Skyrocketing insulin prices are threatening US-American public health. California is taking matters into its own hands now. Could state manufactured insulin be the game changer that’s so direly needed?
Anyone who has paid attention to US healthcare in recent years knows one thing: The prices for insulin are out of control. On average, insulin costs 5 to 10 times more in the United States than it does in other industrialized countries; the current price lies at around 0 per vial.
Not everyone is able to afford a sufficient supply of the live-saving drug and therefore a substantial amount of diabetes patients is skipping doses or taking less insulin than required. Of the approximately 7.4 million insulin users in the US, 1.3 million were found to ration their drug specifically because of the high prices – that’s 16.5 %. The patients’ health is suffering the consequences. Rationing of insulin has been found to increase the risk of stroke, myocardial infarctions, heart failure and renal disease among diabetics. Thousands of life-years might be saved if only the medication was more affordable.
Unfortunately, any efforts to reduce or cap prices so far have been struck down by legal challenges – or they have been plainly ineffective. Enter an exciting initiative by the state of California: In July 2022, Governor Gavin Newsom announced the CalRx Biosimilar Insulin Initiative, which seeks to curb insulin prices by having the state manufacture and distribute the drug on its own. Producing insulin in a state-owned and managed facility, or in close partnership with a pharmaceutical contractor, would allow the state to set its own prices – ideally at a cost well below current market prices.
“It’s been estimated that uninsured patients could save as much as ,000 per year, not to mention all the health benefits associated with not having to ration medication”, Jacob S. Sherkow argues. Together with his coauthors, the professor of law and medicine at the University of Illinois recently assessed the Californian initiative in a JAMA viewpoint.
While it is a great idea, the endeavor is faced with several significant challenges. The first one is of regulatory nature: getting approval from the Food and Drug Administration (FDA) to manufacture and market the drug. So far, no US state has attempted to manufacture their own drugs and thus experience is lacking. However, as Sherkow et al point out, this hurdle should be easy to take. “There is a vibrant consultancy market for biologic manufacturing.”
The continuous funding is another challenge that needs to be overcome. “Like any other drug, the manufacturing of CalRx-branded insulin is not only a function of the cost of raw materials, but also of facility maintenance, personnel, cleaning, documentation and legal expenses,” Sherkow explains. “This potential lack of an ironclad guarantee of future funding is a political problem if a new California governor, especially one facing a budget crunch, cuts CalRx’s budget as if it were any other line-item in the state budget.”
Established insulin manufacturers will certainly not sit still and watch as their franchises are threatened. Offering the same medication at a significantly lower price – and not necessarily limited to California, but potentially throughout the whole country – would stir up the market considerably. “It has the potential for a backlash from the larger players in the insulin market, which means CalRx wouldn’t be immune to political lobbying from pharmaceutical manufacturers or other forms of regulatory gamesmanship.”
If CalRx ends up successful, however, it would be a historic health policy victory according to Sherkow, with policy implications beyond insulin. The state-run pharmaceutical manufacturing could address drug shortages. Furthermore, it would be able to sell certain prescription drugs, where insurance coverage is limited despite enormous public health benefits – for example, preexposure prophylaxis for HIV. “A state-run manufacturer also could produce medications such as contraceptives that are generally available but perhaps aren’t covered by employer insurance programs for religious reasons,” Sherkow suggests.
A lot of potential to be sure. Unfortunately, as of now, only time can tell whether California will succeed.
Image source: Jayy Torres, unsplash.
