Lifecycle Management (Chapter 7)
Historically, drugs are approved for an initial indication; then the lifecycle management team pursued additional indications. Rarely were indications revoked by regulators, so the potential market usually increased indication by indication. Within each indication, companies competed for market share.
Personalized Medicine Implications
As our understanding of genomics increases, it is likely that clinicians will discover subsets of patients for whom a drug is safe and effective as well as subsets for whom it is not. If these subsets are known prior to regulatory approval, the pharmaceutical manufacturer can build this knowledge into its launch plans and price the product accordingly. However, if subsets are discovered long after product launch, appropriate utilization of the product could drop significantly leaving the manufacturer with a difficult choice:
- Attempt to raise the drug’s price to compensate for the smaller market (not likely to be successful in the US and EU) OR
- Dramatically lower the drug’s shareholder value over the patent term
For example, the EGFR antagonists, Vectibix® (Amgen) and Erbitux® (Bristol-Myers Squibb and Lilly) both saw their target markets shrink by 40% when post-approval data showed these drugs to be ineffective in patients whose tumors had KRAS mutations.
In another scenario based on genomics, it is possible that clinicians will discover subsets of patients who require a much higher dose than was approved by regulators. At first glance, such a scenario would appear to be a boon for the pharmaceutical company. However, in order to market or promote such a finding, the manufacturer would be required to perform a clinical trial and submit to the regulator for a label change. Depending on the overall size of this subset of patients, the cost of the trial (both in time and in money) might be prohibitive. Furthermore, any label change would trigger a price renegotiation at the national level in the EU.
The pharmaceutical sales team cannot educate a physician or a payer on the varying genetic profiles, the appropriate genetic test, the dose for the physician to prescribe and the payer to reimburse unless the trials were completed and the indication approved; otherwise they open themselves up to off-label marketing liability. One way to address this challenge might be to fund post-marketing trials and hire/train an even larger team of medical science liaisons (MSLs) to bring such compendia to light, but many pharmaceutical manufacturers are risk averse given tough scrutiny of such practices by regulators.
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