Kelly Davio

Articles by Kelly Davio

Since biosimilars gained a US approval pathway as part of the Affordable Care Act, these follow-on drugs have been widely seen as a key way to address the problem of high-cost biologic drugs. However, cost savings have been disappointing as only 12 biosimilar products have been approved to date, and just 4 have become commercially available. That’s a reality that led FDA Commissioner Scott Gottlieb, MD, to call the US market for biosimilars “anemic.”

A new, post-hoc study has reported that adalimumab, used as monotherapy, led to positive clinical, functional, and radiographic outcomes in patients with rheumatoid arthritis (RA) for up to 3 years in more than half of patients who reached low disease activity (LDA) following combination therapy.

In July 2018, the FDA approved iobenguane I 131 (Azedra), the first treatment for patients with unresectable pheochromocytoma or paraganglioma, which are rare tumors of the adrenal gland, that require systemic anticancer therapy. These tumors, which typically appear at an early age and are associated with premature death, can increase the production of epinephrines and norepinephrines, leading to a host of symptoms, including hypertension, vomiting, weakness, and chest pain.

Because the majority of a patient’s time is spent outside the clinic, physicians may find it difficult to arrive at an accurate assessment of performance status (PS) for patients who have advanced cancer. Objectively evaluating PS, which measures a patient’s level of function and ability of self-care, can be challenging, but new research suggests that fitness trackers may help clinicians gain better insight into their patients’ PS.

Unplanned hospital readmissions, which affect more than 18% of Medicare beneficiaries each year, are generally understood to be tied to gaps in care coordination between hospitals and community healthcare providers, and new research suggests that readmission more than a week after discharge may be tied to patients’ inability to access appropriate outpatient care after discharge.

During the European Hematology Association’s 23rd Congress, held from June 14 to 17 in Stockholm, Sweden, researchers announced that the ELOQUENT-3 phase 2 study, evaluating elotuzumab with pomalidomide and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma, met its primary endpoint in showing a statistically significant, clinically meaningful improvement in progression-free survival.

On June 14, 2018, the Senate Judiciary Committee voted 16 to 5 to report the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act to the Senate floor. Here are 5 key things to know about the proposed legislation.

A new analysis from the Kaiser Family Foundation finds that most Medicaid enrollees who are able to work are already employed, and that work requirements are unlikely to help enrollees rise from poverty but could negatively impact those who are already working or are unable to work because of medical conditions.

While it is well understood that, in the general population, regular exercise is associated with a reduced risk of death, less is known about whether exercise is similarly beneficial for adult survivors of childhood cancer who may already have an increased risk of death and a shortened life expectancy because of late effects of treatment.

The FDA has approved BioMarin’s pegvaliase-pqpz (Palynziq), a drug for the treatment of phenylketonuria (PKU) in adults. PKU is a rare autosomal recessive disorder, affecting approximately 1 in every 10,000 to 15,000 people in the United States, that increases the levels of phenylalanine (an amino acid obtained through all dietary proteins and some artificial sweeteners) in the blood.

Advances in medicine have produced breakthroughs in the treatment of a number of rare diseases, but these advances often come at a high cost. A multi-stakeholder panel at the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting, in Baltimore, Maryland, addressed the question of how to define value in the always evolving and ever more expensive treatment landscape.

Approximately 20% of patients with epilepsy have a co-occurring autoimmune disorder, and autoantibodies directed against the smaller isoform of glutamate decarboxylase (GAD65Ab) have been found in patients with epilepsy, as well as in patients with stiff person syndrome and type 1 diabetes.

The authors write that these differences among Veterans Affairs (VA) populations could reflect variability across the medical centers in terms of quality of care, adherence to evidence-based treatment and screening guidelines, access to urgent care, posthospitalization care protocols, chronic disease management, and access to specialty care, social work services, and behavioral health care.



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