Molecular Diagnostics
Table 1: Assessment of the relative importance and value to the stakeholders of the therapeutic drug compared with the Companion Diagnostic a +++ = Very Important, ++ = Important, + = Modest, ---- = No importance
THERAPEUTIC DRUG
STAKE- HOLDERS
Pharma Company CD Company CRO (Drug) Testing Lab (CD) Physician/HCP COST/PRICE +++a ---- ---- ---- + Patient/Consumer ++ Payor Regulatory +++ ----
SAFETY/ EFFICACY
+++ ---- ---- ---- +++ +++ ++ +++ +++ ---- + ---- +++ +++ ++ +++ VALUE COMPANION DIAGNOSTIC
COST/PRICE SENSITIVITY /SPECIFICITY
+ +++ ---- +++ + + +++ ---- +++ +++ ---- +++ +++ +++ ++ +++ + +++ ---- +++ +++ ++ ++ +++ VALUE
and its CD are of value only in terms of disease management and decision-making. In addition the cost/price is important only in the context of the reimbursement process. vii Payor: cost/price of both the drug and CD are of primary importance to the Payor. In addition they are looking for the most cost-effective treat- ment and increasingly are using comparative effec- tiveness analyses to make determinations. viii Regulatory authorities: the performance char- acteristics of both the drug and CD are the main focus of the regulatory agencies
All the different stakeholders perceive different value propositions of the therapeutic agent versus the CD. In some cases those interests may be radi- cally divergent, as in the case of the cost/price of the CD test. The CD manufacturer as well as the laboratory testing facility would prefer to realise a high margin on the price charged to the end user/payor, whereas the patient would obviously prefer to pay no charge for such information con- tent. Clearly, the value to the patient who needs a cheap or free marker is in the clinical information to help him/her better manage disease. This is in stark contrast to the CD company who has expended considerable financial assets to produce a clinically relevant biomarker and is looking to recoup those sunken costs and build a successful business. To further compound matters, the phar- maceutical companies have no experience in mark-
Drug Discovery World Summer 2010
er/diagnostic discovery and development, and are unsure as to the process and cost of validation and commercialisation, thus they are uncertain as to the monetary value of a CD. All of this is captured and summarised in Table 1.
Pharmaceutical company perspective Andrea Lauber (Head, Technology Transactions- Clinical Biomarkers & Pharmacodiagnostics, Bristol Myers Squibb) and Steven Averbuch (Vice- President, Global Clinical Research, Bristol Myers Squibb) have described the use of CDs in facilitat- ing the “right therapy to the right patients”9,10. They, and others, have argued that this approach when adopted by pharmaceutical companies can bring significant additional value to patient/con- sumer, physician and payor stakeholders. This is manifested via:
i Enhanced efficacy: differentiating patients who will benefit from those patients who may not respond to a specific drug or drug class. ii Improved safety: identify patients at greater risk from therapeutic treatment either due to increased chance of toxicity iii Patient stratification in clinical trials: identify patients and patient sub-populations who respond to treatment.
Based on the use of CDs in such a manner, it has been suggested that a significant number of cost
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