Spotlight on Market Access

The oncology space is undergoing a tremendous amount of innovation, as novel new products and practices become available. But those treatments can do only so much good if oncologists aren’t using them. Biopharma companies have an opportunity to differentiate themselves from their competitors by addressing oncologists’ specific needs, industry experts tell AIS Health, a division of MMIT.

When it comes to drug information, oncologists not only want to understand a product’s efficacy, “but also how to efficiently and effectively diagnose the patient and get that patient to the right targeted drug or combination using the patient’s genetics and the genetics of the tumor,” such as BRCA1 mutation-positive in breast cancer, explains Kristen Pothier, principal at KPMG U.S. Healthcare and life sciences deal advisory and strategy leader.

The FDA has approved a handful of drugs to treat atopic dermatitis recently. Among them is LEO Pharma Inc.’s Adbry (tralokinumab-ldrm), an interleukin-13 (IL-13) antagonist. According to a Zitter Insights survey, payers may take a bit of a restrictive approach in managing the drug.

On Dec. 28, the FDA approved Adbry for the treatment of people at least 18 years old with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those treatments are not advisable. The decision made it the first biologic that LEO Pharma has launched in the U.S. Recommended dosing is an initial dose of 600 mg via four 150 mg subcutaneous injections and then 300 mg every other week.

The Big Three PBMs — Cigna Corp.’s Express Scripts, UnitedHealth Group’s OptumRx, and CVS Health Corp.’s Caremark — once again added new drugs to their formulary exclusion lists for the 2022 plan year, but the rate of new exclusions slowed. Industry insiders tell AIS Health, a division of MMIT, that the slowing amount of exclusions indicates the PBMs find high value in opaque, complex contracting agreements with providers, even though certain preferences in areas like insulins, specialty drugs and biosimilars defy the logic of list prices.

According to an analysis of plan documents by Adam Fein, Ph.D., CEO of the Drug Channels Institute, Caremark now excludes 433 products from its formularies, Express Scripts excludes 485 and OptumRx excludes 492. Each amount sets a record number of exclusions for each company.

Patients’ treatment journeys often are complex as they move through lines of therapies and switch treatments. This can make it a challenge for pharmaceutical companies to accurately predict how their products, as well as those of their competitors, will do on the market. However, certain steps can be taken to improve this essential task.

“Forecasting drugs is challenging,” stated David Wolter, M.B.A., vice president of consulting services at IQVIA, during a recent webinar. While there aren’t many studies on forecasting accuracy within the pharma industry, he referenced one from 2013 that found “the majority of consensus analyst forecasts — so bank analysts for new drugs — are off by more than 40%.” He maintained that part of the reason this is so difficult is tied to “getting the patient part of the forecast correct.…How many patients are being treated, when they’re being treated and when we get the revenue and the volume associated with those patients.”

Founded in Dayton, Ohio, in 1989, CareSource is a not-for-profit health insurer that serves Medicare, Medicaid and Affordable Care Act exchange members in five states, though Ohio remains its largest market. Following its founding mission of expanding health care access to needy populations, in 2015 the insurer branched out to seniors, launching its first Medicare Advantage (MA) plans in Ohio. CareSource also serves Ohio’s Medicare-Medicaid dual eligible population through the state’s CMS-backed duals demonstration program.

Mark Cuban Cost Plus Drug Company (MCCPDC) launched its online, generic-dispensing pharmacy on Jan. 19, becoming the latest entrant into a burgeoning market of prescription drug retailers that operate independent of traditional pharmacy benefits. Health care insiders say that the amount of activity in the emerging segment is encouraging, but they add that no one player is likely to become dominant in the space.

MCCPDC, a discount prescription drug startup launched by venture capitalist and Dallas Mavericks owner Mark Cuban, now operates an online pharmacy that sells directly to consumers and does not accept insurance. MCCPDC CEO Alex Oshmyansky, M.D., Ph.D., told AIS Health, a division of MMIT, in October that the firm is registered as a pharmaceutical wholesaler with the FDA.

People with employer-sponsored health plans spent 11.6% of their median household income on premiums and deductibles in 2020, up from 9.1% in 2010, according to an analysis published by The Commonwealth Fund. In 37 states, premiums and deductibles accounted for 10% or more of employees’ median income in 2020, with those in Mississippi and New Mexico facing the highest potential costs relative to income. The average premium for single coverage and family coverage reached $1,532 and $5,978 nationally.

To say that the FDA’s approval of Biogen and Eisai, Co., Ltd.’s Alzheimer’s disease treatment Aduhelm (aducanumab-avwa) on June 7, 2021, garnered an immense amount of attention would seem to be an understatement. That said, the drug has somehow gathered even more notice over the past few months due to multiple developments, with CMS most recently issuing a proposed National Coverage Determination (NCD) on Aduhelm and other monoclonal antibodies that target beta amyloid plaque that will allow Medicare coverage for the therapies but only under certain circumstances. While commercial payers often follow CMS’s lead, it remains to be seen whether that decision — plus a dramatic price cut on Aduhelm — will prompt payers that have declined to cover the therapy to change course.

There is a 30-day public comment period on the proposed NCD, which was published Jan. 11. A final decision is expected on April 11.

More than a year after pandemic travel restrictions pushed back the FDA’s approval decision on Novartis Pharmaceuticals Corp.’s inclisiran, the agency finally approved it. The new first-in-class therapy targets so-called bad cholesterol and is set to compete with two other biologics that target the same protein.

On Dec. 22, the FDA approved Leqvio as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia who require additional lowering of low-density lipoprotein cholesterol.

As part of a sweeping new Medicare Advantage rule, CMS recently proposed a policy aimed at reforming a reimbursement system that local pharmacies have long claimed is straining them to the breaking point. PBMs, on the other hand, argue that the proposal could hamper value-based contracting in Part D and potentially increase Medicare spending.

At issue are arrangements in which Part D plan sponsors can recoup money from pharmacies for dispensed drugs if the pharmacies do not meet certain metrics. Generally speaking, these payments to plan sponsors are known as price concessions, and when assessed retrospectively — as they currently are — they are counted as direct and indirect remuneration (DIR).