Medicines contribute tremendously to individual health and to the health of our society, which is why we believe it is so important for patients to have access to the medicines their health care professionals prescribe. As discussed earlier in the Value & Pricing section, patients today are paying more out-of-pocket for medicines, creating access challenges for many Americans. For example, you may recall that, according to a recent study, the average patient’s out-of-pocket cost increased more than 25 percent, to $44 per prescription, between 2010 and 2015.1
This section of the Transparency Report describes our efforts to address barriers to access to our medicines. We negotiate and partner with private and public payers and health care systems to support availability of our products. In addition, since patient coverage and financial circumstances vary, we support a variety of programs and services to assist with access to medicines. While we recognize that these programs are not a long-term solution for all patients, they are one way we aim to meet the needs of the patients we serve.
Here, we highlight Janssen programs and donations that support U.S. patient access to approved medicines — and disclose the impact of these programs and donations.
2016 Disclosures: Access to Medicines
To help ensure high out-of-pocket costs do not prevent patients from getting the medicines they need, Janssen offers a variety of support options, including:
Janssen CarePath helps patients understand their health insurance coverage for Janssen therapies and identify options that may help make Janssen products more affordable. For commercially insured patients who meet our criteria, we offer our Janssen CarePath Savings Programs to reduce co-pays. For a list of all of Janssen CarePath’s services, visit www.janssencarepath.com for more information.
In 2016, we helped approximately one million patients through the Janssen CarePath program.2 Of that number, we helped approximately 870,000 commercially insured patients reduce their out-of-pocket spend through the Janssen CarePath Savings Program.3
JANSSEN CONNECT® and JANSSEN CONNECT® ACCESS & CARE TRANSITIONS are two programs offering comprehensive information and assistance to help patients with schizophrenia initiate and maintain their health care professional-prescribed Janssen long-acting injectable atypical antipsychotic therapy.
In 2016, approximately 12,000 patients enrolled in these programs, gaining access to information, education and adherence support throughout their journey of managing their schizophrenia.4
Janssen also supports independent programs and foundations that aim to assist patients in the U.S. For example:
We donate medicines and funding to the Johnson & Johnson Patient Assistance Foundation, Inc., an independent, nonprofit organization that provides Janssen medicines to U.S. patients who do not have insurance coverage for these products and do not have adequate financial resources. More information about the Johnson & Johnson Patient Assistance Foundation is available at www.jjpaf.org.
We donated medicines valued at approximately $620 million5 to support 2016 operations of the Johnson & Johnson Patient Assistance Foundation, enabling the Foundation to provide medicines at no cost to approximately 75,000 patients.6
We make financial donations to independent charitable foundations that assist patients who are underinsured and in financial need with treatment-related expenses. In 2016, our donations to these independent co-pay foundations helped patients with cancer and autoimmune diseases get financial support for medication-related expenses.
In 2016, we contributed over $47 million in donations to independent charitable foundations,7 enabling them to provide assistance with medication-related co-pays to approximately 5,550 patients for any medicine prescribed by their physician.8
More Information on Our Giving
In 2008, Janssen began voluntarily disclosing our charitable giving on our website. Each year, this information is updated to reflect the previous year’s giving.
Access to Investigational Medicines
Our mission is to develop, gain regulatory approval for, and bring to market important medicines that make a difference for patients around the world. While there have been improvements in shortening the time it takes to make new investigational medicines available, some seriously ill patients who have exhausted all available treatment options request, through their physicians, access to investigational medicines that are not yet approved by health authorities, including the U.S. Food and Drug Administration (FDA). There are three pathways to requesting what is known as “pre-approval access” to investigational medicines:
Clinical Trials:The primary method for gaining access to Johnson & Johnson’s investigational medicines is to enroll in a clinical trial. Clinical trials are scientific studies that evaluate the effectiveness and safety of medicines and, ultimately, are submitted to a health authority as part of the request for approval of a medicine. They are one of the most important steps in bringing new medicines to patients.
Expanded Access Programs:Patients may sometimes obtain access to an investigational medicine through “expanded access programs” (EAPs), which provide a pathway for patients to get investigational medicines for serious diseases or conditions. At Johnson & Johnson, generally we consider opening an EAP in the U.S. when our clinical studies are completed and we are awaiting approval of our investigational medicine from government health authorities. However, an EAP is not opened for every investigational medicine, and we do not offer EAPs when investigational medicines are in early testing. The list of Janssen EAPs can be found at www.clinicaltrials.gov.
Individual Patient Requests or Compassionate Use:For some patients who are not eligible for clinical trials or EAPs, and for whom no other alternative therapy exists, physicians — in discussion with patients — may make a “compassionate use” request to our company.
About Compassionate Use
There are important factors we consider when determining whether or not we can fulfill compassionate use requests. Johnson & Johnson follows three important principles when deciding whether or not we can provide compassionate access to investigational medicines:
We must not put patients at risk of unnecessary harm.
We must ensure all patients are treated fairly and equally.
Compassionate use should not impede efforts to conduct thorough scientific studies to understand the potential risks and benefits of any investigational medication.
To enhance our long-standing commitment to ethical and patient-centered decision-making, Janssen Research & Development, LLC, in partnership with the New York University (NYU) School of Medicine’s Division of Medical Ethics, in 2015 launched a first-of-its-kind pilot program, The Compassionate Use Advisory Committee, to obtain independent input to assist in evaluating these requests.
The Compassionate Use Advisory Committee (CompAC)
The Compassionate Use Advisory Committee, or CompAC, was established for the purpose of independently reviewing compassionate use requests and providing external, objective recommendations to Janssen R&D. For each compassionate use request evaluated by CompAC, NYU assembles a committee of internationally recognized medical experts, bioethicists and patient representatives with knowledge of the relevant disease area. CompAC makes recommendations regarding individual requests for compassionate use in accordance with the considerations and principles outlined previously. The committee's recommendations inform Janssen R&D physicians, who make the final decision on each request.
CompAC began in 2015 as a pilot for one medicine under development at that time, daratumumab. In September 2016, Janssen and NYU agreed to expand CompAC to include additional investigational medicines in late-stage development by Janssen R&D. Since the start of the program in July 2015, CompAC has reviewed 182 requests from around the world for compassionate use, seventeen (17) of which originated in the U.S. The results of these 17 requests are outlined below:*
12 requests were recommended by CompAC for approval
Four were deemed to have an unfavorable risk-benefit profile
One was eligible for an expanded access program, clinical trials or other approved therapies
Janssen followed 100% of the CompAC U.S. recommendations.
How to Get More Information
The best and fastest way to get more information on accessing Janssen investigational medicines, or to make a request, is to have your doctor call Janssen Medical Information at 1-800-Janssen or email us at [email protected].
1. “Medicines Use and Spending in the U.S. – A Review of 2015 and Outlook to 2020,” IMS Health, April 2016, http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports/medicines-use-and-spending-in-the-us-a-review-of-2015-and-outlook-to-2020.
2. Data is an approximate number provided by the external program administrator.
5. According to internal financial accounting.
6. Data is an approximate number as reported by the Johnson & Johnson Patient Assistance Foundation, Inc.
7. According to internal financial accounting.
8. This estimate is based on assessment of donation amounts and publicly available data on approximate levels of patient assistance.
* Data based on Janssen’s Pre-Approval Access global tracking system.