The urgent need to improve the tools to assess clinical benefit and value of cancer treatment

There are several controversies in the assessment of the benefit, value and sustainability of cancer drugs | European Journal of Cancer

  1. First, there is a surprising disagreement on the impact of drugs on the overall outcome of cancer treatment.
  2. Second, raising the bar of efficacy in clinical trials is claimed by many, but at the same time, being conservative appears justified as well, given the overall benefit of multiple incremental gains, typically observed in advanced solid tumours.
  3. Third, sustainability of cancer drug cost is a prohibitive challenge, but no major successful action has been taken so far.

The reason for these controversies can be understood using concepts borrowed from psychological and cognitive sciences: each stakeholder has different perspectives generated by different availability biases; this implies different priorities, leading people to think, choose and act differently. Providing an ‘objective’ assessment of the benefit and value of a cancer drug makes sense only if the perspective adopted is clearly identified.

The American Society of Clinical Oncology (ASCO) scale fits the patients’ perspective by helping individual patients to choose the most valuable therapeutic option for their condition. Conversely, the European Society for Medical Oncology (ESMO) scale has a public health perspective: ranking the clinical benefit of oncologic drugs to identify those agents that should be available in every EU country. Because this scale is being adopted for reimbursement purposes in several European regions, the current major methodological problems of the scale should urgently be corrected to avoid unwanted societal consequences.

Full reference: Sobrero, A. et al. (2017) The urgent need to improve the tools to assess clinical benefit and value of cancer treatment. European Journal of Cancer. Published online: 24 July 2017

 

‘Burden of cancer’ increasing as UK trails behind Europe in cancer care

A new report published today shows that the UK is trailing behind the rest of Europe in the treatment of cancer | ABPI

ABPI

Image source: ABPI

British patients have worse survival rates after five years – the international benchmark for measuring the quality of cancer care – compared to the European average in nine out of ten cancers – only exceeding the EU average in melanoma.

​​​​​​​​​​​​Despite the increasing burden of cancer on society, the UK spends over 20 per cent less per person on cancer than the top five EU economies; 20 per cent less of its total health budget on cancer than the rest of the EU; and 10 per cent less of its GDP on healthcare than the rest of the EU.

On cancer survival:

  • UK cancer survival rates lag behind the European average in 9 out of 10 cancers
  • If the UK achieved the cancer survival rates of Germany, over 35,000 more people would be alive five years after diagnosis.
  • The UK has the worst survival outcomes across Europe for ovarian cancer. The UK’s Ovarian cancer survival rate is 34.0% of patients surviving for five years or more. European average is 40.8%​
  • The UK has the second worst survival rates for lung cancer – 8 per cent of patients surviving more than five years (ahead only of Bulgaria – 7 per cent). European average is 12.62 per cent.​
  • The UK has the second worst survival rates for pancreatic cancer – 3 per cent of patients surviving more than five years (ahead only of Iceland – 2.56 per cent) European average is 5.84 per cent.​
  • If the UK had the mortality rates of France, more than 100,000 women’s deaths could be prevented over the next ten years.

View the full report here

Cheap blood test could boost prostate cancer treatment

A cheap genetic test costing less than £50 has been developed that could help target treatment for men with advanced prostate cancer and help offset side effects from ineffective treatments | OnMedica

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Cancer researchers across Europe, including doctors from the Institute of Cancer Research (ICR) in London, analysed blood from 265 men with the disease and found those with multiple copies of a particular gene did not respond to abiraterone and enzalutamide – drugs commonly used to treat advanced cases.

About 46,000 men are diagnosed with prostate cancer in the UK every year, one in four of them at an advanced stage. For the study,* published in the journal Annals of Oncology, scientists took blood samples from patients taking part in three different clinical trials.

The team says that more trials are needed but they hope the test could prevent thousands of men undergoing unnecessary treatment and allow more personalised care. The drugs abiraterone and enzalutamide are given to men whose cancer is no longer responding to traditional hormone therapy and has started to spread.

Read the full commentary via OnMedica here

Read the full original research article here

Cancer experts condemn cancer drug decision

Expert cancer clinicians have condemned a preliminary decision by the National Institute for Health and Care Excellence (NICE) not to approve use of the drug nivolumab (Opdivo) for the treatment of head and neck cancer on the NHS | OnMedica

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NICE has today issued new draft guidance which does not recommend nivolumab in this way, saying that it is not cost-effective.

Nivolumab is administered intravenously every two weeks and the drug works by blocking a protein on the surface of cells known as PD-L1, which reduces the activity of the body’s immune cells. There is more PD-L1 on cancerous cells which stops the immune system from attacking the tumour.

NICE said the anticipated marketing authorisation for nivolumab was for treating squamous cell carcinoma of the head and neck which has progressed during or after platinum-based chemotherapy.

The watchdog found that the evidence showed a significant improvement in overall survival rates in the short term after nivolumab. However, its value for money was considerably above that which is usually a cost-effective use of NHS resources.

Read the full commentary here

NICE draft guidance is available here

Cost-effectiveness research in cancer therapy

Al-Badriyeh, D. et al. (2017) BMJ Open, 7:e012648

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Objective: To perform a first-time analysis of the cost-effectiveness (CE) literature on chemotherapies, of all types, in cancer, in terms of trends and change over time, including the influence of industry funding.

Conclusions: This analysis demonstrates clear trends in how the CE cancer research is presented to the practicing community, including in relation to journals, study designs, authorship and consultation, together with increased financial sponsorship by pharmaceutical industries, which may be more influencing study outcomes than other funding sources.

Read the full systematic review here

Impact of laparoscopic versus open surgery on hospital costs for colon cancer

Laudicella, M. et al. (2016) BMJ Open. 6:e012977

L0028353 A gynaecological operation. Colour lithograph by Virginia Po

Image source: Virginia Po – Wellcome Library // CC BY-NC-ND 4.0

Objective: Laparoscopy is increasingly being used as an alternative to open surgery in the treatment of patients with colon cancer. The study objective is to estimate the difference in hospital costs between laparoscopic and open colon cancer surgery.

Design: Population-based retrospective cohort study.

Settings: All acute hospitals of the National Health System in England.

Population: A total of 55 358 patients aged 30 and over with a primary diagnosis of colon cancer admitted for planned (elective) open or laparoscopic major resection between April 2006 and March 2013.

Primary outcomes: Inpatient hospital costs during index admission and after 30 and 90 days following the index admission.

Results: Propensity score matching was used to create comparable exposed and control groups. The hospital cost of an index admission was estimated to be £1933 (95% CI 1834 to 2027; p<0.01) lower among patients who underwent laparoscopic resection. After including the first unplanned readmission following index admission, laparoscopy was £2107 (95% CI 2000 to 2215; p<0.01) less expensive at 30 days and £2202 (95% CI 2092 to 2316; p<0.01) less expensive at 90 days. The difference in cost was explained by shorter hospital stay and lower readmission rates in patients undergoing minimal access surgery. The use of laparoscopic colon cancer surgery increased 4-fold between 2006 and 2012 resulting in a total cost saving in excess of £29.3 million for the National Health Service (NHS).

Conclusions: Laparoscopy is associated with lower hospital costs than open surgery in elective patients with colon cancer suitable for both interventions.

Read the full article here

Overspending driven by oversized single dose vials of cancer drugs

Bach, P. B. et al. BMJ 2016; 352:i788

Wasting away: why cancer drug vial sizes cost billions.

Peter B Bach and colleagues call for an end to contradictory regulatory standards in the US that allow drug manufacturers to boost profits by producing single dose vials containing quantities that increase leftover drug

Even though reducing waste in healthcare is a top priority, analysts have missed the waste that can be created when expensive infused drugs are packaged containing quantities larger than the amount needed.1 2 This is particularly true for drugs for which dosage is based on a patient’s weight or body size and that come in single dose packages. These drugs must be either administered or discarded once open, and because patients’ body sizes are unlikely to match the amount of drug included in the vial, there is nearly always some left over. The leftover drug still has to be paid for, even when discarded, making it possible for drug companies to artificially increase the amount of drug they sell per treated patient by increasing the amount in each single dose vial relative to the typically required dose.

Increasing the amount of drug sold per treated patient also increases profits to doctors and hospitals in the United States. Under a system nicknamed “buy and bill,” doctors and hospitals buy single dose vials of drugs and then bill insurers or patients when they are used. The bill includes a percentage based mark-up which can vary widely, but even low percentages can equate to large amounts of money given that many of the drugs cost thousands of dollars per vial.

Although doctors and hospitals sometimes use leftover drug to treat a subsequent patient, thus reducing the amount of leftover drug for which they bill, this practice is very limited. Safety standards from the US Pharmacopeial Convention permit sharing only if leftover drug is used within six hours, and only in specialised pharmacies.

Read the full article here