As consumers, advocates and others prioritize their fight to lower prescription drug costs, insulin is generally on the front line.
Now, the momentum to curb rising insulin costs appears to be building, with state and federal policymakers rolling out proposals to provide diabetics with long-awaited financial relief. The questions now: What will materialize and in how long?
This week in California, Governor Gavin Newsom’s administration said it was moving forward with a nationwide first plan to manufacture and distribute more affordable versions of insulin under its generic label, dubbed Cal Rx.
RELATED: Port of Entry Podcast: Crossing the Border for More Affordable Insulin
As part of that plan, the administration wants to spend $100 million in this year’s budget. Of this amount, $50 million to develop low-cost insulin with the help of a drugmaker. The other half would be used to set up an insulin manufacturing plant in the state, as stated in a budget proposal by the State Department of Health Care Access and Information.
The initiative is unique for a state, and it comes as Congress debates own measurements of the cost of insulinincluding limiting what people pay out of pocket to $35 a month.
Meanwhile, the state legislature is considering its own bill that would cap what Californians pay over the counter at the pharmacy. And a California county, seeking to provide its residents with more immediate relief, is piloting a subsidy program for residents struggling to pay for their insulin.
In California, 3.2 million people have been diagnosed diabetics and many of them depend on insulin to survive. Insulin is a hormone that helps regulate blood sugar levels. Prolonged periods of high sugar levels can damage organs. An additional 10.3 million Californians are estimated to have prediabetes.
Stories of people having to ration their insulin because they can’t afford their prescriptions are commonplace. Between 2012 and 2016, the price of insulin has doubled, which results in higher costs for people with diabetes, according to the Health Care Cost Institute. Today, a 10 milliliter vial of insulin can go anywhere $170 to $400, depending on type and brand. A person usually needs two to three vials per month, and some may need more.
Some people’s prescriptions come in the form of insulin pens. A pack of five pens can cost up to $700. What consumers pay for their insulin will largely depend on their health insurance.
Annemarie Gibson of San Diego, for example, pays $200 a month for her two sons’ insulin, or $100 per child. But first, it must meet an annual deductible of $2,900 per person before coverage kicks in. She said that with drugs, insulin pumps and glucometers, they meet their deductible at the start of the year. Her sons, ages 12 and 14, have type 1 diabetes and use the drug Humalog.
For 10 years, Gibson watched the price of insulin rise. It has also seen lawmakers enthusiastically roll out proposals to cut costs, only to then derail those plans.
Still, she’s optimistic her sons will never have to worry about unaffordable insulin prescriptions when they grow up. The projects and proposals currently in play, she said, give her some hope that something can actually be done in the next few years.
“Dealing with diabetes is already extremely stressful. Offering financial help to people, that would make a huge difference,” Gibson said.
State to make your own insulin
In 2020, Newsom signed in the law a bill that ordered the state to seek partnerships with drugmakers to develop generics and biosimilars for a number of drugs, but plans have been slow to roll out and it is unclear which other drugs will be prioritized. Insulin will be the first to be tested.
Insulin is a biological drug, which means it is made from living cells. Drugs that copy a brand name biologic are called biosimilars. Like generics, they tend to be more affordable.
The state has yet to identify a drugmaker to partner with, but a Newsom administration official said it could happen in the coming months. State insulin would be available to all Californians, publicly and privately insured, as well as the uninsured. It’s unclear how long this insulin could be on the market, but it would likely be at least two years, an administration official said.
The goal is to provide “Californians with access to insulin products that are only a fraction of the $300 per vial prices charged by insulin manufacturers in the United States,” the application states. administrative budget.
Some researchers say Newsom’s biosimilar initiative will result in significant savings for consumers.
Drug manufacturing is not the only source of the problem, said Karen Van Nuys, executive director of the Value of Life Sciences Innovation Project at the Schaeffer Center at the University of Southern California. She said policymakers looking for solutions should look at all actors involved in the supply chain: from drug manufacturers to wholesalers, pharmacies, insurers and pharmacy benefit managers, who are companies that negotiate prices with drug manufacturers and pharmacies on behalf of an insurer. All entities benefit and contribute to the final price, she said.
In a study published last fallVan Nuys and his team found that while insulin prices have gone up, what drug companies take has gone down over time, and what middlemen take has gone up.
“There’s a whole lot of stuff going on between what the patient pays for and what the manufacturer gets,” Van Nuys said. “More than half of what we spend on insulin goes to intermediaries.”
State plans to make biosimilar insulin could help consumers to some extent, she said, but efforts must also be made to address costs in other parts of the distribution process. .
Insurance companies calling for drug price reforms are also looking for their own ways to get involved in insulin manufacturing.
California Blue Shield, for its part, announced last month he participates in a initiative led by Civica Rx, a Utah-based nonprofit drugmaker, to produce insulin that would cost patients $30 or less per vial. Mark Seeling, a spokesman for Blue Shield, said that of hundreds of prescription drug classes, insulins are in the top 10 by the company’s spending on pharmaceutical coverage.
According to Civica Rx, his insulin could be available from 2024following approval by the United States Food and Drug Administration.
Because it could be years before any of these plans materialize, local governments are also looking for their own ways to provide immediate relief to residents. Santa Clara County recently launched a $1 million need-based grant program for people who use insulin, as well as asthma inhalers and epinephrine injections (PPE pens). .
Narinder Singh, Santa Clara County Pharmacy Manager, said the MedAssist program could reduce the number of people skipping or rationing their medications, and greater adherence means fewer sick days and emergency room visits. The county expects 1,000 people to enroll in the coming months.
“It’s a very small local effort – a million dollars in a community like this is a very small part, but it’s a step in the right direction,” Singh said. “If we can all start building momentum on this…we can make a huge difference.”
The cost-sharing caps in play
The affordability of insulin has been the subject of recent discussions at the federal level. the US House recently passed affordable insulin now law, which would cap what people with insurance pay out of pocket at $35 a month. The Senate has yet to vote on the measure, and is work on their own proposals.
The $35 cap was also part of President Joe Biden’s Build Back Better plan – the president mentioned it in this year’s State of the Union address, sharing the story of Joshua Davis, 13 years old with type 1 diabetes who was present at the event.
A cost-sharing cap solves the problem on the insurance side; it offers consumers consistency and relief at the pharmacy counter. But experts say it doesn’t lower the real price of insulin and wouldn’t benefit people without insurance. The California Department of Health Access and Information also makes this point in its budget request.
Cost caps would provide financial relief to at least 1 in 5 insulin users, according to the Kaiser Family Foundation.
Limits on personal spending have become popular in recent years. At least 15 states have passed their own laws limiting copayments of insulin — from $100 for a 30-day supply in Colorado to $25 in New Mexico. New York, Illinois, and Washington also have their own copayment caps.
Similar efforts have failed in California in the past, but Senate Bill 473 by Senator Pat Batesa Republican from Laguna Niguel, who would also cap copayments at $35 per prescription per month is currently pending in the Assembly.
Assemblyman Adrin Nazarian, a Democrat from North Hollywood, has authored two bills in recent years aimed at capping copayments and eliminating deductibles for insulin prescriptions. Last year, his franchise bill was retained by the Senate Appropriations Committee.
“It didn’t happen because there’s no support in the Senate. It happened because there are games being played” that end up hurting patients, he said.
“If the feds do something, fantastic, but I feel embarrassed that a state like California didn’t jump ahead of them,” Nazarian said.
Such bills usually face strong opposition from industry. In their rejection of price caps, such as those presented by Nazarian and Bates, health insurers argued that California-regulated health insurance plans already limit a person’s share of prescription drugs to $250 at $500 for a 30 day supply. They say the further reduction in direct insulin costs does nothing to lower the unit price of the drug.
“Tell that to a single mom or dad trying to make ends meet,” Nazarian said.