The “skinny label” case between GSK and Teva has drawn the attention of the Biden administration, which asked the US Supreme Court to weigh in. The case centers around Teva adding a third indication for its generic version of GSK's blood pressure drug Coreg under the direction of the US Food and Drug Administration. GSK claims this violated one of their patents, leading them to sue Teva in a case that resulted in an appeals court victory for the plaintiff. According to Fraiser Kansteiner, “Skinny labels are a common generic carve-out that allow drugmakers to get their copycat medicines approv ..read more

A recently published study in AJPM Focus found that data regarding the social determinants of health (SDoH) that impact cardiovascular disease outcomes is sorely lacking. Interviews with several healthcare leaders across New York City revealed that health systems are prioritizing SDoH, but several barriers stand in the way of implementation efforts. According to Maggie L. Shaw, “Barriers to the collection, sharing, and use of more comprehensive and updated SDOH data include manual data entry; unanswered screening questions on race, ethnicity, and housing status; lack of standardization in dat ..read more

  The COVID-19 pandemic exposed deep disparities in care health outcomes in marginalized groups. One contributor to this problem are widely-used fee-for-service (FFS) payment models. In a new Forbes article, Rita Numerof argues that moving to a patient-centered value-based care model that accounts for social determinants of health (SDoH) is key to helping providers promote health equity through their care decisions. According to Numerof, “To illustrate the point, I recently had a conversation with an executive at one of the largest and best-known nonprofit academic medical centers in the ..read more

Bristol Meyer Squib (BMS) has scored a win with the European Commission (EC) approval of Sotyktu, its new treatment for plaque psoriasis. The treatment would be the first of its kind, an oral allosteric tyrosine kinase inhibitor. The approval covers adults with moderate-to-severe psoriasis that may benefit from systemic treatment for the disease. According to Emily Kimber, “The EC's decision was supported by positive results from the phase 3 POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once-daily Sotyktu in patients with moderate-to-severe plaque psoriasis versus placebo and twice-da ..read more

With the imminent end to the COVID-19 public health emergency looming large, pandemic-era Medicaid expansions are set to kick millions off the program in the US. A newly published report from the Urban Institute and Robert Wood Johnson Foundation predicts that up to 18 million people are set to be dropped from Medicaid in the coming weeks and months. Examine this at the state-by-state level in a new Becker's Payer Issues article. According to Rylee Wilson, “The Urban Institute and Robert Wood Johnson Foundation report, published in December 2022,  predicts Utah will have the highest shar ..read more

The UK's National Institute for Health and Care Excellence (NICE) released a final draft guidance recommending the use of Amgen and Astrazeneca's Tezspire in maintenance treatment for some patients with severe asthma. The biologic is the only one of its kind, targeting an important asthma-related inflammatory protein. According to Emily Kimber, “The final draft guidance from the National Institute for Health and Care Excellence (NICE) specifically applies to patients who are inadequately controlled with high dose inhaled corticosteroids plus another maintenance therapy. Eligible patients will ..read more

US Senators from both sides of the aisle put forward several ideas on how to reform the pharmacy benefit manager (PBM) industry, which negotiates drug prices and coverage decisions between pharma, payers, and pharmacies. Although the senators acknowledged that PBMs cut prices for many patients, they lambasted the industry's lack of transparency and practices that raise costs for older adults enrolled in Medicare part D. According to Zachary Brennan, “In addition to finance committee work, the Senate Committee on Commerce, Science and Transportation last week advanced a bill by a bipartisan 18 ..read more

The payer giant UnitedHealthcare announced plans to cut down on prior authorizations by introducing a new gold-card program. The gold-card program would be implemented nationwide and would cut the number of prior authorizations by 20%. Once implemented, the program will relieve a significant work burden for the provider groups involved. According to Andrew Cass, “The program will apply to most UnitedHealthcare members across commercial Medicare Advantage and Medicaid plans. Qualifying provider groups will follow a simple notification process for most procedure codes rather than the prior auth ..read more

  Earlier this month, ISPOR's Board of Directors announced they appointed a new CEO to guide the organization, Rob Abbott. Mr. Abbott has over 20 years of executive experience and lead Health Technology Assessment International as CEO and executive director. He took over the new leadership role at ISPO after the retirement of the former CEO, Nancy S. Berg. According to ISPOR, “He has successfully guided a number of organizations through their transformation and growth. He is also a pioneering social responsibility thinker and advisor who has authored 2 books and numerous articles on the ..read more

As May approaches, the US Food and Drug Administration (FDA) is planning for three advisory committees that have major implications for healthcare in the US. The first will review Perrigo's over-the-counter contraceptive. Next, a committee will examine an intranasal epinephrine spray for severe asthma. The final will focus on a yet unnamed product from Intarcia Therapeutics. According to Katherine Lewin, “The letter does not specify what the adcomm for Intarcia will be about, but by August of last year the company's leaders had left and the FDA had denied Intarcia's request for a hearing to r ..read more