According to the CDC, an estimated 6 million Americans are living with Alzheimer's disease. In 2020, the estimated cost of caring for and treating people with Alzheimer’s — health care, long-term care, and hospice and more — was $305 billion. Supporting efforts to better detect, treat, and prevent the onset of this costly chronic disease is critical. Resources RESOURCES > ALZHEIMERS Alzheimer's Disease According to the CDC, an estimated 6 million Americans are living with Alzheimer's disease. In 2020, the estimated cost of caring for and treating people with Alzheimer’s — health care, long-term care, and hospice and more — was $305 billion. Supporting efforts to better detect, treat, and prevent the onset of this costly chronic disease is critical. For more information on the fight fo Alzheimer's patients, families and caregivers, please visit pfcdalz.org . LETTER Sign On Letter to Congress re: CMS NCD with CED for Alzheimer's treatments VIDEO Congressional Leaders Champion Access for People with Alzheimer's Disease April 2023 PATIENT PROFILE Geri Taylor INFOGRAPHIC Leaving Medicare Beneficiaries in Limbo INFOGRAPHIC The Long Road to Treatment: Medicare's CED Clinical Trial Policy INFOGRAPHIC Patient Registries Under CED: Checklist of Endless Difficulties INFOGRAPHIC The Overwhelming Evidence in Support of Amyloid PET INFOGRAPHIC Amyloid Beta PET Scans: By the Numbers INFOGRAPHIC Alzheimers Disease Fact Sheet

The data support preserving access to accelerated approval drugs for the seriously ill. States seek to limit coverage of drugs approved through the FDA’s accelerated approval pathway designed to accelerate availability of medications that treat serious or life-threatening conditions — many cancers, HIV/AIDS, sickle cell and several other rare diseases. Resources RESOURCES > QUANTIFYING IMPACT OF ACCELERATED APPROVAL DRUGS ON MEDICAID SPENDING Quantifying Impact of Accelerated Approval Drugs on Medicaid Spending: De Minimus Impact, Maximum Attention States seek to limit coverage of drugs approved through the FDA’s accelerated approval pathway designed to accelerate availability of medications that treat serious or life-threatening conditions — many cancers, HIV/AIDS, sickle cell and several other rare diseases. A new national and state analysis of Medicaid spending from 2007 to 2020 shows: From 2007 to 2020, accelerated approval medicines accounted for well under one percent of total Medicaid spending , not including drug rebates. At the national level, spending on accelerated approval drugs also accounted for just 0.5% of overall growth in national Medicaid spending between 2007 and 2020. Hospital spending (30%) and physician and clinical services (15.4%) were the primary drivers of growth. After accounting for drug rebates, retail prescription drugs accounted for 5.0% of growth. Accelerated approval drugs accounted for less than 1% of the growth in Medicaid spending in 48 states and the District of Columbia. Only Alabama (1.3%) and South Dakota (2.1%) were slightly higher. In states requesting Medicaid waivers due to cost concerns, 2020 spending data shows accelerated approval drug spend is minuscule — Massachusetts (0.1%), Tennessee (0.4%) and Oregon (0.1%). These data support preserving access to accelerated approval drugs for the seriously ill. WHITE PAPER Quantifying Impact of Accelerated Approval Drugs on Medicaid Spending: An Update through 2020 and State-Level Analysis May 2022 WHITE PAPER March 2021 - Quantifying Impact of Accelerated Approval Drugs on Medicaid Spending: De Minimus Impact, Maximum Attention March 2021 COMMENTARY Health Affairs Forefront: Accelerated Approval Drugs Are Not Driving Medicaid Spending June 3, 2022 COMMENTARY American Journal of Managed Care: Limiting Access to Accelerated Approval Drugs: Costs and Consequences March 30, 2021 LETTER Letter to MACPAC about Considerations on Accelerated Approval Drugs VIDEO Accelerated Approval 101 VIDEO Accelerated Approval: Getting Essential New Treatments to Patients PATIENT VOICES Faces of Accelerated Approval FACT SHEET Patient-Centered Principles: Accelerated Approval INFOGRAPHIC Accelerated Approval Drugs Do Not Drive Medicaid Spending FACT SHEET FDA's Expedited Programs: Getting Essential New Treatments to Patients FACT SHEET What Experts Say About FDA's Expedited Programs PRESS RELEASE New Analysis Finds Accelerated Approval Drugs Do Not Drive Medicaid Spending June 3, 2022 PRESS RELEASE New Analysis of Medicaid Spending Reinforces Value and Patient Impact of FDA Accelerated Approval Pathway March 30, 2021 OP ED FDA's Accelerated Approval Pathway: Separating Fact from Fiction — Pat Furlong, Annie Kennedy & Ken Thorpe October 20, 2021 OP ED Curtailing Medicaid coverage of accelerated approval therapies threatens patients' access — Terry Wilcox & Teonna Woolford May 3, 2021 PODCAST Patents and Accelerated Approval for Drugs PODCAST This is Growing Old by the Alliance for Aging Research — Episode 27

The Partnership to Fight Chronic Disease (PFCD) is an internationally-recognized organization of patients, providers, community organizations, business and labor groups, and health policy experts committed to raising awareness of the number one cause of death, disability, and rising health care costs: chronic disease Terms of Use Last Updated: February 6, 2026 Partnership to Fight Chronic Disease You agree to receive recurring automated informational text (e.g., SMS and MMS) messages from the Partnership to Fight Chronic Disease, including text messages that may be sent using an automatic telephone dialing system, to the mobile telephone number you provided when signing up or any other number that you designate. All the different types of messages you may receive (Informational messages, vote reminders, shall be known collectively as the "Programs." Consent to receive automated informational text messages is not a condition of any purchase. Cost Msg & Data rates may apply. Please consult with your carrier for rate information. Message Frequency Message frequency will vary. The Partnership to Fight Chronic Disease reserves the right to alter the frequency of messages sent at any time, so as to increase or decrease the total number of sent messages. The Partnership to Fight Chronic Disease also reserves the right to change the phone number from which messages are sent. Not all mobile devices or handsets may be supported and our messages may not be deliverable in all areas. The Partnership to Fight Chronic Disease, its service providers and the mobile carriers supported by the program are not liable for delayed or undelivered messages. Cancellation If you do not wish to continue participating in any Program or no longer agree to these Terms, you agree to text the applicable Short Code (or regular long code phone number where applicable) or directly reply to any mobile message received from a Program with STOP, END, CANCEL, UNSUBSCRIBE, or QUIT in order to opt out of that Program at any time. You may receive an additional mobile message confirming your decision to opt out. You understand and agree that the foregoing options are the only reasonable and exclusive methods of opting out. You also understand and agree that any other method of opting out, including, but not limited to, texting words or phrases other than those set forth above or verbally requesting the Partnership to Fight Chronic Disease to remove you from our list, is not a reasonable means of opting out. You may be subscribed to multiple Programs across different Short Codes or regular long code phone numbers, and therefore you must separately text or reply STOP to each Short Code or long code phone number from which you wish to unsubscribe. Support For support regarding the Program, text “HELP” to the applicable Program’s Short Code or long code, or email us at info@fightchronicdisease.org . Please note that the use of this email address, or texting “HELP” to the Program’s Short or long Code is not an acceptable method of opting out of the program. Opt outs must be submitted in accordance with the procedures set forth above. Our Disclaimer of Warranty The Programs are offered on an "as-is" basis and may not be available in all areas at all times and may not continue to work in the event of product, software, coverage or other changes made by your wireless carrier. We will not be liable for any delays or failures in the receipt of any mobile messages connected with any Program. Delivery of mobile messages is subject to effective transmission from your wireless service provider/network operator and is outside of our control. We are not liable for delayed or undelivered mobile messages. Privacy Policy We respect your privacy. We will only use information you provide to transmit your mobile messages and respond to you, if necessary. This includes sharing information with our program partners, message content providers, phone companies, and vendors who assist us in the delivery of mobile messages. EXCEPT AS SET FORTH IN THIS SECTION, WE DO NOT SELL, RENT, LOAN, TRADE, LEASE OR OTHERWISE TRANSFER FOR PROFIT ANY PHONE NUMBERS OR CUSTOMER INFORMATION COLLECTED THROUGH PROGRAMS TO ANY THIRD PARTY. Nonetheless, we reserve the right at all times to disclose any information as necessary to satisfy any law, regulation or governmental request, to avoid liability, or to protect our rights or property. When you complete forms online or otherwise provide us information in connection with a Program, you agree to provide accurate, complete, and true information. You agree not to use a false or misleading name or a name that you are not authorized to use. If in our sole discretion, we believe that any such information is untrue, inaccurate, or incomplete, or you have opted into a Program for an ulterior purpose, we may refuse you access to the Program and pursue any appropriate legal remedies. This Privacy Policy and Terms and Conditions is strictly limited to these Programs and has no effect on any other privacy policy(ies) that may govern the relationship between you and us in other contexts.

For many patients, access to treatment is about more than whether a therapy is covered. It is also about what it takes to realistically fit that care into their lives. On July 30, the Partnership to Fight Chronic Disease (PFCD) hosted a Congressional Hill Briefing examining the Centers for Medicare & Medicaid Services’ (CMS) proposed treatment of fixed-dose combination (FDC) therapies under the qualifying single-source drug (QSSD) definition in Medicare’s Drug Price Negotiation Program. The discussion focused on the patient impacts related to how a proposed change could treat two separately FDA-approved products as a single qualifying single-source drug, even when one product contains an additional active ingredient that enables a different route of administration, such as moving from an intravenous infusion to a subcutaneous injection. These kinds of distinctions can have a meaningful impact on patients. More convenient treatment options can reduce the time patients spend traveling to and receiving care, as well as the burden on family members and caregivers. For older adults and people living in rural or underserved communities, reducing these barriers can make a significant difference in their ability to stay on course with prescribed treatment. During the briefing, patient and community advocates shared what these barriers can look like in real life. As PFCD's Vice President of Policy and Advocacy Candace DeMatteis emphasized the importance of policymakers more fully considering the patient experience when evaluating changes to Medicare’s drug negotiation framework. Innovation is not only about developing new medicines; it can also mean finding better ways for patients to receive the treatments they need. Anna Howard of the American Cancer Society Cancer Action Network highlighted the significance of understanding patients as people with lives, responsibilities, and challenges beyond their treatment. For patients living in rural communities, accessing care can mean traveling several hours to reach a cancer treatment facility. When a therapy offers a less burdensome way to receive treatment, that difference matters. Burton Eller of the National Grange shared the story of a rancher in his 60s battling stage three cancer who was driving to Fort Worth three days a week for infusions, a schedule that consumed much of the week for both him and his wife. Stories like these underscore why Medicare policy should account for the real-world impact of how care is delivered. Policies that unintentionally discourage investment in new formulations or routes of administration could limit future treatment options and make it harder for patients to benefit from innovations designed to make care more accessible. PFCD, joined by 50 patient, provider, and health organizations, recently submitted comments to CMS urging the agency to reconsider its proposed approach to FDC therapies. As CMS considers changes to the Medicare Drug Price Negotiation Program, policymakers should ensure that the framework continues to support patient-centered innovation and recognizes the importance of expanding how and where patients can receive care. Read the full comments to CMS from PFCD and 50 other organizations HERE.

The Partnership to Fight Chronic Disease (PFCD), joined by 50 patient, provider, and health organizations, submitted comments urging the Centers for Medicare & Medicaid Services (CMS) to reconsider a proposed change to how fixed-dose combination therapies are classified under the Medicare Drug Price Negotiation Program. The proposal could treat two separately FDA-approved products as a single qualifying single source drug – even when one product includes an additional active ingredient that enables a different route of administration, such as a shift from intravenous infusion to subcutaneous injection. For patients, these distinctions matter. A shorter or more convenient administration method can reduce travel, time away from work or caregiving responsibilities, and other barriers to staying on treatment – particularly for older adults and people living in rural or underserved communities. Medicare policy should recognize the scientific advances and patient benefits associated with therapies that expand where and how care is delivered. Read PFCD’s full letter to CMS here.

If you're one of nearly 200 million Americans living with a chronic disease, Medicare policy debates can often feel far removed from your daily life. But sometimes, a technical-sounding proposal can have real consequences for the treatments you rely on — and that's exactly what's happening right now. The Centers for Medicare and Medicaid Services (CMS) is considering a change to how it classifies certain drugs under the Medicare Drug Price Negotiation Program (MDPNP) established under the Inflation Reduction Act. Specifically, the agency is looking at whether an IV infusion and a subcutaneous (under-the-skin) injection of the same medication should be counted as one product — not two – for the purposes of price setting. At first, that might sound like a bureaucratic accounting question. But for patients and caregivers, the stakes are very real. An IV infusion requires patients to travel to an infusion center or hospital outpatient facility, often for appointments lasting several hours. By contrast, a subcutaneous injection can be administered in minutes, typically in a doctor’s office or even at home. Giving patients the choice between treatments – and administration of treatments – is critically important. Injections are often less costly than IV infusions and far more accessible for many populations, including rural patients who may live hours from an infusion center, individuals without reliable transportation, and elderly patients and caregivers. When given the choice, 71% of patients prefer injection over IV administration (for a given therapy) – but this proposal from CMS effectively eliminates that choice for patients – and sends a signal that could discourage further innovation in this space. The implications of this proposed rule extend beyond patient experience. Developing an injectable alternative is not a simple modification—it requires years of research, substantial investment, and a separate FDA review process. The FDA, not CMS, has the scientific expertise and statutory authority to determine whether therapies are distinct medicines. When the FDA approves both an IV and a subcutaneous version as separate products, it does so based on independent evaluation of each formulation’s safety, efficacy, and delivery. Treating them as the same product under Medicare policy disregards these distinctions and the meaningful differences they represent for patients. It also risks exceeding CMS’s regulatory role while undermining FDA determinations. This issue is not about a single therapy or company. It is about the signal this policy sends to researchers and developers about which types of innovation are worth pursuing. Under the proposed rule, CMS would effectively eliminate financial incentives for pharmaceutical companies to develop more convenient, patient-friendly delivery options. If Medicare policy treats an improved delivery method the same as its predecessor, it raises a fundamental question: why invest in making treatments easier and safer for patients if those improvements are not recognized as meaningful advancements? The likely result is that resources will be redirected elsewhere. Over time, this could slow progress on innovations that make chronic disease more manageable. early evidence already suggests that the Inflation Reduction Act has had negative effects on research and development, which this policy could further exacerbate. Your voice matters CMS is accepting public comments on this proposal through August 17. That means patients, caregivers, providers, and advocates have a real opportunity to weigh in before decisions are made. Policymakers need to hear from the people who live these realities every day — not just the technical arguments, but the human ones. What does it mean to you to have a treatment option that fits your life? What would you lose if those options disappeared or stopped being developed? Innovation means finding better ways to deliver treatments with less burden, more flexibility, and greater dignity for the people who need them most. Medicare policy should reflect that. Comments on the Medicare Drug Price Negotiation Program for IPAY 2029 are open through August 17, submit comments here.