Formulary Watch |

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.

The FDA emergency use authorization allows the nonprescription test to use at-home sample collection with testing performed in a laboratory.

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.

Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors, which leads to improved blood sugar control.

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.

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.

Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval.

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 move to limit Janssen’s vaccine comes after an analysis finds there is a risk of thrombocytopenia syndrome (TTS), a rare syndrome of blood clots and low levels of blood platelets.

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

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.

The FDA’s Prescription Drug User Fee Act action date for its regulatory decision for Imfinzi for BTC is during the third quarter of 2022.

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