British Fertility Society welcomes NICE publication of Quality Standards report calling for end to IVF postcode lottery

The British Fertility Society (BFS) welcomes the publication of the National Institute for Health and Care Excellence (NICE) Quality Standards report on fertility treatment, which calls for the NHS to make three full cycles of IVF available to all in England who need it.

This is the strongest call yet for commissioners to end the postcode lottery of NHS funding for fertility treatments such as IVF, which results in healthcare inequalities across the country. The BFS urges those making such decisions to take the NICE guidelines on board and do so without invoking other discriminatory exclusion criteria.

The Quality Standards report also identified other areas where improvements in fertility care and services are most needed, such as GPs referring couples for specialist consultation in a more timely manner and the provision of adequate fertility preservation services for those people who are about to undergo treatment for cancer. The BFS calls for all UK commissioners and healthcare providers to follow the new Quality Standards and fully implement the 2013 NICE Fertility Guidelines without delay.

British Fertility Society Chairman Allan Pacey said:

“During my time as the BFS Chairman, it is disappointing to see to see that there has been no improvement in the funding available for assisted conception services in England. Some areas such as Mid Essex are worse off now compared to a few years ago, suffering from reduced or even complete withdrawal of funding. By cherry-picking aspects of guidelines to fund services of their choice, local commissioners fly in the face of what NICE is all about. Their guidelines must be taken as a whole if we are to deliver the best and most cost-effective use of NHS resources.”

British Fertility Society Secretary Jane Stewart added:

"For the inclusion of appropriate and equitable funding as a quality standard, we should applaud NICE for giving the first truly direct national steer to commissioners on this important issue.” 

NICE FAILS TO GRANT ACCESS TO INNOVATIVE TREATMENT FOR WOMEN WITH ADVANCED BREAST CANCER, DESPITE EVIDENCE THAT IT COULD EXTEND THEIR LIVES

Today the National Institute for Health and Clinical Excellence (NICE) announced that it will continue not to recommend Halaven^® (eribulin) for the treatment of locally advanced or metastatic breast cancer in England and Wales, despite this innovative therapy demonstrating proven benefits of improving overall survival rates, with an expected and manageable safety profile.

Following an appeal by Eisai, NICE has observed that ‘the discussion and decision of the Appraisal Committee on toxicity were not reported appropriately in the Final Appraisal Document (FAD)’ in relation to eribulin. The corresponding sections of the FAD are being re-drafted in light of the error. Despite the need for new treatment options, their overall recommendation denying eribulin use in England and Wales remains. Eribulin is the first, single-agent chemotherapy to show a statistically significant overall survival benefit in women with heavily pre-treated advanced breast cancer (compared to treatment of physician choice). Importantly, eribulin has an expected and manageable safety profile which is in line with other single-agent chemotherapy treatments for advanced breast cancer in this setting.²

Chris Twelves, Professor of Clinical Cancer Pharmacology and Oncology, Leeds, commented, “I am delighted that NICE has recognised the errors made regarding eribulin in the original report and made these corrections. However, the fact remains that NICE’s decision denies women with advanced breast cancer access to the only chemotherapy that we know can prolong the time they could spend with their loved ones. The EMBRACE trial demonstrated that eribulin provides improved overall survival compared to the single agent treatments that oncologists are currently able to use. Importantly, the survival benefit from eribulin is not outweighed by any unexpected or unmanageable side effects, which is important for these women. NICE has ignored the innovative nature of eribulin and failed to recognise the value for women with advanced breast cancer in England and Wales.”

Despite NICE’s ruling, patients in England can access eribulin the via the Government’s Cancer Drugs Fund (CDF). To date many women in England have been treated with eribulin via this route and it is within the top twelve most prescribed drugs through this system. However, the CDF does not extend to patients nationally and Northern Ireland so unequal access will continue to be a problem.

“Eisai is dismayed that NICE has chosen not to rethink its denial of eribulin for women with locally advanced or metastatic breast cancer in England and Wales. At this point NICE is not giving enough support to women with advanced breast cancer and the physicians who want to treat them. We hope that NICE grant a rapid re-review as new data is constantly emerging that will help inform their decision,” said Nick Burgin, European Director of Market Access, Eisai.

Today’s published FAD on eribulin use comes after an appeal by Eisai on NICE’s earlier ruling (November 2011) to not recommend eribulin.

Dronedarona obtiene la opinión favorable del NICE en un nuevo informe de evaluación

Sanofi-aventis (EURONEXT: SAN y NYSE: SNY) anuncia que el National Institute for Health and Clinical Excellence (NICE) – organismo encargado de elaborar recomendaciones sobre el fomento de la salud y la prevención y el tratamiento de enfermedades en Inglaterra y en el País de Gales – acaba de hacer público un nuevo informe de evaluación (Appraisal Consultation Document o ACD)1 de dronedarona (Multaq®), en el que el Instituto informa de su intención de recomendar la administración de dicho medicamento en el tratamiento de pacientes con fibrilación auricular (FA).
En sus recomendaciones preliminares, el comité de evaluación del NICE propone autorizar dronedarona como tratamiento de primera línea después de los betabloquantes, que son la opción inicial propuesta en las recomendaciones clínicas emitidas por el NICE. Según esta recomendación, dronedarona sería prescrito a pacientes afectados por fibrilación auricular no permanente que presentan, al menos, uno de los siguientes factores de riesgo cardiovascular: hipertensión arterial con prescripción de, al menos, dos clases de medicamentos diferentes, diabetes, antecedentes de accidente isquémico transitorio, ictus o embolia sistémica, diámetro del ventrículo izquierdo igual o superior a 50 mm, fracción de eyección ventricular izquierda (FEVI) inferior al 40%, o edad superior a 70 años sin presentar insuficiencia cardiaca inestable de clase III o IV, según la clasificación de la New York Heart Association (NYHA).
Esta población de pacientes corresponde a la población incluida en el ensayo ATHENA, el mayor ensayo realizado hasta la fecha sobre un antiarrítmico en el tratamiento de la fibrilación auricular y el único que ha demostrado un impacto positivo sobre la morbi-mortalidad cardiovascular.
En el ensayo ATHENA, dronedarona, añadido al tratamiento convencional con betabloqueantes, redujo significativamente, un 24% (p<0,001), el riesgo de ingreso por causas cardiovasculares o de mortalidad, comparado con placebo, sin diferencias en cuanto a la tasa de reacciones adversas graves (19,9% frente a 21,1%, respectivamente; p=0,31).
“Para sanofi-aventis es una gran noticia que el NICE haya reconocido los beneficios de dronedarona (Multaq®) para los pacientes que sufren fibrilación auricular no permanente, que estaban esperando desde hace mucho tiempo un nuevo tratamiento que pudiera tratar sin riesgos los síntomas y disminuir eventos cardiovasculares a largo plazo” comentó Belén Garijo, Vicepresidenta Senior de Operaciones Farmacéuticas para Europa de sanofi-aventis. “Apreciamos la exhaustiva y compleja evaluación realizada por el NICE sobre los datos clínicos y económicos de dronedarona y creemos que esta opinión preliminar del NICE es una importante referencia de calidad para sanofi-aventis, para que dronedarona pueda convertirse en un valioso tratamiento para los pacientes que sufren fibrilación auricular, tanto en Europa como en otros países “.
Dronedarona estará disponible en el mercado británico a partir del 30 de marzo de 2010.