USA Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho, Arnold & Porter
(and is not always entirely transparent). These variations can include: • the criteria considered appropriate for evalu- ation (eg, whether a product’s cost or cost- effectiveness is taken into account in cover- age decisions); • the scientific rigour of the evidence consid- ered and the weight placed on the types of evidence considered; • the decision-making body and the processes for making coverage decisions; and • the legal standards that apply to the coverage decision-making process and the resulting package of covered products and services. Many organisations are engaged in developing value-assessment tools of various sorts and the CMS has experimented with outcome-based models. Essentially, these tools are designed to help payors, healthcare providers, and patients assess outcomes of competing pharmaceuticals on a systematic basis and thereby reach con- clusions about their value in a more systematic and rigorous way than is currently usual. The future of such programmes is uncertain under the Trump Administration. 8.5 Regulation of Prescriptions and Dispensing by Pharmacies Pharmacists are paid for dispensing prescrip- tions by the patient’s insurer (assuming the
patient is insured and the product is covered) and the patient. The circumstances in which pharmacists may dispense a substitute for the prescribed product without obtaining the pre- scriber’s authorisation are governed by state law. State laws on this issue can vary but, in general, they permit pharmacists to substitute a product approved by the FDA as a generic equivalent for the prescribed product (unless the prescrip- tion specifically states “dispense as written” or a similar phrase indicating no substitution). There has also been a recent regulatory focus and extensive litigation relating to pharmacy compounding of approved weight loss drugs in the USA, which was permitted in bulk only when such products were in shortage. During the past several years, the standards for permitting pharmacists to substitute “biosimilar” product for a prescribed biological product have been a topic of considerable debate. The provi- sions of these laws vary but often only permit biosimilar pharmacy-level substitution if: • the substituted product has been designated as “interchangeable” with the prescribed bio- logical product by the FDA; • the prescriber and the patient are both noti- fied of the substitution; and • the pharmacist maintains records of the sub- stitution.
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