Even as federal lawmakers squabble and navigate political divisions, a key issue for this new Congress has been high drug prices and how to bring them down. Insulin, in particular, has captured the spotlight and become a sort of poster child for America's dysfunctional healthcare system.

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In just the first weeks of the year, we've seen clear evidence that Congress is listening and many have gone out of their way to highlight diabetes and insulin prices as they discuss ways to address this crisis.

Among those who've testified before Congressional committees lately are D-Mom Antroinette Worsham from Ohio, who lost one of her daughters with T1D to insulin rationing, and whose other daughter also lives with T1D, and Indiana D-Mom Kathy Sego whose T1D son has rationed his insulin due to cost. Minnesota D-Mom Nicole Smith Holt -- whose 26-year-old son Alec died after rationing insulin -- was the guest of Senator Amy Klobuchar (D-MN) at the 2019 State of the Union address, and Klobuchar also featured Nicole and mentioned insulin pricing in her recent presidential run announcement.

Meanwhile, the powerful Chair of the Senate Finance Committee Charles Grassley (R-IA) demanded that the CEOs of Pharma companies (including one of the three insulin manufacturers) appear before his committee to explain why PWDs (people with diabetes) are being deprived of affordable insulin.

But will Congress really do anything to help? Will the Trump Administration, which also claims that reducing prescription drug prices is a high priority?

While there's a lot happening at the state level on drug pricing transparency, action from the federal government on anything is always a question mark. Still, since the new Congress started (with a Democrat-led House) there have been so many bills and policy proposals targeting high drug prices that it’s been hard for even policy wonks like me to keep track of them all.

To help you cut through the clutter, here are a few of the Big Ideas floating around DC that could have an impact on skyrocketing insulin prices: 

 

Big Idea 1: Target the Middlemen

One of the most recent proposals floated to address the issue of high drug prices -- and insulin in particular -- has been from President Donald Trump’s Health and Human Services (HHS) Secretary, Alex Azar. He wants to target pharmacy benefit managers (PBMs), the middlemen who play a role in jacking up insulin prices. His plan aims to reduce out-of-pocket costs by eliminating some rebates – discounts on medications – that drugmakers offer PBMs in Medicare plans. Azar has also called on Congress to take a similar approach to rebates in the commercial insurance market. The JDRF has already issued a statement applauding the idea and saying it's good news for our Diabetes Community.   

While these plans were announced with great fanfare, they’ve received mixed reviews in Congress, where some Democrats worry they will end up increasing insurance premiums. 

 

Big Idea 2: Allow Prescription Drug Imports

In Canada, people who need insulin pay up to 10 times less than they do in the U.S., yet it’s illegal to import prescription drugs from north of the border. Two new Congressional bills would change that.  

Chuck Grassley (R-Iowa) and Klobuchar (D-Minn.) have introduced legislation that would permit American consumers to buy prescription drugs from Canadian pharmacies and bring them home for personal use. 

A more ambitious bill co-authored by Sens. Cory Booker (D-NJ) and Bob Casey (D-PA) would initially allow U.S. wholesalers, pharmacies, and individuals to import medications from Canada. After two years, imports from other countries would also be permitted.

If either of them becomes law, there’s no doubt that insulin and other lifesaving drugs would be far more affordable.

Objections from Big Pharma

Big Pharma doesn’t like either bill (surprise, surprise). Their main, stated objection is that there is no way to guarantee the drugs’ safety. That’s a legitimate concern, but both bills have inspection requirements and protocols meant to stop the flow of counterfeit and unsafe medications.

The one with at least a fighting chance in the Senate is the Grassley-Klobuchar bill, as Grassley has considerable clout and has championed the idea of importing medications in the past.

But don’t get too excited.   

Any drug-importation legislation “faces a steep challenge in the GOP-controlled Senate,” according to Hill-watchers in Health Leaders, as many members have long opposed importing foreign-approved prescription drugs due to “concerns over public health.”

Also, the new trade deal with Canada and Mexico (another hot spot for American PWDs who need insulin) prohibits imports of medications. “When you talk prescription drugs, we don’t like getting them from foreign countries," Trump said in October.

That would seem like the kiss of death from a normal president, but since this orange-haired leader contradicts himself continuously, the Grassley-Klobuchar bill might have a shot.

 

Big Idea 3: Pegging U.S. Prices to Those Abroad

“It is unacceptable that Americans pay vastly more than people in other countries for the exact same drugs, often made in the exact same place,” Trump said in his State of the Union speech. “This is wrong, unfair, and together we can stop it.”  There was applause from both sides of the aisle.

Closing that price gap is also the goal of the Prescription Drug Price Relief Act recently introduced by Sen. Bernie Sanders (I-VT), Reps. Elijah Cummings (D-MD) and Ro Khanna (D-CA) and other Democrats. The bill pegs the price of “excessively priced" prescription drugs in the U.S. to the median price in five major countries: Canada, the United Kingdom, France, Germany and Japan.

Great idea, huh?  According to Sanders, this would dramatically reduce the cost of Lantus insulin and Januvia, among other medications.

If we were weighing the political odds based on the past, this would have little chance in the Senate, where Republicans who tried to kill ObamaCare are reluctant to embrace the idea of Big Government fixing prices in the private sector.

But they’re also reluctant to pick a fight with Trump, and his Department of Health and Human Services is now exploring a similar idea: they want to peg some Medicare payments to an index based on sales prices in more than a dozen countries. This won’t be formally proposed until next year, but if the Republicans don’t squelch it, there is at least a  chance that it will be the basis for genuine, bi-partisan reforms that would help PWDs.

Stranger things have happened.  After all, a reality TV show star became President.

 

Big Idea 4: Remove Barriers to Cheaper Generic Insulin

The health bills most relevant to PWDs that may be most likely to succeed are the hardest ones to get excited about.They might help reduce insulin prices… but just a little.

Also from Grassley-Klobuchar, it’s the “Preserve Access to Affordable Generics Act,” which cracks down on the practice of"pay-for-delay." That’s a corporate scam in which drug makers whose patents are about to expire pay competitors not to produce cheaper, generic versions for years.

Then there's a similar bill by the bipartisan Congressional Diabetes Caucus co-chairs, Rep. Diane Degette (D-CO) and Rep. Tom Reed (R-NY), which was introduced on April 2. They have been grilling Big Pharma on insulin prices since 2017, demanding answers and calling Congressional hearings, and this legislation would also open the door for more generics and biosimilar insulins. It would also prevent future administrations and the FDA from repealing the measures.

“We know that one of the best ways to reduce the cost of insulin is to increase competition,” said DeGette, who is a D-Mom herself, having an adult daughter who was diagnosed with T1D as a young child. “Despite insulin being available for nearly 100 years now, there are still only three companies that manufacture the drug here in the U.S. and only one generic version of the drug available to consumers.”   

Why should PWDs care? Well, pay-for-delay deals have helped to keep less expensive, generic variants of older insulins  -- called "biosimilars" -- off the market, according to a Congressional Diabetes Caucus report released last November.  

The Grassley-Klobuchar bill explicitly singles out pay-for-delay deals involving biosimilars, expanding the reach of prior legislation that covered other kinds of generic drugs.

Unfortunately, thus far, biosimilars haven’t made much of a dent in the insulin pricing crisis in the U.S.  We only have to of them so far -- a long-acting and short-acting insulin. So far, they are only about about 15% less than their name-brand versions made by competing manufacturers.

Still, every little bit helps. One source of hope is that encouraging generics is a less radical idea than others being pushed in Congress and it has bi-partisan appeal. At a Senate hearing on drug prices on January 28th, free-market-loving Republicans seemed open to changing the patent system.

That could be moderately good news for PWDs in the U.S.

 

Big Ideas 5, 6, 7 and Beyond

I’ve just scratched the surface here. Senator Elizabeth Warren (D-MA) has yet another Big Idea: she wants  the U.S. government manufacture generic drugs. Rep. Bobby Rush (D-IL) wants to eliminate all out-of-pocket payments for insulin in Medicare and Medicaid plans.   

I'll bet there will be even more proposals to cut drug prices from the Administration or Congress by the time you read this. For what it’s worth, I’m allowing myself a bit of optimism that something constructive is going to be done to make insulin at least a little more accessible and affordable.

Stay tuned.