Medicare to cover CAR-T therapies when offered in a CMS-approved registry or clinical study.

View as webpage.

hpw - topbar hpw - topbar - diag hpw - topbar xce

Feb. 22, 2019


Forward to a Friend



View Archived Issues


Proposing to Put the Horse Back Behind the CAR-T With a Coverage Decision


Last Friday, the Centers for Medicare & Medicaid Services (CMS) released the proposed decision memo for CAR T-cell therapy for cancers in response to the formal request for a national coverage determination (NCD) from UnitedHealthcare. CMS is proposing to cover CAR-T treatment for relapsed or refractory cancer for patients who are not experiencing any comorbidity that would preclude benefit through coverage with evidence development (CED) when specific conditions outlined in the NCD are met.

Medicare would cover on-label use for 1 treatment only of a product unless a new primary cancer diagnosis is made for the same patient. CMS outlined treatment criteria for inpatient or outpatient administration. Medicare would cover off-label use for Food and Drug Administration (FDA)-approved CAR-T products for uses identified by the NCCN Drugs & Biologics Compendium with grade 2 or 1 on or after August 2017 for a known antigen expressed in the patient’s cancer when enrolled in a CMS-approved clinical study. It is not clear if a positive rating in any of the other compendia in the absence of a negative rating would be an alternate path for coverage at the contractor level.

Hospitals administering CAR-T therapy must participate in a CMS-approved registry that collects data on patient outcomes and characteristics at baseline, at treatment, and then at 3-month, 6-month, 1-year, and 2-year follow-ups after administration.

The data from these registries and trials will help CMS determine the types of patients who will benefit most from the therapy, which, in turn, will help the agency decide which cases Medicare will cover without a registry or trial requirement.

Interested parties have until March 17, 2019 to comment on this proposed decision; CMS will post a final decision within 60 days of the close of the comment period.

On Tuesday, the American Hospital Association (AHA) followed the release of the proposed decision memo with a letter urging CMS to consider alternative payment solutions for CAR-T therapy, stating that “[i]mmunotherapies such as CAR T, as well as other new technologies, offer extraordinary potential to save lives, but are also associated with extraordinary costs.”

The lack of an overarching CMS coverage policy has meant that coverage decisions generally have been the responsibility of local Medicare Administrative Contractors. Once finalized, the CMS coverage policy will help make coverage consistent across the country for Medicare beneficiaries.


CBI PAP 2019 Keynote: Empathy and Expertise: Evolving Patient Support Programs in the Digital Age


Lash Group is a proud Platinum Sponsor of the 20th Annual Patient Assistance & Access Programs Conference coming March 4–6 to Baltimore, MD.

Join Dr. Tommy Bramley, PhD, President of Lash Group, for a keynote discussion on how continuous improvement of patient access programs requires the right technology and technique. Delve into the environment of high-performance programs and learn more about next-generation patient care. Learn more >

Join us in Baltimore and save $300! Use promo code PBC877. Register here.



HPW Rebuild


Legislative Byte

  • House Ways and Means Health Subcommittee Chairman Lloyd Doggett (D-TX) introduced H.R. 1264, a bill to provide the Medicare Payment Advisory Commission (MedPAC) and the Medicaid and CHIP Payment and Access Commission (MACPAC) with access to specified drug payment information, including certain rebate information.

HPW Rebuild


Companies Jump the Shark on ICER’s Value-Based Price Announcement


Last Friday, the Institute for Clinical and Economic Review (ICER) published a new evidence update for PRALUENT (alirocumab), a PCSK9 inhibitor used in the treatment of high cholesterol. This report closely followed an announcement from co-developers Sanofi and Regeneron that came out the preceding week, stating that the companies were cutting the list price of alirocumab by 60%, to $5,850 annually. While this price reduction was substantial, ICER recommended an even lower value-based price range of $2,300 to $4,000 per year.

The evidence update conducted by ICER was based on new data published from the ODYSSEY Outcomes trial. Based on these new findings, ICER revised its value-based price benchmark ranges for alirocumab to $2,300–$3,500 per year if used to treat all patients who meet ODYSSEY trial eligibility criteria, and $2,700–$4,000 per year if only used to treat higher-risk patients with LDL cholesterol ≥100 mg/dL despite intensive statin therapy. ICER previously assessed the cost-effectiveness of alirocumab shortly after it was first granted regulatory approval in the US in 2015, in which it recommended an 85% reduction from the list price.

Based on this most recent report, it appears that ICER does not believe that the recent 60% price cut for alirocumab was enough. As ICER continues to publish evidence updates for other products when new data are available, it will be interesting to see how its findings impact the evolving value and pricing landscape. It is unclear if the ICER evaluations of the PCSK9 inhibitors directly influenced these price cuts by Sanofi/Regeneron and rival Amgen, or if this is simply a circumstance of a competitive market in which there are 2 competitors battling for their share.

As always, if you need assistance with all things ICER or value-related, please contact

HPW Rebuild


FDA Asks—Help Us, Help You Introduce Generics


Last Friday, the FDA announced draft guidance for a new pathway for competitive generic therapies (CGTs) to incentivize developing generic versions of drugs facing little or no competition. Pathway benefits include product development meetings with the FDA to advance study design or alternative approaches, reducing the time to receive approval, or a 180-day period of marketing exclusivity.

The FDA noted that “these early benefits may also help to reduce the number of application review cycles ultimately decreasing the time it takes for the generic drug to receive approval.”

This draft guidance is a further step in the FDA’s effort to bolster generic competition, which it hopes will help lower the cost of drugs and improve patient access.


Didn’t You Get the Memo? Value-Based Reimbursement Programs Are Hard


In recent years, value-based reimbursement (VBR) programs have been gaining momentum. According to the results of HealthEdge’s latest Voice of the Market Survey, however, payers continue to struggle with the transition to a payment model that rewards value. The HealthEdge survey was based on interviews with 151 health insurance executives and their organizations’ experiences with VBR.

As shown in the chart below, it is a prevalent practice—92.7% of payers have at least a quarter of their provider contracts tied to VBR, with almost half (46.4%) of payers having between one-half and three-quarters of their provider contracts being VBR-based.

The survey findings indicated that, while there is overall agreement that provider alignment on key performance indicators is the first step to success, mass adoption of VBR programs among traditional health insurers will be challenging. Responses point to payers being concerned with each of 5 challenges.

Unfortunately, there are no selections that are either dominant or miniscule, implying that payers will be having to tackle implementing VBR across a number of barriers. Steve Krupa, CEO of HealthEdge, stated that for payers and providers to overcome these challenges, they will need to build trust and establish shared goals.

Despite the hope that VBR will help lower healthcare costs and result in higher-quality care, this survey demonstrates how difficult it is to implement and execute a successful VBR arrangement.


Information Buffet (AKA, Other Stuff That Caught Our Attention)


We kept running into stories we wanted to bring to your attention, so here’s a quick hit list of other news we thought you should know:


“[W]e’re also fully aware of the need to address the impact of certain headwinds that are having a disproportionate impact in ’19 when compared to prior years…. [M]ost significant is the ongoing pharmacy reimbursement pressures in our businesses and the reduction in offsets to those pressures. What we’re experiencing in ’19 is the declining benefit from new generics, lower brand inflation, and the ongoing questions around rebates, along with some structural and CVS-specific challenges in the long-term care space.”

– CVS Health President and CEO Larry Merlo, commenting that the company could be hurt by lower drug prices and the proposed rebate rule

Source: “CVS Health Corp. (CVS) CEO Larry Merlo on Q4 2018 Results—Earnings Call Transcript,” February 20



5.5% | 7.4%, 5.5%, 4.8%


The CMS Office of the Actuary projects national healthcare spending will grow an average of 5.5% annually over the next decade. Medicare costs are expected to increase by 7.4% per year, Medicaid costs are projected to bump up by 5.5% each year, and private insurance expenditures are expected to grow 4.8%.

Source: “CMS Office of the Actuary Releases 2018–2027 Projections of National Health Expenditures,” CMS, February 20


CBI PAP 2019: 20th Annual Patient Assistance & Access Programs

March 4–6 | Baltimore, MD
Join Xcenda and Lash Group at the upcoming CBI PAP 2019 Conference in Baltimore, MD March 4–6. Xcenda’s Vice President of Reimbursement and Policy Insights and Editor-in-Chief of Health Policy Weekly, Jennifer Snow, MPH, will deliver the state of the industry address titled, “The Evolving Healthcare Landscape and the Impacts on Patient Access and Affordability.” Lash Group President Tommy Bramley, PhD, will deliver the conference’s keynote on “Empathy and Expertise—Evolving Patient Support Programs in the Digital Age.” Learn more


AMCP Managed Care & Specialty Pharmacy Annual Meeting

March 25–28 | San Diego, CA
Join AmerisourceBergen companies, US Bioservices and Xcenda, at AMCP’s Annual Meeting at the San Diego Convention Center, March 25–28. Meet with our specialty pharmacy, commercialization, and market access experts at the largest gathering of managed care professionals who work, lead, and innovate in the ever-changing world of pharmaceutical management. Visit AmerisourceBergen at booth 818. Learn more


Count on Health Policy Weekly for an at-a-glance view of legislative and regulatory developments and news that impacts the healthcare industry.


Jennifer Snow
Vice President,
Reimbursement and
Policy Insights,

Scott Shields
Associate Director,
Health Policy



Amy Grogg, PharmD
Senior Vice President | Commercialization Solutions | AmerisourceBergen Corporation

Kristine Flemister, PharmD
President | Xcenda

Tommy Bramley, PhD, RPh
President | Lash Group

Stacie Heller
Vice President | Government Policy | AmerisourceBergen Corporation

Rita Norton
Senior Vice President | Government and Public Policy | AmerisourceBergen Corporation

Ana Stojanovska
Vice President | Commercial Consulting | Xcenda


Joaquin Zabalza Seguin | Scott Shields | Linnea Tennant | Tammy Washington


Laurie Kozbelt | Ellen Olson | Tia O’Brien


Feb. 22, 2019


Forward to a Friend



View Archived Issues



Connect with AmerisourceBergen:   I  AmerisourceBergen Insights  |   LinkedIn   I  Twitter  

Connect with Xcenda:   I   LinkedIn   I  Twitter