Spotlight on Market Access

Although CMS has released its list of the first drugs to be negotiated under the Inflation Reduction Act (IRA), questions surrounding the process, as well as other provisions of the law, still exist. During a recent webinar, Mark McClellan, M.D., Ph.D., the Robert J. Margolis Professor of Business, Medicine, and Policy, and founding director of the Duke-Margolis Center for Health Policy at Duke University, addressed some of those issues, including the real-world evidence that CMS is looking for and how the redesign of Medicare Part D will play out.

The Sept. 18 webinar was the second in a series presented by Innopiphany on navigating the IRA, following the initial one held June 20.

The FDA recently approved the first biosimilar for the treatment of multiple sclerosis (MS): Tyruko (natalizumab-sztn) from Novartis Pharmaceutical Corp. subsidiary Sandoz Inc. The drug is entering a fairly crowded class, and payers have said they expect it to have a moderate impact on their management of the other agents available to treat the condition.

On Aug. 24, the FDA approved Tyruko for the treatment of two indications: (1) adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, and (2) adults with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s therapies and tumor necrosis factor (TNF) inhibitors.

Following the launch of almost 10 biosimilars of AbbVie Inc.’s Humira (adalimumab) this year, 2025 will be another big year for the U.S. biosimilar market, when no less than three versions of Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson are set to become available. Having the experience of assessing multiple competitors with varying attributes could help payers as they prepare for the launches, say industry experts.

Stelara is a human interleukin-12 (IL-12) and -23 (IL-23) antagonist indicated for the treatment of adults with moderately to severely active Crohn’s disease, adults with moderately to severely active ulcerative colitis, people at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 years old with active psoriatic arthritis.

List prices for the 25 branded drugs associated with the highest Medicare Part D spending in 2021 have increased by an average of 226% since they first entered the market, according to a recent report from AARP’s Public Policy Institute. These drugs were responsible for $80.9 billion in total Medicare Part D spending in 2021.

Overall, lifetime price increases among the 25 drugs ranged from 20% to 739%, with all but one of them greatly exceeding the annual rate of inflation over the same period. The list price of Enbrel (etanercept), a treatment for rheumatoid arthritis and psoriatic arthritis, skyrocketed by 701% since entering the market in 1998.

The guessing game surrounding the identities of the first 10 drugs to be selected for Medicare price negotiations under the Inflation Reduction Act (IRA) finally ended on Aug. 29 when CMS published the list of agents. While many on the list were expected, there were still a few surprises, and other uncertainties around the process remain, industry experts say.

The first 10 Medicare Part D drugs selected by CMS to be negotiated — listed in order of their total Part D gross covered prescription drug cost from June 1, 2022, through May 31, 2023 — are:

Founded by a physician in 1980 as a primary care clinic for low-income Californians, Molina Healthcare is now the fourth-largest Medicaid insurer in the U.S., serving more than 4 million lives. In addition to its Medicaid products, Molina also offers Affordable Care Act exchange plans in 16 states and is growing its Medicare Advantage (MA) business. The insurer in June unveiled a $600 million deal to acquire struggling insurtech Bright Health's California MA assets, which is expected to close in the first quarter of 2024. Molina has been on an acquisition spree of smaller, public sector-focused insurers in recent years. Other deals include its purchases of YourCare Health Plan, Affinity Health Plan, Magellan Complete Care, Senior Whole Health, Passport Health Plan and My Choice Wisconsin.

Two patient advocacy groups are declaring victory after Blue Cross Blue Shield of North Carolina made midyear formulary changes that shifted several HIV treatments from higher to lower tiers, meaning patients can access them at much lower cost-sharing levels.

In an Aug. 31 press release, the HIV+Hepatitis Policy Institute and the North Carolina AIDS Action Network pointed out that the move came after they filed discrimination complaints with the North Carolina Dept. of Insurance and HHS’s Office for Civil Rights arguing that the Blue Cross NC formulary violated the Affordable Care Act’s prohibitions against discriminatory plan design. The formulary in question is the Blue Cross and Blue Shield of North Carolina Essential Formulary, which applies to ACA marketplace plans sold in the state.

Major blood thinners are among the first 10 prescription drugs for which the Biden administration will seek lower Medicare prices as part of the Inflation Reduction Act (IRA). The negotiated prices will be announced on Sept. 1, 2024, and go into effect in 2026.

Medicare beneficiaries who filled prescriptions for the 10 selected drugs paid a total of $3.4 billion in out-of-pocket costs for those therapies in 2022. The Medicare program paid more than $50 billion for the drugs between June 2022 and May 2023, CMS reported. Bristol Myers Squibb’s blood thinner Eliquis (apixaban) alone accounted for more than $16 billion.

Digital health funding hit a six-year low in the second quarter of 2023, dropping for the sixth quarter in a row. That’s one of the findings of CB Insights’ State of Digital Health Q2’23 report. And while funding is unlikely to return to the peaks it saw in 2021, the industry may be undergoing more of a reset to funding seen in 2018-2019.

“The headline here really is that digital health funding has hit a six-year low,” remarked Chris Sekerak, intelligence analyst II at CB Insights, speaking during an Aug. 10 webinar titled Digital Health’s Midyear Review & What to Expect Next. For the second quarter of 2023, funding on a global basis dropped to $3.4 billion, a 3% decline from $3.5 billion in the first quarter. The last time that funding was this low was third-quarter 2017.

The FDA recently granted another approval to Taiho Pharmaceutical Co., Ltd. division Taiho Oncology, Inc.’s Lonsurf (trifluridine/tipiracil) for a type of colorectal cancer. The decision provides another treatment option for a condition that respondents to a Zitter Insights survey regard as in need of more effective therapies.

On Aug. 2, the FDA approved Lonsurf as a single agent or in combination with bevacizumab for the treatment of adults with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) drug and, if Rat sarcoma (RAS) wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The agency first approved the oral nucleoside antitumor agent on Sept. 22, 2015. The newest use had priority review. Dosing for the tablet is 35 mg/m2 twice daily on days one through five and days eight through 12 of each 28-day cycle. Drugs.com lists the price of 20 6.14 mg/15 mg tablets as more than $4,204.