Louisiana Letter [RE: SCR 87 of 2016 Legislature – study of specialty drugs and specialty pharmacies]
December 2, 2016
Dear Mr. Broussard:
The State Patient Access Coalition appreciates your willingness to share with the Regulation Revision Committee our suggested definitions for “specialty pharmacies” and “specialty drugs” that the committee will consider at their meeting on December 6, 2016. Our membership includes manufacturers of specialty drugs, and specialty pharmacies that provide individuals with the specialty drugs as well as the intensive clinical monitoring and patient education that are vital components in ensuring optimal patient health outcomes.
We would recommend defining “specialty pharmacy” as a pharmacy that provides the services and management necessary to ensure optimal patient health outcomes when using a specialty drug, including, but not limited to, clinical monitoring, patient training, compliance assistance, and specialized product handling and administration requirements.
We would recommend defining “specialty drug” as a drug that has one or more of the following characteristics:
- An FDA required Risk Evaluation and Mitigation Strategy;
- Requires special handling, storage, inventory, distribution or ancillary supplies; or
- Requires patient management or education prior to, during, or following administration requires, and may require patient management or education prior to, during, or following administration.
In preparing our definition, we reviewed other specialty drug definitions. Many included route of administration (infused, injected, inhaled, etc.), “high cost” “and “limited distribution” as components of the definition. We are not opposed to the inclusion of these components, but we decided not to include these components because they are not determinative of a therapy being a specialty drug since these components would potentially allow for drugs that do not require the special treatment that differentiates specialty drugs from other drugs.