Spotlight on Market Access

Inflation Rebates Would Cost Manufacturers Millions, Studies Say

Drug manufacturers would be on the hook to pay the federal government hundreds of millions of dollars in rebates per year should the Build Back Better Act (BBBA) — and a key inflation-based penalty provision within it — become the law of the land. The breadth of the penalties, however, hinges on various factors, including the current runaway rate of inflation.

While the BBBA, passed by the House in November 2021, remains stalled, lawmakers have expressed a renewed sense of interest in picking up the pieces following President Joe Biden’s March 1 State of the Union address.

A previous holdout to the Democrats’ wide-ranging spending plan, Sen. Joe Manchin (D-W.V.) recently issued an informal counteroffer to Biden’s speech, calling for prescription drug spending to remain central to any legislation that moves ahead.

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Biomarkers’ Role in Oncology Is Growing, but They’ve Already Had Huge Impact

When the first targeted oncology therapy — Novartis Pharmaceuticals Corp.’s Gleevec (imatinib) — came to market in the U.S. more than 20 years ago, industry experts believed it was ushering in a slew of similar agents focused on a particular mutation, or biomarker. The field, however, did not quite live up to lofty expectations. And while more research has grown the industry exponentially in recent years, it still faces some challenges. But no one can deny that biomarkers have had a profound impact on cancer care.

Agents that target drivers of cancer “have fundamentally changed the way that we treat a wide range of cancers,” maintained Josina Reddy, M.D., Ph.D., global head and vice president of product development for lung, agnostic, skin and rare cancers at Genentech, Inc., a member of the Roche Group, during a recent webinar sponsored by her company. “And in this era of cancer care, identifying those biomarkers in a patient’s tumor tissue or using blood is an essential step in developing a personalized treatment plan, and for a growing share of patients, that treatment plan might include those targeted therapies.”

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MMIT Payer Portrait: GuideWell Mutual Holding Corp.

Founded in 1944 as the Florida Hospital Service Corp., GuideWell Mutual Holding Corp. is one of the largest Blue Cross and Blue Shield affiliates in the U.S. GuideWell is the parent company of Florida Blue, Capital Health Plan, Inc., Florida Health Care Plan, Inc. and, as of Feb. 1, Triple-S Management Corp. With more than 3.7 million members enrolled its in commercial and Medicare Advantage products, Florida Blue is the largest insurer in Florida.

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Pharma Industry Spent Big to Block Drug Reform in 2021

With drug price reforms on the agenda, pharmaceutical companies last year rallied their significant lobbying resources to block or water down transformational policies. Partly as a result of those lobbying efforts, drug price reform is on the ropes, though sources say there is a meaningful chance that a standalone drug price reform bill could pass Congress this year before the midterm elections.

Drug price reform efforts have most recently been part of the proposed Build Back Better Act (BBBA), a bill that contains much of President Joe Biden’s proposed policy agenda. That bill stalled out in December, when centrist Sen. Joe Manchin (D-W.Va.) said he could not back the measure as proposed. When Congress disbanded for the holiday recess, the BBBA had several notable drug-pricing provisions. The federal government would have been able to negotiate the prices of certain high-cost medications with pharmaceutical manufacturers. Also, drug prices would be barred from rising at a higher rate than inflation, the Medicare Part D benefit design would be revamped to lower beneficiaries’ out-of-pocket costs and the price of insulin would be capped. Moreover, the never-implemented Trump-era rule that would have overhauled the prescription drug rebate structure in Medicare Part D would have been repealed.

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Within Innovative Oncology Space, Companies Need to Address Oncologists’ Needs

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.

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FDA Approves Adbry for Use in the Growing Class of Atopic Dermatitis Biologics

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.

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Big 3 Implement Conflicting Formulary Exclusions on Biosimilars

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.

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Drilling Down on Patient Data Is Crucial for Accurate Forecasting

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.”

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MMIT Payer Portrait: CareSource

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.

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Mark Cuban’s Cash Pharmacy Launches Amid Strong Competition

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.

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