Laboratories - the forgotten stakeholder
"Pathologists and laboratories are often overlooked as key stakeholders by pharma and this factor can have a considerable impact on the uptake of targ...
Managing the commercialization of companion diagnostic and drug combinations requires a different approach to sales and marketing than that employed for conventional treatments. The pharmaceutical industry is well aware of the need to target physicians with information about its products; but commercialization now entails so much more. Peter Thornton of FirstWord Dossier examines how new stakeholders, such as laboratories, should become part of an early engagement process that paves the way towards an efficient testing market.
The development of biomarker-based pharmaceuticals that require a companion diagnostic (CDx) to confirm that a patient is suitable for the targeted therapy is driving a new business model in which the diagnostic plays a key role in the development and commercialization of these therapies. Managing the commercialization of drug-companion diagnostic (drug-CDx) combinations requires a different approach to sales and marketing than that employed for conventional drugs and diagnostics.
According to a recent report by FirstWord Dossier, the relationship between two widely differing industries that operate in different environments with different end users of their products is perhaps the most vital aspect in ensuring the success of any drug-CDx. As pharmaceutical companies increasingly incorporate biomarker studies into drug research and development programmes, they are forging collaborations with diagnostic partners at an earlier stage than previously in order to provide the enabling technology to stratify patient populations in clinical trials. These collaborations are fostered by the current US regulatory environment where the labelling of targeted therapies stipulates the need for a CDx that has been approved by the US FDA. In the EU, the regulatory environment for diagnostics is more relaxed and, as a result, CE-marked CDx kits have to compete with laboratory-developed tests (LDTs).
The regulatory ambiguity surrounding LDTs in both the US and EU poses a challenge for the manufacturers of approved CDx products, with the EU market presenting an even more difficult challenge as a result of its fragmented nature.
The pharmaceutical industry is well aware of the need to target physicians with information about its products. However, the laboratory is a new stakeholder that the industry needs to be more aware of. Communication with laboratories, not only by IVD manufacturers but also by pharmaceutical companies, is a vital component of sales and marketing strategies for drug-CDx products. Early engagement with laboratories will pave the way to creating an efficient testing market since surveys have shown that it takes over six months to achieve seamless integration of new tests into laboratories.
Commercialization planning needs to start early, with the roles of each partner clearly defined in co-commercialization arrangements. The value proposition message of personalized medicine needs to be tailored to the different stakeholders, including regulators, payers, laboratories, physicians and patients. Cross-training between pharmaceutical and diagnostics sales teams is viewed as a valuable way of allowing each to understand the other’s industry and to ensure alignment of the value proposition message.
The promotional focus of personalized medicine is related to changing treatment paradigms so that testing becomes part of routine clinical practice where targeted therapies are available to treat sub-groups of patient populations. This entails detailing not only medical specialists but other health care professionals (HCPs) who are involved in diagnosis and treatment, such as pathologists and interventional radiologists. The challenges in achieving changes in approaches to treatment are exemplified by the experience of HER2 testing in breast cancer patients, which took many years and several different technologies for testing to be widely incorporated into clinical practice.
There is consensus that educating the broad spectrum of stakeholders is a vital part of sales and marketing strategies, involving a multidisciplinary approach and employing a range of different methodologies. Collaboration with professional medical groups and patient advocacy organizations is a key component in helping to raise awareness of biomarker testing and its role in personalized medicine.
Widely varying pricing and reimbursement policies pose obstacles to market access for personalised medicine. While professional and payer endorsement of testing in the US has facilitated reimbursement, the fragmented diagnostic reimbursement systems in Europe present a tough environment in which pharmaceutical companies frequently step in to fund testing so that uptake of the targeted therapy is not impeded. Initial moves by some health technology organizations towards developing evaluations of co-dependent technologies would contribute to linking the value proposition of the combination of a targeted therapy and the CDx in reimbursement systems in the future.
The rapid innovation and shorter lifecycle of diagnostics compared with pharmaceuticals and the widely differing testing environments will foster multiple modalities for identifying eligible patients for targeted therapies. The emerging trend for pharmaceutical companies to enter into collaborations with more than one diagnostic partner, particularly once the initial regulatory approval for the drug-CDx duo has been obtained in the US, could become the norm. More framework partnerships that extend beyond co-development to commercialization can also be expected. Competition between CDx kits and LDTs will remain a feature of the testing marketplace: the challenge will be to ensure consistency in quality and eliminate inter-laboratory variability.
For more information on the FirstWord report into commercialization of drugs and their companion diagnostic, please contact mailto:firstname.lastname@example.org.
Peter Thornton is Senior Analyst at FirstWord Dossier.