[Ip-health] Rationing of patented cancer drugs: Xalkori not cost effective at $7, 100 per month
james.love at keionline.org
Fri Mar 29 17:04:40 PDT 2013
NICE nixes Pfizer's targeted lung cancer drug as too pricey
Xalkori not cost-effective at $7,100 a month, agency says
March 27, 2013 | By Tracy Staton
Pfizer's targeted lung cancer drug Xalkori got a thumbs down from the
U.K.'s cost-effectiveness gatekeepers. But in its announcement of draft
guidance, the National Institute for Health and Clinical Excellence seemed
ready to change its mind--if the price was right. So, if Pfizer ($PFE)
comes forward with the right discount, then NICE may accept Xalkori soon
Xalkori, known generically as crizotinib, was developed for patients with a
specific type of non-small cell lung cancer seen in only 5% of patients. A
companion diagnostic for the anaplastic lymphoma kinase enzyme identifies
the right patients for treatment, NICE says. Because relatively few
patients qualify for treatment--and because Xalkori works in such a high
percentage of those patients--the idea is that it's worth a higher price.
That's the rationale, anyway. But while NICE recognized Xalkori's efficacy,
it balked at the cost. The pill costs £4,689, or about $7,079, for a 30-day
supply, NICE says, with a course of treatment costing up to £51,579 per
patient, or about $77,000. Under the agency's quality-adjusted life year
analysis, Xalkori costs much more than the highest-priced end-of-life
"[A]lthough the independent committee that considered the evidence found
crizotinib to be clinically effective treatment for ALK-positive
non-small-cell lung cancer, ... crizotinib could not be considered a
cost-effective use of NHS [funds]," NICE chief Sir Andrew Dillon said in a
The agency's draft guidance is now open for comment, and you can be sure
that Pfizer will be in the mix. NICE's decisions not only affect use by the
U.K.'s National Health Service, but by state healthcare systems in other
countries that closely watch the agency's decisions.
- see the NICE release
NICE consults on new draft recommendations for lung cancer drug
NICE, the healthcare guidance body, has issued new draft guidance on
crizotinib (Xalkori, Pfizer) for previously treated
anaplastic-lymphoma-kinase-positive advanced non-small-cell lung cancer.
The draft guidance does not recommend crizotinib.
Crizotinib is a tyrosine kinase inhibitor (TKI) - it works by blocking
enzymes which can stimulate cancers to grow. Crizotinib blocks a specific
enzyme called anaplastic lymphoma kinase (ALK) which is present in some
non-small-cell lung cancers. NICE is appraising the drug for those patients
whose cancer test positive for the ALK enzyme.
Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive,
said: "When assessing the cost effectiveness of a treatment, NICE appraisal
committees will take numerous factors into account. These include how
effective the drug is, its side effects, the effect it can have on the
patient's quality of life and also the financial cost. This enables them to
determine the cost of using the drug to provide a year of the best quality
of life available or quality adjusted life year (QALY).
"Appraisal committees will normally recommend treatments that cost around
£20,000 to £30,000 per QALY or less. If a drug meets the criteria to be
considered under NICE's supplementary advice for end of life treatments,
then a higher cost per QALY may be accepted. There is no set threshold cost
per QALY of drugs that meet the end of life criteria, but since the
supplementary advice was introduced, the highest cost per QALY of a
recommended drug has been around £50,000."
The Committee concluded that the most plausible cost per QALY would lie
somewhere between £63,800 and £181,100 for crizotinib compared with
docetaxel, and between £51,700 and £80,500 for crizotinib compared with
best supportive care.
Andrew Dillon continued: "We have already recommended a number of
treatments for the various stages of non-small-cell lung cancer. However,
although the independent committee that considered the evidence found
crizotinib to be clinically effective treatment for ALK-positive
non-small-cell lung cancer, even if the supplementary advice to the
Committee for life-extending treatments had applied, crizotinib could not
be considered a cost-effective use of NHS."
Consultees, including the manufacturer, healthcare professionals and
members of the public are now able to comment on the preliminary
recommendations which are available for public consultation. Comments
received during this consultation will be fully considered by the Committee
and following this meeting the next draft guidance will be issued.
Until final guidance is issued to the NHS, NHS bodies should make decisions
locally on the funding of specific treatments. Once NICE issues its final
guidance on a technology, it replaces local recommendations across the
Notes to Editors
About the guidance
1. The draft guidance will be available on the NICE website from 27 March
2013. Embargoed copies of the draft guidance are available from the NICE
press office on request.
2. Treatment with crizotinib resulted in a median gain of 5.1 months in
progression free survival compared with docetaxel. The exact magnitude of
the survival gain was uncertain because of the immaturity of the 1007 trial
data and the impact of crossover in the trial
3. The Committee concluded that the most plausible ICERs would lie
somewhere between £63,800 and £181,100 per QALY gained for crizotinib
compared with docetaxel, and between £51,700 and £80,500 per QALY gained
for crizotinib compared with best supportive care.
4. Acquisition cost is £4689 for 1 pack of 60×200 mg (or 250 mg) capsules
(30-day supply). Assuming treatment until disease progression, the cost of
a course of treatment would be between £37,512 and £46,890. Assuming
treatment after disease progression, the cost of a course of treatment
would be £51,579.
5. The drug does not meet the criteria to be considered under end-of-life.
6. SMC is in the process of appraising the drug for this condition.
1. The National Institute for Health and Clinical Excellence (NICE) is the
independent organisation responsible for providing national guidance and
standards on the promotion of good health and the prevention and treatment
of ill health.
2. NICE produces guidance in three areas of health:
public health - guidance on the promotion of good health and the prevention
of ill health for those working in the NHS, local authorities and the wider
public and voluntary sector
health technologies - guidance on the use of new and existing medicines,
treatments, medical technologies (including devices and diagnostics) and
procedures within the NHS
clinical practice - guidance on the appropriate treatment and care of
people with specific diseases and conditions within the NHS
social care - the Health and Social Care Act (2012) sets out a new
responsibility for NICE to develop guidance and quality standards for
social care. To reflect this new role, from 1 April 2013 NICE will be
called the National Institute for Health and Care Excellence (NICE) and it
will become a Non-Departmental Public Body.
3. NICE produces standards for patient care:
quality standards - these describe high-priority areas for quality
improvement in a defined care or service area
Quality and Outcomes Framework - NICE develops the clinical and health
improvement indicators in the QOF, the Department of Health scheme which
rewards GPs for how well they care for patients
CCG Outcomes Indicator Set (formerly known as COF) - NICE develops the
potential clinical health improvement indicators to ensure quality of care
for patients and communities served by the clinical commissioning groups
4. NICE provides advice and support on putting NICE guidance and standards
into practice through its implementation programme, and it collates and
accredits high quality health guidance, research and information to help
health professionals deliver the best patient care through NHS Evidence.
This page was last updated: 26 March 2013
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