The train ride towards a new commissioning landscape will reach its final destination next April, but is already encountering leaves on the track along the way.

It’s been another eventful few weeks as the commissioning structure continues to take shape. On Monday 1 October, the NHS Commissioning Board (NHS CB) was finally formally established as an independent body with executive powers and exceptional responsibilities. But it will have to wait until April 2013 to take on its full range of responsibilities.

Professor Malcolm Grant, NHS Commissioning Board Chair, said the formal establishment was a “new phase
in the history of the NHS”. Sir David Nicholson, Chief Executive of the Board, called the new responsibilities the Board now holds a “once in a lifetime opportunity to do things differently”.

The transition completes a hectic twelve months for the Board. Having only been established at the end of October last year, it has played a fundamental role in the Government’s vision to modernise the health service as outlined in the Health and Social Care Act. Arguably its main and most important task, before it takes on full statutory responsibilities next April, has been to assist in the development and authorisation of more than 200 evolving clinical commissioning groups.

As you would expect, this has not been an easy process. Alongside the introduction of clinical commissioning, it has also been given the responsibility for authorising Commissioning Support Units
(CSUs), who will assist clinicians in the procurement of certain services. While this may seem a routine task compared with the authorisation of a raft of CCGs, the Board has been criticised for the time it has taken them to appoint managing directors for the CSUs when clinicians are finally in a position to tender services.

The Board has also issued its response to the Government on the draft mandate for its NHS care objectives. Professor Malcolm Grant agrees the mandate is “fundamental” to the Government’s vision of a ‘liberated NHS’. However, he urged David Cameron and Health Secretary Jeremy Hunt to be “ambitious” in searching for new opportunities to focus on the “outcomes that matter to patients and the public.”

Professor Grant said that the “critical tests” of the mandate will be whether newly empowered CCG leaders can address and analyse the mandate and then say ‘‘Yes, this gives me the necessary freedom to address the needs of my local population.” Grant added that the mandate “provides a unique opportunity to make this happen.”

The Commissioning Board has also been informed by the Department of Health of an initial set of specialist
services it will be expected to commission nationally. Although the central powers for commissioning have now been transferred locally, the NHS CB will still retain responsibility for certain services which are defined as treating rare and uncommon conditions and illnesses. The 38 specialist services, which were selected by the Clinical Advisory Group for Prescribed Services, include:

• Specialised Cancer Services (adults)
• Haemophilia and related bleeding disorders (all ages)
• Cystic Fibrosis services (all ages)
• HIV/AIDS treatment and care services (adults)
• Specialised Mental Health Services (all ages)
• Morbid Obesity Services (all ages).

A final set of regulations will be established later in the year on which services will be commissioned nationally – following a consultation between the DH and the NHS CB on the initial recommendations.

Board under fire
But it hasn’t all been clear sailing for the NHS CB. Alongside being accused of delaying the authorisation of certain CCGs because of its stuttering CSU MD recruitment drive, the Board has admitted that it has failed to recruit a significant number of individuals from ethnic minority backgrounds. Jo-Anne Wass, HR Director, admitted the Board’s recruitment data did “not make easy reading”.

Questions have also been raised about the huge variation between clinical commissioning groups’ internal staff levels when compared to support service organisations. Critics have argued that CCGs will be forced to rely heavily on support units after analysis showed huge variations in staffing levels. Recent estimates from the DH show there are 4,200–6,300 staff employed by CCGs. Commissioning support units are expected to employ around 8,000 people.

Dame Barbara Hakin, National Director for Commissioning Development, has also been put under the spotlight by the General Medical Council. The GMC has commenced an investigation after a complaint against the commissioning director, who allegedly placed United Lincolnshire Hospital Trust under unnecessary pressure in 2009 when she was Chief Executive of the now disbanded East Midlands Strategic Health Authority. It’s claimed that waiting times and A&E targets were prioritised ahead of patient safety, despite warnings the trust was over capacity. Depending on the outcome of the investigation, the GMC may decide to take no action, issue a warning, refer Dame Barbara to a fitness to practise panel where she may be ‘struck off’, or decide on undertakings to allow her to keep her registration.

Commissioning Groups
Yet despite the disparity in numbers, evolving CCGs appear to be in good shape. Following the successful scheduling of all of the wave one applications, the NHS CB confirmed that all 67 CCGs in the second authorisation wave had submitted their applications on time. In fact, every proposed CCG is now involved in an aspect of authorisation with the Board – be it a 360° stakeholder survey, a desk-top review, a case study or a site visit.

However, the authorisation process has been delayed. Initially the Board moved the ‘waves’ back by a month each. It subsequently moved the waves back by an additional month, meaning all CCGs will now be authorised by March 2013.

CCGs have also learnt when their final commissioning budgets will be confirmed. Commissioning Groups will have to wait until December to find out how much money they have been allocated to organise local services to meet the needs of their residents. The budgets will be decided using a system called the Fair Shares formula, which analyses the unique circumstances practices face and the health and wellbeing
of local populations.

Commissioners have aired frustration about the amount of ‘red tape’ they face when trying to organise new local health services. NHS Clinical Commissioners, who represent CCGs across the country, say bureaucracy is hindering doctors in their attempts to redesign new services. Dr Charles Alessi, Chair of the National Association of Primary Care, said there was an “overwhelming number of rules and regulations” which were having a significant impact on commissioners.

Supporting units
But it seems the frustration many commissioners have aired at the slow rate at which CSUs are being established may soon be coming to an end. David Stout has left the NHS Confederation to lead CSUs in Essex and Hertfordshire; Tim Andrews has also been given joint responsibilities at Cheshire, Warrington and Wirral CSU and at Merseyside CSU; Derek Kitchen will lead Staffordshire CSU and Lancashire CSU. Dr Leigh Griffin has also been appointed as the MD of Greater Manchester CSU – meaning only two of the 23 CSUs are still awaiting a permanent managing director.

While the NHS Commissioning Board is readily completing the authorisation process for CSUs it has recently been distanced from employing their support staff. The NHS Business Services Authority has agreed to employ some 8,000 staff during the hosting period up to 2016. The move means that although the NHS
CB will provide oversight and direction to CSUs it will not be the legal employer of CSU employees to avoid conflicts of interest. The new distancing arrangements were welcomed by the Board, who said it would help CSUs “develop appropriately as organisations in their own right.”

After confirming four lead CSUs to provide communications and engagement services around the country last month, the Commissioning Board will now focus on assisting support units to provide services and help to CCGs through the authorisation process, to ensure they are as individually autonomous as possible, to
help CSUs develop to become specialist suppliers and to ensure units seize opportunities open to them.

As the NHS reforms continue to evolve it would seem the commissioning landscape is far from being complete. It’s going to be a busy few months.

The FDA has fast-tracked the New Drug Application (NDA) of Salix Pharmaceuticals’ Crofelemer for the control and relief of diarrhoea in people with HIV/AIDS on anti-retroviral therapy (ART).

The Priority Review designation is granted for treatments which are believed to offer major advances in treatments, or provide welcomed options where no adequate therapy exits.

Bill Forbes, Executive Vice President, Medical, Research and Development, and Chief Development Officer, Salix, says the review “signals” the belief the FDA has in the tablets.

Around half of the 1 million people in the US living with HIV/AIDS currently take an ART. Approximately 30% of these experience episodic or chronic diarrhoea.

Crofelemer is a first-in-class, gastrointestinal agent of botanical origin. Investigational studies support the use of the tablets as an anti-secretory, anti-diarrheal agent that may provide relief to patients through the inhibition of chloride secretion by both gut CFTR (Cystic Fibrosis Transmembrane Conductance Regulator Protein) as well as gut CaCC (calcium-activated chloride channel).

“We are pleased with the FDA’s acceptance of the NDA for Crofelemer and their decision to grant Priority Review for our application,” said Bill Forbes. “We believe the availability of Crofelemer has the potential to change the treatment paradigm for HIV/AIDS patients suffering from diarrhoea.”

An action date of June 5^th 2012 has now been set for the Priority Review.

The North Carolina-based company develops and markets prescription products for the treatment of gastrointestinal diseases.

Gilead Sciences has become the first pharmaceutical company to sign a licence agreement with the Medicines Patent Pool to improve the access of HIV medicines to developing countries.

The agreement will see generic versions of HIV and Hepatitis B treatments available at lower costs and in easier to use formulations without the delays which currently occur.

Ellen ‘t Hoen, Executive Director of the Medicines Patent Pool, says the agreement is a “milestone in managing patents for public health”.

The World Health Organization estimates that as many as 15 million people currently require HIV treatment, and expects that figure to double within the next five years.

The landmark licence will allow generic versions of Gilead’s products to enter the market shortly after they have been launched in western markets.

The agreement allows for the production of tenofovir, emtricitabine, cobicistat, and elvitegravir, as well as a combination of these products in a single pill known as the “Quad”. The development and other combinations that include these medicines will also be made available.

Gregg Alton, Executive Vice President, Corporate and Medical Affairs for Gilead Sciences, says the company hopes to see the Pool become an “effective mechanism” for increasing important treatments in “resource-limited parts of the world”.

The Pool, established in July 2010 with the support of UNITAID, aims to collaborate with other pharmaceutical companies to expand global access to quality, low-cost antiretroviral therapies through the licensing of patents.

Philippe Douste-Blazy, Chair of the UNITAID Executive Board, said: “I salute this first important step by Gilead and urge other pharmaceutical companies to place their intellectual property at the service of global public health.”

The HIV/AIDS market in Europe will exhibit strong growth due to the introduction of novel drug classes and increasing efforts to achieve high diagnosis rates, industry analysts Frost & Sullivan predict.

The market faces a number of hurdles in the form of late diagnosis and low awareness levels. However, new analysis from Frost & Sullivan, European HIV/AIDS Therapeutics Markets, finds that the markets earned revenues of $3.88 billion in 2008 and estimates this will reach $6.79 billion in 2015.

“Market growth will be spurred by the new drug classes and combination therapies introduced recently,” notes Sylvia M. Findlay, programme manager Pharmaceuticals & Biotechnology from Frost & Sullivan. “Novel drug classes which treat drug resistant HIV strains are expected to be used in combination with first-line therapy in experienced patients. Combination therapies which minimise side-effects and pill burden are supporting market development.”

A difficult market

New drug classes are being researched and introduced into the market, especially targeting experienced patients, Frost & Sullivan explains. These drugs are being tested in clinical trials for use in combination with established first-line therapies and also as first-line therapies themselves. Proving the long-term safety and efficacy of these drugs is anticipated to boost their uptake and revenues.

The analysts point out, however, that Europe is at a disadvantage because of the ban on direct-to-consumer marketing and because the launch and uptake of drugs is slower than in the US market. Social stigma and discrimination associated with HIV/AIDS, especially in Eastern Europe, is further limiting the growth potential of the market.

“Europe is a very diverse market where epidemiology, regulations and awareness levels vary considerably,” explains Miss Findlay. “The level of adherence to recommended therapy regimens varies across the region, largely due to the lack of awareness about the safety and efficacy profiles of drugs used.”

Moreover, she adds, diagnoses rates, which are influenced by awareness and societal pressures, vary across the region. This demands the formulation of region-specific strategies to promote market growth.

Call to action

Frost & Sullivan urges companies to update their knowledge of epidemiology, promote adherence to recommended therapies and enhance awareness on a continuous basis. Companies need to devise strategies to address challenges that impede the growth of their product portfolio, they argue. Market participants should use prescription trends to assess the market potential for their drugs, both as a first-line and a second-line therapy.

“Physicians are the sole point of contact for patients in Europe, given the absence of direct-to-consumer marketing,” says Miss Findlay. “Analysing prescription trends and patients’ perception towards new drugs as well as the drugs they are currently using is imperative to maintain patient base.”

Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best in class positions in growth, innovation and leadership. The company leverages over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 35 offices on six continents.