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.

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.

Aligning with the Biden administration’s goal of improving health equity, the CMS Center for Medicare and Medicaid Innovation (CMMI) last year unveiled a “strategy refresh” that included health equity as a key objective in testing models of care for Medicare and Medicaid beneficiaries. Another strategic goal was to increase the number of beneficiaries in a care relationship where the provider is accountable for quality and total cost of care, with the objective of having all Medicare beneficiaries aligned with accountable entities by 2030.

Addressing a few recent changes to existing models, CMMI Director Elizabeth Fowler, Ph.D., said the agency’s goal in redesigning the Global and Professional Direct Contracting (GPDC) Model was to reorient it toward provider participants and respond to feedback from stakeholders. The model had been criticized for furthering the privatization of Medicare and allowing for-profit entities to manage fee-for-service (FFS) Medicare beneficiaries without their full knowledge and consent.

The Biden administration’s proposed budget includes an ambitious mental health care agenda that would step up enforcement of mental health parity, change medical necessity standards and require expanded mental health benefits. Though the budget is only a proposal and must pass Congress, where it will be heavily modified, the document arrives at a moment when legislators in both parties have made expanding access for behavioral health care a central element of their responses to the COVID-19 pandemic and opioid misuse epidemic.

The administration’s proposed 2023 HHS budget in brief includes several notable behavioral health proposals that would impact commercial insurers. That list of proposed policies includes stepped-up behavioral health parity enforcement, more funding for Medicare and Medicaid behavioral health benefits and a requirement that all health plans — including commercial group plans backed by employers — provide three behavioral health visits per member every year without charging any cost sharing.

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.

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. And with multiple new biologics approved for the condition and more potential agents coming onto the market, payers may impose more utilization management strategies on the therapeutic class as a whole, say industry experts.

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.

Medicare Advantage membership has grown by 8.5% since February 2021 to top 28.6 million lives, according to AIS Health’s analysis of data that included enrollment during the 2022 Annual Election Period (AEP). While nearly two-thirds of all new enrollees selected a plan from market leaders UnitedHealthcare, Humana Inc. or CVS Health Corp.’s Aetna, several regional insurers performed well above average, driven largely by service area expansions, provider pacts and benefit enhancements. (Per AIS’s research methodology, the following figures do not include lives enrolled in CMS’s Financial Alignment Initiative demonstration plans serving about 451,000 Medicare-Medicaid dual eligibles or participants in Programs of All-Inclusive Care for the Elderly.)

CMS on March 1 issued a request for applications (RFA) for the 2023 Medicare Advantage Value-Based Insurance Design Model, which will include new elements such as a Health Equity Incubation Program that will encourage testing of interventions in “the most promising focus areas” (e.g., food insecurity) and designing best practices for such interventions. Thirty-four MA organizations are currently offering benefit packages that feature tailored VBID model benefits and rewards and incentives to more than 3.7 million enrollees, according to the model’s website. CMS on Feb. 28 also released an RFA from Medicare Part D sponsors and pharmaceutical manufacturers interested in participating in the 2023 Part D Senior Savings Model. Now in its third year, the insulin-focused model is intended to lower out-of-pocket costs for seniors by featuring “predictable” copayments of no more than $35 for a broad set of insulins. The voluntary model has 106 participants, including five manufacturers. CMS is accepting applications for the VBID model through April 15 and for the SSM through April 8.

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.

Most older adults in the U.S. have been diagnosed with one or more chronic illnesses, and managing these conditions presents a significant cost burden, according to a January study in JAMA Internal Medicine. The authors studied eight of the most common chronic conditions, both as single disease states and in clusters, and determined hypothetical annual out-of-pocket (OOP) costs for individual seniors enrolled in Medicare Advantage-Prescription Drug plans and Standalone Part D plans in 2009 and 2019. While annual costs for many of the conditions dropped, likely due to the availability of new generic drugs, OOP costs for atrial fibrillation, type 2 diabetes and heart failure skyrocketed. This was attributed to the introduction of brand-name therapies without generic alternatives that received clinical guideline recommendations. To remedy this, study authors urged Congress to act on drug pricing reforms, including allowing Medicare to negotiate list prices and cap annual OOP costs for seniors.