By: Vincent Marino, Director of Strategic Partnerships, SHYFT Analytics
The last decade has seen an explosion in the volume of patient-level data available to companies marketing specialty therapies. Drug manufacturers and industry business partners have responded by building and deploying innovative tools and strategies to maximize the utility of those data across life sciences organizations with the goal of reaching peak year sales faster by finding patients, removing barriers to approval, and ensuring treatment adherence. While aggregating patient data may seem like a simple challenge to overcome, the most successful manufacturers follow best practices that provide value at launch and lay the foundation for more advanced analytics in the months following approval.
Regardless of distribution network design, there are steps manufacturers can take to ensure accurate and timely data is available at launch and beyond.
- Right-size the network – While many specialty manufacturers have largely moved to closed networks to ensure access to data and pricing control, much debate continues in the specialty world on the number of pharmacies and distributors to be included in the eventual network. Some find the balance in one or two of the largest national chains, while many choose to bring smaller independent pharmacies to the table. For smaller biotechs, it’s often helpful to keep the network to 2-3 pharmacies, assuming they have adequate coverage and geographic reach. It may seem simple but having fewer vendors to manage at launch can lead to higher data quality, lower cost, and greater control. This approach has also been shown to reduce confusion amongst the patient population by minimizing transfers between pharmacies and providing a more stable treatment environment.
- Build the right Service Level Agreements (SLA) into pharmacy contracts – One of the most common pitfalls of specialty launches stems from inaccurate data leading to poor decision making and confusion across sales, marketing, and commercial leadership. Without timely access to accurate data, field and market access users cannot be as effective as possible. While negotiating specialty pharmacy and distributor contracts, it’s crucial to build in SLAs for timely data delivery and same-day turnaround on restatements. Perhaps more crucial than data performance, SLAs are patient-centric metrics that illustrate the performance of each Specialty Pharmacy (SP). Service levels for metrics like time to fill, refill performance, and time to transfer unfillable scripts will optimize the performance of the network and reduce barriers to therapy across the patient population.
- Standardize data feeds across pharmacies – It is important to complete SP network contracting early in order to allow more time to implement the delivery of feeds, test the restatement process, and ensure that data will flow seamlessly on day 1 of a launch. Simply stated, the best way to mitigate these risks is to minimize and standardize the number of file layouts across the network. Most pharmacies will have no problem using a shared layout, provided that they have adequate notice. One highly successful best practice is to have one master layout for SP status and dispense data across all brands and all pharmacies in network. This not only makes it much easier to set up data cleansing and restatement processes, it greatly reduces the burden of generating daily data at the pharmacy while ensuring that the right data will be available to drive meaningful insights post-launch.
- Partner with pharmacies that allow for linking patient data (tokenization) – With any network larger than one pharmacy, manufacturers need to deploy technology capable of providing a longitudinal view of each patient within the referral network – a critical success factor for delivering meaningful insights, enabling decision making, and understanding product utilization. The past half-decade has seen a proliferation of tokenization technologies that can power this longitudinal view while maintaining HIPAA compliance. Without it, calculating accurate patient counts will be nearly impossible and lead to confusion and poor planning. Tokenization of the SP data also lays the groundwork for linking the patient population to claims, EMR, and other sources to provide even greater insight after launch. While most specialty pharmacies are now accustomed to having these technologies deployed behind their firewalls, having contractual language ensuring that the SPs will allow for tokenization will save a great deal of stress down the road.
The weeks and months after filing a product’s New Drug Application or Biologics License Agreement are exciting but hectic for commercial organizations, especially those operating under a shortened timetable with Fast Track or Breakthrough status. Preparing the specialty pharmacy network is one of the most crucial activities taking place and failure to optimize the network in advance of launch can have lasting and damaging consequences for brand performance.
Right-sizing the specialty network, de-risking contracts with strong SLA protection, and ensuring the ability to link patients throughout the network with tokenization creates optimal launch conditions and a competitive advantage for the industry’s best-run specialty manufacturers.