Commissioning Board again delays CCG authorisation

by IainBate 12. October 2012 12:18

NHS_commissioningBoard The NHS Commissioning Board has pushed the dates by which CCGs will be fully authorised back by another month – for the second time.

Key meeting dates as part of the authorisation process have been confirmed and show that all CCGs will now be authorised in March instead of February 2013.

Meetings with the moderation panel, the conditions panel and the CCG authorisation sub-committee will be completed by:

  • Wednesday 5 December 2012 for CCGs in wave 1
  • Friday 18 January 2013 for wave 2
  • Friday 15 February 2013 for wave 3
  • Wednesday 6 March 2013 for wave 4

The Board’s moderation panel will make recommendations as to whether commissioning groups should be fully authorised or authorised with conditions. A meeting will then take place with the conditions panel who will consider what support a CCG requires if it has not supplied sufficient evidence to meet a threshold for one or more authorisation criteria. Finally, the CCG authorisation sub-committee will make the final authorisation decision.

The conclusions from each meeting will be published immediately after they have taken place – once decision letters have been issued to CCGs.

Despite the NHS CB confirming the dates by which the authorisation process will be completed, the Board has yet to confirm the individual dates for wave 4 CCGs moderation and sub-committee meetings. Additionally, dates for the moderation and conditions panel for waves 2 and 3, and when the conditions panel for wave 4 CCGs will visit are still being agreed by the Commissioning Board.

The schedule as it stands is:

Meeting

Date

Wave 1

Wave 1 Moderation Panel

23/10/2012

Wave 1 Conditions Panel

02/11/2012

Wave 1 Sub-committee

05/12/2012

Wave 2

Wave 2 Moderation Panel

13/11/2012

Wave 2 Moderation Panel

26/11/2012

Wave 2 Conditions Panel 1.1

23/11/2012

Wave 2 Conditions Panel 1.2

03/12/2012

Wave 2 Conditions Panel 1.1

07/12/2012

Wave 2 Conditions Panel 1.2

10/12/2012

Wave 2 Sub-committee

18/01/2013

Wave 3

Wave 3 Moderation Panel 1

11/12/2012

Wave 3 Moderation Panel 2

07/01/2013

Wave 3 Conditions Panel 1.1

08/1/2013

Wave 3 Conditions Panel 1.2

11/01/2013

Wave 3 Conditions Panel 2.1

15/01/2013

Wave 3 Sub-committee

15/02/2013

Wave 4

Wave 4 Moderation Panel

28/01/2013

Wave 4 Conditions Panel 1

05/02/2013

Wave 4 Conditions Panel 2

08/02/2013

Wave 4 Sub-committee

06/03/2013

CCG struggling with ‘ridiculously tight’ deadline

by IainBate 2. October 2012 17:01

CCG News NHS Croydon Clinical Commissioning Group is struggling to meet the NHS Commissioning Board’s (NHS CB) deadline for authorisation, its chair has admitted.

Dr Anthony Brzezicki said the December deadline set by the NHS CB was “ridiculously tight”.

The CCG is in the fourth and final wave of the authorisation process and should be fully authorised next February.

At the first open board meeting of the Group, commissioners also revealed they are struggling to meet NHS savings targets.

Mike Sexton, Finance Director, said that Croydon PCT was £4m short of reaching a £25m target to break even by the end of the financial year.

“Our objective is to still as far as possible to achieve the break-even position by the end of the year,” he said. “That is an incredible challenge but we want to be able to do it in a way that does not affect patient care.”

Commissioners also outlined plans to reduce the number of patients visiting A&E outside of working hours. Research found that parents are taking their children to emergency services for minor treatments such as doses of Calpol or Nurofen.

Around 150,000 people visit local emergency departments in the area each year. That figure could rise by another 20,000 if services are cut at St Helier Hospital in Sutton. It’s estimated that each A&E visit costs a minimum of £59.

The CCG is now developing a partnership with local pharmacies and educational facilities to raise awareness of alternative treatment options.

CCG authorisation dates pushed back

by IainBate 14. September 2012 16:33

CCG News The authorisation dates for clinical commissioning groups have been pushed back a month by the NHS Commissioning Board.

The Board has extended its original deadlines to allow for an extra period of dialogue between itself and the commissioning groups in the four separate waves of authorisation.

Dame Barbara Hakin, Managing Director of Commissioning Development, said the delay was not “material” in the day to day running of CCGs across England.

The switch means CCGs in wave one of the authorisation process will now be confirmed in November, rather than next month. Waves two, three and four have also been similarly affected. All CCGs should now be fully authorised by February 2013.

Board papers from the Commissioning Board’s recent monthly meeting also revealed how authorisation process will work. CCGs will be initially assessed by the Board’s local area teams. Those findings will then be reviewed by a ‘moderation panel’ to ensure applications are consistent across the country.

Applications will then be assessed by a ‘conditions panel’ which will apply further checks before the Board completes the authorisation process. CCGs will be able to discover the outcomes of the ‘conditions panel’ in order to supply any comments or new evidence to prevent the need to have any conditions imposed upon them.

EC approves DuoCort's adrenal insufficiency therapy

by Emma 8. November 2011 16:50

 

The European Commission (EC) has authorised DuoCort Pharma’s Plenadren (hydrocortisone) to be marketed in the EU for the treatment of adrenal insufficiency.

The dual release hormone replacement therapy is the first pharmaceutical innovation in over 50 years for adults suffering from adrenal insufficiency, or cortisol deficiency.

Professor Gudmundur Johannsson, Chief Medical Officer at DuoCort Pharma, said: “Plenadren offers a welcome new treatment option to help patients suffering from adrenal insufficiency. It can improve therapy for many of the almost 200,000 patients in Europe who suffer from this disease and who need lifelong cortisol replacement therapy for their survival.”

The once-daily tablet is designed to imitate the normal physiological cortisol profile, with an outer layer that releases hydrocortisone immediately into the bloodstream and an inner core releasing the rest of the medicine gradually throughout the day.

Although glucocorticoid replacement therapy for adrenal insufficiency has been available for decades, complications have been linked to the medication, including premature death, impaired quality of life, increased risk of cardiovascular diseases, and decreased bone mineral density.

Adrenal insufficiency (cortisol deficiency) is a rare, life-threatening disease that affects patients in their active years. Patients require lifelong replacement therapy with hydrocortisone, the synthetic form of cortisol, replacing or substituting the hormones that the patient's adrenal glands are not producing.

DuoCort Pharma provides drug development with a focus on improving glucocorticoid therapy. The company is currently being absorbed by ViroPharma, who acquired the pharmaceutical company for an upfront payment of $33 million dollars in October.

Cluster time

by emma 4. November 2011 15:32

Cluster time

Despite the ongoing criticism of the Health Bill as it passes through the House of Lords, structural changes are still happening at ground level. Dr Thoreya Swage outlines the timescale for changes as PCT clusters switch responsibilities to CCGs.

The momentum of reform of the National Health Service in England continues to gather pace. Following a four month hiatus while the wise and the good of the NHS Future Forum pondered and produced recommendations for the adjustment of the Bill, the DH published further guidance on the developing role of the Primary Care Trust (PCT) clusters.

Although the 151 PCTs have been squeezed into fifty-one PCT clusters in preparation for their demise in April 2013, it seems that they have a vital part to play in the development of the emerging Clinical Commissioning Groups (CCGs).

This guidance or ‘shared operating model for PCT clusters’ has been produced by the mandarins at the DH to ensure that the commissioning landscape is as consistent and smooth as possible in time for the takeover by the CCGs. This is so that the nascent NHS Commissioning Board inherits a robust enough system to take account of further developments and improvements in healthcare in early 2013.

 

A shared model

There are six main functions or ways of working for the shared operating model for the clusters. These have been identified where consistency of approach is considered to be of importance and they are listed as commissioning development, financial and operational issues, ensuring quality, emergency planning, development of providers as Foundation Trusts and communications.

 

CCG development

The most important function is the preparation of CCGs for authorisation as soon as possible following the successful passage of the Health Bill through Parliament. The process of authorisation to become fully fledged commissioners is due to begin in the second half of 2012.

Although this is a year away, CCGs can commence their preparations now using a self diagnostic tool – an interactive computer-based assessment that helps them to determine their capability in six domains and identify their development needs.

The areas covered include:

  • A clear clinical focus of the CCG commissioning plans to include tackling health inequalities and improving primary care
  • Demonstration of meaningful involvement of patients and the wider community
  • A plan for development that is clear and credible which, in particular, delivers the QIPP (quality, innovation, productivity and prevention) agenda
  • Capacity and capability of the CCG, i.e. robust constitutional and governance arrangements which enable the CCG to commission care effectively and ensure financial control
  • Collaborative arrangements for working with other CCGs, local authorities and the NHS Commissioning Board
  • Capacity and capability of the CCG leadership which ensures effective working.

The tool helps the CCGs identify priority development areas which form the basis of the developmental plan paving the way to full authorisation.

To support all this work CCGs will receive £2 per head from the PCT clusters as well as extra management resource to help the groups hone their commissioning skills and capability.

CCGs experiencing difficulty in defining their boundaries will have guidance from PCT clusters on how to resolve this. PCT clusters also have the unenviable task of engaging the reluctant practices that so far have not participated in their local CCG discussions, with the aim of being part of a viable commissioning group by October.

 

Separating commissioning functions

All through the last quarter of this year a very detailed exercise is being carried out by PCT clusters to identify and segregate the service areas that CCGs and the NHS Commissioning Board will be responsible for. Although CCGs will be commissioning acute, mental health, community and ambulance care there are other services that PCTs currently commission which will need to be transferred to the Board.

Services such as GP and other primary care contractor groups – primary dental care, pharmacy and optical services – secondary dental care, prison, specialised and military health services are set to go under the umbrella of the NHS Commissioning Board. Even though the contracts for GP services are held by another body, the CCGs are expected to have an input into primary care development and improvement.

 

Quality assurance

A vital component of the commissioning process is ensuring the quality of healthcare. Practices may have been involved to a greater or lesser degree in various quality assurance processes in the past. However, CCGs are required to take on board these responsibilities seriously.

There is a whole raft of procedures and measures including delivery of better health outcomes for patients, meeting the Care Quality Commission (CQC) requirements for safety and quality of services, standard contracts, the NHS Operating Framework, professional guidance and other relevant requirements that CCGs need to get to grips with.

This could potentially be a vulnerable time for the development of the CCGs if attention wanders and serious patient safety incidents are not acted on promptly. Clinical governance processes must therefore be extra secure.

 

Budgets and responsibilities

Over the next year or so there will be a period of dual functioning and handover as the CCGs mature and the PCT clusters delegate more and more responsibilities until April 2013. The handing over of the baton has started now with PCT clusters having identified a “clear percentage of budgets” to CCG pioneers or pathfinders in August and plans for future delegation of budgets set by October.

Sandwiched in between will be the agreement on which mental health and community services will be subject to ‘Any Qualified Provider’ (AQP). This policy is set to be implemented from April next year when GPs can refer to providers of certain services eligible for AQP from a list of approved organisations, including the private sector, drawn up by the DH.

A review of commissioning support required by CCGs has already been undertaken in July with clear arrangements agreed by the end of the year.

In March next year, CCGs will be required to enable the development of the local health and wellbeing boards supported by their PCT clusters – health and wellbeing boards being the mechanism for joint health and social care planning and commissioning locally.

Meanwhile, individual PCTs will continue to carry out their statutory functions through the clusters until their abolition in April 2013. The statutory functions include contract monitoring, ensuring that providers meet their QIPP obligations and other statutory requirements, for example, safeguarding children and vulnerable adults.

The big challenge for CCGs will begin when they will be required to lead the next planning round for 2012/13. This begins in the latter part of this year and is a function previously undertaken by the PCTs.

This will involve doing a needs analysis, identifying local inequalities, understanding demand and activity for local services, negotiating and setting priorities with partners and developing the local strategic vision. Handover of commissioning functions will continue with CCGs being an active participant in the subsequent contract negotiations and agreement.

 

The outside world

It is apparent that despite the pause for reflection on the proposed changes in the NHS earlier this year, the momentum for restructuring and dissolving healthcare organisations continues. The picture remains a little confusing however, as CCGs are in varying stages of development and maturity and it is not clear that all will be truly viable by the tight deadline set for October.

What is clear is that that work of commissioning and delivering healthcare has to go on and now is a good time to find out who the key movers are within the CCGs.

It is at this point in time when the developmental needs of CCGs will be uppermost and it is here that pharma can provide some input. Skills and knowledge in leadership development and highlighting therapeutic areas where evidence-based care really works are two such possibilities.

CCGs will be keen to smooth patient pathways across primary and secondary care and nowhere is this more pertinent than in prescribing effectively. Delegated prescribing budgets are now very real for CCGs and they will be keen to ensure value for money and improvements in care for their patients. This provides a good opportunity for pharma companies to demonstrate the effectiveness of their drugs in specific disease areas.

On the commissioning front, by December of this year, CCGs and PCT clusters will have had to agree what commissioning support they need to carry out this function. Given the requirement to reduce costs, commissioning skills and expertise may actually be thin on the ground within CCGs.

Bearing in mind that effective commissioning will be judged by outcomes achieved as outlined in the NHS Outcomes Framework, pharma is well placed to demonstrate how their products can meet the requirements of domain 1: preventing premature deaths, domain 2: enhancing the quality of life of people with long-term conditions and domain 3: aiding the recovery of people who have an acute illness or injury.

The next few months will be busy while the NHS sorts itself out structurally. Once the picture begins to clear, pharma will need to engage with the new clinically skilled commissioners who now have the financial responsibility for making decisions about healthcare.

Thoreya Swage Dr Thoreya Swage was formerly an NHS clinician and a senior manager in various NHS organisations covering acute and primary care. She has expertise in commissioning health services and is currently working for a number of NHS organisations, including DH agencies, to develop a more commercial approach to the commissioning of healthcare.

Servier osteoporosis pair under EMA review

by emma 24. October 2011 10:36

Protelos

A review has begun into the benefit-risk profile and the conditions of use of Servier’s Protelos (pictured) and Osseor following cases of venous thromboembolism (VTE) and drug rash with eosinophilia and systemic symptoms (DRESS).

The EMA is now analysing strontium-ranelate-containing osteoporosis medicines after links to cardiovascular and cutaneous events were found.

The CHMP says it is now reviewing all relevant data into the links before making a decision whether to change the benefit-risk balance of the medications.

Protelos and Osseor were authorised via the centralised procedure in September 2004 and are indicated for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.

The EMA says that VTE and DRESS are known risks of these medicines and are addressed in the risk management plan and have been closely reviewed by the CHMP since their authorisation.

A study analysing the side effects associated with strontium-ranelate-containing medicines noted that there were 199 severe adverse reactions between January 2006 and March 2009. More than half of these (52%) were cardiovascular and more than a quarter (26%) were cutaneous.

The authors of the study concluded that DRESS is unpredictable but the VTE risk could be reduced by adding a contraindication for patients with a risk of cardiovascular risks and by stopping treatment if a new risk occurs.

Based on recent pharmacovigilance update and pending an European review, the French competent authority Afssaps have advised restricting the use of medication including strontium ranelate to patients who are under 80 years of age, at high risk of fractures and who cannot take bisphosphonates.

Novo’s insulin get double boost

by emma 27. September 2011 16:57

Levemir

The CHMP has given a positive opinion to Novo Nordisk’s basal insulin analogue Levemir as an add-on treatment in patients with type 2 diabetes.

The opinion is based on a clinical trial where, as an add-on therapy to Victoza, in combination with metformin, reduced glycated haemoglobin (HbA1C) and sustained weight loss were demonstrated.

Alan Moses, Global Chief Medical Officer at Novo Nordisk, says the decision provides an “additional treatment option” for patients who need more options to achieve personalised glucose targets.

Meanwhile, the Committee has also adopted a positive opinion on the extended use of the insulin in children aged between two and five years old with type 1 diabetes.

It reviewed data that showed children treated with Levemir plus a fast-acting insulin analogue experienced a lower rate of all-day and nocturnal hypoglycaemia when compared to those taking human basal insulin and insulin aspart.

Dr Nandu Thalange, Norfolk and Norwich University Hospital, says that when treating children their safety must always come first and welcomed the CHMP’s decision. “Reducing risk of hypoglycaemia – particularly at night – is a vital part of modern management of young children with diabetes,” said Dr Thalange. “Children under six years are at the highest risk of severe hypoglycaemia and other acute diabetes complications, and any treatment which improves safety – not least in this group – is to be welcomed.”

Novo Nordisk now anticipates that the European Commission will shortly approve the usage of Levemir as an add-on therapy to Victoza in patients with type 2 diabetes and extend the marketing authorisation to make the insulin detemir the only basal insulin analogue for the use in this young patient group with type 1 diabetes.

Levemir, Victoza and NovoRapid, another insulin therapy by Novo Nordisk, contributed to a profit increase of 27% for the company in 2010.

Review begins into orlistat-containing medicines

by emma 26. September 2011 13:18

Pf industry news

The EMA has opened a review of all orlistat-containing medicines to determine whether rare cases of liver injury have an impact on their benefit-risk profile and conditions of use.

Anti-obesity medicines, including centrally authorised medicines Xenical (orlistat 120mg) and Alli (orlistat 60mg), plus medication already, or in the process of being authorised, will be analysed.

The Agency says the risk of liver reactions with this type of medicines if “well known” and has been kept under “close review” by its CHMP since the initial marketing authorisations were issued.

Risks are already reflected in the product information for products centrally authorised with the EMA and also addressed in the risk management plan for the medicines.

Between 1997 and January this year, the EMA says there were 21 cases of suspected serious liver toxicity in patients using Xenical for which a link to the medicines cannot be excluded. Of the 21 cases, the most recent analysis identified four cases of severe liver toxicity.

During May 2007 and January 2011, there were a total of nine reports of severe liver injury with Alli, although in some cases there were possible explanations for the hepatic issues.

Despite the number of severe cases, the Agency says they must be taken into consideration when 38 million patients use Xenical and 11 million people use Alli.

The CHMP is now harmonising the product information of information for the two centrally authorised medicines and will review all relevant data on the risk of hepatotoxicity before issuing an opinion whether the drugs should be revoked, suspended or changed.

First ‘child’ approval granted to epilepsy treatment

by emma 9. September 2011 15:16

Pf product news

ViroPharma’s Buccolam has been specifically licensed for infants, children and adolescents to treat severe convulsions and epileptic seizures in Europe.

It is the first children’s medicine to be granted the Paediatric Use Marketing Authorisation (PUMA), delivering an age-specific dose in the right form for the child.

Dr June Raine, Director of Vigilance and Risk Management of Medicines, MHRA, said: “They are not simply ‘small adults’ and they respond differently to medication”.

The midazolam and oromucosal solution comes in a pre-filled syringe indicated for patients aged three months to 18 years of age.

The dose is administered via the cavity between the cheek and gum, a less invasive method than its current treatment option, which is rectally-administered diazepam.

The marketing authorisation is based on data gathered from four clinical trials testing Buccolam against diazepam, where Buccolam proved to be either comparable to, or better than the existing treatment.

“Children should have access to medicines that have been especially designed for them,” added Dr Raine.

The medicine previously received a positive opinion in June from the Committee for the Medicinal Products for Human Use (CHMP) and will now be available across the EU as well as Norway, Iceland and Liechtenstein.

Thierry Darcis, Vice President and General Manager of ViroPharma Europe, said: “We look forward to working closely with physicians across Europe as we launch Buccolam into the European markets”.

DH outlines CCG authorisation process points

by emma 19. August 2011 10:00

Pf NHS News

A draft document by the DH has set out a list of key points of the authorisation process for clinical commissioning groups (CCG).

The document, Developing clinical commissioning groups: towards authorisation, discloses the six attributes that the NHS commissioning board will expect CCGs to have:

  • A strong clinical and professional focus which brings real added value
  • Meaningful engagement with patients, carers and their communities
  • Clear and credible plans which continue to meet the Quality, Innovation, Productivity and Prevention (QUIPP) challenge within financial resources
  • Proper constitutional and governance arrangements, with the capacity and capability to deliver all their duties and responsibilities, including financial control as well as effectively commission all the services for which they are responsible
  • Collaborative arrangements for commissioning with other CCGs, local authorities and the NHS commissioning board as well as the appropriate external commissioning support
  • Leaders who individually and collectively can make a difference

The document also “sets out some areas where we anticipate the NHS commissioning board will wish to focus in authorisation”.

The NHS Commissioning Board will use the information to decide whether CCGs are ready to take on commissioning budgets or if they need financial support.

National Director for Commissioning Development Dame Barbara Hakin has urged CCGs to focus initially on achievements concerning patients and “how they can be really different”.

The “road map” begins in October, when CCGs, assisted by strategic health authorities, are expected to carry out a risk assessment of their size and shape. Those judged too risky will be rated “red”.

But if successful, groups will be able to take on a full range of functions from April 2013. Authorised CCGs will also undergo an annual assessment.

A full authorisation framework will be published in early 2012.

TextBox

Tag cloud

Calendar

<<  May 2013  >>
MoTuWeThFrSaSu
293012345
6789101112
13141516171819
20212223242526
272829303112
3456789

View posts in large calendar