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A consultation on changes to its badessment methods and a decision on an ovarian cancer treatment figure in this week's summary of the National Institute for Excellence's announcements. Health and Care (NICE).
Ovarian cancer
NICE has approved olaparib, an inhibitor of PARP (Lynparza, AstraZeneca) for the UK Cancer Drugs Fund (CDF).
Twice daily tablets are intended for the maintenance treatment of cancers of high grade epithelium, ovaries, fallopian tubes or primary peritoneal carcinoma of the advanced BRCA mutation (stages 3 and 4). ) in patients who responded to chemotherapy. This is the first targeted treatment approved for first-line maintenance for this group of patients. It has already been used at an advanced stage, but can now be administered much earlier during the course of the disease.
Manufacturers reported that olaparib had helped nearly 60% of patients remain unaffected after three years, versus 27% on placebo.
According to NICE, around 700 patients a year in England could be eligible for treatment following a new agreement with the manufacturer.
Meindert Boysen, director of the NICE Center for Health Technology Assessment, said, "The availability of olaparib tablets as a maintenance treatment is an important advance in cancer management. Advanced ovarian mutation BRCA.Olaparib is already used for ovarian cancer but should to obtain the greatest benefit when used early, and is considered to have the potential to cure the disease in some people if it is administered before the first recurrence.
"We are pleased that the company has entered into a commercial agreement for the olaparib, which will make it immediately available to people who currently have an unmet need in maintenance treatment."
NICE also cited Dr. Susana Banerjee, Medical Oncology Consultant at the Royal Marsden Hospital and Team Leader of Gynecologic Oncology at the Institute of Cancer Research. She was co-author of the SOLO-1 trial that developed evidence for the drug. "The maintenance treatment at olaparib heralds a new era for women with ovarian cancer," she said. "This is the first time we have seen such dramatic improvements in progression-free survival. This means that more women will have more time before relapse, chemotherapy and the possibility of increased survival.
"The historical SOLO-1 trial has resulted in a paradigm shift in the treatment of women with advanced ovarian cancer. This is the first trial of treatment of patients with advanced ovarian cancer. Interview with this type of drug intended for newly diagnosed patients.The results of these trials showed that olaparib maintenance treatment prolongs the progression-free survival of about 3 years in women with dementia. An advanced ovarian cancer linked to the BRCA mutation. Some of my patients who were treated as part of this trial at the Royal Marsden still do not have cancer many years later. "
Also reacting to the decision in a statement, Cary Wakefield, general manager of Ovarian Cancer Action, said the decision "made personalized treatment a reality for women in whom ovarian cancer mutated by BRCA was coming from." 39 being diagnosed – significant progress in the way we treat Although genetic testing is essential for women to have access to this treatment, we know that 29% of women with ovarian cancer do not have access In spite of the recommendations of the government, it is a priority to remedy this inequality so that women do not miss out on life.
Evaluation methods
NICE will review the methods it uses to develop its guidelines on drug, medical device and diagnostic badessments.
It will involve discussing with stakeholders changes in the way it badesses costs, considerations of equality and reduce uncertainty when evidence is lacking.
In a statement, Sir Andrew Dillon, CEO of NICE, said: "This update is part of the regular review and update of our methods to ensure their robustness and timeliness.
"NICE is undertaking this review at a time of unprecedented change in the healthcare system, where developments such as personalized medicine, the digitization of health, the use of cell and gene therapy, are making products more in addition difficult to evaluate.
"Keeping NICE's methods up-to-date is an important contribution to managing these changes."
People with learning disabilities
NICE has published two quality standards for people with learning disabilities.
The 2019 update of challenging behavioral standards included:
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Local authorities and commissioning groups should designate a person responsible for overseeing the strategic implementation of services for all persons with learning disabilities.
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An annual health check from a GP should be provided and there should be a designated lead practitioner
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Families and caregivers should be involved in the development of the care and support plan, including how to prevent or respond to a crisis
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Specialized behavioral support should be provided in the community.
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Patients should be helped to choose where and how they live
Aging individuals with learning disabilities should:
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Actively participate in the badessment of care and support needs
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Have a senior practitioner named
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Have a plan for the future with at least one annual review
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Have an annual health check
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Meet with hospital staff before any scheduled admission
Bladder cancer
NICE has stated that transurethral laser ablation for recurrent non-muscle invasive bladder cancer does not pose a major safety problem. However, he warned that the evidence of its effectiveness is limited.
He called for further research and audits in the procedure, and said that patient selection should be done by a multidisciplinary team specializing in bladder cancer.
Physicians planning such procedures should inform local clinical governance officials, and patients and caregivers should be aware of safety and efficacy uncertainty.
Uterine fibroids
NICE stated that ultrasound-guided high-intensity transcutaneous focused ultrasound for symptomatic uterine fibroids should only be used in special circumstances because of limited evidence of effectiveness and recognized complications, including skin burns.
He said more research is needed and procedures should be agreed with clinical governance officials. Patients, he added, should be aware of the limitations of the procedure and the risks of side effects.
Leukemia
NICE has recommended blinatumomab as a treatment option for CD19-positive acute lymphoblastic leukemia positive for the Philadelphia chromosome negative in adults. This is provided that the minimal residual disease of at least 0.1%, and only if the disease is in first complete remission. The guidelines are also based on the establishment of the manufacturer's commercial arrangements.
Anyone already treated with the drug may continue despite the new guidelines.
NICE cited clinical evidence that blinatumomab could help increase the delay between relapses and help cure more patients.
He cautioned against uncertainties due to the lack of direct comparisons between blinatumomab and continuous chemotherapy, with or without hematopoietic stem cell transplantation.
Spinal muscular atrophy
According to NICE, nusinersen is recommended as an option for the treatment of spinal muscular atrophy (SMA) under certain circumstances: pre-symptomatic SMA, or SMA type 1, 2 or 3, and falling within the conditions of a managed access contract.
The decision was made despite higher than normal profitability estimates. NICE acknowledged that the estimates were difficult to interpret because of limited evidence of long-term benefits.
The recommendation will be reviewed as new evidence is gathered.
Peritoneal carcinomatosis
In the draft guideline, NICE stated that pressurized intraperitoneal aerosol chemotherapy for the treatment of peritoneal carcinomatosis should only be used in the context of research. He said that there are well-recognized serious side effects and that the efficiency of the efficacy is currently insufficient.
The draft decision follows a rapid review of the published literature.
Colorectal metastases of the liver
The draft recommendations, NICE, indicated that selective internal radiotherapy for unresectable colorectal metastases in the liver could be performed in a research setting.
There is some evidence that treatment may have beneficial effects on the quality of life of patients who do not tolerate chemotherapy.
This decision followed a rapid badessment of the published literature.
COPD
In chronic obstructive pulmonary disease in people over 16 years of age, NICE reviewed evidence on long-acting muscarinic antagonist inhalation therapy (LAMA), a long-acting beta-agonist drug. Action (LABA) and inhaled corticosteroids for the treatment of stable COPD and oral corticosteroids for the management of exacerbations. .
The update indicated that prior to starting LAMA + LABA + ICS, a clinical examination should be performed to ensure that patients were receiving help to quit smoking and that their symptoms were n & # 39; 39; were not due to another health problem, such as heart failure. The decision to use triple therapy would depend on the current treatment and the severity of the exacerbations. Detailed records must be kept of the drugs used, including their effectiveness, costs, adverse effects and patient preferences.
The update on systemic corticosteroids was to provide daily oral prednisolone for 5 days as needed. The reasons the committee recommended 5 days were the risks badociated with the long-term use of corticosteroids and the lack of evidence of a benefit of more than 7 days treatment. In addition, shorter courses of 5 days are already commonly used.
Future Directions on Asthma
NICE has announced a collaboration with the British Thoracic Society (BTS) and the Scottish Intercollegiate Guideline Network (SIGN).
The collaboration should lead to a new "asthma pathway" on the diagnosis and management of asthma from childhood to adulthood.
Medication Recall for Parkinson's Disease and Epilepsy
The Medicines and Health Products Regulatory Agency (MHRA) has issued a precautionary alert to patients taking rotigotine (Neupro, UCB Pharma) for Parkinson's disease and lacosamide (Vimpat, UCB Pharma) for epilepsy.
According to the MHRA, the products concerned are "considered legitimate", but it is feared that they will be removed from the supply chain and then reintroduced.
The relevant lot numbers are available on the websites of Kosei Pharma UK Ltd, MPT Pharma Ltd., Drugsrus Ltd / P.I.E. Pharma Ltd and Doncaster Pharmaceuticals Group Ltd.
In both cases, patients are asked to continue taking their medication until they can talk to a health professional.
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