Specialty drugs treat a wide array of people at every age and stage of life. They are used to treat diseases that include cancer, Hepatitis C, multiple sclerosis (MS), rheumatoid arthritis (RA), and Chron's Disease. Medication nonadherence for these diseases is high (63% for MS, 50% for RA, and up to 80% for cancer). This results in emergency room visits, complications, hospitalizations, and the need for medications to treat secondary conditions, estimated to cost $250 billion.1,2,3
One of the defining characteristics of a specialty drug is its high cost compared to traditional medication. Depending on the condition, the annual cost per patient can be $150,000 or more.4 Three specialty therapeutic classes rank in the top ten in sales and three of the top selling drugs are specialty drugs.5 Among the top ten therapeutic classes are antineoplastic monoclonal ant6bodies, erythropoietins, and antiarthritics.6 Among the top ten pharmaceutical products are Enbrel® ($3.4 billion), Neulasta® ($3.1 billion), and Epogen® ($3.1 billion).7
In the treatment of cancer, there is a major shift towards oral chemotherapy agents, moving treatment from the clinic to the home where the drugs are self administered. It is expected that the percentage of oncology drugs available in oral form will reach 25% by 2013 up from 10% today.8 This puts more downward pressure on adherence as patients are "outside" the clinical care management process.
In a study of a drug called imatinib, used to treat chronic myelogenous leukemia (CML), adherence had a notable impact on healthcare resource utilization and cost. Good imatinib adherence was significantly associated with lower total medical and total health care costs, as well as fewer and shorter inpatient hospital stays. Patients with good adherence had $121,247 lower total medical costs and $57,266 lower total health care costs, on average, than did patients with poor adherence. Similarly, good adherence was associated with 0.03 times the number of inpatient hospital stays and 0.11 times the length of hospital stay relative to poor adherence, after controlling for the same factors. The lower medical care costs associated with good adherence more than offset the higher pharmacy costs one would expect from higher levels of imatinib use.
In 2008, the FDA mandated drug manufacturers to develop a Risk Evaluation and Mitigation Strategy (REMS) for many specialty drugs. As part of a REMS for a drug, the manufacturer and its specialty pharmacy channel(s) must "provide a prescribing or dispensing plan that defines the elements of safe use of a particular medication." This often involves care management teams providing therapy management plans for patients and coordinating care with providers. There are now 186 REMS-approved drugs.9
Management of specialty pharmaceuticals is an increasingly important cost factor for health plans and payers due to the aging workforce and growing pipeline of advanced, high-cost drugs. High-cost patients include those with cancer, severe joint diseases, or life-threatening combinations of hemophilia, hepatitis, and HIV. New products are also emerging for conditions that affect large patient populations, including drugs for diabetes, asthma and rheumatoid arthritis. Savings associated with effectively managed specialty pharmaceuticals can be significant.
The rise in Pay for Performance (P4P) and Pay for Outcomes (P4O) contracting models is driving increased importance of medication adherence programs/technologies for specialty pharmacies and drug manufacturers. In these programs, the payer ties a percentage of the reimbursement for the specialty drugs to the patient outcomes. In this way, the manufacturer and specialty pharmacy share in the risk.
eMedonline can help to ensure the safe and effective use of specialty therapies, decreasing the expense associated with wasted prescriptions resulting from poor patient compliance. eMedonline automates the collection of high quality, detailed data on drug use and delivery from the point of care, and makes it possible to monitor and manage adherence and outcomes—all from the patient's smartphone. The end result is significant added value to the specialty pharmacy:
- Delivers a "smart on-demand telehealth service" using a patented medication therapy adherence system
- Mobile device acts as a medication sensor to help patients identify the right medicine at the right time, and understand how to take it
- Content can be customized for each patient based on disease state
- Personalized messaging helps elicit behavior modification without direct care team intervention
- Monitors compliance dose-by-dose, with real-time reports of symptoms, side effects, and health status
- Creates social support system with care team and family members
- Creates a 24/7 automated touchpoint with the patient
- Enables coordination of care with patient, physician, pharmacist and payer
- Provides service differentiation
References:1 Walgreens Specialty Pharmacy report 2009.
2 Express Scripts Drug Trend Report 2010.
3 Barclays Capital July 2011 Report on Specialty Pharmacy.
4 IMS National Sales PerspectivesTM, IMS Health 2008.
5 Walgreens Specialty Pharmacy report 2009.
6 IMS National Sales PerspectivesTM, IMS Health 2008.
7 IMS National Sales PerspectivesTM, IMS Health 2008.
8 Walgreens Specialty Pharmacy Report 2009.
9 Walgreens Specialty Pharmacy Report 2009.