Disease management keeps evolving

Due to an increasing number of extraordinary partnerships and innovative disease management programs among certain managed care and pharmaceutical firms, the face of disease management is finally changing, even if only slightly.

During the early 1990s, they say many drug companies were apparently spurred into creating disease management programs because they feared impending health care reform legislation would negatively impact their pharmaceutical profit margins. "The general sense back in 1993 was that being in the business of developing and selling pharmaceutical products was not going to be as lucrative as it once was," said Mark Zitter, president of the Zitter Group, San Francisco, CA. "Fast forward four years and you see that pharmaceutical margins are plenty healthy and that managed care, which was perceived to be the big threat to pharmaceutical profits, has apparently been good for it. Certainly the correlation is there."

Zitter said pharmaceutical firms that merely stuck their toes into the waters of disease management ultimately determined it too costly to pursue and folded back their programs into more general operations, while others increased their commitment by expanding their programs or setting up separate disease management subsidiaries.

Measuring outcomes

However, at least two obstacles remain in the way of both managed care and pharmaceutical companies with regard to disease management: the time it takes to conduct thorough studies and the financial resources necessary to put integrated data systems into place. "The essence of disease management is to organize your resources efficiently around groups of patients," said Victor Freeman, M.D., research fellow, Clinical Economics Research Unit, Georgetown University Medical Center. "Because this is still new, we don't necessarily know how to organize it effectively, so it's taking longer for disease management to continue."

Although the computer capabilities necessary to establish integrated data systems are available, Freeman said cost continues to be an issue. However, he said one of the advantages of for-profit managed care is that it brings more capital to the table for this kind of investment. "One of the big problems though is that people often don't stay in the same health care delivery system because of competing systems in the market," he said. "Thus far, it has not been profitable to establish elaborate computer systems for long-term follow-up if people are going to be leaving your plan."

Because many pharmaceutical manufacturers lack the in-house capabilities to rigorously measure patient treatment episodes and prevalence rates, they must sometimes depend on outside consultants to help them develop their programs. Increasingly, they are looking to pharmacy benefit managers and pure economic research firms to provide them with pharmacoeconomic data they can use in addition to their own clinical data.

"While pharmacoeconomics is focused on the most cost-effective way to use a medication, some drug companies also want to look at the risk factors related to the care of a disease so they can advise doctors and managed care organizations on how to best use their product," said Freeman.

Eric Colwell, director of health care programs, Novartis Pharmaceuticals Corp., East Hanover, NJ, believes his firm has secured a unique foothold within the industry in this regard. At Novartis, where disease management falls under the direction of the health care management department, a significant number of staff members are devoted exclusively to health economics, outcomes research and disease management. "Not only does it help us in defining the value of products," said Colwell, "but it helps us in understanding the disease states we compete in so that we can more effectively offer solutions to our customers."

Similarly, the principle behind disease management at Pfizer Inc., New York, is a focus on entire diseases and disease categories rather than on isolated pharmaceutical interventions. Its strategy: Map a disease, identify the drivers, isolate the drivers that can be changed, then develop the interventions that can change them.

Researchers at Pfizer have determined, for example, that while recovery from an illness like depression doesn't always follow a predictable course, there are predictable points at which recovering patients may relapse.

In response, the company created Rhythms, a landmark patient education and adherence program for depression that includes videotapes, newsletters and a phone number for patients to call when they feel they are in trouble.

There are currently more than 60,000 patients involved in the program.

Defining value

For disease management programs to be truly successful, managed care organizations and their customers must have a voice in program development and implementation, according to Colwell. "A disease-management program needs to be built from the plan perspective up, beginning with providers," he said. "We are building some great value-based tools that will help us find collaboration with our customers."

Colwell said customers define value differently. Some managed care organizations welcome the idea of partnering with pharmaceutical manufacturers because of the manufacturers' ability to bring additional knowledge to a disease area or to effectively communicate with physicians. Others may be uncomfortable working with drug companies and continue to look upon partnerships cautiously.

"I think there will always be suspicion, particularly among physicians, when there is an alignment between a pharmaceutical company and a PBM because they control all the information," said Freeman. However, he said suspicion is more likely to diminish if information is focused on the local population.

Creating programs

For the past year, Novartis has been successfully collaborating with Lovelace Health care Systems, an integrated health care network based in Albuquerque, NM, on the development, implementation and outcomes assessment of a comprehensive disease management program for epilepsy.

Novartis, which has provided Lovelace with a health economic research fellow to help manage the project on site, also supplies educational materials for use in conjunction with Lovelace's own disease-management guidelines.

On the other hand, Sanofi Pharmaceuticals, New York, has decided to pursue a different approach to disease management. "I think some accounts seem much more receptive to a program if the pharmaceutical company is not directly involved," said Jim Hoyes, the firm's director of cardiovascular product marketing.

For example, Sanofi's Advanced Heart Failure Shared Clinical Experience Network, also known as AHF SCENE, is a program provided as a professional service and funded by an unrestricted educational grant underwritten by Sanofi.

The program offers physicians who treat patients with congestive heart failure the opportunity to visit other leading heart-failure treatment centers around the country, where they can compare experiences and explore optimal treatment approaches.

Sanofi also supports the initiative with traditional items like patient education materials, as well as innovative efforts like health economic benchmarking programs. More than 200 physicians, nurses and administrators from 130 hospitals around the country attended a SCENE program in 1996.

Although the firm is conducting market research case studies to gauge its success among participating institutions, Hoyes said initial feedback has been positive. "We hope the program will provide physicians with a more aggressive model they can implement within their own institutions and that our product, Primacor,® (milrinone lactate injection) might benefit them in that implementation process," he said. "But physicians could just as easily go to one of these sites and learn an aggressive way to use a competitive product."

What sales reps can do

Freeman said that as more and more health systems become vertically integrated, they will be better able to provide comprehensive care across different continuums. In this context, disease management programs will flourish, although they may be structured differently and be harder to recognize as such.

As these programs evolve, pharmaceutical sales reps will need to refocus their traditional selling efforts, becoming brokers of information as well as products. "We've asked our sales professionals to think more like business consultants," said Hoyes. He said reps are learning how to identify and evaluate the problems that a hospital or physician is facing and then be able to offer them a number of solutions, which may include the use of the pharmaceutical Sanofi's product.

Sales representatives will need to learn more, not only about the changing relationship between drug manufacturers and providers, but between providers and payers as well.

Capitation has resulted in changing financial incentives for both sales reps and physicians, and has affected the way physicians think about prescribing products for certain diseases. This can sometimes be quite beneficial from a pharmaceutical standpoint. "If a psychiatrist is getting paid [on a] fee-for-service [basis], he may require more doctor visits," said Zitter. "If he's capitated, he may just [prescribe] Prozac."

Both drug companies and managed care organizations are looking to pharmaceutical sales forces to educate physicians on the importance of disease protocols and formulary compliance. But it's not that easy. "I don't think the average sales rep who calls on a physician is aware of his managed care restrictions," said Bob Shewbrooks, executive director of managed health care services, Scott-Levin Associates, Newtown, PA. "Outside of staff and group models, which are very restrictive, I don't think open-model health maintenance organizations are at the point where they've managed to reign in their physicians."

Freeman said billions of health care dollars are currently being wasted because patients do not take their medications as prescribed.

However, he said drug companies can help physicians deliver care to their patients in a more cost-effective manner by providing additional support, such as mailing out prescription reminder cards or packaging certain medications in unit doses. He said drug companies must also recognize and address the needs of special niches, such as the growing Hispanic market.

Despite all its potential, disease management continues to be a slowly moving process, and at least a few industry experts remain skeptical about its place in the health care industry. "I think in the short-term, disease management is going to be a reality," said Shewbrooks. "But I'm not sure about the big picture. I think all the indications are that for HMOs to continually cut costs, they're going to have to focus on something they can get their hands around...and that's the pharmacy benefit." PR