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Centric Health Resources in St. Louis, Mo., serves patients who have the rarest diseases and need the most expensive drugs.
Pssst!! Hey, pharmacists! How about investing $100,000 in inventory for a single patient, who has a disease you've probably never heard of?
But serving patients with diseases such as pemphigus, alpha1-antitrypsin deficiency, hemophilia, or cystic fibrosis can be a practical business model for a specialty pharmacy. Managing distribution for drugs costing $10,000 a month is just the beginning, Westrich said. "Our mission is to improve the lives of people with ultra-orphan conditions," he told Drug Topics. "We integrate the delivery of specialized pharmacy services with comprehensive, patient-centered health management and patient advocacy. We involve and coordinate patients, physicians, nurses, families, manufacturers, patient advocacy groups, and payers to provide the best care and the best quality possible."
"Most pharmacies find it cost-prohibitive to keep these kinds of products in stock," said Maria Hardin, vice president of patient services for the National Organization for Rare Disorders. NORD is an alliance of voluntary health and patient advocacy groups working with rare diseases.
"As the cost of drugs increases, management of the financial side has gotten more complex," Hardin continued. "The issues range from Medicare Part D to tiered benefits, prior authorizations, and no benefits. These patients need a pharmacy with the expertise and the clout to go to bat for them. If the patient doesn't get treated, the specialty pharmacy doesn't get paid."
That makes specialty pharmacies the one link in the care community with a vested interest in making sure that patients get the most appropriate care, she said. Wholesalers and retail pharmacies don't want to tie up inventory dollars in high-cost, low-volume products that require special handling at every step in distribution, payment, and administration. "Specialty pharmacies have stepped into that gap," Hardin said. "They run disease-specific, drug-specific, or manufacturer-specific programs that patients, caregivers, manufacturers, and clinicians need to keep treatment moving in the right direction."
Specialty pharmacy handling also focuses distribution on patients who need a product. Westrich noted that attempts to distribute drugs such as Prolastin (alpha1-proteinase inhibitor [human], Talecris), used to treat alpha1-antitrypsin deficiency, through wholesale channels resulted in shortages. Most available product was sitting on wholesaler and pharmacy shelves, not going to the few patients who actually needed it. "It is critical to make sure that product is actually utilized," he said. "Otherwise, you have to deal with expensive credit and return situations that harm everyone, from patients back to manufacturers."
Direct distribution is also attractive to drug makers who must implement risk management programs. Specialty pharmacy distribution gives manufacturers and the Food and Drug Administration a more robust system to gather information and monitor adverse events, Westrich said.
The financial piece of patient and therapy management is also growing. Patients without drug coverage need help gaining access to manufacturers' patient-assistance programs. Patients with drug coverage need help managing co-pays, deductibles, and benefit limits. And manufacturers need help designing pricing and patient-assistance programs that maximize access.