Oncology Care Clinical Review For Clinical Program Managers


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  • Welcome to the Oncology Care Review for CPMs.
  • This presentation will provide background clinical information on oncology, review the basics of pharmacotherapy used in oncology and discuss the advantages and challenges relating to oral chemotherapy as well as how our Oncology Care program can assist with those challenges.
  • Oncology is a payer priority because of its high cost and rapid market growth. In 2004 the US spent $72 billion on cancer alone. The US oncology spend is growing at a current rate of 14% per year and that number is expected to rise in the next few years. This trend of growth is driven by the vast oncology pipeline. Currently there are over 750 new medications in the oncology pipeline and as these drugs are approved, it is expected that utilization will shift to them, causing an increase in cost. Despite these new drugs developments, cancer is still highly prevalent and continues to cause over 1500 deaths per day in the US alone.
  • Oncology is the science of cancer and cancer is a collective term for over one hundred different disease states that have similar characteristics. These three similar characteristics are uncontrolled cell growth, invasion by the cancer into local tissues, and eventually a spread of the diseased cells to distant areas of the body, known as metastasis.
  • Carcinogenesis is the process by which healthy cells are transformed into cancer cells. There are many steps to this process and it can take years to progress to the point where cancer is detectable.The first step is initiation, where cells are exposed to carcinogenic substances that cause damage to the cell DNA. Some carcinogens that cause this damage are UV light, radiation, tobacco, asbestos, and many others, some of which have not yet been identified. Due to the cell mutations caused by carcinogens, the cells may develop an enhanced ability to grow and replicate.The second step is promotion which is when an altered cellular environment leads to favored growth and replication of the mutated cells over the healthy cells. Transformation is when the mutated cells become cancerous cells. This step could take up to 20 years to see.After transformation is progression where further genetic changes within the cell leads to increased proliferation which may lead to invasion of the local tissues and the development of metastasis.
  • In this slide we see the process by which cancer occurs. At the top of the slide you see normal cell division where the cell has become mutated, but due to internal signaling, the cell goes through programmed cell death, known as apoptosis and the mutation has been eliminated. In cancer cell division, there is a problem in the mechanism telling the mutated cell to die so it continues to proliferate and make more mutated cells, which eventually lead to a tumor.
  • This slide depicts the many mechanisms by which cancer cells can survive and proliferate. These mechanisms are important to pharmacists because they are often the targets of pharmacotherapy used to fight the cancer. This slide is busy, so we will focus on it piece by piece. In the center we have a cancer cell and around it the circle shows all of the different mechanisms by which the cancer cells thrives.As mentioned on the previous slide one mechanism by which cancer cells thrive is to evade apoptosis. This evasion is related to lack of tumor suppressor genes and the over expression of oncogenes. These 3 mechanisms are all located on the top portion of the diagram. Oncogenes provide cancer cells with growth signals so they survive and continue to proliferate far beyond what a healthy cell would. On the top right of the diagram is insensitivity to anti-growth signals. Tumor suppressor genes provide anti-growth signals to cells and when these genes are lost or suppressed you can have immortal cells that will continue to rapidly grow and proliferate. On the bottom of the slide is mechanism by which cells are able to continue proliferating. Each cell has a set number of telomeres which are cells parts used in division. In healthy cells, once these telomeres run out the cell can no longer divide and proliferate. However, cancerous cell produce telomerase which replaces those lost telomeres and allows the cancer cell to continue dividing. As theses cells proliferate and form a tumor, they need more and more blood supply to support their increasing mass. To do this cancer cells secrete substances that stimulate the growth of blood vessels, known as angiogenesis. After all these other mechanisms are in place the tumor can then grow and invade local tissues as well as break off and invade surrounding blood and lymph vessels which may eventually lead to metastasis.
  • Metastasis is the spread of the cancer from the primary tumor site to distant unrelated sites. The primary tumor site cells are transferred to a new site, so breast cancer cells that move to the lungs become breast cancer of the lung. Metastasis occurs through the blood and lymph vessels. Tumor cells break off, travel through these vessels and then seed and begin growing in a new site. This new site may be lymph nodes where doctors check first for signs of metastatic disease or it may be the brain, bone, lungs, or liver which are the most common sites that solid tumors metastasize to.
  • Cancer is diagnosed by biopsy, but can often be found on screenings. Currently only four cancers are routinely screened for. Cancer may also be detected by changes noticed by patients. These changes that people are warned to watch for are known as the 7 warning signs of cancer.
  • The acronym for these 7 signs is CAUTION and they are listed here. However, many people will have no signs of cancer at all until the disease is advanced.
  • The over 100 cancer diseases can be split into two general categories: Solid tumors and hematological tumors. The next slides will discuss each of these in more detail.
  • Oncology Care Clinical Review For Clinical Program Managers

    1. 1. Oncology Care<br />A Clinical Review for CPMs, AMs, and ADs<br />
    2. 2. Objectives<br />Provide background clinical information about oncology<br />Review the basics of oncology pharmacotherapy<br />Discuss obstacles in treating oncology patients and the role of Oncology Care<br />2<br />
    3. 3. Oncology: A Payer Priority <br />US cancer spend was $72 billion in 2004<br />US oncology spend is growing at 14% and rising<br />Pharmaceutical researchers working on 750 medicines for cancer<br />Utilization shifts to new drugs, increasing cost<br />565,650 Americans are expected to die of cancer this year, &gt;1500 per day<br />3<br />
    4. 4. Cancer Statistics<br />US Mortality, 2006<br />Cause of Death<br />No. of deaths<br />% of all deaths<br />Rank<br />1. Heart Diseases 631,63626.0<br />2. Cancer559,888 23.1<br />3. Cerebrovascular diseases 137,1195.7<br />Highest Incidence Cancer Sites<br />From 2004 SEER data<br />Lung & bronchus 13%<br />Colorectal 12%<br />Prostate 11%<br />Breast 11%<br />.Source: US Mortality Data 2006, National Center for Health Statistics, Centers for Disease <br />Control and Prevention, 2009.<br />
    5. 5. What is cancer?<br />Cancer consists of over 100 different diseases with similar characteristics<br />Three characteristics of cancer<br />uncontrolled cellular growth<br />local tissue invasion<br />distant metastasis<br />5<br />
    6. 6. Carcinogenesis<br />A multi-step process by which normal cells are transformed into cancer cells<br />6<br />
    7. 7. 7<br />
    8. 8. 8<br />Self-sufficiency in growth signals<br />Loss of tumor suppressor genes leads to “immortal” cells<br />Oncogenes signal cells to survive and continue proliferating<br />Insensitivity to antigrowth signals<br />Evading Apoptosis<br />Stimulate growth of blood supply<br />Metastasis via blood and lymph vessels<br />Tissue Invasion and metastasis<br />Sustained angiogenesis<br />Invasion of surrounding vasculature<br />Produce telomerase to replace lost telomeres<br />Limitless replicative potential<br />
    9. 9. How does cancer spread?<br />Metastases- the spread of cancer from the primary site to a distant site<br />Occurs via blood and lymph vessels<br />Most common sites are:<br />Brain<br />Bone<br />Lungs <br />liver<br />9<br />
    10. 10. How is cancer diagnosed?<br />Screening:<br />Breast cancer<br /> Colorectal cancer<br /> Prostate Cancer<br /> Cervical cancer<br />Diagnosis is made by BIOPSY!<br />10<br />
    11. 11. Cancer’s Seven Warning Signs for Adults<br />Change in bowel or bladder habits<br />A sore that does not heal<br />Unusual bleeding or discharge<br />Thickening or lump in breast or elsewhere<br />Indigestion or difficulty in swallowing<br />Obvious change in wart or mole<br />Nagging cough or hoarseness <br />11<br />
    12. 12. Types of Cancer<br />Cancer can be split into two broad categories<br />12<br />Hematological Tumors<br /><ul><li>Leukemias
    13. 13. Lymphomas </li></ul>Solid Tumors<br /><ul><li>Breast
    14. 14. Lung
    15. 15. Prostate</li></li></ul><li>13<br />Solid Tumors<br /><ul><li>Tumors that occurs outside of the vasculature
    16. 16. Most often treated with surgery to remove tumor
    17. 17. May be a sore or inflammation rather than a noticeable bump
    18. 18. i.e. skin cancer, inflammatory breast cancer</li></ul>Oncology Care Drugs for Solid Tumors<br />Thalomid, Tarceva, Hycamtin, Temodar, Nexavar,Tykerd, Xeloda, Sutent, Afinitor, Iressa <br />Nature Publication Group<br />
    19. 19. 14<br />Hematological Malignancies<br />Oncology Care Drugs these uses:<br />Gleevec, Thalomid, Tasigna, Revlimid, Sprycel, Zolinza<br />http://www.healthsystem.virginia.edu/internet/hematology/hessedd/malignanthematologicdisorders/leukemias/atl-l.cfm<br />
    20. 20. Modalities for treatment<br />Surgery<br />Oldest modality <br />Treatment of choice for most solid tumors diagnosed in early stage<br />Provides local control<br />Radiation<br />Local treatment for tumor, can also be to surgical bed where a tumor was <br />Chemotherapy <br />Provides local and systemic control<br />Can treat local tumor and distant metastasis <br />Designed to target rapidly dividing cells<br />Biologic and Targeted Therapy<br />Systemic control<br />Targeting features specifically found on the cancer cells <br />More specific targets than traditional chemotherapy <br />15<br />
    21. 21. Cancer Treatment is Complex<br /><ul><li>Protocols vary by drug, diagnosis, stage, cell type, and treating physician
    22. 22. Multiple models
    23. 23. Most therapies are unique and intense side effects
    24. 24. Off label drug use is common </li></ul>16<br />
    25. 25. Traditional Chemotherapy<br />17<br />
    26. 26. 18<br />Chemotherapy drugs target rapidly dividing cells<br />Tumor cells<br />Bone marrow cells<br />Hair follicle cells<br />Epithelial mucosal cells<br />Epithelial non-mucosal cells<br />Reproductive cells<br />Alopecia<br />Mucositis<br />Neutropenia<br />Tumor shrinkage <br />Skin irritation and dryness<br />Infertility and sexual dysfunction<br />Anemia <br />Thrombocytopenia <br />Traditional chemotherapy <br />causes damage to cells by interfering with cellular division<br />Bruising and bleeding<br />Fatigue<br />Infections<br />
    27. 27. 19<br />Chemotherapy drugs target<br />rapidly dividing cells<br />Tumor cells<br />Bone marrow cells<br />Hair follicle cells<br />Epithelial mucosal cells<br />Epithelial non-mucosal cells<br />Reproductive cells<br />Hair loss<br />Inflammation of oral cavity<br />↓ White blood cells<br />Tumor shrinkage <br />Skin irritation and dryness<br />Infertility and sexual dysfunction<br />Infection risk<br />↓ Red blood cells<br />Traditional chemotherapy <br />causes damage to cells by interfering with cellular division<br />Fatigue<br />↓ Platelets<br />Bruising and bleeding<br />
    28. 28. 20<br />Complications of Cancer Chemotherapy<br />Targeted Drug-Specific Adverse Effects:<br />Traditional Chemo Problems:<br />Fatigue<br />Cardiac toxicity<br />Nausea and vomiting<br />Hair loss<br />Hand-foot skin reaction<br />Bruising and bleeding<br />Bowel perforation<br />Anemia<br />Diarrhea <br />Wound healing problems<br />Infection <br />High blood pressure<br />Anorexia <br />Thyroid disorders<br />Dizziness <br />Heart failure<br />Mouth sores <br />Fluid retention/edema<br />Skin sensitivity <br />
    29. 29. 21<br />Targeted Oncology Drugs<br />http://caonline.amcancersoc.org/cgi/reprint/59/2/111<br />
    30. 30. 22<br />Oncology Pipeline<br />Glutamine<br />Approvable<br />Adjuvant <br />Afibercept<br />Phase III<br />Ovarian CA<br />Genasense<br />Complete<br />CLL<br />Apthera<br />Phase III<br />Breast CA <br />Sarasar<br />Phase III<br />MDS, CMML<br />Onconase<br />2009<br />NSCLC<br />AastromReplicell <br />Phase III<br />Solid Tumors<br />Mepact<br />Phase III<br />Osteoscarcoma <br />S-1<br />Phase III<br />Gastric CA<br />Lestaurtinib<br />Phase III<br />AML<br />Deforolimus<br />Phase II<br />Soft Tissue Sarcomas<br />TNFerade<br />Phase III<br />Pancreatic CA<br />Saforis<br />Approvable<br />Adjuvant <br />Picoplatin<br />Phase III<br />SCLC<br />Pixantrone<br />Phase III<br />NHL<br />Galiximab<br />Phase III<br />NHL<br />Provenge<br />2009<br />Prostate CA<br />Biovest<br />2009<br />NHL<br />Virulizin<br />Phase III<br />Pancreatic CA<br />Bosutinib<br />Phase III<br />Leukemia<br />Afinitor<br />2009<br />Pancreatic CA<br />Ipilimumab<br />Phase III<br />Melanoma<br />Telcyta<br />Phase III<br />Ovarian and Lung CA<br />Prochymal<br />Phase III<br />BMT, Leukemia<br />Arzerra<br />2009<br />NHL<br />Pazopanib<br />Phase III<br />Renal CA<br />Romidepsin<br />Phase II<br />Lymphoma<br />Zactima<br />Phase III<br />NSCLC<br />Trabectedin<br />Phase III<br />Ovarian CA<br />Opaxio<br />Phase III<br />NSCLC<br />Phenoxodiol<br />Phase III<br />Prostate CA<br />
    31. 31. Advantages of Oral Chemotherapy<br />Greater patient convenience<br />Flexibility for timing and location of administration (home vs. physician office)<br />Flexibility of drug exposure<br />Potential to reduce the use of healthcare resources including supplies, services, and personnel<br />Better quality of life<br />23<br />
    32. 32. Challenges Associated with Oral Chemotherapy<br />Interactions with other drugs, supplements and food<br />Dysphagia, nausea, vomiting can preclude the oral route <br />More diverse toxicity profiles associated with targeted therapies<br />Non-adherence<br />Patient confusion and misunderstanding<br />Patient drug rationing due to cost<br />Inadvertent exposure of family members to hazardous substances<br />24<br />
    33. 33. Challenges Associated with Oral Chemotherapy<br />Interactions with other drugs, supplements and food<br />Difficulty swallowing, nausea,andvomiting can preclude the oral route <br />More diverse toxicity profiles associated with targeted therapies<br />Non-adherence<br />Patient confusion and misunderstanding<br />Patient drug rationing due to cost<br />Inadvertent exposure of family members to hazardous substances<br />25<br />
    34. 34. Adherence<br />Rates of adherence to oral chemotherapy vary from less than 20% up to 100%<br />Factors affecting adherence:<br />Patient’s knowledge and understanding of the disease<br />Beliefs and attitudes about health<br />Quality of interaction between patient and healthcare providers<br />Social and financial resources<br />Complexity and duration of the treatment<br />26<br />
    35. 35. Why is adherence important?<br />Physician may attribute progression of disease to lack of activity unnecessarily change a regimen  drug waste<br />Non-adherence associated with:<br />Increase consumption of healthcare resources<br />More physician visits<br />Higher hospitalization rates and longer stays<br />Toxicities may be increased due to taking doses to close together or at the wrong time of day<br />27<br />
    36. 36. Barriers to Timely Fills at Retail Pharmacies<br />Restricted distribution<br />Prior authorizations<br />Limited retail stock<br />28<br />http://www.yorkdownspro.com/canadapharmacy.htm<br />http://www.yorkdownspro.com/canadapharmacy.htm<br />
    37. 37. Oncology Care<br />A look at our care management program<br />
    38. 38. 30<br />Pieces of Oncology Care<br /><ul><li>Highly intense patient care
    39. 39. Intense clinical assessments, telephonic and on-line
    40. 40. Intense patient education and support
    41. 41. Track and support compliance at the patient/drug level
    42. 42. Close collaboration with treating physician
    43. 43. Next waves
    44. 44. Analyzing the potential to limit initial quantity dispensed
    45. 45. Reviewing clinical trial discontinuation rates
    46. 46. Reviewing MPRs
    47. 47. Further enhanced reporting
    48. 48. End of life education</li></ul>http://www.mymedicalconcierge.com/contact%20Us/images/Doctor-on-phone-w-xray.jpg<br />
    49. 49. 31<br />Clinical Assessments<br /><ul><li>Assessment Schedule
    50. 50. 0, 1, 2, 4, 8, and every six months thereafter
    51. 51. Assessment Content
    52. 52. Review drug name, dose, route and frequency
    53. 53. Diagnosis/Diagnosis date
    54. 54. Therapy commencement
    55. 55. Comorbidities
    56. 56. Proper administration and adherence to treatment
    57. 57. Pregnancy / Lactation
    58. 58. Education for common and severe adverse events and management techniques
    59. 59. Additional questions/education of interest</li></ul>http://www.dshs.state.tx.us/famplan/images/nurse_phone.jpg<br />http://www.boydandboydpc.com/estate-planning-massachusetts-estate-trust-administration.asp <br />
    60. 60. 32<br />Dynamic Data Capture<br />
    61. 61. References<br />Ainse, J. “Overview of the changing paradigm in cancer treatment: Oral chemotherapy.” American Journal of Health-System Pharmacists. 1 May 2007; 64: S4-S7.<br /> <br />Bartel, S. &quot;Safe practices and financial considerations in using oral chemotherapeutic agents.&quot;<br />American Journal of Health-System Pharmacists. 1 May 2007; 64: S8-S14. <br /> <br />Campbell, M. &quot;Oral Oncology Drugs.&quot; Drugs Topics. Advanstar Communications, 1 Feb. 2009.<br />Accessed 9 July 2009. &lt;http://drugtopics.modernmedicine.com/drugtopics/Modern+Medicine<br />+Now/Oral-oncologydrugs/ArticleStandard/Article/detail/578180?contextCategoryId=42534&gt;. <br /> <br />Ruddy K, et al. Patient adherence and persistence with oral anticancer treatment. CA: A Cancer Journal for Clinicians. 2009; 59: 56-66.<br /> <br />Vielle, C. Managing oral chemotherapy: The healthcare practitioner’s role. American Journal of Health-System Pharmacists. 1 May 2007; 64: S25-S32.<br />33<br />
    62. 62. Summary<br />Oncology drug therapy is complex and unique to each patient.<br />New oncology drugs are targeted at specific cancer types, cause less overall side effects than older therapies, and are often orally dosed.<br />Oncology Care helps to increase patient adherence by providing high touch clinical care.<br />34<br />