Spotlight on Market Access

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).

On Jan. 10, the U.S. reported 1.35 million new coronavirus cases as the highly contagious Omicron variant swept across the nation, breaking the previous daily record of 1.03 million. While a COVID-19 vaccine booster could increase immune response, the Centers for Disease Control and Prevention’s data show that only 36.7% of fully vaccinated people have received a booster dose nationwide, as of Jan. 11, 2022. Doubling the pace of booster vaccinations per day could prevent more than 41,000 deaths and 400,000 hospitalizations by the end of April, according to a recent analysis by The Commonwealth Fund.

As 2021 began, the pharmaceutical topic arguably drawing the most attention was COVID-19 and the rollout of vaccines against it. Moving into 2022, the COVID pandemic unfortunately continues to dominate headlines, as the U.S. marked 1 million new cases of COVID on Jan. 3, a single-day record for any country. However, it’s not all bad news, as the pandemic is continuing its impact across various services. For example, drugmakers are applying knowledge gained in their innovative efforts to develop vaccines and treatments to other areas of drug development, and a shift to virtual operations and health care is expected to continue.

AIS Health spoke with a variety of industry experts about their 2022 projections for pharma.

Paroxysmal nocturnal hemoglobinuria (PNH) is an ultra-rare, potentially fatal disease. The FDA approved the first therapy, Alexion Pharmaceuticals, Inc.’s Soliris (eculizumab), a complement C5 inhibitor (C5I), to treat adults with the condition on March 16, 2007. Then the agency approved another C5I to treat adults with PNH from the same company, Ultomiris (ravulizumab-cwvz), on Dec. 21, 2018. A recent study of those two therapies from Prime Therapeutics LLC shows that there may be opportunities for payers in PNH management that will result in better health care outcomes for their members.

Prime presented findings from the study at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting, which was held Oct. 18 through 21 in Denver. Funding for the study was provided by Apellis Pharmaceuticals, Inc., manufacturer of Empaveli (pegcetacoplan), a C3 inhibitor approved May 14, 2021, for the treatment of PNH in treatment-naïve people, as well as ones switching from any C5I. Researchers were from Prime, Apellis and the University of Minnesota College of Pharmacy.