Pharma Insights

The European Medicines Agency approved its first biosimilar product in 2006; the United States biosimilar market remains in its infancy. The United States must look to the European Union as biosimilar adoption continues to grow.
New drugs for orphan and rare diseases have the potential to positively impact the lives of patients where historically few or no treatments had been available to manage the disease.
Annual updates to formulary exclusion lists suggest a need for careful evaluation by benefit sponsors, clinicians, patient advocacy groups, and the pharmaceutical industry to determine implications on treatment outcomes and achieving value-based care.
Dr Larry Blandford, PharmaD, provides a discussion of discounts, management approach, and expected challenges of the biosimilar era.
Value measurement strategies and managed care may serve to reconcile the rapid treatment advances occurring in oncology with the attendant high costs of care.
Alternative management approaches, including clinical pathways, should be considered to allow payers to facilitate transitions of care while practicing antimicrobial stewardship.
The value of different gene therapies is likely to vary based on both potential for clinical benefit and what they are able to demonstrate in registration trials.
The increase of insurers investing in quality initiatives has driven healthy competition to develop strategic models to ensure better outcomes and engagement.
Traditional markets have grown crowded with acceptable treatments for large patient populations, which can limit access for drugs in development for these therapeutic areas. Rather than taking a head-on approach to an entire market and the competition therein, it may be advantageous for manufacturers initially to consider more targeted opportunities.
Authors discuss how the use of formulary exclusion lists is expanding and what this trend means for different patient populations and payer organizations.