234:
Thereby pharmaceutical companies could realize high returns and firm valuations. Companies like CVS and
Express Scripts in the US have begun implementing pricing based on indication and in countries like Italy, similar forms of pricing are already being used. For example, Express Scripts' "Oncology Care Value Program," uses indication-based pricing for certain oncology medications and was launched in 2016. Italy on the other hand, uses a model similar to indication-based pricing where the amount the hospital pays for certain drugs varies based on what it's used for. Patients can receive reimbursements for treatments based on their response and either be fully or partially refunded. Italy's reimbursement system is run by AIFA, the Italian Medicines Agency, which is the national authority that regulates drugs in Italy. In contrast, Germany and France use weighted-average pricing - a pricing system that calculates a single price based on the average volume and value of all approved indications. Using weighted-average pricing effectively reduces cancer drugs' list prices as new indications are approved. England, Scotland, and Canada use another form of indirect indication-based pricing: differential discounts on single list prices for each indication. Furthermore, European countries were shown to restric coverage to supplemental low-value indications using clinical coverage restrictions or financial coverage restrictions, such as managed entry agreements.
49:. Indications are included in the Indications and Usage section of the Prescribing Information. The primary role of this section of labeling is to enable health care practitioners to readily identify appropriate therapies for patients by clearly communicating the drug's approved indication(s). The Indications and Usage section states the disease or condition, or manifestation or symptoms thereof, for which the drug is approved, as well as whether the drug is indicated for the treatment, prevention, mitigation, cure, relief, or diagnosis of that disease or condition. Additionally, the Indications and Usage section should contain the approved age groups as well as other information necessary to describe appropriate use (e.g., identifying the indicated patient/disease subgroups, stating if adjunctive therapy is required).
63:
205:
if it is found that there is substantial evidence that benefits of treatment outweigh the risks, the proposed labeling in the
Prescribing Information is appropriate, and the manufacturing process is safe and adequate, then the drug is approved to go to market under that now FDA-approved indication. Even after approval, the FDA CDER continues to do postmarking surveillance of the drug through
225:, also known as indication specific pricing or indication value-based pricing. Since drugs can be used for different indications, this form of pricing would set different prices for each indication based on the value the drug offers for whatever it is being used to treat. This pricing scheme is often discussed in relation to
242:
There has been some thought on incorporating the indication in prescription drug labeling as an approach to improve patient understanding of the medications they are on. This information can help healthcare providers reduce medication errors related to drugs that may look and sound alike. Knowing the
233:
Currently, most medications in the United States are priced the same regardless of what they're being used for or how effective they are at improving outcomes. Concerns were therefore raised that patients and insurers may be paying too high prices for indications with a relatively low clinical value.
269:
of conditions (such as diseases) that the test is expected to achieve. Additional factors that influence a decision whether a medical test should be performed or not include: cost of the test, time taken for the test or other practical or administrative aspects. The possible benefits of a diagnostic
246:
However, there are still some challenges with incorporating the indication of use on prescription drug labels. Revealing the indication of use on prescription drug labels can breach patient confidentiality since the label will disclose private information publicly. Some medications can also be used
204:
or a
Biologics License Application (BLA) for approval to the FDA's Center for Drug Evaluation and Research (CDER) and the proposed scientific evidence for use in an intended population is evaluated by a team of physicians, statisticians, chemists, pharmacologists, and other scientists. Essentially,
194:
The purpose for adding FDA-approved indications in the United States is to ensure that healthcare providers can easily identify appropriate use of drug therapy. Gaining FDA approval is based on the body of scientific evidence supporting the effectiveness of a drug treatment. The scientific evidence
181:
Off-label indications are drugs that are used for medical indications that have not been approved by the FDA. Off label indications often have some clinical significance to back the use, but they have not gone through the extensive testing required by the FDA to have an official labeled indication.
229:
drugs, which are costly. Oncology drugs can be used for multiple different types of cancers so by applying indication-specific pricing, the drug would be priced based on how effective it is for treating each type of cancer. If the drug is more effective for Cancer A than Cancer B, then the patient
164:
for the indication and manufacturers are allowed to market their drug for the indication. A drug can have more than one FDA labeled indication, which means that it can be used for multiple medical conditions. As the evidence and consensus for use of the drug increases and strengthens, its class of
580:
247:
for multiple diseases and one disease may have multiple medications for its prevention or treatment, therefore adding an indication on prescription labels in these cases may cause some confusion and may not be able to actually fit onto the label.
995:
Michaeli DT, Michaeli T (December 2022). "Overall
Survival, Progression-Free Survival, and Tumor Response Benefit Supporting Initial US Food and Drug Administration Approval and Indication Extension of New Cancer Drugs, 2003-2021".
911:
Michaeli DT, Michaeli T (December 2022). "Overall
Survival, Progression-Free Survival, and Tumor Response Benefit Supporting Initial US Food and Drug Administration Approval and Indication Extension of New Cancer Drugs, 2003-2021".
737:
199:
process: discovery and development, pre-clinical research (testing safety), and clinical research (testing efficacy). After there is adequate completion of research and development phases by the drug companies, they send a
672:
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34:
is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term
1145:
734:
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indication of the drug can also help providers determine if the dose of the drug is appropriate per indication, and this can greatly improve patient safety and drug effectiveness.
1312:
664:
702:
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test may also be weighed against the costs of unnecessary tests and resulting unnecessary follow-up and possibly even unnecessary treatment of incidental findings.
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116:
Most countries and jurisdictions have a licensing body whose duty is to determine whether to approve a drug for a specific indication, based on the relative
261:
Each test has its own indications and contraindications, but in a simplified fashion, how much a test is indicated for an individual depends largely on its
38:. A diagnosis is the assessment that a particular medical condition is present while an indication is a reason for use. The opposite of an indication is a
783:
356:
519:
1336:
960:
Michaeli DT, Michaeli T (July 2023). "Cancer Drug Prices in the United States: Efficacy, Innovation, Clinical Trial
Evidence, and Epidemiology".
1137:
490:
73:
639:
327:
735:
Indication-specific pricing of pharmaceuticals in the United States health care system: a report from the 2015 ICER Membership Policy Summit
125:
609:
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548:
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taking the drug to treat Cancer A will pay more than the person using it for Cancer B because they are getting more value out of it.
1284:
694:
1259:
377:
815:"Value and Price of Multi-indication Cancer Drugs in the USA, Germany, France, England, Canada, Australia, and Scotland"
319:
460:
103:
864:"Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA"
570:"Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format"
169:" or "primary" while others are called "second line", "third line" etc. A drug may be indicated as an "adjunct" or "
286:
42:, a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits.
1367:"Rapid magnetic resonance imaging vs radiographs for patients with low back pain: a randomized controlled trial"
755:
266:
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348:
511:
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Medication that have label indications mean that they were approved by the FDA. This means that they are
20:
85:
183:
137:
133:
631:
482:
456:
1041:"Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors"
124:
for the particular use. In the United States, indications for medications are regulated by the
81:
1365:
Jarvik JG, Hollingworth W, Martin B, Emerson SS, Gray DT, Overman S, et al. (June 2003).
1173:
Flume M, Bardou M, Capri S, Sola-Morales O, Cunningham D, Levin LA, Touchot N (January 2016).
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161:
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8:
1223:"SafeGuardRx Improves Affordability and Access to Budget-Busting Drugs | Express Scripts"
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indication is improved. Preferred drugs (and other treatments) are also referred to a "
1175:"Feasibility and attractiveness of indication value-based pricing in key EU countries"
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1304:
1285:"Incorporating Indications into Medication Ordering--Time to Enter the Age of Reason"
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405:"Medication-indication knowledge bases: a systematic review and critical appraisal"
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for that individual, which largely depends on the absolute difference between
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In the United States, indications for prescription drugs are approved by the
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In the United States there are label indications and off-label indications.
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1138:"Indication-Specific Drug Pricing – Simple in Theory, Complex in Reality"
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Drug companies can not provide any official medication information (e.g.
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862:
Michaeli DT, Mills M, Michaeli T, Miracolo A, Kanavos P (August 2022).
955:
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349:"What's the Value of the Drug Indication? | Clinical Drug Information"
378:"Contraindication - Medical Definition and More from Merriam-Webster"
320:"Indications for Drugs: Approved vs. Non-approved by MedicineNet.com"
16:
Valid reason to use a certain test, medication, procedure, or surgery
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27:
1252:"The Italian Medicines Agency | AIFA Agenzia Italiana del Farmaco"
140:) holds this responsibility for centrally authorized drugs in the
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Michaeli DT, Yagmur HB, Achmadeev T, Michaeli T (November 2022).
744:. Boston: Institute for Clinical and Economic Review, March 2016.
166:
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287:"Indication - Medical Definition and More from Merriam-Webster"
1039:
Michaeli DT, Yagmur HB, Achmadeev T, Michaeli T (March 2022).
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Incorporating indication of use on prescription drug labeling
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Salmasian H, Tran TH, Chase HS, Friedman C (November 2015).
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Indications can impact the pricing of medications through
46:
1090:"Value drivers of development stage biopharma companies"
409:
Journal of the
American Medical Informatics Association
812:
695:"Surveillance - Postmarketing Surveillance Programs"
1283:Schiff GD, Seoane-Vazquez E, Wright A (July 2016).
813:Michaeli DT, Mills M, Kanavos P (September 2022).
1403:
994:
959:
910:
1045:Therapeutic Innovation & Regulatory Science
756:"Indication-Specific Pricing for Cancer Drugs"
132:under the phrase "Indications and Usage". The
70:The examples and perspective in this section
1358:
1179:Journal of Market Access & Health Policy
632:"Development & Approval Process (Drugs)"
1337:"The Case for Indications on Prescriptions"
396:
148:Label indications vs. off-label indications
819:Applied Health Economics and Health Policy
211:FDA Adverse Event Reporting System (FAERS)
88:, or create a new section, as appropriate.
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693:Center for Drug Evaluation and Research.
663:Center for Drug Evaluation and Research.
630:Center for Drug Evaluation and Research.
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104:Learn how and when to remove this message
1094:The European Journal of Health Economics
195:is gathered in the first 3 steps in the
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463:from the original on 16 April 2013
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512:"NCI Dictionary of Cancer Terms"
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173:", added to a first line drug.
128:(FDA), and are included in the
602:"The Drug Development Process"
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267:pre- and post-test probability
1:
453:"Off-Label Use - MeSH Result"
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186:) for off label indications.
998:Journal of Clinical Oncology
914:Journal of Clinical Oncology
665:"New Drug Application (NDA)"
257:Indications of medical tests
126:Food and Drug Administration
7:
84:, discuss the issue on the
21:Indication (disambiguation)
10:
1428:
1106:10.1007/s10198-021-01427-5
1057:10.1007/s43441-021-00364-y
974:10.1016/j.jval.2023.06.020
880:10.1007/s10637-022-01227-5
831:10.1007/s40258-022-00737-w
254:
202:New Drug Application (NDA)
18:
1256:www.agenziafarmaco.gov.it
868:Investigational New Drugs
516:National Cancer Institute
134:European Medicines Agency
1384:10.1001/jama.289.21.2810
457:Medical Subject Headings
353:www.wolterskluwercdi.com
52:
1227:lab.express-scripts.com
772:10.1001/jama.2014.13235
754:Bach, Peter B. (2014).
1191:10.3402/jmahp.v4.30970
217:Effect on drug pricing
162:clinically significant
1142:Managed Care magazine
487:TheFreeDictionary.com
255:Further information:
1301:10.1056/nejmp1603964
1010:10.1200/JCO.22.00535
926:10.1200/JCO.22.00535
421:10.1093/jamia/ocv129
120:of the drug and its
82:improve this section
72:may not represent a
19:For other uses, see
1412:Medical terminology
545:The Free Dictionary
223:Value-based Pricing
740:2020-08-16 at the
483:"second-line drug"
156:Label indications:
1377:(21): 2810–2818.
1004:(35): 4095–4106.
968:(11): 1590–1600.
920:(35): 4095–4106.
766:(16): 1629–1630.
384:on 3 October 2011
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1341:Drug Topics
699:www.fda.gov
669:www.fda.gov
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606:www.fda.gov
467:14 December
388:14 December
324:MedicineNet
297:14 December
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