Is it time for a new drug development paradigm?

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1 Is it time for a new drug development paradigm? Robert McDonough, M.D. Senior Director, Clinical Policy Research and Development 1 The Aetna Way Our Cause To make quality health care more affordable and more accessible Our Strategy To be the global leader in empowering people to live healthier lives 2

2 Overview We will discuss the following issues: The criteria Aetna uses to evaluate medical technologies Aetna s clinical policy development process Aetna s clinical policy, Medicare policy and FDA approval Role of observational data and cost-effectiveness in clinical policy 3 Clinical Policy Unit Function Aetna s Clinical Policy Unit is responsible for evaluating medical technologies to determine whether they are experimental and investigational and medically necessary as defined in applicable coverage documents Aetna has developed more than 700 Clinical Policy Bulletins (CPBs). The goal is to develop objective, clinically supported and defensible determinations. 4

3 Definitions Medically necessary and experimental and investigational terms are defined in the benefit plan Embedded in definition are both certain evidence standards and may include an explicit consideration of cost should there be an alternative service that produces comparable outcomes Some plans exclude coverage for services or supplies that Aetna considers medically necessary. The member s benefit plan determines coverage. 5 Medical Necessity Definition Medically Necessary or Medical Necessity shall mean health care services that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury, disease or its symptoms, and that are: a) in accordance with generally accepted standards of medical practice; b) clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for the patient s illness, injury or disease; and c) not primarily for the convenience of the patient, physician, or other health care provider, and not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient s illness, injury or disease. For these purposes, generally accepted standards of medical practice means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community or otherwise consistent with the standards set forth in policy issues involving clinical judgment. 6

4 TEC Criteria The following criteria are considered in evaluating a medical technology: The technology must have final approval from the appropriate governmental regulatory bodies, when required The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes The technology must improve net health outcome The technology must be as beneficial as any established alternatives The improvement must be attainable outside investigational settings 7 Prioritizing CPB Requests The following factors are considered in prioritizing requests for developing CPBs: The quantity and importance of questions that have arisen regarding the medical technology New evidence, guidelines, consensus statements, changes in regulatory status, coding or other information that is material to the status of the medical technology The potential impact of the technology on Aetna and its members 8

5 Drafting Clinical Policy Bulletins The Clinical Policy Unit conducts a comprehensive search of the peer-reviewed published medical literature: Search National Library of Medicine s PubMed database of peerreviewed medical literature Assess regulatory status of technology Review evidence-based clinical practice guidelines in AHRQ s National Guideline Clearinghouse database For oncology drugs, Aetna considers the indications from ASCO and from NCCN Review technology assessments indexed in NLM s Health Services/Technology Assessment Text (HSTAT) database Opinions of relevant experts may be solicited where necessary 9 CPB Approval Process 10 The draft CPB is reviewed and approved by the Clinical Policy Council Review by head of Aetna s National Medical Policy and Operations Department Review by Aetna s Legal Department Review and approval by Aetna s Chief Medical Officer Members of the Clinical Policy Unit work with persons from coding and reimbursement areas (Medical Policy and Operations) regarding implementation of clinical policies in Aetna systems Policies updated each calendar year

6 Clinician input into clinical policies Regional Quality Advisory Committees Specialty Society Policy Liaison Group Transplant Advisory Committees External Review Organization Committee Physician Advisory Board Aetna receives inquiries from vendors, providers, members and others regarding clinical policy issues. 11 Coverage of Clinical Trials Aetna also covers the routine care costs of persons enrolled in approved clinical trials. In addition, under most benefit plans, Aetna covers promising experimental interventions to members with cancer or terminal illnesses who have exhausted standard approaches and are enrolled in certain clinical trials sponsored by a national cooperative body. Commercial plans have no provision for coverage with evidence development 12

7 Use of Registry Data Because registries have substantial risks of bias, clinical trials will remain necessary to determine efficacy Registries may provide evidence that complements evidence from a clinical trial Registries provide evidence of real-world effectiveness (outside trial) Registries may provide evidence on the impacts of an intervention over the long-term 13 Use of Registry Data Registries may provide evidence on rare or late-occurring adverse effects Registries may contribute data on comparative effectiveness of different interventions within a therapeutic class May identify particular subgroups of patients who may receive the greatest benefit from an intervention Generally less expensive than clinical trials 14

8 Comparative Effectiveness and Cost Effectiveness Aetna considers the comparative effectiveness of new medical technologies. Aetna considers the relative costs of equally effective established alternative medical technologies. Cost-effectiveness is not considered 15 Clinical Policy and FDA Approval FDA approval, where applicable, is necessary but not sufficient to meet Aetna s coverage criteria. FDA does not take into account all of Aetna s clinical evaluation criteria Effectiveness outside of the investigational setting Comparative effectiveness with other alternatives Comparative costs of equally effective alternatives Lack of long-term outcome data No evaluation of off-label uses 16

9 Clinical Policy and Medicare For its Medicare risk members, Aetna is required to follow Medicare s policy The Centers for Medicare and Medicaid Services (CMS) determines whether an item or service falling within a benefit category is reasonable and necessary for the Medicare population More than 90 percent of Medicare coverage determinations are left to the discretion of local Medicare carriers 17 Accountable Care Solutions Commercial ACOs are much more variable in organization than Medicare ACOs ACOs involve some degree of risk sharing arrangements Pharmaceutical and medical device manufacturers need to demonstrate the value of their products 18

10 19 Discussion

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