Patients should have access to affordable medicines. In the previous section, we discussed how we contract with insurers to support the availability of our medicines. We also help patients obtain appropriate access to our medicines, as we know that insurance coverage can be complicated and finding financial assistance can be challenging.
In this section we describe the services we provide to patients, caregivers, and health care providers through our Janssen CarePath and JANSSEN CONNECT® programs. We also include information about our support for charitable organizations and foundations that help patients get the medicines they need.
While we recognize these programs are not a longterm solution for all patients, they are one way we strive to meet the needs of the patients we serve and the health care professionals who care for them.
• Prior authorization,in which doctors are required to obtain approval from an insurer before a patient can receive a particular medicine. While prior authorization helps make sure patients get the insurer-preferred medicine, the practice can result in delays that cause some patients to forego their treatment altogether.
• Step therapy,also known as “fail first,” in which insurers require that patients try medicines on an insurer’s preferred list of prescriptions before the insurer will cover the cost of another medicine.
• Non-medical switching,in which insurers eliminate coverage for a patient’s current medicine, switching them to treatment that has a lower cost for the insurer. While some patients can switch to a different treatment without issue, this practice may be harmful to some patients, especially those with complex, chronic, or rare conditions, who have found that one medication works better for them than another.
Even with health insurance, some patients experience high prescription medication out-of-pocket expenses. Others are limited in the types of medicines they can access due to medication management measures like prior authorization and step therapy. (See "Medication Management Tools" for more information.) For patients facing these challenges, we've created some tools to help.
Janssen CarePath provides access, affordability, and treatment-support resources to help patients get started on, and stay on, the Janssen medicines their health care providers prescribe. Janssen CarePath program coordinators offer various forms of patient access support: they answer questions about insurance coverage for Janssen medicines; locate nearby treatment centers for certain medicines; provide education to help patients take their medicines as directed; and, if needed, identify options that may help make the medicines more affordable.
For commercially insured patients who meet our criteria, we also offer our Janssen CarePath Savings Programs to reduce copays. Such programs — which provide copay coupons to help reduce out-of-pocket costs — are an important tool for helping patients gain access to the medicines prescribed by their health care provider. A recent study found that 51 percent of all copay coupons were offered for medicines that had either no generic equivalent or no generic substitute — meaning that the only option for these patients was a branded medicine. This finding suggests that copay coupons continue to play a critical role in making out-of-pocket costs more manageable for patients.93
1.2 millionpatients94 through the Janssen CarePath program.
This includes approximately
610,000commercially insured patients who reduced their out-of-pocket expenditures through the Janssen CarePath Savings Program.95
Director for Patient Access Solutions for Oncology at Janssen, discusses how our Janssen CarePath Program helps support patient access and affordability of our medicines.
Janssen CarePath also helps health care providers focus on treating patients. For health care providers, navigating complex insurance benefits adds to their administrative burden. According to a survey by the American Medical Association, physicians and staff spend more than 16 hours a week seeking pre-approval — also known as prior authorization — from insurers to prescribe medicines, with 75 percent of physicians saying such requests impose a “high” or “extremely high” burden.96 Janssen CarePath helps by verifying patients’ health insurance benefits to make sure providers are familiar with their patients’ coverage for Janssen medicines and any requisite prior authorization, step therapy, or other payer policies.
In 2017, we helped approximately 1.2 million patients97 through the Janssen CarePath program. This includes approximately 610,000 commercially insured patients who reduced their out-of-pocket expenditures through the Janssen CarePath Savings Program.98
Janssen CarePath helps by verifying patients’ health insurance benefits to make sure providers are familiar with their patients’ coverage for Janssen medicines ...
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 2017, approximately 10,000 patients enrolled in these programs, gaining access to information, education, and adherence support throughout their journey of managing their schizophrenia.99
While we can’t help seniors directly through copay cards, we contribute to foundations and independent charitable organizations that can assist seniors with medication-related copays. (See more information on our charitable contributions later in this section.) In addition, Medicare patients may be eligible for one or more programs not affiliated with Janssen such as the Medicare Savings Program, Medicare Extra Help (Part D), and state-sponsored programs. More information is available at: medicare.gov/your-medicare-costs/helppaying-costs/get-help-paying-costs.html.
Independent Program & Foundation Support
The Partnership for Prescription Assistance (PPA):This organization helps patients who are uninsured or underinsured access the medicines they need through a program that is right for them. Since 2005, PPA has helped more than 10 million people get their prescriptions for free or nearly free. Visit pparx.org to find out whether PPA can help you or someone you know.
Healthcare Ready:Through collaboration between the public health and private sectors, Healthcare Ready helps address pressing health issues before, during, and after major natural disasters. Visit healthcareready.org to learn about the resources that may be available to help those affected by hurricanes and other natural disasters.
Clinical Trials:Patients and health care professionals can visit ClinicalTrials.gov to view a database of clinical studies being conducted around the world. We also developed the Janssen Global Trial Finder to help individuals easily access information on Janssen clinical trials. People interested in enrolling in a clinical study can use the Janssen Global Trial Finder, available at globaltrialfinder.janssen.com, to search for Janssen clinical trials by medical condition and geographic location.
We also support independent programs and foundations that help patients in the U.S.:
We donate medicines and funding to the Johnson & Johnson Patient Assistance Foundation, Inc.,
an independent, nonprofit organization that provides Janssen medicines to eligible U.S. patients. More information about the Johnson & Johnson Patient Assistance Foundation is available at jjpaf.org or by calling 1-800-652-6227 (9 pm to 6 pm ET).
We donated approximately $875 million100 to support 2017 operations of the Johnson & Johnson Patient Assistance Foundation, enabling the Foundation to provide medicines at no cost to approximately 86,000 patients.101
We make financial donations to independent charitable foundations
that assist underinsured and financially needy patients with treatment-related expenses.
In 2017, we donated approximately $61 million to independent charitable foundations,102 enabling them to provide assistance with medication-related copays to an estimated 9,750 patients for any medicine prescribed by their physician.103
The programs offered or supported by Janssen are one way to meet the needs of the patients we serve and the health care professionals who care for them. In addition to the programs and services we offer, patients and providers should be aware of the many other resources and programs available to help patients access medicines. (See “Other Patient Programs and Resources” for more information.)
We provide three pathways to pre-approval access:
1. 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 health authorities as part of the request for approval of a medicine.
2. Expanded Access Programs
Patients may sometimes obtain access to an investigational medicine through expanded access programs. At Johnson & Johnson, we typically consider opening an expanded access program in the U.S. when our clinical studies are complete and we are awaiting approval from the FDA. We do not, however, open an expanded access program for every investigational medicine or offer investigational medicines when they are in their early testing. The list of expanded access programs for the Janssen Pharmaceutical Companies of Johnson & Johnson can be found at clinicaltrials.gov.
3. Individual Patient Requests for Compassionate Use
Patients who are not eligible for clinical trials or expanded access programs, and for whom no other alternative therapy exists, can make a “compassionate use” request to our company through their physician.
The evaluation of individual requests for compassionate use are guided by three important ethical principles:
1. That we are not putting patients at risk of unnecessary harm.
2. That we continue to conduct thorough scientific studies to understand the potential benefits of new medicines to acquire the fundamental information needed to obtain approval from government health authorities and bring new medicines to all patients who need them.
3. That we treat all patients fairly and equally.
In 2017, Janssen received and reviewed 161 global requests for compassionate use, 132 of which were approved.104
The Compassionate Use Advisory Committee (CompAC)
The Compassionate Use Advisory Committee, or CompAC, is an innovative approach that the Janssen Pharmaceutical Companies of Johnson & Johnson employs globally to help provide a fair, ethical evaluation of compassionate use requests. Developed in collaboration with New York University Langone Health, CompAC facilitates the review of compassionate use requests by an independent, external body of internationally recognized medical experts, bioethicists, and patient representatives. After a successful pilot that began in 2015, CompAC was expanded to include additional investigational medicines in development at Janssen.
For every compassionate use request, our physicians conduct an initial review to identify patients who may be immediately eligible for a clinical trial or expanded access program, and they direct those requests accordingly. If a patient has exhausted all available treatment options, and does not qualify for any established pre-approval access program, the request will be assessed internally and may also be forwarded to CompAC based on pre-established criteria. CompAC evaluates such requests and provides a recommendation to Janssen. A Janssen physician makes the final decision on patient access for all compassionate use requests.
How to Get More Information
The best and fastest way for patients to get more information on how to access Janssen investigational medicines, or to submit a request for access, is for their physicians to call 1-800-JANSSEN or email email@example.com. For information about how we process requests, please visit our website at janssen.com/compassionate-use-pre-approval-access.