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With PDUFA Up for Renewal, AMCP Aims for PIE Again


PIE, or a preapproval information exchange, is aimed at streamlining payer and health plan involvement so that it happens at the same time a drug developer submits an application to the FDA, instead of after a drug is approved, with the intent of speeding patient access to therapies.

The Academy of Managed Care Pharmacy's (AMCP) number one federal legislative priority for 2021 is the enactment of a preapproval information exchange (PIE), either through a stand-alone bill or in a new Prescription Drug User Fee Act (PDUFA), according to the organization.

Besides federal legislation to watch, AMCP’s government and regulatory affairs professionals reviewed regulatory issues as well as trends in state capitols, including bills that would affect various aspects of utilization management, during a session at AMCP 2021.

At the Federal Level

Jennifer L. Mathieu, MA, director, Government Relations, kicked off the virtual session by reviewing various items of interest from a managed care pharmacy perspective at the federal level, including COVID-19 relief, drug pricing, supply chain issues, and the Biden administration’s “Build Back Better” plan.

Notably, PDUFA VI expires September 2022. Mathieu said that industry representatives will begin talks with Congress later this year, with recommendations due by January 3, 2022. PDUFA is reauthorized by Congress every 5 years, and fees generated by industry fund about 70% of the FDA’s drug review budget.

AMCP has been advocating for the idea of a PIE for several years, and to that end, will begin work with a new government affairs firm this spring to outline a plan for approaching Congress, Mathieu said.

The idea is to have 2 steps, now separate in the current process, happen simultaneously, she said: As a developer submits its product to the FDA for review, payers and health plans could begin an evaluation of clinical trial and economic information at the same time in order to calculate demand and budgetary impacts.

This would speed patient access to therapies, said Mathieu. Currently, payers do not begin their evaluations until after a drug is approved.

The act that reauthorizes PDUFA could be one way to get PIE through Congress, she said; AMCP is also considering a stand-alone bill.

AMCP is also monitoring which health care provisions could become permanent, or not, in the American Rescue Plan, such as those related to telehealth, COVID-19 strategies around testing, treatment, and immunization, and the use of utilization management tools.

At the State Level

On the state level, there are 5 priorities for the organization, said Adam Colburn, JD, manager, Policy and Government Relations, including meaningful transparency on drug pricing and patient cost-sharing; the development of metrics to shift pharmaceutical payments to value-based care; data sharing and interoperability of electronic health records; advocating for the group’s position on formulary requirements, tier restrictions, and coverage mandates; and supporting the use of managed care tools.

Although dozens of bills regarding these issues have been filed around the country, in most of their priority areas, few bills have actually become laws.

In Utah, a new law requires a pharmacy software system that receives electronic prescriptions for a controlled substance to allow an unfilled prescription to be transferred to a different pharmacy.

A number of states passed laws regarding cost-sharing, tier restrictions, formulary requirements, and other utilization management tools. Two have to do with insulin.

In Kentucky, the cost of insulin is capped at $30 for a 30-day supply and requires it to be in a plan’s lowest tier; Utah passed a similar law. In Virginia, Medicaid must cover hormonal contraceptives and prevents certain utilization controls.

Other states, such as Arkansas and Virginia, enacted bills regarding step therapy and prior authorization, respectively.

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