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Costs and Benefits of New Colon Cancer Therapies
Gastroenterology and Hepatology News continued
cator eligibility criteria. The P4P program financially incentivizes physicians in Hawaii (additional 1.5%–7.5% of their base professional fees) to perform quality care processes. Results showed that a P4P program in a PPO setting can improve quality of care. This was particularly the case for quality measures such as mammography, cervical cancer
screening, A1C testing, and childhood immunization measures. Overall, the majority of quality scores were good, because more than three quarters of the eligible population received the recommended care in both groups. However, low-performing physicians using P4P improved significantly more than the comparison group. Further, although colo-
rectal cancer screening had the lowest quality score, it showed the greatest improvement with time. In addition, the study found that the positive benefit of the P4P program may not be realized until the third or fourth year, highlighting the importance of sustaining P4P over longer periods of time. See: Journal for Healthcare Quality 2010;32:13–22.
The US Food and Drug Administration Approves a New Gaucher Disease Drug he US Food and Drug Administration (FDA) on February 26, 2010, approved a parenteral form of velaglucerase alfa (VPRIV) to treat children and adults with Gaucher disease, a rare lysosomal storage disorder caused by a deficiency of the enzyme glucocerebrosidase. Because of the deficiency of functional glucocerebrosidase, which would normally degrade glucocerebroside, the lipid accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. About 1 in 50,000 to 1 in 100,000 people in the general population have the disorder.
According to the FDA, VPRIV provides long-term enzyme replacement therapy for type 1 Gaucher disease, the most common form of the disorder. It offers an alternative to Cerezyme (imiglucerase), another enzyme replacement therapy, which is currently in short supply. “Patients who previously received Cerezyme as an enzyme replacement therapy for their Type 1 Gaucher disease can be safely switched to VPRIV,” says Julie Beitz, MD, director of the FDA’s Office of Drug Evaluation III. Type 1 Gaucher disease accounts for ⬎90% of all cases and does not involve the central nervous system. Typical manifestations of type 1 Gaucher disease include hepatomegaly, splenomegaly, thrombocytopenia, bleeding tendencies, anemia, hy-
permetabolism, skeletal pathology, growth retardation, pulmonary disease, and decreased quality of life. Symptoms can appear at any age. Safety and effectiveness of VPRIV was assessed in three clinical studies involving 82 patients with type 1 Gaucher disease ages ⱖ4 years. The studies included patients who switched to VPRIV after being treated with Cerezyme. The most common adverse reactions to VPRIV are of allergic manifestations. Other observed adverse reactions with VPRIV are headache, dizziness, abdominal pain, back pain, joint pain, nausea, fatigue/weakness, fever, and prolongation of activated partial thromboplastin time. VPRIV is manufactured by Shire Human Genetic Therapies Inc. of Cambridge, Massachusetts.
Costs and Benefits of New Colon Cancer Therapies ew chemotherapy agents seem to be associated with improvements in survival times for patients with metastatic colorectal cancer, but at substantial cost, according to a report in the March 22 issue of Archives of Internal Medicine. Health economist, David H. Howard, PhD, and colleagues at Emory University in Atlanta, Georgia, used a cancer registry database to measure trends in life expectancy and lifetime medical costs in 4,665 patients age ⱖ66 who were diagnosed with metastatic colon cancer between 1995 and 2005. Patients were clas-
sified according to whether they received ⱖ1 of the 6 chemotherapeutic agents approved for the treatment of metastatic colon cancer between 1996 and 2004. Among those who received the new agents, life expectancy increased by 6.8 months, but lifetime costs increased by $37,100, equating to a cost of $66,200 per year of life gained. After additional adjustments, the cost for each qualityadjusted life year (a year of life in perfect health) gained was $99,100, the authors note. “New chemotherapeutic agents for colorectal cancer have been singled out as examples of high-cost/low-value medical care; no doubt they are the
types of therapies that would receive close scrutiny if Medicare and other payers were to consider cost-effectiveness in coverage decisions,” the authors write. “Our estimate of the cost per quality-adjusted life year gained, $100,000, is below most estimates of the willingness to pay for a life-year. However, continuation of Medicare’s open-ended coverage policy for new chemotherapeutic agents and other expensive technologies will prove difficult to sustain as costs for the program continue to rise.” See Archives of Internal Medicine 2010;170:6.
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Stories by Les Lang
cator eligibility criteria. The P4P program financially incentivizes physicians in Hawaii (additional 1.5%–7.5% of their base professional fees) to perform quality care processes. Results showed that a P4P program in a PPO setting can improve quality of care. This was particularly the case for quality measures such as mammography, cervical cancer
screening, A1C testing, and childhood immunization measures. Overall, the majority of quality scores were good, because more than three quarters of the eligible population received the recommended care in both groups. However, low-performing physicians using P4P improved significantly more than the comparison group. Further, although colo-
rectal cancer screening had the lowest quality score, it showed the greatest improvement with time. In addition, the study found that the positive benefit of the P4P program may not be realized until the third or fourth year, highlighting the importance of sustaining P4P over longer periods of time. See: Journal for Healthcare Quality 2010;32:13–22.
The US Food and Drug Administration Approves a New Gaucher Disease Drug he US Food and Drug Administration (FDA) on February 26, 2010, approved a parenteral form of velaglucerase alfa (VPRIV) to treat children and adults with Gaucher disease, a rare lysosomal storage disorder caused by a deficiency of the enzyme glucocerebrosidase. Because of the deficiency of functional glucocerebrosidase, which would normally degrade glucocerebroside, the lipid accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. About 1 in 50,000 to 1 in 100,000 people in the general population have the disorder.
According to the FDA, VPRIV provides long-term enzyme replacement therapy for type 1 Gaucher disease, the most common form of the disorder. It offers an alternative to Cerezyme (imiglucerase), another enzyme replacement therapy, which is currently in short supply. “Patients who previously received Cerezyme as an enzyme replacement therapy for their Type 1 Gaucher disease can be safely switched to VPRIV,” says Julie Beitz, MD, director of the FDA’s Office of Drug Evaluation III. Type 1 Gaucher disease accounts for ⬎90% of all cases and does not involve the central nervous system. Typical manifestations of type 1 Gaucher disease include hepatomegaly, splenomegaly, thrombocytopenia, bleeding tendencies, anemia, hy-
permetabolism, skeletal pathology, growth retardation, pulmonary disease, and decreased quality of life. Symptoms can appear at any age. Safety and effectiveness of VPRIV was assessed in three clinical studies involving 82 patients with type 1 Gaucher disease ages ⱖ4 years. The studies included patients who switched to VPRIV after being treated with Cerezyme. The most common adverse reactions to VPRIV are of allergic manifestations. Other observed adverse reactions with VPRIV are headache, dizziness, abdominal pain, back pain, joint pain, nausea, fatigue/weakness, fever, and prolongation of activated partial thromboplastin time. VPRIV is manufactured by Shire Human Genetic Therapies Inc. of Cambridge, Massachusetts.
Costs and Benefits of New Colon Cancer Therapies ew chemotherapy agents seem to be associated with improvements in survival times for patients with metastatic colorectal cancer, but at substantial cost, according to a report in the March 22 issue of Archives of Internal Medicine. Health economist, David H. Howard, PhD, and colleagues at Emory University in Atlanta, Georgia, used a cancer registry database to measure trends in life expectancy and lifetime medical costs in 4,665 patients age ⱖ66 who were diagnosed with metastatic colon cancer between 1995 and 2005. Patients were clas-
sified according to whether they received ⱖ1 of the 6 chemotherapeutic agents approved for the treatment of metastatic colon cancer between 1996 and 2004. Among those who received the new agents, life expectancy increased by 6.8 months, but lifetime costs increased by $37,100, equating to a cost of $66,200 per year of life gained. After additional adjustments, the cost for each qualityadjusted life year (a year of life in perfect health) gained was $99,100, the authors note. “New chemotherapeutic agents for colorectal cancer have been singled out as examples of high-cost/low-value medical care; no doubt they are the
types of therapies that would receive close scrutiny if Medicare and other payers were to consider cost-effectiveness in coverage decisions,” the authors write. “Our estimate of the cost per quality-adjusted life year gained, $100,000, is below most estimates of the willingness to pay for a life-year. However, continuation of Medicare’s open-ended coverage policy for new chemotherapeutic agents and other expensive technologies will prove difficult to sustain as costs for the program continue to rise.” See Archives of Internal Medicine 2010;170:6.
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Stories by Les Lang