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Overview
A core principle of the U.S. healthcare system is that treatment decisions should be made through shared decision-making between patients and physicians.1 This decision is informed by an individual’s medical history, disease state and personal preferences and is influenced by the patient’s insurance benefit design.2 The American approach to valuing medicines should reflect the diverse, decentralized U.S. system - a system that supports treatment decisions that fit the unique needs of each patient.
However, top-down methods and frameworks to determine value are increasingly being considered for use in the U.S.3 For example, some countries with different systems and preferences than the U.S. rely on predetermined arbitrary monetary thresholds to determine a medicine’s value.4 If top-down value assessment models were applied to treatments for multiple myeloma, multiple sclerosis, and non-small cell lung cancer in Medicare Part B, many patients could be forced to switch from therapies that are currently working for them.5 These one-size-fits-all approaches risk undervaluing medicines, fail to reflect patient and provider choice and ultimately undermine access and innovation.6
Part 1: Putting patient values first
Every patient is unique. Their medical history, preferences and circumstances shape what treatments are best for them. In the U.S., valuations must be clinically nuanced and patient-centric to enable each individual to obtain the therapy that they and their doctor determine is best.
The flaws of one-size-fits-all value assessments
Some argue the U.S. should adopt top-down value assessment models used in some parts of the world with inherent flaws, including:
- Strict decision rules relying upon arbitrary predetermined thresholds.4
- Oversimplified metrics that embed discriminatory assumptions.7
- Focus on a hypothetical “average” patient, not real patients with real needs.6
Too often, value assessment models fail to account for the unique needs of individual patients. These impersonal models can cause medicines to be excluded from coverage for entire populations, even if those medicines would help specific patients within those populations.6
Evidence from Europe illustrates how rigid, threshold-driven health technology assessment (HTA) frameworks can limit or delay access to innovative cancer therapies.8 Similar issues are observed in Canada, where a complex and sequential HTA and reimbursement process frequently delays the availability of new oncology treatments compared with peer countries.9
Part 2: When the U.S. system works: A patient-centered approach to valuing medicines
A national survey of practicing U.S. physicians found that pharmaceutical and biopharmaceutical innovations were considered the single largest driver of improved patient outcomes, accounting for over half (56%) of post-diagnosis health gains in diseases like breast cancer, HIV, diabetes and lung cancer between 1990 and 2015.10 During this period, overall U.S. life expectancy increased by 3.3 years.11 In a study estimating the factors contributing to this change between 1990 and 2015, pharmaceuticals were found to be the second-largest contributor, behind only public health improvements like reduced smoking and better vehicle safety.11
Delivering positive health outcomes can depend on timely and broad access to innovative therapies, an area where the U.S. system consistently outperforms other countries.12 The U.S. system is driven by a market-based approach to understanding the value of medicines that supports strong incentives for biopharmaceutical innovation and investments.13 As a result, American patients benefit from the earliest availability and access to the broadest, most innovative set of therapies in the world, enabling patients to find treatments that work for them.12
The U.S. advantage at a glance
- A greater share of drugs is approved in the U.S.: 25 of the 37 novel drugs the U.S. Food and Drug Administration approved in 2022 (68%) were approved in the U.S. before any other country.14
- Longer wait times abroad: From 2018-2022, publicly insured patients in Canada waited an average of 2.5 years longer than Americans with Medicare for access to newly approved drugs.15
- Broader treatment options: 78% of drugs launched by G20 nations between 2012 and 2021 were available in the U.S. within one year of their launch, compared to just 38% in the United Kingdom and 21% in Canada.12
- U.S. cancer patients have more treatment options: Of the 124 new cancer medicines approved globally from 2012 to 2021, American patients have access to 94% of these treatments, compared to the average of 46% in other G20 countries.12
How medicines add value in many forms
Recognizing the importance of innovation when evaluating the value of new therapies is essential to understanding their full benefits. Innovative medicine
can deliver improvements that extend beyond clinical outcomes, improving standards of care, enhancing patient quality of life and increasing healthcare system efficiency.13, 17, 20, 21
- Long-acting injectable antipsychotics: For adults with schizophrenia or schizoaffective disorder, treatments with long-acting injectables have been associated with a longer time to treatment failure, including events such as psychiatric hospitalization, arrest or incarceration, or discontinuation due to inadequate efficacy, and lower overall rates of such events compared with a group of commonly prescribed oral antipsychotics across different illness durations.18
- Development in oncology care: Real-world U.S. evidence suggests some innovative oncology treatments create additional value by “bridging” patients to later breakthroughs—helping more patients live long enough to benefit from subsequent innovations—an effect known as “real option value” and not captured in traditional value assessments.22
Multiple drivers of value in healthcare
Recognizing and incorporating broader drivers is essential to capturing the full spectrum of value to patients and society. Some examples include:23, 24
- Scientific spillover: Medical innovations often lead to knowledge gains that benefit future research and treatment development.
- Value of hope: Some treatments offer intangible but meaningful benefits, such as giving patients hope for longer survival or a future cure.
- Productivity: Effective treatments can improve patients’ ability to perform their daily tasks, reducing societal and economic burden.
- Severity of disease: Treatments for more serious or life-threatening conditions tend to offer greater relative value due to the high burden they alleviate.
Assessments of value should also consider how treatments impact society outside of healthcare: for example, by increasing labor force participation and thereby economic growth.25
Part 3: The path forward for value and success
Adopting one-size fits all value assessment models for decision-making in the U.S. risks undermining the benefits of a patient-centric approach to innovation.
Johnson & Johnson supports valuations of medicines that adhere to the following principles:26
- Patient-centered: A patient-centered approach is fundamental to achieving the most efficient and effective use of medicines and ensuring that access to treatment is nondiscriminatory. Without such an approach, providers may direct patients toward treatments that are inefficient and ineffective, resulting in wasted resources for the patient, provider and healthcare system. This approach respects patient autonomy by placing every patient’s outcome at the forefront of decision-making.
- Holistic: Valuations must not rely on information from a small set of simple summary statistics, such as average life expectancy and average cost, but instead consider the full range of impacts to patients, the healthcare system and society. Valuations that are incomplete will distort the marketplace, resulting in both today’s and tomorrow’s patients receiving suboptimal care.
- Deliberative and flexible: Using a deliberative decision-making process is critical, as is avoiding the use of strict rules or oversimplified metrics, such as discriminatory quality-adjusted life year (QALY), expected value of life years gained (evLYG) or healthy years in total (HYT). Instead, the full diversity of healthcare values must be considered, prioritizing those of patients.
- Decentralized and locally relevant: Valuations must consider the specific needs of local health systems and local patients. Treatment needs in rural areas or underserved communities, for instance, may differ significantly from treatment needs in metropolitan areas or communities that are adequately resourced.
- Clinically driven: Clinically driven valuations best preserve the opportunity to maximize the health of every patient. Financing of medicines should be considered separately and addressed through insurance solutions.
Policies to improve the U.S. healthcare system
Although the U.S. system supports patient-centered decision-making, opportunities for reform remain. Policymakers should support patients by:
- Increasing transparency in the drug supply chain, including PBM reforms to bolster patient access and lower patient costs.
- Ensuring that patient cost sharing is based on net prices and that cost-sharing assistance is counted toward patient out-of-pocket contributions.
- Eliminating the ability of large health systems and for-profit middlemen to continue profiting from the 340B Drug Pricing Program while vulnerable patients are left behind.
The bottom line
Johnson & Johnson supports value assessment that is patient-centered, locally relevant, deliberative, flexible, holistic and clinically driven. To make good decisions and avoid discrimination, it is important to look at all aspects of value and how different patients might be affected. Undervaluing medicines will not address access issues for today’s patients. Instead, it can distort the innovation ecosystem needed to develop the treatments of tomorrow.
© Johnson & Johnson and its affiliates 2026 03/26 cp-550387v1
Citations
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