Health Technology Assessment in the U.S. – A Vision for the Future

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Editor’s note: The USC Schaeffer Center for Health Policy & Economics and the Aspen Institute have together established an advisory panel to consider how the U.S. can better link the price of health technologies to the benefits they provide to patients while ensuring a sustainable healthcare ecosystem that supports innovation. While the U.S. can learn from other countries’ implementation of health technology assessment, the panel’s aim is to make practical recommendations that are tailored to the unique U.S. healthcare system and can garner broad support.

Health technology assessment (HTA) can help achieve the dual health policy goals of ensuring affordability and encouraging innovation. It represents a formal, systematic and transparent multidisciplinary process that uses explicit methods and available evidence to determine the value of a health technology. The dimensions of value most often include clinical effectiveness, safety, costs and economic implications and may include ethical, social, cultural and legal issues, organizational and environmental aspects, as well as wider implications for the patient, relatives, caregivers and population. The overall value may vary depending on the perspective taken, the stakeholders involved and the decision context.

The U.S. relies mostly on privately funded HTA. However, there is an economic and healthcare rationale to supplement private HTA activities by shifting some funding from the private to the public sector, and to reduce the inefficient and duplicative multiple efforts within the current HTA ecosystem. We developed a set of six recommendations for public funding of an advisory-only HTA in the U.S. that—when taken together—will bolster the HTA landscape and improve decision-making in the healthcare marketplace. The recommendations are both coherent and complementary; as such, they are meant to be taken together. On their own, individual recommendations should not be interpreted as discrete options that could provide incremental improvement.

Recommendation 1: Private HTA efforts should be encouraged.

Given the case for a potentially expanded role for HTA in the U.S., and the unique features of the U.S. market and diversity of stakeholders, we support continued HTA provision by a broad network of independent organizations that produce HTAs or engage in activities such as data collection to support HTA.

Recommendation 2: The U.S. should establish a publicly funded HTA coordinating entity, the Institute for Health Technology Assessment (IHTA), to support HTA beyond individual private efforts and to evaluate the quality of HTAs conducted by such organizations.

IHTA would (a) conduct HTA, especially for health interventions that are poorly studied in the existing literature; (b) evaluate existing HTA evidence where it exists and identify gaps where it does not; (c) engage in data collection and management; (d) advance HTA research methods and fund methodological research. Nonetheless, we affirm the need for continued HTA activities by third-party organizations even if a publicly funded HTA body is created, and recommend that the IHTA build partnerships with appropriate organizations to coordinate activities and reduce duplicative efforts.

Recommendation 3: IHTA-conducted and -approved reports should include an economic evaluation with findings presented in a disaggregated format.

While our recommendations remain otherwise neutral on methodological issues, we do recommend that economic evaluation be included in all IHTA-supported work, provided that its findings are presented in a disaggregated format. Using this approach, HTA reports would include a presentation of clinical results, followed by an economic evaluation that lists all relevant costs and outcomes (consequences) associated with a healthcare intervention, stratified by relevant subgroups (e.g., age, sex, race, geography) when possible. Outcomes could include summary measures like life-years or quality-adjusted life-years but would not be limited to them, and the magnitude of health impact given the additional costs of covering a technology (i.e., opportunity costs) should be estimated for individual plans and states.

Recommendation 4: HTA should be conducted across a broad array of technologies and healthcare services—new and old—including drugs, devices, diagnostics, procedures and public health interventions.

Although HTA has tended to focus on drugs, and in particular newly approved drugs, the U.S. can benefit from HTA in all areas of healthcare. Consequently, the panel recommends that HTA be applied broadly, extending beyond drugs to include devices, diagnostics, procedures and public health interventions.

Recommendation 5: A stakeholder engagement process should provide input to the priorities and activities of the IHTA.

To ensure that the IHTA avoids the perception of bias or political influence from any one stakeholder group, we recommend that a broad group of stakeholders be involved in the activities of the IHTA to ensure it meets the needs of the U.S. healthcare system. Relevant stakeholders would belong to five broad groups including: (a) patient and healthcare consumer organizations; (b) healthcare providers (including hospitals and health systems); (c) payers (private and public); (d) employers; and (e) the drug, device and diagnostic industry.

Recommendation 6: The U.S. should implement policies that allow an advisory-only HTA organization to have an impact on decision-making.

Since HTA reports would be advisory-only at the outset, we do not recommend that the Centers for Medicare & Medicaid Services (CMS) be required to make HTA-based coverage decisions. However, we do recommend that CMS be required, as part of the public comment process, both to confirm its consideration of the findings of a relevant IHTA report and to explain the impact (if any) of such findings in its coverage determinations for Medicare Part A and Part B.

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