Source of Prior authorisation

{{Infobox concept | name = Prior authorisation | subtitle = Insurance and coverage | Also called = Pre-authorisation, pre-approval | Decided by = The payer, not the prescriber | Common criteria = Body-mass index, comorbidity, prior therapy }} '''Prior authorisation''' is a requirement imposed by a payer that a prescription be approved before it will be covered. It is a coverage mechanism rather than a clinical one, and the decision is made by the payer against its own criteria.{{r|ada2024}} For incretin therapies it is close to universal where these drugs are covered at all, and the criteria commonly include a body-mass index threshold, a comorbidity, documented prior attempts at other management, and sometimes a requirement to try a specified alternative first.{{r|ada2024}} Its effect on access is substantial. Requirements add delay, administrative burden on prescribers, and a failure mode in which coverage is denied for a prescription a clinician judged appropriate.{{r|kyle2021}} == How it operates == A prescriber submits a request with supporting documentation; the payer assesses it against published or unpublished criteria; approval, denial, or a request for further information follows. Denials may be appealed, in a process with its own timelines.{{r|kyle2021}} Step therapy — a requirement to have tried and failed a specified alternative — is a common form. Its rationale is cost containment; its cost is delay and, where the specified alternative is less effective, a period of less effective treatment.{{r|ada2024}} Reauthorisation is often required periodically, sometimes conditional on documented response such as a minimum weight reduction. A person who responds moderately may therefore lose coverage.{{r|kyle2021}} == Consequences == | Consequence | Direction | |---|---| | Delay to treatment | Days to months | | Administrative burden | Falls on prescribers and staff | | Denial despite clinical judgement | Occurs; appealable | | Discontinuation on coverage change | Common; see [[Weight regain after discontinuation]] | | Migration to unregulated supply | Documented in community reporting | The last row is where this intersects with the rest of the wiki. Where a licensed product is unaffordable or coverage is denied, some people obtain material outside licensed channels, with the identity, content and sterility uncertainties this wiki documents throughout.{{r|reports}} That is a description of an observed pattern, not an endorsement of it. Research-use compounds are not approved for human administration.{{r|usp1503}} == Variation == Prior authorisation is a feature of insurance-based systems and is largely absent where medicines are supplied through a national formulary, which uses different mechanisms — inclusion decisions, prescribing criteria, and volume controls — to the same cost-containment end. See [[Formulary tier]].{{r|ada2024}} Coverage of weight-management indications differs from coverage of diabetes indications for the same molecule in many systems, so status can depend on the indication rather than the drug.{{r|kyle2021}} International differences in coverage are one component of the broader pattern described at [[Global access disparity]].{{r|ada2024}} == References == {{reflist}} <ref name="ada2024">American Diabetes Association. "Standards of Care in Diabetes." ''Diabetes Care'' 47(Suppl 1) (2024).</ref> <ref name="kyle2021">Kyle TK, Stanford FC. "Moving toward health policy that respects both science and people living with obesity." ''Nursing Clinics of North America'' 56(4):635–645 (2021). PMID 34749900.</ref> <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> == See also == * [[Insurance coverage of GLP-1 drugs]] * [[Formulary tier]] * [[Cost per milligram]] * [[Global access disparity]] * [[Telehealth prescribing]] {{DEFAULTSORT:Prior authorisation}} [[Category:Insurance and coverage]] [[Category:Access and economics]] [[Category:Prescribing and telehealth]]