[Ip-health] BMJ: NICE approval of new hepatitis drug could result in £700m bill for NHS

Thiru Balasubramaniam thiru at keionline.org
Wed Oct 21 23:46:56 PDT 2015

NICE approval of new hepatitis drug could result in £700m bill for NHS

BMJ 2015; 351 doi:
(Published 21 October 2015) Cite this as: BMJ 2015;351:h5554

Nigel Hawkes

The National Institute for Health and Care Excellence (NICE) has approved
another treatment for hepatitis C, presenting NHS England with a dilemma
over how to pay for it.1

NICE has now approved three new treatments as cost effective: daclatasvir
(Daklinza, Bristol-Myers Squibb); ledipasvir/sofosbuvir (Harvoni, Gilead
Sciences); and ombitasvir/paritaprevir/ritonavir with or without dasabuvir
(Viekirax with or without Exviera, AbbVie).

All are more effective than previous treatments for hepatitis C, but they
are expensive. To make them affordable for the NHS, NHS England has
announced a scheme to pay for the drugs for 3500 people who have developed
cirrhosis of the liver as a result of hepatitis C infection. This is a
small fraction of the estimated 160 000 people in England with the virus.

Fewer than half of these people are aware that they are infected, and
widespread testing has not been implemented because of cost and the fact
that previous treatments were lengthy, had significant side effects that
stopped many patients completing the course, and were not completely

Health services are reeling over the potential cost of treating all of
those infected by hepatitis C with the new medicines. In its draft guidance
NICE had said that access to the drugs should be managed by the programme
put in place by NHS England and that prescribing decisions should be made
by multidisciplinary teams and centres to ensure that treatment is
prioritised for patients with the highest unmet clinical need.

The Hepatitis C Trust has argued that this sets a precedent in which
affordability rather than cost effectiveness is allowed to determine use.
When NICE issued draft guidance on sofosbuvir earlier this year Charles
Gore, chief executive of the trust, said he believed that a new criterion
had been invented by the back door.

But, given the cost of the medicines, some form of rationing is
unavoidable. The cost of a 12 week course of Viekirax plus Exviera will be
£35,300 (48,000€ ) ($54,500) at the list price of the drugs, the NICE
guidance said, and many patients will require a 24 week course, doubling
the cost. Sofosbuvir costs much the same.

In practice, the NHS will not pay the full price. AbbVie has said that its
medicines have been found to be cost effective on the basis of a tender
price that it will not disclose for commercial reasons.

NHS England submitted evidence to NICE, saying that it considered the new
oral treatments to be 'excellent options' but that it was concerned about
cost. If NICE approved them for people with chronic hepatitis C infection
(including those who have not progressed to cirrhosis), as many as 20,000
people a year would be eligible. A simple calculation shows that treating
this many people would cost at least £700m and possibly as much as £1bn,
depending on how many required a 24 week course.

NICE has questioned NHS England's numbers and said that a more realistic
estimate would be 7000 to 10,000 people a year -but treating even 7000
would not be affordable within the existing NHS budget, NHS England noted.
NICE said that the costs should be seen in the context of the 2014
Pharmaceutical Price Regulation Scheme, under which the drug companies have
agreed to reimburse drug spending above a pre-agreed ceiling. However, it
did not include this rebate in its cost effectiveness calculations, which
showed that the drugs cost less than £20,000 per quality adjusted life year
gained, meeting its threshold of cost effectiveness.

The guidance, which should come into operation within three months,
concluded, 'This means that if a person has chronic hepatitis C and the
doctor responsible for their care thinks that
with or without dasabuvir is the right treatment, it should be available
for use in line with NICE recommendations'

Gore said, 'It is now vital that NHS England ensures patients have access
to these drugs as quickly and widely as possible. There really is no excuse
for delaying treatment and continuing to allow ever increasing numbers of
hepatitis C patients to progress to end stage liver disease and liver

Cite this as: BMJ 2015;351:h5554

National Institute for Health and Care Excellence. Final appraisal
determination: ombitasavir-paritaprevir-rotonavir with or without
dasabuvir. Oct 2015.

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