Much of the future of the biosimilars sector in the US depends on whether an incoming wave of Humira biosimilars will be placed on formularies as they become available, said executive director of the Biosimilars Forum, Julie Reed.
Humira is the world’s best-selling drug and currently faces no US competition amidst a 470% price increase since first introduced, she noted.
“It is a watershed moment for the industry and for the marketplace as the countdown clock has started for the sequential launch in 2023 of seven adalimumab or Humira biosimilars in the US. This is where the rubber hits the road and it is up to the Biden Administration, to Medicare, to the private commercial payers, and to the pharmacy benefit managers (PBMs) to act and support the launch of these new low-cost biosimilars on the US market.
“One adalimumab or Humira biosimilar is launching in January, the others are launching mid-year and some towards the end of year. These payers, and Medicare, need to put these Humira biosimilars on their drug formularies. It is a serious issue if they don’t because we all know that the more biosimilars competing at the one time with the reference biological, the greater the cost savings, the faster the prices go down.
“[This new wave of Humira biosimilars] is huge opportunity for the US biosimilars sector and the wider pharma industry, a sea change, but it is now in the hands of the government and the payers to make this happen,” the executive told BioPharma-Reporter.
The members of the Biosimilars Forum represent the companies with the most significant US biosimilars development portfolios. They have spent 6-8 years and around US$1.5bn in total in developing these Humira biosimilars and getting them approved, noted Reed.
“They could launch, though, and not have any access to the market if the administration, the private commercial plans and the PBMs don’t do anything. And that would have a negative effect on the industry overall.”
A recent publication by the US Office of Inspector General for the Department of Health and Human Services (OIG) concluded that Medicare Part D, and Medicare beneficiaries, could reduce spending with increased use of biosimilars.
The report noted most Medicare spending on biosimilars occurs in Part B, but that Part D spending is expected to grow, especially as the biosimilars for Humira hit the market. Humira is covered only under Part D.
The OIG set out to analyze trends in biosimilar use and spend in Part D and the review found that biosimilars were used much less in the Part D setting than their reference products. A critical reason for this, said the OIG, was the fact that many plans did not cover biosimilars at all, and those plans that did cover biosimilars rarely designed their formularies in such a way as to encourage use of lower-cost biosimilars over the reference biologic.
It calculated that increased biosimilar use could have reduced Part D spending between 18% and 31% in 2019 and beneficiary spend between 12% and 22%, suggesting potential for greater spend reduction in the future.
The OIG recommended that the Centers for Medicare & Medicaid Services (CMS) encourage Part D plans to increase access to biosimilars and that it monitor plans’ coverage of biosimilars.
The Biosimilars Council said that there are several options for CMS and Congress to encourage greater biosimilar adoption in Medicare Part D, one option being the clarification that all biosimilars are eligible for non-maintenance mid-year formulary changes. That move, it said, would give plans additional flexibility to make biosimilars available to patients more quickly.
In addition to challenges around Medicare Part D inclusion for Humira biosimilars, there are also concerns about how PBMs will consider these multiple adalimumab products, said Reed.
PBMs are middlemen, contracted by health plan sponsors, including US government programs, self-insured employers, and insurance companies, to negotiate on their behalf with pharmaceutical companies.
But the PBMs’ practice of maximizing rebates effectively blocks biosimilars’ market access, according to Reed.
“Biosimilars launch at a reduced cost, at lower list prices. And, at a lower list price without a high rebate, the biosimilar will not be placed on a formulary by a PBM. That is the opposite of what PBMs wanted when they advocated with us to get the biosimilars law passed in the US over 12 years ago.
“The PBMs need to change their mindset, their policies and get these biosimilars on formularies.
“They are not doing what they committed to which was to create a competitive and robust biosimilars marketplace, and that includes the PBMs that work for the US government.”
Large employer groups like the National Alliance of Healthcare Purchasers in the US maintain that biosimilars savings could hit upwards of $133bn by 2025, but only if policymakers encourage greater biosimilar adoption.
The Alliance conducted roundtable discussions with its employer members about the current biosimilar landscape, current challenges to implementing biosimilars, and best practice strategies for making formulary and benefit design decisions.
A key finding was that a lack of transparency and misaligned incentives in the US drug market have contributed to purchasers’ lack of engagement and reduced adoption of biosimilars.
“There was significant conversation about drug pricing and how rebates and credits are used. Some employers said their PBMs and payers have told them biosimilars/biologics are more expensive and less safe than the branded counterpart and an unnecessary addition to the formulary. One of the most common concerns employers expressed was that they have been told they could lose their rebates if they switched patients from branded products to biosimilars and would therefore pay more.”
A report prepared by legal firm, Frier Levitt, and commissioned by the Community Oncology Alliance, a US non-profit organization, also claimed that many health plans do not include biosimilars in their preferred tiers as PBMs prefer the higher cost, branded biologics that offer rebates, over cheaper biosimilar alternatives.
“The result is that when biosimilars do make their way to the market, many patients do not have access to them because their PBM does not cover it. These policies stifle advancements, and will, in the long term, keep plan sponsors beholden to higher cost, branded medications.”
Reed noted recent draft legislation that would hold PBMs accountable for their business practices - the Pharmacy Benefit Manager Transparency Act of 2022, introduced by Senator Maria Cantwell (D-WA) and Senator Chuck Grassley (R-IA).
She claimed this bipartisan legislation would provide much-needed oversight on PBMs business model:
“Three PBM companies currently process about 80% of all prescription drug transactions. Yet, they act with little transparency or regulation. This bill will ensure state and federal authorities can squash PBM-led market manipulation, and it will support a fair competitive biosimilars market that benefits patients and delivers much needed lower costs to the healthcare system.”