Additionally, Aitken continued, “precision medicines are associated with a significant amount of health-care data. All this data needs to be incorporated and analyzed to provide value back into the health-care system. The amount of data involved presents significant challenges around standardization, storing, and sharing, as well as protecting patient privacy,” he said.
There are also hurdles, he said, in demonstrating sufficient value to payers to perform diagnostic testing and to physicians to routinely screen patients. “These are obstacles to patient access,” said Aitken. Smaller patient pools [of clinical data] can also be a deterrent.”
“The therapies are costly and can run into tens of thousands of dollars per month,” said. McBride. Because many of the drugs are being used off-label, it can be difficult to convince payers to cover the cost.
One of the biggest drivers of reimbursement, he said, are patient assistance program. It is important for pharmacist to understand these programs so they can help navigate between the payer and the patient.
Not Just Health-System Pharmacy
McBride also noted that while precision therapy is commonly delivered through health systems, it is also available to patients through specialty and infusion pharmacies. Pharmacists in all settings need to be aware of the different dosing regimens and delivery systems associated with these drug products, he said.
“The pharmacist is responsible for the quality of the medicinal products; this includes the manufacturing of tailor-made medicines,” said Danhof. “There will be a lot of innovation here. Pharmaceutical companies will prepare the components of the treatment, which are then assembled into the product that is then administered to the patient,” said Danhof, who chaired the recent Pharmaceutical Sciences World Congress in Stockholm.
In assembling these drugs, pharmacists need to be aware that there is a high propensity for the development of resistance, Danhof continued. As a result, the treatments are often complex and based on a combination of multiple drugs. “Such treatments cannot be developed nor be implemented in clinical practice by trial and error. Mathematical models must constitute the basis for this,” Danhof said.
“Pharmacists provide value to clinical decisions for precision medicines by understanding and managing the patient’s total drug profile,” said Aitken. “Pharmacists are also point of care references for dosing and administration and can warn of potential side effects.”
“The pharmacist needs to be aware of the mechanism of action of these drugs, and needs to encourage patients to be adherent with therapy,” added McBride.
According to the QuintilesIMS report, 41% of these products are associated with black box warnings for serious adverse effects that require special monitoring by trained clinicians. Side effects that may be mentioned include malignancy, hepatotoxicity, dermatologic toxicity, QT prolongation, and anaphylaxis. “Because of this, pharmacist engagement with patients is important; the relationship that a patient has with a pharmacist can help those side effects be more quickly identified. It’s critical for pharmacists to step up and play the fullest role that they can,” Aitken concluded.