The pharmaceutical industry’s advancements in the development of biologics, a class of medications, have expanded the range of treatable disease conditions, but at extremely high costs and insurance copays. This post focuses on a concerning aspect of manufacturer copay programs – initiatives designed to help cover insurance copays associated with biologic treatments. Specifically, we will examine copay program agreement of Sandoz and raise concerns about patient privacy and medical information sharing.

We start with an outline of biologics and cost without going into depth about either the medications or the business strategies, as the topic of the post concerns implementation of a copay agreement.

Biologics vs Previous Generation Chemical Drugs – Commonalities and Contrasts

Biologics, a class of medications that are mostly made from live cells, have revolutionized the treatment of diseases that were not accessible to previous generation of drugs nearly all of which were derived from chemicals. However, these revolutionary biological medicines often come at substantially higher costs and high copays even with high-cost health insurance. The high cost of these drugs (most new drugs of any class) is due to the extensive costs associated with their discovery, development, testing, and regulatory approval. In addition, the justification in drugs of biologics class is also the cost of manufacturing is higher. The first biologic to market was insulin. The subsequent generation of approximately a dozen biologics, many of which are based on a specific type of protein called monoclonal antibodies, followed. However, biologics, particularly those developed after insulin, often incur substantial costs of discovery, development, and sales, sometimes resulting in monthly expenses close to, or exceeding, $10,000 per month for many patients. It should be highlighted that most of these drugs are to be taken lifelong by the patient as they treat the disease and symptoms.  There are a few recent drugs that can cure diseases and they are far higher priced, accounting for the long-lasting or lifelong effect of their treatment.

Once patent protection expires, other companies can manufacture generic versions at lower costs, known as generics for chemical-based drugs and biosimilars when it is developed for a biologics class of drug. Nearly all of the drugs in the market pre-dating the biologics revolution were chemicals based, the generic version of those drugs on the initial developer/marketing company losing patent protection brought down the cost to a very small fraction of the original patented drug. Unlike generics for chemical-based drugs, biosimilars have seen relatively modest price reductions. Market research indicates a range of 10-30% reductions in the US market from the extremely expensive original biologic medicine’s price tag.

The Role of Copay Programs in Market Adoption Strategies

To address these concerns of costs, manufacturers have introduced copay programs designed to help cover insurance copays associated with biologic treatments. Copay programs are an integral part of market adoption strategies, contributing to the overall pricing of biologics. These programs offer a crucial marketing strategy for manufacturers, encouraging more patients to utilize these medications. However, the pricing for these coupons and other marketing strategies is integrated into the total cost.

The Sandoz Copay Program Agreement: A Concerning Read

The focus of this post is on Sandoz’s copay program agreement for patients insured through commercial plans, that recently came to my attention. The Sandoz Copay agreement for Hyrimoz, one of the biosimilars to Humira, used to treat diseases including rheumatoid arthritis, plaque psoriasis and Crohn’s disease, has raised concerns about patient privacy and medical information sharing. The copay program agreement for US patients is in this site https://portal.trialcard.com/sandoz/hyrimoz/ *** in the /patient/authorization/ section. This data collection practice raises concerns about potential privacy violations, creating an ethical dilemma for patients seeking treatment for their medical condition.

Some key points of concern in that agreement that a patient has to accept are:

1. Granting Sandoz the authority to disclose personal information to healthcare providers, pharmacies, insurers, caregivers, and other third-party contractors or service providers for purposes specified in the agreement.
2. Acknowledging that once personal information is disclosed, it may no longer be protected by federal and state privacy laws.
3. Permitting Sandoz One Source for HYRIMOZ program and its vendor, to obtain information from a patient’s credit profile, covered under the Fair Credit Reporting Act (FCRA), or other information from Experian Health.

The Need for Clarification: A Patient’s Experience

One patient who attempted to sign up for the copay program discovered that the agreement’s terms of acceptance encompassed all possible medical and personal financial information. The patient found this fact particularly concerning because the agreement further mentioned that this information is not covered by federal or state privacy laws.

The patient’s concerns were met with mixed responses from Sandoz, including an assertion from the team running One Source program for Sandoz that the above referenced points of the agreement only apply only to patients without commercial insurance, and inability to get someone to pick up phone line in Sandoz Customer Interactions Center.

The patient sought to resolve concerns by writing to Sandoz after confirming with a legal expert that it is a point on concern and wrote to Sandoz Data Protection Office. An abridged version of that email sent to Sandoz in late January 2025 is below:

"Hello Sandoz team, I am writing to express my concerns regarding the terms of the Hyrimoz manufacturer's coupon agreement. The agreement permits the collection of medical and financial information from patients, explicitly stating that they may not be protected by federal or state laws. I find the provisions concerning and request you to review and address them. Please refer to the 'Patient Authorization' section at https://portal.trialcard.com/sandoz/hyrimoz/patient/authorization for further information. A long-time Humira user, I transitioned to Hyrimoz due to Sandoz's reputation and being a division of Novartis. Last year, my insurance arranged to utilize the Humira/Hymiroz coupon. However, this year, through a different insurance provider, I am requested to sign up for the Hyrimoz coupon, specifying that it is approved on need to use medication basis. Kindly investigate whether the agreement aligns with patient rights and privacy laws. I request immediate clarification as a medical need and this issue is of public interest."

The Response from Sandoz

Sandoz Data Protection Office responded to that email in about a week by acknowledging concerns and assuring data protection, which actually is contradictory to what the team running this program in the US had mentioned repeatedly. The Sandoz email read as below:

"We apologize for creating confusion. The personal data you provide to Sandoz will be safeguarded and processed in accordance with the terms and conditions outlined in the program for as long as you decide to participate. Although Sandoz, as a pharmaceutical company, may not directly subject to HIPAA regulations, we ensure that your data is handled with security, care, and in compliance with applicable U.S. laws and international privacy and data protection standards."

However, this response did not address the concern about signing the agreement as it is currently posted on their website.

Further Inquiries

The patient responded to that email from Sandoz the same day, clarifying that their response did not address the concern in signing the agreement as it is on their website, and has not received a response until the date of this post.

The Analogy: Sell Your Kidney or Sell Your Data?

The phrase Sell Your Data or Sell Your Kidney is not just a clever title, but rather a stark reality that patients may face when seeking biologic treatments. As we explore the concerns surrounding copay program agreement of Sandoz, it becomes clear that the line between access to life-altering or life-saving medications and personal privacy can be blurred. In some countries, people are forced to make difficult decisions to survive due to financial constraints. They even go the extent to sell their kidneys or other vital organs to cover basic needs. Similarly, patients seeking biologic treatments are being asked to compromise their privacy and security for access to these medications.

Conclusions and Call to Action

It is crucial for patients to carefully review and consider the terms of any agreements before signing them. In this case, the individual’s concerns regarding Sandoz’s copay program agreement have not been adequately addressed, despite multiple attempts to contact Sandoz’s customer interactions center and Data Protection Team. This post serves as a reminder for patients to be vigilant when entering into such agreements and encourages Sandoz to address these concerns promptly.

*** A copy of the relevant part of the Copay Agreement discussed here as it was on January 29, 2025 is here.

 ^ Minor changes in language (not affecting meaning, content or tone) were made subsequent to posting.

^^ The post picture aims to show a depiction of common auto-injector syringe used to deliver many biologics with an individual surrounded by variety of personal data on the left and an illustration of kidney on the right.

^^ ^ On March 30, 2025 it was brought to my attention that the company Boehringer Ingelheim has similar wordings, to that referred to here as used by Sandoz, on their copay card agreement. However, the company Abbvie the seller of the original biologic Humira does not have such wordings in their copay card. The three company names and ‘Humira’ were added to tags of this post.