Breaking News
January 18, 2019 - New study shows link between secondhand smoke and cardiac arrhythmia
January 18, 2019 - DZIF scientists reveal problems with available diagnostics for Zika and chikungunya virus
January 18, 2019 - Breast cancers more likely to metastasize in young women within 10 years of giving birth
January 18, 2019 - Blood vessels can now be created perfectly in a petri dish
January 18, 2019 - Study identifies prominent socioeconomic and racial disparities in health behavior in Indiana
January 18, 2019 - Young-Onset Type 2 Diabetes Tied to Increased Hospitalization Risk
January 18, 2019 - For-profit nursing schools associated with lower performance on nurse licensure test
January 18, 2019 - Considering the culture of consent in medicine
January 18, 2019 - Researchers identify comprehensive guidelines for managing severe atopic dermatitis
January 18, 2019 - Analyzing proteins in blister fluid may classify burn severity more accurately
January 18, 2019 - Study finds higher suicide rates among youth who were Medicaid enrollees
January 18, 2019 - Opioid drugs often overprescribed to children for pain relief, say CHOP surgeons
January 18, 2019 - New biodegradable wound dressing material accelerates healing
January 18, 2019 - Life in Space May Take Toll on Spinal Muscles
January 18, 2019 - Bulldogs’ screw tails linked to human genetic disease
January 18, 2019 - Immunotherapy target identified for pediatric cancers
January 18, 2019 - Financial stress may increase heart disease risk in African Americans
January 18, 2019 - Scientists solve another piece of Ebola virus puzzle
January 18, 2019 - New project finds how endocrine disruptors interfere with thyroid functions
January 18, 2019 - Research finds decline in ketone body utilization when coronary circulation is reduced
January 18, 2019 - Let’s map our DNA and save billions each year in health costs
January 18, 2019 - AI demonstrates potential to identify irregular heart rhythms as well as humans
January 17, 2019 - Study shows link between air pollution and increased risk of sleep apnea
January 17, 2019 - Neck-strengthening exercises can protect athletes from concussions
January 17, 2019 - Computer model shows how to better control MRSA outbreaks
January 17, 2019 - Pain is unpleasant, and now scientists have identified the set of responsible neurons
January 17, 2019 - CUIMC Celebrates 2018-2019
January 17, 2019 - Study reveals potential pathway for endothelial cells to avoid apoptosis
January 17, 2019 - Hamilton Storage launches LabElite DeCapper SL to expand LabElite product family
January 17, 2019 - Location of epigenetic changes co-locate with genetic signal causing psychartric disorder
January 17, 2019 - Researchers awarded 6.1 million euros to address female fertility problems
January 17, 2019 - Counseling appointments fail to reduce weight gain during pregnancy, shows study
January 17, 2019 - Contraceptive patch that could provide 6 months of contraception within seconds
January 17, 2019 - Yeast model may pave way for development of novel therapies for metabolic disorders
January 17, 2019 - Study determines impact of antibiotic perturbation of the gut microbiome on skeletal health
January 17, 2019 - Cardiometabolic Risk Up With Tourette, Chronic Tic Disorder
January 17, 2019 - Hong Kong scientists claim ‘broad-spectrum’ antiviral breakthrough
January 17, 2019 - Researchers discover the brain cells that make pain unpleasant | News Center
January 17, 2019 - Hepatitis Is Common in New Cancer Patients
January 17, 2019 - Podcast: KHN’s ‘What The Health?’ Drug Prices Are Rising Again. Is Someone Going To Do Something About It?
January 17, 2019 - Smoking significantly increases your biological age, study shows
January 17, 2019 - B-group vitamins may be beneficial for people with first episode psychosis
January 17, 2019 - Researchers demonstrate how manganese produces parkinsonian syndrome
January 17, 2019 - Researchers suggest link between personality type and attitude towards others’ bodies
January 17, 2019 - Mutant mice administered with cocaine failed to exhibit hyperactivity, shows study
January 17, 2019 - Health Tip: Understanding a Heart Murmur
January 17, 2019 - Gut protein mutations shield against spikes in glucose
January 17, 2019 - Engineered immune cells target broad range of pediatric solid tumors in mice | News Center
January 17, 2019 - Study provides comprehensive description of associations between mental disorders
January 17, 2019 - Study finds link between high pesticide exposure and poor sense of smell among farmers
January 17, 2019 - Many cancer patients have undiagnosed hepatitis
January 17, 2019 - New study finds only 13% of outpatient antibiotic prescriptions to be appropriate
January 17, 2019 - Stem cell-based approach to diabetes offers hope for treatment
January 17, 2019 - New project receives €8.65 million from EU and Canada to ease genomic, health data sharing
January 17, 2019 - Improvements in pharmacological study to fight cognitive impairment in schizophrenia
January 17, 2019 - Study looks at trends over time in oral antibiotic prescribing by dermatologists
January 17, 2019 - Most substance use disorder treatment facilities do not offer medication treatment
January 17, 2019 - Multiple sclerosis could benefit from stem cell therapy
January 17, 2019 - Researchers manipulate T cells to improve transplant success
January 17, 2019 - Put away your rulers and reach for your phone
January 17, 2019 - Mindfulness linked with fewer menopausal symptoms
January 17, 2019 - Integrated care to women with PMADs offered at several levels
January 17, 2019 - Researchers identify MANF as a rejuvenating factor in parabiosis
January 17, 2019 - Truncal mutations study suggests new direction in origins of cancer
January 17, 2019 - Beckman Coulter launches new ClearLLab 10C System for clinical flow cytometry lab
January 17, 2019 - Effects of linoleic acid on the body are largely dependent on genes, shows study
January 17, 2019 - Pre-injury exercise reduces damage to both muscles and nerves, study finds
January 17, 2019 - Minimizing Antibody Size to Maximize Research Potential
January 17, 2019 - Research finds large genome in tiny forest defoliator
January 17, 2019 - Technology helps reduce the yearning for unhealthy food
January 17, 2019 - Imec develops prototype cardiovascular device
January 17, 2019 - New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States
January 17, 2019 - What you should know about teeth whitening
January 17, 2019 - Why Older Adults Should Eat More Protein (And Not Overdo Protein Shakes)
January 17, 2019 - Colorectal cancer mortality rates predicted to increase globally
January 17, 2019 - Scientists discover mutational signatures of tumor hypoxia
January 17, 2019 - New evidence shows how fever alters immune cells
January 17, 2019 - Researchers find new class of blood pressure-regulating peptides in vampire bat venom
January 17, 2019 - Promega to exhibit new Maxwell RSC48 platform at 2019 Festival of Genomics
January 17, 2019 - Study pinpoints immune cells that could be key to tackling hypertension
Some countries take more time for reimbursement decisions on new cancer drugs

Some countries take more time for reimbursement decisions on new cancer drugs

image_pdfDownload PDFimage_print

Some European countries take more than twice as long as others to reach health technology assessment (HTA) decisions to reimburse new cancer drugs following their approval by the European Medicines Agency (EMA). The average decision time is longer than one year in some countries, according to a study to be reported at ESMO 2018 Congress.

Once the EMA has approved a new treatment, many countries evaluate its benefit and cost-effectiveness through a systematic health technology assessment process as part of making a decision on whether to reimburse use of the treatment for routine patient care.

Researchers identified all new cancer drugs approved for solid tumors by the EMA between January 2007 and December 2016. They then tracked the time between EMA approval for each of the drugs and HTA decisions being taken by health authorities in four European countries: England, France, Germany and Scotland.

Results for 47 drugs approved for 77 solid tumor indications revealed that the median time from EMA approval to HTA decisions was two to three times longer in England (405 days) and Scotland (384 days) compared to Germany (209 days) and France (118 days).

“In contrast to the centralized approval of anticancer drugs by the EMA, the time to HTA decisions remains a national responsibility,” explained study co-author Dr Kerstin Vokinger, senior research scientist at the University Hospital of Zurich, Switzerland, and affiliated researcher at Harvard Medical School, Boston, USA. She added: “Among other things, the different amount of resources invested in such assessments and different national regulations regarding HTA systems may lead to variation in the time from EMA approval to HTA decisions in different countries.”

Commenting on the findings, Dr Bettina Ryll, founder of Melanoma Patient Network Europe and Chair of the ESMO Patient Advocacy Working Group, said: “We in melanoma still mourn the lives we lost due to the tardy and inconsistent introduction of approved innovative therapies. It is a country’s responsibility to ensure sufficient administrative capacity so that processes like HTA that were put in place for the benefit of society do not start harming citizens. And we need more pragmatic approaches to reducing uncertainty- simply letting patients die while waiting for data to mature is not a civilized option.”

The study found that health authorities generally made decisions much more quickly for drugs ranked as being of “highest benefit” on the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) compared to those with less clinical benefit. However, the variation in time from EMA approval to HTA decisions remained between different countries for these “highest benefit” drugs.

The ESMO Magnitude of Clinical Benefit Scale uses a rational, structured and consistent approach to grade the magnitude of clinical benefit that can be expected from anti-cancer treatments. “Lowest benefit” refers, for example, to drugs increasing median progression-free survival by a few weeks, whereas the category of “highest benefit” is given to drugs improving long-term survival in the neo/adjuvant setting.

In France, the median time to an HTA decision on “highest benefit” drugs was 154 days compared to 198 days for drugs of less benefit. Faster HTA decisions for “highest benefit” cancer drugs were also made in Germany and England but the time to HTA decisions was much longer in England (median 302 days) than in France or Germany (203 days).

Further analysis showed that nearly all cancer drugs ranked as being of “highest benefit” on the ESMO-MCBS were approved for reimbursement by all four countries: Germany (100%), Scotland (95%), England (92%) and France (90%)… In addition, the researchers found high concordance between ESMO-MCBS and scores health regulators gave in HTA procedures for cancer drugs of “highest benefit”.

“Our study shows that there is a high concordance between ESMO Magnitude of Clinical Benefit Scale and HTA scores for the categorization of “highest benefit”. Therefore, the ESMO Magnitude of Clinical Benefit Scale could serve different countries as a helpful tool to assess the clinical value of anticancer drugs,” suggested Vokinger.

Commenting on the findings for ESMO, Prof. Elisabeth de Vries, Medical Oncologist at the University Medical Center Groningen, Groningen, The Netherlands, Chair of the ESMO-MCBS Working Group, said: “It is reassuring that in the countries studied, anticancer drugs with greatest clinical benefit on ESMO-MCBS (version 1.1) are associated with faster times to HTA decisions and nearly all are approved for reimbursement.”

Noting the variation in times to final decisions, she suggested, “Hopefully, this information can be helpful to raise the interest of HTA agencies in their performance and timeframes.” de Vries added, “Data were analyzed only for England, France, Germany and Scotland. This means data for HTA procedures and reimbursement decisions were reported for only part of Europe, with no countries included from Southern or Eastern Europe. Insights into these procedures in other European countries might be of interest.”

Vokinger said the research group now plans to expand research in this area. “Among other things, we plan to include more countries for assessing HTA decisions and to explore access to new cancer medicines by individual patients,” she said.

Source:

http://esmo.org/Press-Office/Press-Releases/MCBS-HTA-cancer-drugs-approval-Hwang

Tagged with:

About author

Related Articles