Spotlight on Market Access

Mental Health Care Access Varies Across Demographics, Insurance Coverage

One in four adults reported symptoms of anxiety and/or depression prior to the COVID-pandemic, according to a Kaiser Family Foundation analysis of the National Health Interview Survey in 2019. While the rates of people reporting mental health symptoms across racial and ethnic groups are similar, a much larger share of Black adults with moderate to severe symptoms did not receive treatment. Meanwhile, uninsured people were significantly more likely to not receive mental health care (62%) compared to their insured counterparts (36%). Since the pandemic began, more people suffered from poor mental health, with one-third of adults reporting anxiety and/or depressive disorder in February 2022.

Health Care and Life Sciences Are Facing Headwinds, but Investors Remain Interested in Deals

Health care and life sciences (HCLS) organizations took a tremendous hit from COVID-19 and its secondary effects, including labor shortages, rising wages, supply chain problems and inflation. In addressing the challenge posed by the pandemic, these companies were able to produce impressive progress, not the least of which were the development and delivery of vaccines, therapeutics and tests for COVID. In addition, telehealth evolved quickly, producing new delivery models across multiple parts of the health care system.

But even when faced with multiple headwinds and more uncertainty, investors continue to compete for HCLS acquisitions. According to a recent KPMG LLP report, merger-and-acquisition (M&A) activity across both sectors “bounced back with a vengeance” in 2021: 1,839 deals, not counting joint ventures, minority investments and venture funding. That’s up from 1,618 deals in 2020 and 1,543 deals in 2019.

Oncologists Are Showing More Enthusiasm for Carvykti Than Are Payers

With its Feb. 28 approval, the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc.’s Carvykti (ciltacabtagene autoleucel; cilta-cel) becomes the second chimeric antigen receptor T-cell (CAR-T) therapy to treat multiple myeloma. Payers report being less likely to prefer it over some or all other multiple myeloma treatments with a similar indication, but oncologists are showing more enthusiasm for prescribing the new agent, according to Zitter Insights.

The FDA approved Carvykti for the treatment of adults with relapsed or refractory multiple myeloma after at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The product is a B-cell maturation antigen (BCMA)-directed CAR-T agent. The one-time treatment will have a phased launch and will be available through a limited network of certified treatment centers. The FDA gave the drug breakthrough therapy and orphan drug designations. The therapy’s wholesale acquisition cost is $465,000.

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.

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.”

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.

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.

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.

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.

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.