Formulary Watch |

Formulary Watch covers formularies, pharmacy benefit management companies, drug approvals, and other matters related to medications, their prices and insurance coverage.

Editorial Contact: Denise Myshko: dmyshko@mjhlifesciences.com

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 Genentech Reintroduces Susvimo for Age-Related Macular Degeneration
 Genentech Reintroduces Susvimo for Age-Related Macular Degeneration
Genentech Reintroduces Susvimo for Age-Related Macular Degeneration
July 9, 2024
Genentech had recalled the Susvimo ocular implant two years ago. The FDA has approved changes to the implant and needle.
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FDA Approves Vabysmo as Prefilled Syringe
FDA Approves Vabysmo as Prefilled Syringe
July 8, 2024
The prefilled syringe of Vabysmo will become available in the coming months. It treats age-related macular degeneration, diabetic macular edema and macular edema following retinal vein occlusion.
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Ardelyx Won’t Include Xphozah in CMS Bundle Payment Program
Ardelyx Won’t Include Xphozah in CMS Bundle Payment Program
July 3, 2024
Company officials have said the bundled payment program could negatively impact sales of Xphozah, which was approved last year to reduce serum phosphorus in patients with kidney disease on dialysis.
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FDA Approves Lilly’s Alzheimer’s Disease Drug
FDA Approves Lilly’s Alzheimer’s Disease Drug
July 2, 2024
Donanemab — now with the brand name of Kisunla — slows cognitive and functional decline by up to 35% and has a list price of $695.65 per vial.
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FDA Approves Third Stelara Biosimilar
FDA Approves Third Stelara Biosimilar
July 1, 2024
Samsung Bioepis’ Pyzchiva (ustekinumab-ttwe) will be available beginning Feb. 22, 2025 and will be marketed by Sandoz.
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FDA Issues Complete Response Letter for Kresladi for Rare Immune Disorder
FDA Issues Complete Response Letter for Kresladi for Rare Immune Disorder
June 28, 2024
For the second time, the FDA is asking for additional information about chemistry manufacturing and controls.
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FDA Approval Granted for Novel COPD Treatment
FDA Approval Granted for Novel COPD Treatment
June 27, 2024
Ohtuvayre - an inhaled bronchodilator with non-steroidal anti-inflammatory effects - is the first new mechanism in COPD approved in more than 20 years.
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FDA Grants Accelerated Approval for Second Epkinly Indication
FDA Grants Accelerated Approval for Second Epkinly Indication
June 27, 2024
Epkinly is a bispecific antibody now approved to treat both relapsed or refractory follicular lymphoma and relapsed or refractory diffuse large B-cell lymphoma.
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3Axis Report Scrutinizes PBM Spread Pricing Practice
3Axis Report Scrutinizes PBM Spread Pricing Practice
June 26, 2024
The 3Axis Advisors analysis suggests PBMs’ spread pricing practices leads to employers being charged different amounts for the same medications and to pharmacists facing reimbursement challenges.
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FDA Issues Second Complete Response Letter for AbbVie’s Parkinson’s Therapy
FDA Issues Second Complete Response Letter for AbbVie’s Parkinson’s Therapy
June 25, 2024
The FDA cited issues related to a third-party manufacturer. The agency did not request any additional testing from AbbVie.
Glenmark Recalls 114 Batches of Potassium Chloride
Glenmark Recalls 114 Batches of Potassium Chloride
Glenmark Recalls 114 Batches of Potassium Chloride
June 25, 2024
The recalled batches have been found to have potassium chloride that does not dissolve, which can cause high potassium levels that can lead to hypertension, heart failure, or renal dysfunction.
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FDA Grants Accelerated Approval to Krazati for Colorectal Cancer
FDA Grants Accelerated Approval to Krazati for Colorectal Cancer
June 24, 2024
Krazati is already available to treat patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer.
Prime Therapeutics Launches Pharmacy Solution for Specialty Drugs
Prime Therapeutics Launches Pharmacy Solution for Specialty Drugs
Prime Therapeutics Launches Pharmacy Solution for Specialty Drugs
June 21, 2024
Nathan Downhour, Pharm.D., discusses the Pharmacy Match program, which will engage with physicians to make sure a specialty prescription gets to the best-fit pharmacy across a network powered by Free Market Health.
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FDA Grants Full Approval to Elevidys for Duchenne Muscular Dystrophy
FDA Grants Full Approval to Elevidys for Duchenne Muscular Dystrophy
June 21, 2024
Full approval was granted for the one-time gene therapy to ambulatory patients aged 4 years older. The FDA also granted accelerated approval to Elevidys for non-ambulatory patients.
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FDA Expands Skyrizi’s Indications to Include Ulcerative Colitis
FDA Expands Skyrizi’s Indications to Include Ulcerative Colitis
June 20, 2024
Skyrizi is also available to treat patients with plaque psoriasis, psoriatic arthritis, and Crohn’s disease and has a list price of $21,017.36 for one dose.
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Physicians Say Prior Authorization Leads to Bad Outcomes
Physicians Say Prior Authorization Leads to Bad Outcomes
June 19, 2024
Physicians in a new survey by the American Medical Association said prior authorization leads to delayed care and a high administration burden for physician practices.
FDA Advisory Committee Supports Donanemab in Alzheimer’s Disease
FDA Advisory Committee Supports Donanemab in Alzheimer’s Disease
FDA Advisory Committee Supports Donanemab in Alzheimer’s Disease
June 11, 2024
Committee members, however, also said more data are needed on donanemab to treat patients in underrepresented patient groups, including Latin American and African American patients and special populations such as Down syndrome.
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FDA Sets Review Date for Tagrisso for Specific Lung Cancer Mutations
FDA Sets Review Date for Tagrisso for Specific Lung Cancer Mutations
June 10, 2024
Tagrisso, which is already available to treat patients with non-small cell lung cancer and EGFR mutations, is being reviewed by the FDA for patients with this cancer and exon 19 deletions or exon 21 mutations.
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 FDA Assigns Goal Date for Maintenance Dosing of Leqembi
FDA Assigns Goal Date for Maintenance Dosing of Leqembi
June 10, 2024
The FDA is considering a monthly IV maintenance dose of Leqembi to treat people with Alzheimer’s disease. The action date is set for Jan. 25, 2025.
ICER Releases List of Drugs for Fair Access Review
ICER Releases List of Drugs for Fair Access Review
ICER Releases List of Drugs for Fair Access Review
June 7, 2024
Included in this review will be 11 drugs that ICER assessed for cost-effectiveness in 2022. New this year is an assessment for consumer accessibility of drugs, including the burdens of prior authorization and patient cost-sharing measures.
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What We’re Reading: Counterfeit Ozempic
What We’re Reading: Counterfeit Ozempic
June 6, 2024
Vanity Fair shines a light on how fake Ozempic and other semaglutide products have found their way into the U.S. supply chain.
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Updated: FDA Committee, Concerned about Bias, Votes No on Psychedelic in PTSD
Updated: FDA Committee, Concerned about Bias, Votes No on Psychedelic in PTSD
June 5, 2024
Patients with PTSD in the clinical trials of midomafetamine were able to guess whether they received treatment or placebo. Regulators and advisory committee members said this could have impacted efficacy results. FDA’s decision is expected by Aug. 11, 2024.
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