A large number of epilepsy sufferers are not having their physical and mental health needs met, according to a recently published article. Researchers found that every month 9–12 days of impaired physical or mental health was suffered by adults with active epileptic seizures, compared with only 2–4 days for adults without epilepsy.
A quality-of-life study used data obtained in the largest state health survey conducted in the USA, the 2003 California Health Interview Survey (CHIS), to assess the burden of the disorder.
Approximately 1.2% of adults who took part in the CHIS had a self-reported history of epilepsy, and a further 0.7% were living with active epilepsy, defined as either taking medication or having had at least one seizure within the previous 3 months. Approximately 25% of people who self-reported a seizure within the past 3 months were not taking medication for their condition.
The study found that a total of 36% of adults with active epilepsy were physically disabled or unable to work compared with 5% of unaffected adults. Epilepsy sufferers not only had a worse general health status but were also more likely to partake in risky activities, such as smoking. In addition, there is a higher chance that they are unemployed and live in lower income households.
The authors summed up, “As with other chronic diseases, epilepsy takes a toll on physical and mental health, including interfering with daily activities,” and concluded “that interventions need to be provided to help those affected by epilepsy”. Measures they proposed for consideration include improved access to mental healthcare, job training and self-management programs.
Source: Kobau R, Zahran H, Grant D, Thurman DJ, Price PH, Zack MM. Prevalence of active epilepsy and health-related quality of life among adults with self-reported epilepsy in California: California Health Interview Survey, 2003. Epilepsia 48(10), 1904–1913 (2007).
Study supports economic benefits of population-based screening to prevent ovarian cancer
Recent findings presented at the American Society of Human Genetics 57th Annual Meeting, San Diego (CA, USA) indicate that population testing of Ashkenazi Jewish (AJ) women for BRCA1/2 has the potential to prevent ovarian cancer (OC), prolong survival and save nondiscounted costs of screening.
OC is the seventh most common cancer in women worldwide; nearly half of all cases occur in women aged between 50 and 69 years, and in this age group the annual incidence of ovarian cancer is approximately 45 per 100 000. The overall 5-year survival rate is currently approximately 30%; a poor figure that has seen little improvement over the past 20–30 years.
The relatively low prevalence of OC compared with other cancer types means that the positive predictive value of screening tests, even those with very high specificity, is low, limiting the potential cost–effectiveness of population screening. The balance of potential benefits, harms and costs of screening may be more favorable in the small group of women who are at significantly increased risk owing to a strong family history.
Increased BRCA1 and BRCA2 germline mutation rates have been reported in AJ women in North America, Europe and Israel, and are thought to be responsible for a higher incidence of breast cancer and OC among these communities. Testing allows targeted surveillance for gene mutation carriers, which ensures the cost-effective use of resources and reduces cancer-related morbidity if clinical recommendations for intervention are adopted. Population screening of AJ women may therefore result in earlier diagnosis and reduce mortality and morbidity from this disease.
Although current guidelines recommend BRCA1/2 testing if there is a positive family history, they do not recommend the screening of all AJ women. Numerous studies have shown that family history fails to identify half of the women who carry the mutations responsible for OCs in this population.
“If you start with an unselected group of women, you don’t know what their family history is, but [if] they have OC and they’re Jewish, and then you test for the founder mutations, you’ll find about 30–50% have that cancer due to an inherited tendency,” said Wendy S Rubinstein, Medical Director, Center for Medical Genetics, Evanston Northwestern Healthcare Research Institute (IL, USA), and lead author of the study. “It’s a very high proportion, it's not seen at that rate in very many other populations.”
The analysis broke down the health and cost benefits of extending BRCA1/2 testing to the entire population of AJ women based on the cost of testing for founder mutations, bilateral prophylactic salpingo-oophorectomy (BPSO), OC treatment, follow-up care and last-year-of-life care. It predicted that population-based BRCA1/2 screening in the AJ population would increase average survival by approximately 384 days for a 40-year-old AJ woman BRCA1/2 carrier who had BPSO and would save approximately US$100 in nondiscounted costs for each woman screened.
Source: www.ashg.org/genetics/ashg/menu-annmeet.shtml
Act quickly on stroke warning signs
Rapid treatment of transient ischemic attacks (TIAs), often considered a warning sign of stroke, cuts the risk of a subsequent stroke by approximately 80%, according to two recent studies published in The Lancet and The Lancet Neurology.
It is currently estimated that there is approximately a 10% risk of suffering from a major stroke within 1 month of a TIA. Current studies impressively demonstrate that this risk may be dramatically reduced by early treatment.
Writing in The Lancet, Peter Rothwell and colleagues from the University of Oxford (Oxford, UK) reported the results of their Exelon in Parkinson's Disease Dementia Study (EXPRESS). From April 2002 to September 2004, 310 TIA patients were referred by their doctors to the hospital, resulting in an average 3-day wait for assessment, and an average 20-day wait to receive drug treatment. From October 2004 to March 2007 patients were told to visit a stroke clinic immediately and were assessed and treated within 1 day of the TIA. It was found that the risk of a subsequent stroke fell from 10.3 to only 2.1% when TIA sufferers received early treatment.
Similarly, in a French study published in The Lancet Neurology, it was found that the 90-day stroke rate following a TIA was slashed from the predicted rate of 5.96 to 1.24% when patients visited a 24-h TIA clinic.
Joe Korner, of The Stroke Association (London, UK) commented, “This research is of the utmost importance. It clearly shows that thousands of people could be saved from life-shattering strokes every year simply by making sure that everyone who has a TIA or minor stroke gets currently available treatment quickly.”
Stroke can cause severe impairment of motor function or even paralysis. According to the American Stroke Association, approximately 700,000 people each year in the USA suffer a new or recurrent stroke. Currently, there are approximately 5.5 million stroke survivors in the USA, many of whom have permanent stroke-related disabilities. Clearly, early intervention following a TIA could not only vastly reduce the number of people suffering from stroke-related disabilities, not to mention reducing the number of fatalities caused by stroke, but also save millions in treatment costs. Peter Rothwell pointed out, “The financial implication is these clinics will pay for themselves. The strokes we’ll prevent would cost a lot more than the service to prevent them. We’ve shown we could prevent 10,000 strokes in the UK, costing £200 million to the NHS [National Health Service].”
Sources: Rothwell PM, Giles MF, Chandratheva A et al. Effect of urgent treatment of transient ischaemic attack and minor stroke on early recurrent stroke (EXPRESS study): a prospective population-based sequential comparison. The Lancet (Epub ahead of print) (2007);
Lavallée PC, Meseguer E, Abboud H et al. A transient ischaemic attack clinic with round-the-clock access (SOS-TIA): feasibility and effects. Lancet Neurology (Epub ahead of print) (2007).
US FDA approves Tasigna® for treatment of Philadelphia chromosome-positive chronic myeloid leukemia
Tasigna® (nilotinib) has been approved by the US FDA to treat chronic myeloid leukemia (CML) in patients who are resistant or intolerant to other therapies, including Gleevec® (imatinib), an established treatment standard.
CML is amongst the most common forms of leukemia, accounting for 15% of all leukemias in adults and affecting approximately 4500 people in the USA each year. An abnormal chromosome, called the Philadelphia chromosome, is located in the leukemic cells and is present in the majority of CML patients. Without treatment, CML typically progresses over 3–5 years from the initial (chronic) phase through a transition period (accelerated phase) to a rapidly fatal form (blast crisis).
Gleevec remains the most frequently prescribed treatment for patients with CML, with recent clinical trials demonstrating that nearly 90% of newly diagnosed chronic-phase Philedelphia-positive CML adult patients treated were alive after 5 years. However, some patients develop resistance or cannot tolerate this therapy. Applying experience gained from the development of Gleevec, a team of scientists created Tasigna, manufactured by Novartis Pharmaceuticals Corp. (East Hanover, NJ, USA) in 2002, just a year after the launch of Gleevec.
“This represents another treatment option for CML patients who are resistant to, or can no longer tolerate, imatinib,” said Janet Woodcock, the FDA’s Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer and Acting Director, Center for Drug Evaluation and Research. “Patients should consult with their physicians, however, because of possible life-threatening heart problems associated with this drug.”
Tasigna works by inhibiting the proliferation of cells containing the Philadelphia chromosome. It does this by targeting the production of the Bcr–Abl protein, which is produced only by Philadelphia chromosome-containing cells, and is responsible for the overproduction of white blood cells that characterizes this form of CML. Tasigna was specifically designed to target the Bcr–Abl protein more effectively than Gleevec, without adding new mechanisms of action.
At 6 months follow-up, Tasigna reduced or eliminated cells carrying the abnormal Philadelphia chromosome in 40% of patients in the chronic phase of the disease. In clinical trials, the primary end point for patients in the chronic phase was an unconfirmed major cytogenetic response (MCyR). After a minimum follow-up of 6 months (median treatment duration: 8.7 months), Tasigna produced a MCyR in 40% of 232 chronic-phase patients evaluated for efficacy. The complete cytogenetic response in these patients was 28%. For patients in accelerated phase, there was a minimum follow-up of 4 months and a median treatment duration of 6.4 months. The primary end point was confirmed hematological response, and was reported in 18% of patients in accelerated phase. In addition, 24 different mutations in Bcr–Abl were noted in 19% of chronic-phase and 25% of accelerated-phase CML patients who were evaluated for mutations.
Reported side effects of Tasigna were mild to moderate in severity, primarily hematological and included neutropenia and thrombocytopenia. The most frequent nonhematologic drug-related adverse events were rash, vomiting, nausea, fatigue, headache, constipation and diarrhea.
The effectiveness of Tasigna is based on response rates observed in an ongoing clinical trial. Further follow-up of patients is needed to determine how long these responses will last.
Source: US FDA, at: www.fda.gov/bbs/topics/NEWS/2007/NEW01734.html
New long-term analysis demonstrates COPAXONE® is more effective that Tysabri® in treating patients with relapsing–remitting multiple sclerosis
In a Markov cost–effectiveness model, a comparison of the long-term economic outcomes associated with COPAXONE® (glatiramer acetate injection), and Tysabri® (natalizumab, a monoclonal antibody), combined with symptom management versus symptom management alone demonstrated that COPAXONE was shown to be less costly and more effective over a patient’s lifetime than Tysabri for relapsing–remitting (RR) multiple sclerosis (MS).
A literature-based analysis of a Markov model published previously in the Journal of Managed Care Pharmacy in April 2007 has been updated to include Tysabri; results of the study were announced at the 10th Annual International Society for Pharmacoeconomics and Outcomes Research congress in Dublin, Ireland. The updated study estimates the economic outcomes of symptom management combined with COPAXONE and Tysabri compared with symptomatic treatment (e.g., physical therapy/exercise and pharmacological treatment) alone in RRMS patients.
MS is a chronic neurodegenerative inflammatory disease of the CNS with an overall prevalence rate of approximately 400,000 people. Previous research has indicated that the costs associated with MS rise at an exponential rate with increasing MS disability levels.
The analysis indicates that COPAXONE and Tysabri are both more effective and more costly than symptomatic treatment alone. The total lifetime costs per patient for COPAXONE were estimated to be 14% less than for Tysabri. The incremental cost per quality-adjusted life year versus symptomatic treatment alone was US$208,879 for COPAXONE and $525,463 for Tysabri. Results demonstrated that COPAXONE was less costly and more effective than Tysabri in treating MS over a patient’s lifetime.
“The results are consistent with the previously published analysis of this Markov model, which evaluated use of COPAXONE and the β-IFNs compared with symptom management alone for the treatment of RRMS. Both analyses demonstrated that in the presence of long-term treatment outcomes, COPAXONE was the preferred treatment strategy in terms of outcomes and costs,” said MerriKay Oleen-Burkey, director of Health Outcomes Research at Teva Neuroscience, Inc. (MO, USA) “COPAXONE continues to show its value in reducing relapses and slowing detrimental change in EDSS [expanded standard disability status scale], a measure of disability. Now we can confidently say in this model, it’s less costly and more effective over a patient’s lifetime than other treatments for RRMS.”
“Cost–effectiveness and cost–utility analyses are useful tools for assessing the relationship between added costs and potential treatment benefits,” Oleen-Burkey commented. “Although this study offers decision makers relevant data to evaluate the cost–effectiveness of treatments for RRMS versus symptom management alone, it is important to point out that head-to-head randomized clinical trials comparing the immunomodulatory therapies are necessary to validate the projections from pharmacoeconomic models.”
Source: www.ispor.org/congresses/Ireland0507/index.asp
Government immunization program to include routine HPV vaccination of girls aged 12–13 years
Health Secretary Alan Johnson announced the introduction of a UK human papilloma virus (HPV) immunization program to routinely vaccinate girls aged 12–13 years against cervical cancer, starting from September 2008, and a catch-up campaign starting in Autumn 2009 for girls aged up to 18 years, in an effort to cut as many as 1000 deaths per year from the disease. The routine program could cost up to £100 million per year and the catch-up program could cost up to £200 million in 2009/10 and 2010/11, but the Department of Health aims to negotiate a reduction in vaccine price during the procurement process. The vaccine is given in three injections over 6 months at a cost of approximately £300 a course.
HPV is a sexually transmitted virus that is reported to cause up to 99% of invasive cervical cancers. In England, approximately 2200 cases of cervical cancer are reported each year, resulting in over 800 deaths. The vaccine protects against the viruses responsible for approximately 70% of cases. To ensure maximum benefit and protection from this vaccine, it would be necessary to administer it before the onset of sexual activity.
“The benefits of introducing this vaccine into the national immunization programme will be felt by women and their families for generations to come. The vaccine protects against the viruses that cause about 70% of cervical cancers,” said David Salisbury, Director of Immunisation at the Department of Health. “We will work closely with PCTs [Primary Care Trusts] to ensure the success of this ambitious programme that combines routine and catch-up immunization and we will consult with all groups who may play a part”.
The announcement reflects the Health Secretary’s determination to make the NHS a service that prevents ill health and prioritizes well-being.
“As a society we need to do more to prevent disease and not just treat it. Now more than ever before we need to make the NHS a service that prevents ill health and prioritizes keeping people well. This means a shift in focus from a sickness service to a wellbeing service,” commented Alan Johnson. “Prevention is always better than cure and this vaccine will prevent many women from catching the HPV in the first place, potentially saving around 400 lives a year.”
The highly successful and comprehensive cervical screening program (smear tests) will continue after the HPV vaccine has been introduced. This is because the vaccine does not protect against all causes of cervical cancer.
“This is an exciting step towards preventing cervical cancer in the UK. While the vaccine has the potential to prevent many cases of the disease, the impact of a vaccination programme won’t be felt for many years. Cervical screening remains vital in preventing the disease. We urge all women take up the invitation when they receive it,” said Harpal Kumar, Cancer Research UK’s Chief Executive. “The cervical screening programme is very effective. For women between 25 and 49 [years], 3-yearly screening prevents 84 cervical cancers out of every 100 that would develop without screening.”
Source: www.ingentaconnect.com/content/adis/peon/2007/00000001/00000540/art00033
The cost–effectiveness of drug-eluting stents
Researchers conducting the Basel Stent KostenEffektivitäts Trial (BASKET) have revealed that drug-eluting stents are not cost effective if used in all patients. They found the stents are good value for money in a portion of high-risk patients, such as in patients needing small vessel or bypass graft stenting, however, even if the price was reduced substantially they would still not be cost effective for all patients.
The 18-month BASKET was conducted by Matthias Pfisterer and colleagues at the University Hospital, Basle, Switzerland. The study compared 545 patients who had drug-eluting stents with 281 who had bare-metal stents. They worked out the incremental cost–effectiveness ratios (ICERs) for both low- and high-risk patients, and conducted patient questionnaires to measure quality-adjusted life years (QALYs).
There was a mean difference of €1358 for overall costs between the two methods; with the cost for those fitted with drug-eluting stents being €11,808 per patient and for bare-metal stents €10,450.
They also calculated an ICER of €64,732 to prevent one major adverse cardiac event, and €40,467 for each QALY gained. Thus, they concluded that in low-risk patients, the probability of drug-eluting stents achieving an ICER of €10,000 or less to prevent one major adverse cardiac event was 0.016 compared with 0.874 in high-risk patients.
The authors say, “Our data, based on a comprehensive cost–effectiveness analysis of a randomized controlled trial in unselected, real-world patients, using the latest stent technology with long-term follow-up, show that drug-eluting stents are not cost effective if used in all patients, compared with other accepted medical procedures. However, in a subset of high-risk patients with small vessel or bypass graft stenting, which represented about a third of the study sample, drug-eluting stents were truly cost effective or even cost saving.”
They concluded that, “Targeted stent use could be the preferred strategy today. Lower prices of drug-eluting stents alone are unlikely to result in such stents being cost effective in all patients, even if the problems of late stent thrombosis are solved with new generations of drug-eluting stents.”
Source: Brunner-La Rocca HP, Kaiser C, Bernheim A et al. BASKET Investigators. Cost–effectiveness of drug-eluting stents in patients at high or low risk of major cardiac events in the Basel Stent KostenEffektivitäts Trial (BASKET): an 18-month analysis. Lancet 370(9598), 1552–1559 (2007).
What is the most important factor for cancer survival?
It may not come as much of a surprise to many healthcare professionals, but a recent study has concluded that the most important factor in the survival of cancer is a patient’s quality of life and patients who were married or had a partner had the highest quality of life scores.
The prospective, multi-institutional study led by Benjamin Movsas examined the quality of life of 218 patients who had completed a pretreatment quality-of-life questionnaire. The patients all had locally advanced non-small-cell lung cancer and were enrolled in the Radiation Therapy Oncology Group 9801 trial. It was found that patients with a quality-of-life score less than 66.7, which was the median, had a 69% higher rate of death compared with those who had a quality-of-life score greater than the median.
On top of the quality-of-life surveys, overall survival predictions were also performed using the stage of disease, gender, age, race, marital status, type of tumor, tumor location in the lung, blood oxygen level and type of treatment. However, they found that the patient’s quality of life is so crucial that it outweighs the other standard predictors of survival.
“In the past, we’ve considered the stage of disease or tumor size along with other empirical data to predict how long a patient will survive, but now we know quality of life is a critical factor in determining survival,” said Nicos Nicolaou, lead author of the abstract, which was presented at the American Society for Therapeutic Radiology and Oncology’s 49th Annual Meeting (CA, USA).
“We found a significantly lower quality-of-life score for single, divorced and widowed patients, which deserves further study,” Nicolaou expanded. “These findings underscore the importance of helping our patients improve the quality of life where we can in order to help them live longer better.”
“Our study shows that what matters most is what patients themselves are telling us about their quality of life,” said senior author Benjamin Movsas. “We conducted two different statistical analysis including all the usual prognostic factors and either way, quality of life remained the strongest predictor of overall survival. What’s more, if a patient’s quality of life increased over time, we saw a corresponding increase in survival.”
Movsas concluded, “Quality-of-life measures should be incorporated into treatment decision making and clinical trials.”
Source: The American Society for Therapeutic Radiology and Oncology’s 49th Annual Meeting, Los Angeles, CA, USA, 28 October–1 November 2007.
www.astro.org/Meetings/AnnualMeetings