The Health Policy War Room

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 informe...

In the CY 2022 Physician Fee Schedule Proposed Rule, released yesterday (https://public-inspection.federalregister.gov/2021-14973.pdf) CMS is proposing two changes to its long-standing policies on drug pricing.  First, CMS is proposing to require manufacturers of drugs covered under Part B to report ASP data even if the manufacturer does not have a Medicaid rebate agreement. Noting that many manufacturers without a Medicaid rebate agreement currently report ASP data to CMS, CMS believes its proposed will cause little upset to manufacturers and would in fact preserve the status quo.  In a 2017 report (http://medpac.gov/docs/default-source/reports/jun17_ch2.pdf), MEDPAC presented findings many repackagers do not report ASP data to CMS and that this failure to report could be skewing Medicare payment rates. In this year’s proposal, CMS presents its own findings that exempting repackagers from reporting ASP data could increase errors in ASP calculations and delay CMS’s ability to ...

On June 22, Senator Ron Wyden (D-Ore.), Chairman of the Senate Finance Committee released his own set of “principles” for lowering prescription drug prices. Characterized as a step toward “comprehensive legislation” on the matter, the principles are said to guide Wyden’s work during the summer months with the ultimate goal of delivering relief from high prescription drug prices. Wyden’s principles largely reflect the concepts that have been widely circulated as parts of many prior statements on reducing drug prices. Medicare negotiation, limiting out-of-pocket costs at the pharmacy counter, controlling price increases for older drugs, and rewarding innovation are concepts that have been debated at length in the past. Wyden also suggests that any drug pricing proposals should apply to all Americans – not just those covered by Medicare. Acknowledging the work already done by the Senate Finance Committee, Wyden’s goal is to develop a legislative package, with bipartisan support, that can ...

After reading Dr. Adam Fein's blog about growth in the biosimilar market (here:https://www.drugchannels.net/2020/10/the-booming-biosimilar-market-of-2020.html) I decided to take my own look at Medicare payments for biologicals and their biosimilar competitors to see if there have been any recognizable changes. Read on to see what I found.... Biologicals are products that include blood, tissues, recombinant proteins and others that are developed using natural sources. Unlike small molecule drugs, which are chemically synthesized and have well known and understood chemical structures, biologics are exceptionally complex and can be complicated to manufacture. Because of their nature, biologics are highly susceptible to production variations -- making them difficult to replicate. This manufacturing sensitivity is what makes it virtually impossible for manufacturers to develop an exact replica, or a “generic” biologic. This is part of what led to the development of biosimilars. Biosimil...