Denise Myshko

Launched last year, Prime’s MedDrive is an integrated drug management solution that leverages biosimilars to help reduce drug spend.

In COVID-19 news, FDA expanded EUA for Pfizer/BioNTech COVID-19 booster to children 5 to 11 years and cleared first at-home combo COVID-19, RSV and flu test, but declined an EUA for the antidepressant fluvoxamine to treat COVID-19. Regulators also approved Lilly’s novel diabetes drug and Dupixent eosinophilic esophagitis, modified Dsuvia REMS program and issued a CRL for bimekizumab for psoriasis.

Generics are now available for the two drugs: Vimpat and Combigan.

The FDA has changed how often AcelRx Pharmaceuticals is required to audit healthcare settings that administer Dsuvia, which is a synthetic opioid.

Aetna has made available four specialty drugs that were approved early in 2022 through prior authorization. These include a biosimilar, a CAR-T immunotherapy, and therapies for macular degeneration and a rare auto-immune disease.

While regulatory flexibility is important for drugs for rare diseases, investigators are concerned the trend toward surrogate endpoints decreases confidence that new drugs can improve patient outcomes.

FDA regulators said the data to support the EUA, which was submitted by a physician, is not sufficient to support the use of the antidepressant fluvoxamine for the treatment of patients with COVID-19.

The role of health economic and real-world evidence has become, and will continue to be, an important aspect of healthcare decision-making.

The label for Imbruvica now includes information about the possibility of cardiac failure, which has occurred in 1% of patients. Imbruvica is used to treat B-cell blood cancers.

In COVID-19 news, the FDA has approved Olumiant for new COVID-19 indication, but had limited Janssen’s COVID-19 vaccine. The agency has launched a new program for rare disease drug development and approved a new oral form of ALS therapy. Regulators have also extended the review time for both a new Pompe disease therapy and the sNDA for Myfembree for endometriosis. Additionally, Eisai has completed its submission of lecanemab for Alzheimer’s disease.

Apokyn and Kynmobi contain apomorphine hydrochloride, which can cause hemolytic anemia that requires hospitalization. The products both treat the loss of muscle movement control caused by Parkinson’s disease.

Radicava ORS has the same dosing regimen as the IV form of the ALS therapy, with a treatment cycle followed drug-free periods.

The FDA needs more time to assess information submitted by the company.

Financial hardship was more likely to be reported by older patients who don’t have insurance, take multiple medications, and have a low annual household income.

The administration of adult stem cells increased survival in patients with both acute and chronic graft-versus-host disease in a compassionate use program.

Drug rebates can reduce plans’ net costs but they do not reduce patients’ cost sharing.

The FDA has approved a rare disease therapy and an additional indication for Enhertu, and grants priority review for Imfinzi in biliary tract cancer. Regulators have issued complete response letters for three therapies. The agency also has scheduled an advisory committee for Nuplazid in Alzheimer’s psychosis.

Some children who received GnRH agonists for precocious puberty have experienced a serious side effect known as idiopathic intracranial hypertension, which results in elevated spinal fluid pressure in the brain.

Tracy Spencer, senior vice president at PSG, discusses what large, self-insured employers and plan sponsors want from their specialty drug benefit.

Centene is divesting both Magellan Rx and PANTHERx Rare and will exit the pharmacy benefit management space.

The FDA has made the labels consistent for combined hormonal contraceptives about the risk these products have to women who have or have had breast cancer.

The Build Back Better legislation would have had far-reaching effects on Medicare Parts B and D but the legislation has stalled, and it is unclear if any significant federal legislation affecting specialty pharamcy will pass this year. Meanwhile, several states are addressing white bagging, according to Tracy Russell of CoverMyMeds.

It’s been a busy week at the FDA. The agency has approved mavacamten for hypertrophic cardiomyopathy, an oral therapy for yeast infections, an additional indication for Ultomiris, Rinvoq and Veklury. Additionally, Moderna seek EUA for vaccine for young children and the FDA will hold an advisory committee meeting for both Xphozah in kidney disease and Novavax’s COVID-19 vaccine.

The FDA approval in active ankylosing spondylitis is the fifth indication for Rinvoq in chronic immune-mediated diseases. It joins Xeljanz, which was the first approved JAK inhibitor for this condition in December 2021.

Javier Gonzalez, Pharm.D., Abarca’s chief growth and commercial officer, talks about Assura, the PBM’s net cost pricing solution, which provides more predictability to drug costs and guarantees an annual fixed cost.

Now called Camzyos, the therapy is first-in-class and treats the underlying cause of the disease. It is expected to be available next week.

Pramod John, CEO, and Bhargav Raman, M.D., director, clinical product, at Vivio Health, discuss how their system can match patients to therapies based on data.

The FDA is seeking input from committee members about the phosphate lowering effect seen in trials for tenapanor, which now has the brand name of Xphozah.

The FDA is expected to make decisions on several products later this week, including mavacamten, Qelbree, meloxicam-rizatriptan, surufatinib and toripalimab.

Phase 3 trials show CSF-1, a low-dose pilocarpine, met clinical endpoints for improving presbyopia, or age-related blurry vision.