Exemplary quotes regarding downstream effects of the proposed NCD on health disparities
| The proposed NCD would … | |
| … harm disadvantaged populations. | • ‘And now, once again, we have raised hopes for an Alzheimer’s disease modifying therapy only to now declare that it will be available primarily to affluent, white Americans, not the communities who have the greatest need, the communities whose trust and trial participation we seek to encourage.’ (Person living with Alzheimer’s disease; Alzheimer’s patient advocacy organization) • ‘The concentration of CED trials at major academic medical centers engendered by the agency’s proposal could worsen existing disparities in Alzheimer’s treatment against minority racial and ethnic groups, socioeconomically disadvantaged Americans, and persons residing in rural areas.’ (Pharmaceutical company/industry association) • ‘But with CMS’s proposed decision limiting coverage to those in clinical trials, access is severely restricted to only those few who live near research institutions, or can afford to pay out-of-pocket.’ (Alzheimer’s patient advocacy organization) |
| … help disadvantaged populations. | • ‘We support the requirement that the RCTs reflect “the diversity of patients [and be a] representative [cross-section] of the national population diagnosed with [Alzheimer’s],” (eg age, gender, disease severity). … This expansion of trial populations will proactively avoid potential disparities in care.’ (Pharmaceutical company/industry association) • `We strongly support CMS’ emphasis on the importance of evaluating the safety and effectiveness of treatment on different groups beyond those enrolled in the clinical trials, including minorities, underserved, and low-income individuals, many of whom are at greater risk for developing AD and who may be more likely to have a missed diagnosis of the disease. Without this additional research, it will be unclear whether access to this treatment, with its accompanying risks, is in the best interests of diverse populations that have been systematically underserved by prior clinical trials.' (Insurer or other payer) |
| … favor those who can afford to pay out of pocket. | • ‘Restricting access only to patients that can afford to pay out of pocket is unfair and worsens the inequity in health care.’ (Not specified) • ‘The draft NCD establishes two distinctly separate tiers of access. Wealthy individuals who qualify for the drug can pay out of pocket. The rest of those who may benefit from such a treatment can only access the drug through clinical trial participation.’ (Other advocacy organization) |
| … discriminate against AD patients as a group by treating them differently than patients with other diagnoses. | • ‘This proposed decision is inequitable compared to decisions made in the past for other terminal diseases without any treatments. When the first treatments for HIV or various cancers were approved by the FDA, they were all covered fully by CMS. It is not fair to treat Alzheimer’s Disease treatments any differently.’ (Family member/caregiver of person living with Alzheimer’s disease) • ‘[T]his seems highly discriminatory against a very specific population—those with a diagnosis of Alzheimer. I guess they should have just had cancer instead—that’s the message you are sending.’ (Family member/caregiver of person living with Alzheimer’s disease) • ‘If this were a drug for children or young adults there would no such roadblock—CMS is clearly ageist.’ (Clinician or other health care worker) |
| The proposed NCD would … | |
| … harm disadvantaged populations. | • ‘And now, once again, we have raised hopes for an Alzheimer’s disease modifying therapy only to now declare that it will be available primarily to affluent, white Americans, not the communities who have the greatest need, the communities whose trust and trial participation we seek to encourage.’ (Person living with Alzheimer’s disease; Alzheimer’s patient advocacy organization) • ‘The concentration of CED trials at major academic medical centers engendered by the agency’s proposal could worsen existing disparities in Alzheimer’s treatment against minority racial and ethnic groups, socioeconomically disadvantaged Americans, and persons residing in rural areas.’ (Pharmaceutical company/industry association) • ‘But with CMS’s proposed decision limiting coverage to those in clinical trials, access is severely restricted to only those few who live near research institutions, or can afford to pay out-of-pocket.’ (Alzheimer’s patient advocacy organization) |
| … help disadvantaged populations. | • ‘We support the requirement that the RCTs reflect “the diversity of patients [and be a] representative [cross-section] of the national population diagnosed with [Alzheimer’s],” (eg age, gender, disease severity). … This expansion of trial populations will proactively avoid potential disparities in care.’ (Pharmaceutical company/industry association) • `We strongly support CMS’ emphasis on the importance of evaluating the safety and effectiveness of treatment on different groups beyond those enrolled in the clinical trials, including minorities, underserved, and low-income individuals, many of whom are at greater risk for developing AD and who may be more likely to have a missed diagnosis of the disease. Without this additional research, it will be unclear whether access to this treatment, with its accompanying risks, is in the best interests of diverse populations that have been systematically underserved by prior clinical trials.' (Insurer or other payer) |
| … favor those who can afford to pay out of pocket. | • ‘Restricting access only to patients that can afford to pay out of pocket is unfair and worsens the inequity in health care.’ (Not specified) • ‘The draft NCD establishes two distinctly separate tiers of access. Wealthy individuals who qualify for the drug can pay out of pocket. The rest of those who may benefit from such a treatment can only access the drug through clinical trial participation.’ (Other advocacy organization) |
| … discriminate against AD patients as a group by treating them differently than patients with other diagnoses. | • ‘This proposed decision is inequitable compared to decisions made in the past for other terminal diseases without any treatments. When the first treatments for HIV or various cancers were approved by the FDA, they were all covered fully by CMS. It is not fair to treat Alzheimer’s Disease treatments any differently.’ (Family member/caregiver of person living with Alzheimer’s disease) • ‘[T]his seems highly discriminatory against a very specific population—those with a diagnosis of Alzheimer. I guess they should have just had cancer instead—that’s the message you are sending.’ (Family member/caregiver of person living with Alzheimer’s disease) • ‘If this were a drug for children or young adults there would no such roadblock—CMS is clearly ageist.’ (Clinician or other health care worker) |
Exemplary quotes regarding downstream effects of the proposed NCD on health disparities
| The proposed NCD would … | |
| … harm disadvantaged populations. | • ‘And now, once again, we have raised hopes for an Alzheimer’s disease modifying therapy only to now declare that it will be available primarily to affluent, white Americans, not the communities who have the greatest need, the communities whose trust and trial participation we seek to encourage.’ (Person living with Alzheimer’s disease; Alzheimer’s patient advocacy organization) • ‘The concentration of CED trials at major academic medical centers engendered by the agency’s proposal could worsen existing disparities in Alzheimer’s treatment against minority racial and ethnic groups, socioeconomically disadvantaged Americans, and persons residing in rural areas.’ (Pharmaceutical company/industry association) • ‘But with CMS’s proposed decision limiting coverage to those in clinical trials, access is severely restricted to only those few who live near research institutions, or can afford to pay out-of-pocket.’ (Alzheimer’s patient advocacy organization) |
| … help disadvantaged populations. | • ‘We support the requirement that the RCTs reflect “the diversity of patients [and be a] representative [cross-section] of the national population diagnosed with [Alzheimer’s],” (eg age, gender, disease severity). … This expansion of trial populations will proactively avoid potential disparities in care.’ (Pharmaceutical company/industry association) • `We strongly support CMS’ emphasis on the importance of evaluating the safety and effectiveness of treatment on different groups beyond those enrolled in the clinical trials, including minorities, underserved, and low-income individuals, many of whom are at greater risk for developing AD and who may be more likely to have a missed diagnosis of the disease. Without this additional research, it will be unclear whether access to this treatment, with its accompanying risks, is in the best interests of diverse populations that have been systematically underserved by prior clinical trials.' (Insurer or other payer) |
| … favor those who can afford to pay out of pocket. | • ‘Restricting access only to patients that can afford to pay out of pocket is unfair and worsens the inequity in health care.’ (Not specified) • ‘The draft NCD establishes two distinctly separate tiers of access. Wealthy individuals who qualify for the drug can pay out of pocket. The rest of those who may benefit from such a treatment can only access the drug through clinical trial participation.’ (Other advocacy organization) |
| … discriminate against AD patients as a group by treating them differently than patients with other diagnoses. | • ‘This proposed decision is inequitable compared to decisions made in the past for other terminal diseases without any treatments. When the first treatments for HIV or various cancers were approved by the FDA, they were all covered fully by CMS. It is not fair to treat Alzheimer’s Disease treatments any differently.’ (Family member/caregiver of person living with Alzheimer’s disease) • ‘[T]his seems highly discriminatory against a very specific population—those with a diagnosis of Alzheimer. I guess they should have just had cancer instead—that’s the message you are sending.’ (Family member/caregiver of person living with Alzheimer’s disease) • ‘If this were a drug for children or young adults there would no such roadblock—CMS is clearly ageist.’ (Clinician or other health care worker) |
| The proposed NCD would … | |
| … harm disadvantaged populations. | • ‘And now, once again, we have raised hopes for an Alzheimer’s disease modifying therapy only to now declare that it will be available primarily to affluent, white Americans, not the communities who have the greatest need, the communities whose trust and trial participation we seek to encourage.’ (Person living with Alzheimer’s disease; Alzheimer’s patient advocacy organization) • ‘The concentration of CED trials at major academic medical centers engendered by the agency’s proposal could worsen existing disparities in Alzheimer’s treatment against minority racial and ethnic groups, socioeconomically disadvantaged Americans, and persons residing in rural areas.’ (Pharmaceutical company/industry association) • ‘But with CMS’s proposed decision limiting coverage to those in clinical trials, access is severely restricted to only those few who live near research institutions, or can afford to pay out-of-pocket.’ (Alzheimer’s patient advocacy organization) |
| … help disadvantaged populations. | • ‘We support the requirement that the RCTs reflect “the diversity of patients [and be a] representative [cross-section] of the national population diagnosed with [Alzheimer’s],” (eg age, gender, disease severity). … This expansion of trial populations will proactively avoid potential disparities in care.’ (Pharmaceutical company/industry association) • `We strongly support CMS’ emphasis on the importance of evaluating the safety and effectiveness of treatment on different groups beyond those enrolled in the clinical trials, including minorities, underserved, and low-income individuals, many of whom are at greater risk for developing AD and who may be more likely to have a missed diagnosis of the disease. Without this additional research, it will be unclear whether access to this treatment, with its accompanying risks, is in the best interests of diverse populations that have been systematically underserved by prior clinical trials.' (Insurer or other payer) |
| … favor those who can afford to pay out of pocket. | • ‘Restricting access only to patients that can afford to pay out of pocket is unfair and worsens the inequity in health care.’ (Not specified) • ‘The draft NCD establishes two distinctly separate tiers of access. Wealthy individuals who qualify for the drug can pay out of pocket. The rest of those who may benefit from such a treatment can only access the drug through clinical trial participation.’ (Other advocacy organization) |
| … discriminate against AD patients as a group by treating them differently than patients with other diagnoses. | • ‘This proposed decision is inequitable compared to decisions made in the past for other terminal diseases without any treatments. When the first treatments for HIV or various cancers were approved by the FDA, they were all covered fully by CMS. It is not fair to treat Alzheimer’s Disease treatments any differently.’ (Family member/caregiver of person living with Alzheimer’s disease) • ‘[T]his seems highly discriminatory against a very specific population—those with a diagnosis of Alzheimer. I guess they should have just had cancer instead—that’s the message you are sending.’ (Family member/caregiver of person living with Alzheimer’s disease) • ‘If this were a drug for children or young adults there would no such roadblock—CMS is clearly ageist.’ (Clinician or other health care worker) |
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