Setting a familiar tone for the Specialty Drug landscape, the presentation by Express Scripts during AMCP’s opening session (Speaker: Aimee Tharaldson, PharmD) included staggering cost increases within both the medical and pharmacy benefit, however encouraging news of emerging treatments. Beyond that “given” (and the fact that oncolytics represent their industry), here are ten (10) observations worth considering at the ground-level.
Specialty Drug Trend Takeaways
- The average cost of a specialty drug therapy is $2,900/month and impacts only 2% of the overall patient population despite representing ~50% of total drug costs.
- The increased production of compounding drugs can be largely attributed to greater access to drug information online. Compounding spend amplified 625% from 2006 to 2015.
- A 5-year low of Specialty Drug approval in 2016 (17 drugs) is expected to rebound by 100% in 2017, led by the following therapeutic categories; Cancer (10 new drugs), Inflammatory (9 new drugs), and MS (6 new drugs).
- The US is expected to have 11 FDA-approved biosimilars by the end of 2017. Marketing of newly approved products will be a moving target due to pending litigation on patents. Normalizing coding and pricing will become critical for Payors and Manufacturers.
- Orphan drug trend is emerging! There are 7,000 orphan conditions that impact 30 million individuals in the US. What to look for? Four (4) drugs coming out in 2017-18 and a 30% chance an orphan drug achieves $1BN in sales
- There were 10M Osteoporosis diagnoses as of 2016 making this one of the bigger therapeutic categories for both traditional and specialty spend. And 1M Parkinson’s diagnosis last year, making this a worthy target for Manufacturers.
- Half of the Hep-C population doesn’t know they have the disease, making early detection and diagnosis an important factor in ensuring the usage of proper drug therapy.
- The inflammatory condition class remains an area of robust therapeutic development. Within the class, there will be increased competition due to the approval of several new products, which are currently thought to be options for those who fail treatment with TNF inhibitors, such as Enbrel and Humira.
- Multiple Sclerosis remains an active area of development with new oral products in the pipeline. Newer pipeline products are being submitted for FDA approval for progressive MS, which is a current gap within the marketed therapeutic options.
- The Alzheimer’s pipeline is still 2-3 years off, with at least eight products in development.
Looking forward to diving into these issues in the months and years ahead.
Paul D. Rector