Skip to main content

CMS Unveils Plan to Ensure Availability of New Alzheimer's Drugs

The Centers for Medicare & Medicaid Services (CMS) has recently announced a comprehensive plan aimed at ensuring the availability of new Alzheimer's drugs for beneficiaries granted full approval by the FDA. This significant development comes in response to the anticipated full FDA-approval of the first new drug for Alzheimer's disease in nearly two decades, signaling a critical milestone in the fight against this debilitating condition. CMS recognizes the urgent need to make these treatments accessible to patients, and their plan outlines several key measures to support coverage and access.


Under the plan, CMS intends to provide Medicare coverage for the newly approved Alzheimer's drugs under the national coverage determination for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. The plan acknowledges the ongoing debate surrounding the efficacy of these drugs, and CMS emphasizes the importance of allowing patients to make informed decisions about their care in consultation with their healthcare providers. 

By allowing coverage for these drugs when part of a registry, CMS emphasizes the significance of gathering real-world evidence to evaluate the effectiveness of these new treatments. By collaborating with the Food and Drug Administration (FDA), CMS aims to collect data on patient outcomes, adverse events, and other critical factors. This robust data collection will contribute to a better understanding of the drugs' impact on patients and assist in informing future coverage decisions and treatment guidelines.

The data collected through the CMS sponsored registry will be made available to researchers to conduct studies, furthering knowledge of how these drugs can potentially help people. Additionally, CMS is working with other organizations that are getting ready to open their own registries. By leveraging this data, CMS aims to provide information and guidance on available treatment options, potential side effects, and other pertinent topics. This initiative aims to empower patients and caregivers with the knowledge needed to navigate their healthcare journey effectively.

Comments

Popular posts from this blog

Selecting Therapeutic Alternatives: A Critical Perspective for Drug Manufacturers

The Inflation Reduction Act (IRA) of 2022 instructed the Centers for Medicare and Medicaid Services (CMS) to initiate drug price negotiations with manufacturers for the first time. A key component of these negotiations involves considering factors like the drug's benefits and costs to establish a "lowest maximum fair price." (MFP) For drug manufacturers, CMS’s process for making comparisons of therapeutic alternative(s) to determine the MFP raises a number of crucial questions. The IRA's guidance suggests that CMS will initially compare drugs within the same class as the negotiated drug to determine a starting point for pricing. For drug manufacturers, this approach raises concerns regarding price competition within drug classes. As new drugs are often priced in line with preexisting brand-name drugs in the same class, the negotiation process may result in downward pressure on prices for all drugs in the class. This could significantly affect the revenue and profitabi...

The Problem of Limited-Supply Agreements for Medicare Price Negotiation

A recent JAMA Viewpoint article discusses how limited-supply agreements between brand name and generic drug makers could impact Medicare price negotiation under the Inflation Reduction Act (IRA). These agreements allow brand manufacturers to maintain some market exclusivity by limiting the supply of generic competitors. The article suggests these deals may increase as the Centers for Medicare and Medicaid Services (CMS) implements the IRA's price negotiation provisions. From a business perspective, it's understandable why brand manufacturers might find limited-supply agreements preferable to having their drugs subject to Medicare negotiation. Maintaining even partial exclusivity is likely better for revenue than triggering government-dictated price reductions. However, policymakers and patients are increasingly concerned that these deals keep prices high despite generic availability. The use of limited supply agreements could also produce unintended consequences.  Balancing som...

TCET Pathway Could Accelerate Access to Innovating Technologies

The Centers for Medicare & Medicaid Services (CMS) proposed the Transitional Coverage for Emerging Technologies (TCET) pathway to enable quicker coverage decisions for breakthrough devices needing accelerated regulatory review. As described in JAMA Health Forum, TCET allows tailored oversight based on an innovation’s specific benefits and risks. TCET focuses on FDA Breakthrough-designated devices for serious conditions supported by limited clinical data for market authorization. By facilitating transitional coverage, TCET aims to help make cutting-edge technologies accessible to patients while additional real-world evidence is gathered to meet CMS’ “reasonable and necessary” standard.  For developers to optimize TCET’s streamlined approach they should be sure to: - Pursue FDA Breakthrough designation when criteria are met. This opens the TCET pathway.   - Engage CMS early on study designs and evidence needs. Incorporate draft guidance on endpoints and real-world data....