Spotlight on Market Access

The pharmaceutical industry and the broader health care services market currently are experiencing a series of trends that are likely to persist into 2023, said Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a Dec. 16 webinar titled Drug Channels Outlook 2023. These include pressure on insurers’ traditional coverage of generics from patient-paid prescriptions, ongoing 340B litigation and providers’ increased presence within the specialty pharmacy market. But the impact of the biggest disruption, the Inflation Reduction Act (IRA), is yet to come. In this second of a two-part series, AIS Health highlights these trends projected by the longtime industry expert.

The FDA recently approved a new HIV drug for a small patient population desperately in need of treatments. And the twice-yearly medication’s annual price came below the level that respondents to a Zitter Insights poll said they would consider a good value.

On Dec. 22, the FDA approved Gilead Sciences, Inc.’s Sunlenca (lenacapavir) for the treatment, in combination with other antiretroviral(s), of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The agency gave the first-in-class capsid inhibitor priority review, fast track and breakthrough therapy designations.

A group of Blue Cross and Blue Shield-affiliated companies recently unveiled a new medication contracting organization focused on medical benefit drugs. The new company, known as Synergie Medication Collective, will be successful in improving the affordability of these treatments and patients’ access to them, an industry expert says, but it also will need to show that patients are seeing those savings.

Unveiled Jan. 5, the company says it “is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans.” It will focus not only on infusible treatments for conditions such as cancer but also on multimillion dollar gene therapies. The company says its goal is to “significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders.” It plans to “bring to market several new product offerings” this year, among them “transformative value-based models.”

The U.S. Dept. of Defense recently awarded $136 billion in contracts for its TRICARE program that provides health care benefits to military service members, retirees and their families. The contract award for the West region went to TriWest Healthcare Alliance of Phoenix, which is partnering with Regence health plans and Health Care Service Corp. to administer the program. Humana Government Business Inc. will continue to serve the East region when the next contracts begin in 2024. Currently, Health Net Federal Services LLC, a subsidiary of Centene Corp., covers the West region with about 2.8 million beneficiaries, and Humana covers the East region with more than 6.8 million enrollees. In 2024, six states in the East region — Arkansas, Illinois, Louisiana, Oklahoma, Texas and Wisconsin, with a total of 1.5 million beneficiaries — will transfer to the West region in order to balance out the number of beneficiaries served by the two regions.

Multiple trends within the pharmaceutical industry and the broader health care services market currently are underway and likely to persist into 2023, said Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a Dec. 16 webinar titled Drug Channels Outlook 2023. Others, such as the launch of the first biosimilar versions of Humira (adalimumab) are set to take place in the upcoming year. In this first of a two-part series, AIS Health highlights the first half of the trends projected by the longtime industry expert.

Cigna Corp. is the fifth-largest health insurer in the U.S., serving more than 15 million lives nationwide. Roughly 80% of its members are enrolled in administrative services only (ASO) contracting arrangements. While Cigna largely covers employer groups, the insurer is working to build its individual and Medicare Advantage (MA) businesses. The insurer will expand its Affordable Care Act exchange offerings to 50 new counties in Georgia, Mississippi and North Carolina in 2023 and add three new states — Indiana, South Carolina and Texas — to its market. Cigna currently ranks 12th in national exchange enrollment, with 307,500 members. In the MA arena, Cigna ranks 8th nationally. For the 2023 plan year, the company is expanding its MA plans to 106 new counties and two new states — Kentucky and New York.

Tucked into the annual payment rule for Affordable Care Act exchange plans is a proposal that, if finalized, would upend the way health plans and PBMs go about designing formularies — if only for one business line. Already, industry groups are weighing in to both applaud and criticize the concept of requiring ACA marketplace plans to put only generic drugs on their lowest cost-sharing tiers.

“There will be legitimate points to be made on multiple sides of this, and I think that this is going to be a very delicate tightrope that is going to have to be walked,” says Massey Whorley, a principal at Avalere Health.

Three years into the COVID-19 pandemic, enrollment in both commercial health coverage and public health insurance continued its growth. Managed Medicaid membership jumped from 61.4 million in December 2020 to 74.0 million in 2022, while Medicare Advantage (MA) enrollment reached 29.9 million this year, compared with 25.2 million in 2020, according to AIS’s Directory of Health Plans. Commercial health coverage gained 300,000 enrollees over the past year, yet several major health plans reported slight decreases in commercial enrollment, including Centene Corp. and CVS Health Corp.’s Aetna.

As the pharma industry dealt with the ongoing COVID-19 pandemic amid heightened economic pressures, it largely weathered the storm that was 2022. But with provisions of the Inflation Reduction Act (IRA) set to start rolling out next year, many questions remain that may impact pharma manufacturers. The industry, however, saw continued innovation in novel therapeutics, and in the second half of the year, the number of gene therapies on the U.S. market more than doubled with the approval of three new agents. And while the merger and acquisition (M&A) activity may have been a bit muted compared with past years, 2022 is closing out with the unveiling of the biggest biotech deal of the year: Amgen Inc.’s agreement to purchase Horizon Therapeutics plc for $27.8 billion. AIS Health, a division of MMIT, spoke to industry experts about other 2022 pharma trends.

The FDA recently approved the fifth gene therapy to gain FDA approval, with three of those decisions coming in the second half of this year. While payer respondents to a Zitter Insights survey have expressed interest in the drug, its price may prove to be an obstacle to coverage.

On Nov. 22, the FDA approved uniQure N.V.’s Hemgenix (etranacogene dezaparvovec-drlb) for the treatment of people at least 18 years old with hemophilia B who currently use factor IX prophylaxis therapy or have current or historical life-threatening hemorrhage or have repeated serious spontaneous bleeding episodes. CSL Behring LLC, a CSL business, will market the gene therapy. The agency gave the first-in-class adeno-associated virus A5-based gene therapy — which previously was known as EtranaDez — priority review and orphan and breakthrough therapy designations.