MONTH YEAR

FormularyDecisions Connection Newsletter

Browse new features, discover platform releases, learn about upcoming events, and stay up to date on all the latest insights.

In this month's Connection newsletter:

 

February is American Heart Month

Catch up on facts and figures from the American Heart Association (AHA) on cardiovascular disease:1 
  • Cardiovascular disease has been the leading cause of death in the United States since 1921.  
  • Although death rates from cardiovascular disease have declined 60% since 1950, the AHA recently reported 702,880 annual deaths. 
  • The rates have fluctuated over the years and recently trended upward, given worsening risk factors such as diabetes, population aging, and health inequities. 
  • From 2019 to 2020, heart disease costs were $252.2 billion, which includes the cost of healthcare services, medication, and lost productivity.    

Utilize our resources below to access the latest information:

Utilize Disease Pages, Clinical Guideline Snapshots, and Metasearch Results to access the latest information and support coverage decisions for cardiovascular conditions. A sample of Metasearch Results articles from cardiovascular and cardiomyopathy disease pages on FormularyDecisions are included below.

Disease Pages


hcdm

 

Acute decompensated heart failure – reduced ejection fraction (acute HFrEF)
Atherosclerosis
Cardiovascular disease
Chronic heart failure and other cardiomyopathies 
Chronic heart failure – preserved ejection fraction (chronic HFpEF)
Chronic heart failure – reduced ejection fraction (chronic HFrEF)
Congestive heart failure (CHF) 
Coronary artery disease (CAD)
Heart failure
Hypertrophic cardiomyopathy
Ischemic cardiomyopathy
Transthyretin amyloid cardiomyopathy (ATTR-CM)

 

Clinical Guideline Snapshots

 

hcdm

 

American College of Cardiology (ACC)/AHA guidelines for chronic coronary disease 
ACC guidelines for the management of heart failure, including HFpEF

Metasearch Results


Atherosclerotic cardiovascular disease risk assessment for primary prevention in adults2
Overview of pediatric risk factors for premature atherosclerotic cardiovascular disease3
Skin inflammation, systemic inflammation, and cardiovascular disease in psoriasis4
External validation of the AHA PREVENT cardiovascular disease risk equations5
Treatment of ischemic cardiomyopathy6
Heart failure drug development over the eras7
Heart failure and all-cause hospitalizations in patients with heart failure: a meta-analysis8

 

 

New and Updated eDossiers

Did you know that the eDossier PDF viewer includes a user-friendly table of contents for seamless navigation, as well as tools for annotation that are included in eDossier exports? Explore all these features and more in this 2-minute video tutorial.

Leverage tools from the video tutorial to help you navigate eDossiers like a pro. See below for links to the product pages with eDossiers that were posted or updated within the last 90 days. On any product page, you have the option to access the specific eDossier by submitting an eRequest. Log into FormularyDecisions today to view all eDossiers available. 

 

PDUFA date
Pipelinea product name

06/26/2025

Elinzanetant

09/26/2025

CK-274 (aficamten)

Second half 2025

LP-0133 (delgocitinib)

 

FDA approval date*
Product name
FDA-approved indicationb

01/15/2025

OMVOH® (mirikizumab-mrkz)9

UC, CD

12/20/2024

ZEPBOUND® (tirzepatide)10

Obesity, OSA

12/13/2024

CRENESSITY™ (crinecerfont)11

CAH

12/04/2024

BIZENGRI® (zenocutuzumab-zbco)12

NSCLC,c pancreatic adenocarcinomac

11/22/2024

ATTRUBY™ (acoramidis)13

ATTR-CM

11/20/2024

ZIIHERA® (zanidatamab-hrii)14

BTC

11/15/2024

REVUFORJ® (revumenib)15

Leukemia

10/18/2024

VYLOY® (zolbetuximab-clzb)16

Gastric or GEJ adenocarcinoma

09/27/2024

DUPIXENT® (dupilumab)17

AD, asthma, CRSwNP, EoE, PN, COPD

09/19/2024

RYBREVANT® (amivantamab-vmjw)18

NSCLC

09/17/2024

KEYTRUDA® (pembrolizumab)19

Melanoma, NSCLC, MPM, HNSCC, cHL, PMBCL, urothelial cancer, CRC, gastric cancer, esophageal cancer, cervical cancer, HCC, BTC, MCC, RCC, endometrial cancer, TMB-H cancer,c cSCC, TNBC

08/14/2024

NIKTIMVO™ (axatilimab-csfr)20

cGVHD

07/02/2024

KISUNLA™ (donanemab-azbt)21

Alzheimer’s disease

04/05/2024

ENHERTU® (fam-trastuzumab deruxtecan-nxki)22

Breast cancer

03/26/2024

WINREVAIR® (sotatercept-csrk)23

PAH (WHO Group 1)

12/14/2023

WELIREG® (belzutifan)24

VHL, RCC

09/21/2023

JARDIANCE® (empagliflozin)25

HF, CKD, type 2 diabetes mellitus

08/11/2023

AKEEGA® (niraparib and abiraterone)26

Prostate cancer

05/23/2023

BRIXADI® (buprenorphine)27

Opioid use disorder

11/14/2022

ELAHERE® (mirvetuximab soravtansine-gynx)28

Ovarian, fallopian tube, or primary peritoneal cancer

12/22/2022

SUNLENCA® (lenacapavir)29

HIV-1

07/18/2022

OPZELURA® (ruxolitinib)30

AD, nonsegmental vitiligo

12/15/2021

ZEPOSIA® (ozanimod)31

MS, UC

08/25/2021

SKYTROFA® (lonapegsomatropin-tcgd)32

Inadequate GH

03/06/2020

ISTURISA® (osilodrostat)33

Cushing’s disease

09/12/2019

IBSRELA® (tenapanor)34

IBS-C

05/09/2017

BAVENCIO® (avelumab)35

MCC, urothelial cancer

04/27/2017

STIVARGA® (regorafenib)36

CRC, GIST, HCC

10/21/2015

VELTASSA® (patiromer)37

Hyperkalemia

05/15/2013

XOFIGO® (radium Ra 223 dichloride)38

Prostate cancer

10/10/2010

ACTHAR® GEL (repository corticotropin)39

Infantile spasms, MS, rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases, respiratory diseases, edematous state

*For multi-indication products, the FDA-approved date for the most recently updated approved indication is listed.

Key: AD – atopic dermatitis; ATTR-CM – transthyretin amyloid cardiomyopathy; BTC – biliary tract cancer; CAH – congenital adrenal hyperplasia; CD – Crohn’s disease; cGVHD – chronic graft-versus-host disease; cHL – classical Hodgkin lymphoma; CKD – chronic kidney disease; COPD – chronic obstructive pulmonary disease; CRC – colorectal cancer; CRSwNP – chronic rhinosinusitis with nasal polyps; cSCC – cutaneous squamous cell carcinoma; EoE – eosinophilic esophagitis; GEJ – gastroesophageal junction; GIST – gastrointestinal stromal tumor; GH – growth hormone; HCC – hepatocellular carcinoma; HF – heart failure; HIV-1 – human immunodeficiency virus type 1; HNSCC – head and neck squamous cell cancer; IBS-C – irritable bowel syndrome with constipation; MCC – Merkel cell carcinoma; MPM – malignant pleural mesothelioma; MS – multiple sclerosis; NSCLC – non-small cell lung cancer; OSA – obstructive sleep apnea; PAH – pulmonary arterial hypertension; PMB – primary mediastinal large B-cell lymphoma; PN – prurigo nodularis; RCC – renal cell carcinoma; TMB-H – tumor mutational burden-high; TNBC – triple-negative breast cancer; UC – ulcerative colitis; VHL – Von Hippel-Lindau disease.

 

 

Upcoming webinars

Stay current with the latest sessions by registering for upcoming webinars and accessing past recordings.

AMCP PIE Webinar

Investigational Cell-Based Autologous Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB)a

Date: Tuesday, March 4, 2025 
Time: 2:00-3:00 pm ET 

This product is in the clinical evaluation stage and has not been approved for use by the FDA. The safety and efficacy of this product have not been established. 

This PIE webinar is sponsored by Abeona Therapeutics. The content of the webinar and opinions expressed by the presenters are those of the sponsor or presenters and not of AMCP or FormularyDecisions. FormularyDecisions is proud to partner with AMCP to enable information sharing between healthcare decision-makers and biopharma companies. 

Click below for webinar details and to register: 

AMCP Webinar hosted by FormularyDecisions®

The missing PIEce: Best practices for implementing Pre-approval Information Exchange (PIE) in a payer communication plan

Date: Friday, March 14, 2024
Time: 2:00-3:00 pm ET

Join us for an interactive, engaging, and informative discussion as we dive into the evolving landscape of pre-approval information exchange (PIE). Our diverse panel of biopharma and market access and communication experts will guide you through a live session filled with valuable insights and strategies for engaging healthcare decision-makers with pre-approval information. We will explore opportunities and innovative solutions for leveraging PIE when collaborating with stakeholders.

Learning Objectives

  • Understand the latest trends in how pre-approval information exchange (PIE) is leveraged by biopharma companies to communicate with healthcare decision-makers through various channels.
  • Explore the impact of effective PIE strategies on stakeholder engagement and decision-making.

Click below for webinar details and to register through the AMCP website:

 
 

Cencora | NASP Webinar

Enhancing Specialty Drug Review and Formulary Insights

Date: Tuesday, March 25th, 2025 
Time: 1:00-2:00 pm ET 

FormularyDecisions | Cencora, in partnership with The National Association of Specialty Pharmacy, is pleased to announce a webinar, where you'll receive an overview of FormularyDecisions®, an online platform that supports the exchange of information between healthcare decision-makers and biopharma companies to streamline the product review process. This resource provides healthcare decision-makers complimentary access to evidence on more than 3,900 pipeline and FDA-approved products. 

Key features covered in this webinar: 

  • Biosimilar Hub: an industry-recognized resource with an interactive chart of the US market landscape, a repository of state substitution laws, and a biosimilar indication tool 
  • Formulary Coverage Insights Tool: pharmacy and medical coverage data on formulary placement of hundreds of products 
  • Product Snapshots: curated pre-approval product information, clinical trial summaries, and P&T considerations created by clinical pharmacists 

AMCP PIE Webinar

UGN-102 Pre-Approval Information Exchange (PIE) Presentationa

Date: Wednesday, March 26, 2025
Time: 2:00-3:00 pm ET

This product is in the clinical evaluation stage and has not been approved for use by the FDA. The safety and efficacy of this product have not been established.

This PIE webinar is sponsored by UroGen Pharma, Inc. The content of the webinar and opinions expressed by the presenters are those of the sponsor or presenters and not of AMCP or FormularyDecisions. FormularyDecisions is proud to partner with AMCP to enable information sharing between healthcare decision-makers and biopharma companies.

Click below for webinar details and to register:

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Learn something new

Equip your clinical team with a resource that streamlines the search for relevant product information. Schedule a demo and ensure your team is leveraging all that FormularyDecisions has to offer.

 

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Need assistance logging into FormularyDecisions, interesting in referring a peer or colleague, or looking to schedule a personalized refresher demo – we're here to help!
 
References:
  1. Martin S, Aday A, Almarzooq Z, et al.; American Heart Association Council on Epidemiology and Prevention Statistics Committee; Stroke Statistics Subcommittee. 2024 Heart disease and stroke statistics: a report of US and global data from the American Heart Association. Circulation. 2024;149:e347-913. https://www.ahajournals.org/doi/10.1161/CIR.0000000000001209
  2. Wilson P. UpToDate. Atherosclerotic cardiovascular disease risk assessment for primary prevention in adults. Literature review current through: Jan 2025. Topic last updated Sept 2024. https://www.uptodate.com/contents/atherosclerotic-cardiovascular-disease-risk-assessment-for-primary-prevention-in-adults?search=cardiovascular+disease+cardiovascular+disease&source=search_result&selectedTitle=7%7E150&usage_type=default
  3. Hartz J, de Ferranti S. UpToDate. Overview of pediatric risk factors for premature atherosclerotic cardiovascular disease (ASCVD). Literature review current through: January 2025. This topic last updated: January 24, 2025. https://www.uptodate.com/contents/overview-of-pediatric-risk-factors-for-premature-atherosclerotic-cardiovascular-disease-ascvd?search=cardiovascular+disease+cardiovascular+disease&source=search_result&selectedTitle=4%7E150&usage_type=default
  4. Svedbom A, Mallbris L, González-Cantero Á, et al. Skin inflammation, systemic inflammation, and cardiovascular disease in psoriasis. JAMA Dermatol. 2025;161(1):81-86. doi: 10.1001/jamadermatol.2024.4433
  5. Scheuermann B, Brown A, Colburn T, Hakeem H, Chow CH, Ade C. External validation of the American Heart Association PREVENT cardiovascular disease risk equations. JAMA Netw Open. 2024;7(10):e2438311.
    doi: 10.1001/jamanetworkopen.2024.38311
  6. Fang J, Aranki D, Anyanwu A. UpToDate. Treatment of ischemic cardiomyopathy. Literature review current through: January 2025. This topic last updated: May 11, 2023. https://www.uptodate.com/contents/treatment-of-ischemic-cardiomyopathy?search=heart+failure+heart+failure&source=search_result&selectedTitle=4%7E150&usage_type=default
  7. Medscape.com. Heart failure drug development over the eras. December 1, 2024. https://www.medscape.com/s/viewarticle/1002042
  8. Sayed A, ElRefaei M, Awad K, et al. Heart failure and all-cause hospitalizations in patients with heart failure: a meta-analysis. JAMA Netw Open. 2024;7(11):e2446684. doi: 10.1001/jamanetworkopen.2024.46684
  9. Omvoh. Prescribing information. Eli Lilly and Company; 2025. Accessed February 10, 2025. https://pi.lilly.com/us/omvoh-uspi.pdf?s=pi
  10. Zepbound. Prescribing information. Eli Lilly and Company; 2024. Accessed February 10, 2025. https://pi.lilly.com/us/zepbound-uspi.pdf
  11. Crenessity. Prescribing information. Neurocrine Biosciences, Inc.; 2024. Accessed February 10, 2025. https://pi.neurocrine.com/crenessity/CRENESSITY-Full-US-Prescribing-Information.pdf
  12. Bizengri. Prescribing information. Partner Therapeutics, Inc.; 2025. Accessed February 10, 2025. https://www.bizengri.com/pdf/pi.pdf
  13. Attruby. Prescribing information. BridgeBio Pharma, Inc.; 2024. Accessed February 10, 2025. https://attruby.com/attruby-prescribing-information.pdf
  14. Ziihera. Prescribing information. Jazz Pharmaceuticals plc. Accessed February 10, 2025. https://pp.jazzpharma.com/pi/ziihera.en.USPI.pdf
  15. Revuforj. Prescribing information. Syndax Pharmaceuticals, Inc.; 2024. Accessed February 10, 2025. https://cms.syndax.com/wp-content/uploads/Revuforj-full-prescribing-info.pdf
  16. Vyloy. Prescribing information. Astellas Pharma US, Inc.; 2024. Accessed February 10, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761365s000lbl.pdf
  17. Dupixent. Prescribing information. sanofi-aventis U.S. LLC; 2024. Accessed February 10, 2025. https://www.regeneron.com/downloads/dupixent_fpi.pdf
  18. Rybrevant. Prescribing information. Janssen Biotech, Inc.; 2024. Accessed February 10, 2025. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf
  19. Keytruda. Prescribing information. Merck & Co., Inc.; 2024. Accessed February 10, 2025. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
  20. Niktimvo. Prescribing information. Incyte Corporation; 2025. Accessed February 10, 2025. https://www.niktimvo.com/niktimvo-prescribing-information
  21. Kisunla. Prescribing information. Eli Lilly and Company; 2024. Accessed February 10, 2025. https://pi.lilly.com/us/kisunla-uspi.pdf
  22. Enhertu. Prescribing information. Daiichi Sankyo, Inc.; 2024. Accessed February 10, 2025. https://daiichisankyo.us/prescribing-information-portlet/getPIContent?productName=Enhertu&inline=true
  23. Winrevair. Prescribing information. Merck & Co., Inc.; 2024. Accessed February 10, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761363s000lbl.pdf
  24. Welireg. Prescribing information. Merck Sharp & Dohme LLC; 2023. Accessed February 10, 2025. https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_pi.pdf
  25. Jardiance. Prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc.; 2023. Accessed February 10, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s040lbl.pdf
  26. Akeega. Prescribing information. Janssen Biotech, Inc.; 2024. Accessed February 10, 2025. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/AKEEGA-pi.pdf
  27. Brixadi. Prescribing information. Braeburn Pharmaceuticals, Inc.; 2023. Accessed February 10, 2025. https://www.brixadihcp.com/pdfs/brixadi-prescribing-information.pdf
  28. Elahere. Prescribing information. AbbVie Inc.; 2024. Accessed February 10, 2025. https://www.rxabbvie.com/pdf/elahere_pi.pdf
  29. Sunlenca. Prescribing information. Gilead Sciences, Inc.; 2024. Accessed February 10, 2025. https://www.gilead.com/-/media/files/pdfs/medicines/hiv/sunlenca/sunlenca_pi.pdf
  30. Opzelura. Prescribing information. Incyte Corporation; 2024. Accessed February 10, 2025. https://www.opzelura.com/opzelura-prescribing-information
  31. Zeposia. Prescribing information. Bristol Myers Squibb; 2024. Accessed February 10, 2025. https://packageinserts.bms.com/pi/pi_zeposia.pdf
  32. Skytrofa. Prescribing information. Ascendis Pharma Inc.; 2024. Accessed February 10, 2025. https://ascendispharma.us/products/pi/skytrofa/skytrofa_pi.pdf
  33. Isturisa. Prescribing information. Recordati Rare Diseases, Inc.; 2023. Accessed February 10, 2025. https://www.recordatirarediseases.com/sites/www.recordatirarediseases.com/files/inline-files/Isturisa-Prescribing-Information-Current.pdf
  34. Ibsrela. Prescribing information. Ardelyx Inc.; 2022. Accessed February 10, 2025. https://ardelyx.com/wp-content/uploads/2021/11/IBSRELA-Prescribing-Information-1.pdf
  35. Bavencio. Prescribing information. EMD Serono, Inc.; 2024. Accessed February 10, 2025. https://www.emdserono.com/us-en/pi/bavencio-pi.pdf
  36. Stivarga. Prescribing information. Bayer HealthCare Pharmaceuticals; 2020. Accessed February 10, 2025. https://labeling.bayerhealthcare.com/html/products/pi/Stivarga_PI.pdf
  37. Veltassa. Prescribing information. Vifor Pharma, Inc.; 2023. Accessed February 10, 2025. https://www.veltassa.com/hcp/pi
  38. Xofigo. Prescribing information. Bayer HealthCare Pharmaceuticals; 2019. Accessed February 10, 2025. https://labeling.bayerhealthcare.com/html/products/pi/Xofigo_PI.pdf
  39. Acthar gel. Prescribing information. Mallinckrodt Pharmaceuticals; 2024. Accessed February 10, 2025. https://www.actharhcp.com/globalassets/pdf/acthar_pi.pdf
 
a The products listed are in the clinical evaluation stage and have not been approved for use by the FDA. The safety and efficacy of these products have not been established. FormularyDecisions is providing this information to alert you to the status of this product and is not promoting this product generally or otherwise recommending this product for use in the treatment of any disease or inclusion on any formulary for which it has not yet been approved. Any questions about such products must be directed to the biopharma companies. The availability of this product information follows the guidance outlined in the Pre-approval Information Exchange Act of 2022 (Section 810 of H.R. 7667).  
 
b The material is being shared to inform you of the availability of information on FormularyDecisions. In providing this information, FormularyDecisions is not promoting any products mentioned, making claims about risks or benefits, or otherwise recommending any product in general or for any patient or formulary. For complete information about the indications, risks, and benefits of any product, please consult appropriate clinical and safety information, including the complete product label and important safety information. All prescribing decisions and/or coverage decisions should be made independently by individuals with appropriate experience in reliance on their independent judgement.

FormularyDecisions is owned and operated by Xcenda L.L.C., which is a subsidiary of Cencora, a global pharmaceutical sourcing and distribution services company. 
 
The contents of this communication are non-promotional and intended exclusively for healthcare decision-makers, formulary committees, and other similar entities responsible for selecting healthcare products for coverage or reimbursement. Do not forward this communication. FormularyDecisions strongly encourages our members to review all available information about a particular product, including but not limited to the product label, and to rely on their experience and expertise in making decisions about coverage or prescribing.