Radar on Specialty Pharmacy
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Study: Opportunities to Improve Management of PNH Exist
Paroxysmal nocturnal hemoglobinuria (PNH) is an ultra-rare, potentially fatal disease. The FDA approved the first therapy, Alexion Pharmaceuticals, Inc.’s Soliris (eculizumab), a complement C5 inhibitor (C5I), to treat adults with the condition on March 16, 2007. Then the agency approved another C5I to treat adults with PNH from the same company, Ultomiris (ravulizumab-cwvz), on Dec. 21, 2018. A recent study of those two therapies from Prime Therapeutics LLC shows that there may be opportunities for payers in PNH management that will result in better health care outcomes for their members.
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Biomarker Testing Is Not Keeping Up With Drug Innovations
Despite the tremendous progress made over the past decade in developing targeted oncolytic therapies, testing for specific mutations —or biomarkers — to determine the proper candidates for those treatments lags behind. A few states have passed or are considering legislation requiring insurers to cover biomarker testing, with California becoming the most recent state to pass such a law.
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Scemblix Is First-in-Class STAMP Inhibitor for CML
The FDA recently approved a first-in-class agent for the treatment of chronic myeloid leukemia (CML). The drug’s novel mechanism of action may offer an improvement over other therapies within the class, industry experts say.
On Oct. 29, the FDA approved Novartis Pharmaceuticals Corp.’s Scemblix (asciminib) for the treatment of CML in two indications: (1) adults with Philadelphia chromosome-positive CML in chronic phase previously treated with at least two tyrosine kinase inhibitors (TKIs), which was given accelerated approval, and (2) adults with PH+ CML-CP with the T315I mutation, which was granted full approval. It is the first FDA approval of a CML therapy that is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor.
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Two More Accelerated Approval Indications Are Being Pulled
Within the span of one week, Secura Bio, Inc. has revealed that it will withdraw one oncology drug from the U.S. market, as well as an indication for another oncolytic. The FDA had given both accelerated approval. The moves come amid growing scrutiny of that approval pathway, and they mark the ninth and 10th oncology indications and/or drugs taken off the U.S. market since December 2020.
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BCBST, Oncology Group Launch Oncology Medical Home
BlueCross BlueShield of Tennessee (BCBST) and community oncology practice Tennessee Oncology recently launched a value-based cancer care program aimed at providing high-quality, cost-effective health care. The oncology medical home (OMH) will be a model for future programs, says the Blues plan.
The initiative launched in October for BlueCross commercial networks P, S and L members. It will support members beginning with their diagnosis and then through treatment and follow-up care. The partners will work to make sure that best practices in care planning and treatment are followed, that care guidelines are met, that patients get the correct treatment at the right time and that patient-centered care is provided.
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