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Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
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Tuesday, November 25, 2014
Important Comment from Reader Regarding Question of Whether PBMs and Insurance should Reimburse for Compounded Medications
Compounded drugs as finished dosage forms do not have population-level, data-driven, scientifically sound and vetted benefit-risk determinations at the federal, state or non-federal/professional levels--in their traditional scope of use, their "extemporaneous" nature generally precludes population determinations.
Compounded drug active and inactive ingredients also do not have population-level, data-driven, scientifically sound and vetted benefit-risk determinations at the federal, state or non-federal/professional levels--in their traditional scope of use, their very nature precludes population determinations.
Payment determinations are based on populations--applying a population-level pass through for the payment of unproven drugs is reckless from a public health perspective, and risks an unintended channeling of untested drugs to targeted sub-populations that may be the most medically vulnerable.
A reasonable justification may be made for payment where commercial formulations found safe and effective for their intended use at population levels cannot be used to treat a specific individual for important medical reasons--this justification should reflect consideration of expected benefit, potential/theoretical risks, missing information and uncertainties.
Setting aside benefit-risk assessments for meeting urgent needs that cannot be met with commercial formulations makes sense. But today, we are only very rarely operating within the parameters of historical, traditional prescribing and use of compounds--there are layers of businesses with strategies extending into public markets, that depend on the exploitation of conditional exemptions to provisions of the FFDCA as novel drug development platforms for ushering in unapproved drugs intended for and heavily marketed to broad populations.
Payers, beware. What sounds like cost-savings by paying for ingredients went badly askew with compounded pain creams. And asking patients on a population-level to be exposed to unapproved treatments, potentially baring an added burden of harm or delayed access to effective treatment, for an immediate gain on cost but with unknown future costs, is reckless public health policy (and bad financial/investor stewardship).
Compounded drug active and inactive ingredients also do not have population-level, data-driven, scientifically sound and vetted benefit-risk determinations at the federal, state or non-federal/professional levels--in their traditional scope of use, their very nature precludes population determinations.
Payment determinations are based on populations--applying a population-level pass through for the payment of unproven drugs is reckless from a public health perspective, and risks an unintended channeling of untested drugs to targeted sub-populations that may be the most medically vulnerable.
A reasonable justification may be made for payment where commercial formulations found safe and effective for their intended use at population levels cannot be used to treat a specific individual for important medical reasons--this justification should reflect consideration of expected benefit, potential/theoretical risks, missing information and uncertainties.
Setting aside benefit-risk assessments for meeting urgent needs that cannot be met with commercial formulations makes sense. But today, we are only very rarely operating within the parameters of historical, traditional prescribing and use of compounds--there are layers of businesses with strategies extending into public markets, that depend on the exploitation of conditional exemptions to provisions of the FFDCA as novel drug development platforms for ushering in unapproved drugs intended for and heavily marketed to broad populations.
Payers, beware. What sounds like cost-savings by paying for ingredients went badly askew with compounded pain creams. And asking patients on a population-level to be exposed to unapproved treatments, potentially baring an added burden of harm or delayed access to effective treatment, for an immediate gain on cost but with unknown future costs, is reckless public health policy (and bad financial/investor stewardship).