In this month's Connection newsletter:
- Explore resources related to diabetes for National Diabetes Month in November
- Discover the latest updates on the FormularyDecisions Homepage
- Navigate to new and updated eDossiers with enhanced functionality
- Reconnect with our pharmacists after the NASP Annual Meeting and AMCP Nexus conferences
- Register for an upcoming AMCP Pre-approval Information Exchange (PIE) Webinar
November is National Diabetes Month
You can use information from FormularyDecisions to learn more about diabetes. The CDC reports that 38.4 million people in the US have diabetes, representing 11.6% of the population, with 8.7 million, or 22.8%, undiagnosed. Additionally, 352,000 children and adolescents under 20 years of age have diagnosed diabetes, including 304,000 with type 1 diabetes. Among adults, 1.7 million aged 20 and older—5.7% of all US adults with diagnosed diabetes—have type 1 diabetes and use insulin. Furthermore, 3.6 million adults aged 20 and older—12.3% of all diagnosed adults—began using insulin within a year of their diagnosis.1
Biosimilar Hub
See the latest updates to the pipeline and market biosimilar landscape for diabetes, link directly to each biosimilar’s product page, and easily find each state’s substitution laws for interchangeable biosimilars. |
Clinical Guideline Snapshots
Review a summary of the American Diabetes Association 2024 update to the standards of care in the Diabetes mellitus, type I Clinical Guideline Snapshot – prepared by The Medical Letter, Inc. |
Disease Pages
Navigate to associated products and related links from third-party resources and publications in our Metasearch Results from the following disease pages: Diabetic peripheral neuropathy |
Discover what’s new on our homepage
Ever wonder which content is new or updated on the site?
Did you know?
There’s a wealth of valuable information just waiting for you on the homepage. Scroll down on the homepage to explore the features below and stay informed with the latest updates.
- Surveys and feedback opportunities: Share your insights and help shape future resources and evidence.
- Upcoming webinars and webinar recordings: Don't miss upcoming AMCP PIE webinars, and catch up on past webinars at your own convenience.
- Product pages: Explore new or updated Resource Center and Spotlight content.
- eDossiers: Access new and updated eDossiers.
- ICER reports: Get quick access to reports from the Institute for Clinical and Economic Review.
- Product snapshots: Review curated product overviews for pre-approval and newly FDA-approved products.
- Full-text articles: Enjoy complimentary access to the latest articles from Pharmacist’s Letter and The Medical Letter.
- FDA updates: Scroll through the latest FDA approval announcements.
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 |
|
08/22/2024 |
Product name |
FDA approval date* |
FDA-approved indicationb |
|
12/27/2021 |
AD |
|
|
09/24/2024 |
NPC |
|
|
07/26/2022 |
SLE |
|
|
BIKTARVY® (bictegravir, emtricitabine, tenofovir alafenamide)5 |
02/23/2024 |
HIV-1 |
|
05/23/2023 |
Opioid use disorder |
|
|
04/01/2024 |
MM |
|
|
09/26/2024 |
Schizophrenia |
|
|
08/23/2021 |
COVID-19 |
|
|
08/07/2024 |
Parkinson’s disease |
|
|
11/16/2015 |
MM |
|
|
09/27/2024 |
AD, asthma, CRSwNP, EoE, PN, COPD |
|
|
04/05/2024 |
Breast cancer |
|
|
09/05/2024 |
IgAN |
|
|
11/22/2022 |
Hemophilia B |
|
|
05/18/2023 |
CLL, SLL, WM, cGVHD |
|
|
09/21/2023 |
HF, CKD, type 2 diabetes mellitus |
|
|
04/28/2023 |
CSCC, BCC, NSCLC |
|
|
08/14/2024 |
PBCc |
|
|
10/3/2024 |
RSV |
|
|
07/18/2022 |
AD, nonsegmental vitiligo |
|
|
05/25/2023 |
COVID-19 |
|
|
09/19/2024 |
NSCLC |
|
|
07/30/2021 |
SLE |
|
|
09/20/2024 |
MM |
|
|
06/18/2024 |
PsA, PsO, CD, UC |
|
|
08/01/2024 |
Synovial sarcomac |
|
|
09/11/2024 |
PsA, PsO, UC |
|
|
07/17/2024 |
Erosive esophagitis, GERD, H. pylori infection |
|
|
12/14/2023 |
VHL, RCC |
|
|
03/26/2024 |
PAH (WHO Group 1) |
|
|
10/18/2017 |
Large B-cell lymphoma |
|
|
08/04/2023 |
PPD |
*For multi-indication products, the FDA-approved date for the most recently updated approved indication is listed.
Key: AD – atopic dermatitis; BCC – basic cell carcinoma; CD – Crohn’s disease; cGVHD – chronic graft versus host disease; CKD – chronic kidney disease; CLL – chronic lymphocytic leukemia; COPD – chronic obstructive pulmonary disease; CRSwNP – chronic rhinosinusitis with nasal polyps; cSCC – cutaneous squamous cell carcinoma; EoE – eosinophilic esophagitis; GERD – gastroesophageal reflux disease; HIV – human immunodeficiency virus type 1; HF – heart failure; IgAN – immunoglobulin A nephropathy; MM – multiple myeloma; NPC – Niemann-Pick disease type C; NSCLC – non-small cell lunch cancer; PAH – pulmonary arterial hypertension; PBC – primary biliary cholangitis; PN – prurigo nodularis; PPD – postpartum depression; PsA – psoriatic arthritis; PsO – plaque psoriasis; RCC – renal cell carcinoma; RSV – respiratory syncytial virus; SLE – systemic lupus erythematosus; SLL – small lymphocytic lymphoma; UC – ulcerative colitis; VHL – von Hippel-Lindau disease; WM – Waldenström’s macroglobulinemia.
Upcoming webinars
Session
AMCP PIE Webinar: Overview of clinical data for a potential treatment for PTSD in adultsb
Date: Thursday, December 5, 2024
Time: 2:00-3:00pm ET
Click below for webinar details and to register:
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 Otsuka America Pharmaceutical 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:
Session
AMCP PIE Webinar: Delgocitinib for the treatment of chronic hand eczemab
Date: Monday, November 20, 2024
Time: 2:00-3:00pm ET
Click below for webinar details and to register:
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 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 register:
References:
1. Centers for Disease Control and Prevention. National Diabetes Statistics Report. May 15, 2024. Accessed November 4, 2024. https://www.cdc.gov/diabetes/php/data-research/index.html
2. Adbry prescribing information. LEO Pharma Inc.; 2024. https://mc-df05ef79-e68e-4c65-8ea2-953494-cdn-endpoint.azureedge.net/-/media/corporatecommunications/us/therapeutic-expertise/our-product/adbrypi.pdf?rev=d8ced7cbd6874a6997427ab88a2093e0
3. Aqneursa prescribing information. IntraBio; 2024. https://aqneursa.com/wp-content/aqneursa-prescribing-information.pdf
4. Benlysta prescribing information. GlaxoSmithKline plc; 2024. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG-IFU.PDF
5. Biktarvy prescribing information. Gilead Sciences, Inc.; 2024. https://www.gilead.com/~/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi.pdf
6. Brixadi prescribing information. Braeburn Pharmaceuticals, Inc.; 2023. https://www.formularydecisions.com/d1-package-inserts/7278?From=ProductCarousel
7. Carvykti prescribing information. Janssen Biotech, Inc.; 2024. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/CARVYKTI-pi.pdf
8. Cobenfy prescribing information. Bristol-Myers Squibb Company; 2024. https://packageinserts.bms.com/pi/pi_cobenfy.pdf
9. Comirnaty prescribing information. Pfizer, Inc.; 2024. https://labeling.pfizer.com/ShowLabeling.aspx?id=16351&format=pdf
10. Crexont prescribing information. Amneal Pharmaceuticals; 2024.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217186s000lbl.pdf
11. Darzalex prescribing information. Janssen Biotech, Inc.; 2024. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf
12. Dupixent prescribing information. sanofi-aventis U.S. LLC; 2024. https://www.regeneron.com/downloads/dupixent_fpi.pdf
13. Enhertu prescribing information. Daiichi Sankyo, Inc.; 2024. https://daiichisankyo.us/prescribing-information-portlet/getPIContent?productName=Enhertu&inline=true
14. Filspari prescribing information. Travere Therapeutics; 2024. https://filsparihcp.com/igan/filspari-prescribing-information.pdf
15. Hemgenix prescribing information. CSL Behring; 2022. https://labeling.cslbehring.com/PI/US/Hemgenix/EN/Hemgenix-Prescribing-Information.pdf
16. Imbruvica prescribing information. Pharmacyclics (an AbbVie company) and Janssen Biotech, Inc.; 2024. https://www.rxabbvie.com/pdf/imbruvica_pi.pdf
17. Jardiance prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc.; 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s040lbl.pdf
18. Libtayo prescribing information. Regeneron Pharmaceuticals, Inc.; 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761097s023lbl.pdf
19. Livdelzi prescribing information. Gilead Sciences, Inc.; 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217899s000lbl.pdf
20. Mresvia prescribing information. Moderna, 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
21. Opzelura prescribing information. Incyte Corporation; 2024. https://www.opzelura.com/opzelura-prescribing-information
22. Paxlovid prescribing information. Pfizer Inc.; 2023. https://www.formularydecisions.com/d1-package-inserts/9181?From=ProductCarousel
23. Rybrevant prescribing information. Janssen Biotech, Inc.; 2024. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf
24. Saphnelo prescribing information. AstraZeneca Pharmaceuticals LP; 2024. https://den8dhaj6zs0e.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/44b6985c-8268-46b1-ba3e-2bb43bfd4d4c/44b6985c-8268-46b1-ba3e-2bb43bfd4d4c_viewable_rendition__v.pdf
25. Sarclisa prescribing information. sanofi-aventis U.S. LLC; 2024. https://products.sanofi.us/Sarclisa/sarclisa.pdf
26. Skyrizi prescribing information. AbbVie Inc.; 2024. https://www.rxabbvie.com/pdf/skyrizi_pi.pdf
27. Tecelra prescribing information. Adaptimmune LLC; 2024. https://d1io3yog0oux5.cloudfront.net/_a2f385b85806f15c0d899c699b298e41/adaptimmune/files/documents/TECELRA_Final_PI.pdf
28. Tremfya prescribing information. Janssen Biotech, Inc.; 2024. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf
29. Voquezna prescribing information. Phathom Pharmaceuticals, Inc.; 2024. https://www.phathompharma.com/wp-content/uploads/VOQUEZNA-tablets-Prescriber-Information.pdf
30. Welireg prescribing information. Merck Sharp & Dohme LLC; 2023. https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_pi.pdf
31. Winrevair prescribing information. Merck & Co., Inc.; 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761363s000lbl.pdf
32. Yescarta prescribing information. Kite Pharma, Inc.; 2024. https://www.fda.gov/media/108377/download
33. Zurzuvae prescribing information. Sage Therapeutics; 2024. https://documents.sage-biogen.com/us/zurzuvae/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.
c This indication is approved by the FDA under the accelerated approval pathway.
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.