The pharmaceutical industry is flooded with
talk of value; value dossiers, the value story, value messages, value
demonstration and value-based pricing. Value is now even more pertinent with
the new NHS value-based pricing system launching early next year. This follows
the expiration of the current Pharmaceutical Price Regulation Scheme in January
2014. The new scheme aims to have a greater focus on the value medicines offer
to NHS patients and the wider community.
The Government’s response to the latest
report from the Health Select Committee states that suggested changes to the
pricing system appear modest and there are yet to be any final decisions as to
how the new system will be used in practice. The Government report advises any
such uncertainties should be resolved by the end of this month (March 2013).
What
is value?
As value is strongly linked to the price of
a new treatment it is important to fully understand what value means in this
setting. When assessing the overall value of a medicine, clinical, economic and
patient factors must be considered.
Clinical
value is defined by the product’s efficacy data
from clinical trials and how these compare to existing and future competitors.
The safety profile, method of administration and effect when used alongside
other treatments are also important.
Economic
value can be demonstrated using cost-effectiveness
analyses, such as a budget impact model. Indirect costs or out-of-pocket
expenses for the patient may also be evaluated.
Value
to the patient and carers includes the impact on
quality of life, adverse events and ability to perform daily activities.
Patient reported outcome tools, such as the EQ-5D, can be used to measure these
end-points.
Real
world value is a new concept, where the product is
evaluated in practice – Do doctors prescribe it? Do pharmacists recommend it?
Do patients prefer it? Data from real world studies will help payers re-assess the
value of products that are already available.
What
does this mean for pharma?
Pharmaceutical companies have an enormous
challenge ahead – products will have to demonstrate value in early clinical
trials to prevent high research and development costs which may not be able to
be recovered. It is also no longer enough for a new medicine to display similar
properties to existing products – innovation and an increase in efficacy,
reduction in cost, or improved quality-of-life evidence is required.
References
1. NICE. NICE
“central” to value-based pricing of medicines. 22 March 2013. Accessed 24 March
2013. Available at: http://www.nice.org.uk/newsroom/news/NICECentralToValueBasedPricingOfMedicines.jsp
2. HM Government.
The Government’s Response to the Health Select Committee’s Eighth Report of
Session 2012-13 on the National Institute for Health and Clinical Excellence.
March 2013 Available at: http://www.officialdocuments.gov.uk/document/cm85/8568/8568.pdf ISBN: 9780101856829
