Each issue of the CoramClick provides an in-depth focus on timely and practical solutions. In this issue of the Click, we are focusing on Specialty Infusion. Full, printable issues of the Click are available in the CoramClick archive for easy reference!

	Specialty Infusion Twenty-five years after the advent of the first home infusion pharmacies, and a decade after the earliest specialty pharmacies began to appear, a new category is emerging that combines many aspects of home infusion and specialty pharmacy, but is markedly different.		Bug of the Month: Hepatitis C Hepatitis C can lead to a number of complications including liver cirrhosis, failure or cancer. Hepatitis C can be treated via specialty infusion therapy, however decades of inflammation can occur before the symptoms of liver dysfunction become evident.
	Diseases with Specialty Infusion Needs: Multiple Sclerosis and Rheumatoid Arthritis Multiple sclerosis (MS) and Rheumatoid arthritis (RA) are two diagnoses that are increasingly being treated through high-tech specialty infusion therapies.		Do You Know? What percentage of biotech molecules in late-stage development are believed to require specialty infusion (professional administration and/or complex clinical protocols)?   a) 20%    b) 60%    c) 80%
	Common ICD-9 Codes A list of certain ICD-9 codes for MS, RA and Hepatitis C.		Resource Center The National MS Society, the Arthritis Foundation and the Hepatitis Foundation International.
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Specialty Infusion

Twenty-five years after the advent of the first home infusion pharmacies, and a decade after the earliest specialty pharmacies began to appear, a new pharmacy is emerging that combines many aspects of home infusion and specialty pharmacy, but is markedly different. Specialty Infusion is quickly becoming the latest buzz word among health plan and PBM executives, biotech drug manufacturers, physicians and chronic disease communities. But what exactly is Specialty Infusion, and what is driving the interest in this area? This edition of CoramClick provides a brief overview of this important topic.

Specialty Infusion is the management and administration of complex, non-oral, biotech drug therapies; treating specific categories of (generally) rare, chronic conditions, either in the patient’s home or in the Ambulatory Infusion Suite (AIS) of the Specialty Infusion Provider. Examples of specialty infusion therapies and the conditions they treat are listed below:

Specialty infusion therapies differ from traditional specialty pharmacy. Traditional specialty pharmacies focus on providing injectable drugs for self-administration by the patient, or administration in a physician’s office or hospital outpatient setting. Self-administration is not a safe option for most specialty infusion drugs, and physician office and hospital outpatient settings generally represent an expensive and inconvenient site of care for chronic — often lifelong — specialty infusion therapies.

Diseases with Specialty Infusion Needs:
Multiple Sclerosis and Rheumatoid Arthritis

Multiple Sclerosis

One of the diagnoses that can now be successfully treated with a high-tech, specialty infusion drug is multiple sclerosis (MS).

MS is a disease that affects the nervous system. A thin, protective sheath (called the myelin sheath) surrounds the brain and spinal cord, and this sheath actually breaks down in patients who have MS. The exact cause of this sheath breakdown is not known, although research has shown that it might be caused by the body’s immune system attacking itself.

Symptoms of MS can vary from mild to severe. Initially, a patient may experience fatigue, numbness, vision problems, headaches or hearing loss. More significant symptoms can include problems with walking, inability to maintain balance and problems with motor coordination. In addition, some MS patients may have bladder and bowel problems as well as some difficulty with breathing.

The symptoms of MS often come and go, and actually this is the reason that the diagnosis is sometimes missed. Some patients may have severe loss of motor skills, and with some treatment, or even without treatment, may return to their previous level of functioning. Some patients lose a bit of function with each flareup of the disease.

Treatment for MS includes drug therapies used to return function after an attack, to prevent new attacks from occurring and to prevent long-term disability. Some of the following medications are used in the treatment of MS:

• Interferons help to regulate the immune system which may help prevent the body from attacking itself, causing a breakdown of the myelin sheath
• Polypeptides may protect important myelin proteins by substituting itself as the target of immune system attack
• Immunosuppressants can help by decreasing the immune system response
• Monoclonal antibodies are the newest form of drugs that are showing promise decreasing the symptoms in MS patients

Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a form of arthritis that affects women more than men. It often starts between ages 25 and 55 with symptoms presenting for short time periods or the severe form of RA that can last a lifetime. It is estimated that over 2 million people in the United States have rheumatoid arthritis.

RA is different from osteoarthritis, which is the more common arthritis that occurs with age. RA is a chronic arthritis that occurs in joints on both sides of the body (such as both hands, wrists and knees) causing pain, swelling, stiffness and loss of function in the joints. In addition to affecting the joints, RA may also affect other body systems such as skin, eyes, blood, nerves or major organs such as lungs, heart and kidneys.

RA, like MS, is thought to be an autoimmune disease. This means the arthritis results from the immune system attacking the body’s own tissues. The cause for RA is unknown but there is general consensus that genes, environment and hormones might contribute to the disease. Since there is no single test for diagnosing RA, and the symptoms differ from person to person, it may take some time to get to a final diagnosis.

Symptoms of RA include pain, swelling, stiffness and loss of function in the joints, fatigue, occasional fevers and a general malaise.

Therapy is prescribed with the goal to reduce joint inflammation, joint pain and swelling. The overall goal is to slow or stop joint damage which can cause severe debilitation. Medication may include the following drugs:

• Non-steroidal anti-inflammatory drugs to reduce pain and inflammation
• Corticosteroids which are taken by mouth, and are used to decrease inflammation as well as pain while decreasing the growth of abnormal synovial tissue
• Immunosuppressants which are used to decrease the body’s immune response
• Biologic agents are the new high-tech specialty infusion drugs that block the effects of specific factors that are thought to create the inflammatory response that creates the symptoms of RA
  

Oftentimes, a combination of these drugs has been shown to be very effective to successfully treat the symptoms of RA.

Common ICD-9 Codes

Below is a list of certain ICD-9 codes for MS, RA and Hepatitis C. Please note that this list is not all-inclusive.

Bug of the Month: Hepatitis C

Hepatitis virions; image courtesty of the CDC

Hepatitis C (HCV) was discovered in 1989 and is a virus that, over time and often silently, attacks the liver. Once inoculated, it can take decades of inflammation before the symptoms of liver dysfunction become evident. During that time, most people have no symptoms and do not know they have the disease. In fact, diagnosis is often obtained during a routine medical exam. HCV can lead to a number of complications including liver cirrhosis, failure or cancer. Among the hepatitis viruses (A, B, D, E and G), HCV is often considered the most serious. There is neither a vaccine for HCV nor a cure, however treatment is available via specialty infusion medications.

Incidence
About four million people in the U.S. have HCV with 35,000 new cases diagnosed and 8,000 deaths each year. HCV is much more common than HIV, is the most common reason for liver transplantation and is the leading cause of liver cancer.

Transmission
HCV is primarily transmitted by contact with blood infected with HCV through blood transfusion (prior to 1992 when blood donations were not tested for HCV) or contaminated needles through intravenous drug abuse. There is some risk from tattooing and body piercing, as well as for an infant born to an infected mother. Transmission through sexual contact is rare.

Risk Factors
Risk factors include:

• IV drug abuse
• Organ transplant and/or blood transfusions before 1992
• Clotting factor concentrates before 1987
• Hemodialysis
• Exposure to infected blood in the hospital setting
• Birth from a woman positive with HCV

Diagnosis
HCV is diagnosed with a blood test which can also determine viral load and genotype. The genotype may influence the course of treatment and prognosis.

A liver biopsy may also be performed. The liver biopsy helps determine:

• The degree of liver damage
• Other causes of liver failure
• Treatment choices

Complications
Most persons infected with HCV develop chronic hepatitis. Over the next 20 to 30 years many will develop cirrhosis and liver failure at a rate of about four percent a year. One percent to five percent of patients are likely to develop liver cancer.

Treatment
In its early stages, when liver abnormalities are minor, one option is no medical treatment. Since the long-term risk of developing significant liver damage is small, and the adverse effects of treatment options are often harsh, the physician may choose to monitor the patient and consider treatment as symptoms progress. Other physicians may choose early treatment to decrease the risk of cirrhosis.

Medications
The standard of care for HCV treatment is weekly injections of pegylated interferon alfa [peginterferon alfa-2b (Peg-Intron™) and peginterferon alfa-2a (Pegasys®)] combined with oral doses of the anti viral ribavirin (Rebetol®, Copegus®). Combined pegylated interferon and ribavirin clears HCV infection in 40 percent to 80 percent of patients. Treatment goals are to reduce the amount of virus, slow the progression of liver damage and help prevent relapse.

Duration
For genotype 1 HCV, a 48-week course of high-dose medications is often prescribed. For genotype 2 or 3, lower doses for 24-weeks may be effective. In some cases, two courses of treatment may be needed.

Adverse Effects
The medication side effects can be severe, particularly during the first weeks of treatment. Some patients will require a reduced dose, and some patients will need to discontinue therapy. Combination therapy may cause psychosis or suicidal behavior.

Liver Transplantation
Liver transplantation is one of the better treatments for HCV, but recurrence is likely with cirrhosis developing within five years. Patients with HCV, or patients with emergent need for a liver, may be offered an organ from a donor also infected with HCV. Treatment with HCV-fighting medications may help prevent and treat a recurrence, but additional research is needed.

What percentage of the hundred or more biotech molecules in late-stage development are believed to require specialty infusion (professional administration and/or complex clinical protocols)?
   a) 20%   b) 60%   c) 80%

Answer – b) 60%
Several industry sources suggest that more than 60% of the hundred or more biotech molecules in late-stage development will require specialty infusion in that they require some form of professional administration and/or complex clinical protocols.

The National MS Society is a collective of passionate individuals who want to do something about MS now — to move together toward a world free of multiple sclerosis. The National MS Society helps each person address the challenges of living with MS through its 50-state network of chapters. The society helps people affected by MS by funding cutting-edge research, driving change through advocacy, facilitating professional education and providing programs and services that help people with MS and their families move their lives forward. For more information, please visit The National MS Society is a collective of passionate individuals who want to do something about MS now — to move together toward a world free of multiple sclerosis. The National MS Society helps each person address the challenges of living with MS through its 50-state network of chapters. The society helps people affected by MS by funding cutting-edge research, driving change through advocacy, facilitating professional education and providing programs and services that help people with MS and their families move their lives forward. For more information, please visit www.nationalmssociety.org.
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The Arthritis Foundation is the only national not-for-profit organization that supports the more than 100 types of arthritis and related conditions. Founded in 1948, the Arthritis Foundation has multiple service points located throughout the country. The Arthritis Foundation is the largest private, not-for-profit contributor to arthritis research in the world, funding more than $380 million in research grants since 1948. Celebrating its 60th anniversary this year, the foundation helps people take control of arthritis by providing public health education, pursuing public policy and legislation, and conducting evidence-based programs to improve the quality of life for those living with arthritis. To learn more, visit www.arthritis.org.

The Hepatitis Foundation International (HFI) is dedicated to the eradication of viral hepatitis. The organization seeks to raise awareness of this enormous worldwide problem and to motivate people to support this important — and winnable — battle. To accomplish this mission, the HFI initiates a wide range of programs. The common thread in each one is educating the public, patients and professionals about the prevention, diagnosis and treatment of viral hepatitis. To learn more about HFI, please visit www.hepfi.org.

Bibliography

• Manns MP, McHutchison JG, Gordon SC et al. Pegi-interferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomized trial. Lancet. 2001;358:958-965.