A pharmaceutical company that conducts research in order to develop and then manufacture (produce) specialty prescription drug products.
- Products are sold for distribution to wholesalers or distributors as well as physician offices, hospitals and pharmacy dispensers.
- They may contract directly with other stakeholders or middlemen related to formulary coverage or access to a product.
A REMS (Risk Evaluation and Mitigation System) may be required by the FDA as part of the approval of a new product, as a way to be sure that the benefits of a new drug outweigh the risks. Most REMS require that drug manufacturers provide health care providers and patients with educational materials so they understand the risks and how to use the drug safely.
A wholesaler or medical distributor who sells and distributes drugs that require special handling (temperature, storage, transport), support, tracking, reporting, reimbursement and other services that traditional drugs do not require.
- They may offer support such as billing, nursing support, collection and account management.
- They may also provide broad-based distribution and accountability for specialty drugs in the health care delivery system.
A pharmacy provider or dispenser fills prescriptions, files claims for reimbursement with insurance companies, handles specialty drug reporting requirements and distribution of drugs to patients. They may also follow-up on a patient’s experience which could include reporting adverse events to the manufacturer or FDA through REMS * and offer nursing support and assistance with benefits investigation. They also include the following:
- Pharmacy Benefits Manager (PBM) that has its own in-house dispensing specialty pharmacy.
- Independent specialty pharmacy focused solely on providing and supporting the use of specialty drugs.
- Health plan with an in-house dispensing specialty pharmacy.
- Retail or hospital owned pharmacy that has the ability to provide or dispense specialty drugs.
A clinician in a clinical setting such as physician/prescriber, hospital outpatient/clinic, infusion center or home health care that offers similar services as the Pharmacy Provider and includes:
- Intensive hands-on patient drug administration or supervision, education and follow-up that may include reporting adverse events to the manufacturer or the FDA through REMS.*
- Diagnostic testing to monitor dosage and effectiveness of drugs.
- May offer special handling and storage of drugs for administration to patients.
Prescription Claims Administrator/Third Party Payer
This entity receives the prescription expense claim from plan members/patients or providers and reimburses them for the cost of the drug. They may be one of the following:
- Health plan
- Accountable Care Organization (ACO)
- Patient-centered Medical Home (PCMH)
Employer as the Purchaser or Plan Sponsor
The purchaser provides their share of payment to the third party Medical or Prescription Claims Administrator for the cost of the drug cost. They may be one of the following:
- Public (state, city or county entity) or private employer (self-funded or private exchange), Government (Medicare, Medicaid, Veteran’s Administration, Department of Defense)
- Insurance/health plan
- Patient (e.g. through payment of deductible, co-pay or co-insurance)
* Note: REMS requirements can also limit the availability of specialty drugs designated by the FDA as higher risk to a limited number of pharmacies, hospitals or physicians offices.