Formulary Watch |

FDA Sets PDUFA Date for Drug to Treat Patients with NASH

The FDA has granted priority review and assigned a review date of March 14, 2024, for resmetirom treat adult patients with nonalcoholic steatohepatitis (NASH) who have liver fibrosis.

Drugs to Watch: Gene Therapies

Dr. Benjamin Rome Discusses Ways to Address High Drug Prices

Bausch + Lomb Launches Miebo for Dry Eye Disease

Miebo, approved in May, addresses tear evaporation in dry eye disease. It will have a wholesale acquisition cost of $771 for a one-month supply.

FDA Approves Aphexda for Use in Stem Cell Mobilization

In clinical trials, Aphexda plus filgrastim enabled a majority of patients to achieve the collection goal to enable stem cell transplantation for patients with multiple myeloma. It will have a list price 5,900 per vial, with most patients needing two vials for treatment.

GAO: Rebates Resulted in Medicare Patients Paying More for Drugs Than Plans

FDA Assigns Review Date for Libervant Film for Young Children

Libervant is film version of diazepam that is placed inside the cheek to treat children between two and five years of age who have refractory epilepsy. The PDUFA target goal date is April 28, 2024.

Crystal Formation in Bottles Leads to Recall of Sandimmune

Crystal formation could lead under- or over-dosing of Sandimmune oral solution, which is used to prevent organ rejection in kidney, liver, and heart allogeneic transplants.

New House Bill Focuses on Healthcare Price Transparency

Scripius Removes Dupixent from Formulary

Long-term Study Shows Gardasil 9 Effective Against HPV-Related Cancers

FDA Accepts BLA for Crovalimab for Rare Blood Condition

If approved, crovalimab will be the first monthly subcutaneous treatment for patients with paroxysmal nocturnal hemoglobinuria, a rare, life-threatening condition.

X4 Pharmaceuticals Submits NDA of Mavorixafor for Rare Immunodeficiency Disease

If approved, mavorixafor would be the first therapy to address the genetic defect that results in WHIM syndrome, an ultra-rare disease that can cause recurrent lung infections, papillomavirus-related warts, and an increased risk of developing certain types of cancer.

FDA Grants Tentative Approval of Triumeq PD Generic for Children with HIV

With this tentative approval of abacavir/dolutegravir/lamivudine, Viatris aims to help adherence to HIV treatment in low- and middle-income countries.

State Medicaid Programs Look to Value-Based Contracts for Gene Therapies

New Analysis Suggests Current Rebates Will Influence Medicare Savings for Negotiated Drugs

Label Mix Up Leads to Recall of Digoxin

The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose. Digoxin is used to treat patients with heart failure and chronic atrial fibrillation.

What We’re Reading: Appealing Insurance Denials; the Sackler Bankruptcy Settlement; Medicare Advantage Enrollment

KFF: 82% of Adults Say Prescription Drug Costs are Unreasonable

About three in 10 adults report not taking their medicines as prescribed at some point in the past year because of the cost, according to a survey by KFF.

FDA Issues CRL for Bevacizumab to Treat Wet AMD

The anti-cancer drug bevacizumab is used off-label to treat wet AMD. Outlook Therapeutics had developed an ophthalmic formulation of bevacizumab for intravitreal injection.

BCBS of Massachusetts to Cover OTC Narcan Nasal Spray

FDA Approves First Generics of ADHD Drug Vyvanse

At least 15 manufacturers have received approval for both capsule and chewable tablet generic versions of Vyvanse.

Legal Challenges Likely for Drugs Listed for Medicare Price Negotiation

FDA Approves Reblozyl as First-Line Treatment in MDS-Related Anemia

In head-to-head study, Reblozyl nearly doubled the percent of patients achieving primary endpoint of concurrent transfusion independence and hemoglobin increase vs. epoetin alfa.

Janssen Seeks Full Approval for Balversa for Urothelial Carcinoma

The FDA granted accelerated approval to Balversa in 2019. Patients who received Balversa in Janssen’s confirmatory study achieved a median overall survival of more than one year. It reduced the risk of death by 36%.

EmpiRx Health to Scale Its Value-Driven Pharmacy Program

AbbVie Submits Skyrizi to FDA, EMA for Ulcerative Colitis Indication

The submissions to both the FDA and the EMA are supported by two phase 3 trials demonstrating Skyrizi achieved the primary endpoint of clinical remission. Skyrizi is already available to treat patients with plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

FDA Approves First Biosimilar of MS Drug Tysabri

Sandoz’s Tyruko, the first biosimilar to Biogen’s Tysabri, is expected to be available as soon as possible. Pricing has not yet been made available.

Switching to Long-Acting Injectable Paliperidone is Not Cost-Effective in Stable Schizophrenia

Humira Biosimilar Hadlima Making Coverage Inroads on Formularies