Thursday, 17 September 2009
The company, based in Indiana, expects the plans to cut annual costs by US$1 billion.
The reorganisation will split the company into five business areas: oncology, diabetes, established markets, emerging markets and animal health. Lilly also plans to establish a Development Centre of Excellence, which will focus on the development of new medicines.
Although Lilly is yet to confirm where the job losses will take place, they will exclude strategic sales additions in emerging markets and Japan.
The company attributed the restructure to upcoming challenges for the company, including patent expiries, increased generic competition, rising costs and slowing innovation.
Lilly is currently preparing for the patent expiry of its top-selling antipsychotic drug Zyprexa (olanzapine), while generic competition has reduced sales of its chemotherapy Gemza (gemcitabine) since it went off-patent.
Further reading - A detailed analysis of the US pharmaceutical market is available from Espicom: The Pharmaceutical Market: USA (published June 2009)
The plant, which currently has 730 employees, manufactures tablets and inhalers, but following the job losses the production of tablets will be relocated to a factory in Hungary. It is expected that tablet production at the site will cease within 12 months.
Further reading - An in-depth analysis of the Irish pharmaceutical market is available from Espicom: The Pharmaceutical Market: Ireland (published June 2009)
N-Gene, a biotech firm, and Mecsek Pharma, an R&D business, are about to start clinical trials of a new diabetes drug, a formula which is the sole intellectual property of N-Gene.
Further reading - A detailed analysis of the Hungarian pharmaceutical market is available from Espicom: The Pharmaceutical Market: Hungary (published June 2009)
The review studied 26 drugs positively appraised by NICE, covering 13 technology appraisals.
The report indicates that out of 12 appraisals where a comparison could be established, use on the NHS in 2008 was higher than expected for seven appraisals and lower for five appraisals.
The appraisals where observed use exceeded the predicted use in 2008 are:
- Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s disease;
- Ezetimibe for the treatment of primary (heterozygous-familial and non-familial) hypercholesterolaemia;
- Entecavir for the treatment of chronic hepatitis B;
- Zaleplon, zolpidem and zopiclone for the short-term management of insomnia;
- Varenicline for smoking cessation;
- Hormonal therapies for the adjuvant treatment of early oestrogen-receptor-positive breast cancer; and
- Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women, plus alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women.
- Omalizumab for severe persistent allergic asthma;
- Natalizumab for the treatment of adults with highly active relapsing-remitting multiple sclerosis;
- Drotrecogin alfa (activated) for severe sepsis;
- Riluzole (Rilutek) for the treatment of motor neuron disease; and
- Orlistat, sibutramine and rimonabant for the treatment of obesity in adults.
The Association of the British Pharmaceutical Industry (ABPI), however, has questioned the basis on which the predictions were made as it appears to be too low. The ABPI also believes that the statistics on the use of such medicines in England should be set against a comparison of uptake in other, comparable European countries.
Further reading - An in-depth review of the UK pharmaceutical market, including some background information on NICE appraisals, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
The National Institute for Health and Clinical Excellence (NICE) has recommended the use of Humira (adalimumab) and Remicade (infliximab) on the NHS for the treatment of Crohn’s disease, on a preliminary basis.
Abbott Laboratories’ Humira has preliminary approval as an option for induction and maintenance therapy in adults with severe active non-fistulising Crohn’s disease. Schering Plough/ Johnson & Johnson’s Remicade has also been approved but only if the patient is intolerant of Humira, if the patient is a child or if the Crohn’s disease is fistulising.
Humira has been given preference over Remicade purely for cost reasons. They are considered to be as effective as each other, with Humira costing £9,295 a year while Remicade costs £12,584 a year, and so Humira is judged to be more cost effective.
There is no cure for Crohn’s disease, which affects around 60,000 people in the UK, and so treatment strategies focus on reducing the symptoms of the illness and extending periods of remission.
NICE Approves NHS Use of Hycamtin for Cervical Cancer
NICE has issued a final appraisal recommending the use of GlaxoSmithKline’s Hycamtin (topotecan) on the NHS to treat recurrent cervical cancer.
Initially, NICE expressed “considerable uncertainty” over the effectiveness of the drug compared to other available treatments, when taking into account potential side effects, and so it was thought it would be rejected.
However, following a second appraisal committee and additional data submitted by GSK, NICE now recommends the use of Hycamtin, in combination with the chemotherapy cisplatin, to treat recurrent or stage IVB cervical cancer.
However, it is under the condition that the patient must not have received previous therapy with cisplatin, and so only a small number of patients will be eligible, since around 90-95% of the current licensed population for Hycamtin will have already received some form of therapy with cisplatin. This condition is important, however, as response rates in patients who have not been treated with cisplatin are about 45%, compared to just 10% for those who have been exposed to the drug.
NICE Approves Blood-Thinner Efient Under Certain Conditions
NICE has published a final appraisal approving the blood-thinner Efient (prasugrel) for use on the NHS, but only for a select group of patients.
Specifically, NICE has approved Eli Lilly/Daiichi Sankyo’s Efient in combination with aspirin as an option for preventing atherothrombotic events in patients with acute coronary syndromes having percutaneous coronary intervention. However, the drug should only be used in limited cases, firstly when immediate primary PCI for ST-segment-elevation myocardial infarction is necessary. Efient can also be used when stent thrombosis has occurred during treatment with sanofi-aventis and Bristol-Myers Squibb’s blockbuster Plavix (clopidogrel) or if the patient has diabetes mellitus.
NICE Rejects Nexavar for the Treatment of Liver Cancer on the NHS
NICE has rejected Nexavar (sorafenib) for the treatment of liver cancer on the NHS.
The decision comes despite Bayer’s offer to lower the cost of the drug, which has also been turned down for the treatment of kidney cancer on the NHS. Nexavar treats advanced hepatocellular carcinoma (HCC), which accounts for around 90% of all liver tumours.
Janssen-Cilag’s Stelara Approved for Treatment of Psoriasis on the NHS
Stelara (ustekinumab) has been approved for use on the NHS by NICE as a treatment for moderate to severe plaque psoriasis.
Janssen-Cilag’s Stelara is a new, fully human monoclonal antibody which works by targeting the p40 subunit of the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23). The drug also has a convenient dosing regimen with just five injections per year, compared to a possible 104 injections with alternative treatment etanercept.
The drug was considered a cost-effective use of NHS resources but only under a patient access scheme proposed by Janssen Cilag, whereby it provides the 90mg dose necessary for patients weighing more than 100kg at the same cost as a single 45 mg vial, to keep the cost of treatment at £9,335 a year.
Eli Lilly’s Alimta Approved for NHS Use
NICE has approved Eli Lilly’s Alimta (pemetrexed) for use on the NHS, as a first-line treatment for patients with non-small cell lung cancer (NSCLC) in combination with the chemotherapy cisplatin. However, it has only been recommended if the disease has spread, or if the tumour is classed as an adenocarcinoma or large-cell carcinoma.
Every year around 38,000 people are diagnosed with NSCLC in the UK, of which 45% are adenocarcinoma and 10% large cell carcinoma.
Pfizer’s Sutent Recommended for Use on the NHS for GISTs
NICE has published final guidance recommending the use of Sutent (sunitinib) on the NHS in patients who have unresectable or metastatic gastro-intestinal stromal tumours (GIST) and are intolerant or unresponsive to therapy with Novartis’ Glivec (imatinib).
The guidance is subject to a patient access scheme, whereby the manufacturer Pfizer pays for the first cycle of treatment with the drug.
Further reading - A detailed review of the UK pharmaceutical market, including more information on NICE and its appraisal procedures, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
The survey, conducted by the UK MDS Patient Support Group, also found that 56 of 100 haematologists believe lower priority is given to rarer cancers than other types of cancer.
Of those surveyed, 89% said they had faced situations in which they have been unable to provide treatments for a patient because the drug they needed is not available on the NHS or has not been approved by NICE. Furthermore, around 12% of respondents said they had not informed patients of treatments which could be beneficial to them, at the risk of distressing them over treatments they cannot have.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NICE appraisals, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Consultancy firm McKinsey and Company advised the Department of Health in September 2009 that the loss of 137,000 clinical and administration posts would save around £20 billion by 2014. The report also recommended a recruitment freeze to begin within two years, with the possibility of medical school places being reduced, and also suggested an early retirement programme should be established.
However, Health Minister Mike O’Brien said, “Ministers have rejected the suggested proposals in the McKinsey report and there are no plans to adopt these proposals in the future”, claiming that certain services, particularly maternity, nursing and primary care, need more staff rather than fewer.
McKinsey also claimed that up to £3 billion a year could be saved by improving staff productivity, while nearly £2 billion could be saved on external contracts for areas such as food and waste.
Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on healthcare personnel, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
The study, conducted using the QResearch general practice database, revealed that an average patient had 5.5 consultations in 2008, compared with 3.9 in 1995. Meanwhile, the average GP surgery carried out 34,200 appointments in 2008, up from 21,100 in 1995.
The study also highlighted an increase in the number of patients seen by a nurse in primary care. In 1995, 76% of consultations were undertaken by GPs, 21% by nurses and 3% by other clinicians, whereas in 2008, 62% were carried out by GPs, 34% by nurses and 4% by other clinicians. However, this increase in proportion could be explained by an increase in patients seeing nurses in general, rather than fewer patients seeing a GP.
However, the study did not take into account the length of consultations, or the number of tasks undertaken within a consultation, which could impact on the reliability of the findings.
Further reading - A detailed analysis of the UK pharmaceutical market, including further statistics on ambulatory care, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
The 307 drugs on the list account for around 25% of national drug spending, and are used to treat around 80% of the most common diseases in China.
The list has been put together as part of the country’s 850 billion yuan (US$124.5 billion) health service reform, which is aiming to provide basic healthcare cover for at least 90% of the population by 2011.
The price-controlled medicines will be sold at 30% of the community medical facilities, and by 2020 they will be the first-choice medicines at all state-run health institutions. The government will regulate the cost of the drugs and they will be purchased by provincial governments through procurement auctions. Guideline prices will be published every year, and the list will be updated every three years according to changes in demand.
The drugs on the list, which include both Western and traditional Chinese medicines, will be eligible for state subsidies of up to 100%, making them more affordable for the population of 1.3 billion.
China’s Health Ministry said the list would create competition among manufacturers to get drugs approved, and could lead to more mergers and acquisitions in the pharmaceutical industry.
Further reading - For more information see related article: China - Essential Medicines System May Lead to Market Expansion. An in-depth analysis of the Chinese pharmaceutical market, including some background information on healthcare reforms, is available from Espicom: The Pharmaceutical Market: China (published July 2009)
The 33 year-old plant, which sanofi-aventis has owned since 2000, manufactures solid-dose oral medications including Allegra.
The operations will slowly be shut down before being closed altogether by mid-2012.
Further reading - Detailed reviews of the pharmaceutical markets in the USA and France are available from Espicom: The Pharmaceutical Market: USA (published June 2009) and The Pharmaceutical Market: France (published June 2009)
Warner Chilcott is a specialist in women’s health, and the deal will expand its focus to musculoskeletal disorders and gastrointestinal problems too.
Procter & Gamble’s portfolio of branded drugs includes Asacol (mesalamine) for ulcerative colitis, and Actonel (risedronate), an osteoporosis drug. Warner Chilcott will also acquire Procter & Gamble’s drug pipeline.
Warner Chilcott will take over manufacturing sites in Puerto Rico and Germany, which will add to its existing sites also in Puerto Rico and in Northern Ireland. It is expected that the 2,300 Procter & Gamble employees will be transferred to the new owner.
The transaction should be completed by the end of 2009.
Further reading - In-depth reviews of the pharmaceutical markets in the USA and the UK are available from Espicom: The Pharmaceutical Market: USA (published June 2009) and The Pharmaceutical Market: United Kingdom (published June 2009)
In a survey of 150 community pharmacies, compiled by Chemist and Druggist in August 2009, nearly a third of respondents claimed patients had suffered because of delays in accessing medicines, while 89% said they were “very concerned” and 11% had “some concern” that patients would be affected.
The Association of the British Pharmaceutical Industry (ABPI) said that three pharmaceutical companies had been forced to arrange 77,020 shipments for the UK in January to May this year because of supply shortages, whereas in the same period in 2008 this amounted to just 6,134 cases.
Historically, drug prices in the UK have been comparatively high, and the country was often a destination for parallel imports from countries with lower prices, such as Greece and Spain. However, the weakening British pound against the euro has meant that prices of medicines have fallen and are now being exported to other EU countries.
The ABPI has put together a ‘watch list’ of 24 prescription drugs which pharmacies are having difficulties obtaining. However, manufacturers of these drugs have said that they provided more than enough to treat patients across the UK. For example, Novartis provided 65% more of Myfortic, a drug which prevents rejection in kidney transplant patients, than was required for patients in the UK, suggesting that much of it is being diverted for sale abroad.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on parallel importing and exporting in the country, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
NICE issued guidance on 26th August 2009, which does not recommend Roche’s Avastin, Bayer’s Nexavar and Wyeth’s Torisel as a first-line treatment for advanced and/or metastatic renal cell carcinoma. NICE has also refused approval on the NHS for the use of Nexavar and Sutent (sunitinib) as secondary treatment options.
In August 2008, all four drugs were rejected as first-line treatments, but NICE changed its mind about Pfizer’s Sutent in March 2009, approving it for NHS use. However, NICE still rejected the other three drugs because they were not considered to be a cost effective use of NHS resources. An appeal was lodged against the Final Appraisal Determination by Roche, Wyeth, the James Whale Fund for Kidney Cancer and a joint appeal from Rarer Cancer Forum and Macmillan Cancer Support, but these have not been upheld.
NICE said Avastin costs £,5,982 per patient for the first six-week cycle and £6,117 for subsequent six-week cycles (around £53,000 per patient per year). Nexavar is £2,980.47 for 112 tablets while Torisel costs £620 per vial.
The guidance will be considered for review in June 2011.
Further reading - An in-depth review of the UK pharmaceutical market, including more information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
More specifically, Merck KGaA’s Erbitux has been approved for use in combination with the chemotherapy FOLFOX (5-fluorouracil, folinic acid and oxaliplatin) as a first-line treatment for patients with colorectal cancer. However this is subject to the following conditions: the tumour in the bowel must be operable; the cancer must only have spread to the liver and is inoperable; and the patient must be well enough for surgery on both tumours if this is possible after the treatment has taken effect.
NICE has also approved the use of Erbitux in combination with FOLFIRI (5-FU, folinic acid and irinotecan) as a first-line treatment if the patient is unable to take oxaliplatin.
The drug is subject to a cost-sharing agreement proposed by Merck, whereby it offers a 16% rebate to the NHS on the cost of treatment per patient. NICE has also stipulated that no one should be treated with the drug for more than 16 weeks.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)
Wednesday, 2 September 2009
It is estimated that between one third and a half of patients incorrectly take their medications, and the costs incurred amount to 13% of the total health expenditure.
The report, Thinking Outside the Pillbox: A System-wide Approach to Improving Patient Medication Adherence for Chronic Disease, also found that it is patients with chronic illnesses, such as diabetes or high blood pressure, who are less likely to take their medications as intended, than those being treated for an urgent problem.
The study attributes the mistakes to high costs, unpleasant side effects, confusing regimes, forgetfulness and other patient behaviours, such as feeling too good to need medication. It outlines four solutions which could reduce the problem:
- Creating healthcare teams - incorporating nurses, pharmacists and other clinicians in supporting medication adherence;
- Patient engagement and education - involving primary care providers and pharmacists to ensure patients know the importance of taking their medication properly;
- Payment reform - changing reimbursement incentives away from rewarding volume and towards rewarding good patient outcomes, which would encourage providers to invest in resources, such as counselling services, to improve medication adherence; and
- Leveraging health information technologies - using technology such as e-health records and e-prescribing, to give providers secure knowledge of the patient’s current medications and when prescriptions are due to be refilled.
Further reading - A detailed analysis of the US pharmaceutical market is available from Espicom: The Pharmaceutical Market: USA (published June 2009)
The study, Access Delayed, Access Denied: Waiting for New Medicines in Canada, by the Fraser Institute, found that the regulatory agency, Health Canada, takes around 14 months to approve new drugs as safe and effective. Although private insurers will then cover these medicines immediately, it can take the provincial governments up to a year to decide whether they will cover them. The findings of the study then state that, in many cases, the drugs are then not given coverage at all.
The report found that Health Canada took an average of 453 days to approve new drugs in 2007, and the provinces then took a further 314 days to approve them under their drug plans. However, this is a marked improvement from 2004, when Health Canada took an average of 839 days and the provinces took around 552 days to approve new medicines, totalling 1,391 days or almost four years.
Furthermore, only 10.1% of new drugs approved by Health Canada in 2007 were being fully or partially reimbursed under provincial drug plans by the end of 2008.
The report proposed three policy changes which could speed up the approval process to ensure Canadians have access to new medicines:
- Regulatory co-operation with other countries - Canada should enter into mutual recognition agreements with other countries, introducing new medicines onto the Canadian market far more rapidly.
- Performance-based user fees - the government should establish, and strictly enforce, targets that Health Canada must meet before it receives user fees from drug companies, as is the case in the US.
- Replace government drug programmes with subsidized access to private insurance - introduce means-tested, publicly standardized access to private insurance for prescription drugs, to ensure that everyone has adequate drug insurance coverage, without delaying access to new medicines.
Further reading - An in-depth analysis of the Canadian pharmaceutical market, including some background information on drug approval processes, is available from Espicom: The Pharmaceutical Market: Canada (published June 2009)
The Executive of the IPU said the industrial action had to end to prevent the recurrence of “chaotic scenes” which have occurred since many pharmacies withdrew their services on 1st August 2009 (See Ireland - Pay Cut Leads to Pharmaceutical Supply Crisis and Ireland - Pharmacy Row Taken to High Court).
The Minister for Health and Children, Mary Harney, has agreed to carry out a review of the operation, effectiveness and impact of the new fees amounts and rates, by 30th June 2010.
However, the IPU has warned of further disruption to patient services if the dispute is not resolved.
Further reading - A detailed review of the Irish pharmaceutical market, including some background information on pharmacies, is available from Espicom: The Pharmaceutical Market: Ireland (published June 2009)