As consumers, advocates and others prioritize their fight to lower prescription drug costs, insulin is usually first in line.
Now, momentum to curb rising insulin costs seems to be building, with policymakers at the state and federal levels rolling out proposals seeking to provide diabetics some long-awaited financial relief. The questions now: What will materialize and how soon?
This week in California, Gov. Gavin Newsom鈥檚 administration said it is moving forward with a first-in-the-nation plan to manufacture and distribute more affordable versions of insulin under its generic label, dubbed Cal Rx.
As part of that plan, the administration wants to spend $100 million in this year鈥檚 budget. Of that, $50 million to develop low-cost insulin with the help of a drug manufacturer. The other half would be used to set up an in-state insulin manufacturing facility, by the state鈥檚 Department of Health Care Access and Information.
NEW: CA will explore ways to contract and manufacture our own insulin to reduce costs.
— Gavin Newsom (@GavinNewsom)
Insulin should not drain your bank account.
The initiative is unique for a state, and it comes as Congress debates , including 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 at the pharmacy counter. And one California county, looking to provide its residents more immediate relief, is piloting a grant program for residents struggling to afford their insulin.
In California, with diabetes and many of them rely on insulin to survive. Insulin is a hormone that helps regulate blood sugar levels. Prolonged periods of elevated sugar levels can damage organs. An additional 10.3 million Californians are estimated to be prediabetic.
鈥淒ealing with diabetes is already extremely stressful. Providing some financial relief for people, it would make a huge difference.鈥ANNEMARIE GIBSON, SAN DIEGO MOTHER OF TWO CHILDREN WITH DIABETES
The stories of people who have to ration their insulin because they can鈥檛 afford their prescriptions are commonplace. Between 2012 and 2016, , prompting higher out-of-pocket costs for diabetics, according to the Health Care Cost Institute. Today a 10-milliliter vial of insulin can go for anywhere A person usually needs two to three vials a month, and some may need more.
Some people鈥檚 prescriptions come in the form of insulin pens. A package of five pens can go for as much as $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鈥 insulin 鈥 $100 per kid. But first, she has to meet a $2,900 per-person yearly deductible before coverage kicks in. She said that with the medication, insulin pumps and glucose monitors, they meet their deductible early in the year. Her sons, 12 and 14, have Type 1 diabetes and use the drug Humalog.
For 10 years Gibson has watched the cost of insulin go up. She has also seen legislators enthusiastically roll out proposals to reduce costs, only to have those plans fizzle out.
Still, she is optimistic that her sons will never have to worry about unaffordable insulin prescriptions when they become adults. The projects and proposals currently in play, she said, give her some hope something can actually get done in the next few years.
鈥淒ealing with diabetes is already extremely stressful. Providing some financial relief for people, it would make a huge difference,鈥 Gibson said.
State to make its own insulin
into law to seek partnerships with drug manufacturers to develop generics and biosimilars for a number of drugs鈥 but plans have been slow to roll out and it鈥檚 unclear which other drugs will be prioritized. Insulin will be the first to be tested.
Insulin is , meaning it鈥檚 made from living cells. Medications that copy a brand-name biologic are called biosimilars. Like generics, they tend to be more affordable.
The state has yet to identify a drug manufacturer to partner with, but a Newsom administration official said this could happen in the next few months. The state鈥檚 insulin would be available to all Californians, publicly and privately insured, as well as to the uninsured. It鈥檚 unclear how soon this insulin could hit the market, but it would likely be at least a couple of years, an administration official said.
The goal is to provide 鈥淐alifornians with access to insulin products that are a fraction of the $300 per vial prices charged by insulin manufacturers in the U.S.,鈥 the administration鈥檚 budget request reads.
Whether Newsom鈥檚 biosimilar initiative will result in significant savings for consumers is a maybe, some researchers say.
Drug manufacturing isn鈥檛 the only source of the problem, said , executive director of the Value of Life Sciences Innovation Project at the University of Southern California鈥檚 Schaeffer Center. She said policy makers seeking solutions should be looking at all the players involved in the supply chain: from drug manufacturers to wholesalers, pharmacies, insurers and pharmacy benefit managers, which are companies that negotiate prices with drugmakers and pharmacies on behalf of an insurer. All entities profit and contribute to the final price, she said.
, Van Nuys and her team found that while insulin prices have increased, what drug companies pocket has been decreasing over time and what middlemen take has been increasing.
鈥淭here鈥檚 a bunch of stuff that鈥檚 happening in the middle, between what the patient pays and what the manufacturer gets,鈥 Van Nuys said. 鈥淢ore than half of what we spend on insulin goes to intermediaries.鈥
The state鈥檚 plans to manufacture biosimilar insulin could help consumers to some extent, she said, but work also needs to be done to address the 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 the manufacturing of insulin.
Blue Shield of California, for one, it is taking part in an , a Utah-based nonprofit drug manufacturer, to produce insulin that would cost patients $30 or less per vial. Mark Seeling, a Blue Shield spokesperson, said that among hundreds of prescription drug classes, insulins are in the top 10 in terms of what the company spends in pharmacy coverage.
According to Civica Rx, its insulin could be , following approval from the U.S. Food and Drug Administration.
鈥淢ore than half of what we spend on insulin goes to intermediaries.鈥KAREN VAN NUYS, EXECUTIVE DIRECTOR OF THE VALUE OF LIFE SCIENCES INNOVATION PROJECT AT USC鈥橲 SCHAEFFER CENTER
Because it could be years before any of these plans come to fruition, local governments are also looking for their own ways to provide some immediate relief to residents. Santa Clara County recently began a $1 million needs-based grant program for people who use insulin, as well as asthma inhalers and epinephrine injections (EPI pens).
Narinder Singh, pharmacy director for Santa Clara County, said that the could result in fewer people skipping or rationing their medications, and greater adherence means fewer sick days and visits to the emergency room. The county expects 1,000 people to sign up in the coming months.
鈥淚t鈥檚 a very small local effort 鈥 a million dollars in a community like this is a very small piece of it, but it鈥檚 a step in the right direction,鈥 Singh said. 鈥淚f we can all start building momentum on this鈥e can make a huge difference.鈥
Cost-sharing caps at play
Insulin affordability has been the focus of recent discussions at the federal level. The the Affordable Insulin Now Act, pay out of pocket to $35 a month. The Senate has yet to vote on the measure, and is .
The $35 cap was also part of President Joe Biden鈥檚 stalled Build Back Better Plan 鈥 the president referenced it in this year鈥檚 State of the Union speech, sharing the story of with Type 1 diabetes who was present at the event.
A cost-sharing cap gets to the problem on the insurance side; it provides consumers consistency and relief at the pharmacy counter. But experts say it doesn鈥檛 lower the actual price of insulin and would not benefit people without insurance. The California Department of Health Access and Information also makes this point in its budget request.
Capping costs would provide financial relief to at least 1 in 5 insulin users, according to the .
Limits on out-of-pocket costs have become popular in recent years. have passed their own laws limiting insulin copays 鈥 from $100 for a 30-day supply in Colorado to $25 in New Mexico. New York, Illinois and Washington also have their own copay caps.
Similar efforts have failed in California in the past, , a Laguna Niguel Republican, that would also cap copays at $35 per prescription per month is currently pending in the Assembly.
At least 15 states have passed their own laws limiting insulin copays 鈥 from $100 for a 30-day supply in Colorado to $25 in New Mexico.
Assemblymember Adrin Nazarian, a Democrat from North Hollywood, was the author of two bills in recent years looking to cap copays and eliminate deductibles for insulin prescriptions. Last year, his bill on deductibles was held up in the Senate Appropriations Committee.
鈥淚t wasn鈥檛 held because there isn鈥檛 support for it in the Senate. It was held because there are games being played鈥 that ultimately hurt patients, he said.
鈥淚f the federal government does something, fantastic, but I feel embarrassed that a state like California didn鈥檛 jump in front of it,鈥 Nazarian said.
Such bills usually also face strong industry opposition. In their pushback to price caps, such as the ones presented by Nazarian and Bates, health insurers have argued that California-regulated health insurance plans already limit a person鈥檚 share of prescription drugs to $250 to $500 for a 30-day supply. They say further reducing out-of-pocket costs for insulin does nothing to bring down the unit price of the drug.
鈥淭ell that to a single mother or father trying to make ends meet,鈥 Nazarian said.
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