Posts Tagged ‘NICE’

NICE to review local formularies to end post-code prescribing lottery

February 7, 2012

NICE is to produce a best practice guide to help trusts develop local formularies, as part of a move to ensure that all patients in England have access to clinically and cost-effective drugs.

Local formularies provide a list of selected or preferred drugs available to local prescribers and have an important role in underpinning safe and effective use of medicines.

However, there is currently no standard process or advice for putting together a local formulary which has led to variations across the country.

Medicines Management departments within many PCTs currently operate a controversial traffic light sytem of red lists and green lists, which does not necessarily reflect NICE guidance.

A recent report into innovation in healthcare by The Department of Health has highlighted that not all local formularies are including all of NICE’s technology appraisals. This can lead to a postcode lottery where patients miss out on drugs approved by NICE.

In some cases, local formularies are duplicating NICE assessments and challenging appraisal recommendations, acting as a barrier to the uptake of NICE-approved medicines.

The report states that the Department of Health is “committed to ensuring that NHS patients have access to clinically and cost-effective drugs and technologies, and that NICE appraisal guidance is promptly delivered throughout the NHS.

“There should be no local barriers to accessing technologies recommended in NICE appraisals, beyond a clinical decision relating to an individual patient.”

The report recommends that formulary processes should proactively consider the impact of new NICE Technology Appraisals, and all NICE Technology Appraisal recommendations should – where clinically appropriate – be automatically incorporated into local formularies.

This process should take place within 90 days to support compliance with the three month funding direction and the NHS Constitution ensuring that these medicines are available for clinicians to prescribe, should they choose to, in a way that supports safe and clinically appropriate practice.

To help achieve this, NICE will develop a best-practice guide covering the creation and review of local formularies to assist local trusts and clinical commissioning groups.

Dr Gillian Leng, Deputy Chief Executive of NICE said: “NICE will embark on a specific piece of work to look at how local formularies are put together. At the moment there is no standard process for them and there tends to be a lot of variation and inconsistencies across England. This has been flagged up in the recent NHS Innovation report.

“NICE will produce a best-practice guide on how to develop a local formulary. We will be holding a workshop to develop the guide, which will then go out to consultation before being published later this autumn.”

“NICE-approved drugs should not be excluded from local formularies on the grounds of cost. We want all patients to have access to medicines that we consider to be effective,” added Dr Leng.
Elsewhere, the report outlines plans to introduce, within three months, a NICE Compliance Regime for the funding direction attached to NICE technology appraisals to ensure rapid and consistent implementation throughout the NHS.

The Department of Health will also establish a NICE Implementation Collaborative (NIC) to support the implementation of NICE guidance. The NIC will bring together the NHS Commissioning Board, NICE, the Chief Pharmaceutical Officer, the main industry bodies, the NHS Confederation, the Clinical Commissioning Coalition and the Royal Colleges.

Reference: http://www.nice.org.uk/

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VALUE BASED PRICING (VBP) – How the NHS will purchase drugs

February 15, 2011

 The government intends to reform the way in which drugs purchased by the NHS are priced by the end of 2013. It aims to ensure that drug costs more fully reflect clinical benefit and to improve patient access to new treatments. At present the prices are determined by the Pharmaceutical Price Regulatory Scheme (PPRS). These prices are usually reviewed at 5 yearly intervals. Pharmaceutical companies are relatively free to set the price of a newly launched product (assuming it is accepted for use by NICE, the Scottich Medicines Consortium or the All Wales Medicines Strategy Group in the first instance). The PPRS then reviews these prices so that the profits that are made from the sale of drugs to the NHS are not considered to be excessive.

The Office of Fair Trading argues that drug prices should reflect their clinical benefits and current policy wastes NHS resources. The pharmaceutical industry welcomes the concept of value-based pricing, but is concerned about the impact on profits which are needed to make research viable. The Office of Fair Trading (OFT) estimates that up to 25% of world pharmaceuticals sales reference UK prices to some extent. Companies are thus particularly sensitive about any agreement that reduces the UK list price of a drug as this can have a knock-on effect on the profits made on sales elsewhere in the world.

Successive price cuts and exchange rate movements mean that UK prices are currently amongst the lowest in Europe. This has led to parallel-exporting (the opposite of the practice of parallel-importing cheaper non-English language versions of the same branded product from the EEU to the UK) of UK branded medicines to the EEU, by wholesalers, pharmacies and NHS trusts for commercial gain which has led to severe shortages of many popularly prescribed medicines in the UK.

Under the new system of value-based pricing, the Government would apply weightings to the benefits provided by new branded medicines, which would imply a range of price thresholds reflecting the maximum they are prepared to pay for medicines. These thresholds or maximum prices would be adjusted to reflect a broader range of relevant factors that are not fully taken into account by the current sytem of using Quality Adjusted Life Years (QALYs) by NICE so they could be used to calculate the full value of a new product.

The Government proposes that the price threshold structure is determined as follows:

  • there would be a basic threshold, reflecting the benefits displaced elsewhere in the NHS when funds are allocated to new medicines
  • there would be higher thresholds for medicines that tackle diseases where there is greater “burden of illness”: the more the medicine is focused on diseases with unmet need or which are particularly severe, the higher the threshold
  • there would be higher thresholds for medicines that can demonstrate greater therapeutic innovation and improvements compared with other products
  •  there would be higher thresholds for medicines that can demonstrate wider societal benefits.

 

Designing the new system to be both stable and transparent would allow companies to predict well in advance how prospective products may fare, and to focus their research efforts on the treatments that society values most. Companies would be informed of these weightings – allowing them to orient their research and development investments appropriately. This may well draw to a close the ‘me too’ concept of launching ‘newer versions’ of drugs which treat similar conditions with little demonstrable benefit over the original.

Thus, a new product would be launched, then reviewed by the Government to access its impact on patient health and the others factors discussed above, and the price to the NHS adjusted accordingly over a period of time.

The work of NICE as a provider authoritative advice and information would continue, but the decision as to whether a new medicine will be used in clinical practice will ultimately be made by the clinicians themselves.

VBP models are already implemented in many European countries including Germany, Sweden, France, Spain and Italy.

Health White Paper

August 5, 2010
 

LANSLEY’S HEALTH REFORMS

Tuesday 13th July 2010

The new Health Minister announced the White Paper that lays out the future of the NHS over the course of this parliament (which is now a guaranteed 5 years).  He described this as a ‘blueprint’ for Health Policy up to the next General Election.  The main aim is to cut £20bn from the Health Budget over the next 4 years.  One of the main issues is the end of the current PCTs, which means that GPs will have direct control of the commissioning of services.  NHS Management costs are set to reduce by 45% as a part of this reduction.

This is considered by many to be the most radical NHS White Paper to date, and is expected to be well received by the Conservative back benches.  As for the Lib Dems, they had the abolition of StHAs as part of their 2010 manifesto, so this should sit well with them also.

Lansley said ‘the provision of healthcare service will be led by patients and professionals and not by politicians’.

The basics of the White Paper are set out below:

 More power to GPs

The most contentious issues will be the compulsory devolvement of huge commissioning powers to GP and GP Consortia and the abolition of Primary Care Trusts (PCTs). None of this was proposed by the Conservatives when they were in opposition.  These decisions emerged after the General Election. There is concern that a large number of GPs do not want to take on commissioning functions, and in fact are ill-equipped to do so.

It is interesting therefore to note that the British Medical Association has welcomed today’s announcement.

More power to patients

The Government is going to launch HealthWatch England, a new ‘consumer champion’, which will sit within the Care Quality Commission (CQC). The White Paper provides an ethos for structural change; the NHS must be patient led and choices must be led by those at the frontline of delivering those services to patients, i.e. clinicians. On a national level, it will be able to propose CQC investigations of poor service. This organisation will help to strengthen the patient voice and ensure that patient feedback is heard at a local level. Patients will not only have power over the choice of GP they would like to attend (regardless of where they live), but will also have power over who has sight of their patient record.

Abolition of Primary Care Trusts (PCTs)

The complete removal of PCTs, instead of simply reducing their numbers, came as a big surprise when compared to the proposals contained in the Conservative manifesto from January 2010. However, it is in keeping with current measures when you look at the plan to reduce admin costs by 45%.  Some form of supervisory role is of course required, particularly in respect of GPs and other primary care services, and it is a role which Monitor (the body currently responsible for the regulation of Foundation Trusts) may find challenging.   

Abolition of Strategic Health Authorities (SHAs)

SHAs will be abolished as early as  2012. Their functions will be taken over by Monitor. Monitors’ remit will extend to establish it as the key economic regulator in healthcare.

Foundation Trusts

All NHS Trusts will become or be part of a Foundation Trust and this will be the preferred governance model for the health service. Trusts will be given more freedom to innovate to improve patient care. NHS staff will have the opportunity – where appropriate – to manage these organisations as ‘the largest social enterprise sector in the world’.

NHS Commissioning Board

A review of existing quangos is due to report in the autumn but the White Paper makes provision for a number of new bodies which will help implement this new, patient led vision of the NHS. The most vital is the NHS Commissioning Board which will act to ensure quality in commissioning and be responsible for commissioning certain services, such as community pharmacy, which GPs cannot commission. It will also be responsible for increasing patient choice through helping patients manage their personal health budgets. The intention is for this body to be fully operational in April 2012. The underpinning concept is to reduce the number of quangos but those that do exist will be interlinked and more accessible to patients.

Value based pricing

The White Paper confirms that the Government intends to move to value based pricing when the current Pharmaceutical Price Regulation Scheme (PPRS) runs out at the end of 2013. A reference is made to the Cancer Drugs Fund, which will operate from April 2011, but no further details are provided.

NICE

In a further strengthening of its powers, NICE will be in charge of developing new quality standards for all the main pathways of care. The paper estimates that NICE will develop up to 150 new quality standards over the next five years. This will position NICE as the key quality regulator building on Lord Darzi’s work on quality improvements, under the previous Government.

 Scrapping targets

As mentioned in the NHS Operating Framework, targets with ‘no clinical justification’ will be scrapped (although not as many as were discussed in Opposition). There is a concession that some targets do work but the paper is not clear on which ones and a consultation is promised on new measureables.

Long Term Care

A Commission will be set up to look into long-term care from the Department of Health. This is in keeping with the move to strip away the Department’s NHS functions and replace them with longer term social care objectives.

Consultation

A number of consultation papers will be published in the near future, getting stakeholder views on policies including; commissioning for patients, freeing providers and economic regulation, the NHS outcomes framework, the framework for transition. This process will be an important part of the transition to the new system as will the proper management of the financial risk.

Legislation

Primary legislation will be required to make many of the proposed changes in the White Paper. The Health Bill announced in the Queen’s Speech provides for many of these reforms and is due to be introduced in late 2010. The main legislative reforms in the Bill will include: Making improvement in outcomes central to the NHS; Reforming NICE;  creating the independent NHS Commissioning Board; creating a framework for a comprehensive system of GP consortia; establishing HealthWatch; reforming the Foundation Trust model; developing Monitor’s role and reducing the number of arms length bodies in health. The Department of Health is taking comments on implementing all the changes in the Health Bill, which must be submitted by 5 October 2010. We can therefore deduce that the Health Bill will not be laid before Parliament before this date.  

The Health Bill will also support the creation of a new Public Health Service, which will streamline existing health improvement and protection bodies. Another White Paper, this time on public health will be published later this year. In addition, the public health budget will be ring-fenced and local Directors of Public Health will be responsible for health improvement funds allocated according to local need.

Sources: white paper and Mr Lansleys press release.