Personalized cancer medicine in corporate health management
How your company can support sick employees by offering COPE®
*Corporate Oncology Program for Employees
Exceptional times call for exceptional measures
Receiving the diagnosis of cancer changes a person’s entire life — not just on a personal level, but their work life as well. It remains a major challenge for anyone who experiences it. And by extension, it is a challenge for every company, since their most important pillar is their employees.
This is why it is worthwhile for employers to deal more closely with the topic of cancer treatment, in light of the growing numbers of cases accompanied by higher survival rates. According to surveys by the Robert-Koch-Institut*, there are currently some 477,000 new cases of cancer each year. Nearly half of them affect people in the work force. The majority of those patients return to work.
In particular, one solid opportunity for companies to support their employees in times of illness is offering them access to the latest personalized tumor diagnostics tools; this enables the patients to pursue better treatment.
“Employees are the most valuable thing a company has.”
Friedrich von Bohlen, CEO, Molecular Health
Fighting cancer together –
with the Corporate Oncology Program for Employees (COPE®)
Molecular Health (MH), a company of the dievini Hopp Group, has developed a trail-blazing medical software which lets physicians pinpoint customized treatment options for individual patients. This software — Molecular Health Guide® (MH Guide) — has been registered and approved throughout Europe as an in vitro diagnostic medical device. It analyzes the patient’s genetic data, and the findings are used as the basis for oncologists to select the appropriate medication.
COPE® – the program
COPE is designed to give companies a direct and uncomplicated way to offer this new medical milestone in personalized diagnostics to the employees who need it.
Who is eligible to take part?
Employees who have been diagnosed with a kind of cancer that involves a solid tumor (e.g. not leukemia). Each company has to decide for itself whether it will offer the program to employees’ family members as well.
MH Guide: The step-by-step procedure for you as a company
Discussion with the treating physician:
Employees meet with their treating physician to discuss the possibility of taking part in the program for personalized treatment recommendations.
Discussion with the company:
In a conversation at the company, employees learn whether they can participate in the program, and if so, receives a statement of cost coverage.
Contact to Molecular Health:
The patient’s treating physician contacts Molecular Health to receive detailed information about the process, the modalities and contact to a MH-certified physician.
Contact to the MH-certified physician:
The treating physician contacts the MH-certified physician to finalize the patient’s eligibility, transfer clinical patient data (cf. data privacy protection) and commission the analysis.
Preparing the documents:
The MH-certified physician fills out the order form for NGS sequencing of the tumor specimen, sends the treating physician a specimen-shipping box and resolves the consultation relationship.
Acquiring, preparing and sending the samples:
The treating physician receives the necessary informed consent from the patient and acquires the tumor specimen. The doctor also fills out the pick-up form for shipping the specimen. This is then faxed or e-mailed to Molecular Health. A logistics company transports the specimens to the proper qualified independent contact laboratory.
At the laboratory, the specimens are genetically sequenced using state-of-the-art laboratory equipment. In analyzing the data with MH Guide, the results of the sequencing and clinical information about the patient are sent to Molecular Health electronically via a secure network.
The MH Guide-certified physician receives information about efficacious drugs and therapeutic options as well as inefficacious or potentially harmful medications based on the findings of the analysis and individual genetic mutations. With the help of MH Guide, the physician then documents the ideal approach to treatment in a report and sends it to the treating physician along with the clinical findings. The report includes treatment options as well as cancer-relevant biomarkers, efficacy and safety of individual drugs as well any appropriate recruiting clinical trials which might be an option for the patient.
Informing the patient:
The treating physician discusses the options indicated in the analysis with the patient.
How your company can benefit from COPE®
Offering an active form of care for your employees and their families
Adding a valuable feature to your corporate health-management program
Enhancing your image in the eyes of the public and the employees’ families
Creating another USP to distinguish you from the competition
Generating positive effects on your company culture, employee loyalty and the attractiveness of your company to new qualified applicants
Being part of a trail-blazing development in the field of precision medicine
Which kinds of cancer can be analyzed with the MH Guide?
Molecular Health Guide can be used to analyze every kind of cancer that has solid tumors, i.e. not leukemia. Analyses with MH Guide are considered especially useful for patients with rare forms of cancer as well as cases in which the cancer has metastasized (spread to other organs) or in which previous treatment regimens had limited or no success.
How long does the analysis take?
The entire processing period takes around four weeks for sequencing both the genetic panel (approximately 600 genes) and whole exome sequencing (approximately 20,000 genes). This covers the entire period from when the sample arrives at the laboratory to the time when the report is sent to the treating physician, and it includes genome sequencing, data processing, and generating the report.
What kind of information does the genetic analysis provide?
Molecular Health Guide® (MH Guide) provides information about the presence or absence of certain mutations in the patient’s tumor or the control sample. Furthermore, potentially relevant clinical and scientific data as well as information about the reliability of the findings are made available for physicians to include in their assessment.
The data about the mutations that have been identified do not always lead to clear-cut clinically actionable findings, since genetic changes cannot be directly linked to a potentially effective therapeutic option in every case. For example, there may not be clear-cut information if there is not enough clinical evidence of a mutation or if the reliability of the findings is not robust enough due to quality problems with the sample.
As a rule, the process of analyzing the genetic variants in a tumor has shown to be a valid approach to gaining more insight into the nature of an individual patient’s cancer. This helps the specially trained physicians and treating physicians make therapeutic decisions with greater precision. MH Guide provides access to high-quality biomedical reference data in great depth so that our specially trained doctors have an optimal foundation of evidence for clinically interpreting mutations in cancer patients.
What are incidental findings, and how are they handled?
In the course of analyzing genetic data via Molecular Health Guide® (MH Guide), the physicians may discover information about genetic changes which are not directly related to the cancer diagnosis that was the reason for the analysis, but the information may nevertheless be of medical relevance to you and your family. This kind of additional information is known as incidental findings. The physicians who work with MH Guide are not actively looking for such findings. If, however, they come across something that indicates a preventable or curable disease, they can communicate this information to a genetic counselor if you wish.
Any incidental findings involving genetic diseases that are not relevant to your cancer can be discussed in a consultation with the genetic specialist. In the informed-consent declaration, you can indicate whether you wish to be informed about any such findings.
What does Molecular Health use the tissue samples for?
Molecular Health uses your samples for the genetic analysis of your tissue specimens. Furthermore, if you have given your consent, they may also be used for quality-control purposes.
The right to withdraw consent and to remain uninformed
You have the right to refuse a genetic analysis from the outset. Once a genetic examination has begun, you still have the right to remain uninformed about some or all of the results, or even to have all of the related information deleted. You can contact your physician to withdraw your consent to the analysis at any time, verbally (by telephone) or in writing, and do not need to provide any further reasons. You have the right not to be informed about the results of the analysis (the right not to know). In addition, you also have the right to stop the ongoing examination process at any time up until the results are communicated to you, and to demand the destruction of materials as well as of results which are have already been obtained at that point in time. Please note that subsequent inquiries about the findings will then be no longer possible.
Do patients have to undergo a medical procedure to provide a tissue sample?
When a Molecular Health Guide® (MH Guide) analysis is ordered, histological and other routine diagnostic information about your disease should already have been collected. For most patients, enough of a tumor sample has already been taken and stored, and it is thus available without any further medical intervention at the time of the MH Guide analysis. Should additional material or blood samples be required for the analysis, your physician will speak to you about it and inform you of any possible related health risks.
Are there risks related to genetic data?
Genetic data can contain information about whether you have an inherited predisposition to certain diseases. This can also affect your family members and confront you with a new situation.
Furthermore, there is a very slight chance of identifying someone by their genetic characteristics, but this risk is very low. This risk only exists in the unlikely event that the patient published their own genetic data online at an earlier time (e.g. for genealogy purposes) and that an unforeseen data breach accidentally made Molecular Health information available to a third party. The security measures implemented for MH Guide comply with the state of the art and are designed to rule out the misuse of data. Any misuse of patient data is a punishable crime.
How is confidentiality guaranteed?
Both the MH-Guide-certified physician and treating physician are bound by medical confidentiality, although they may communicate with each other. This is necessary so that they can discuss the indication and stage of the illness, co-medication as well as any clinical information necessary for the ideal therapeutic decision.
Informed consent before conducting the genetic analysis
The law states that you have to give your consent before a procedure is performed. This ensures that you were given enough information about the procedure and understand what it involves. By signing the document, you confirm this and agree to have the genetic analysis conducted.
Which advantages do companies have when they offer COPE?
By offering COPE to employees with cancer, companies ensure access to personalized treatment options.
The advantages for companies:
- Lowering the costs of health care
- Maintaining productivity by reducing employee absence
- Increasing their attractiveness as an employer
- Improving employee satisfaction
- Decreasing fluctuation
- Enhancing employee loyalty
- Having a positive impact on corporate culture
How long has COPE existed?
COPE has been on the market in the EU and USA since mid-2014.
What expenses are involved for participating companies?
Companies that choose to participate in COPE establish a confidential point of contact. One way to organize this is through the company physician’s office. Molecular Health recommends that the confidential contact be created externally.
Does the company as an employer have access to patient data?
All of the patients’ data are anonymized by the confidential contact. The employer then has no access to or information about these data whatsoever. The employee / patient has all of the rights to his or her genetic data and the resulting documentation, and they can have their records deleted at any time.
Which employees is COPE suitable for?
It is generally suitable for any employee who has cancer or has received a cancer diagnosis. MH Guide analyses can be especially effective in patients with rare forms of cancer, in cases where the diseased is highly advanced and has metastasized, and when previous treatment has not been successful.
If you can not find the answer to your question, please contact us.