According to a report from the federal government's Medicare Payment Advisory Commission released last month. More than 40% of Medicare beneficiaries Despite discounts of over 80% on some products compared to the original Humira, it is still not possible to obtain biosimilars referencing Humira through insurance.When biosimilars are covered, typically same The patient's cost burden is the same as Humira, and there is no advantage for patients to take it. This comes more than seven years after the first Humira-referenced biosimilar was approved by the Food and Drug Administration and more than a year after the biosimilar was cleared for sale in the United States.
AbbVie announces it can protect Humira's market share Until 2025 or 2026according to Endpoint news. AbbVie's statement seems plausible given that autoimmune disease products have lost only 2% of market share since biosimilar launches last year.
Notably, Friday's report said Humira had sales of $14.4 billion last year. financial statement From AbbVie.
This blockbuster drug first received marketing approval more than 20 years ago. Since then, he has amassed more than $210 billion in sales worldwide. Shortly after Humira's patent expired in 2016, the FDA began approving biosimilars that referenced Humira. A biosimilar is a drug that is very similar to a reference macromolecule biologic, in this case Humira (adalimumab). However, patent litigation and complex legal compromises prevent any biosimilars from being released in the US until 2023, effectively extending Humira's US exclusivity for seven years.
Furthermore, once launched, biosimilars have failed to gain significant traction due to byzantine systems of pricing and reimbursement, often accompanied by rebate systems.
Rebates are payments made by drug companies to health plans and pharmacy benefit managers. Instead, PBMs shift market share toward “priority” products on formularies or covered drug lists. This is achieved by positioning the product favorably with lower patient costs and fewer coverage restrictions. Drugs with higher list prices often come with higher rebates, meaning his PBM may prefer brand-name products such as Humira.
On the other hand, from a patient's perspective, products that are cheaper than the list price are preferred because the cost burden is calculated as a percentage of the list price.
Humira Reference Biosimilar Medicare Part D (Outpatient) Plan Coverage Determined scrutiny This is because these products are often excluded from prescriptions or are allowed “equity tiering,” meaning patients pay the same level of cost as the originator.
According to the OIG, Medicare programs may: saved tens of millions of dollars A biosimilar referring to both Humira and Enbrel (etanercept) will be available after the originator receives the patent and will be optimally positioned with lower out-of-pocket costs for beneficiaries and a higher formulation priority. If only there was a system that worked year after year. Enbrel is also the original biologic used to treat autoimmune diseases. It was first approved more than 25 years ago and will not face biosimilar competition until 2029, although there is a biosimilar version of Elergi approved in 2016. As with Humira, the reasons for the prolonged delay are similar. This is a long legal battle over patents.
Among others who support the adoption of biosimilars: biosimilar forum supports a draft legislative proposal to be outlined in the Senate Finance Committee in fall 2023 to facilitate beneficiary access to “low-cost biosimilars within the Medicare Part D program.”
Senators supporting the proposal want Part D plans to meet certain coverage and cost-sharing requirements for “high-discount” biosimilars by 2026. A biosimilar is defined as offering a discount of at least 45% compared to the reference biological product. Specifically, the draft legislative proposal anticipates that the Centers for Medicare and Medicaid Services will publish a list of biosimilars that qualify as high-discount biosimilars.
A look at 40 high-rebate brand-name drugs and their generic equivalents. General Affairs and Accounting Office Report We found that about 25% of the Part D plans we studied listed brand-name drugs on their prescriptions, but not generic or biosimilar alternatives. Generic drugs are bioequivalent to brand name small molecule drugs.
Federal Trade Commission Announced in June 2022 It said it would crack down on kickback arrangements that prevent patients from accessing competitive, low-cost medicines, warning that such kickbacks “may violate competition and consumer protection laws.”
The FTC also notes that rebates may shift costs and disalign incentives in ways that ultimately increase out-of-pocket costs for beneficiaries, especially if generic drugs or biosimilars are excluded from or not prioritized from the formulation. he pointed out.
Another story of biosimilars in Europe
Biosimilar penetration in the US is relatively low, in sharp contrast to Europe, where Humira-referenced biosimilars have been on the market for more than five years.
Patent disputes are one of the reasons why biosimilar launches tend to be significantly delayed in the United States; small impact Compared to Europe, where patent law is not as broad in scope. In Europe, by contrast, Humira lost its monopoly six years earlier, and was virtually immediately followed by competition and a significant usurpation of market share by biosimilars.
Additionally, European payers' purchasing practices favor lower-cost alternative treatments whenever they enter the market. For example, organizations such as the UK's National Institute for Healthcare Excellence, when developing health technology assessments, recommend using the lowest-cost treatment when given a choice of equally effective alternatives. We advise healthcare providers to:
In the US, on the other hand, payers and PBMs may favor more expensive treatments due to rebate arrangements.
This perverse incentive structure provided by kickbacks does not exist in Europe. Additionally, European health systems tend to procure biosimilars on a tender basis. Bidding follows a formal procedure in which, for example, a hospital conducts a competitive bidding process for a particular contract with the aim of controlling drug spending when alternative treatments for a particular drug are available. Biosimilars almost always receive priority bidding due to their lower prices.
By the last quarter of 2019, less than a year after Humira-referenced biosimilars entered the European market, the average 35% of patients across Europe had already made the switch Toward biosimilars.In the UK, this figure is 63% This was achieved just six months after biosimilar competition was allowed.In Denmark, which has a winner-take-all system, that number is 80% This was achieved within three months of being on the market.
Besides rebates and patent battles, the U.S. has several regulatory hurdles that European biosimilar manufacturers don't have to contend with. One is the seemingly redundant treatment compatibility designation that must be obtained from the FDA in order to automatically switch one prescribed drug for another. In Europe, proving biological similarity is sufficient to establish therapeutic compatibility in practice.
Second, the United States is the only country where biosimilar generic names have a meaningless four-letter suffix, whereas originator biologics do not. This can be confusing for doctors and patients alike.
It's no surprise, then, that research shows that U.S. physicians may be reluctant to prescribe biosimilars. clearly, 60% of doctors surveyed A study conducted by Cardinal Health found that patients only feel “comfortable” prescribing biosimilars that are therapeutically compatible, but not undesignated biosimilars.
Expanding the scope to include all therapeutic classes for which biosimilars are approved, the European Medicines Agency has approved more than twice as many biosimilars as the US (93 in total as of December last year). Become.fast and extensive Biosimilar intake across most therapeutic classes for which biosimilars are approved.
U.S. patients, including Medicare beneficiaries, continue to suffer from a largely dysfunctional system where barriers to accessing biosimilars increase patient out-of-pocket costs. This in turn undermines the long-term sustainability of future biosimilar development.
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