The generally accepted distribution model for traditional pharmaceuticals has always been pretty clear — walk into your neighborhood pharmacy, hand over the written prescription, fork over your copayment, follow the simple instruction on the label, and call your physician if any problems arise. It’s a routine almost everyone follows dozens of times throughout their lives. It works, and it works well.
But with the emergence of specialty pharmaceuticals, it became obvious that patient management was not going to be as simple as filling out a form. Because of the complexity of specialty pharmaceuticals — along with the financial investment they required — the rise of value-added services was inevitable.
Promoting behavior change, not policing or lecturing patients, is more effective in managing conditions over time, believes Dexter Shurney, MD, MPH.
As so often happens in new niche industries, the carnival barkers initially came out in full force, promising everything to any health plan and employer willing to listen: We’ll promise you 100 percent compliance for your patients with rheumatoid arthritis on biologic therapies! Naturally, those that could not deliver on promises were slowly weeded out.
What has evolved is a complex array of offerings that may be attached to specialty pharmacy on either the distribution or service side. It can seem like a confusing mix of choices; is one-on-one counseling to help individuals quit smoking worth any more or less than a neonatal care management program? But those are the kinds of decisions that many employers are faced with.
“If 80 percent of chronic conditions are lifestyle-related, then we need to address the root cause of the problem first to have any chance of success,” says Dexter Shurney, MD, MPH, senior vice president and chief medical officer for Healthways, a Nashville-based provider of patient care and health-support services. “It doesn’t make sense to prescribe three or four extremely high-cost drugs for patients without also addressing behavior and expect that to be the most cost-effective way of dealing with their conditions over time. You need to promote behavior change — not by policing patients and lecturing them on why they need to take their medications, but by coaching them and readying them to change their lifestyles.
What is a value-added service?
Value-added services provide employers and health plans with an array of choices, such as:
Adherence and disease management programs
Reimbursement assistance
Data products for payers and manufacturers
Infusion therapy
Physician education and support
Patient education and support
Patient lifestyle management
“So many of these high-touch services promoting lifestyle change are effective across multiple conditions and have such a low price compared with the overall cost of a specialty drug. If you bring about change, even a little, it’s clearly a winning proposition for better patient outcomes.”
Today’s value-added services cover a wide scope. They can be as simple as lifestyle management programs that encourage people to participate in exercise protocols intended to help manage symptoms of RA, or as complex as hands-on, day-to-day management of hepatitis C patients so that they take their prescribed dose of antiviral medications.
Although their working mechanisms may be very different, the promise of every proposed value-added service is simple: improve patient outcomes and, consequently, save money. But the primary question surrounding them remains as complex as ever: Which value-added services truly add value — and which are merely marketing?
“Most value-added services are centered around one of two concepts — cost or convenience,” says Judi Grupp, president of ActiveCare Network, a provider of vaccine, injection, and infusion services throughout the United States. “When you have chronic patients you are trying to manage over long periods of time, you want not only patient-reported data, which can be very subjective, but also clinical data that show whether the drug is working like it’s supposed to. Health plans ... don’t mind covering a biologic if it does what it is supposed to do, but they need data to help make that decision. More and more frequently, that’s what we’re asked to provide.”
DRIVEN BY DATA
It’s not surprising that in this data-rich era, providers of value-added services are increasingly being asked for statistical evidence of their effectiveness. As Shurney points out, those that can show value are easy for health plans to embrace, but the bar is being set higher as the cost of specialty pharmaceuticals rise. Health plans are trying to stretch dollars every which way, and throwing money at providers of value-added services that cannot prove their value is not even close to being good enough.
“You have to be able to show them that you can deliver on your promises,” Grupp says. “When there were only a few biologics on the market, people noticed, but the amount was small and it wasn’t taken that seriously. But as soon as the pipeline grew exponentially, the conversations changed. Unless you can validate that a diagnostic test was given, or that a patient is growing on a growth hormone, or that a patient received four vials of a drug last month as opposed to the five the patient was supposed to get, it’s very hard to determine that your service is justified.”
Grupp points to the push by health plans to get data from providers of value-added services that compare biologics in the same or competing classes for treatment of a specific condition. Health plans have asked her to develop mechanisms that stratify disease progression and patient compliance on such drugs as the infusible agents given to RA patients. The data she turns over is not as scientific as a clinical trial, but can be used to differentiate products.
Today’s data-driven focus is hardly a fad. With more and better ways to manage the health of patients who need specialty pharmaceuticals, Shurney says providers of value-added services must invest heavily in technology that allows them to gather comprehensive data on every patient.
“People are very mobile today, and it’s hard to contact them by phone. You have to have technology that reaches members wherever they are,” Shurney says. “That could mean working with device manufacturers to transmit data on a real-time basis. It could mean a device that records lab values and transmits them to a call-center nurse. It could mean automatic prompts sent to a patient’s cell phone. There is a lot of options, and a lot of smart people are doing a lot of innovative things.
“But the bottom line is that you have to find ways to generate data showing that your services work in the most cost-effective way possible. That’s the name of the game.”
The rationale behind value-added services
Rheumatoid arthritis is one of the primary medical conditions for which value-added services could reduce utilization costs. Here are the costs of the six FDA-approved biologics for the treatment of RA.
| Product | Dosing schedule | Cost/dispensing unit | Cost/patient/year ($) |
|---|---|---|---|
| Abatacept (Orencia)a | 500 mg (<60 kg)
750 mg (60–100 kg) 1 g (>100 kg) every 4 weeks |
$337/15 mL vial (250 mg/15 mL vial) | <60 kg: $10,105
60–100 kg: $15,158 >100 kg: $20,210 |
| Rituximab (Rituxan) | 1000 mg in IV infusions twice, given 2 weeks apart | $1,646/50 mL vial (10 mg/mL injection 50 mL vial) | $6,585 |
| Adalimumab (Humira) | 40 mg every other week | $688/2 single-use syringes (40 mg/1 mL syringe) | $8,941 |
| 40 mg weekly | $17,881 | ||
| Anakinra (Kineret) | 100 mg once daily | $824/28 single-use syringes (100 mg/1 mL syringes) | $10,718 |
| Etanercept (Enbrel) | 25 mg twice weekly | $360/4 SDV (25 mg/vial) | $9,362 |
| 50 mg once weekly | $720/4 SDV (50 mg/vial) | $9,362 | |
| Infliximab (Remicade)b | 3 mg/kg once every 8 weeks | $393/20 mL vial (100 mg/20 mL vial) | <70 kg: $7,071–$10,606
>70 kg: $10,606–$14,141 |
| 10 mg/kg once every 8 weeks | $393/20 mL vial (100 mg/20 mL vial) | <70 kg: $21,212–$24,747
>70 kg: $24,747–$28,282 |
SDV=single-dose vials.
Costs include infusion at weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52: <60 kg=2 vials; 60–100 kg=3 vials; >100 kg=4 vials.
Costs include infusion at weeks 0, 2, 6, 14, 22, 30, 38, 46, and 54; 3 mg/kg: <70 kg=2–3 vials; >70 kg=3–4 vials; 10 mg/kg: <70 kg = 6–7 vials; >70 kg=7–8 vials.
Source: National PBM Drug Monograph Abatacept (Orencia) 2006