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Rule Category: Pharmaceutical Ref: No: 2013-PH-0005 ` Version Control: Version No. 1.1 Effective Date: December 2013 Revision Date: December 2014 Prostate Cancer – Pharmacological treatment Adjudication Rule Table of content Abstract Scope Adjudication Policy Page 1 Page 2 Page 2 Adjudication examples Page 3 Denial codes Page 3 Appendices Page 4 Approved by: Daman Abstract Responsible: Medical Strategy & Development Department For Members Prostate cancer, one of the most common types of cancer in men, refers to a cancerous growth within the prostate gland - a small gland that produces the seminal fluid that nourishes and transports sperm. One of the treatment modalities involves chemotherapy (and use of other drugs) to treat Cancer. Prostate cancer drugs are covered by Daman as per policy terms and conditions, if medically indicated. For Medical Professionals The goals of pharmacotherapy for prostate cancer are to induce remission, reduce morbidity, and prevent complications. Agents used include hormone therapy, chemotherapeutic agents, Corticosteroids etc. Prostate cancer drugs are covered by Daman as per policy terms and conditions, if medically indicated. Related Adjudication Rules: None. Disclaimer By accessing these Daman Adjudication Rules (the “AR”), you acknowledge that you have read and understood the terms of use set out in the disclaimer below: The information contained in this AR is intended to outline the procedures of adjudication of medical claims as applied by the National Health Insurance Company – Daman PJSC (hereinafter “Daman”). The AR is not intended to be comprehensive, should not be used as treatment guidelines and should only be used for the purpose of reference or guidance for adjudication procedures and shall not be construed as conclusive. Daman in no way interferes with the treatment of patient and will not bear any responsibility for treatment decisions interpreted through Daman AR. Treatment of patient is and remains at all times the sole responsibility of the treating Healthcare Provider. This AR does not grant any rights or impose obligations on Daman. The AR and all of the information it contains are provided "as is" without warranties of any kind, whether express or implied which are hereby expressly disclaimed. Under no circumstances will Daman be liable to any person or business entity for any direct, indirect, special, incidental, consequential, or other damages arising out of any use of, access to, or inability to use or access to, or reliance on this AR, including but without limitation to, any loss of profits, business interruption, or loss of programs or information, even if Daman has been specifically advised of the possibility of such damages. Daman also disclaims all liability for any material contained in other websites linked to Daman website. This AR is subject to the laws, decrees, circulars and regulations of Abu Dhabi and UAE. Any information provided herein is general and is not intended to replace or supersede any laws or regulations related to the AR as enforced in the UAE issued by any governmental entity or regulatory authority, or any other written document governing the relationship between Daman and its contracting parties. This AR is developed by Daman and is the property of Daman and may not be copied, reproduced, distributed or displayed by any third party without Daman’s express written consent. This AR incorporates the Current Procedural Terminology and Current Dental Terminology (CPT® and CDT®, which is a registered trademark of the American Medical Association (“AMA”), and the American Dental Association (“ADA”) respectively), and the CPT and CDT codes and descriptions belong to the AMA. Daman reserves the right to modify, alter, amend or obsolete the AR at any time by providing one month prior notice. National Health Insurance Company – Daman (PJSC) (P.O. Box 128888, Abu Dhabi, U.A.E. Tel No. +97126149555 Fax No. +97126149550) Doc Ctrl No.: TEMP/MSD-006 Version No.: 1 Revision No.: 0 Date of Issue: 08.05.2013 Page No(s).: 1 of 4 Prostate Cancer – Pharmacological treatment Scope b. This Adjudication Rule defines the medical necessity for prescribing Prostate cancer drugs. Antiandrogen tablets prevent the testosterone in the testicles from getting to the cancer cells. The scope of this AR is only limited to the pharmacological treatment of Prostate cancer itself; any other drugs, such as those related to symptomatic treatment of prostate cancer or complications of chemotherapy, are out of the scope of this AR. Anti-androgens Examples: Cyproterone acetate Flutamide Bicalutamide Abiraterone Medical Necessity Used in combination with other hormone therapy to prevent a rise in testosterone at the beginning of LHRH agonist therapy For the palliation of symptomatic metastases and as neoadjuvant therapy for radiation therapy. Adjudication Policy Eligibility / Coverage Criteria Daman covers Prostate cancer drugs when medically necessary (in terms of type, frequency, extent, site, duration and effectiveness) as per the indications listed below and as per policy terms and conditions. Abiraterone Indication - to treat late stage castration-resistant prostate cancer before the administration of chemotherapy. It is used in combination with prednisone in castrationrecurrent metastatic disease prostate cancer for the following: as initial therapy in patients with symptomatic disease who are not candidates for a docetaxel-based regimen in castration recurrent metastatic disease; for initial treatment of asymptomatic or minimally symptomatic patients; and For subsequent treatment of symptomatic disease previously treated with a docetaxelbased regimen. Indications 1. Hormone Therapy [3] Prostate cancer cells rely on testosterone to help them grow. Hormone therapy is treatment to stop the body from producing the male hormone testosterone. a. Antiandrogen therapy LH-RH Agonists/GnRH Agonists Luteinizing hormone-releasing hormone (LHRH) agonists and gonadotropin-releasing hormone (GnRH) agonists are hormone therapy drugs that lower the production of testosterone in a man's body. Hormonal therapy is not routinely recommended for men with prostate cancer who have a biochemical relapse unless they have: LH-RH Agonists/GnRH Agonists Examples: Goserelin Leuprolide Triptorelin Degarelix Histrelin acetate symptomatic local disease progression, or any proven metastases, or PSA doubling time < 3 months. 2. Chemotherapy Daman covers chemotherapy. Medical Necessity the Drugs Degarelix, goserelin acetate, histrelin acetate, leuprolide acetate, or triptorelin pamoate is considered medically necessary for the treatment of prostate cancer when any of the following indications are met: 1. Clinically localized disease with intermediate (T2b to T2c cancer, Gleason score of 7, or prostate specific antigen (PSA) value of 10-20 ng/mL) or higher risk of recurrence; or 2. Locally advanced disease; or 3. Other advanced, recurrent, or metastatic disease; or 4. In combination with antiandrogen (flutamide or bicalutamide) for locally confined stage T2b-T4 (stage B2-C) disease. Docetaxel [2] Cabazitaxel [12] Degarelix, goserelin acetate, histrelin acetate, leuprolide acetate or triptorelin pamoate is considered medically necessary to shrink an enlarged prostate to an acceptable size prior to brachytherapy, cryosurgery or external beam radiation therapy for the treatment of prostate cancer. following drugs as Indications FDA approved docetaxel injection for use in combination with prednisone for the treatment of metastatic, androgenindependent (hormone-refractory) prostate cancer. Used for prostate cancer that has not responded to hormone therapy. Used if hormone treatment is no longer controlling the cancer. For use in combination with prednisone for treatment of metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen. 3. Bisphosphonates [13] Bisphosphonates will be covered when used as an adjuvant therapy in patients with prostate cancer at high risk of developing bone metastases. National Health Insurance Company – Daman (PJSC) (P.O. Box 128888, Abu Dhabi, U.A.E. Tel No. +97126149555 Fax No. +97126149550) Doc Ctrl No.: TEMP/MSD-006 Version No.: 1 Revision No.: 0 Date of Issue: 08.05.2013 Page No(s).: 2 of 4 Prostate Cancer – Pharmacological treatment 4. Steroids ICD code 185 - Malignant neoplasm of prostate (principal diagnosis Steroids will be covered for hormone refractory prostate cancer or parallel to chemotherapy. V58.11- Encounter for antineoplastic chemotherapy 1286-4147-001 – Docetaxel Requirements for Coverage How should this claim be adjudicated? ICD and CPT codes must be coded to the highest level of specificity. Answer: The claim will be paid if V58.11 is coded as the principal diagnosis and 185 is coded as the secondary diagnosis. Non-Coverage Pharmacological treatment of Prostate cancer is not covered when it does not meet medical necessity. Denial codes (Investigational use of any prostate cancer drug is not considered medically necessary). Code Daman does not cover all those drugs for basic plan, which are not tagged as Abu Dhabi in green rain code list. Payment and Coding Rules Please apply HAAD payment rules and regulations and relevant coding manuals for ICD, CPT, etc. [1] Assign code V58.11, Encounter for antineoplastic chemotherapy, as the principal diagnosis if a patient is admitted solely for chemotherapy administration. Assign a code for the malignancy for prostate cancer as the secondary diagnosis. Sequence the malignancy (primary or secondary) as the principal diagnosis if a patient is admitted for staging the prostate malignancy even though chemotherapy may be administered. AUTH-008 Inappropriate Drug Dose CODE-010 Activity/Diagnosis inconsistence with clinician speciality MNEC-003 Service is not clinically indicated based on good clinical practice MNEC-004 Service is not clinically indicated based on good clinical practice, without additional supporting diagnosis/activities. NCOV-001 Diagnosis(es) is (are) not covered NCOV-003 Service(s) is (are) not covered Appendices A. References 1. AMA editorial staff (2011-2012). Current Procedural Terminology. 4th ed. Chicago: American Medical Association. 373-375 Frequency of Services Code description Adjuvant hormonal therapy is recommended for a minimum of 2 years in men receiving radical radiotherapy for localised prostate cancer who have a Gleason score of ≥ 8. [6] 2. Cancer Research UK. (2012). About Chemotherapy for prostate cancer. Available: http://www.cancerresearchuk.org/cancerhelp/type/prostatecancer/treatment/chemotherapy/aboutchemotherapy-for-prostate-cancer. Last accessed 08072013 Repeat cycles of treatment with docetaxel are not recommended if the disease recurs after completion of the planned course of chemotherapy [6] 3. Cancer Research UK. (2012). About hormone therapy for prostate cancer. Available: http://www.cancerresearchuk.org/cancerhelp/type/prostatecancer/treatment/hormone/about-hormonetherapy-for-prostate-cancer#pitreg. Last accessed 08072013 Adjudication Examples Example 1 Question: A 51 year old male patient holding a Regional plan, presented to the hospital with Prostate cancer stage T2b, and was treated with Degarelix (to shrink the prostate prior to brachytherapy). Will Daman pay for this drug? 4. FDA. (2010). Vantas (histrelin implant). Available: http://www.accessdata.fda.gov/drugsatfda_ docs/label/2011/021732s013lbl.pdf. Last accessed 08072013. Answer: Yes, the payment will be covered. Example 2 Question: A 50 year old male holding a Thiqa plan with Prostate cancer undergoes chemotherapy and the provider bills as follows: 5. ICD-9 CM Official Guidelines for Coding and Reporting National Health Insurance Company – Daman (PJSC) (P.O. Box 128888, Abu Dhabi, U.A.E. Tel No. +97126149555 Fax No. +97126149550) Doc Ctrl No.: TEMP/MSD-006 Version No.: 1 Revision No.: 0 Date of Issue: 08.05.2013 Page No(s).: 3 of 4 Prostate Cancer – Pharmacological treatment 6. Institute for Health and Care Excellence. (2008). NICE clinical guidelines; Prostate cancer: Diagnosis and Treatment. Available: http://publications.nice.org.uk/prostatecancer-cg58/guidance. Last accessed 08072013. 7. National Cancer Institute. (2013). Drugs Approved for Prostate Cancer. Available: http://www.cancer.gov/cancertopics/druginf o/prostatecancer. Last accessed 08072013. 8. National Collaborating Centre for Cancer. (2008). Prostate cancer; Diagnosis and Treatment. Available: http://www.nice.org.uk/nicemedia/pdf/CG58 NICEGuideline.pdf. Last accessed 08072013. 9. National Comprehensive Cancer Network. (2013). NCCN Guidelines for Patients Prostate Cancer. Available: http://www.nccn.org/patients/guidelines/pro state/index.html#34/z. Last accessed 23092013. 10. Prostate Cancer Foundation of Australia. (2013). Prostate Cancer Staging and Grading. Available: http://www.prostate.org.au/articleLive/page s/Staging-and-Grading.html. Last accessed 07/10/2013. 11. Prostate Cancer UK. (2012). Prostate Cancer. Available: http://prostatecanceruk.org/information/pro state-cancer/getting-the-results. Last accessed 07/10/2013. 12. Sanofi-Aventis (2010). Highlights of prescribing information; JEVTANA (Cabazitaxel). Available: http://www.accessdata.fda.gov/drugsatfda_ docs/label/2010/201023lbl.pdf. Last accessed 08072013. 13. The Prostate Cancer Charity Information Team. (2011). Bisphosphonates. Available: http://www.nhs.uk/ipgmedia/national/Prosta te%20Cancer%20UK/Assets/Bisphosphonate s(PCC).pdf. Last accessed 07/10/2013. B. Revision History Date 01-11-13 15-07-14 Change(s) N.A 1. V 1.1 2. Disclaimer updated as per system requirements National Health Insurance Company – Daman (PJSC) (P.O. Box 128888, Abu Dhabi, U.A.E. Tel No. +97126149555 Fax No. +97126149550) Doc Ctrl No.: TEMP/MSD-006 Version No.: 1 Revision No.: 0 Date of Issue: 08.05.2013 Page No(s).: 4 of 4