Breast Cancer - Pharmacological Treatment Adjudication Rule

Transcription

1 Rule Categry: Pharmaceutical ` Ref: N: 2013-PH-0006 Versin Cntrl: Versin N. 1.1 Effective Date: December 2013 Revisin Date: December 2014 Breast Cancer - Pharmaclgical Treatment Adjudicatin Rule Table f cntent Abstract Page 1 Scpe Page 2 Adjudicatin Plicy Page 2 Adjudicatin examples Page 2 Denial cdes Page 3 Appendices Page 3 Abstract Fr Members There have been significant develpments in the management f breast cancer including new types f chemtherapy, bilgical and hrmnal agents. The prgnsis and treatment decisins f breast cancer mainly depend n the extent f the disease. This is assessed by Tumr staging thrugh which assessment is dne fr all the stages given belw: Size and nature f the primary tumur, The invlvement f the reginal lymph ndes and The presence f distant metastases. Daman cvers treatment f breast cancer, if medically indicated as per best practice standards and as per plicy terms and cnditins f each plan. Fr Medical Prfessinals Stage and mlecular features determine the need fr adjuvant systemic therapy and the chice f mdalities used. Varius types f adjuvant therapies benefit certain subgrups f patients. The selectin f therapy is mst apprpriately based upn knwledge f an individual s risk f tumur recurrence balanced against the shrt-term and lng-term risks f adjuvant treatment. Drug administratin services are nt cvered when the drug is given fr a nn-cvered indicatin. Apprved by: Daman Respnsible: Medical Strategy & Develpment Department Related Adjudicatin Rules: Nne Disclaimer By accessing these Daman Adjudicatin Rules (the AR ), yu acknwledge that yu have read and understd the terms f use set ut in the disclaimer belw: The infrmatin cntained in this AR is intended t utline the prcedures f adjudicatin f medical claims as applied by the Natinal Health Insurance Cmpany Daman PJSC (hereinafter Daman ). The AR is nt intended t be cmprehensive, shuld nt be used as treatment guidelines and shuld nly be used fr the purpse f reference r guidance fr adjudicatin prcedures and shall nt be cnstrued as cnclusive. Daman in n way interferes with the treatment f patient and will nt bear any respnsibility fr treatment decisins interpreted thrugh Daman AR. Treatment f patient is and remains at all times the sle respnsibility f the treating Healthcare Prvider. This AR des nt grant any rights r impse bligatins n Daman. The AR and all f the infrmatin it cntains are prvided "as is" withut warranties f any kind, whether express r implied which are hereby expressly disclaimed. Under n circumstances will Daman be liable t any persn r business entity fr any direct, indirect, special, incidental, cnsequential, r ther damages arising ut f any use f, access t, r inability t use r access t, r reliance n this AR, including but withut limitatin t, any lss f prfits, business interruptin, r lss f prgrams r infrmatin, even if Daman has been specifically advised f the pssibility f such damages. Daman als disclaims all liability fr any material cntained in ther websites linked t Daman website. This AR is subject t the laws, decrees, circulars and regulatins f Abu Dhabi and UAE. Any infrmatin prvided herein is general and is nt intended t replace r supersede any laws r regulatins related t the AR as enfrced in the UAE issued by any gvernmental entity r regulatry authrity, r any ther written dcument gverning the relatinship between Daman and its cntracting parties. This AR is develped by Daman and is the prperty f Daman and may nt be cpied, reprduced, distributed r displayed by any third party withut Daman s express written cnsent. This AR incrprates the Current Prcedural Terminlgy and Current Dental Terminlgy (CPT and CDT, which is a registered trademark f the American Medical Assciatin ( AMA ), and the American Dental Assciatin ( ADA ) respectively), and the CPT and CDT cdes and descriptins belng t the AMA. Daman reserves the right t mdify, alter, amend r bslete the AR at any time by prviding ne mnth prir ntice. Natinal Health Insurance Cmpany Daman (PJSC) (P.O. Bx , Abu Dhabi, U.A.E. Tel N Fax N ) Dc Ctrl N.: TEMP/MSD-006 Versin N.: 1 Revisin N.: 0 Date f Issue: Page N(s).: 1 f 6

2 Breast Cancer - Pharmaclgical Treatment Scpe This AR highlights the pharmacy benefits and medical necessity cverage f drugs used in the treatment f breast cancer. The scpe f this AR is nly limited t the pharmaclgical treatment f breast cancer itself; any ther drugs, such as thse related t symptmatic treatment f breast cancer r cmplicatins f chemtherapy, are ut f the scpe f this AR. Adjudicatin Plicy Eligibility / Cverage Criteria Daman cvers drug treatment f breast cancer, if medically indicated and as per plicy terms and cnditins f each health insurance plan administered by Daman. Pharmaclgical treatment f breast cancer and its indicatins: Decisins abut adjuvant systemic therapy shuld be made based n: (9) Assessment f the prgnstic and predictive factrs The ptential benefits and side effects f the treatment Pharmactherapy (Adjuvant Systemic Therapy) Treatment Optins Endcrine Therapy Indicated fr tumurs that test psitive fr either estrgen r prgesterne receptrs (ERpsitive r PRpsitive; in bth earlystage and metastatic cancer [1] Chemtherapy Given at repeating intervals fr a set perid f time t treat early-stage breast cancer [2] Given if a patient has a metastatic breast cancer recurrence. May be given befre surgery t shrink a large tumur and reduce the risk f recurrence called neadjuvant chemtherapy Bilgical targeted Treatment Apprved t treat breast cancer. They are targeted at HER2. Used t treat cancer that has spread t the bne. Fr drug specific indicatins (please refer t page n. 4, tables 1-3) Requirements fr Cverage ICD and CPT cdes must be cded t the highest level f specificity. Nn-Cverage Drugs that are given fr experimental and investigatinal purpse are nt cvered. Tamxifen is nt cvered fr hrmnereceptr-negative breast cancer. Adjuvant Chemtherapy is nt cvered fr tumur smaller than 1 cm (abut 1/2 inch) unless it has any unfavurable features. [8] Daman des nt cver all thse drugs fr basic plan, which are nt tagged as Abu Dhabi Basic plan in green rain cde list. Payment and Cding Rules Please apply HAAD payment rules and regulatins and relevant cding manuals fr ICD, CPT, etc. [4,1] If the cancer has nt been eradicated and treatment is n-ging, r if adjuvant endcrine therapy r adjuvant chemtherapy is being administered (e.g. fllwing primary surgery fr early breast cancer), the cancer shuld be dcumented as an active cnditin and cded frm the Neplasm Table f ICD cdes Assign cde V58.11, Encunter fr antineplastic chemtherapy, as the principal diagnsis if a patient is admitted slely fr chemtherapy administratin. And assign a cde fr the malignancy as the secndary diagnsis. Sequence the malignancy as the principal diagnsis when a patient is admitted fr surgical remval f a malignancy fllwed by chemtherapy. Adjudicatin Examples Example 1 Questin: Hw will a claim be adjudicated f a 50 year ld female hlding a Reginal plan underging chemtherapy fr breast cancer? Answer: The claim will be paid if V58.11 (Encunter fr antineplastic chemtherapy) is cded as the principal diagnsis and the breast cancer cde is cded as the secndary diagnsis. Example 2 Questin: A female patient hlding a Thiqa plan is treated with Tamxifen fr hrmne-receptrnegative breast cancer. Is it apprpriate t apprve this claim? Answer: N, this claim will be rejected with MNEC- 003, since Tamxifen is nt medically indicated fr hrmne-receptr-negative breast cancer. Example 3 Questin: A 45 year ld female hlding a Basic plan is prescribed Dcetaxel fr breast cancer. Hw will this claim be adjudicated? Answer: The claim will be rejected with NCOV-003, because dcetaxel is nt cvered fr Basic plan. Natinal Health Insurance Cmpany Daman (PJSC) (P.O. Bx , Abu Dhabi, U.A.E. Tel N Fax N ) Dc Ctrl N.: TEMP/MSD-008 Versin N.: 1 Revisin N.: 0 Date f Issue: Page N(s).: 2 f 6

3 Breast Cancer - Pharmaclgical Treatment Denial cdes Cde MNEC-003 MNEC-004 NCOV-026 NCOV-003 MNEC-005 AUTH-001 PRCE-010 PRCE-002 NCOV-001 Appendices A. References Cde descriptin Service is nt clinically indicated based n gd clinical practice. Service is nt clinically indicated based n gd clinical practice, withut additinal supprting diagnsis/activities. Drug nt listed in frmulary Service(s) is (are) nt cvered. Service/supply maybe apprpriate, but t frequent. Prir apprval is required and was nt btained Use bundled cde Payment is included in the allwance fr anther service Diagnsis (es) is (are) nt cvered 1. AMA editrial staff ( ). Current Prcedural Terminlgy. 4th ed. Chicag: American Medical Assciatin Cancer.Net Editrial Bard. (2013). Breast Cancer. Available: Last accessed 02th July Cancer Research UK. (2012). Chemtherapy fr breast cancer. Available: Last accessed 04 July ICD-9-CM Official Guidelines fr Cding and Reprting 5. Natinal Cancer Institute. (2013). Breast Cancer Treatment. Available: ent/breast/healthprfessinal/page6. Last accessed 04 July Natinal Cancer Institute. (2012). Dcetaxel. Available: cetaxel. Last accessed 04 July Natinal Cancer Institute. (2012). Hrmne Therapy fr Breast Cancer. Available: herapy/hrmne-therapy-breast. Last accessed 02th July Natinal Cancer Sciety. (2013). Treatment f invasive breast cancer, by stage. Available: ailedguide/breast-cancer-treating-by-stage. Last accessed 04 July Natinal Institute f Health and Clinical Excellence. (2009). Early and lcally advanced breast cancer. Available: EGuideline.pdf. Last accessed 04 July Natinal Institute f Health and Care Excellence. (2009). Early and lcally advanced breast cancer: Diagnsis and treatment. Available: Last accessed 04 July Natinal Institute f Health and Care Excellence. (2013). Hrmnal therapies fr the adjuvant treatment f early estrgen-receptrpsitive breast cancer. Available: Last accessed 02th July Nrth Trent Cancer Netwrk. (2012). Referral and Management Guidelines fr Breast Cancers within Nrth Trent. Available: wnlads/breast- NSSG/NEW%20NTBreast%20NSSG%20Guidelin es% pdf. Last accessed 02th July Natinal Cmprehensive cancer netwrk. (2013). Breast Cancer. NCCN clinical practice guidelines n nclgy. 3 (1), p US Fd and Drug administratin - FDA. (Apprved in 1997, latest revisin December 2011). FDA apprval fr Femara (Letrzle). Drug safety guide FDA. 1 (1), p US Fd and Drug administratin - FDA. (). FDA. Available: gsatfda/index.cfm. Last accessed 13th Nvember B. Revisin Histry Date V Change(s) 1. V Disclaimer updated as per system requirements Natinal Health Insurance Cmpany Daman (PJSC) (P.O. Bx , Abu Dhabi, U.A.E. Tel N Fax N ) Dc Ctrl N.: TEMP/MSD-008 Versin N.: 1 Revisin N.: 0 Date f Issue: Page N(s).: 3 f 6

4 Breast Cancer - Pharmaclgical Treatment Table: 1a Endcrine Therapy Drugs Drugs that blck estrgen prductin are Armatase Inhibitrs (anastrzle, exemestane r letrzle) [11] Drugs Indicatins Limitatins Anastrzle (reversible, nnsteridal armatase inhibitr) Exemestane (irreversible steridal armatase inhibitr) Letrzle (reversible, nnsteridal armatase inhibitr) Indicated fr primary adjuvant therapy Adjuvant treatment f pstmenpausal wmen with early hrmne-receptr-psitive invasive breast cancer. Indicated fr pstmenpausal wmen as initial therapy fr metastatic hrmne-sensitive breast cancer Indicated as adjuvant treatment f pstmenpausal wmen with estrgen-receptr-psitive invasive early breast cancer, fllwing 2 3 years f initial adjuvant tamxifen therapy. Indicated fr treatment f advanced breast cancer in wmen with natural r induced pstmenpausal status whse disease has prgressed fllwing anti-estrgen therapy. Indicated fr adjuvant treatment f pstmenpausal wmen with hrmne-receptr-psitive invasive early breast cancer Indicated fr treatment f pstmenpausal wmen with hrmnereceptr-psitive invasive early breast cancer wh have already received standard adjuvant tamxifen therapy fr 5 years. Indicated fr pstmenpausal wmen as initial therapy fr metastatic hrmne-sensitive breast cancer Fr early disease the recmmended duratin f treatment with anastrzle is 5 years In wmen with early breast cancer, the recmmended duratin f treatment with exemestane is 5 years f cmbined sequential adjuvant hrmnal therapy (tamxifen fllwed by exemestane) r until tumr relapse ccurs, whichever cmes first. The recmmended duratin f adjuvant treatment with letrzle is 5 years r until tumr relapse ccurs, whichever cmes first. Fllwing standard adjuvant tamxifen therapy, treatment with letrzle is recmmended t cntinue fr 3 years r until tumr relapse ccurs, whichever cmes first. Drugs used fr varian suppressin/ablatin fr early invasive breast cancer Gnadtrpin releasing hrmne (GnRH) agnists. Or luteinizing hrmne-releasing hrmne (LH-RH) agnists (Gserelin,Leuprlide} [9] In premenpausal wmen Adjuvant varian ablatin/suppressin is recmmended t be used in additin t tamxifen t premenpausal wmen with ER-psitive early invasive breast cancer wh have been ffered chemtherapy but have chsen nt t have it; varian ablatin/suppressin is nt recmmended fr premenpausal wmen with ER-psitive early invasive breast cancer wh are being treated with tamxifen and, if indicated, chemtherapy. Drugs Indicatins Limitatins Gserelin Leuprlide Hrmne-receptr psitive breast cancer in men and premenpausal wmen Treatment f metastatic breast cancer in pre-menpausal patients whse disease has prgressed r recurred despite a 3 r mre mnth s trial f tamxifen. N.A Drugs that blcks estrgen s effects Tamxifen (blcks estrgen frm binding t breast cancer cells.) Fulvestrant (anti-estrgen drugs - attaches t the estrgen receptr and functins as an estrgen antagnist) Apprved by the FDA fr adjuvant hrmne treatment f premenpausal and pstmenpausal wmen (and men) with ER-psitive early-stage breast cancer. As per NCCN it is recmmended fr patients treated with breast cnserving therapy (lumpectmy) and radiatin therapy fr ERpsitive ductal carcinma in situ (DCIS) Reduces the risk f develping breast cancer in wmen at high risk f the disease. Prvides prtectin against bne fractures in pstmenpausal wmen and it lwers serum chlesterl levels. Indicated fr pstmenpausal wmen with metastatic ERpsitive breast cancer after treatment with ther antiestrgens. Adjuvant tamxifen nt indicated after breast cnserving surgery t patients with ER negative ductal carcinma in situ (DCIS). [9,13] Nt recmmended, within its licensed indicatin, as an alternative t armatase inhibitrs fr the treatment f estrgen-receptr-psitive, lcally advanced r metastatic breast cancer in pstmenpausal wmen whse cancer has relapsed n r after adjuvant antiestrgen therapy, r wh have disease prgressin n anti-estrgen therapy. Natinal Health Insurance Cmpany Daman (PJSC) (P.O. Bx , Abu Dhabi, U.A.E. Tel N Fax N ) Dc Ctrl N.: TEMP/MSD-008 Versin N.: 1 Revisin N.: 0 Date f Issue: Page N(s).: 4 f 6

5 Breast Cancer - Pharmaclgical Treatment Table 1 b: Adjuvant treatment in Pre-menpausal and Pst-menpausal wmen [12] Pre-menpausal wmen: Pst-menpausal wmen: First line treatment Tamxifen + Gserelin First line endcrine treatment Armatase inhibitr - Letrzle r Anastrzle. Tamxifen is indicated if armatase inhibitrs are cntra-indicated. Tamxifen indicated fr five years. Gserelin (LHRH analgue): indicated as mnthly dept injectins fr tw years as an apprpriate alternative t chemtherapy fr sme patients Fr pre-menpausal wmen receiving adjuvant chemtherapy there is n clear evidence that an LHRH analgue adds t the benefits f chemtherapy + Tamxifen Armatase inhibitrs (AI) are superir t Tamxifen in the adjuvant setting and are indicated t cnstitute all r part f the adjuvant endcrine prgram. Tamxifen alne fr five years is indicated as the treatment f chice fr patients with excellent r very gd prgnsis disease. Tamxifen is indicated t be used fr 2-3 years fllwed by an AI (usually Exemestane r Anastrzle) t cmplete 5 years treatment. AI (usually Anastrzle r Letrzle) indicated frm the utset fr 5 years in wmen at high risk f early recurrence (e.g. HER 2 psitive r PR negative and nde psitive), r with a recent histry f thrmb-emblic disease. AI (usually Letrzle) indicated fr extended adjuvant treatment in patients cnsidered at cntinuing significant risk fr relapse (e.g. nde psitive) wh are cmpleting a previusly planned 5 year curse f Tamxifen. Table 2 Adjuvant Chemtherapy* Adjuvant chemtherapy is recmmended fr ne r mre f fllwing reasns: [3] Axillary lymph ndes cntaining breast cancer cells Have had a large primary cancer in the breast High grade (grade 3) breast cancer cells Hrmne receptrs negative cancer cells that are nt likely t respnd well t hrmne therapy. Drugs Indicatin Limitatins Dcetaxel [6] Paclitaxel Dxrubicin Capecitabine Oral chemtherapy drug Lcally advanced disease r has metastasized (spread t ther parts f the bdy) and has nt gtten better with ther chemtherapy Breast cancer that is nde-psitive and can be remved by surgery. Paclitaxel Injectin, USP is indicated fr the treatment f breast cancer after failure f cmbinatin chemtherapy fr metastatic disease r relapse within 6 mnths f adjuvant chemtherapy. Prir therapy shuld have included an anthracycline unless clinically cntraindicated Indicated fr early stage and metastatic breast cancer Indicated as neadjuvant treatment Indicated fr early-stage r nde-psitive breast cancer Indicated fr HER2-psitive breast cancer Indicated fr metastatic disease Indicated fr metastatic breast cancer that has nt respnded t ther chemtherapy. N.A paclitaxel is nt indicated as an adjuvant treatment fr lymph ndepsitive breast [9 pg: 18] cancer. N.A Methtrexate Indicated t be used alne r in cmbinatin with ther anti-cancer drugs *Cmbinatin drugs will be cvered as per medical necessity. Natinal Health Insurance Cmpany Daman (PJSC) (P.O. Bx , Abu Dhabi, U.A.E. Tel N Fax N ) Dc Ctrl N.: TEMP/MSD-008 Versin N.: 1 Revisin N.: 0 Date f Issue: Page N(s).: 5 f 6

6 Breast Cancer - Pharmaclgical Treatment Table 3 Bilgical targeted therapy Targeted therapies are apprved t treat HER2 breast cancer Cancer that has spread t the bne. Drugs Indicatins Limitatins Trastuzumab Treatment f advanced breast cancer As an adjuvant therapy fr early-stage HER2-psitive breast cancer Cardiac functin t be assessed befre starting treatment with trastuzumab. Trastuzumab [9 pg: 18] treatment nt recmmended fr wmen wh have any f the fllwing: a left ventricular ejectin fractin (LVEF) f 55% r less a histry f dcumented cngestive heart failure high-risk uncntrlled arrhythmias angina pectris requiring medicatin clinically significant valvular disease evidence f transmural infarctin n electrcardigraph (ECG) Prly cntrlled hypertensin. Dse - intravenus infusin given at intervals f either 1 r 3 weeks (nceweekly r 3-weekly dsing regimens). Natinal Health Insurance Cmpany Daman (PJSC) (P.O. Bx , Abu Dhabi, U.A.E. Tel N Fax N ) Dc Ctrl N.: TEMP/MSD-008 Versin N.: 1 Revisin N.: 0 Date f Issue: Page N(s).: 6 f 6