Spotlight on Market Access

As Congress again proposes drug pricing efforts, many of its members, as well as a couple of government agencies, have pharma manufacturers in their crosshairs for a somewhat related reason: their patent processes. The FDA and the U.S. Patent and Trademark Office (USPTO) recently said they would be working together to scrutinize certain practices that could potentially lead to delays in competition from biosimilars and generics.

The move follows President Biden’s July 9, 2021, Executive Order on Promoting Competition in the American Economy in which he called for “a fair, open, and competitive marketplace” across numerous industries. “Too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.”

In 2022, the majority of plan sponsors used a drug benefit consultant while designing their drug benefit programs, according to Pharmaceutical Strategies Group’s 2022 “Trends in Drug Benefit Design Report,” sponsored by Rx Savings Solutions. The report, which is based on surveys of 153 individuals representing employers, union/Taft-Hartley plans and health plans that covered an estimated 35.1 million lives, also revealed an increasing focus on member satisfaction.

When pharma companies launch a successful product, the process leading up to that point contains many key decisions from various teams across a manufacturer, including commercial. And with science leading to more and more innovations and many drugs coming to market via an accelerated process, it’s critical now more than ever to understand when to bring in the commercial team and how it can help with the development of a drug and its ultimate success in the market.

During a recent webinar, which was part of the Fierce Leaders in Sciences Forum sponsored by Fierce Pharma, moderator Lisa Johnson Pratt, a board member for Assembly Biosciences, kicked off the discussion by asking what the biggest challenges are for companies that are trying to bring a strong commercial point of view and input into the product development process.

Priority Health is the insurance unit of BHSH Health, a health system of 22 hospitals based in Grand Rapids, Michigan. BHSH Health is the temporary name for the combined entity formed by the merger of Spectrum Health (the original owner of Priority Health) and Beaumont Health, which was finalized in February 2022. It is the second-largest health insurer in Michigan, serving members across the spectrum of insurance products, including Michigan’s managed Medicaid program and the Affordable Care Act exchanges. Cigna Corp.’s Express Scripts serves as Priority Health’s primary pharmacy benefits manager, while Accredo Health Group, Inc. (a unit of Express Scripts) manages specialty pharmacy.

With COVID-19 infections surging once again, the Biden administration has stepped up efforts to increase the supply of Paxlovid, the Pfizer Inc. antiviral that garnered emergency use authorization as a therapeutic treatment for the coronavirus. However, increased availability for Paxlovid might end in coming months — Congress has stalled on providing the increased COVID-19 response funding that the administration requested, and experts say health plans are likely to treat the drug like any other if the federal government isn’t picking up the tab for treatments.

The Biden administration has pushed in recent weeks to increase the availability of Paxlovid, free of charge, to COVID-19 patients. On May 26, the White House released a statement touting the rollout of more than 2,500 “test-to-treat” sites where free testing and Paxlovid courses are available, along with 40,000 locations where antivirals are available for patients. The administration also noted that it had “increased the number of people benefiting from oral antivirals in the last seven weeks, from about 27,000 prescriptions filled each week to more than 182,000 last week.”

A U.S. district court judge has struck down a CMS rule that would have narrowed the exclusions from Medicaid best price for manufacturer-provided patient-assistance programs. The rule, which was set to go into effect on Jan. 1, would have required drugmakers to determine exactly where their patient assistance is going. If 100% of it was not reaching the patient — particularly via copayment accumulators and maximizers when payers are taking this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — that assistance would need to have been included in Medicaid best price and average manufacturer price (AMP) calculations for prescription drugs. This decision, as well as a recent pharma lawsuit against a maximizer company, may spur more pushback against these copay programs, one industry expert tells AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ best price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.

A new drug to treat plaque psoriasis is the first topical novel chemical entity launched in the U.S. for the condition in 25 years. Both payers and dermatologists have expressed interest in the agent, according to Zitter Insights.

On May 23, the FDA approved Roivant Sciences subsidiary Dermavant Sciences, Inc.’s Vtama (tapinarof) cream for the topical treatment of plaque psoriasis in adults, regardless of disease severity. The company says the agent is the first and only FDA-approved steroid-free topical medication in its class. Dosing of the aryl hydrocarbon receptor agonist is once daily on affected areas, and the drug has no restrictions on length of use. The price for one tube of the drug is $1,325.

The Federal Trade Commission (FTC) said on June 7 that it will investigate the business practices and consolidation of PBMs, following months of pressure from health care stakeholders.

The FTC’s investigation, which is just the latest escalation in a nationwide regulatory push to clamp down on PBMs’ most controversial methods, was praised by plan sponsors and pharmaceutical groups.

The FTC’s leadership, a panel of five commissioners, voted unanimously to launch the investigation under section 6(b) of the Federal Trade Commission Act of 1914. The commissioners are a mix of two Democrats and two Republicans, with the fifth seat filled by the party that holds the White House.

The notion of value-based care certainly is not a new one. But the concept of what it involves within the health care system and how it can be measured is undergoing a shift, asserted two industry experts. Life sciences companies in particular have an important role to play to ensure that quality and equity in health care are truly achieved.

A value-based care approach “is not centered around a certain payment model or a certain program demonstration,” maintained Taylor Musser, associate principal in the healthcare transformation practice at Avalere Health. Rather, it’s focused on ways to improve the quality of care, she told attendees at a recent webinar sponsored by Avalere. Such an approach will “encompass what care could be delivered by a provider or health system or the care that is coordinated by health plans. And some of the quality objectives” include “are we getting the clinical outcomes we want, are we improving people’s general quality of life and what they experience day to day, [and do] the services or processes of care…align with clinical practice guidelines, for example? We know there are gaps there.” She stated that “avoiding inappropriate or low-value services…is still a concern in our health care systems.”

UPMC Health Plan is the health insurance unit wholly owned by the University of Pittsburgh Medical Center (UPMC). UPMC operates a health system of 40 hospitals throughout Pennsylvania and Appalachian regions of New York and Maryland, as well as several international locations. Its health plans serve members across the spectrum of insurance products, including Pennsylvania’s managed Medicaid program and the Affordable Care Act exchanges. It is currently the third-largest insurer in the state. Cigna Corp.’s Express Scripts serves as UPMC’s primary pharmacy benefits manager, while Accredo Health Group, Inc. (a unit of Express Scripts) manages specialty pharmacy. UPMC manages its own behavioral health benefits.