Prescription digital therapeutics (PDTs) are health software, available by prescription only, intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.
AMCP supports increased access to Prescription Digital Therapeutics (PDTs). PDTs are software-based therapies that deliver clinical benefits to patients, either alone or in combination with other forms of treatment. These therapeutics require a prescription and are subject to oversight by the Food and Drug Administration (FDA). To be approved by the FDA, PDTs must demonstrate both safety and efficacy.
AMCP recognizes that many patients today depend on high‐cost specialty medications that often do not have therapeutic alternatives. Medication cost-share offset programs provide out-of-pocket discounts or free product at the point of sale.
AMCP opposes attempts to erode the Employee Retirement Income Security Act (ERISA) and Medicare Part D preemption. AMCP believes that the certainty that comes with a single uniform federal standard ensures that plans subject to these laws are better able to provide access to needed medications regardless of where the patient lives or works.
AMCP supports a wide range of measures that strike a balance between market-oriented principles and prudent regulations. Pharmacy benefit managers (PBMs) help facilitate patient access to medication at an affordable price.
The rebate system is an important lever for ensuring the affordability of prescription medications and health care premiums for Americans. AMCP supports the use of a rebate system as one of many levers to help to control drug costs.