments with the potential to treat previously incurable diseases or those with significant unmet treatment needs. However, considerable challenges remain in their health technology assessment (HTA), mainly stemming from the inability to perform robust clinical trials to convince decision-makers to pay the high prices for the potential long-term treatment benefits provided. This article aims to review the recommendations that have been published for evidence generation and economic analysis for GTs against the feasibility of their implementation within current HTA decision analysis frameworks. After reviewing the systematically identified literature, we found that questions remain on the appropriateness of GT evidence generation, considering that additional, broader values brought by GTs seem insufficiently incorporated within proposed analytic methods. In cases where innovative methods are proposed, HTA organizations remain highly conservative and resistant to change their reference case and decision analysis framework. Such resistances are largely attributed to the substantial evidence uncertainty, resource-consuming administration process, and the absence of consensus on the optimized methodology to balance all the advantages and potential pitfalls of GTs.

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The impact of COVID-19 on the cell and gene therapies industry: Disruptions, opportunities, and future prospects

Cited by 14 publications

References 62 publications

Claim Analysis of Cost Reimbursement COVID-19 Patient Service to Badan Penyelenggara Jaminan Sosial (BPJS) in health by Hospital

Claim Analysis of Cost Reimbursement COVID-19 Patient Service to Badan Penyelenggara Jaminan Sosial (BPJS) in health by Hospital

A Risk Assessment Study of SARS-CoV-2 Propagation in the Manufacturing of Cellular Products

Gene Therapy Evidence Generation and Economic Analysis: Pragmatic Considerations to Facilitate Fit-for-Purpose Health Technology Assessment

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