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Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
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Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
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In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
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Updated: Mar 20, 2026

Proton Therapy Delivery and Its Clinical Application in Select Solid Tumor Malignancies
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Are payers treating orphan drugs differently?

Joshua P Cohen1, Abigail Felix1

  • 1Tufts Center for the Study of Drug Development, Boston, MA, USA.

Journal of Market Access & Health Policy
|May 27, 2016
PubMed
Summary

Payer coverage for orphan drugs varies, with restrictions often higher than for non-orphan drugs. Payers should use consistent criteria like disease severity and cost-effectiveness for all drug evaluations.

Area of Science:

  • Health Economics
  • Pharmaceutical Policy
  • Orphan Drug Access

Background:

  • Rising costs of orphan drugs necessitate increased payer scrutiny.
  • Growing number of new orphan drug launches impacts market dynamics.
  • Analysis focuses on outpatient orphan drugs approved 1983-2012 and top 11 most expensive drugs.

Purpose of the Study:

  • To examine payer coverage policies for outpatient orphan drugs.
  • To compare coverage restrictions across different jurisdictions (US, England, Wales, Netherlands).
  • To evaluate the economic perspective on orphan drug pricing and coverage.

Main Methods:

  • Data collection from regulatory agencies, payers, and drug evaluation authorities.
  • Comparative analysis of coverage policies.
Keywords:
orphan drugspricingreimbursement

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  • Examination of drug approval dates and cost.

    • Main Results:

    • Orphan drugs face more coverage restrictions than non-orphan drugs in all studied regions.
    • High cost or orphan status alone should not trigger unique payer evaluations or restrictions.
    • Jurisdictional differences in coverage were observed.

    Conclusions:

    • Payers should apply consistent decision criteria for all drugs, including orphan drugs.
    • Key criteria include disease severity, treatment alternatives, unmet medical need, and cost-effectiveness.
    • Reimbursement decisions should balance these criteria for both orphan and non-orphan drugs.