Large numbers of Medicare beneficiaries who are ineligible for low-income subsidies and have been prescribed high-price prescription drugs for conditions such as cancer don’t initiate their treatment, likely because they can’t afford it, according to new research published in Health Affairs. One of the study’s authors tells AIS Health that severe illness is a possible outcome of noninitiation in the studied clinical areas and adds that proposals under consideration in Congress to cap out-of-pocket spending for Medicare beneficiaries would make a big difference to the affected patients.

According to the paper, “among beneficiaries without subsidies, we observed noninitiation for 30 percent of prescriptions written for anticancer drugs, 22 percent for hepatitis C treatments, and more than 50 percent for disease-modifying therapies for either immune system disorders or hypercholesterolemia.”

Gaining market access for therapies is key to pharma manufacturers’ success. And it’s not merely access but where on a formulary that access occurs — as well as the formulary tier of competitor products — that’s crucial. To help secure placement, drugmakers enter into contracts with PBMs — and, increasingly, their group purchasing organizations (GPOs) — entities that in turn enter into pharma contracts on behalf of their health plan and employer clients. But these contracts have grown increasingly complex and opaque and can result in pharma manufacturers losing significant amounts of money, according to industry experts. In a two-part series, AIS Health, a division of MMIT, explores the details within the contracts and how those complexities may result in losses of billions of dollars across the pharma industry.

These contracts are proprietary, almost always have nondisclosure clauses and vary by manufacturer, PBM and GPO, so many details around them remain unknown. However, sources tell AIS Health that certain standard items should be included. Those include “definitions, financial terms, requirements to qualify for payments, payment timelines, data sharing, confidentiality,” among other aspects, says Katie Asch, Pharm.D., senior director and U.S. consulting pharmacy practice lead at Willis Towers Watson. In addition, states Jenisha Malhotra, senior manager in Risk & Financial Advisory at Deloitte Life Sciences & Health Care, other items that may be addressed are details around the effective dates of the contract; pricing or incentives, including rebates or discounts; eligible products; responsibilities of the contract signees; and eligibility requirements, including eligible facilities.

Founded in the 1930s by a Washington, D.C.-based hospital association, CareFirst BlueCross BlueShield is now one of the largest insurers in the Washington metropolitan area, leading the Maryland market and snagging the No. 2 spot in the District itself. It offers commercial health products, including plans sold on the Affordable Care Act exchanges in D.C., Maryland and Virginia, as well as Medicare Advantage (MA) and Medicaid plans. CareFirst is also the second-largest participant in the Federal Employee Health Benefits Program, behind Anthem, Inc., with about 627,000 members.

The FDA’s accelerated approval of Alzheimer’s drug Aduhelm (aducanumab) last year was extremely controversial, prompting harsh criticism and calls for reform of the accelerated approval process itself. Congress has taken up the issue and is considering one bill from each major party that would revamp the process in the hope of addressing concerns that the pathway has allowed flawed drugs to stay on the market without being revisited.

Medical research and health care policy experts have raised a number of critiques of the current accelerated approval framework. Two critiques stand out: The first concerns the quality of data used in measuring the effectiveness of accelerated approval drugs. After a drug is granted accelerated approval, the FDA mandates that the drug be evaluated using confirmatory clinical trials. Experts have criticized the quality of data collected for accelerated approval drugs; in particular, the measurements used to gain approval for Aduhelm were heavily criticized by clinicians.

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.

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.

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.

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.”

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.

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.