Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.
First product in new therapeutic category for the prevention of migraines is approved by the FDA
The first CGRP (calcitonin gene related peptide) for the prevention of migraines was approved by the Food and Drug Administration on May 17. Aimovig (erenumab) is a once a month injection indicated for the prevention of migraine.
This is the first product within this category approved by the FDA with other products expected to be approved by the end of 2018. Oral formulations within this same category are expected in 2019. The estimated annual cost of Aimovig is approximately $6,900 which is lower than many estimates which may influence whether this product is considered a specialty medication or not. Even though the annual price may have been set lower than expected, migraines impact up to 10 million patients in the United States. The potential budget impact to payors may still be significant.
IQVIA Institute for Human Data Science releases Global Oncology Trends 2018 Report
Oncology is among the fastest growing categories within the fastest growing portion of the market (specialty pharmacy). Multiple factors drive this including an aging population and more effective treatments resulting in longer courses of therapy. The newly approved products are becoming available with a higher price tag. The median annual cost of a cancer drug launched in 2013 was $79,000, while four years later in 2017, the costs exceed $150,000. U.S. spending for oncology has risen from $38 billion in 2013 to $61 billion in 2017. There is no end in sight with estimates of the U.S. oncology market reaching $100 billion by 2022, averaging 12-15% annual growth.