Coverage and Reimbursement (Chapter 6)
The market access/reimbursement teams at pharmaceutical companies work closely with payers, advocacy groups, commercial copay programs, and 501(c)(3) patient assistance foundations to help ensure approved medicines are covered by public and private payers. Once coverage has been established, these groups focus on understanding the payer-to-payer differences in processing and paperwork needed to receive reimbursement for the therapy.
Personalized Medicine Implications
Payers need as much information as possible about the clinical condition being treated and the percentage of patients who have the specific genomic profile. One way payers determine coverage is by weighing the benefit of the therapy against the sum of the following:
- The aggregate diagnostic testing costs necessary to identify a single patient with the appropriate genomic profile. For example, if 5% of the population has the needed genomic profile, then, on average, 20 patients must tested to find one with the desired profile.
- The cost of treating the patient with the personalized medicine.
- The risks/side effects of the therapy.
Once coverage is determined, pharmaceutical companies need to work closely with each payer to understand the reimbursement process for both the diagnostic test as well as the therapeutic and then communicate this information to prescribers.
In the US, payers often will not reimburse for the cost of diagnostic testing until the patient’s deductible is met. As mentioned in an earlier section, drug companies need to have direct-to-patient materials about coverage and reimbursement options (e.g. copay programs, 501c3 foundations) associated with the diagnostic test as well as the personalized medicine.
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