A therapy or medical treatment is the attempted remediation of a health problem, usually following a medical diagnosis . Both words, treatment and therapy , are often abbreviated tx , Tx , or T x .
34-492: As a rule, each therapy has indications and contraindications . There are many different types of therapy. Not all therapies are effective . Many therapies can produce unwanted adverse effects . Treatment and therapy are often synonymous, especially in the usage of health professionals . However, in the context of mental health , the term therapy may refer specifically to psychotherapy . The words care , therapy , treatment , and intervention overlap in
68-426: A semantic field , and thus they can be synonymous depending on context . Moving rightward through that order, the connotative level of holism decreases and the level of specificity (to concrete instances) increases. Thus, in health-care contexts (where its senses are always noncount ), the word care tends to imply a broad idea of everything done to protect or improve someone's health (for example, as in
102-469: 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, if it is found that there is substantial evidence that benefits of treatment outweigh the risks, the proposed labeling in
136-462: A chemotherapy regimen used for the initial treatment of a disease. A " maintenance regimen " refers to the ongoing use of chemotherapy to reduce the chances of a cancer recurring or to prevent an existing cancer from continuing to grow. Chemotherapy regimens are often identified by acronyms , identifying the agents used in the drug combination. However, the letters used are not consistent across regimens, and in some cases - for example, "BEACOPP" -
170-417: 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 test may also be weighed against the costs of unnecessary tests and resulting unnecessary follow-up and possibly even unnecessary treatment of incidental findings. Chemotherapy regimens A chemotherapy regimen
204-587: A licensing body whose duty is to determine whether to approve a drug for a specific indication, based on the relative safety of the drug and its efficacy for the particular use. In the United States, indications for medications are regulated by the Food and Drug Administration (FDA), and are included in the package insert under the phrase "Indications and Usage". The European Medicines Agency ( EMA ) holds this responsibility for centrally authorized drugs in
238-634: 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. There has been some thought on incorporating
272-473: A relatively low clinical value. 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
306-430: Is a regimen for chemotherapy , defining the drugs to be used, their dosage, the frequency and duration of treatments, and other considerations. In modern oncology , many regimens combine several chemotherapy drugs in combination chemotherapy . The majority of drugs used in cancer chemotherapy are cytostatic , many via cytotoxicity . A fundamental philosophy of medical oncology , including combination chemotherapy,
340-484: Is a specific type of prioritization by lines of therapy. It is controversial in American health care because unlike conventional decision-making about what constitutes first-line, second-line, and third-line therapy, which in the U.S. reflects safety and efficacy first and cost only according to the patient's wishes, step therapy attempts to mix cost containment by someone other than the patient (third-party payers) into
374-401: Is also called polychemotherapy, whereas chemotherapy with one agent at a time is called single-agent therapy or monotherapy. Adjuvant therapy is therapy given in addition to the primary, main, or initial treatment, but simultaneously (as opposed to second-line therapy). Neoadjuvant therapy is therapy that is begun before the main therapy. Thus one can consider surgical excision of a tumor as
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#1732786728117408-432: Is based on the body of scientific evidence supporting the effectiveness of a drug treatment. The scientific evidence is gathered in the first 3 steps in the drug development 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 New Drug Application (NDA) or
442-409: Is that different drugs work through different mechanisms, and that the results of using multiple drugs will be synergistic to some extent. Because they have different dose-limiting adverse effects , they can be given together at full doses in chemotherapy regimens. The first successful combination chemotherapy was MOPP , introduced in 1963 for lymphomas . The term " induction regimen " refers to
476-460: Is the first therapy that will be tried. Its priority over other options is usually either: (1) formally recommended on the basis of clinical trial evidence for its best-available combination of efficacy, safety, and tolerability or (2) chosen based on the clinical experience of the physician. If a first-line therapy either fails to resolve the issue or produces intolerable side effects , additional (second-line) therapies may be substituted or added to
510-532: The European Union . In the United States there are label indications and off-label indications. Label indications: Medication that have label indications mean that they were approved by the FDA. This means that they are clinically significant 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
544-503: 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. Drug companies can not provide any official medication information (e.g. package inserts ) for off label indications. 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
578-556: 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
612-681: 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 MedWatch and FDA Adverse Event Reporting System (FAERS) . Indications can impact the pricing of medications through Value-based Pricing , 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
646-428: The algorithm. Therapy freedom and the negotiation between individual and group rights are involved. Treatments can be classified according to the method of treatment: Indication (medicine) In medicine , an indication 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
680-420: 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). Most countries and jurisdictions have
714-464: The evidence and consensus for use of the drug increases and strengthens, its class of indication is improved. Preferred drugs (and other treatments) are also referred to a " first line " or "primary" while others are called "second line", "third line" etc. A drug may be indicated as an "adjunct" or " adjuvant ", added to a first line drug. Off-label: Off-label indications are drugs that are used for medical indications that have not been approved by
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#1732786728117748-594: The first-line therapy for a certain type and stage of cancer even though radiotherapy is used before it; the radiotherapy is neoadjuvant (chronologically first but not primary in the sense of the main event). Premedication is conceptually not far from this, but the words are not interchangeable; cytotoxic drugs to put a tumor "on the ropes" before surgery delivers the "knockout punch" are called neoadjuvant chemotherapy, not premedication, whereas things like anesthetics or prophylactic antibiotics before dental surgery are called premedication. Step therapy or stepladder therapy
782-500: 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 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. However, there are still some challenges with incorporating
816-476: 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 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
850-399: The label. 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 net benefit for that individual, which largely depends on the absolute difference between pre- and post-test probability of conditions (such as diseases) that the test is expected to achieve. Additional factors that influence
884-424: The middle of the semantic field, can connote either the holism of care or the discreteness of intervention , with context conveying the intent in each use. Accordingly, they can be used in both noncount and count senses (for example, therapy for chronic kidney disease can involve several dialysis treatments per week ). The words aceology and iamatology are obscure and obsolete synonyms referring to
918-418: The patient 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. 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
952-695: The study of therapies. The English word therapy comes via Latin therapīa from ‹See Tfd› Greek : θεραπεία and literally means "curing" or "healing". The term therapeusis is a somewhat archaic doublet of the word therapy . Levels of care classify health care into categories of chronology, priority, or intensity, as follows: Treatment decisions often follow formal or informal algorithmic guidelines. Treatment options can often be ranked or prioritized into lines of therapy : first-line therapy , second-line therapy , third-line therapy , and so on. First-line therapy (sometimes referred to as induction therapy , primary therapy , or front-line therapy )
986-469: The term diagnosis . 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 contraindication , a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits. In the United States, indications for prescription drugs are approved by the FDA . Indications are included in
1020-408: The terms preventive care and primary care , which connote ongoing action), although it sometimes implies a narrower idea (for example, in the simplest cases of wound care or postanesthesia care , a few particular steps are sufficient, and the patient's interaction with the provider of such care is soon finished). In contrast, the word intervention tends to be specific and concrete, and thus
1054-534: The treatment regimen, followed by third-line therapies, and so on. An example of a context in which the formalization of treatment algorithms and the ranking of lines of therapy is very extensive is chemotherapy regimens . Because of the great difficulty in successfully treating some forms of cancer, one line after another may be tried. In oncology the count of therapy lines may reach 10 or even 20. Often multiple therapies may be tried simultaneously ( combination therapy or polytherapy). Thus combination chemotherapy
Therapy - Misplaced Pages Continue
1088-425: The value the drug offers for whatever it is being used to treat. This pricing scheme is often discussed in relation to oncology 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
1122-473: The word is often countable ; for example, one instance of cardiac catheterization is one intervention performed, and coronary care (noncount) can require a series of interventions (count). At the extreme, the piling on of such countable interventions amounts to interventionism , a flawed model of care lacking holistic circumspection —merely treating discrete problems (in billable increments) rather than maintaining health. Therapy and treatment , in
1156-637: 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 -
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