Overview of a Specialty Pharmacy

33013_Tabs
6/1/05
8:50 AM
Page 3
OVERVIEW OF A
SPECIALTY PHARMACY
overview of
a specialty pharmacy
CuraScript Specialty Pharmacy Management Guide & Trend Report
33013_Guts
6/1/05
8:27 AM
Page 19
Specialty pharmacies use several strategies to address the challenging
characteristics of specialty drugs. These strategies include:
• Availability of specialty medications and supplies for administration
• Experienced and knowledgeable clinical-support teams
• Patient-care coordination and compliance monitoring
• Coordination of home-care services
• Clinical pharmacy management of disease-specific programs
• Pharmacy and medical benefit billing and reimbursement
• Combined pharmacy and medical benefit specialty-drug
utilization management
• Formulary management support services
Most specialty drugs are used to treat chronic diseases that affect less
than 3% of the general population. Thus, the volume of specialty-drug
use is relatively low when compared with the use of traditional drugs.
Additionally, many of the specialty drugs currently available are not available
through open distribution channels. Due to lowered treatment prevalence
or limited supply of the drugs, pharmaceutical manufacturers may control
access to their specialty products by using specified distributors. These
distribution factors, combined with the typically high acquisition and
inventory carrying costs associated with specialty drugs, make specialtydrug distribution impractical for traditional distribution channels
such as retail pharmacies.
Specialty pharmacies focus on the supply and distribution of specialty
drugs; therefore, they have immediate inventory of specialty drugs and
the supplies needed for proper administration. Specialty-drug distributors
work with manufacturers and wholesale distribution channels to ensure
continuous supplies and to leverage volume, resulting in discounts that
can be passed to clients.
19
overview of a specialty pharmacy
Overview of a Specialty Pharmacy
overview of a specialty pharmacy
33013_Guts
6/1/05
8:27 AM
Page 20
PATIENT-CARE COORDINATION
Patient-care coordination is the process that oversees multiple aspects of therapy
for patients receiving specialty drugs. Because specialty-drug treatment may
change frequently, patient-care management includes monitoring for:
• Adequate home or office inventory levels of the drugs
• Adherence to prescribed drug regimens
• Continuity of care
• Coordination of home-care services
• Patient assessment screening surveys
• Ongoing prior authorization requirements
• Eligibility or benefits changes
Patient-care coordinators work in conjunction with licensed clinicians
to provide comprehensive clinical-management services. By providing
patient-assessment screening surveys at each refill, patient-care coordinators
assist the clinical team in identifying high-risk patients and adverse clinical
events at routine intervals. Exhibit 11 provides an example of a CuraScript
patient-care management process flow.
Exhibit 11
CuraScript Patient-Care Management Process Flow
20 CuraScript specialty pharmacy management guide & trend report 2004
33013_Guts
6/1/05
8:27 AM
Page 21
CLINICAL MANAGEMENT
In addition to pharmacist specialization and training, specialty-drug
management frequently extends beyond the pharmacy and the physician’s
office, since patients will often require home-healthcare services to support
in-home injection training or ongoing infusion services. Therefore,
specialty pharmacies need to be able to provide coordination of nursing
services in the home setting. Many times the need for nursing care may
be a one-time, education and training home visit — not a long-term
need. Separating drug delivery from nursing care often decreases costs
by limiting higher-than-necessary levels of care.
Clinical pharmacy oversight can often be provided by telephone, reducing
the need for acute in-home services. Thus, specialty pharmacies use
a multidisciplinary team of experienced registered nurses and social
workers, in addition to trained pharmacists, to support the complex
management requirements of chronically ill patients receiving specialty
medications. This team of licensed clinicians provides clinical management,
including the following interventions:
• Medication self-administration oversight
• Clinical assessment and patient monitoring
• Disease state and medication education
• Side-effect management
• Physician consultation
• Drug utilization evaluation and poly-pharmacy review
21
overview of a specialty pharmacy
Specialty drugs have unique handling and administration needs that
require knowledgeable management. Therefore, specialty pharmacies
recruit healthcare professionals who have experience with the treatment
of patients using specialty drugs. Similar to physicians who require specific
educational backgrounds to specialize in the treatment of diseases such
as hepatitis and multiple sclerosis (MS), healthcare professionals who
manage specialty drugs also require specialized, ongoing training to
maintain high levels of expertise. Standard training for pharmacists
does not specifically address the handling requirements of specialty
drugs. Additionally, the majority of pharmacists do not encounter
these drugs in general practice. Specialty pharmacists, however, undergo
extensive education in all aspects of specialty-drug management.
overview of a specialty pharmacy
33013_Guts
6/1/05
8:27 AM
Page 22
• Therapeutic interchange and formulary management
• Care coordination with other healthcare providers
• Psychosocial support
• Community resourcing
These services bring the added value of disease-management concepts
to pharmacy, with critical pathway management and targeted, proactive
clinical interventions at specific intervals throughout treatment to optimize
clinical outcomes. Ongoing, objective measurement of clinical-outcomes
indicators specific to the disease and its treatment is paramount to quantifying
the success of care-management strategies. For example, in the treatment
of rheumatoid arthritis (RA) with specialty medications such as Enbrel®
or Humira®, the key measurements of response to the treatment are
improved joint mobility and functional capacity, which can both
be measured objectively at established intervals. By evaluating clinical
measurements, specialty pharmacies can document and provide
treatment outcomes to clients.
A high rate of adherence with specialty-drug regimens is often critical
to both short- and long-term outcomes. For example, therapy adherence
of greater than 80% is linked directly to positive treatment outcomes
for patients with hepatitis C.9 Specialty-pharmacy programs, such
as patient-care management and clinical oversight by experienced
healthcare professionals, increase adherence rates among specialtypharmacy patients when compared with patients receiving drugs
from other distribution channels.
Exhibit 12 presents the results of one analysis that evaluated adherence
rates between patients using CuraScript Specialty Pharmacy versus
retail pharmacies to obtain drugs to treat hepatitis C.
9
McHutchinson JG, et al. Adherence to combination therapy enhances sustained response in genotype 1 infected patients with
chronic hepatitis C. Gastroenterology. 2002;123:1061-1069.
22 CuraScript specialty pharmacy management guide & trend report 2004
33013_Guts
6/1/05
8:27 AM
Page 23
overview of a specialty pharmacy
Exhibit 12
Adherence to Hepatitis C Therapy
Specialty Pharmacy vs Retail Pharmacy Distribution Models 10
100
80
60
40
20
0
10
Burton, D., Shenouda, S., Smith, C., Spears, J. Adherence to Hepatitis C Treatment Based on Refill Rates, Poster
Presentation, Academy of Managed Care Pharmacy 17th Annual Meeting, April 2005, Denver.
23
overview of a specialty pharmacy
33013_Guts
6/1/05
8:27 AM
Page 24
BILLING, REIMBURSEMENT AND DATA MANAGEMENT
Coverage for specialty drugs may be provided under the medical benefit,
the prescription-drug benefit or both. Due to these complex coverage
issues, specialty pharmacies must be prepared to manage multiple types
of billing and reimbursement, ranging from electronic adjudication
using the National Council for Prescription Drug Programs (NCPDP)
format to more traditional paper claims. The higher cost of specialty
drugs leads to other billing-related issues that include coordination of
benefits and prior authorization requirements. To be successful, specialty
pharmacies must also support these additional reimbursement needs.
Combined prescription- and medical-benefit billing requirements
in a specialty-pharmacy setting also create unique opportunities for
comprehensive specialty-utilization management. Working with client
sponsors, specialty pharmacies have designed programs that supervise
appropriate utilization of specialty drugs and ensure medical necessity
of ongoing treatment, regardless of benefit coverage.
For example, to manage the treatment of RA, clients need to consider
all of the specialty RA drugs. Although most self-injected specialty drugs
for RA (Humira®, Enbrel® and Kineret®) usually are currently covered
as a prescription-drug benefit, another specialty drug used to treat RA,
Remicade®, an infused agent, is more likely to be covered under medical
benefits. Requiring prior authorization on the prescription-drug benefit
side could increase the use of these drugs on the medical benefit side
if medical benefits are not also managed. By distributing all four products
through a specialty pharmacy, however, the client can evaluate all the
specialty-drug treatments for appropriateness prospectively — regardless
of benefit coverage — not only when they are started, but also periodically
during therapy.
In evaluating combined pharmacy and medical benefit specialty-drug
utilization management, the following results were reported at the spring
2004 Academy of Managed Care Pharmacy meeting (Exhibit 13).
24 CuraScript specialty pharmacy management guide & trend report 2004
33013_Guts
6/1/05
8:27 AM
Page 25
Health Plan Case Study of IVIG Management Through Specialty-Pharmacy Model
50
40
30
20
10
0
In this analysis, CuraScript and the client worked together to combine
medical and pharmacy benefit specialty drugs for MS, including
Avonex®, Betaseron®, Rebif ®, Copaxone® and IVIG, under an isolated
single-source distribution channel. Through limited distribution by the
client and by applying utilization-management strategies in the specialty
pharmacy at the point of distribution, the pharmacy and client were able
to identify a prescribing pattern of concomitant use of IVIG along with
another MS therapy. Although IVIG is an appropriate treatment for MS
patients in some circumstances, there is no research supporting improved
outcomes with use of combination therapy. Thus, the client and CuraScript
were able to apply management strategies to reduce this prescribing pattern.
Through this program, the client was able to reduce concomitant IVIG
utilization by 42% over the following months, resulting in a significant
saving from inappropriate utilization of IVIG.11
FORMULARY DEVELOPMENT AND MANAGEMENT
With the multifaceted benefit structure and the clinical complexity
of managing step therapy, specialty pharmacies with their expertise and
delivery model can support clients to drive performance and cost savings
to client formulary offerings. More specialty drugs are entering the market
with multiple indications. Additionally, some therapy classes now include
several specialty drugs. Both factors allow for development of formularies
for certain specialty disease states and drugs (Exhibit 14).
11
McDermott R, Duong L. Health Plan Case Study of IVIG Management through Specialty Pharmacy Model.
Poster Presentation, Academy of Managed Care Pharmacy 16th Annual Meeting, April 2004, San Francisco.
25
overview of a specialty pharmacy
Exhibit 13
overview of a specialty pharmacy
33013_Guts
6/1/05
8:28 AM
Page 26
Exhibit 14
Specialty Disease-State Categories and Drugs With Formulary Potential
26 CuraScript specialty pharmacy management guide & trend report 2004
33013_Guts
6/1/05
8:28 AM
Page 27
overview of a specialty pharmacy
Continued
27
6/1/05
8:28 AM
Page 28
overview of a specialty pharmacy
33013_Guts
Specialty pharmacies are positioned not only to provide formulary
administrative and consultative services, but also to align the payer’s
cost-containment objectives with optimal therapy. Formulary management
for specialty drugs, similar to traditional oral medications, requires
management oversight to maximize penetration and performance
from the formulary offering.
In analyzing all the services required to manage specialty drugs and
the required services provided by specialty pharmacies to meet this need,
it is evident that not all distribution channels are set up operationally
to handle the unique challenges of specialty drugs’ inherent service
requirements. Exhibit 15 compares the various distribution channels
based on service requirements of specialty drugs.
28 CuraScript specialty pharmacy management guide & trend report 2004
33013_Guts
6/1/05
8:28 AM
Page 29
overview of a specialty pharmacy
Exhibit 15
Service Requirements of Specialty Drugs Compared With Distribution Channels
29
overview of a specialty pharmacy
33013_Guts
6/1/05
8:28 AM
Page 30
Notes
30 CuraScript specialty pharmacy management guide & trend report 2004