National Association of Primary Care - Partners

NAPC News 17 August 2012

Cluster Revokes Policy After Legal Threat

A primary care trust cluster that faced legal action of recommending the use of an unlicensed drug has revoked its policy after the pharmaceutical company cut the price of the medication.

Novartis launched judicial review proceedings against the Southampton, Hampshire, Isle of Wight and Portsmouth cluster earlier this year.

The company claimed the cluster’s decision to recommend clinicians use the unlicensed Avastin over its own licensed drug, Lucentis for the treatment of age-related macular degeneration was unsafe.  However, the cluster insisted there was evidence to show Avastin was just as efficient as Lucentis and was also a tenth of the cost.

Avastin is licensed for the treatment of bowel cancer but not for use in the eye.  Studies have shown it to have the same outcomes as Lucentis, but there are some concerns about its safety.  It is not recommended for the treatment of wet AMD by the National Institute for Health and Excellence.

However, Novartis has agreed to reduce the price in excess of the discount offered by an existing national patient access scheme.  It is understood the company is keen to come to similar arrangements with other commissioners, provided they have a satisfactory policy regarding the prescription of Lucentis.

The price cut is part of a national patient access scheme.  Such schemes have become increasingly common in the past two years at both local and national level.  However, pharmaceutical companies closely guard the actual discount from the price list to protect their prices elsewhere in the world.

The agreement to reduce the price comes as a competitor drug, Bayer’s aflibercept, has been licensed in the United States.  European licensing is expected to follow.

GSK Sells Australian Brand To Aspen

GlaxoSmithKline has sold a portfolio of 25 of its Australian brand to Aspen for £172m, including the herpes treatment, Valtrex, the epilepsy drug, Lamictal, the antibiotic, Amoxil, and antidepressant, Aropax.

The sales were part of its drive to sell low-growth or non-core businesses and to focus on ‘priority brands, products and pipeline opportunities that have long term growth potential.

Elan Spin Off Fuels Talk Of Takeover

Days after it admitted that a hoped for breakthrough treatment for Alzheimer’s disease had failed its final trials, Elan Corporation announced that it is to spin off its loss making research unit, Neotope, in a move that will immediately make the pharmaceutical company profitable.

Splitting off Neotope will also fuel speculation that Biogen Idec, which Elan partners to market multiple sclerosis drug, Tysabri, could use the separation to take full control of the drug by buying Elan.

Pfizer’s Unit To Float In United States

Pfizer’s animal health unit, Zoetis, filed for a $100m initial public offering as it narrowed its focus on its core prescription business.

AstraZeneca Sells Heartburn Pill

Pfizer has agreed to pay AstraZeneca $250m to secure the exclusive global rights to the over the counter version of the heartburn pill, Nexium, that will lose patent protection in the United States in

AstraZeneca will continue to manufacture and market the prescription version of Nexium and will receive milestone and royalty payments from Pfizer, based on the launch and sales of two years’ time.the drug.  It filed a marketing authorisation application for Nexium in 20mg tablets with the European Medicines Agency in June and is aiming for a new drug application in the United States for 20mg capsules in the first half of next year.  If approved, Pfizer could begin US sales in 2014.

AstraZeneca has been with a permanent chief executive since the departure of David Brennan in the spring, but this has not been evident with the rate of deals emerging from the company.

New Drug Hope For Thyroid Cancer

A new drug almost doubles survival rates in patients with the most common type of thyroid cancer.

A trial for patients with advanced differentiated thyroid cancer showed those treated with vandetanib survived almost twice as long as those on a placebo.

Australian Court Upholds Plain Packaging Law

Australia’s High Court has upheld a controversial new law on tobacco promotion, which will soon prevent manufacturers from placing logos on cigarette packs.

The legislation will come into effect in December, as planned, with tobacco companies no longer able to print distinctive colours, brand designs or logos on packs.

Instead, cigarette cartons will be a uniform olive colour and will merely feature graphic health warnings and images of the effects of smoking on the body.

Government ministers and health experts believe the move will make smoking less attractive to children,, but tobacco companies had protested that it would devalue their trademarks.

In a joint statement on the ruling, attorney general, Nicola Roxon, and health minister, Tanya Plibersek, said: ‘This is a victory for all those families who have lost someone to tobacco-related illness.  No longer when a smoker pulls out a packet of cigarettes will that packet be a mobile billboard.

Peter Hollins, chief executive of the British Heart Foundation, described the Australian court ruling as a ‘triumph’ and urged countries around the globe to take similar action.

Mandate Criticised For Being Too Detailed And Confused

NHS Commissioning Board directors have criticised the draft mandate the government has set for them as being confused, too detailed and over-reaching in its purpose.

Directors discussed the document at a recent meeting and resolved to work with the Department of Health to rewrite it.

Board chair, Malcolm Grant, said it was ‘impossible to underestimate the importance’ of the mandate, parts of which ‘completely fit with the government’s objective of liberating’ the NHS, and specifying desired improvements in outcomes.

However, ‘there are other parts where you might find the mandate goes further than you would have wished’, he said.  ‘I hope we would, over the coming weeks, have an opportunity to review those parts and have constructive discussion ……… as to how we can ensure that we do deliver the government’s overriding objective for the mandate, which is a liberated NHS.’  He added that clinical commissioning groups must be given the freedom to improve services through trial and error.  

Professor Grant said the Board could work with the Department of Health to create a mandate, ‘which would not be more of the same, but something quite inspirational’.

Commissioning Board chief executive, Sir David Nicholson, said: ‘There is something here we can work on but it is some way from where we need to be.  Where you have process-driven targets you need to be really clear about how, why and what for.  Just listing thins is difficult to communicate and difficult to work with people on.’

Tim Kelsey, the Board’s director for patients and information said: ‘If this document does not provide the kind of manifesto for a very positive, but real disruption in the service of patients, then we’ve just lost a massive historic opportunity.

Policy director, Bill McCarthy, said the final document must ensure CCGs had the ‘headroom’ to enable them to make the right decision locally and to be creative and innovate.  A Board paper in his name said: ‘The NHS Commissioning Board intends to give CCGs freedom to innovate ,which we can only do if the government allows us that freedom’.