In this month's Connection newsletter:
- Explore resources related to HIV/AIDS for World AIDS Day in December
- Read about how the Biosimilar Hub is industry-recognized as a Pharmaceutical Market Excellence Award (PMEA) finalist
- Navigate to available MyInsights Program survey and feedback opportunities
- Watch the latest AMCP PIE webinar recording
December 1st was World AIDS Day
Approximately 1.2 million people in the US have HIV and about 13% are undiagnosed. In 2022, an estimated 31,800 people acquired HIV in the US. Estimated new HIV infections decreased 12% from 36,300 in 2018 to 31,800 in 2022.1 Progress in HIV prevention continues to drive incidence rates down with pre-exposure prophylaxis (PrEP) prescriptions, viral suppression, and HIV testing.2 Leverage resources on FormularyDecisions to stay informed on products associated with HIV.
Clinical Guideline Snapshots
Review a summary of the latest Antiretroviral drugs for treatment and prevention of HIV infection in adults. The USA Panel of the International Antiviral Society’s 2022 recommendations were prepared by The Medical Letter, Inc. |
Product Snapshots
Leverage Product Snapshots on products associated with HIV – created by clinical pharmacists at ForHealth Consulting (formerly Commonwealth Medicine), the healthcare consulting and operations division of the University of Massachusetts Chan Medical School. |
Disease Pages
Navigate to associated products and related links from third-party resources and publications in our Metasearch Results from the following disease pages: OraQuick® (in-home oral HIV test) |
The FormularyDecisions Biosimilar Hub is industry-recognized for excellence
We are proud to announce that the FormularyDecisions Biosimilar Hub has been recognized as a finalist in the Excellence in Engagement through Digital Channels and New Technology category at the Pharmaceutical Market Excellence Awards (PMEA). This honor highlights our commitment to excellence, best practices, and innovation. We remain dedicated to improving and innovating FormularyDecisions to streamline your product review process, enabling you to make informed formulary decisions for your patients with confidence.
Explore our comprehensive resources designed to enhance your understanding of biosimilars:
- Market landscape: Get the latest updates on the biosimilar pipeline and market, categorized by development phase, launch status, and interchangeability
- State substitution laws: Access a repository outlining each state’s substitution laws for interchangeable biosimilars
- FDA-approved indications: Quickly reference our organized tables of biosimilars’ indications relative to their innovator products
- Curated resources: Benefit from a collection of the latest Food and Drug Administration (FDA) guidance, Institute for Clinical and Economic Review (ICER) reports, as well as key articles and white papers on biosimilars
MyInsights Program Survey Opportunities Available
Product surveys are an important way to share your insights with biopharma companies. Not only does your feedback communicate specific content requests to biopharma companies (eg, comparative effectiveness analysis, real-world evidence) so that they are more likely to post helpful files to FormularyDecisions, but it also helps biopharma companies identify potential evidence gaps that can be filled over time.
Log into FormularyDecisions to view all survey and feedback opportunities available. Earn points for completing surveys that can be redeemed in the form of gift cards and/or donated to a charity.
Below are links to the Product Pages for surveys that are at the top of the list of all available surveys when you sort by “Most Recent” on FormularyDecisions.
Status |
Product page with survey opportunities |
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Pre-approvala |
|
|
FDA-approvedb |
CARVYKTI® (ciltacabtagene autoleucel)6 FILSUVEZ® (birch triterpenes topical gel)8 mRESVIA11 RYBREVANT® (amivantamab-vmjw)12 SKYTROFA® (lonapegsomatropin-tcgd)14 TECELRA® (afamitresgene autoleucel)15 |
Don’t forget to also check out the following survey opportunities that may be leaving soon.
Status |
Product page with survey opportunities |
|
FDA-approvedb |
BIKTARVY® (bictegravir, emtricitabine, and tenofovir alafenamide)26 DESCOVY® (emtricitabine and tenofovir alafenamide)28 TECARTUS® (brexucabtagene autoleucel)38 |
AMCP PIE Webinar
Webinar recording available!
Session: Delgocitinib for the treatment of chronic hand eczema (CHE)
Available until: December 18, 2024
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.
Click below for webinar details and to access the recording:
Available until: December 18, 2024
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 LEO Pharma. 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 access the recording:
Ripple Effect Leaders
As we close out 2024, we want to honor our Ripple Effect leaders—those who have taken the initiative to share FormularyDecisions with their peers and colleagues. We encourage you to continue this in the new year, inspiring others to join the largest community of healthcare decision makers and keeping the ripples flowing!
References:
1. CDC. Fast facts: HIV in the United States. April 22, 2024. Accessed December 3, 2024. https://www.cdc.gov/hiv/data-research/facts-stats/index.html
2. HIV.gov. U.S. statistics. Updated August 15, 2024. Accessed December 3, 2024. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics
3. Aqneursa prescribing information. IntraBio; 2024. https://aqneursa.com/wp-content/aqneursa-prescribing-information.pdf
4. Attruby prescribing information. BridgeBio Pharma, Inc.; 2024. https://attruby.com/attruby-prescribing-information.pdf
5. Benlysta prescribing information. GlaxoSmithKline plc; 2024. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG-IFU.PDF
6. Carvykti prescribing information. Janssen Biotech, Inc.; 2024. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/CARVYKTI-pi.pdf
7. Darzalex prescribing information. Janssen Biotech, Inc.; 2024. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf
8. Filsuvez prescribing information. Chiesi USA, Inc.; 2024. https://resources.chiesiusa.com/Filsuvez/FILSUVEZ_PI.pdf
9. Kevzara prescribing information. sanofi-aventis; 2024. https://products.sanofi.us/kevzara/kevzara.pdf
10. Livdelzi prescribing information. Gilead Sciences, Inc. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217899s000lbl.pdf
11. mRESVIA prescribing information. Moderna US, Inc; 2024. https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/36130c97-6fb0-4bea-9f2e-fb5be7a90729/36130c97-6fb0-4bea-9f2e-fb5be7a90729_viewable_rendition__v.pdf
12. Rybrevant prescribing information. Janssen Biotech, Inc.; 2024. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf
13. Skyclarys prescribing information. Reata Pharmaceuticals, Inc.; 2024. https://www.skyclarys.com/docs/skyclarys_us_prescribing_information/
14. Skytrofa prescribing information. Ascendis Pharma Inc.; 2024. https://www.ascendispharma.us/products/pi/skytrofa/skytrofa_pi.pdf
15. Tecelra prescribing information. Adaptimmune LLC; 2024. https://d1io3yog0oux5.cloudfront.net/_a2f385b85806f15c0d899c699b298e41/adaptimmune/files/documents/TECELRA_Final_PI.pdf
16. Turalio prescribing information. Daiichi Sankyo, Inc.; 2023. https://daiichisankyo.us/prescribing-information-portlet/getPIContent?productName=Turalio&inline=true
17. Tzield prescribing information. sanofi-aventis U.S. LLC. https://products.sanofi.us/tzield/tzield.pdf
18. Vanflyta prescribing information. Daiichi Sankyo, Inc.; 2024. https://daiichisankyo.us/prescribing-information-portlet/getPIContent?productName=Vanflyta&inline=true
19. Vibrant Capsule prescribing information. Vibrant Gastro, Inc.; 2023. https://www.vibranthcp.com/wp-content/uploads/ifu-hcp.pdf
20. Voranigo prescribing information. Servier Pharmaceuticals LLC; 2024. https://d11vmvycldsjdg.cloudfront.net/7fffe4c3-9746-4e82-9582-df9879a712d5/5939acdd-1c44-41f5-b2f6-260ab3860288/5939acdd-1c44-41f5-b2f6-260ab3860288_web_ready__c.pdf
21. Wainua prescribing information. AstraZeneca Pharmaceuticals LP; 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217388s000lbl.pdf
22. Winrevair prescribing information. Merck & Co., Inc.; 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761363s000lbl.pdf
23. Xphozah prescribing information. Ardelyx Inc.; 2023. https://ardelyx.com/XPHOZAH-Prescribing-Information.pdf
24. Yorvipath prescribing information. Ascendis Pharma Inc.; 2024. https://ascendispharma.us/products/pi/yorvipath/yorvipath_pi.pdf
25. Apretude prescribing information. ViiV Healthcare; 2024. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF
26. Biktarvy prescribing information. Gilead Sciences, Inc.; 2024. https://www.gilead.com/~/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi.pdf
27. Caplyta prescribing information. Intra-Cellular Therapies, Inc.; 2023. https://www.intracellulartherapies.com/docs/caplyta_pi.pdf
28. Descovy prescribing information. Gilead Sciences, Inc.; 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s020lbl.pdf
29. Empaveli prescribing information. Apellis Pharmaceuticals, Inc.; 2024. https://pi.apellis.com/files/PI_Empaveli.pdf
30. Ibsrela prescribing information. Ardelyx Inc.; 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211801s004lbl.pdf
31. Ingrezza prescribing information. Neurocrine Biosciences, Inc.; 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209241s026lbl.pdf
32. Jakafi prescribing information. Incyte Corporation; 2023. https://www.jakafi.com/jakafi-prescribing-information
33. Opzelura prescribing information. Incyte Corporation; 2024. https://www.opzelura.com/opzelura-prescribing-information
34. Penbraya prescribing information. Pfizer Inc.; 2024. https://labeling.pfizer.com/ShowLabeling.aspx?id=19937
35. Rukobia prescribing information. ViiV Healthcare; 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212950s004lbl.pdf
36. Sarclisa prescribing information. sanofi-aventis U.S. LLC; 2024. https://products.sanofi.us/Sarclisa/sarclisa.pdf
37. Sunlenca prescribing information. Gilead Sciences, Inc.; 2024. https://www.gilead.com/-/media/files/pdfs/medicines/hiv/sunlenca/sunlenca_pi.pdf
38. Tecartus prescribing information. Kite Pharma, Inc.; 2024. https://www.gilead.com/-/media/files/pdfs/medicines/oncology/tecartus/tecartus-pi.pdf
39. Veklury prescribing information. Gilead Sciences, Inc.; 2024. https://www.gilead.com/-/media/files/pdfs/medicines/covid-19/veklury/veklury_pi.pdf
40. Veltassa prescribing information. Vifor Pharma, Inc.; 2023. https://www.veltassa.com/hcp/pi
41. Vitrakvi prescribing information. Bayer HealthCare Pharmaceuticals; 2023. https://labeling.bayerhealthcare.com/html/products/pi/vitrakvi_PI.pdf
42. Vowst prescribing information. Seres Therapeutics, Inc.; 2024. https://www.serestherapeutics.com/our-products/VOWST_PI.pdf
43. Welireg prescribing information. Merck Sharp & Dohme LLC; 2023. https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_pi.pdf
44. Yescarta prescribing information. Kite Pharma, Inc.; 2024. https://www.fda.gov/media/108377/download
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.
c Breakthrough Therapy Designation.
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.