Legal Matters

Texas Legislature Passes New Law That Limits White Bagging

By Mark S. Armstrong, J.D. Polsinelli, Pc

TheTexas Legislature recently passed HB 1647, prohibiting certain health plans from imposing limitations relating to coverage of clinician-administered drugs for patients with chronic, complex, rare and life-threatening medical conditions. Texas follows several other states that limit white bagging of specialty pharmacy products out of concerns for patient safety, access, clinician burden and drug waste.

Specialty drugs, many of which are very expensive, are prescribed to treat a variety of conditions, including cancer, autoimmune disease, multiple sclerosis and rheumatoid arthritis. Many specialty drugs also treat rare conditions for which there are limited treatment options. These specialty drugs often have complex handling and distribution requirements. For that reason, many specialty products are not distributed through standard retail pharmacies but are either purchased directly by providers or dispensed by specialty pharmacies.

Traditionally, providers purchased clinic-administered specialty drugs directly from a pharmaceutical wholesaler and were responsible for storing and administering the drugs to their patients. As specialty drug spend increased, payers developed strategies to facilitate cost savings. These strategies changed the typical distribution model where specialty drugs were dispensed by physicians and mandated that the drugs be dispensed through a specialty pharmacy, often owned by the health insurance provider or pharmaceutical benefits manager (“PBM”). This approach is often referred to as white bagging or brown bagging, depending on who receives the drug from the specialty pharmacy.

White bagging is an arrangement between payers and selected specialty pharmacies to deliver directly to providers at the site of the patient’s medications directly to site of care (typically a physician’s office, hospital-based outpatient department, or home infusion provider). Providers are responsible for receiving the drug delivery from the specialty pharmacy, unboxing it, and storing it until the patient is on site and ready for administration.

Brown bagging is an arrangement that requires a specialty pharmacy to deliver the clinician administered drugs to the patient at the specialty pharmacy or directly to the patient, following which, the patients are responsible for storing these drugs appropriately until their appointment with a clinician. Patients then bring their specialty drug with them to hand over to a clinician for administration.

Despite the potential for reducing costs, some patient advocates have see Legal Matters...page 14

Mental Health

Researchers Discover Positive Effects of Intravenous Ketamine For Treatment-Resistant Depression In Noninferiority Study

Electroconvulsive therapy (ECT) is considered to be the gold standard to treat an episode of refractory depression. However, over the last decade, ketamine has proved itself as a rapid-acting and effective treatment option as well. Researchers from Baylor College of Medicine and the Michael E. DeBakey Department of Veterans Affairs Medical Center studied whether ketamine was noninferior to ECT for treatment-resistant, non-psychotic, unipolar depression patients. The ELEKT-D study is the largest trial to date comparing the real-world effectiveness of ECT versus ketamine. Other participating institutions include the Cleveland Clinic, Yale University School of Medicine, Mount Sinai School of Medicine and Johns Hopkins Medical Institute. Their findings were published in the New England Journal of Medicine.

Researchers enrolled patients with major depressive disorder who had been referred for ECT, presenting them the option of enrolling in a comparative trial versus ketamine. ECT requires general anesthesia for a brief period of time, while the 40-minute ketamine infusion is a low dose of a commonly used anesthetic in which patients are awake. They compared the effects of both treatment options by studying patients randomized in two groups: ECT and ketamine. Patients in the ECT arm received a standard course of three weeks of ECT, which was given to them every Monday, Wednesday and Friday each week. Patients randomized to ketamine received it twice per week for three weeks. The patients were evaluated several days after the three-week period with a commonly used questionnaire for depression. As the primary outcome measure, they looked for patients who demonstrated at least a 50% decrease in depression severity scores.

Ketamine had a 55% response rate versus ECT, which had a 41% response rate at the end of the three weeks of treatment. The sample size was the largest study ever done of its kind comparing ECT to another modality, with 170 patients randomized to ECT and 195 patients randomized to ketamine. The Baylor site enrolled almost 100 patients for this trial. ECT was associated with memory disturbance that persisted for a few months post-treatment, while ketamine was associated with transient feelings of disconnection on treatment days.

“Statistically, it was a robust finding showing that ketamine was noninferior to ECT,” said Dr. Sanjay Mathew, primary investigator of the Baylor site and Marjorie Bintliff Johnson and Raleigh White Johnson, Jr. Vice Chair for Research and professor in the Menninger Department of Psychiatry and Behavioral Sciences at Baylor. “This study can give clinicians and patients confidence that ketamine is a reasonable and safe alternative to ECT, at least for the short-term management of treatmentresistant, non-psychotic depression.”

Mathew and his team plan to further investigate the comparison between ECT and ketamine among suicidal patients. The patients in the current study were not acutely suicidal and the majority were treated as outpatients.

“ECT is often used for suicidal patients in the inpatient setting, so now we need to do a large-scale comparison of ketamine versus ECT for our most critically ill and suicidal patients,” he said. 

Give