We are passionate about our work to develop transformational medicines because we have all experienced, personally or through loved ones, the devastation of disease and the dramatic impact medicines can have on human life. In this exciting era of medical innovation, it is helpful to consider the many and varied ways new therapies translate into longer, healthier lives for patients.
Our Value Assessment Principles
How does Janssen define and measure the value a medicine will have for patients and society? We employ our Janssen Value Assessment Principles to help us.
1. What matters most in determining a medicine’s value is its impact on patients.37
First, we look at a medicine's clinical profile — its effectiveness, ability to improve health-related quality of life, tolerability, side effects, etc. — compared with alternative treatments for the same condition or disease. We also look at how the medicine will be administered, and in what setting; the length or difficulty of the regimen; and whether the treatment requires any diagnostic tests — all factors that matter to patients. We consider the importance patients and their families place on having additional months or years of life; being able to avoid disability, hospitalization, and extensive medical procedures; and not having to depend on others for daily care. And because patients respond differently to different medicines, even those within the same class, we think about the benefit of having a variety of treatment options from which to choose.
• Patients taking one of our medicines for schizophrenia were hospitalized less frequently than patients taking different medications for the same serious mental illness. This reduced rate of hospitalizations produced savings of greater than $8,500 per patient per year for the specific health care system that was our partner on this research.
• Patients taking our medicine for diabetes were less likely to stop taking the medicine as prescribed, to change to another medicine, or to need a second medicine in order to achieve the desired health outcome. This is important because adherence — taking a medicine as prescribed — can result in better long-term health outcomes.
2. The value of a medicine includes its impact on the health care system and society.38
Medicines have impacts that go beyond patient health. They can generate health care savings by reducing the need for future doctor visits, emergency room use, hospitalizations, nursing home stays, and procedures or operations. Medicines can add value to the broader economy by improving workplace productivity, reducing disability, and preventing health-related interruptions in work or education. And in cases of serious mental illness like schizophrenia, medicines can delay or reduce relapses, which may result in less frequent use of law enforcement or justice system resources.39
3. Treatment outcomes should be assessed over an appropriate timeframe to capture all the benefits and risks for patients, the health care system, and society.47
Some medicines have an immediate benefit that lasts a lifetime. Some medicines significantly extend a lifetime. Others have a more moderate benefit or a benefit over a shorter period. Our assessment of a medicine’s value considers the time needed to fully realize all its outcomes for all stakeholders, not just the first few months or a year or two.
4. Evidence considered in assessing the value of a medicine should be high-quality, current, and relevant.48
We evaluate clinical trial data and real-world evidence from a variety of sources, including academic medical centers, government agencies, and health care systems, as well as our own research. We know evidence can vary in quality and certainty, which is why we strive to fully evaluate all the evidence to confirm its credibility, identify uncertainties, and determine how best to address differences in conclusions. Quality evidence, regardless of its source, makes clear study methods, assumptions, and limitations, and is transparent about any uncertainties in the data.
Value is one of several factors we consider when we determine the price of a new medicine. For more information on our pricing approach, please see the "Pricing and Patient Access" section.
Our assessment of a medicine’s value considers the time needed to fully realize all its outcomes …
The Role of Value Assessment
Measuring and defining the value of medicines has been the subject of much discussion. In the U.S., several organizations have introduced frameworks and methodologies to assess the relative value of medicines. These approaches, or “value assessment frameworks,” can be helpful, but many of them fail to include factors that are critical to fully assessing value.
Most of these frameworks do consider important measures like how well the medicine works compared to other existing treatments and how much the medicine drives down more costly forms of health care spending. But some take a short-term view of value — for example, considering only the period in which the patient is being treated or the time it takes to see if a treatment is working — that fails to reflect the full benefits a medicine can provide to a patient over a lifetime.50 And some frameworks focus heavily on the impact a medicine has on health care budgets, not on the value it brings to individual patients.51
Most importantly, value assessment frameworks need to measure value according to factors that matter most to patients — for example, improved quality of life, the ability to be productive at work, or the chance to remain independent for a longer period of time. But these types of factors are not reflected in many of the current value frameworks.52
Value assessment frameworks are still evolving, and developers should address these and other important limitations before they are widely accepted. Doing so will allow us to have more informed conversations about health system costs and the respective value of health care interventions, including medicines. In the next section, we further explore the importance of defining and measuring the value of medicines (see “A Better Way to Pay for Health Care”).
Medicines have impacts that go beyond patient health. They can generate health care savings by reducing the need for future doctor visits, emergency room use, hospitalizations, nursing home stays, and procedures or operations.