Spotlight on Market Access

The FDA recently gave an additional approval to BeiGene, Ltd.’s Brukinsa (zanubrutinib), which is already approved for three other rare types of non-Hodgkin lymphoma. Respondents to a Zitter Insights survey said that while its availability will result in a lower level of unmet need in the treatment of chronic lymphocytic leukemia (CLL), there is still moderate or high unmet need for the condition.

On Jan. 19, the FDA expanded the label of Brukinsa to include the treatment of adults with CLL or small lymphocytic lymphoma (SLL). CLL and SLL are the same disease, a type of non-Hodgkin lymphoma, except CLL cancer cells are mostly in the blood and bone marrow, while in SLL, the cells are mainly in the lymph nodes.

In 2028, the federal government will likely negotiate the prices of 38 drugs covered under Medicare Part D and two under Medicare Part B, according to an analysis published this month in the Journal of Managed Care & Specialty Pharmacy. Inmaculada Hernandez, Pharm.D., Ph.D., one of the study’s authors, tells AIS Health the evaluation “is going to be very helpful for health plans and PBMs to know which drugs are going to be negotiated” as they evaluate the impact of the Inflation Reduction Act (IRA).

The IRA, which passed last year, includes a provision that requires the government to negotiate for the first time with pharmaceutical manufacturers the prices of some high-cost medications that are not subject to generic or biosimilar competition. It will begin with 10 Part D drugs in 2026, an additional 15 Part D drugs for 2027, another 15 Part D and Part B drugs in 2028 and an additional 20 Part D and Part B medications each year starting in 2029. Part D covers retail prescription drugs, while Part B covers provider-administered medications.

Medicare will likely focus on 38 Part D and two Part B drugs in the first three years of Medicare drug price negotiation — a provision of the Inflation Reduction Act — and these drugs combined accounted for $67.4 billion in gross Medicare spending in 2020, according to a study published in the Journal of Managed Care & Specialty Pharmacy. The authors identified 40 drugs expected to be negotiated by CMS for 2026-2028 based on “drug age, drug or biologic status, orphan drug status, Part B and Part D gross spending in 2020, and estimates of when a drug will be subject to generic or biosimilar competition.”

The 10 drugs likely to be selected for negotiation in 2026, which include several anticoagulants and cancer therapies, accounted for $33.7 billion of Medicare Part D gross spending as of 2020. The majority of insured people under Medicare formularies have plans that put these drugs under the preferred/preferred (prior authorization and/or step therapy) tier and covered/covered (PA/ST) tiers, according to data from MMIT Analytics. (MMIT is AIS Health’s parent company.) Biden administration officials said that the first 10 drugs selected for negotiation will officially be announced on Sept. 1, 2023.

As the world enters the fourth year of the COVID-19 pandemic, a recent report from the IQVIA Institute for Human Data Science found — not surprisingly — that a significant shift has occurred in the outlook for global medicine spending. The report, titled The Global Use of Medicines 2023: Outlook to 2027, revealed that global spending on pharmaceuticals, including COVID vaccines and therapeutics, from 2020 to 2027 is anticipated to surpass the Institute’s pre-pandemic estimations by $497 billion.

“Here we are at the beginning of 2023, with perhaps more uncertainties still ahead of us than we might have hoped for a year ago,” observed Murray Aitken, executive director of the IQVIA Institute for Human Data Science, during a recent webinar presented by his company. “Despite the progress on the pandemic front, it’s still out there; it’s still shaping our lives to a greater or lesser extent, depending on where in the world we are. It’s also still shaping our health care systems.

Independence Health Group is the parent company of Independence Blue Cross, the second-largest Blues insurer in Pennsylvania (behind Highmark Health), and AmeriHealth Caritas, a managed Medicaid payer serving more than 2.3 million beneficiaries in seven states and the District of Columbia. It also operates the AmeriHealth Insurance Company of New Jersey, a commercial payer serving about 209,000 members. Founded in 1938 as the Associated Hospital Service of Philadelphia, Independence now counts more than 4.5 million members across the spectrum of health insurance products. Still based in Philadelphia, it leads its home state’s individual, self-funded (administrative services only, or ASO) and managed Medicaid insurance markets. Optum’s FutureScripts serves as the primary pharmacy benefits manager for Independence Blue Cross. AmeriHealth Caritas, meanwhile, operates its own in-house PBM, PerformRx.

During a recent hearing held by a U.S. Senate committee, a variety of witnesses took the stand who nearly all had one message in common: criticizing the role PBMs play in increasing medication costs for consumers. The hearing — which is just the latest indication lawmakers are more closely monitoring PBMs — occurred less than three weeks after Sens. Chuck Grassley (R-Iowa) and Maria Cantwell (D-Wash.) introduced the Pharmacy Benefit Manager Transparency Act of 2023 to the Senate floor.

Ryan Urgo, managing director of health policy at Avalere Health, tells AIS Health that the hearing and bill are part of “a broader effort by lawmakers right now to apply more scrutiny to the PBM business model and certain PBM business practices that lawmakers feel are either anticompetitive or contribute to the broader growth of drug prices.”

In 2021, the net cost per prescription drug claim in 25 Medicaid fee-for-service (FFS) programs went up 11.0%, or $5.81, according to Magellan Rx Management’s latest annual Medicaid Pharmacy Trend Report. It is the first time that drug spending growth reached double digits since the inception of Magellan’s report in 2016. Net spending on specialty drugs continued to see double-digit growth at 13.0%, compared with 10.9% in 2020, while net trend on traditional drugs rose 5.8%, up 4.1 percentage points from 2020. For the second year in a row, specialty drugs accounted for more than half of total drug spending in Medicaid FFS, while only representing 1.3% of total pharmacy utilization.

On Sept. 1, CMS will publish its list of 10 Medicare Part D drugs that it has chosen for negotiations for 2026, the first year that negotiated prices will be in effect via the Inflation Reduction Act (IRA). But a lot of unknowns exist around the law, including how CMS will determine the drugs up for negotiation. During an Evercore ISI webinar held Jan. 30, analysts broke down this aspect of the IRA and shared the drugs and manufacturers they expect to be impacted.

“We are looking at an escalating number of drugs subject to negotiation starting in 2026,” noted Tobin Marcus, policy analyst at Evercore ISI. “There’s been some misunderstanding about the fact that these numbers are cumulative.” So while 2026 will have 10 drugs up for negotiation, 2027 will have an additional 15 Part D drugs for a total of 25 for the year. The following year will see an additional 15 Part D and Part B drugs, and then starting in 2029 and later years, 20 more Part D and Part B agents will be up for negotiation.

The FDA recently approved the first gene therapy for bladder cancer, Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg). Almost three-quarters of oncologists surveyed by Zitter Insights expressed at least moderate interest in the agent, and payers said they likely will manage the drug to label.

On Dec. 16, the FDA approved Adstiladrin for the treatment of adults with high-risk, Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. The agency gave the novel adenovirus vector-based gene therapy priority review, breakthrough therapy and fast track designations. Dosing is once every three months into the bladder via a urinary catheter. The company said it expects the therapy to be available in the second half of 2023.

More than six years after the FDA approved it, the first biosimilar of AbbVie Inc.’s Humira (adalimumab) has finally launched in the U.S. On Jan. 31, Amgen Inc.’s Amjevita (adalimumab-atto) became available at two different wholesale acquisition costs — one 55% below Humira’s WAC and one 5% below it — a strategy that acknowledges the lure of rebates within the U.S. market. It remains to be seen whether additional adalimumab biosimilars launching this year will follow suit or explore a different strategy to differentiate themselves.

Initially approved Sept. 23, 2016, Amjevita was the first of eight Humira biosimilars that the FDA had OK’d as of early February. The tumor necrosis factor (TNF) inhibitor is approved for seven of Humira’s nine indications, including rheumatoid arthritis, plaque psoriasis and Crohn’s disease, although the biosimilar is indicated for ulcerative colitis in adults, while Humira is approved for UC in people at least 5 years old. The two Humira indications not on Amjevita’s label are hidradenitis suppurativa and uveitis.