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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 newsletter ...

Duchenne muscular dystrophy (DMD)

The therapeutic landscape in DMD continues to be rich with numerous products that are Food and Drug Administration (FDA)-approved or under development to restore or replace dystrophin, combat fibrosis, reduce inflammation, regulate calcium balance, or improve muscle growth and protection.1

payer

Parent Project Muscular Dystrophy (PPMD) estimates that there are about 15,000 young men, as well as a few young women, living with DMD today in the United States.

You can use the following 3 FormularyDecisions pages to connect you with resources to better understand the disease state and complex treatment landscape: Metasearch results, Product Snapshots, and the Cell & Gene Therapy Hub, each detailed further below.  

The Metasearch results section of the Duchenne muscular dystrophy page on FormularyDecisions sheds light on the science and advances: 

Be sure to also reference available Product Snapshots on DMD products. Product Snapshots, curated by clinical pharmacists at ForHealth Consulting team at UMass Chan Medical School, not only provide a high-level overview of the product, but they also include a summary of key clinical trials and Pharmacy & Therapeutics considerations.  

For products in the cell & gene therapy space, the Cell & Gene Therapy Hub denotes FDA designations and expedited pathways, such as Accelerated Approval, Breakthrough Therapy, Fast Track, and Orphan Drug.  

 

Join us for afternoon bubble tea in New Orleans!

AMCP Annual is right around the corner! Back by popular demand, we’re bringing bubble tea back. Network with your peers while you preview our latest platform enhancements, including the new Cell & Gene Therapy Hub and recent additions to the Clinical Guideline Snapshots.  

Session: Afternoon Bubble Tea With FormularyDecisions, an Exclusive Networking Event 
Date: Wednesday, April 17, 2024 
Time: 2:00-2:45 PM CT 
Location: Ernest N. Morial Convention Center Room 215/216  

Space is limited – so sign up below to reserve your spot today. 


Looking for time outside of this event to meet with us? Find our team at the FormularyDecisions kiosk and photo booth near AMCP registration and the Cencora booth #613 at the Expo Hall.  Click below to discover the full extent of Cencora’s participation at AMCP Annual including educational sessions, research posters, and more!  

Can’t make it to our event? FormularyDecisions will also be hosting a kiosk on Tuesday, April 16 from 10:00-4:00 PM CT and Wednesday, April 17, 9:00-12:00 PM and 3:00-4:00 PM CT. Meet with our team and come take a picture with your peers and colleagues at our New Orleans-themed photo booth! 

Preceptor Corner

Do you mentor or precept professional students who are interested in a career in managed care or industry? Let them know about an upcoming student webinar opportunity that will introduce them to pharmacist roles in biopharma consulting, FormularyDecisions, the AMCP Foundation P&T competition, student and post-graduate programs, and several unique pharmacy career journeys.  

Webinar: From Classroom to Career: Pathways to Industry-Facing Roles 
Date: Friday, May 3, 2024 
Time: 12:00 pm PT / 3:00 pm ET 

1 lucky student who also completes a 3-minute post-webinar survey will be randomly selected to win free NAPLEX review materials! 


Students can register below to receive the link to this 1-hour webinar. A link to the webinar recording will be emailed to all students who register.  

Question? Contact Webinars@FormularyDecisions.com.

Explore the latest Resource Center files

Several biopharma companies recently posted new or updated content in their Resource Centers, including product briefs, clinical overviews, publications, posters, and more! Many of these resources contain consolidated, up-to-date product information that you can include in your upcoming product reviews. See below for Resource Center files posted in the last 3 months. 

Click below to view a list of all products with Resource Center files.

Product namea 

Resource Center document description(s)

 ASCENIV™ (immune globulin intravenous, human – slra)

 Clinical visual aid and payer value proposition 

 BOTOX® (onabotulinumtoxinA)4 

Real world evidence and a post-hoc analysis of the Phase 4 COMPEL trial 

 BREZTRI AEROSPHERE® (budesonide, glycopyrrolate, and formoterol fumarate)5 

 Medical cost offset analysis in Medicare patient population 
 EPKINLY™ (epcoritamab-bysp)6   Dose preparation guide and adverse reactions management guide
 NEXLIZET® (bempedoic acid and ezetimibe)7   Prior authorization mini checklist and prespecified analyses of the CLEAR Outcomes randomized clinical trial 
 OGSIVEO™ (nirogacestat)  EHR order set clinical instructions, a clinical overview presentation, NCCN Guidelines updates, and information on the limited distribution network 
 RINVOQ® (upadacitinib)9   Medical value portfolio and the efficacy/safety of Rinvoq from three phase 3 clinical trials and a long-term extension of the SELECT-CHOICE study 
 SKYRIZI® (risankizumab-rzaa)10   Medical value portfolio 
 TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)11   Real world evidence and an evaluation of the impact on daily treatment burden 
 TYVASO DPI® (treprostinil)12  PH-ILD disease state overview
 VRAYLAR® (cariprazine)13   Clinical data in schizophrenia and bipolar 1 disorder, and real-world healthcare resource utilization and costs in bipolar 1 disorder 
 VYVGART® (efgartigimod alfa-fcab)14   Scientific posters presenting real-world outcomes and a network meta-analysis
 WAINUA™ (eplontersen)15   Value proposition 

 

Upcoming Webinars

Virtual event on tablet

AMCP PIE Webinar:

A fundamentally different approach to the treatment of schizophreniab

Virtual event on tablet
Date: Tuesday, April 23, 2024 
Time: 2:00-3:00pm 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 Karuna 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. 
Virtual event on tablet
Woman on laptop with medical data in the background

Webinar recording available!

Click below to access the webinar recording on-demand

Woman on laptop with medical data in the background
Session: AMCP Webinar hosted by FormularyDecisions – Leveraging the pre-approval information safe harbor to accelerate patient access 
Recorded on: March 14, 2024 
 
Join Cencora thought leaders for an interactive, engaging, and informative discussion as they dive into the evolving landscape of pre-approval information exchange (PIE) and explore opportunities and innovative solutions for leveraging PIE.  
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FormularyDecisions-body1-504x504

 

Share with your peers

Know someone who could benefit from access to information on over 3,000 pipeline and FDA-approved products? Take a few seconds and use our email template to inform your peers or colleagues about FormularyDecisions.
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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.

 

Questions?

We welcome your questions and feedback! Please reach out to the FormularyDecisions team today.

References 

1. Parent Project Muscular Dystrophy. Drug development pipeline. 2024. Accessed March 25, 2024. https://www.parentprojectmd.org/duchenne-drug-development-pipeline/ 
2. Parent Project Muscular Dystrophy. About Duchenne. 2024. Accessed March 25, 2024. https://www.parentprojectmd.org/about-duchenne/ 
3. Asceniv prescribing information. ADMA Biologics, Inc.; 2019. https://www.fda.gov/media/122525/download 
4. Botox prescribing information. AbbVie Inc.; 2023. https://www.rxabbvie.com/pdf/botox_pi.pdf 
5. Breztri Aerosphere prescribing information. AstraZeneca Pharmaceuticals LP; 2022. https://den8dhaj6zs0e.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/9d44f9af-438a-448b-bb5c-dae506e17e49/9d44f9af-438a-448b-bb5c-dae506e17e49_viewable_rendition__v.pdf 
6. Epkinly prescribing information. Genmab A/S; 2023. https://www.genmab-pi.com/prescribing-information/epkinly-pi.pdf 
7. Nexlizet prescribing information. Esperion Therapeutics, Inc.; 2024. https://pi.esperion.com/nexlizet/nexlizet-pi.pdf 
8. Ogsiveo prescribing information. SpringWorks Therapeutics, Inc.; 2023. https://springworkstx.com/wp-content/uploads/2023/11/OGSIVEO-US-Prescribing-Information-11.27.23.pdf 
9. Rinvoq prescribing information. AbbVie Inc.; 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s012lbl.pdf  
10. Skyrizi prescribing information. AbbVie Inc.; 2024. https://www.rxabbvie.com/pdf/skyrizi_pi.pdf 
11. Trikafta prescribing information. Vertex Pharmaceuticals Incorporated; 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212273s009lbl.pdf 
12. Tyvaso DPI prescribing information. United Therapeutics Corp.; 2023. https://www.tyvaso.com/pdf/TYVASO-DPI-PI.pdf 
13. Vraylar prescribing information. AbbVie Inc.; 2024. https://www.rxabbvie.com/pdf/vraylar_pi.pdf  
14. Vyvgart prescribing information. argenx US, Inc; 2024. https://www.argenx.com/product/vyvgart-prescribing-information.pdf 
15. Wainua prescribing information. AstraZeneca Pharmaceuticals LP; 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217388s000lbl.pdf 

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.

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.  
 
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. 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.