The ABPI welcomes this Inquiry into health inequalities and hopes that this will add to the Committee's thinking.

1.  INEQUALITIES IN PATIENTS' ACCESS TO MEDICINES

  1.1  The Department of Health and ABPI, commissioned by the Ministerial Industry Strategy Group, conducted a joint study as part of the Long Term Leadership Strategy in Medicines (LTLS), which reported in February 2006[330]. This was a statistical analysis of 13 therapeutic areas covering over 50% of medicines expenditure in England to investigate changes in rates of prescribing over time and geographical variation within England. It also identified areas with consistently "high" or "low" prescribing. The MISG regarded this as an extension of the analysis conducted for the report Variations in usage of cancer drugs approved by NICE—Report of the review undertaken by the National Cancer Director, which was published on 14th June 2004 and showed major differences in the rate of uptake of cancer medicines approved by NICE across England.

  1.2  The LTLS study looked at:

—  trends in England over time;

—  variation between geographical areas—at lowest possible sub-national level;

—  changes in variation over time.

  1.3  The medicines examined covered a wide range of therapeutic areas, some including only one or a few chemical entities and others including a substantial number. In each therapeutic area there existed NICE guidance and/or a national service framework, or some other guidance on the use of the relevant medicines. The therapeutic areas included a mixture of those where medicines are used mainly or exclusively in primary care, mainly or exclusively in hospitals, and where therapies are initiated in hospitals or clinics and then continued in primary care. Volume, rather than value, measures were used.

  1.4  The study found that volume of medicines use has increased but that the rate of increase varied substantially, especially in newer medicines and in those used mainly in secondary care. Further analyses took place to establish factors that could explain the variation in use of medicines between localities. Variation could not be fully explained by disease prevalence, nor was there a significant relationship with relative deprivation in different geographical areas.

  1.5  Further, qualitative, research was undertaken to establish reasons for variation[331]. The key drivers of prescribing were reported to be:

—  in primary care: the Quality and Outcomes Framework (QOF) of the General Medical Services contract, clinical attitudes and preferences as the main drivers; with funding and financial status and national priorities secondary drivers;

—  in secondary care, NICE guidance and clinical attitudes and preferences as the main drivers, with funding and financial status, national priorities and pharmaceutical industry activity secondary.

  1.6  The processes used by PCTs to manage the introduction of new medicines had an impact, with processes tending to be more streamlined in PCTs with higher levels of uptake, whereas processes with lower levels were more complex and lengthy. The ABPI's conclusion from this, and the experience of our member companies, is that local management processes have a major part to play in determining the equality of patients' access to medicines. Such processes include the general approach taken by PCT managers to communication and engagement with local prescribers and stakeholders; with those PCTs taking a more proactive, open, consultative approach achieving greater engagement and earlier, more consistent prescribing.

  1.7  This work represents the most comprehensive analysis of variations in uptake of medicines in England to date and indicates that substantial inequalities exist in many important areas of prescribing. Patients' access to medicines still depends on where they live. Local management processes and attitudes, along with clinicians' attitudes, have a substantial part to play in these inequalities.

2.  INTERNATIONAL INEQUALITIES IN PATIENTS' ACCESS TO MEDICINES

  2.1  The Department of Health and ABPI also examined 27 medicines in a sample of 10 therapy areas where new medicines have been launched in the UK in recent years, with treatment areas selected from among those included in the Uptake of Medicines quantitative study above[332]. The analysis used IMS data and compared the rates of medicines use per thousand population in the UK with those in France, Germany, Italy, the Netherlands, Spain and Switzerland.

  2.2  There was wide variation between uptake of individual medicines in the UK versus that in the other countries. Two analyses were conducted: comparisons in year 2005 (the latest full year of data available at the time of the study) and comparisons three years from launch in each country.

  2.3  UK uptake was relatively high for anti-obesity, sepsis and smoking cessation medicines, and low in the case of drugs for the important public health areas of hepatitis C, dementia, osteoporosis and cancer. For anti-TNFs, glitazones and anti-psychotics, UK uptake was high overall in terms of 2005 but not always three years from launch and was not necessarily high for each drug in the group.

3.  IMPLEMENTATION OF NICE GUIDANCE

  3.1  The Committee has acknowledged in its recent report of its Inquiry into the National Institute for Health and Clinical Excellence that implementation of NICE guidance is variable. One of the objectives of NICE is to improve the quality and consistency of NHS care, and despite many years of concerted effort to support better implementation of its guidance by the NHS, performance remains disappointing. National guidance should be national and the Committee's report gives some useful recommendations in this regard, not least better focus by the Healthcare Commission on this aspect of NHS core and developmental standards and better measurement of performance.

  3.2  What is disappointing, however, is the report's almost exclusive focus on medicines. NICE guidance goes far beyond evaluation of medicines, with clinical guidelines and public health guidance presenting real opportunities to reduce health inequalities. We would suggest that work is done urgently to better understand the issues around implementation of guidelines and public health guidance.

4.  QUALITY AND OUTCOMES FRAMEWORK (QOF)

  4.1  As indicated by the work described above, the QOF is a major driver in changing clinical behaviour in primary care. It has already gone some way to improving focus on identification and management of patients in priority health areas, such as heart disease and diabetes, which tend to affect those in disadvantaged communities most. More needs to be done to focus the QOF on targeting activity at those at highest risk of disease.

  4.2  The QOF should also be used to incentivise implementation of NICE guidance. There seems little logic to a situation where two initiatives designed to improve the quality and equity of NHS care are not linked.

5.  PAY FOR PERFORMANCE/PAYMENT FOR QUALITY

  5.1  The QOF relates to activity in primary care. One of the future options in secondary care to improve the quality and consistency of services, discussed in the context of Payment by Results, is to introduce direct financial incentives for provider Trusts, and a pilot scheme is currently being prepared by NHS North West. It draws inspiration from a major "pay for performance" scheme operating in the US and is planned to be introduced in the North West in 2008-09. Under the proposal, all provider Trusts in the region would submit auditable quality data based on pre-specified measures. The best X% (e.g. 10%) of providers would then receive a 2% uplift to the PbR revenues they receive. The next best Y% of providers (e.g. the second decile) would receive a 1% uplift. All other providers—the majority—would receive only the tariff price. This idea is presented favourably in the Department of Health consultation document on Payment by Results of March 2007:

"We see considerable potential in adopting a "pay for performance" type approach in England, to operate alongside, and complementary to, the national tariff." (para. 3.27)

  5.2  The ABPI believes that this initiative should be encouraged and used more widely to increase standards of care in the hospital environment, including appropriate use of medicines. Payment for Quality and other such incentives should also be aligned with implementation of NICE guidance.

6.  INEQUALITIES CREATED BY PUBLIC POLICY

  6.1  One consequence of a focus on major public health issues is that diseases and therapies that do not fall within these priorities receive less attention, thus creating inequalities. This is a general area of concern to the ABPI, but is particularly manifest in the management of orphan conditions and access to medicines for these conditions.

  6.2  Specialist treatments in the UK may pose funding difficulties at local PCT level, particularly where there are no national recommendations, such as from NICE, because the treatment has not been referred for assessment owing to its low total budget impact, or where there is a delay in the recommendation being made. In addition, few orphan diseases have a national clinical guideline from a professional body to inform commissioning.

  Two issues exist in the way that orphan medicines are commissioned:

—  Only treatments for extremely rare diseases (unlikely to be over 400 patients for a particular disease in the whole of the UK) are commissioned nationally by the National Commissioning Group (NCG). The budget is held centrally and specific providers are designated to provide these services for a national caseload. The funding of very rare diseases by the NCG is primarily about service and infrastructure and medicines may not be funded.

—  The 10 Specialist Commissioning Groups that commission specialised services at a regional level are still in development and local commissioning for orphan medicines is often left to the local PCT to make decisions. These medicines are therefore subject to case-by-case decisions, a system which is inefficient in terms of NHS time and leads to many patients being denied the treatment they need.

  6.3  The ABPI believes commissioning decisions for orphan medicines should be included in the remit of the 10 regional SCGs. PCTs cannot predict the likelihood of occurrence of a rare disease which does not present evenly across local geographies, making it difficult to assign budgets at PCT level.

  6.4  Health Technology Assessment for orphan medicines is problematic. Because of the rarity of the conditions under examination, the consequent paucity of natural history data, generally poorly validated clinical end-points and low patient numbers in trials, there is likely to be a relatively high level of uncertainty around some aspects of the evidence, including long-term outcomes and cost effectiveness, at time of launch. Orphan medicines by definition are indicated to treat serious, life threatening or chronically debilitating diseases for which no satisfactory treatment exists. For these reasons, the ABPI believes that orphan medicines should be exempted from standard HTA processes. Where HTA processes are applied, cost per QALY "modifiers" should be applied, so that equity and societal preferences are taken into consideration as well as economic efficiency. These modifiers should include severity of disease, unmet need (innovation), clinical effectiveness and overall budget impact.

7.  INDUSTRY SUPPORT FOR REDUCING HEALTH INEQUALITIES

  7.1  Pharmaceutical companies are working with a number of NHS organisations on "find and treat" strategies, whereby people with diseases of priority to the locality, who are often difficult to reach, are identified for appropriate treatment and management. This "joint working" is where the pharmaceutical industry and NHS organisations pool skills, experience and/or resources for the joint development and implementation of projects for the benefit of patients and share a commitment to successful delivery. Joint working agreements and management arrangements are conducted collaboratively in an open and transparent manner with appropriate governance arrangements. Joint working differs from sponsorship, where pharmaceutical companies simply provide funds for specific events or work programmes.

  7.2  Examples of successful joint working that support the tackling of health inequalities are growing rapidly, and as part of the work commissioned by the MISG described above, DH guidance and a "best practice toolkit" will be launched to the NHS and industry in the spring of this year.

January 2008

331   Qualitative analysis of variations in uptake of medicines. Back

332   International comparisons of uptake of medicines. Back