[Ip-health] Pharmafile: Roche falls foul of NICE rules, again

Thiru Balasubramaniam thiru at keionline.org
Fri Oct 3 02:52:01 PDT 2014


http://www.pharmafile.com/news/195062/roche-falls-foul-nice-rules-again

--

<SNIP>

The drug costs £3,312 per 1,000 mg vial, and Roche says that a course of
treatment is £26,496 (£9,936 for cycle one and £3,312 for cycles two to
six). The Swiss firm has not offered a patient access scheme to lower the
price.

NICE adds that this price puts the drug above the average cost bracket that
it would usually consider when assessing a new medicine.

<SNIP>

CLL is a type of cancer that affects the cells in the bone marrow (where
blood cells develop) and causes overproduction of abnormal white blood
cells. The abnormal white blood cells replace the normal cells in the bone
marrow but are unable to function properly.

<SNIP>

This is certainly not the first time that Roche has fallen foul of NICE,
and has in fact had a major public spat with the body relating to the
furore around its £90,000 price tag
<http://www.pharmafile.com/news/191874/storm-brewing-over-roche-cancer-drug-price>
for
its breast cancer drug Kadcyla (trastuzumab emtansine), which was rejected
in draft guidance in August.

But these drugs will from now have their costs assessed before being given
patients, a first for the CDF, meaning Roche – by the far the biggest
winner from the Fund – may no longer receive a blank cheque
<http://www.pharmafile.com/news/193712/nice-cancer-drugs-fund-must-use-our-processes>
for
expensive medicines.



--

Roche falls foul of NICE rules, again
*Published on 03/10/14 at 09:16am*
Uncertainties in the data and high cost have seen NICE make an initial
rejection of Roche’s new blood cancer drug Gazyvaro (obinutuzumab).

In new draft guidance NICE is saying no to Gazyvaro in combination with
chemotherapy agent chlorambucil for patients with untreated chronic
lymphocytic leukaemia (CLL), and who are not able to take the standard
fludarabine-based therapy.

The UK NHS costs watchdog says that uncertainties in the company’s data
mean it cannot recommend the treatment.

Sir Andrew Dillon, NICE’s chief executive, explains: “Although obinutuzumab
is a clinically effective treatment, there were too many uncertainties in
the company’s submission and we cannot be confident that it is an effective
use of NHS resources.

“It is disappointing that we are not able to add this to the range of
treatments already available. However, with limited resources we need to
ensure that each treatment we recommend gives patients not only the best
care but is also of the best value to the NHS.”

The drug costs £3,312 per 1,000 mg vial, and Roche says that a course of
treatment is £26,496 (£9,936 for cycle one and £3,312 for cycles two to
six). The Swiss firm has not offered a patient access scheme to lower the
price.

NICE adds that this price puts the drug above the average cost bracket that
it would usually consider when assessing a new medicine.

CLL is a type of cancer that affects the cells in the bone marrow (where
blood cells develop) and causes overproduction of abnormal white blood
cells. The abnormal white blood cells replace the normal cells in the bone
marrow but are unable to function properly.

There are already a number of medicines for CLL, including Janssen’s
Imbruvica (ibrutinib), Gilead’s Zydelig (idelalisib) and Arzerra
(ofatumumab), from GlaxoSmithKline and Genmab. None have yet been
recommended by NICE for this particular blood cancer.

Roche does already have a medicine recommended by NICE for CLL however,
namely its MabThera (rituximab) which is funded by the NHS as a first-line
treatment for patients with CLL who are able to take fludarabine in
combination with cyclophosphamide.

*Roche rejections*

This is certainly not the first time that Roche has fallen foul of NICE,
and has in fact had a major public spat with the body relating to the
furore around its £90,000 price tag
<http://www.pharmafile.com/news/191874/storm-brewing-over-roche-cancer-drug-price>
for
its breast cancer drug Kadcyla (trastuzumab emtansine), which was rejected
in draft guidance in August.

Over the years the Swiss firm has seen this time and again, with its
multi-licensed cancer drug Avastin (bevacizumab) – the world’s biggest
selling oncology product – constantly knocked back for all five of its
licences by NICE.

In recent interviews with Pharmafile, NICE’s chair Professor David Haslam
<http://www.pharmafile.com/news/187169/david-haslam-nice-drug-pricing-and-ethics>
says
it is clear that Avastin is simply not cost-effective with minimal efficacy
for its money. But the drug now alongside Gazyvaro, are both available on
the government’s £280 million per year Cancer Drugs Fund.

This was recently extended from a £200 million annual injection for cancer
drugs not recommended by NICE to £280 million by the UK government, as both
cost and demand were skyrocketing – nearly bankrupting NHS England’s
specialist commissioning budget.

But these drugs will from now have their costs assessed before being given
patients, a first for the CDF, meaning Roche – by the far the biggest
winner from the Fund – may no longer receive a blank cheque
<http://www.pharmafile.com/news/193712/nice-cancer-drugs-fund-must-use-our-processes>
for
expensive medicines.

The Fund is due to end in 2016 with no word on an extension. NICE is
currently in the middle of a reform that could see it allow more cancer
medicines through in the future, although just how this will work is yet to
be ironed out
<http://www.pharmafile.com/news/194507/nice-reform-put-hold-now>.

*Ben Adams *



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