From vision to decision Pharma 2020 - pwc

Creating companion diagnostics for medicines that target
a specific disease subtype lets doctors maximise the value
of those medicines themselves
Table 1
Product
Erbitux
Herceptin +
Perjeta
Tarceva
Xalkori
Indication
Colorectal, head
and neck cancer
Annualised
cost per
patient in US
Biomarker
$84,000 EGFR+
KRAS-wt
Population
testing positive
for biomarker
(%)
Projected sales
(2012-2018)
37.5 $13.42 billion
Breast cancer $124,800 HER-2+ 25 $49.96 billion
Non-small cell
lung cancer
Non-small cell
lung cancer
Develop companion diagnostics
for specialist medicines
Another way companies can maximise
the molecules they’re developing is to
create companion diagnostics that let
doctors maximise the value of those
molecules themselves. There’s no point
in prescribing therapies that target one
disease subtype for patients who suffer
from another, as healthcare payers
recognise. And they’re prepared to
reward innovations that help them direct
precious resources more effectively.
(see Table 1).
Targeted medicines with companion diagnostics generate high revenues
because they work so well for specific patient segments
$52,800 EGFR+ 10-15 $10.8 billion
$115,200 ALK+ 4-7 $4.76 billion
Zelboraf Melanoma $112,800 BRAF+ 13.5 $4.25 billion
The FDA has also signalled that it would
like to see more specialist medicines
paired with companion diagnostics and
sometimes accelerates the review
process for such products. But when the
‘carrot’ doesn’t work, it’s ready to wield
the stick. In 2010, the agency refused to
approve leukaemia treatment Omapro
without a diagnostic to identify the
target patient base. 66
NICE rejected melanoma therapy Yervoy
for reimbursement on the same grounds
in 2011. 67 So failing to develop a
diagnostic test for a costly treatment
that’s aimed at a tiny patient population
may damage its prospects of commercial
success. Indeed, we think that, by 2020,
companion diagnostics will be mandatory
for approval of all such medicines.
Sources: EvaluatePharma and The Pink Sheet
Note: Projected sales are cumulative and global.
14 Pharma 2020