A Medicare Part D policy forbidding plan sponsors’ formularies from excluding nearly all drugs in six “protected” classes hinders payers’ ability to negotiate prices and may lead to significantly higher costs to the health care system, according to a recent analysis published in Health Affairs. The study’s lead author notes this is the first peer-reviewed trial suggesting Part D plans “can’t negotiate as high of rebates as they might otherwise be able to” for drugs in the protected classes.

In the seven years since the approval of the first chimeric antigen receptor T-cell (CAR-T) therapy, the agents have proved to be effective in the treatment of non-Hodgkin lymphoma. But the one-time-use agents come with risks, including the potentially fatal cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), so the FDA requires patients remain near their treatment center for four weeks after administration, which can be onerous for patients. But a recent study finds that side effects were rare after the first two weeks post-infusion, perhaps helping lead to less of a burden for patients.

An article in Blood Advances, a journal of the American Society of Hematology, revealed the findings of a retrospective study of 475 patients who received three CD19-directed CAR-Ts at nine different centers: Yescarta (axicabtagene ciloleucel) from Gilead Sciences Inc. subsidiary Kite Pharma, Inc., Novartis Pharmaceuticals Corp.’s Kymriah (tisagenlecleucel) and Breyanzi (lisocabtagene maraleucel) from Juno Therapeutics, Inc., a Bristol Myers Squibb company.

Aug. 7: The FDA approved Citius Pharmaceuticals, Inc.’s Lymphir (denileukin diftitox-cxdl) for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one systemic therapy. The immunotherapy is the only CTCL treatment that targets the interleukin-2 (IL-2) receptor found in T-cell lymphomas and regulatory T cells (Tregs). The rare disease is a chronic non-Hodkin lymphoma that primarily affects the skin. The drug is a reformulation of Ontak (denileukin diftitox), which was on the U.S. market from 2008 to 2014, when it was voluntarily withdrawn “to enable manufacturing improvements.” The FDA gave the therapy orphan drug designation. The recommended dose is 9 mcg/kg per day based on actual body weight via a 60-minute intravenous infusion on days one through five of a 21-day cycle. The company says it expects to launch the agent within the next five months.

One year in, most of the initial active participants in CMS’s Enhancing Oncology Model (EOM), a value-based, patient-centered care model, are still involved in the program. Participants tell AIS Health, a division of MMIT, that overall, the experience is going well, but some concerns exist around issues including social determinants of health (SDOH) and whether the reimbursement is appropriate for what CMS is requiring.

The purpose of the EOM is “to drive transformation in oncology care by preserving or enhancing the quality of care furnished to beneficiaries undergoing treatment for cancer while reducing program spending under Medicare fee-for-service.” CMS says it “envision[s]” that the model not only will improve quality but also lower costs “because its payment methodology is aligned with care quality, and because EOM participants will have significant opportunities to redesign care and improve the quality of care furnished to beneficiaries receiving care for certain cancers.” The model makes physician practices accountable for total costs of care.

Some findings from the new report by Pharmaceutical Strategies Group (PSG), an EPIC company, may have seemed like old news: AbbVie Inc.’s Humira (adalimumab) was the top specialty drug in terms of spend. Inflammatory treatments dominated the top 10 of those agents. But the 2024 Artemetrx State of Specialty Spend and Trend Report, released July 25, also revealed some new findings, including that rebates had a smaller impact in 2023 than they did the previous year and that cost per claim played a bigger role in the 2023 specialty drug trend than it did in the prior time frame.

PSG based the report — which is sponsored by Walmart Specialty Pharmacy — on integrated pharmacy and medical claims data from the book of business for its proprietary SaaS platform Artemetrx. In its eighth year, the newest report is based on 138 million medical claims and 136 million pharmacy claims. The findings are based mainly on commercial health plans.

July 8: The FDA approved ANI Pharmaceuticals, Inc.’s L-glutamine oral powder to reduce the acute complications of sickle cell disease in people at least 5 years old. The company says it is the first AA-rated approved generic for Emmaus Medical, Inc.’s Endari. Dosing for people weighing less than 30 kilograms is one packet twice daily; for those between 30 and 65 kilograms, dosing is two packets twice daily, and for those more than 65 kilograms, dosing is three packets twice daily. Drugs.com lists the price of 60 packets of Endari as more than $1,505.

Some findings from the new report by Pharmaceutical Strategies Group (PSG), an EPIC company, may have seemed like old news: AbbVie Inc.’s Humira (adalimumab) was the top specialty drug in terms of spend. Inflammatory treatments dominated the top 10 of those agents. But the 2024 Artemetrx State of Specialty Spend and Trend Report, released July 25, also revealed some new findings, including that rebates had a smaller impact in 2023 than they did the previous year and that cost per claim played a bigger role in the 2023 specialty drug trend than it did in the prior time frame.

PSG based the report — which is sponsored by Walmart Specialty Pharmacy — on integrated pharmacy and medical claims data from the book of business for its proprietary SaaS platform Artemetrx. In its eighth year, the newest report is based on 138 million medical claims and 136 million pharmacy claims. The findings are based mainly on commercial health plans.

When benefits managers from a range of employers gathered at the Midwest Business Group on Health’s (MBGH) recent forum in Chicago, the final session of the day revealed that specialty drugs were some of their top concerns. And it appears employers are getting savvier about managing them.

A big focus of the conference was benefits managers’ fiduciary duty to their employees — and how shirking that duty could land them in hot water.

“If you haven't done a market check, do a market check,” recommended Dan Dentzer, manager of health and wellness design for United Airlines, at the June 26 MBGH Employer Forum on Pharmacy Benefits, Specialty and Biopharma Therapies. “I do market checks like I change my socks because you have to know what's going on out there. You have to know what others are doing. You have to know you're getting the best deal possible. If you haven't done that, please do.”

As the U.S. continues to grapple with drugs in short supply, a variety of strategies from onshoring production of agents to stockpiling have been proposed. A recent event by The Hill brought together a mix of stakeholders to take a closer look at the situation. Multiple factors are contributing to it, and, thus, one single solution is not going to address the situation, but numerous steps could help alleviate the current, as well as future, shortages, industry experts claimed.

Sponsored by the Healthcare Distribution Alliance, the event, titled “Keeping Pharmacy Shelves Filled: Solutions to Address Drug Shortages,” was held June 25 in Washington, D.C.

Cancer has become the top condition driving costs for employers, and a recent report found that most of them expect their annual spend on the condition will increase by up to 9% each year over the next three years. Last fall, the Midwest Business Group on Health and the Florida Alliance for Healthcare Value, in collaboration with MBGH employer members, shared information around the management of oncology benefits with an eye on making sure that the right care is given to the right person at the right place, right time and right price, for both the employer and the member.

Among the topics of discussion for the Oncology Learning Collaborative were prevention, including screening and early identification; navigation, including psychosocial support and return to work; and diagnosis, including a second opinion, biomarkers and treatment.