ICER Found Plans Provided Fair Access, But Greater Transparency of Policies is Needed
November 3rd 2023The Institute for Clinical and Economic Review’s fair access report found that it was difficult to determine how well policies translate into real-world access and affordability for patients.
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ICER: Greater Transparency of Coverage Policies Needed
November 3rd 2023The Institute for Clinical and Economic Review’s fair access report found that for the drugs assessed, formularies provided fair access, but it was difficult to determine how well that translates into real-world access and affordability for patients.
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Elevidys Misses Primary Endpoint, but Shows Evidence of Modifying the Course of Duchenne
October 31st 2023Sarepta Therapeutics plans to submit an application for full approval of Elevidys to treat all ages of patients with Duchenne muscular dystrophy. Company officials said the FDA is open to evaluating the application based on the totality of the evidence.
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FDA Approves First-in-Class Therapy for Ulcerative Colitis
October 27th 2023Mirikizumab — now with the brand name — Omvoh is the first therapy that targets interleukin-23p19, which plays a role in inflammation. It has a list price of $9,593 per month for the IV formulation and $10,360 per subcutaneous administration.
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Gene Therapy for Rare Immune Disorder Gets FDA Review Date
October 25th 2023RP-L201 (marnetegragene autotemcel) is a one-time gene therapy that delivers a functional copy of the ITGB2 gene, which provides instructions for immune response to infections. The Prescription Drug User Fee Act (PDUFA) target action date is March 31, 2024.
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The Oncology Pipeline Is Delivering Exciting New Treatments — and Sticker Shock | AMCP Nexus 2023
October 19th 2023Research continues to develop new therapies for rare cancers and to provide options that allow for fewer toxicities. At the same, however, more new drugs are launching with high price tags.
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Magellan’s AI-Assisted Program Saved up to $4,300 PMPY | AMCP Nexus 2023
October 19th 2023Using an AI platform, Magellan Health was able to better support providers in prescribing behavioral health medications and addressing medication problems, which reduced pharmacy costs and increased adherence.
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Mayo Clinic Saves Almost $34 Million In Two Years With Biosimilar Strategy | AMCP Nexus 2023
October 17th 2023A pharmacist-led program to switch patients to biosimilars at the Mayo Clinic improved access and lowered costs, the clinic's Chelsee Jensen, Pharm.D., said during a presentation today.
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FDA Issues Complete Response Letter for Onpattro in Heart Failure Indication
October 9th 2023Alnylam Pharmaceuticals will no longer pursue this indication of Onpattro and will instead on focus on a label expansion for Amvuttra, which is in phase 3 development to treat patients with cardiomyopathy of ATTR amyloidosis.
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FDA Updates for the Week of Oct. 2, 2023
October 7th 2023The FDA approved the first biosimilar of the arthritis medication Actemra, as well as plaque psoriasis drug Zoryve for children. The agency issued a complete response letter for lebrikizumab in atopic dermatitis and for liquid formulation of botulinum toxin for frown lines, and assigned a review date for a gene therapy for a rare immune disorder. Additionally, Takeda plans to withdraw the oncology drug Exkivity from the market while Coherus resubmits BLA for Udenyca OnBody.
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