NCCN Clinical Practice Guidelines for Oncology updated to recommend BESREMi® (ropeginterferon alfa-2b-njft) as the preferred intervention for polycythemia vera - World Government Bonds (2023)

BESREMi switched to the preferred intervention based on superior efficacy, safety and evidence for both high and low risk patients, regardless of treatment history

BURLINGTON, Massachusetts – (BUSINESS WIRE) –PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TPEx:6446, LuxSE: PHECA, PHECR), a Taiwan-based global biopharmaceutical innovator leveraging deep knowledge and proven scientific principles to deliver new biologics in hematology and oncology, today announced that National Comprehensive Cancer Network Clinical Oncology Practice Guidelines (NCCN Guidelines®) have been updated to include BESREMi®(ropeginterferon alfa-2b-njft) as the preferred therapeutic option for the treatment of both high- and low-risk polycythemia vera (PV) adults, regardless of treatment history.

NCCN Clinical Practice Guidelines for Oncology updated to recommend BESREMi® (ropeginterferon alfa-2b-njft) as the preferred intervention for polycythemia vera - World Government Bonds (1)

"Importantly, the NCCN guideline update includes moving BESREMi to a preferred status, emphasizing to physicians and patients that BESREMi is recommended for proactive treatment of PV due to its widespread use," said Dr. John Mascarenhas, professor of medicine, hematology and medical oncology at the Icahn School of Medicine in Mount Sinai, New York.

NCCN is a well-recognized non-profit association of leading cancer centers in the United States. Its treatment practice guidelines, which are constantly reviewed and updated to reflect the most up-to-date evidence, are widely respected and followed by the U.S. medical community and are designed to inform and facilitate coverage decisions with cancer care payers. Based on the growing body of supporting clinical evidence and broad labeling, BESREMi is now classified in the latest NCCN update, published May 19, 2023, as the preferred intervention based on superior efficacy, safety and evidence1as well as Category 2A therapies, meaning there is a unified NCCN consensus that the intervention is appropriate1.

“The recent update of NCCN's treatment guidelines demonstrates the community's recognition of the value of BESREMi as a treatment option for all adults with PV, regardless of their medical history,” said Raymond Urbanski, MD, PhD, Head of Development and Medical Affairs. "Given its deep, sustained disease control beyond symptoms, we continue to study BESREMi in PV as well as other myeloproliferative neoplasms (MPNs) and hematologic malignancies."

THE BESREMI®(ropeginterferon alfa-2b-njft)

BESREMi is an innovative monopegylated, long-acting interferon. Thanks to its unique pegylation technology, BESREMi has a long duration of action in the body and is designed to be administered once every two weeks (or every four weeks if hematologically stable for at least one year), allowing flexible dosing to help meet individual patient needs.

BESREMi has an orphan drug designation for the treatment of polycythemia vera (PV) in adults in the United States. The product was approved by the European Medicines Agency (EMA) in 2019, Taiwan in 2020, South Korea and the US in 2021, and recently received approval in Japan. The drug candidate was developed by PharmaEssentia and is manufactured at the company's facility in Taichung, which was cGMP certified by the TFDA in 2017 and EMA in January 2018. PharmaEssentia retains full global intellectual property rights to the product for all indications.


BESREMi is indicated for the treatment of adults with polycythemia vera.

Important, secure information


Alpha interferon products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic and infectious disorders. Patients should be closely monitored with periodic clinical and laboratory evaluations. Therapy should be discontinued in patients who experience signs or symptoms of these conditions that persist or worsen. In many, but not all, cases, these disorders resolve after discontinuation of therapy.


  • Presence or history of severe mental disorders, in particular severe depression, suicidal thoughts or suicide attempts
  • Hypersensitivity to interferons, including interferon alfa-2b or any of the inactive ingredients of BESREMi.
  • Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
  • History or presence of active, serious or untreated autoimmune disease
  • Immunocompromised transplant recipients


  • Depression and suicide: Life-threatening or fatal neuropsychiatric reactions have been reported in patients receiving interferon alfa-2b products, including BESREMi. These reactions may occur in patients with or without pre-existing psychiatric conditions.

    Other central nervous system effects, including suicidal ideation, suicide attempts, aggression, bipolar disorder, mania and confusion, have been observed with other products containing alpha interferon.

    Patients should be closely monitored for signs of psychiatric disorders and psychiatric consultation and treatment should be considered if such symptoms occur. If psychiatric symptoms worsen, discontinuation of BESREMi treatment is recommended.

  • Endocrine toxicity: This toxicity may include worsening of hypothyroidism and hyperthyroidism. BESREMi should not be used in patients with active, serious or untreated endocrine disorders associated with an autoimmune disease. Thyroid function should be assessed in patients who develop symptoms suggestive of thyroid disease during treatment with BESREMi. BESREMi should be discontinued in patients who develop endocrine disorders that cannot be adequately managed during treatment with BESREMi.
  • Cardiovascular Toxicity: Toxicity may include cardiomyopathy, myocardial infarction, atrial fibrillation and coronary ischemia. Patients with a history of cardiovascular disorders should be closely monitored for cardiovascular toxicity during treatment with BESREMi. BESREMi should be avoided in patients with severe or unstable cardiovascular disease (e.g. uncontrolled hypertension, congestive heart failure (NYHA grade ≥ 2), severe arrhythmias, severe coronary artery stenosis, unstable angina) or a recent history of strokes or myocardial infarctions.
  • Decreased peripheral blood cell count: These toxicities may include thrombocytopenia (increased risk of bleeding), anemia, and leukopenia (increased risk of infection). Monitor a complete blood count at baseline, during titration, and every 3-6 months during the maintenance phase. Patients should be monitored for signs and symptoms of infection or bleeding.
  • Hypersensitivity reactions: Toxicity may include severe acute hypersensitivity reactions (e.g. urticaria, angioedema, bronchospasm, anaphylaxis). If such reactions occur, administration of BESREMi should be discontinued and appropriate medical therapy instituted immediately. Transient rashes may not require discontinuation of treatment.
  • Pancreatitis: Pancreatitis occurred in 2.2% of patients receiving BESREMi. Symptoms may include nausea, vomiting, upper abdominal pain, bloating and fever. Patients may experience an increase in lipase, amylase, white blood cell count or altered kidney/liver function. Discontinue BESREMi treatment in patients with possible pancreatitis and evaluate promptly. Discontinuation of BESREMi should be considered in patients with confirmed pancreatitis.
  • Colitis: Fatal and severe ulcerative or haemorrhagic/ischemic colitis have occurred in patients receiving alpha interferon, some cases onset as early as 12 weeks after initiation of treatment. Symptoms may include abdominal pain, bloody diarrhea and fever. BESREMi should be discontinued in patients who develop these signs or symptoms. Colitis may resolve within 1 to 3 weeks of discontinuation of treatment.
  • Pulmonary toxicity: Pulmonary toxicity may manifest as dyspnoea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonia, pulmonary hypertension and sarcoidosis. Some events led to respiratory failure or death. BESREMi should be discontinued in patients who develop pulmonary infiltrates or impaired lung function.
  • Ophthalmic Toxicity: This toxicity may include severe eye disorders such as retinopathy, retinal haemorrhage, retinal exudates, retinal detachment, and retinal artery or vein occlusion that may lead to blindness. Eye disease was diagnosed in 23% of patients during BESREMi therapy. Eye disorders ≥5% included cataract (6%) and dry eye (5%). Patients should be advised to have an eye examination prior to and during treatment with BESREMi, especially in patients with conditions associated with retinopathy such as diabetes mellitus or hypertension. Assess eye symptoms quickly. BESREMi should be discontinued in patients who develop new or worsening eye disorders.
  • Hyperlipidemia: Elevated triglycerides can cause pancreatitis. Serum triglyceride levels should be monitored prior to BESREMi treatment and periodically during treatment, and treated if elevated. Discontinuation of BESREMi should be considered in patients with persistently severely elevated triglyceride levels.
  • Hepatotoxicity: These toxicities may include increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT) and serum bilirubin. Elevations in liver enzymes have also been reported in patients after long-term treatment with BESREMi. Liver enzymes and liver function should be monitored at the beginning of treatment and during treatment with BESREMi. BESREMi should be discontinued in patients who develop symptoms of hepatic decompensation (characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal haemorrhage) during treatment.
  • Renal toxicity: Monitor serum creatinine at the start of treatment and during treatment. BESREMi should be avoided in patients with an eGFR <30 ml/min. BESREMi should be discontinued if severe renal impairment occurs during treatment.
  • Dental and Periodontal Toxicity: This toxicity can include dental and periodontal disorders that can lead to tooth loss. In addition, dry mouth may have a detrimental effect on the teeth and oral mucosa during long-term treatment with BESREMi. Patients should maintain good oral hygiene and regular dental examinations.
  • Dermatological toxicity: These toxicity included skin rash, pruritus, alopecia, erythema, psoriasis, dry skin, dermatitis acneiform, hyperkeratosis and hyperhidrosis. If clinically significant dermatological toxicity occurs, discontinuation of BESREMI should be considered.
  • Driving and using machines: BESREMi may affect your ability to drive and use machines. Patients should not drive or operate heavy machinery until they know how BESREMi affects their ability. Patients who experience dizziness, somnolence, or hallucinations during treatment with BESREMi should avoid driving or operating machinery.
  • Embryo-foetal toxicity: Due to its mechanism of action, BESREMI may cause fetal harm when administered to pregnant women. A pregnancy test is recommended in women of childbearing potential prior to initiation of treatment with BESREMi. Women of childbearing potential should be advised to use effective contraception during treatment with BESREMi and for at least 8 weeks after the last dose.


The most common adverse reactions reported in > 40% of patients in the PEGINVERA study (n=51) were flu-like symptoms, arthralgia, fatigue, pruritus, nasopharyngitis and musculoskeletal pain. In the pooled safety population (n=178), the most common adverse reactions greater than 10% were increased liver enzymes (20%), leucopenia (20%), thrombocytopenia (19%), arthralgia (13%), fatigue (12%) ), myalgia (11%) and flu-like illness (11%).


Patients treated with BESREMi who are concomitantly treated with drugs that are CYP450 substrates with a narrow therapeutic index should be monitored to advise on the need for dose adjustments of these concomitant medications. Use with myelosuppressive drugs should be avoided and patients receiving the combination should be monitored for the effects of excessive myelosuppression. Avoid use with narcotics, hypnotics, or sedatives, and monitor patients receiving the combination for the effects of excessive CNS toxicity.


  • Pregnancy: Based on its mechanism of action and role of interferon alfa in pregnancy and fetal development, BESREMi may cause fetal harm and should be assumed to have an abortifacient effect when administered to pregnant women. There are adverse maternal and fetal effects associated with polycythemia vera during pregnancy. Inform pregnant women of the potential risk to the fetus.
  • Lactation: There are no data on the presence of BESREMi in human or animal milk, on the effect on the breast-fed child or on the effect on lactation. Because of the potential for serious adverse reactions in breastfed infants with BESREMi, women should be advised not to breastfeed during treatment and for 8 weeks after the last dose.
  • Women of childbearing potential: BESREMi may cause embryo-foetal damage if administered to pregnant women. For women of childbearing potential, a pregnancy test is recommended prior to initiation of treatment with BESREMi. Patients of childbearing potential should be advised to use effective contraception during treatment with BESRMi and for at least 8 weeks after the last dose.
  • Use in children: Safety and efficacy in children and adolescents have not been established.
  • Use in elderly patients: In general, dose selection for elderly patients should be cautious, usually starting at the lower end of the dosing range, reflecting the higher incidence of hepatic, renal or cardiac impairment and concomitant diseases or other treatments.

See attached full textPrescribing informationincluding boxed warning.

About polycythemia vera (PV)

Polycythemia vera (PV) is a cancer that originates from the disease-initiating stem cell of the bone marrow, causing a chronic increase in the number of red blood cells, white blood cells and platelets. PV can cause cardiovascular complications such as thrombosis and embolism and often progresses to secondary myelofibrosis or leukemia. Although the molecular mechanism underlying PV is still under intense study, the current results point to a set of acquired mutations, the most important of which is the mutant form of JAK2.4

O PharmaEssentia

PharmaEssentia (TPEx: 6446, LuxSE: PHECA, PHECR), headquartered in Taipei, Taiwan, is a fast-growing, fully integrated global biopharmaceutical innovator. Using proven scientific principles and deep expertise in drug commercialization, PharmaEssentia intends to build on its discovery-based innovations to deliver biologics to challenging diseases in hematology, oncology and immunology. With an approved product and diversified offering, PharmaEssentia strives to be an indispensable partner in cancer treatment, transforming the treatment pathway for diseases with significant unmet medical needs. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from US biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the US, Japan, China and Korea along with a world-class biopharmaceutical manufacturing facility in Taichung, Taiwan, and a new research and development facility in the Boston, Massachusetts area.

For more information on PharmaEssentia USA, visit the websitewebsite,LinkedinLubTwitter.

Forward-looking Statement

This press release may contain forward-looking statements, including statements regarding BESREMi's commercialization plans and expectations in the United States and BESREMi's potential benefits or competitive position. For these statements, we claim safe harbor protection for forward-looking statements under the Private Securities Litigation Reform Act of 1995 and similar Taiwanese legislation and laws. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release, and actual results may differ materially from those contained in these forward-looking statements as a result of various factors. These factors include whether BESREMi has been successfully commercialized and adopted by physicians and patients, the extent to which reimbursement for BESREMi is available, the risks and uncertainties associated with the initiation, timing, progress and outcomes of our research and development programs, pre-clinical studies, clinical trials and regulatory proposals. We undertake no obligation to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.


1. NCCN Guidelines, page 60.

© 2023 PharmaEssentia Corporation. All rights reserved.

BESREMi and PharmaEssentia are registered trademarks of PharmaEssentia Corporation and the PharmaEssentia logo is a trademark of PharmaEssentia Corporation.


Rachel Lipsitz,


When are NCCN guidelines updated? ›

The NCCN Guidelines are reviewed and updated on a continual basis to ensure that the recommendations take into account the most current evidence. All active NCCN Guidelines are reviewed and updated at least annually.

What is the new treatment for polycythemia vera? ›

Today, the U.S. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. The excess cells thicken the blood, slowing blood flow and increasing the chance of blood clots.

Is BESREMi FDA approved? ›

Recently approved, by the Food and Drug Administration, Besremi has demonstrated to be effective and safe for patients with polycythemia vera — adding hope to their treatment regimen.

What are the NCCN guidelines? ›

The NCCN Guidelines are a comprehensive set of guidelines detailing the sequential management decisions and interventions that currently apply to 97 percent of cancers affecting patients in the United States.

What is a Category 2B recommendation? ›

A Grade 2B recommendation is a weak recommendation; alternative approaches may be better for some patients under some circumstances. Explanation: A Grade 2 recommendation is a weak recommendation.

What is the NCCN guidelines for elevated PSA? ›

If PSA is measured and is < 4 ng/mL, the DRE is normal (if done), and no other indications for biopsy are present, the NCCN recommends repeat testing in selected patients at 1-4 year intervals. If the PSA is ≥ 4 ng/mL or DRE results are very suspicious, the patient should be evaluated for biopsy.

What is the most effective treatment for polycythemia vera? ›

The most common treatment for polycythemia vera is having frequent blood withdrawals, using a needle in a vein (phlebotomy). It's the same procedure used for donating blood. This decreases your blood volume and reduces the number of excess blood cells.

What is the most common cause of polycythaemia polycythaemia vera? ›

Primary erythrocytosis - polycythaemia vera

Polycythaemia vera is rare. It's usually caused by a change in the JAK2 gene, which causes the bone marrow cells to produce too many red blood cells. It's a slow-growing type of blood cancer.

What's the difference between polycythemia vera and polycythemia? ›

Polycythemia, also called erythrocytosis, refers to increased red blood cell mass, noted on laboratory evaluation as increased hemoglobin and hematocrit levels. Polycythemia vera is a subtype of polycythemia and can be associated with the overproduction of more than just the erythrocytic lineage.

How much does BESREMi cost in the US? ›

The cost for Besremi subcutaneous solution (500 mcg/mL) is around $7,914 for a supply of 1 milliliter(s), depending on the pharmacy you visit.

What is the indication of Ropeginterferon alfa-2b? ›

Ropeginterferon alfa-2b is indicated for the treatment of adult patients with polycythemia vera.

What are the contraindications for BESREMi? ›

BESREMi is contraindicated in patients with a history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt [see Contraindications (4)].

Is NCCN 1 or 2A recommended use? ›

The specific definitions of the NCCN categories for recommendations are: • Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate; • Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate; • Category 2B ...

What is a Category 1 recommendation for NCCN? ›

The NCCN definitions for EC are as follows: category I, high level of evidence with uniform consensus; category IIA, lower level of evidence with uniform consensus; category IIB, lower level of evidence without a uniform consensus but with no major disagreement; and category III, any level of evidence but with major ...

What is the difference between ESMO and NCCN Guidelines? ›

"The ESMO guidelines are written as a review, and the reader is required to interpret the summary of data," they explain. In contrast, "the NCCN guidelines are written in algorithmic form with a supporting manuscript that provides the data behind the recommendation."

What does Class 2A recommendation mean? ›

A Grade 2A recommendation is a weak recommendation, and the best action may differ depending on circumstances or patient or societal values. Explanation: A Grade 2 recommendation is a weak recommendation.

What does Class 2A indication mean? ›

Class II. Conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of the given treatment or procedure. Class IIa. Weight of evidence/opinion is in favour of usefulness/efficacy.

What is Grade B level of recommendation? ›

Grade B: Fairly strong evidence. Based on evidence from case-control or cohort studies, or clinical trials lacking one or more of the above features. Grade C: Weak evidence or firmly held opinion. Based on published case reports, well-written reviews or consensus.

What PSA level justifies a biopsy? ›

The National Comprehensive Cancer Network (NCCN)12 recommends 2.5 ng/mL as a criterion for biopsy referral.

Why is PSA not recommended over 70? ›

Many guidelines recommend against PSA screening in men older than 70 to 75 years because of the risk of over diagnosis and lack of evidence of a mortality reduction in this age group. It's believed that the harms of screening might outweigh the benefits in an older population.

What PSA is indicated for biopsy? ›

Your doctor may recommend a prostate biopsy if: A PSA test shows levels higher than normal for your age. Your doctor finds lumps or other abnormalities during a digital rectal exam. You've had a previous biopsy with a normal result, but you still have elevated PSA levels.

What is the first line treatment for polycythemia vera? ›

Hydroxyurea/hydroxycarbamide or interferons can be used as first-line drugs.

What are the 2 major criteria for a diagnosis of polycythemia vera? ›

Major criteria include (1) hemoglobin >18.5 g/dL in men, 16.5 g/dL in women, or other evidence of increased red cell volume (RCV); and (2) presence of JAK2V617F or other functionally similar mutation such as JAK2 exon 12 mutation.

What foods should be avoided with polycythemia vera? ›

Fat: With polycythemia vera, it is important that you avoid consuming too much high-fat foods because they can increase your risk of blood clots and inflammation. These include red meat with fat, chicken with skin on it, and deep-fried foods or dessert made with heavy creams or large amounts of butter.

What is the life expectancy of someone with polycythemia? ›

Recent studies estimate the average life expectancy after diagnosis with polycythemia vera to be about 20 years. The average age of death is about 77.

What is the main medical problem with polycythemia? ›

Polycythemia vera is a rare blood disorder in which there is an increase in all blood cells, particularly red blood cells. The increase in blood cells makes your blood thicker. This can lead to strokes or tissue and organ damage.

Can stress cause polycythaemia? ›

It is concluded that mild relative polycythaemia could be induced by acute emotional stress. In subjects with the Type A behaviour pattern a slight haemoconcentration is present already at rest, which further increases during stress.

Can COVID trigger polycythemia vera? ›

There are reports that people with COVID-19 have experienced blood clots. 4 People with blood disorders, like polycythemia vera, are already at higher risk for blood clots. Therefore, having both conditions at the same time may further increase their risk.

Can dehydration cause secondary polycythemia? ›

Relative polycythemia is the temporary increase in RBCs secondary to decreased fluid volume (dehydration), as with excessive vomiting, diarrhea, or excessive diuretic use, or after a burn injury.

What level of hemoglobin is dangerously high? ›

The threshold for a high hemoglobin count differs slightly from one medical practice to another. It's generally defined as more than 16.6 grams (g) of hemoglobin per deciliter (dL) of blood for men and 15 g/dL for women.

Can chemotherapy cure polycythemia vera? ›

Hydroxycarbamide is the most common chemotherapy drug used to treat PV. You might get some side effects from this treatment. These might include more infections than normal, diarrhoea or constipation. Your healthcare team will be able to help you manage side effects like this.

How long can you live with polycythemia vera without treatment? ›

According to a 2021 review article in the journal Leukemia, patients diagnosed with PV who get no treatment will survive around 18 months. Those who are treated with only phlebotomy will survive around four years.

How many people in USA have polycythemia vera? ›

Affected populations

Polycythemia vera affects slightly more men than women. The disorder is estimated to affect approximately 44 to 57 per 100,000 people in the US. It occurs most often in individuals more than 60 years old, but can affect individuals of any age. It is extremely rare in individuals under 20.

Is BESREMi safe? ›

BESREMi can cause serious side effects including: Decreased blood cell counts: Your healthcare provider should check your blood cell counts before you start and during treatment with BESREMi . If your blood cell counts are too low you can develop anemia, infections or have problems with bleeding or bruising.

What are the side effects of BESREMi injection? ›

Nausea, vomiting, diarrhea, dry mouth, dry eyes, loss of appetite, dizziness, drowsiness, trouble sleeping, or redness/swelling at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Tooth and gum problems may sometimes occur during treatment.

What are the benefits of BESREMi? ›

Besremi is a medicine used to treat polycythaemia vera in adults who do not have symptoms of an enlarged spleen. In patients with polycythaemia vera, the body produces too many red blood cells, which can cause the blood to thicken and reduce blood flow to the organs.

What are the instructions for BESREMi? ›

Inject BESREMi into the top of the thighs or lower stomach-area just under the skin. Do not inject BESREMi into any other area of the body. Throw away (dispose of) the BESREMi prefilled syringe with needle attached right away after use, even if there is medicine left in the prefilled syringe.

Is BESREMi a chemotherapy drug? ›

BESREMi is not chemotherapy. It's an innovative, long-acting interferon that you take once every 2 weeks. After maintaining stable blood levels for 1 year, you may be able to take BESREMi once every 4 weeks.

What is the strength of BESREMi? ›

The maximum recommended single dose is 500 micrograms injected every two weeks.

What is the difference between NCCN and ASCO? ›

The NCCN'S disease-management guidelines are stage specific, covering work-up through treatment and follow-up, as well as supportive care. ASCO guidelines generally focus on a single question or a group of questions around an important topic.

What is favorable intermediate risk NCCN? ›

Favorable patients were those who had all of the following: Only one intermediate-risk factor (based on the NCCN classification scheme). GS of 3+4=7 or less. Less than 50% of biopsy cores positive for cancer.

How important are NCCN guidelines? ›

The NCCN Guidelines® are the recognized standard for clinical direction and policy in cancer care and are the most thorough and frequently updated clinical practice guidelines available in any area of medicine.

What is a 2B recommendation NCCN? ›

Definitions for NCCN Categories

Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate; Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate.

How do I access NCCN Guidelines? ›

To use the NCCN Guidelines App, an individual must be a registered user on There is no fee to become a registered user on and to view the NCCN Guidelines. Become a registered user (free) on A new registration can be created from the welcome screen of the iPad and Google Play Apps as well.

When did NCCN guidelines start? ›

On January 31, 1995, a press conference was held to announce the creation of a national alliance to develop and institute standards of care for the treatment of cancer and perform outcomes research – and so the NCCN was born.

How many NCCN guidelines are there? ›

The 84 NCCN Guidelines® are developed by 61 panels, each comprised of clinician and researcher volunteers — resulting in input from more than 1,800 multidisciplinary members of the nation's top 33 cancer centers.

Does CMS follow NCCN guidelines? ›

The NCCN Compendium® is recognized by public and private insurers alike, including CMS and UnitedHealthcare as an authoritative reference for oncology coverage policy.

What are the NCCN Guidelines for PSA screening? ›

The NCCN recommends basing repeat testing intervals on PSA, DRE findings, and risk level, as follows:
  • PSA < 1 ng/mL, DRE normal (if done), in patients with average risk – 2-4 years.
  • PSA 1-3 ng/mL, DRE normal (if done), in patients with average risk – 1-2 years.
Apr 21, 2023

What is the difference between ESMO and NCCN guidelines? ›

"The ESMO guidelines are written as a review, and the reader is required to interpret the summary of data," they explain. In contrast, "the NCCN guidelines are written in algorithmic form with a supporting manuscript that provides the data behind the recommendation."

What are the changes in the NCCN guidelines? ›

“The first and most significant change in our guidelines was a lowering of the initial screening age for average-risk individuals from 50 to 45. The second biggest change is to extend the surveillance period from what was 5 to 7 years to 10 years now for patients with only one to two small tubular adenomas.”

What does NCCN mean in oncology? ›

The National Comprehensive Cancer Network® (NCCN®) is a not-for-profit alliance of 33 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, equitable, and accessible cancer care so all patients can live better lives.

What is CMS oncology care model? ›

Under the Oncology Care Model (OCM), physician practices entered into payment arrangements that included financial and performance accountability for episodes of care surrounding chemotherapy administration to cancer patients.

What is CMS proposed rule on prior authorization? ›

CMS' final rule requires that coordinated care plan prior authorization policies may only be used to confirm the presence of diagnoses or other medical criteria and/or ensure that an item or service is medically necessary.

What are the reviews for NCCN? ›

Is NCCN a good company to work for? NCCN has an overall rating of 3.6 out of 5, based on over 20 reviews left anonymously by employees. 64% of employees would recommend working at NCCN to a friend and 68% have a positive outlook for the business. This rating has improved by 13% over the last 12 months.

How do I get access to NCCN Guidelines? ›

To use the NCCN Guidelines App, an individual must be a registered user on There is no fee to become a registered user on and to view the NCCN Guidelines. Become a registered user (free) on


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