No blacklisting costly drugs, trusts told,

http://www.telegraph.co.uk/health/healthnews/9094442/No-blacklisting-costly-drugs-trusts-told.html

I'll believe it if it happens

NICE hypertension guidance ‘too expensive’ to implement,

http://www.pulsetoday.co.uk/newsarticle-content/-/article_display_list/13492310/nice-hypertension-guidance-too-expensive-to-implement

Ministers deny GlaxoSmithKline claims of drug delays, http://www.bbc.co.uk/news/uk-17163958

One has to wonder tho. I do remember seeing on another forum where someone's gp had asked her to take another medication - one not best suited to her - because it cost more than the other. She appealed and was given her original meds again.

Is that not meant to be NICE reason for existing to make clinical judgements on the best value treatments not just to find which drug company is having a reduced to clear sales offer for doctors to decide which meds to buy

NHS will have to ration further treatments, GPs warn,

http://www.guardian.co.uk/politics/2012/feb/27/nhs-treatment-rationing-gp-warning

NICE hits back over "drug delay" claims

http://www.pharmatimes.com/mobile/12-03-01/NICE_hits_back_over_drug_delay_claims.aspx

Department of Health on legal rights to medicines,


http://www.pulsetoday.co.uk/newsarticle-content/-/article_display_list/13568033/dh-advisers-to-review-legal-right-to-medicines

Blood clot care risking lives, NICE says http://www.bbc.co.uk/news/health-18595843

Sue NHS if managers deny approved drugs, says Nice chairman

http://www.telegraph.co.uk/health/healthnews/9444015/Sue-NHS-if-managers-deny-approved-drugs-says-Nice-chairman.html

NHS trusts 'breaking the law' by denying access to treatment
Chair of drugs rationing body says NHS trusts are circumventing legal obligations to save money

http://www.guardian.co.uk/society/2012/aug/03/patients-sue-nhs-access-drugs

End of the postcode lottery? Local hospital trusts to be banned from blacklisting drugs backed by health watchdog

Read more: http://www.dailymail.co.uk/health/article-2186038/Local-hospital-trusts-banned-blacklisting-drugs-backed-health-watchdog.html#ixzz235VPTZBb

NICE compliance scheme set to roll this autumn, says govt - Pharmatimes
http://www.pharmatimes.com/mobile/12-08-30/NICE_compliance_scheme_set_to_roll_this_autumn_says_govt.aspx



Starting this autumn, NHS organisations will have to comply with National Institute for Health and Clinical Excellence (NICE) guidance on new drugs and treatments, or explain to patients why there is a delay, Ministers have announced.
Under a new, three-part regime aimed at getting the latest drugs and treatments to patients more quickly, the government will publish an Innovation Scorecard, allowing patients and the public to see which NHS bodies are quickly adopting the latest NICE-approved drugs.

Also, the NHS will have no excuse not provide the latest NICE-recommended drugs and treatments, which will be automatically added onto lists of what drugs are available in local areas, and these “will be published for all to see," says the Department of Health. This means that NICE's new recommendations will be made available automatically for doctors to prescribe across the NHS.
Third, a new group is to be set up to help local NHS organisations implement NICE guidance and overcome any barriers to doing so. New drugs and treatments can mean the NHS has to make big changes in the way that it provides services, and this can be a complicated process, so the new group will help spread best practice and make uptake by the NHS quicker for patients, says the Department.

"Patients have a right to drugs and treatments that have been approved by NICE. This new regime will be a catalyst for change - we are determined to eradicate variation and drive up standards for everyone," said Health Minister Paul Burstow.
"NHS organisations must make sure the latest NICE-approved treatments are available in their area, and if they are not, then they will now be responsible for explaining why not. Being transparent with data like this is the hallmark of a 21st-century NHS. It is a fundamental tool to help healthcare professionals improve patient care," the Minister added.

The government also points out that as NHS organisations get funding for each new NICE appraisal, "financial issues should not be a barrier to the uptake of innovative new treatments."

But, according to the NHS Confederation, with the NHS facing unprecedented financial challenge, its organisations must live within their means while providing high-quality care.

"The reality is we can only afford to provide new drugs or treatments where they are cost-effective and demonstrably add real patient benefits," said David Stout, deputy chief executive of the Confederation.
"In a health system with no financial growth, any new costs have to be offset by savings elsewhere - that is why it is crucial that NHS organisations engage their local communities and clinicians in decisions about priorities," he added.

Mr Stout also cautioned that while sharing information of uptake on innovative ideas is extremely useful for creating new treatments and medicines, allows NHS bodies to measure their progress and look at new ways of providing care and treatment and can increase transparency, any new measures must not lead to "unnecessary bureaucracy or a duplication of information with no real benefits for hospitals, GPs or patients."

In its response, the Association of the British Pharmaceutical Industry (ABPI) said it warmly welcomes the introduction of the NHS Innovation Scorecard.

"There is still a great deal of variation across the country on which treatments patients are able to access, and so I am hopeful the Scorecard will help highlight discrepancies which can then be addressed," commented ABPI chief executive Stephen Whitehead.

"The Scorecard is a definite step forward and I think it is particularly important that there is a focus on the uptake of new medicines, as UK patients still don't receive the latest treatments as quickly as their European counterparts. This is not only bad for the health of the nation, but also means we lose the opportunity to drive efficiency savings through the use of medicines, which can often reduce the need for expensive hospital care," he said.

Mr Whitehead added that the industry also welcomes the other moves announced by Ministers to support the use of NICE-recommended treatments, such as automatically including themonto local medicine availability lists and the creation of a group to help local NHS organisations implement NICE guidelines.

NICE said it hopes that the Scorecards "will help rapidly get a consistent response to national guidance."

Scorecards will be valuable not just to patients but also help hospitals assess how well they're performing and ensure that best practice is disseminated across the NHS, said the Institute's chief executive, Sir Andrew Dillon.

Plan to ban drug that would help thousands with incurable immune system disease put on hold

Read more: http://www.dailymail.co.uk/health/article-2199897/Plan-ban-drug-help-thousands-incurable-immune-disease-hold.html#ixzz25v1geBru

New guidance sets out public health recommendations for councils

http://www.guardian.co.uk/healthcare-network/2012/sep/25/guidance-public-health-local-government

Patients with rare conditions face postcode lottery
Research shows that patients with rare conditions have less chance of accessing 'orphan' medication if they live in England

http://www.guardian.co.uk/society/2012/oct/20/patients-rare-conditions-postcode-lottery

http://www.pharmatimes.com/mobile/12-10-25/NICE_yes_for_Novartis_Tobi_Podhaler_no_for_Forest_s_Colobreathe.aspx

NICE yes for Novartis' Tobi Podhaler, 'no' for Forest's Colobreathe
The National Institute for Health and Clinical Excellence has made draft recommendations for the treatment of lung infection in patients with cystic fibrosis (CF), and the news is good Novartis but not so good for Forest Laboratories.

The cost regulator for the National Health Service has endorsed the use of Novartis' Tobi Podhaler (tobramycin inhalation powder) for treating pseudomonas lung infection in CF patients aged six years and above.

It has stipulated, however, that it should only be used in cases where treatment with the nebulised form of the drug is considered appropriate, i.e. when patients cannot have/don't respond to treatment with nebulised colistimethate.

Its recommendation is also contingent upon the continued availability of a confidential patient access scheme agreed with Novartis, under which the Tobi Podhaler is provided at a discounted price, helping to boost its cost effectiveness.

The Podhaler is a novel drug delivery system that delivers tobramycin inhalation powder in much less time - just five to six minutes, twice a day - compared to the nebulised form, which takes 20 minutes to administer, twice a day, decreasing treatment time by 72% and improving convenience while maintaining efficacy.

"This preliminary recommendation from NICE is really encouraging," said Diana Bilton, Consultant Respiratory Physician at the Royal Brompton Hospital, London. “Our experience is that patients really benefit from a swap to this antibiotic inhaler in terms of a reduction in treatment burden and being able to get on with life instead of spending time on a nebuliser.”

Forest's version barred

Meanwhile, Forest's Colobreathe (colistimethate dry powder for inhalation) was not recommended by the Institute as a cost effective option for treating chronic pulmonary infection caused by P. aeruginosa in people with CF.

The Committee noted that there was no economic analysis pitting the product against the nebulised form of colistimethate, while results of its preferred economic analysis showed that Colobreathe was "less effective and less costly than nebulised tobramycin".

Although there was a potential for cost savings, the clinical evidence for Colobreathe "was not robust enough to conclusively show that it is a cost-effective use of NHS resources", the Committee said.

Respiratory failure from chronic pulmonary infection caused by P. aeruginosa is the primary cause of death in patients with CF.

http://www.pharmatimes.com/mobile/12-10-26/Pharmaxis_Bronchitol_next_cystic_fibrosis_drug_to_get_the_nod.aspx

Pharmaxis' Bronchitol next cystic fibrosis drug to get the nod
The UK’s drugs watchdog has given another cystic fibrosis drug the thumbs up for NHS use this week – this time for Pharmaxis’ Bronchitol (mannitol dry power).

The final draft recommendation, which allows treatment in adults whose lung function is rapidly declining and who do not use inhaled mucolytics for certain reasons, follows the green light from the National Institute for Health and Clinical Excellence given to Novartis’ Tobi Podhaler (tobramycin inhalation powder) earlier this week.

Bronchitol is inhaled with a hand-held, breathe activated device. It acts by inducing an influx of water into the airway, improving hydration of airway secretions, and increasing mucus clearance by making it less thick and sticky and stimulating a cough.

The drug had previously not been recommended by NICE because of gaps and uncertainties in the evidence on its effectiveness compared with other treatments used in the UK. There was also some concern about the long-term effect of the drug on lung function.

However, Professor Carole Longson, health technology evaluation centre director at NICE, said the U-turn followed discussions with patient experts and clinical specialists who said Bronchitol, as a dry powder inhalation product, could ease the burden of living with cystic fibrosis. It was also associated with fewer side effects, was less costly and required less time to administer than nebulised treatments.

“Following the helpful responses received during consultation on the draft guidance, the Committee concluded that mannitol was a good use of NHS resources when treatment was offered to those who cannot use hypertonic saline or rhDNase and whose lung function is rapidly declining.”

The Cystic Fibrosis Trust has welcomed the positive decision, saying the drug is a key treatment that helps to improve the quality of life for people with cystic fibrosis, by reducing the burden of care.

Jo Osmond, director of clinical care at the CF Trust said: “This treatment is a step change in terms of improving quality of life and significantly improving lung function for people with CF, specifically because mannitol is a dry powder inhaled treatment used to aid lung clearance.”

Meanwhile, efforts continue to make the cystic fibrosis drug Kalydeco (ivacaftor) available on the NHS after the drug was denied on the grounds of cost. More than 12,000 people have signed a petition, organised by the Cystic Fibrosis Trust, which has been presented to the manufacturer Vertex requesting it to drop the drug’s price of £182,000 a year per patient. Kalydeco works in patients that have the specific G55ID gene mutation, which affects about 440 cystic fibrosis patients in the UK.

Kalydeco http://breathingforlife.vforums.co.uk/News/9457/kalydeco-ivacafto#reply-3

http://www.pharmatimes.com/mobile/13-01-11/NICE_to_create_idiopathic_pulmonary_fibrosis_guidance.aspx

Pharma Times - NICE to create idiopathic pulmonary fibrosis guidance

January 11, 2013
Ben Adams

NICE is creating new clinical guidelines on the management of idiopathic pulmonary fibrosis, and is asking for views on its recommendations.

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive disease associated with scarring of the lungs. Most people with the condition experience symptoms of breathlessness and a cough, which both lead to the decline of lung function, reduced quality of life and ultimately death. Each year, around 4,000 adults in the UK are diagnosed with idiopathic pulmonary fibrosis.

IPF is relatively rare and can be mistaken for other diseases – this new draft clinical guidance recommends that healthcare professionals, particularly GPs, should be aware of the clinical features of the condition to ensure patients have access to chest X-rays and specialist referrals.

NICE also says health professionals should look out for key signs and symptoms, such as, breathlessness, persistent cough, and respiratory crackles when listening to the chest, and clubbing of the fingers.

Once IPF is suspected, the NICE draft guideline recommends a diagnosis should only be made with the consensus of a multidisciplinary team, including always a chest physician, a radiologist and a specialist nurse, and that diagnosis should be based on a patient’s clinical features, lung function and radiological findings, with the addition of pathology when indicated.

NICE also provisionally recommends that at the time of diagnosis, people are assessed for pulmonary rehabilitation. It goes on to say that pulmonary rehabilitation should be tailored to each individual’s needs and can improve the wellbeing and quality of life for people with chronic breathing problems.

Professor Mark Baker, director of the centre for clinical practice at NICE, said: “Idiopathic pulmonary fibrosis is a chronic condition that significantly affects a person’s life. After initial symptoms, a person’s condition can decline rapidly, so it is vital that people have access to a timely diagnosis and access to the correct treatments and therapeutic interventions. There are no known causes of this chronic progressive condition, so healthcare professionals must be aware of the signs to be able to provide supportive care that can improve a person’s quality of life.

“We would urge all those registered as stakeholders in the development of this guideline to have their say on our draft recommendations, and submit their comments via the NICE website.” The draft consultation runs from Friday 11 January 2013 to Friday 22 February 2013, and can be found here.

In November, NICE launched a public consultation on its preliminary recommendation that InterMune’s Esbriet (pirfenidone) should not be recommended for the treatment of mild-to-moderate idiopathic pulmonary fibrosis.

The pill, the first of its kind for the disease, was deemed too expensive by the watchdog, and earned NICE a reprimand from the ABPI, which bemoaned its decision not to recommend the medicine.

A decision as to whether NICE will recommend the drug for NHS funding is expected later this year.

Drugs fund axe 'will hit 16,000 cancer patients' as experts claim access to medication will be worst in Europe

http://www.dailymail.co.uk/news/article-2264810/Drugs-fund-axe-hit-16-000-cancer-patients-experts-claim-access-medication-worst-Europe.html#ixzz2ISzhVjFa

The National Institute for Health and Clinical Excellence has suspended routine reviews of published clinical guidelines in 2013 and 2014.

Previously this routine review of the need to update a guideline was usually undertaken three years after its publication.

"At the moment the review process takes too long as it tends to overlap with a lot of the scoping process," says Professor Mark Baker, Director, Centre for Clinical Practice. "We want to redesign the review process so that it achieves what it is intended to do and no more."

"NICE will create a shortened and initially in-house process for the rapid updating of clinical guidelines which will be developed using staff within the Centre for Clinical Practice," continues Professor Baker. "The updates will take into consideration the latest drug information and pricing advice from the NICE Medicines and Prescribing Centre and will harmonise with the production of evidence updates.

"A criticism we have received in the past is that our guidance can become out of date as it is reviewed every three to four years. This can be the case in areas where there is a flood of new drugs on the market such as type two diabetes. In the future our guidance will be reviewed every two years with the expectation that an update of some extent will be more likely than not."

Researchers claim NHS drug decisions 'are flawed' http://www.bbc.co.uk/news/health-21170445

http://www.pharmatimes.com/mobile/13-01-25/Forest_and_Novartis_gain_NICE_yes_for_lung_infections.aspx

Forest and Novartis gain NICE yes for lung infections - Ben Adams PharmaTimes

In final draft guidance NICE has recommended Forest Lab’s Colobreathe and Novartis’ Tobi Podhaler as options for treating certain lung infections in people with cystic fibrosis.

Following the consultation on the previous draft guidance and submission of a revised patient access scheme – which cuts the cost of the drug - Colobreathe is now recommended as an option for treating chronic pulmonary infection caused by Pseudomonas aeruginosa in people with cystic fibrosis, but only in certain circumstances.

These include being used for those patients who would clinically benefit from continued Colobreathe treatment, but do not tolerate it in its nebulised form and thus Novartis’ drug would otherwise be currently considered. It is also contingent upon Forest discounting the drug’s price, which before any deals costs £1,936 for 56 days of treatment.

The treatment was initially knocked back by NICE last year, but the price cut now means the Institute is minded to recommend the treatment.

Novartis’ Tobi Podhaler is also recommended as an option for treating chronic pulmonary infection caused by P. aeruginosa in people with cystic fibrosis, but again with provisos.

These include when nebulised Colobreathe is contraindicated, not tolerated or has not produced an adequate clinical response, and again if Novartis offers the drugs under the revised patient access scheme. The list price cost for 56 days of treatment is £1,790 for this therapy, before any price cuts.

Professor Carole Longson, health technology evaluation centre director at NICE, said: “The primary cause of death in people with cystic fibrosis is respiratory failure resulting from chronic pulmonary infection caused by Pseudomonas aeruginosa. We are therefore pleased to recommend both colistimethate sodium and tobramycin dry powders for inhalation as options for treating such infections in people with cystic fibrosis.”

Cystic fibrosis is one of the UK’s most common life-threatening inherited diseases, and currently affects around 8,000 people. Symptoms of cystic fibrosis can include a troublesome cough, repeated chest infections, prolonged diarrhoea and poor weight maintenance.

The aim of treatment in adults with cystic fibrosis is to clear the respiratory secretions in order to maintain lung function, as well as to reduce inflammation and bacterial growth in the respiratory tract. Treatment includes regular physiotherapy, antibiotics, and inhaled mucolyticsi through a nebuliser. The main goal is to improve or maintain lung function.

Tobi Podhaler is inhaled using a breath activated, hand-held device and works by decreasing the amount of bacteria (Pseudomonas aeruginosa) in the lungs.

Colobreathe is also inhaled with a breath activated, hand-held device. It works by disrupting the structure of bacterial cells, which kills the bacteria.

One fifth of patients' drips 'are dangerous' http://www.bbc.co.uk/news/health-25298855

What is Nice? Drugs body Q&A
Nice explained: what does the National Institute for Health and Care Excellence do?

http://www.telegraph.co.uk/health/healthnews/10726095/What-is-Nice-Drugs-body-QandA.html

NICE conflicts of interest: Call for MPs to investigate http://www.bbc.co.uk/news/health-29705499