USA - Obesity Costs the US Healthcare System US$147 billion

A study has found that obesity-related diseases account for 9.1% of health spending in the USA, equivalent to around US$147 billion. Researchers also found that obese people spend 40% more in healthcare costs, equal to around US$1,429 more per year, than people of a normal weight.

RTI international, the Centers for Disease Control and Prevention (CDC) and the Agency for Healthcare Research and Quality analysed medical cost data for the years between 1998 and 2006. The findings showed that rates of obesity rose by 37% between 1998 and 2006, driving an 89% increase in spending for obesity-related disease treatments such as diabetes, heart disease and arthritis. It also found that an obese Medicare patient spends US$600 more each year in drug costs than a Medicare patient of a healthy weight.

The CDC issued 24 recommendations in July 2009, on how communities can tackle the problem of obesity, mostly by encouraging healthy eating and exercise.

Obesity accounts for 9.1% of health spending, up from 6.5% in 1998. In total, more than 26% of Americans are obese.

Further reading - An in-depth analysis of the US pharmaceutical market, including some background information on health expenditure, is available from Espicom: The Pharmaceutical Market: USA (published June 2009)

USA - Bristol-Myers Squibb to Acquire Medarex in US$2.4 billion Deal

Bristol-Myers Squibb Co. is to acquire Medarex Inc. in a deal worth US$2.4 billion, it was announced on 22nd July 2009. Medarex Inc. is a biotechnology company which has been assisting the US company Bristol-Myers Squibb in developing a treatment for melanoma since 2005. This is an antibody called ipilimumab for patients in the late stages of melanoma, and is now in the final stage trial. The deal is expected to help Bristol-Myers Squibb regain its position as one of the world’s leading players in the oncology market.

Further reading - A detailed review of the US pharmaceutical market is available from Espicom: The Pharmaceutical Market: USA (published June 2009)

India - Call for Tighter Rules on Clinical Trial Imports

India’s Central Drugs Standard Control Organisation (CDSCO) called for tighter rules on the import of larger quantities of drugs for use in clinical trials in July 2009. The proposal by the CDSCO asks for additional documentation and evidence when contract research organisations (CROs) or other companies apply to import large volumes of drugs.

Under Rule 33 of the 1945 Drugs and Cosmetics Regulations, small quantities of drugs may be imported into India for “examination, test or analysis” with a Form 11 licence. However, this does not state specifically what is considered to be a ‘small’ amount, and so more rules are necessary to control it. The new rules would apply to any quantities of drugs, bulk or formulated.

Further reading - An in-depth analysis of the Indian pharmaceutical market is available from Espicom: The Pharmaceutical Market: India (published June 2009)

UK - Innovative Medicines will Reach Patients Faster

Patients will have faster access to innovative medicines, under new proposals announced by the Office for Life Sciences on 14th July 2009.

The measures outlined in the ‘Life Sciences Blueprint’ include:

• The introduction of an Innovation Pass, administered by NICE, which will allow time-limited use of selected innovative medicines on the NHS. The selected medicines will be those which can deliver improved patient outcomes to a small number of patients, but where a lack of cost-effectiveness data is limiting market access. Therefore, they will be funded without going through a NICE appraisal. However, NICE will develop and apply eligibility criteria for the Pass, giving patients with the greatest need earlier access to innovative drugs. The medicines will be evaluated by NICE after the three-year initiative comes to an end. The Pass will be piloted in 2010/11, with a budget of £25 million from the Department of Health.
• The NHS Chief Executive will review system levers and incentives, including Payment by Results, to accelerate the uptake of new medical technologies.
• The Government will reinforce the need for greater emphasis on research and clinical trials in the next NHS Operating Framework.
• The Government will support the formation of a UK Life Sciences Super Cluster to co-ordinate work across industry, higher education and the NHS, and to boost international recognition of UK life sciences.
• The blueprint calls for the Treasury to further investigate the possibility of a ‘patent box’ tax incentive, offering a lower rate of tax on profits derived from patents located in the UK to encourage the creation and exploitation of intellectual property in the UK.
• The Technology Strategy Board will launch an £18 million ‘RegenMed’ programme of investment to support commercial R&D and the development of NHS partnerships, supported by an additional funding of £3.5 million from Research Councils.
• The Government will invest an extra £1 million to promote the UK and NHS brands at flagship life sciences events in the UK and overseas.

The Office for Life Sciences was created on 27th January 2009 and has since been working on this package of measures to transform the operating environment for life science companies in the UK. The next step will be to develop detailed delivery plans for each action, which will be published in the autumn.

Further reading - A detailed review of the UK pharmaceutical market is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)

UK - Think-Tank Proposes £20 Fee for GP Appointments

Patients should be charged £20 for an appointment with a GP to encourage people to visit a doctor only when necessary, according to a report by independent think-tank the Social Market Foundation (SMF).

In the report, From feast to famine: reforming the NHS for an age of austerity, published in July 2009, the SMF states that the NHS will need to change dramatically to survive the impact of the economic downturn. The think-tank says the NHS will have to become more efficient due to the reduction in funding, and change its approach to what is fair. The report outlines three possible approaches that the NHS can take: raise more money, use existing resources better, or slow the growth in healthcare demand.

The report says the NHS must recognise that fair does not necessarily mean free. Charges could not be used to raise revenue, as they would need to be set at a very high level to do so, but charging for access to healthcare could force patients to consider whether they need to use healthcare resources.

The report recommends:

• The NHS charging system should be reformed to reflect income not categories such as pregnancy or retirement;
• Anyone receiving tax credits should be exempt from NHS prescription charges - a good deal for the poorest 30% of society;
• A charge of £20 for GP appointments should be introduced to encourage healthier, wealthier people to avoid using the NHS except when absolutely necessary (those receiving tax credits will be exempt);
• NHS charges for GP appointments and prescriptions should be capped at around £100 per year.

The report also outlines that the only way to achieve efficiency is to move from national targets to a model of local provision based around high quality commissioners. Recommendations to improve efficiency include:

• A reduction in national targets to become a minimum service guarantee;
• The establishment of a single body to regulate commissioners;
• Local contracts for GPs and consultants;
• Public petitions that can trigger a review of commissioner performance;
• A new ‘Royal College of Commissioners’ to give commissioning higher status;
• New powers and responsibilities for commissioners to improve the quality of healthcare providers.

However, Dr Chaand Nagpaul, on the GP committee of the British Medical Association, expressed concern that some patients may be put off visiting a doctor because of the fees. He commented, “All patients have the right to free healthcare that is based on their clinical needs, not the size of their bank balance.”

The Department of Health said ministers are also opposed to charges, with a spokeswoman commenting that it would be against “the founding principles of the NHS”.

Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on the healthcare system, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)

USA - Legislation on Drug Re-Importation Approved

American citizens could obtain drugs from Canada at a lower price, under plans approved by the US Senate. The amendment proposing re-importation passed the Senate by a 55 to 36 vote on 9th July 2009, as part of the Homeland Security funding bill.

Prices of drugs in Canada are far lower than in the United States, and the amendment would allow prescription medicines sanctioned by the US Food and Drug Administration (FDA) to be purchased either in person or over the internet.

The amendment was proposed by Senator David Vitter, who said in a statement, “This is a huge win for Americans concerned about the lowering of the cost of common, expensive prescription drugs and a major defeat for the big drug companies and their powerful lobbying interests.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) opposes re-importation and said that the FDA does not have the resources to monitor the safety of drugs coming into the country.

Currently, American visitors can return from Canada with a three-month supply of drugs, a measure which is supported by the PhRMA.

However, it remains to be seen whether Vitter’s amendment will be kept in the legislation after it goes through the House-Senate talks on a final version of the bill.

Further reading - An in-depth analysis of the US pharmaceutical market, including some background information on legislatory matters, is available from Espicom: The Pharmaceutical Market: USA (published June 2009)

USA - FDA Panel Votes Against Yondelis for Ovarian Cancer

The US Food and Drug Administration (FDA) voted against recommending approval for Yondelis (trabectedin) for ovarian cancer in July 2009. The drug was submitted by partner Johnson & Johnson (J&J).

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-1 against approval of Zeltia’s Yondelis for the treatment of relapsed ovarian cancer, in combination with J&J’s Doxil/Caelyx (doxorubicin). The drug was shown to have a six-week benefit in progression-free survival in a Phase III trial, but the panel decided this does not justify the use of the drug.

The ODAC also noted that there was a notable increase in severe and life-threatening adverse events in the Yondelis treatment group, including more than twice as many pulmonary embolisms, three times more cardiac adverse events and a higher rate of liver enzyme increases.

J&J’s Centocor Ortho Biotech unit said that it still believes trabectedin “has an important role in the treatment of recurrent ovarian cancer” and “remains committed to working with the FDA to address the committee’s concerns".

Further reading - An in-depth analysis of the US pharmaceutical market is available from Espicom: The Pharmaceutical Market: USA (published June 2009)