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Specialty drugs have earned their label. Consider that they're generally used by small patient populations with chronic, often complex, diseases requiring challenging regimens. They're difficult to ship, store, and administer. They demand extra patient care services. They can cost as much as $200,000 a year. And they're a niche that's heating up as community pharmacists try to take an even bigger share of the $24 billion market from specialty pharmacies.

Community pharmacies currently control 89% of the specialty chronic medication market, according to analysts with Warburg Dillon Read in New York City. The remaining 11% belongs to specialty pharmacies, such as Accredo Health, Chronimed Inc., and the Bindley Western spin-off Priority Healthcare, which have sprung up in recent years. However, when it comes to specialty biotech drugs, community pharmacies own only about 18% of that niche. And the makeup of the bigger pie is going to change dramatically in the years ahead, as the specialty pharmacies muscle aside the community pharmacies.

The advantages the specialty pharmacies can muster include contracting with drug manufacturers to deliver their products directly to patients, physicians' offices, and clinics specializing in certain chronic disease states. Some of the therapies are injectables that patients can self-administer at home, but others are administered intravenously in alternate sites, such as physicians' offices or clinics, because hospitalization is too expensive but the treatment is too complicated for patients to use at home. Other drugs require administration by nurses with home health-care agencies.

The services offered by specialty pharmacies go far beyond just delivering the drugs. They also typically handle direct insurance billing and a bank of reimbursement counselors who help patients find alternative payment methods if an insurer denies a claim or the patient is underinsured. They also offer 24-hour free telephone links to a pharmacist trained in the specialty drug and the disease being treated.

Limited distribution of specialty pharmaceuticals has been a thorn in community pharmacy's side at least since Novartis launched Clozaril (clozapine) into a closed network because of the need for close monitoring. Since then, pharmaceutical and biotechnology companies have found that the traditional distribution model of manufacturer-to-wholesaler-to-retail pharmacy does not serve the needs of patients using their more sophisticated products. As a result, some specialty drugs have gotten kid-glove treatment through restricted distribution. For example, the SeroCare Program was created by Serono Laboratories in late 1996 to support Serostim (somatropin [rDNA origin] for injection) prescribed for AIDS wasting. Serostim distribution was limited to select mail-service pharmacies, including American Preferred Pharmacy, Coram Healthcare, Priority Healthcare, and Stadtlanders Pharmacy.

The specialty pharmaceuticals target a wide range of diseases and conditions, but they usually have small patient populations. Consider the menu offered by Gentiva Health Services, Melville, N.Y. The list includes alpha1 antitrypsin deficiency, amyotrophic lateral sclerosis, cancer, Crohn's disease, cystic fibrosis, diabetes, growth hormone deficiency, Guillain-Barré syndrome, hemophilia, HIV/AIDS, multiple sclerosis, myasthenia gravis, and primary immune deficiency. The company also recently reached agreement with United Therapeutics Corp. to distribute Uniprost, a subcutaneous prostacyclin therapy. Currently in phase III clinical trials, the therapy, also known as UT-15, targets late-stage pulmonary hypertension. Getting in on the pre-approval ground floor, Gentiva distributes the therapy to hospitals and patients participating in the clinical trials. If the drug wins Food & Drug Administration approval, the firm will also provide clinical management, distribution, reimbursement, and patient support services for Uniprost.

To be honest, many community pharmacies don't want to deal with the downside of specialty pharmaceuticals. They don't want to purchase and keep in stock these very expensive drugs prescribed for limited patient populations. Many of these high-tech/high-touch products require a constant temperature during distribution and storage. Dosage monitoring and compliance with drug therapy are also big patient care issues with these drugs. Then there are the hassles of insurance. Some drugs are covered by traditional Rx benefit cards, some are billed under major medical coverage, and some are billed to Medicare if a physician administers them.

"These drugs tend to be more expensive and require special handling," said Doug Long, v.p.-supplier relations for IMS Health, who put the specialty pharmacy market at about $13 billion last year. "I don't think these products are for the faint of heart. But I think the good independent and chain operators can compete in this market. Unless patients can self-medicate, a lot of the activity takes place in the physician's office, so [community pharmacies] are kind of a middleman for the doctor."

Specialty pharmaceuticals and services may not be right for every community pharmacy, agreed Susan Winckler, R.Ph., group director of policy and advocacy, American Pharmaceutical Association. But she added that restricted distribution of such products raises issues of patient access and safety. She pointed out that by restricting distribution of a specialty medication to only one pharmacy, a manufacturer exposes patients to the risk of not receiving their medications in a timely manner if there's a disruption in the delivery system. In addition, shunting one part of therapy away from a patient's regular pharmacist can create the potential for undiscovered drug interactions.

"If you have a product going to only one distributor, you have no safety net for the patient," said Winckler. "It creates problems if there are any issues of drug interactions or coordinating therapy. Using an 800 number for patient care may work for some patients, but if they don't want that, what's their alternative? They have to use whatever the system provides."

A better way to handle specialty pharmaceuticals would be for manufacturers to set the criteria for their specialty products and then open distribution to any pharmacy that measures up, suggested Winckler. "What it boils down to is the ability of the professional and the facility to handle these unique products," she said. "That's a question of what skills do you have and what requirements are you willing to meet, rather than a manufacturer arbitrarily going with one pharmacy provider. We need to look at those drugs that might need to be cared for differently, what are the criteria for participation, and then let people compete. This would be the thalidomide model where pharmacies have to meet certain criteria [before being able to stock and dispense the drug]. That makes more sense than saying it's such a dangerous drug we're going to let only one pharmacy have access to it."

Getting in the game

Some drugstore chains also have jumped into specialty pharmaceuticals and services. CVS Corp., for example, created the ProCare subsidiary, which is the most ambitious response to the niche marketplace. Based on combined mail-service and community pharmacies, ProCare focuses on providing support to patients requiring complex, expensive drug regimens. ProCare caters to patients with HIV/AIDS, cancer, and transplantation, as well as those requiring biotech injectables for conditions such as multiple sclerosis and human growth hormone deficiency.

Wrapped inside a larger, long-term alliance CVS forged with Merck-Medco Managed Care last fall, the chain's ProCare became the exclusive provider of specialty pharmacy mail-order services to the pharmacy benefit manager's 51 million plan members. The deal also gave Merck-Medco a 10% equity stake in ProCare.

Sensing that the market is going to grow, Walgreen Co. is looking into options for a move into specialty pharmacy, said Michael Polzin, spokesman for the Deerfield, Ill., chain that just opened drugstore number 3,000 (see story, page 53). Walgreens does have one specialty pharmacy in Chicago. Operating inside the Howard Brown Health Clinic, which specializes in HIV/ AIDS, the pharmacy "is doing very well," Polzin said. In addition, the chain has a few drugstores with extended abilities to work with HIV/AIDS patients in San Francisco. "We are looking at some possibilities for the future, but nothing I can talk about at this time," he added.

Walgreens Health Initiatives was the chain's entry into specialty pharmacy with a mail-service component. Health Initiatives currently runs a growth hormone program, which delivers medications, offers patient counseling, handles reimbursement issues, and periodically informs the physician of the patient's compliance status. Future specialty pharmacy programs in the works include hemophilia, transplantation, and HIV/AIDS, according to the firm's Web site.

Declaration of independents

Not content to just sit on the sidelines and watch patients and business shunted to their old nemesis, mail-service pharmacies, the National Community Pharmacists Association is attempting to build a national network of independent pharmacies willing to stock specialty products and care for the patients who need them. Teaming up with the specialty pharmacy TheraCom, NCPA launched the Specialty Drugs Network in January. So far, about 4,000 independents have agreed to be part of a primary distribution channel for specialty pharmaceutical manufacturers and payer programs. The free network is designed to give independents access to new products, increased revenue streams, and strategic alliances with manufacturers, insurers, and PBMs.

"Our conception of the Specialty Drugs Network was to gain access to products primarily not available through retail today," said Todd Dankmyer, NCPA executive v.p.-communications. "There's a wide range of these products, primarily injectables, that are extremely expensive and usually for very limited patient populations where reimbursement and insurance coverage are the major challenges."

Independent members of the Specialty Drugs Network can pick and choose which drugs they want to stock and provide patient support for. There's also a just-in-time inventory system. "The members don't have to order anything until they know they have a patient coming in who needs this medication," said Dankmyer. "Second, all major medical claims are handled by TheraCom, so the members don't get into any battling to get the reimbursement, and they don't obligate themselves to accept certain levels of reimbursement."

The Specialty Drugs Network's trump card is members providing high-touch, face-to-face counseling of patients who are often battling life-threatening diseases. That's something mail-service specialty pharmacies cannot provide. "TheraCom's view is that most retailers are not positioned to handle a lot of these products," Dankmyer said. "They think independents are much more likely to be suited to handle them. Independent pharmacies do compliance monitoring and follow-ups. We were targeting a way to mainstream some of these products going almost exclusively through mail order or directly to the physicians' offices. TheraCom is convinced there's a huge opportunity downstream, with lots of products coming out with these kinds of compliance, price, and reimbursement concerns."

As a specialty pharmacy, TheraCom is well aware that it may not be the patient's preferred provider, said Mark Hansan, president/CEO. That's where the independent pharmacy network comes in. "The big advantage for independents is high touch at the community level," he said. "The independents are truly a jewel in our health-care system, but they've never been in a position to harness their value in a unified way to meet the needs of the manufacturers. Where they've always been outstanding is in the patient care time to counsel, time to instruct, that these products require. They are a great resource. We think that within a very short time, independent pharmacy will be viewed as the specialty pharmaceuticals provider of choice."

The Specialty Drugs Network sounds like a winner to Tom Lamb, R.Ph., who signed up his Sand Run Pharmacy in Akron, Ohio. "As independents, we want to find a niche that enables us to stay ahead of the competition," he told Drug Topics. "These patients need more than a mail-order pharmacy's toll-free phone call. We feel that independents can provide the necessary services compared with the chains and go the extra mile that you need to take care of claims, counsel patients, or get prior authorization. Along with TheraCom's expertise, the network is kind of a perfect fit for a lot of us, and we anticipate getting more of the specialty drug market share."

Enter the Internet

Some of the specialty pharmacy companies have taken their market share battles to cyberspace. They have erected Web sites that allow patients to directly fill their prescriptions, access information about their conditions and medications, and get answers to their questions from specially trained pharmacists. Some of the companies target a specific disease, such as the Hepatitis Neighborhood maintained by Priority Healthcare Corp., a specialty pharmacy and alternate site specialty drug distributor based in Lake Mary, Fla., or SangStat Medical Corp., which hosts the Transplant Pharmacy Web site for patients on transplantation therapy.

Infu-Tech has taken its Smartmeds. com specialty drug and disease management Web site to another level. The Carlstadt, N.J., specialty pharmaceutical provider will use a wireless Internet platform to deliver medications and drug compliance programs to patients with asthma, diabetes, hypertension, cystic fibrosis, and respiratory syncytial virus. The firm recently reached agreement with CarePlus Health Plan to deliver its wireless services to 1,500 beneficiaries of the New York-based HMO. CarePlus will pay a monthly service fee per enrollee. Patients will be able to order their medications directly from the Web via a wireless device. They will also be notified through the wireless device to take their medications and to verify their compliance. The resulting outcomes data will be given to CarePlus.

"We'll provide a wireless device, such as a cell phone, beeper, or palm top, for drug compliance," said Jack Rosen, Infu-Tech CEO. "When it's time to take their medications, we contact [patients] as a reminder and ask them to respond. By using these tools to reinforce drug compliance, this system will benefit the patient as well as lower medical service costs. And if we provide a wireless platform, the enrollee has less motivation to move to another provider."

Up, up, and away

There's no place for the specialty pharmaceutical market to go but up, according to analysts and pharmacists. Factors contributing to the niche's growth mode include the ongoing shift of patients with serious chronic conditions from hospitals to alternate site care or their own homes; the accelerating development and introduction of biotechnology drugs with high-cost profiles; and the intensifying focus on disease management as payers try to keep the lid on escalating health-care costs for patients with certain chronic conditions.

Clues to where this market is going can be gleaned from the balance sheets of publicly traded specialty pharmacies. Consider Memphis-based Accredo Health Inc., which handles seven specialty pharmaceutical lines for drug companies. The firm's latest financial report showed a 36% jump in revenues for the previous nine months, up to about $255 million, compared with the $187 million posted for the same period in fiscal 1999. A look at the profit-and-loss statement of Priority Healthcare Corp. showed net sales of $428 million in 1999, compared with $275 million the previous year.

"Retail providers still garner [89%] of product sales within the specialty pharmacy space," said Steven Valiquette. He is a director and analyst in the U.S. equity research department with Warburg Dillon Read, which has issued strong buy opinions on some of the specialty pharmacies. "A lot of the drugs being approved today are more complicated to administer than those of the past. And it is the inability of the retail operator to efficiently maintain an inventory and sell these products in a compliant manner that has given birth to the specialty pharmacy industry in the first place. Retail pharmacists simply cannot find enough hours in a day to successfully consult patients on these sophisticated, self-injectable biotech products, and the process is being shifted directly to physicians and specialty pharmacies, which are likely to have stronger clinical expertise than the retail pharmacists. Over the next 10 years, we expect the market share pie…to essentially flip-flop toward the biotech pharmacy companies."

It remains to be seen whether community pharmacy can compete with the specialty pharmacy venue, countered Walgreens' Polzin. "It needs to be determined whether specialty pharmacy can or cannot be translated into community pharmacies. I don't think anyone knows for sure how easily that may be translated. There's a lot of activity, and drugstores are trying a lot of different approaches, just as we will be trying different approaches, but what the ultimate model will be or how successful it may be remains to be seen."

Savvy independents scratching for every opportunity aren't going to let the specialty pharmacies take over without a fight. "We spent years and a lot of energy fighting restrictive distribution, but if you believe the specialty pharmaceutical people, there's going to be more and more of this stuff," said NCPA's Dankmyer. "We think that if we build a strong network of independent pharmacists, it will be better than anything else in the marketplace. Access to products currently beyond our reach is Job One."

TheraCom's Hansan is even more enthusiastic. "We believe this market will explode," he said. "If you look at the drug pipeline, there's an incredible number of products that fit this category. And there are other specialty drugs coming down the line with very large patient populations, and we assume that independent pharmacies would like to be part of that. That's why we believe that Specialty Drugs Network will only become more and more valuable."



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