AUGUST 7, 2020
Originally published by our sister publication, Pharmacy Practice News
Medicines that might aid in the fight against COVID-19 are flooding our newsfeeds. As health care researchers around the world seek treatments and vaccines, the health care system must be ready to identify those therapies that demonstrate the greatest value and expedite them to patients as quickly as possible. To do this, we must effectively share data on promising products with the health plans and
Originally published by our sister publication, Pharmacy Practice News
Medicines that might aid in the fight against COVID-19 are flooding our newsfeeds. As health care researchers around the world seek treatments and vaccines, the health care system must be ready to identify those therapies that demonstrate the greatest value and expedite them to patients as quickly as possible. To do this, we must effectively share data on promising products with the health plans and other payor organizations that provide health care coverage for hundreds of millions of Americans.
These organizations rely on health care decision makers (HCDMs), experts in formulary development and benefit design, who have the unique know-how to examine new drugs and consider their efficacy, safety and cost-effectiveness. HCDMs’ ultimate goal is to get patients the medications they need at costs they can afford—health systems and patients expect that. The process includes working with formulary committees to make timely recommendations about new medications and treatments. Therefore, HCDMs require access to clinical and economic information “before” new products are approved for marketing or expanded indications.
The current situation with COVID-19 offers a clear example of why sharing early information on medications in the pipeline is so important: Payors need new treatment data from manufacturers as early as possible. For example, the FDA recently authorized the emergency use of remdesivir, which early evidence shows may reduce recovery times in patients with the coronavirus. Another example is Utah’s move to spend $800,000 to build a stockpile of chloroquine and hydroxychloroquine without rigorous evidence that the therapies helped patients recover faster from COVID-19. The state later canceled its order. (In mid-June, the FDA revoked emergency use authorization for hydroxychloroquine due to a lack of efficacy and known safety concerns.)
These examples highlight the need to examine drugs’ evidence early. Such an approach is inherent in a process called pharmaceutical information exchange (PIE).
PIE gives manufacturers and HCDMs the ability to proactively share certain nonpromotional health care economic and scientific information on products “ahead of” FDA approval, including for both initial and subsequent indications. PIE has the potential to accelerate patient access to emerging pharmaceuticals and devices, including those granted breakthrough designation by the FDA, by expediting coverage decisions.
Given the current global pandemic, it is even more critical to urge Congress to introduce and pass bipartisan legislation that allows manufacturers and HCDMs to exchange preapproval information. While the FDA has guidance regarding PIE, writing it into law provides a firm and clear basis that will ensure manufacturers that they can lawfully share truthful and non-misleading clinical and economic information about medications in their development pipelines, as well as new uses of approved products, prior to FDA approval.
To be clear, PIE is not to be used for promotional communications about unapproved products, which is prohibited by the FDA. Rather, it is designed specifically for HCDMs to obtain the information they need to evaluate medical products and make population-based coverage and reimbursement decisions quickly and effectively.
Patients are waiting for lifesaving drugs to combat COVID-19. Passing legislation and providing valuable tools that enable and facilitate PIE can help.
Ms. Cantrell is the CEO of AMCP, a professional association that advocates for access to high-quality, cost-effective medications and other therapies.
