The HEDIS Business Case for Quality
HEDIS in 2001 argued that the benefits of high quality care over lower quality of care include direct costs and indirect cost savings (e.g., from absenteeism). Examples and information can be found at NCQA.

• Management of high-cost pharmaceuticals (low molecular weight heparin and statins)—an $800/patient savings for WMWH and an estimated ratio of cost to savings for effective statin treatment is approximately 1:2;
• Chronic care (diabetes management)—projected savings over a ten year period, because of lower service use, was $405 per patient—a net benefit of $75 per patient;
• Prevention (smoking cessation)—business case for these programs is weak from the short-term organizational perspective. The health plan incurs sizable costs but is unable to realize a predictable, measurable return on investment from the long-term payoff;
• Health maintenance (wellness programs in the workplace)—General Motors estimates an opportunity for savings of $350,000 per plant annually in absenteeism costs.

Reference
1.Leatherman S, Berwick D, Iles D, Lewin LS, Davidoff F, Nolan T, Bisognano M. The business case for quality: case studies and an analysis. Health Aff (Millwood). 2003 Mar-Apr;22(2):17-30. PMID: 12674405

Results: Utilization of the restricted PPIs declined sharply after the policy change (-14,850 daily doses per month per 10,000 residents, P < .0001), whereas use of the covered PPI increased sharply (+19,300, P < .0001), with 45% of all PPI users switching to the covered agent within 6 months. The investigators found no increased use of H2 blockers or stopping of gastroprotective drugs. There was no increase in the monthly rate of hospitalization for gastrointestinal hemorrhage after the PPI restriction even though the study had the power to detect these changes. In the first 6 months of the policy change, the provincial health plan saved at least $2.9 million (Canadian) as a result of the policy change. The authors conclude that coverage restriction of 3 leading PPIs led to substantial utilization changes and savings, without increased noncompliance or clinical complication.

Reference
Clin Pharmacol Ther 2006;79:379-88.

Closed versus Open Formulary

Unrestricted Access to Drugs Can Result in Waste and Inappropriate Care
In a review of health care for King County, Washington employees, a comparison of an open drug system, where any drug can be used, versus a closed formulary system, where choices are managed, showed a very large and inappropriate use of drugs, especially anti-depressant drugs, in the open system. The open system was managed through rebates, prior authorization and common strategies used by prescription benefit managers. In the closed system, the drugs were evaluated using an evidence-based review process considering effectiveness, safety, need and cost. The cost was one-third less in the closed system which is also known for very high quality health care. [Presented by Andreas Stergachis, PhD, at King County Healthcare Advisory Task Force Meeting; March 8, 2004 Seattle, Washington.]

Another informal survey of health care systems in the US comparing those which use a Pharmacy & Therapeutics Committee (P & T Committee) versus those that do not, showed that the systems with the P & T committees had annual expenditures of 15 percent less than those without. From our experience it is reasonable to surmise that savings in P & T committees trained in evidence-based methods would be even greater – and care would be even higher quality.

The implications from this research are that the right structures and work processes can help improve care and good use of resources. Evidence-based training of P & T committees and supporting staff is likely to result in improved care and cost savings.

Lessons learned: Evidence- and value-based structures, processes and skills that can help reduce waste and improve care include the following –
1. Closed formulary system
2. Pharmacy & Therapeutics Committee staffed by individuals who have skills in applying a rigorous review of the medical literature

Outcomes: Potential savings for 15 to 30 percent of all drug expenditures

Technology Assessment

Leadership of Mike Stuart MD Evidence-based Processes for New Technologies Reduce Inappropriate Use
Before and after comparison of coverage decisions at a large HMO showed that an evidence-based process used in a technology assessment committee, along with the right structure and processes for the committee, resulted in a significant decrease in the use inappropriate technologies. An organization can expect an absolute decrease of, at least, 30 percent of new technologies as been shown through the medical evidence as being effective with these processes.

Lessons learned: Evidence- and value-based structures, processes and skills that can help reduce waste and improve care include the following –
1. Medical Technology Committee staffed by individuals who have skills in applying a rigorous review of the medical literature

Outcomes: Potential savings for > 30 percent of all new technology expenditures

Power of Guidelines: Example — Dysuria Guideline

Successful Clinical Guideline Implementation Can Result in Significant Cost Savings (Stuart ME et. al. Acute Dysuria in Adult Women. HMO Practice. 1997;11(4):150-157)

• Cost Savings over $500,000 per year in system of 600,000 lives
• High patient satisfaction
• Leadership of Mike Stuart MD

In 1994, at Group Health Cooperative, in Seattle, under the leadership of Dr. Michael Stuart, a team developed an evidence-based clinical practice guideline. Based on the best available valid and useful evidence, we concluded that healthy, low-risk, adult women with symptoms of acute dysuria or urgency and no guideline exclusions could be effectively and safely managed without a clinic visit, physical exam or laboratory tests. Although women with acute dysuria were provided the option for a visit, the guideline specified that patients could be managed through a phone visit with a nurse and a three-day prescription of antibiotics and that no follow-up visits or tests were necessary.

Results:
o After 1 year the number of visits for acute dysuria dropped by one third;
o When compared to usual care, there were no significant differences in complications or recurrence rates;
o Patient satisfaction with phone-based care was extremely high;
o Cost savings were well over $500,000 per year (visits, lab, prescriptions).

Lessons learned: Evidence- and value-based structures, processes and skills that can help reduce waste and improve care include the following –
1. Quality Committee staffed by individuals who have skills in applying a rigorous review of the medical literature and development of clinical recommendations
2. Application of evidence-based implementation strategies
3. Skills in developing information, decision and action aids
4. Application of principles for effective information dissemination

Outcomes: Guidelines, which are developed using a rigorous evidence-based medicine process and which are effectively implemented, can improve care and aid in optimal use of resources.

Power of Guidelines: Example — Diabetes Guideline

Cost savings per patient Evidence-based Clinical Guidelines Can Result in Improved Care and Cost Savings (Wagner EH et al. Glycemic Control and Cost Savings. JAMA 2001;285:182-189)

• Guideline Development Under Leadership of Mike Stuart MD

In the late 1990s, several studies suggested that improved glycemic control in type 2 diabetics might lead to rapid cost savings. It was estimated that for every 1% reduction in HbA1c a cost savings of $400 to $4,000 per patient per 3-year time period could be achieved. At Group Health Cooperative of Puget Sound, we reported that in demographically similar diabetic patients, those with HbA1c =/ >10% whose HbA1c improved had fewer primary care and specialty visits and mean cost savings by years were –
o 1995 $685
o 1996 $950
o 1997 $821

Lessons learned: Evidence- and value-based structures, processes and skills that can help reduce waste and improve care include the following –
1. Quality Committee staffed by individuals who have skills in applying a rigorous review of the medical literature and development of clinical recommendations
2. Application of evidence-based implementation strategies
3. Skills in developing information, decision and action aids
4. Application of principles for effective information dissemination
5. Physicians and clinical pharmacists with basic competencies in evidence-based medicine – specifically critical appraisal and results assessment

Outcomes: Guidelines, which are developed using a rigorous evidence-based medicine process and which are effectively implemented, can improve care and aid in optimal use of resources. In this example, physicians with basic skills in evidence-based medicine may have improved care even without implementation of a guideline.

Harms, benefits, costs and evidence-based medicine: Example —
Cox-2s

Not Applying Evidence-based Medicine Can Drive Up Costs and Result in Potential Patient Harms (Bombardier C, et al. for the VIGOR study group. N Engl J Med. 2000;343:1520-1528)
Cox-2 Inhibitors have not been shown to provide clinically meaningful advantages over older NSAID medications. In fact, Celebrex has not been shown to have better outcomes than older NSAIDS, and the “landmark” study supporting its use is fatally flawed. In the case of Vioxx, harms are likely to outweigh benefits: for every 500 people treated with Vioxx within 9 months, 4 serious ulcer complications may be prevented, but according to the best available valid and useful evidence, there will be 5 blood clots which result in serious harms to patients such as leg thrombosis, heart attack and pulmonary embolus. The evidence of harms outweighing benefits was known in 2000 and yet it was not until 2004 that Vioxx was withdrawn because of the risk of blood clots (Delfini has recommended to P & T committees since 2002 that Cox-2s not be covered). The cost of the Cox-2s ranges from 8 to 16 times the cost of ibuprofen. In this case of a highly promoted new drug, harms outweigh benefits—yet most physicians and patients are not aware of this, and prescriptions for Cox-2s are a $6 billion dollar business annually.

For a health system of 500,000 people, the additional costs of switching to Cox-2s would exceed $3 million per year for drug costs alone. It should be noted that many evidence-based P & T committees using critical appraisal skills taught by Delfini did not approve Cox-2s, but many systems not using EBM methods did approve Celebrex and Vioxx.

Lessons learned: Evidence- and value-based structures, processes and skills that can help reduce waste and improve care include the following –
1. Closed formulary system
2. Pharmacy & Therapeutics Committee staffed by individuals who have skills in applying a rigorous review of the medical literature
3. Physicians and clinical pharmacists with basic competencies in evidence-based medicine – specifically critical appraisal and results assessment

Outcomes: A system-wide approach to evidence-based medicine can improve care and aid in optimal use of resources.

Gap:

• Physicians determined demand through their preference
• Physician preference was not driven by evidence of effectiveness but by personal preference (frequently the newest)

Evidence-based QI initiative:

• Cost and quality problem was addressed by QI team
• Established reference prices for ICDs
• Evaluation of internal data (choice of ICD by physician) and evidence (literature review)
• Presentation to cardiologists
• Agreement: 6 months trial of purchasing from low-priced vendor
• Enthusiastically embraced by the vendors with the lowest market share

Outcomes:

• From: Per procedure dollar loss of $2,000
• To: Per procedure income of almost $5,000 generating annual savings of approximately $2 million

Comment: This program was successful (decreased cost without sacrificing quality) because the evidence did not support the newest technology and the QI team used an evidence-based approach.

Case Study: Evidence-based QI Project for Gastroesophageal Reflux Disease (GERD) at Seattle health care system

Background:

• Proton pump inhibitors (PPIs) reduce acid in stomach and used for heartburn and reflux
• Prilosec=omeprazole
• Nexium=esomeprazole (left handed molecule of omeprazole)

Gap

• No evidence that Nexium is clinically superior to Prilosec or omeprazole
• Prilosec patent expired 2001 and generic omeprazle became available
• Prilosec manufacturer launched Nexium, the purple pill
• Continued high use of Nexium
• Evidence based QI Project
• QI team included clinicians, administrators, insurer, and employer (Costco)
• Team found variation in use of brands and generics and high cost
• Nexium cost $153 at the time of QI project
• OTC Prilosec cost $26
• Evidence-based Solution Based on Evidence
• For Nexium: $23 paid by employee, $130 paid by Costco benefit plan
• For Prilosec: Costco pays $26 and patient pays nothing

Potential Savings
For 1000 brand name PPI scripts per month the potential savings to employee is $23,000 and to the benefit plan is up to $104,000 per month

Elevated Blood Pressure Rx and Cost Savings

Evidence-based Medicine Helps Patient Care Quality and Can Result in Cost Savings (JAMA 2004. 291:1850-1856)
The 2002 ALLHAT study has led to new guidelines for elevated blood pressure. In that study (JAMA 2002.228:2981-2997) patients were randomized to receive amlodipine, lisinopril, or chlorthalidone. The thiazide was found to be the most effective (and least costly) treatment. Initiating therapy with thiazides has been confirmed as the “value” approach in other studies. Potential savings from adherence to an evidence-based guideline for treating elevated blood pressure in patients older than 65 years would result in a significant change in the use of medications for 40% of patients and would result in $20.5 million savings if implemented in the Medicaid program. Savings would be achieved through a decrease in the spending for calcium channel blockers (48% replacement), ACE inhibitors (23% replacement) and beta blockers (14% replacement).

Lessons learned: Evidence- and value-based structures, processes and skills that can help reduce waste and improve care include the following –
1. Quality Committee staffed by individuals who have skills in applying a rigorous review of the medical literature and development of clinical recommendations
2. Application of evidence-based implementation strategies
3. Skills in developing information, decision and action aids
4. Application of principles for effective information dissemination

Outcomes: Guidelines, which are developed using a rigorous evidence-based medicine process and which are effectively implemented, can improve care and aid in optimal use of resources.

Low Molecular Weight Heparin (LMWH) Versus Fractionated Heparin
Many organizations have moved to LMWH as the drug of choice for all clinical conditions previously treated with fractionated heparin. The evidence does not clearly favor LMWH over the older preparation. Depending upon the clinical condition being treated, details of an organization’s structures, processes and roles, either LMWH or fractionated heparin may be associated with the highest quality and lowest cost.

In one institution, using the methods of evidenced-based quality improvement taught by Delfini, significant cost savings were achieved without sacrificing value by creating and implementing a clinical guideline recommending fractionated heparin over LMWH for patients in the intensive care unit requiring heparin.

Another institution achieved savings by creating and implementing a clinical guideline recommending LMWH for patients with deep vein thrombosis.

How could LMWH, a much more expensive drug result in cost savings? In the first organization, the lower price of fractionated “won out” in the cost projections. In the second organization, projections showed that managing DVT at home by using visiting nurses would result in shorter hospitalizations and significant cost savings.

The “take-home message” here is that value is achieved by evaluating the scientific evidence, current costs, projected costs with various options, developing evidence-based clinical recommendations or guidelines, achieving buy-in through leadership and successful implementation by using a combination of proven implementation strategies.

Other Areas with Evidence of Cost Savings or Cost-effectiveness

A Sampling of Other Areas Where There is Evidence of Cost Savings and/or Cost-effectiveness (Am J Prev Med 2002;23(4):276-289)

• Comprehensive diabetes care
• Antidepressant medication management
• Childhood and adolescent immunization
• Cholesterol management after CV event
• Prenatal care 1st Trimester
• Preop Rx to prevent DVT in high risk surgical patients
• Acylovir Rx for chickenpox or herpes zoster in immunoincompetent children or adults

Evidence-based Purchasing:
Total Hip

The Need for Evidence-based Medicine
In order to be successful in achieving evidence and value-based clinical improvements, an organization must have the knowledge, skills and tools of EBM. Specifically the requirements include leadership’s understanding of the issues, staff’s understanding and confidence in approaching clinical improvement through gap analysis (comparing current performance to what could be achieved by basing care on the best available valid and useful evidence), evidence synthesis, projections of “what if’s”, development and implementation of information aids, decision support materials, clinical guidelines and performance measures.