How the US’s pending PIE Act will improve patient access to medication

Market Access

Jennifer Mathieu, vice president of policy and government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process.   

The AMCP backed bill (H.R. 7008), which allows manufacturers to share vital information with healthcare payers and plans while treatments are pending Food and Drug Administration (FDA) approval, was passed by the House of Representatives and is awaiting approval in the Senate.

"We're proud that this bill is broadly supported across the healthcare industry – by payers, manufacturers, patient advocacy groups, and pharmacists across associations. We have a coalition we've created, and each step the PIE bill advances, we get more support and interest in our efforts," Mathieu says.

Though the bill has wide-ranging endorsement at this time, its advancement has been long in the making.

The history of PIE

AMCP initially introduced the concept of PIE between manufacturers and healthcare payers and plans in 2017.

In 2018, the FDA released guidance permitting PIE, but Mathieu says there was a lack of clarity around the information that could be shared with a payer or insurer.

"The reason we are still pursuing the PIE bill today is that FDA's guidance, while it’s been incredibly helpful and it has opened up the door for these communications, has also created some discrepancies between the statute and the guidance," Mathieu says.

The PIE Act of 2022 mirrors the language of the FDA guidance, then takes it a step further and clearly defines the two types of information that can be shared, including clinical trial information and economic information, and who the data can be shared with.

"It also includes a lengthy list of individuals who can receive this information – individuals who serve in a clinical capacity. They are primarily AMCP's members – pharmacists serving on P&T committees or formulary decision-makers within an insurer or payer," says Mathieu.

Manufacturers could not send the communications directly to a practising physician unless that physician were sitting on a formulary board within an insurer.

"We are striving to resolve those discrepancies, bring greater clarity to the pre-approval communication process, and empower the manufacturers who remain hesitant to engage in information sharing," Mathieu states.

An AMCP poll in March showed that 60% of manufacturers hesitate to engage in pre-approval communications due to the lack of clarity in the guidance around the type of information that could be shared and with whom it could be shared.

"The bill serves to clear up all of those points. Then, of course, guidance is not law. It can be revoked at any time and changed by any administration, which leads manufacturers and their legal team to hesitate to engage in the practise of PIE," Mathieu states.

"Also, the entire bill, H.R. 7008, is really empowering FDA, maintaining FDA's guardrails and oversight, and the normal approval process."

Notably, all the information shared during pre-approval from a manufacturer with a payer will be marked with a notification that the FDA has not yet approved the treatment. Therefore, any decisions made around patient populations or coverage come with the caveat "once approved by the FDA."

"At the end of the day, we're striving to help facilitate these communications because it allows patients to access medications sooner than they currently can."

The goal of PIE is to speed up the review and approval process by payers and plans being allowed to access the vast amount of information on treatment faster, which will provide patients access to life-saving treatments much more quickly.

Affecting patient care

The amount of data manufacturers gather about a treatment throughout the clinical trial process alone can be enormous, and once the manufacturer has all the necessary information to submit a drug for FDA approval, the approval process can take six to 10 months.

"What many people don't understand or may not be aware of is that payers don't just take information from manufacturers at face value. They don't just accept it and say, 'Okay, let's give this to our patient right away,'" Mathieu says.

"They have to go through their due diligence process of reviewing the clinical trial data, reviewing the economic data, and that's where our members come into play."

AMCP's members include pharmacists, nurses, and clinicians with varying expertise in clinical trial processes and data. They review the information for insurers to ensure proper decisions are made for patient populations.

If the review process by the insurer happens after FDA approval, that can add at least a six-month delay in patients' access to the treatment.

"Realistically, our members who work with payers are experiencing delays of up to three years to have the ability to get patients these needed medications," Mathieu says.

With the three-year delay, the fear and concern are that the wait will only grow with new types of treatments being explored, such as cell and gene therapies, where little data already exists.

"Therapies become more complex, and pricing becomes more complicated. The PIE Act allows health payers and plans to review the information concurrently while the treatment is being reviewed for FDA approval," Mathieu says.

"That reduces the wait time after a drug is approved to a matter of weeks – for a payer to work out the operational details on the back end and then make the therapy available to patients. We're talking weeks versus years."

The PIE Act, originally introduced by Representative Brett Guthrie (KY-02), was included as Section 810 in the Food and Drug Amendments of 2022 (H.R. 7667), which passed the House 392-28 on 8 June of this year.

Mathieu states that due to this bill's bipartisan nature and the enormous support, it's expected to pass the Senate in September, and AMCP has been thrilled to back it.

"Since AMCP's inception 34 years ago, we've had the mission of getting patients the therapies they need at costs they can afford. Our goal has always been to improve patient health and outcomes and be responsible stewards of the healthcare dollar. It seemed like a natural effort to pursue," Mathieu states.

About the interviewees

Jennifer L MathieuJennifer has spent over 12 years in healthcare-focused government relations, policy, advocacy, and strategy, with more than 14 years of experience in project management, research, communications, and team leadership. She collaborates on AMCP’s policy development while advancing its legislative and regulatory agenda as the lead Capitol Hill representative, acting as a valuable resource for policymakers.

About the author

Jessica HagenJessica Hagen is a freelance life sciences and health writer and project manager who has worked with medical XR companies, fiction/nonfiction authors, nonprofit and for-profit organisations, and government entities.