Technology coverage decision making: further reflections from

‘an Englishman abroad’

Stirling Bryan, PhD

Stanford UniversityUniversity of Birmingham, UK

Overview

• Study rationale and objectives• Methods• Technology coverage decision making

in the US• Cost and cost-effectiveness in the US• Challenges for:

• the US• the UK

Study rationale

• High and rising cost of health care• A near universal problem

• A major cause: ongoing introduction of new health care technologies

• Literature• In the US, cost-effectiveness information is not

routinely considered in coverage decisions• In England & Wales, use of CEA at the national

level (by National Institute for Health & Clinical Excellence)

Fellowship objectives

• To describe technology coverage policy in a number of US health care organizations

• To elicit views of stakeholders on coverage policy and, specifically, on the use of cost-effectiveness information

• To recommend how coverage policy in the UK and US might be strengthened

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You can rest assured, Mrs. Wilson, that your husbandwill receive the best care known to medical coverage.

Methods / Data

• What am I drawing on?• Data from 4 US case studies

Kaiser-Permanente, Aetna, Blue Cross Blue Shield, Veterans Health Administration

• Methodology• Predominantly qualitative• Primarily exploratory in nature

• Data collection• Documentary analysis• Interviews with key professionals (n=16)• (Workshops and surveys)

Appraisal / Decision making

Horizon scanning

Technologyassessment

Review / Re-evaluation

Implementation

Technology coverage process

2. Appraisal / Decision making

Horizon scanning

1. Technologyassessment

Review / Re-evaluation

3. Implementation

Technology coverage process

1. Technology assessment in the US

• Formal, evidence-based, policy processes (in all settings)

• Structured and organization-wide input to policy process (in some settings)

Structured and organization-wide input to policy process

[the draft monograph] “goes to the VISN formulary leaders, who review it and circulate this to people who they think it would be of interest to … a cardiology drug, they send to various cardiologists. We also broadly disseminate these monographs and so there are technical advisory groups in the VA, such as nephrology, etc. … and we send a copy to them.”

1. Technology assessment in the US

• Formal, evidence-based, policy processes (in all settings)

• Structured and organization-wide input to policy process (in some settings)

• Focus on effectiveness (and not costs)

Focus on effectiveness (and not costs)

“That’s important – cost is not discussed. The physicians involved, the literature, nothing discusses cost. It’s only ‘Is it medically necessary, is it safe and is it effective? … occasionally people will try and get a cost discussion going but we have to shut them down because I don’t want anybody saying your medical policy decided this on the basis of cost.”

“We spend a lot of time looking at costs because it’s very important that we are good stewards of federal tax money … and, as you know, most commonly we don’t have good CEA data.”

1. Technology assessment in the US

• Formal, evidence-based, policy processes (in all settings)

• Structured and organization-wide input to policy process (in some settings)

• Focus on effectiveness (and not costs)

• Use of published material predominantly

• Limited input from industry/pharma (in most settings)

2. Appraisal / Decision making

Horizon scanning

1. Technologyassessment

Review / Re-evaluation

3. Implementation

Technology coverage process

2. Appraisal / Decision making

• Decisions by formal committees (e.g. INTC, MAP, CPC)

• Some committees do not make ‘coverage’ decisions

Some committees do not make ‘coverage’ decisions

“The Blue Cross Blue Shield companies … make independent coverage decisions, the Association does not make coverage decisions for them; we make recommendations to them on policies. Most of the time their policies are consistent with the recommendations in our medical policy reference manual”

“The INTC does not make coverage decisions. They issue advice and guidance to the 8 regions ... Coverage decisions are made at the bedside or on an individual patient level.”

2. Appraisal / Decision making

• Decisions by formal committee (e.g. INTC, MAP, CPC)

• Some committees do not make ‘coverage’ decisions

• Explicit criteria used (in most cases)

• Cost rarely considered explicitly at the coverage decision

2. Appraisal / Decision making

Horizon scanning

1. Technologyassessment

Review / Re-evaluation

3. Implementation

Technology coverage process

3. Implementation

• Generally, high levels of adherence to formulary / guidance

• Achieved through:• Broad consultation process in policy

development

Broad consultation process in policy development

“we spend a lot of time up front getting buy-in and we believe that’s important … We believe that by including them up front and giving them the opportunity, by the time we make the decision and they have some action, there’s not going to be as much push-back ... So it works very well.”

“it’s not like we’re trying to reach out and grab people by the scruff of the neck and shake them like the health plans have to do … I don’t mean we never have any problems but, if you sat in on the twelve medical directors meetings during the year, you wouldn’t hear this issue [implementation problems] come up once at this time… not a big deal.”

3. Implementation

• Generally high levels of adherence to formulary / guidance

• Achieved through:• Broad consultation process in policy

development• Use of electronic guidelines• Influence• Payment• Monitoring and feedback

Cost / CEA and US health care

• Cost considerations largely absent from coverage decisions

• Some exceptions:• VHA (as referred to earlier)

• Kaiser-Permanente“CEA tends to be used more in terms of making decisions about selection of drugs within a therapeutic class or for a specific indication”

• BCBS“In a number of situations we have commissioned CE studies … as a means of providing information to the system. Whether individual plans use those in their decision making or not is uncertain.”

Views on cost information and CEA (1)

• Widespread (but not universal) frustration at lack of use

“People don’t like to put a money value on life and it’s dumb. I’ve had these discussions, … and every time I get into this issue of cost, people say ‘Cost should not be your concern, your concern as a physician … should be only one thing, what is the best thing for the patient?’ …

And I have patients who will say to me ‘Ah, the VA is just trying to save money’ and I’m unapologetic. I say, what is so bad about that? If money were no issue, if the well springs were open and we had unlimited dollars, I would love not to worry about money.”

Views on cost information and CEA (2)

• Fear of media reaction“Personally I would support that. From the organisation perspective, they are so much afraid of being accused of deciding coverage on price that they don’t want to do that unless somebody like Medicare does it first. They don’t want to take the heat because we would end up in the New York Times”

• Some fear of courts“we fear the media much more than we do the legal because we get sued 4,500 times a year and most of them are civil suits and we fight them and they’re all done and don’t get in the papers”

“The hands of providers in the US are tied, especially because of the litigious nature of the US society.”

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Views on cost information and CEA (2)

• Fear of media reaction“Personally I would support that. From the organisation perspective, they are so much afraid of being accused of deciding coverage on price that they don’t want to do that unless somebody like Medicare does it first. They don’t want to take the heat because we would end up in the New York Times”

• Some fear of courts“we fear the media much more than we do the legal because we get sued 4,500 times a year and most of them are civil suits and we fight them and they’re all done and don’t get in the papers”

“The hands of providers in the US are tied, especially because of the litigious nature of the US society.”

New Yorker

I don’t feel quite as fulfilledwhen I’ve saved a lawyer.

Views on cost information and CEA (3)

• Mistrust of industry-sponsored CEAs“the problem is, as I’m sure you know working with NICE, that usually when a new drug comes out there is no cost effectiveness stuff, or the only stuff out there is basically garbage from the drug manufacturer”

• Lack of relevant CEAs (e.g. analyses for VA population)

“we don’t have good CEA models. The ones that we’ve looked at are either too rigid, you can’t change the parameters, … or maybe have some basic underlying assumptions which we would not necessarily agree with and that’s the foundation for the model … We don’t have the funding to do a CEA for every drug”

Views on cost information and CEA (4)

• Perceived public resistance

• Problems with state regulators

• Preferable alternatives

Some of the challenges for the US

• Bolder health plans?!• Why not test the market with policies that have explicit

limits/restrictions (‘prudent plans’)?• Would need to overcome multiple fears: media reaction,

public backlash, litigation, regulators, not following Medicare

• Would need strong sales pitch and strong supporters/advocates

• Less duplication of technology assessment activity• More collaboration, including international collaboration?

• More consideration of role/influence of pharmaceutical and device manufacturers (some examples of considerable success)

Some of the lessons/challenges for the UK

• Structured and organization-wide input to policy process

• Practice/utilization monitoring

• Policy implementation

• Appropriate role/influence of pharmaceutical and device manufacturers

• Building ‘resource stewardship’ culture

A very big ‘thank you’ to …

• My mentors, Alan Garber and Marthe Gold

• And everyone else at, or associated with, Stanford

• And everyone who was happy to talk with me

• And, not least, the Commonwealth Fund for sponsorship!