Oncology Care Clinical Review For Clinical Program Managers

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This slide deck was bulit as a clinical refresher for sales teams at Express Scripts.

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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 />

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