Patient Assistance Programs for High-Cost Diabetes Medications: What Is Available for Uninsured Immigrants?

INTRODUCTION

Newer type 2 diabetes medications, such as GLP-1 and dual GLP-1/GIP receptor agonists (RAs), SGLT-2 inhibitors (SGLT-2is), and DPP-4 inhibitors (DPP-4is), offer significant clinical benefits over older therapies, including reduced risks of hypoglycemia, cardiovascular events, and kidney complications.¹ Despite these benefits, the high cost of these medications may limit patient access. Racial and ethnic minority populations are disproportionately impacted by diabetes and more likely to have difficulty affording their treatments.^2–4 These challenges are greater for uninsured populations, such as immigrants ineligible for public programs or subsidized insurance. Uninsured immigrants have high rates of diabetes and experience poor clinical outcomes.⁵

Manufacturers often offer financial assistance to help patients afford necessary medications.⁶ Copay cards and savings programs help reduce the amount that patients pay out-of-pocket, while patient assistance programs (PAPs) provide medications at no cost for eligible patients.⁶ The availability of manufacturer-sponsored PAPs to uninsured immigrants remains poorly understood. Key concerns include whether these programs present language barriers or require patients to share sensitive personal information to determine eligibility, potentially limiting access to this population. This study examined manufacturer-sponsored PAPs for high-cost type 2 diabetes medications, assessing their coverage of uninsured immigrants, available language options, and personal information requirements for eligibility.

METHODS

We reviewed the public-facing websites of all GLP-1 RAs, dual GLP-1/GIP RAs, SGLT-2is, and DPP-4is drugs approved and available in the USA.¹ We assessed the availability and type of PAPs, eligibility criteria, website language options, and personal information requirements for eligibility. Generic medications such as metformin, sulfonylureas, and pioglitazone were excluded due to their low out-of-pocket cost, even for individuals without insurance. Two team members (CPK and FP) independently evaluated each product’s website and recorded their observations in a standardized data table, and discrepancies were resolved by a third reviewer (KRP).

RESULTS

We identified 15 approved and available medications (7 GLP-1RAs, 1 dual GLP-1/GIP RAs, 5 SGLT-2is, and 4 DPP-4is). Among the 13 medications with public-facing websites, 6 were available only in English, 7 in English and Spanish, and none in other languages (Table 1). While every website offered savings cards for patients with commercial insurance (but not for uninsured or those with government insurance), none of the main websites had information on PAPs; information for these programs required separate searches. PAPs were available for 4/7 GLP1-RAs, 3/5 SGLT-2is, and 2/4 DPP-4is. All the PAP websites had information in Spanish and English, but not in other languages. PAPs for GLP-1RAs required applicants to be US citizens or permanent residents, but did not request social security numbers (SSN) (Table 2). Two PAPs (one SGLT2-I, one DPP-4i) did not explicitly restrict eligibility based on immigration status but requested the last four digits of the SSN. All PAPs required personal identifiers such as name, date of birth, and address. All PAPs also required patient authorization to release their medical information and share protected health information (PHI) with the pharmaceutical company and affiliates. PAPs disclosed that federal privacy laws, such as HIPAA, do not protect this information, and that it could be shared with third parties.

Table 1.

Assistance and Accessibility for GLP-1 and Dual GLP-1/GIP Receptor Agonists, SGLT-2 Inhibitors, and DPP-4 Inhibitors

Product	Brand name	Type of assistance	Assistance for uninsured	Website language access	PAP information language access	PAP information on product website
GLP-1 agonists
Dulaglutide	Trulicity1	Patient assistance program**	Yes	English Spanish	English Spanish (Application only)	No
Exenetide	Byetta2	None*	No	English	N/A	N/A
	Bydureon BCise2	None*	No	English	N/A	N/A
Liraglutide	Victoza3	Patient assistance program*	Yes	English	English Spanish	No
Lixisenatide	Adlyxin4	None	N/A	N/A***	N/A	N/A
Semaglutide	Ozempic3	Patient assistance program*	Yes	English Spanish	English Spanish	No
	Rybelsus3	Patient assistance program**	Yes	English Spanish	English Spanish	No
GLP-1/GIP RA
Tirzetapide	Mounjaro1	None*	No	English Spanish	N/A	N/A
SGLT-2 inhibitors
Bexagliflozin	Brenzavvy5	None	N/A	English	N/A	N/A
Canaglifozin	Invokana6	Patient assistance program**	Yes	English	English Spanish (Application not in Spanish)	No
Dapaglifozin	Farxiga2	Patient assistance**	Yes	English Spanish	English Spanish (Application only)	No
Empaglifozin	Jardiance7	Patient assistance**	Yes	English Spanish	English Spanish (Application only)	No
Ertugliflozin	Steglatro8	None	N/A	N/A***	N/A	N/A
DPP-4 inhibitors
Alogliptin	Nesina9	None	N/A	N/A***	N/A	N/A
Linagliptin	Tradjenta7	Patient assistance**	Yes	English	English Spanish (Application only)	No
Saxagliptin	Onglysa2	None	N/A	N/A***	N/A	N/A
Sitagliptin	Januvia8	Patient assistance**	Yes	English Spanish	English Spanish	No

¹Eli Lilly

²Astra Zeneca

³Novo Nordisk

⁴Sanofi

⁵TheracosBio

⁶Janssen

⁷Boehringer Ingelheim

⁸Merck

⁹Takeda

^*Savings card program for patients with commercial insurance, but not for uninsured or those with government insurance. No immigration or social security requirement

^**In addition to PAP, also has savings card program for patients with commercial insurance

Acronyms: GLP, glucose-like peptide; SGLT, sodium-glucose linked transporter; DPP-4, dipeptidyl peptidase-4; PAP, patient assistance program; FPL, federal poverty level

^***No patient-facing website

Table 2.

Eligibility Requirements for Available GLP-1 and Dual GLP-1/GIP Receptor Agonists, SGLT-2 Inhibitors, and DPP-4 Inhibitor PAPs

Product	Brand name	Immigration status requirement	Health insurance requirement	Income requirement	PAP application requests social security	Authorization to share PHI required
GLP-1 agonists
Dulaglutide	Trulicity1	US citizen or permanent resident	Medicare or uninsured	< 300% FPL	No*	Yes**
Liraglutide	Victoza2	US citizen or legal resident	Medicare or uninsured	< 400% FPL	No*	Yes**
Semaglutide	Ozempic2	US citizen or legal resident	Medicare or uninsured	< 400% FPL	No*	Yes**
	Rybelsus2	US citizen or legal resident	Medicare or uninsured	< 400% FPL	No*	Yes**
SGLT-2 inhibitors
Canaglifozin	Invokana3	No	Medicare or uninsured	< 300% FPL	No	Yes**
Dapaglifozin	Farxiga4	No	Medicare or uninsured	< 300% FPL	No	Yes**
Empaglifozin	Jardiance5	No	Medicare or underinsured	< 250% FPL	Last 4 digits	Yes**
DPP-4 inhibitors
Linagliptin	Tradjenta5	No	Medicare or underinsured	< 250% FPL	Last 4 digits	Yes**
Sitagliptin	Januvia6	No	Medicare or uninsured	< 400% FPL	No	Yes**

¹Eli Lilly

²Novo Nordisk

³Janssen

⁴Astra Zeneca

⁵Boehringer Ingelheim

⁶Merck

^*Requires signed certification that the applicant is a legal/permanent resident or US citizen

^**All PAPs require name, date of birth, address, contact information (telephone, email), release of medical information, and authorization to share PHI with the pharmaceutical company and affiliates. All PAPs include a disclosure that federal privacy laws do not protect this information, which may be lawfully shared to other parties by recipients

DISCUSSION

This study highlights several barriers to accessing PAPs for uninsured immigrants. First, navigating PAPs is challenging as information is not prominently featured on product websites, requiring users to conduct additional searches. Second, language access is limited to English and Spanish. Third, eligibility criteria for GLP-1 RAs restrict access to US citizens or legal residents. Privacy concerns further compound these barriers. All PAPs require applicants to provide sensitive personal information and authorize its release to pharmaceutical companies and affiliates. Critically, PAPs state that this information is not protected under federal privacy laws, potentially deterring immigrants from applying due to fears of misuse or disclosure.

The primary limitation of this study is that information on the actual access to these medications through PAPs was not available beyond the information available on the companies’ websites. Further research should examine actual rates of successful access to treatments through PAPs, identifying differences across facilities with and without dedicated staff such as medication access coordinators.

These findings underscore the need for reforms to improve access to PAPs. Simplifying application processes, expanding language access, removing immigration status requirements, and strengthening data privacy protections are essential steps to address structural inequities in diabetes care.

Data Availability:

The data examined in this study is publicly available through pharmaceutical websites.