Congress Takes Fresh Look at GLP-1 Legislation on Cost, Safety

Anti-obesity GLP-1 drugs are one of the hottest medications on the market in America right now. But with their increasing popularity comes issues with access, cost, and quality.

That’s where Congress could step in. Lawmakers have already introduced two bills on GLP-1s, one which would require Medicare to cover them and another that would crack down on copycat mixes of the drugs. Additionally, President Donald Trump is pushing a policy that would force the US to match the medications’ cheaper prices in other countries.

Congress also is aware these medications can work on other issues besides obesity, such as diabetes and cardiovascular disease, and are working to make access easier for Americans.

“Ultimately, what we need to do is we need to change the Medicare policy that views anti-obesity medications as just cosmetic weight loss,” said Rep. Raul Ruiz (D-Calif.), one of the cosponsors of the bill that would allow Medicare to cover GLP-1s.

Medicare and GLP-1s

Federal law currently prohibits Medicare from covering weight loss medications under a 2003 provision that considered such medications cosmetic. But an increasing understanding of obesity as a chronic disease has led to a push to repeal that prohibition.

The Treat and Reduce Obesity Act (S. 1973) would allow Medicare to cover anti-obesity medications, including GLP-1s, for those who are overweight and have one or more other medical conditions.

Senate Health, Education, Labor and Pensions Chair Bill Cassidy (R-La.), one of the bill’s cosponsors, told Bloomberg Government that he would like to take action on GLP-1s but was noncommittal about when, saying his committee had other priorities at the moment.

Some say having Medicare cover this class of drugs would be broadly beneficial.

“We may be able to save ourselves a lot of money down the road by encouraging people and making sure these are covered,” said Rep. Buddy Carter (R-Ga.), a former pharmacist and member of the House Energy and Commerce Committee.

But covering GLP-1s could cost the federal government up front. The Congressional Budget Office estimated that it would cost $35 billion over a nine-year period for Medicare to cover anti-obesity medications.

“The GLP-1s are a game changer. They’re an effective strategy for weight loss. The problem is expense,” said William Dietz, director of the STOP Obesity Alliance at George Washington University.

Compounding Issues

The demand for GLP-1s is so high that some people turn to compounded pharmacies to make copycat versions of the drug, which are often cheaper but have less oversight.

Lawmakers introduced new bipartisan legislation, the Safeguarding Americans from Fraudulent and Experimental Drugs Act (S. 3794), that would crack down on compounding issues by giving the FDA more authority over these facilities. The bill would require compounding manufacturers to report activity to the FDA, mandate inspections, and set a limit on how many “copies” of a drug can be produced each month.

“Americans deserve confidence that their prescription medications are safe, effective and made to the highest quality standards,” Rep. Rudy Yakym (R-Ind.) said in a press release on the bill.

The FDA issued guidance earlier this year that recommended compounded drugs only be accessed if an FDA-approved drug isn’t meeting the patient’s needs or an FDA-approved drug isn’t available.

“Congress has brought pressure on both the health care providers as well as the pharmaceutical industry to deliver better obesity care and deliver it at a more reasonable cost,” said Joseph Nadglowski, president and CEO of the advocacy group Obesity Action Coalition. “Hopefully we’ll get to a point soon where these medicines will become a standard benefit.”

Trump Administration Actions

The Centers for Medicare & Medicaid Services is starting a demonstration project this year that will allow some Medicare and Medicaid beneficiaries to access GLP-1s for obesity treatment.

Nadglowski said that once data on the cost effectiveness of the medication is available, Congress could act.

Already, Trump has pushed for Congress to take up his Most Favored Nation policy, which would link the prices of drugs in the US to lower prices in other countries. So far, Congress has resisted the policy, but if they do take action it could have serious implications for GLP-1s, which are significantly cheaper in European countries and Canada.

The administration is also promoting its TrumpRx website, which offers coupons or allows consumers to buy GLP-1s directly from the manufacturers. Congress is working closely with the Trump administration on legislative text related to Most Favored Nation, which is in line with the agreements the White House made with drug manufacturers last year, a White House official said.

The official added that through those manufacturer agreements, the administration has negotiated prices on most of the popular GLP-1s, which are typically not covered by insurance. But costs for the different brands and forms of GLP-1 medications still range from $149 to $299 per month, according to the information provided on the TrumpRx website — and some of those reduced costs only last for a limited time.