Exemplary quotes regarding adequacy of the evidence that aducanumab is safe and effective
| Based on the current evidence, it is reasonable … | |
| … to conclude aducanumab is safe and effective. | • ‘There is reasonable evidence suggesting a clinical benefit in slowing symptomatic and functional decline which is supported by biomarker findings and initial results of similar drugs in its class that are currently in clinical trials.’ (Clinician or other health care worker) • `Biogen disagrees with the statement in the proposed NCD that no trial has been able to demonstrate a clinically meaningful improvement in patient health outcomes. FDA concluded that the EMERGE study “demonstrated a clinically meaningful and statistically significant treatment effect for the high dose of aducanumab on an accepted primary endpoint, the [Clinical Dementia Rating Sum of the Boxes scale (CDR-SB)], and across multiple secondary and tertiary endpoints.” ... CMS’ proposal does not offer a reasoned explanation for disagreement with FDA’s determination regarding the clinical benefit of ADUHELM.' (Pharmaceutical company/Industry association) |
| … to conclude aducanumab is not safe or effective. | • ‘[T]he data for aducanumab in phase three trials is extremely poor. It would appear that, more likely than not, the medicine provides no clinical benefits and has high potential for serious side effects of brain swelling and brain bleeding.’ (Clinician or other health care worker) • ‘Solloway and colleagues discuss harmful effects of Aduhelm in the JAMA Neurology Journal where results from Aduhelm trials show 41% of patients experienced brain swelling or bleeding when given the FDA approved dose of the drug. Given the overwhelming evidence that Aduhelm is minimally effective at best, why is there such a large push to approve this drug?’ (Academic (including researchers)) |
| … to gather more evidence. | • ‘We strongly agree with CMS that there is insufficient evidence regarding the risks and benefits of aducanumab, and of amyloid targeting therapies in general, and agree that CMS should not provide coverage until there is clear evidence of safety and efficacy with clinically meaningful outcomes in a diverse patient population.’ (Clinician or other health care worker; Academic (including researchers)) • ‘CMS has raised important questions about the available evidence on mAbs for AD, and in particular about the effectiveness of aducanumab, … to support a reasonable and necessary coverage determination for Medicare beneficiaries with MCI and early-stage AD. We agree that there are important evidentiary questions.’ (Academic (including researchers)) |
| Even if more research is conducted, … | |
| … CMS shouldn’t be funding it. | • ‘How can Medicare justify paying for an incredibly expensive drug to be used in CLINICAL TRIALS? ... [T]he government and Medicare users should not be subsidizing clinical trials for Biogen by paying for this. Biogen should pay ... rather than giving Biogen a huge profit on every dose—for them to CONTINUE a clinical trial which should have already been completed before submission to the FDA.’ (Not specified) • ‘Why can’t the pharmaceutical company cover that from their own research budget? The CMS seems to be putting the interests of the drug company ahead of seniors.’ (Self-identified member of the general public/taxpayer) |
| Based on the current evidence, it is reasonable … | |
| … to conclude aducanumab is safe and effective. | • ‘There is reasonable evidence suggesting a clinical benefit in slowing symptomatic and functional decline which is supported by biomarker findings and initial results of similar drugs in its class that are currently in clinical trials.’ (Clinician or other health care worker) • `Biogen disagrees with the statement in the proposed NCD that no trial has been able to demonstrate a clinically meaningful improvement in patient health outcomes. FDA concluded that the EMERGE study “demonstrated a clinically meaningful and statistically significant treatment effect for the high dose of aducanumab on an accepted primary endpoint, the [Clinical Dementia Rating Sum of the Boxes scale (CDR-SB)], and across multiple secondary and tertiary endpoints.” ... CMS’ proposal does not offer a reasoned explanation for disagreement with FDA’s determination regarding the clinical benefit of ADUHELM.' (Pharmaceutical company/Industry association) |
| … to conclude aducanumab is not safe or effective. | • ‘[T]he data for aducanumab in phase three trials is extremely poor. It would appear that, more likely than not, the medicine provides no clinical benefits and has high potential for serious side effects of brain swelling and brain bleeding.’ (Clinician or other health care worker) • ‘Solloway and colleagues discuss harmful effects of Aduhelm in the JAMA Neurology Journal where results from Aduhelm trials show 41% of patients experienced brain swelling or bleeding when given the FDA approved dose of the drug. Given the overwhelming evidence that Aduhelm is minimally effective at best, why is there such a large push to approve this drug?’ (Academic (including researchers)) |
| … to gather more evidence. | • ‘We strongly agree with CMS that there is insufficient evidence regarding the risks and benefits of aducanumab, and of amyloid targeting therapies in general, and agree that CMS should not provide coverage until there is clear evidence of safety and efficacy with clinically meaningful outcomes in a diverse patient population.’ (Clinician or other health care worker; Academic (including researchers)) • ‘CMS has raised important questions about the available evidence on mAbs for AD, and in particular about the effectiveness of aducanumab, … to support a reasonable and necessary coverage determination for Medicare beneficiaries with MCI and early-stage AD. We agree that there are important evidentiary questions.’ (Academic (including researchers)) |
| Even if more research is conducted, … | |
| … CMS shouldn’t be funding it. | • ‘How can Medicare justify paying for an incredibly expensive drug to be used in CLINICAL TRIALS? ... [T]he government and Medicare users should not be subsidizing clinical trials for Biogen by paying for this. Biogen should pay ... rather than giving Biogen a huge profit on every dose—for them to CONTINUE a clinical trial which should have already been completed before submission to the FDA.’ (Not specified) • ‘Why can’t the pharmaceutical company cover that from their own research budget? The CMS seems to be putting the interests of the drug company ahead of seniors.’ (Self-identified member of the general public/taxpayer) |
Exemplary quotes regarding adequacy of the evidence that aducanumab is safe and effective
| Based on the current evidence, it is reasonable … | |
| … to conclude aducanumab is safe and effective. | • ‘There is reasonable evidence suggesting a clinical benefit in slowing symptomatic and functional decline which is supported by biomarker findings and initial results of similar drugs in its class that are currently in clinical trials.’ (Clinician or other health care worker) • `Biogen disagrees with the statement in the proposed NCD that no trial has been able to demonstrate a clinically meaningful improvement in patient health outcomes. FDA concluded that the EMERGE study “demonstrated a clinically meaningful and statistically significant treatment effect for the high dose of aducanumab on an accepted primary endpoint, the [Clinical Dementia Rating Sum of the Boxes scale (CDR-SB)], and across multiple secondary and tertiary endpoints.” ... CMS’ proposal does not offer a reasoned explanation for disagreement with FDA’s determination regarding the clinical benefit of ADUHELM.' (Pharmaceutical company/Industry association) |
| … to conclude aducanumab is not safe or effective. | • ‘[T]he data for aducanumab in phase three trials is extremely poor. It would appear that, more likely than not, the medicine provides no clinical benefits and has high potential for serious side effects of brain swelling and brain bleeding.’ (Clinician or other health care worker) • ‘Solloway and colleagues discuss harmful effects of Aduhelm in the JAMA Neurology Journal where results from Aduhelm trials show 41% of patients experienced brain swelling or bleeding when given the FDA approved dose of the drug. Given the overwhelming evidence that Aduhelm is minimally effective at best, why is there such a large push to approve this drug?’ (Academic (including researchers)) |
| … to gather more evidence. | • ‘We strongly agree with CMS that there is insufficient evidence regarding the risks and benefits of aducanumab, and of amyloid targeting therapies in general, and agree that CMS should not provide coverage until there is clear evidence of safety and efficacy with clinically meaningful outcomes in a diverse patient population.’ (Clinician or other health care worker; Academic (including researchers)) • ‘CMS has raised important questions about the available evidence on mAbs for AD, and in particular about the effectiveness of aducanumab, … to support a reasonable and necessary coverage determination for Medicare beneficiaries with MCI and early-stage AD. We agree that there are important evidentiary questions.’ (Academic (including researchers)) |
| Even if more research is conducted, … | |
| … CMS shouldn’t be funding it. | • ‘How can Medicare justify paying for an incredibly expensive drug to be used in CLINICAL TRIALS? ... [T]he government and Medicare users should not be subsidizing clinical trials for Biogen by paying for this. Biogen should pay ... rather than giving Biogen a huge profit on every dose—for them to CONTINUE a clinical trial which should have already been completed before submission to the FDA.’ (Not specified) • ‘Why can’t the pharmaceutical company cover that from their own research budget? The CMS seems to be putting the interests of the drug company ahead of seniors.’ (Self-identified member of the general public/taxpayer) |
| Based on the current evidence, it is reasonable … | |
| … to conclude aducanumab is safe and effective. | • ‘There is reasonable evidence suggesting a clinical benefit in slowing symptomatic and functional decline which is supported by biomarker findings and initial results of similar drugs in its class that are currently in clinical trials.’ (Clinician or other health care worker) • `Biogen disagrees with the statement in the proposed NCD that no trial has been able to demonstrate a clinically meaningful improvement in patient health outcomes. FDA concluded that the EMERGE study “demonstrated a clinically meaningful and statistically significant treatment effect for the high dose of aducanumab on an accepted primary endpoint, the [Clinical Dementia Rating Sum of the Boxes scale (CDR-SB)], and across multiple secondary and tertiary endpoints.” ... CMS’ proposal does not offer a reasoned explanation for disagreement with FDA’s determination regarding the clinical benefit of ADUHELM.' (Pharmaceutical company/Industry association) |
| … to conclude aducanumab is not safe or effective. | • ‘[T]he data for aducanumab in phase three trials is extremely poor. It would appear that, more likely than not, the medicine provides no clinical benefits and has high potential for serious side effects of brain swelling and brain bleeding.’ (Clinician or other health care worker) • ‘Solloway and colleagues discuss harmful effects of Aduhelm in the JAMA Neurology Journal where results from Aduhelm trials show 41% of patients experienced brain swelling or bleeding when given the FDA approved dose of the drug. Given the overwhelming evidence that Aduhelm is minimally effective at best, why is there such a large push to approve this drug?’ (Academic (including researchers)) |
| … to gather more evidence. | • ‘We strongly agree with CMS that there is insufficient evidence regarding the risks and benefits of aducanumab, and of amyloid targeting therapies in general, and agree that CMS should not provide coverage until there is clear evidence of safety and efficacy with clinically meaningful outcomes in a diverse patient population.’ (Clinician or other health care worker; Academic (including researchers)) • ‘CMS has raised important questions about the available evidence on mAbs for AD, and in particular about the effectiveness of aducanumab, … to support a reasonable and necessary coverage determination for Medicare beneficiaries with MCI and early-stage AD. We agree that there are important evidentiary questions.’ (Academic (including researchers)) |
| Even if more research is conducted, … | |
| … CMS shouldn’t be funding it. | • ‘How can Medicare justify paying for an incredibly expensive drug to be used in CLINICAL TRIALS? ... [T]he government and Medicare users should not be subsidizing clinical trials for Biogen by paying for this. Biogen should pay ... rather than giving Biogen a huge profit on every dose—for them to CONTINUE a clinical trial which should have already been completed before submission to the FDA.’ (Not specified) • ‘Why can’t the pharmaceutical company cover that from their own research budget? The CMS seems to be putting the interests of the drug company ahead of seniors.’ (Self-identified member of the general public/taxpayer) |
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