Moving from one year to the next may “only” involve the turning of a calendar’s page or changing a single number — from a “2” to a “3” as in “2022” to “2023,” but it also means many new opportunities lie before us.
So, too, can adding a single word in state law offer Kentuckians prospects for significant health-care savings and access to needed medicine.
Lawmakers should seriously consider doing just that during the new General Assembly session by adding “biosimilar” to legislation passed last year. That’s it.
This one-word legislative tweak would allow health plans to require biosimilars be prescribed as an alternative to the original — and usually much-more expensive — biologic drugs when available and appropriate at a doctor’s discretion, just like pharmacists can switch out brand-name drugs with their chemical equivalents once patents expire.
Pharmaceutical producers of brand-name drugs must have sufficient time as the lone player to recoup their investments as exclusive providers. This time allows drug companies to sufficiently profit and thus incentivizes them to continue investing in critical research and development of new and needed cures. But they must not be allowed to keep lower-cost alternatives out of the marketplace forever.
Ironically, lower-cost biosimilars address diseases highlighted by those annoying — and costly — advertising campaigns to push expensive brand-name drugs for ailments involving all types of conditions, from chronic skin diseases and rheumatoid arthritis to diabetes and cancer.
At the same time, big pharma inflates its lobbying budgets to fool legislators who want their constituents to have access to safe, affordable options.
No doubt Kentucky lawmakers thought they were covering all available alternatives during the 2022 legislative session when they overwhelmingly passed Senate Bill 140 establishing “step therapy protocols.” The bill allows insurers to — when available and appropriate, and with a doctor’s approval — require patients to at least try using alternatives before being prescribed the higher-cost brand name drug.
While the legislation mentioned generics and “interchangeable” biological products as allowable steps in the treatment process, it left out “biosimilar.”
Pharma lobbyists bent on protecting the turf of the higher-priced branded drugs know this is a small yet big omission.
They know “interchangeable” doesn’t mean “more thoroughly assessed” or “safer.”
They know the only difference between a “biosimilar” designated as “interchangeable” is that the producer of that drug, which closely copies the original biologic, has spent $150 million on additional but unnecessary studies.
Pharma’s representatives know that biosimilars must navigate the rigorous FDA-approval maze just like any other drug to gain approval for use in the health-care marketplace, making all that extra spending largely duplicative and redundant — additional costs that get passed on to patients in the form of higher drug prices.
They also know that the fact that attaining the “interchangeable” designation allows pharmacists to disseminate these drugs is also largely a moot point since physicians, not pharmacists, primarily handle biosimilars. Most, in fact, are dispensed in hospitals and doctors’ offices, where physicians oversee their distribution.
Pharma lobbyists know all this, but are content to keep competitors out of the marketplace, which drives up costs, while keeping lawmakers who aren’t medical experts in the dark.
Tactics used during the 2022 legislative session to ensure “biosimilars” didn’t get included in SB 140 involved failing to enlist policymakers who are health-care experts to lead on the legislation. Instead, the bill’s well-meaning sponsors had unrelated backgrounds.
The U.S. is the only country designating this difference between “biosimilars” and “interchangeable” products, keeping health care costs artificially high and access out of reach — especially for financially challenged Kentuckians.
According to the Association for Accessible Medicines, biosimilars provided the same level of treatment but at nearly half the cost of brand-name products in 2020 and project they will save Americans $130 billion by 2025.
Kentuckians with conditions that can be treated by lower-cost biosimilars — and our commonwealth as a whole — can reap a good chunk of those savings with, again, simply a word.