Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.
FDA Approvals for February
Highlighting two of the new drug approvals for February, both of which would typically be considered specialty products.
- Erleada™ (apalutamide) was approved for the treatment of patients with non-metastatic, castration-resistant prostate cancer (NM-CRPC). This oral oncology product is the first FDA approved product for this indication. Approximately 160,000 diagnoses of prostate cancer occurred in 2017 with about 10-20 percent being castration-resistant. Expected pricing to be approximately $11,000 per month.
- Symdeko™ (tezacaftor/ivacaftor and ivacaftor) was approved or the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. Similar to the currently available CF products from the makers of Symdeko (Vertex), the cost for this product will be approximately $300,000/year.
Prescription spending will grow faster than other health care services
Validating what many have seen in the pharmaceutical industry, prescription drug spending will grow faster than any other major medical good or service over the next decade, according to a projection from the Centers for Medicare and Medicaid Services.
The analysis, published in the journal Health Affairs, estimates that by 2026, national health spending will climb to $5.7 trillion, or nearly a fifth of the economy. Prescription drug spending is forecast to grow at 6.3 percent per year, on average, between 2017 to 2026.
Albertson's to purchase the remaining Rite Aid stores
It was announced on February 20th, that Albertson’s will be purchasing the more than 2,500 remaining Rite Aid stores. The combined company will have almost 4,900 stores and more than 4,300 pharmacies. What does this mean for EnvisionRx, the pharmacy benefit manager (PBM) currently owned by Rite Aid? On the surface, the increase in scale may help buying power. Additionally, Albertsons has more than 280,000 employees under it various brands who may require pharmacy benefits. EnvisionRx is the current PBM for Albertsons and therefore will be able to keep one of its largest clients.