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Health Technology Assessment and Private Payers's Coverage of Personalized Medicine
Julia R. Trosman, PhD; Stephanie L. Van Bebber, MSc; and Kathryn A. Phillips, PhD

Health Technology Assessment and Private Payers's Coverage of Personalized Medicine

Julia R. Trosman, PhD; Stephanie L. Van Bebber, MSc; and Kathryn A. Phillips, PhD
A study of major US private payers showed an important role and considerable shortcomings of external health technology assessment in coverage decisions on personalized medicine.

 

This article was published as part of a special joint issue and also appears in the Journal of Oncology Practice.
 

Objective: Health technology assessment (HTA) plays an increasing role in translating emerging technologies into clinical practice and policy. Private payers are important users of HTA whose decisions impact adoption and use of new technologies. We examine the current use of HTA by private payers in coverage decisions for personalized medicine, a field that is increasingly impacting oncology practice.

 

Study Design: Literature review and semistructured interviews.

 

Methods: We reviewed 7 HTA organizations used by private payers in decision making and  explored how HTA is used by major US private payers (n = 11) for coverage of personalized medicine.

 

Results: All payers used HTA in coverage decisions, but the number of HTA organizations used by an individual payer ranged from 1 (n = 1) to all 7 (n = 1), with the majority of payers (n = 8) using 3 or more. Payers relied more extensively on HTAs for reviews of personalized medicine (64%) than for other technologies. Most payers (82%) equally valued expertise of reviewers and rigor of evaluation as HTA strengths, whereas genomic-specific methodology was less important. Key reported shortcomings were limited availability of reviews (73%) and limited inclusion of nonclinical factors (91%), such as cost-effectiveness or adoption of technology in clinical practice.

 

Conclusion: Payers use a range of HTAs in their coverage decisions related to personalized medicine, but the current state of HTA to comprehensively guide those decisions is limited. HTA organizations should address current gaps to improve their relevance to payers and clinicians. Current HTA shortcomings may also inform the national HTA agenda.

 

(Am J Manag Care. 2011;17(5 Spec No.):SP53-SP60)

Our study explored how private payers use health technology assessment (HTA) in coverage decisions related to personalized medicine, including oncology.
 

  • Both large and smaller payers used HTA more extensively for personalized medicine than for other technologies and preferred using multiple HTAs.
  • A lack of HTA availability and timelines and insufficient inclusion of nonclinical factors limit their relevance in coverage decisions. Our findings may inform:
  • Efforts to improve HTA relevance to private payers, particularly for oncology.
  • The national HTA agenda, which may benefit from considering private payers’ needs related to emerging technologies and how they intersect with patient and provider issues
Health technology assessment (HTA) is the systematic evaluation of properties, effects, and/or impacts of healthcare technology to inform healthcare decision makers in health policy or practice.1 The role of HTA in healthcare decisions in the United States is expected to increase with proliferation of new medical technologies and the implementation of healthcare reform.2,3

Private payers, which insure approximately two-thirds of the US population,4 are important users of HTA. Understanding how they make coverage decisions regarding new technologies is critical, given that it identifies the information needed for decisions and helps clinicians understand payer policies and their impact on clinical practice.5 This article examines how private payers use HTA in coverage and reimbursement decisions related to personalized medicine. We focus on personalized medicine—the use of genetics or genomics to guide healthcare decisions—because the rapid pace of development and lack of evidence in this field are particularly challenging to both payers and clinicians.6,7 We also expand the findings of other studies8,9 by further examining the role, strengths, and shortcomings of external HTA in private payers’ decisions related to personalized medicine.

This topic is particularly relevant in oncology, in which significant growth of personalized medicine is occurring.10 There are more than 100 genetic tests in oncology, of which at least 38 new tests have been introduced since 2006.11 Coverage decisions are critical factors in patient access to these technologies and their use in oncology practice.12,13

Methods

Definitions and HTA Inclusion Criteria

According to the International Network of Agencies for Health Technology Assessment, HTA is the systematic evaluation of properties, effects, and/or impacts of healthcare technology. It may address the direct, intended consequences of technologies as well as their indirect, unintended consequences. Its primary purpose is to inform technology-related policy making in healthcare. HTA is conducted by interdisciplinary groups that use explicit analytic frameworks and draw from a variety of methods.1

Here we refer to the entities conducting HTA as HTA organizations, and we refer to the output of HTA as HTA reviews. We included as HTA organizations the US entities that conduct or propose to conduct systematic evaluation of personalized medicine that could be used in coverage decisions by US payers. We excluded professional medical societies, because not all of them conduct systematic evidence evaluations in development of guidelines.14

Study Data and Methods

The study was conducted under a protocol approved by the institutional review board of the University of California, San Francisco. We conducted a literature review and semistructured interviews with private payers to examine how they used HTA in coverage decisions for personalized medicine.

First, between June and July 2009, we conducted a literature review to identify which HTA organizations to include. We searched the PubMed database, Google, HTA organizations’ Web sites, and private payer Web sites. An initial list of HTA organizations was forwarded to several experts, who provided input.

Second, between August and October 2009, we conducted semistructured hour-long interviews with senior executives (n = 17) who were directly involved in coverage decisions at 11 US private health plans. These included 6 of the 7 largest national plans, based on membership, and 5 smaller regional plans with membership numbers  ranging from 1.6 million to more than 5 million. The 11 plans together covered more than 125 million members.15 We provided interview questions to the payers before the interviews. Verbal consent was obtained in the beginning of each interview.

We asked the interviewees:

• what external HTAs their organizations used in decisions related to personalized medicine;

• how external HTAs were used in the decision process; and

• what they perceived as strengths and shortcomings of the HTAs in informing their decisions related to personalized medicine.

Results are described based on the number of payers versus the number of interviewees. We found similar results among interviewees at the same plan.

Results

HTA Organizations Identified and Described

On the basis of a literature review and input from experts, we identified 7 examples of HTA organizations that might inform private payer coverage decisions related to personalized medicine:

• Blue Cross Blue Shield Technology Evaluation Center (BCBS TEC)16

• Emergency Care Research Institute (ECRI)17

• Evaluation of Genomic Applications in Practice and Prevention (EGAPP)18

• Hayes19

• Institute for Clinical and Economic Review (ICER)20

• United States Preventive Services Task Force (USPSTF)21

• UpToDate22

Six HTA organizations (BCBS TEC, ECRI, EGAPP, Hayes, USPSTF, and UpToDate) had developed genomic technology reviews by the time of our study, and the seventh (ICER) was planning to conduct a genomic technology assessment.

The 7 HTA organizations included 2 private companies, 2 independent panels developed by the government, 1 academic center, and 2 nonprofit organizations (Table 1). Four organizations made HTA reviews publically available; others charged a fee. The HTA organizations ranged in years of existence (from the 40-year-old ECRI to the 3-year-old ICER) and in the number of genetic reviews they produced (fewer than 15 by BCBS TEC, EGAPP, and USPSTF; more than 15 by ECRI; and more than 100 by Hayes and UpToDate).

HTA organizations varied in focus. Only 1 of them focused solely on genomics (EGAPP), and another (USPSTF) included only genomic technologies related to preventive services. Other organizations focused on assessing procedures by using novel technologies, imaging tests, and drugs and biologics. At least 3 HTA organizations also assessed laboratory tests and behavioral services (ECRI, Hayes, and UpToDate).

All 7 HTA organizations conducted rigorous evidence assessment and contained a description of the systematic evidence review. However, the HTAs answered differently formulated overarching research questions. USPSTF and EGAPP answered whether a technology should be used in clinical practice; ECRI and UpToDate provided a comprehensive topic review; BCBS TEC and Hayes evaluated evidence on the basis of their respective predefined criteria; ICER was concerned with comparative value of a technology. The majority (n = 5) provided evidence ranking, but only 3 (EGAPP, UpToDate, and USPSTF) provided recommendations for clinical use.

Payers’ Perceptions of the Strengths and Shortcomings of HTA Reviews

All interviewed payers reported conducting internal technology assessment and using external HTA in their coverage decision making for personalized medicine. Payers valued the following strengths of the HTA reviews as related to decisions regarding personalized medicine (Table 2): expertise and credibility of reviewers (100%); rigor of scientific evidence evaluation (82%); whether HTA methodology was specific to genomics (73%); independence from external influences (73%). Payers valued evaluation rigor as highly as the HTA reviewer expertise. The majority (64%) considered genomicspecific methodology less important than other HTA strengths.

The reported shortcomings of external HTAs were related to review availability (73%) and to the inclusion of nonclinical factors (91%; Table 2). Availability shortcomings included the small number of genetic reviews (64%), a lack of timeliness relative to payer coverage decisions (55%), and the increasing costs of fee-for-service reviews (45%). Fifty-five percent of payers claimed a heavier reliance on Hayes and/or ECRI, because they issued a higher number of reviews, albeit for a fee. The cost concerns were reported by both payers who used the fee-for-service HTAs and stated that the fees were becoming prohibitive, and by payers who considered using them.

Ten of the 11 payers noted that, although all HTA reviews included evaluation of clinical evidence, few of them incorporated other factors that might be importantin coverage  decisions. Payers listed a spectrum of these factors: cost-effectiveness (82%), current level of adoption in clinical care (45%), incorporation of expert opinion (36%), barriers to adoption in care delivery such as a lack of infrastructure or logistical challenges (27%), and local regulations (eg, state coverage mandates; 27%). Interviewees noted that these factors played a role in their coverage decisions, especially regarding technologies with limited evidence and including many personalized medicine tests. All payers stated that cost-effectiveness was currently not a factor in their coverage decisions; however, at least 7 of them believed that it would be a factor in the future as healthcare reform unfolds.

How HTA Organizations Are Used by Private Payers in Decisions Related to Personalized Medicine

All interviewed payers reported using at least 1 external HTA organization in their coverage decision making related to personalized medicine (Table 3). The number of HTA organizations used by individual payers ranged from 1 (n = 1) to all 7 (n = 1); the majority of payers (n = 8) used 3 or more different HTA organizations. Large payers reported using more HTA organizations than smaller payers used. HTA reviews from BCBS TEC and USPSTF were reported as being used by most payers (91% and 82%, respectively), whereas ECRI and UpToDate were used by the least number of payers (36% and 45%, respectively). Fifty-five percent of payers stated that using multiple HTAs and comparing them helped them construct a complete evidence profile for a technology, because they had found no one source that was able to provide complete evaluation for genomics. They experienced a higher need for using reviews from multiple HTA organizations for genomics than for other technologies. The majority of payers (91%) found HTA reviews beneficial to their coverage decision making related to personalized medicine and used them for 1 or more of the following purposes:

• to help internal reviewers with question formulation and methodology (91%);

• to validate internal evidence analyses (36%); and/or

• to demonstrate credibility of decisions to providers and patients (36%).

At least 5 payers reported that they would like to use HTA reviews for question formulation more often, but because HTAs were not available in a timely manner, payers’ internal evaluations were often completed before an external HTA was issued.

All payers found systematic evidence analyses by external HTAs useful, but their opinions differed on the usefulness of other HTA review components. Many payers found evidence ranking (45%) and HTA recommendations (55%) helpful. However, others found ranking confusing, preferred to use their own ranking methods, or deemed external recommendations not relevant to their decisions.

Discussion

Private Payers Rely on External HTA in Coverage Decisions for Personalized Medicine, but HTA Shortcomings Limit the Use

 
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