WASHINGTON, Oct 30 (Reuters) - Vice President Kamala

Harris on the campaign trail has frequently touted capping the

price of insulin at $35 a month as a major accomplishment of the

Biden administration, referring to a provision of the Inflation

Reduction Act.

Harris, the Democratic presidential candidate, and President

Joe Biden describe the cap as one of their most important health

policy wins, helping those who often could not afford the

life-sustaining treatment. The real-world impact is more

complicated, with many diabetes patients still vulnerable to

higher costs, advocacy groups say. Here's what you need to know:

WHO DOES IT HELP?

The price of insulin has been a major flashpoint in the

conversation around rising U.S. healthcare costs. Individual

stories of patients having to ration the drug or skip doses, and

in a few cases dying, made headlines and sparked congressional

investigations.

An estimated 8.4 million people with diabetes in the United

States rely on insulin to survive, according to the American

Diabetes Association.

Nearly one-third of those patients were paying $35 or far

more per month in 2019, according to the latest available data

from the Department of Health and Human Services. The study said

20% of all insulin users paid more than $70 per month at the

time, including many who were spending hundreds of dollars.

The IRA out-of-pocket cap took effect at the start of 2023.

But it only applies to the government's Medicare program for

people age 65 or older and the disabled. Medicare beneficiaries

make up about half of U.S. insulin users. Before the cap, 37.5%

of them, or 1.5 million people, paid more than $35 a month.

WHAT ABOUT INSULIN USERS NOT ON MEDICARE?

Almost 1 million people who are either covered by private

health plans, state Medicaid programs, or who have no insurance

were paying more than $35 per month for their insulin in 2019,

according to HHS data.

They have benefited to some extent from voluntary price cuts

announced by drugmakers last year, under public pressure from

Biden and U.S. Senator Bernie Sanders, among others.

The three largest insulin makers - Novo Nordisk,

Sanofi and Eli Lilly ( LLY ) - implemented price cuts

of up to 78% for some of their insulin products and expanded

discounts offered by patient assistance programs. None of these

measures is protected by law, and drugmakers can choose to raise

prices again.

WHY ARE SOME LEFT OUT?

Patient advocates say some people who are not on Medicare

still pay well above $35. Their medicines originally had monthly

list prices set at hundreds of dollars. Even after dramatic

price cuts, a month's supply of injector pens may still cost

more than $150. Many diabetes patients also need to use a

combination of insulins.

Some of the cheaper products, like Eli Lilly's ( LLY ) $25 Lispro,

have not been available in pharmacies. Lilly announced a

shortage of Lispro in March. Patients say it is still ongoing.

A Lilly spokesperson said there are currently over 50,000

Lispro prescriptions filled weekly at U.S. pharmacies which can

get the drug within two days of ordering.

Novo said last year it would pull its Levemir insulin from

the U.S. market at the end of 2024, months after cutting its

price by 65% to $108 a vial and $162 for a 5-pack of injector

pens. It has also reported shortages of NovoLog, another insulin

product.

The drugmakers run patient assistance programs that cap

prices at $35 or under, but can be hard to access for both

patients and pharmacies, advocates say.

These programs "are no replacement for real policy. Everyone

deserves consistent access to affordable insulin," said Shaina

Kasper, executive director of advocacy group T1 International.

"This is a band-aid on a bullet wound."

Kasper and other advocates have called for federal

regulation of insulin prices, or even state-level manufacturing,

to address the root cause of high prices.

Harris, if elected, has said she would work to expand the

insulin cap for all patients. Former President Donald Trump, the

Republican presidential candidate, has falsely claimed he was

the one who lowered insulin costs to $35 a month for Medicare

patients. He had introduced a more limited, voluntary co-pay cap

that plans could choose to participate in.

WHAT DO THE DRUGMAKERS SAY?

Drugmakers blame middlemen known as pharmacy benefit

managers for high drug prices. PBMs negotiate drug prices and

rebates with manufacturers for their employer and health plan

customers.

A Novo Nordisk spokesperson said the company's insulin

discounts of up to 75% have not been passed on to patients. "We

are frustrated when the savings we provide are not realized by

patients," the spokesperson said.

The company's NovoCare patient assistance program helped 1

million patients in 2023, the spokesperson said.

Sanofi said its patient assistance program capping co-pays

at $35 for a month's supply of insulin can be utilized by all

commercially insured patients, and that it is automatically

applied at the counter at participating pharmacies.

A second program for uninsured patients allows them to buy a

monthly supply of any combination of the company's insulins for

$35 and was used 128,609 times in 2023, saving patients almost

$62 million, according to the company.

Lilly said any of its insulins are available for $35 or

less, that its savings plan helped over 100,000 people save $20

million in 2023, and will be renewed in 2025 with the same cap.

"Industry wholesalers and pharmacies decide how much of each

product to make available, and pharmacies set the price they

charge per vial," a Lilly spokesperson said.