Cellular Immunotherapy for Prostate Cancer

Transcription

1 MEDICAL POLICY Cellular Immunotherapy for Prostate Cancer BCBSA Ref. Policy: Effective Date: Oct. 1, 2018 Last Revised: Sept. 20, 2018 Replaces: N/A RELATED MEDICAL POLICIES: Adoptive Immunotherapy Select a hyperlink below to be directed to that section. POLICY CRITERIA CODING RELATED INFORMATION EVIDENCE REVIEW REFERENCES HISTORY Clicking this icon returns you to the hyperlinks menu above. Introduction Immunotherapy is a way to fight disease, even cancer, by using a person s own immune system. Dendritic cells are part of the immune system. They help the immune system spot cancer cells. When the dendritic cells find and start to break down cancer cells, other immune cells are activated to also attack the cancer cells. In some cases of advanced prostate cancer, a vaccine can be made using a person s own immune cells. Certain immune cells are removed, treated in a lab to create dendritic cells, and then given back to the person. This very specialized vaccine then helps the body fight prostate cancer. This policy describes when this type of immunotherapy may be approved for prostate cancer. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria

2 Therapy Sipuleucel-T therapy Medical Necessity Sipuleucel-T therapy may be considered medically necessary in the treatment of asymptomatic or minimally symptomatic, androgen-independent (castration-resistant) metastatic prostate cancer. Note: Provenge is the brand or trade name for sipuleucel-t. Therapy Sipuleucel-T therapy Investigational Sipuleucel-T therapy is considered investigational in all other situations, including but not limited to: Treatment of hormone-responsive prostate cancer Treatment of moderate to severe symptomatic metastatic prostate cancer Treatment of visceral (liver, lung, or brain) metastases Coding Code HCPCS Q2043 Note: Description Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GM- CSF, including leukapheresis and all other preparatory procedures, per infusion (Provenge ) CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS). Related Information N/A Page 2 of 9

3 Evidence Review Description Sipuleucel-T (Provenge) is a class of therapeutic agent used to treat symptomatic castrationresistant, metastatic prostate cancer. The agent comprises specially treated dendritic cells obtained from the patient through leukapheresis. The cells are then exposed in vitro to proteins that contain prostate antigens and immunologic-stimulating factors and reinfused into the patient. The proposed mechanism of action is that treatment stimulates the patient s own immune system to resist cancer spread. Background Prostate Cancer Prostate cancer is the second leading cause of cancer-related deaths among American men, with an estimated incidence of 164,690 cases and an estimated number of 29,430 deaths in In most cases, prostate cancer is diagnosed at a localized stage and is treated with prostatectomy or radiotherapy. However, some patients are diagnosed with metastatic disease or recurrent disease after treatment of localized disease. Treatment Androgen ablation is the standard treatment for metastatic or recurrent disease. Most patients who survive long enough eventually develop androgen-independent (castration-resistant) prostate cancer. At this stage of metastatic disease, docetaxel, a chemotherapeutic agent, has demonstrated a survival benefit of 1.9 to 2.4 months in randomized clinical trials. 2,3 Chemotherapy with docetaxel causes adverse effects in large proportions of patients, including alopecia, fatigue, neutropenia, neuropathy, and other symptoms. Trials evaluating docetaxel included both asymptomatic and symptomatic patients, and results have suggested a survival benefit for both groups. Because of the burden of treatment and its adverse effects, most patients therefore defer docetaxel treatment until cancer recurrence is symptomatic. Cancer immunotherapy has been investigated as a treatment that could be instituted at the point of detection of androgen-independent metastatic disease before significant symptomatic Page 3 of 9

4 manifestations have occurred. The quantity of cancer cells in the patient during this time is thought to be relatively low, and it is thought that an effective immune response to the cancer during this interval could effectively delay or prevent progression. Such a delay could allow a course of effective chemotherapy, such as docetaxel, to be deferred or delayed until necessary, thus providing an overall survival benefit. Summary of Evidence For individuals who have asymptomatic or minimally symptomatic metastatic castrationresistant prostate cancer who receive sipuleucel-t (Provenge), the evidence includes 3 randomized controlled trials (RCTs) and a systematic review of these RCTs. Relevant outcomes are overall survival, disease-specific survival, change in disease status, and treatment-related morbidity. The 2 earlier RCTs of sipuleucel-t were not specifically designed to demonstrate a difference in overall mortality but did show a survival difference. The third RCT, which was designed to demonstrate a mortality difference, showed a similar improvement in overall survival. All 3 studies were consistent in demonstrating that sipuleucel-t does not delay time to measureable progression of disease. A meta-analysis of the 3 RCTs found significantly improved overall survival, but not time to progression, with sipuleucel-t compared with placebo. Serious adverse events did not increase in the sipuleucel-t group. However, the available data suggested, but did not confirm, an increase in stroke risk; this risk is being evaluated in a postmarketing study. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. For individuals who have nonmetastatic androgen-dependent prostate cancer who receive sipuleucel-t (Provenge), the evidence includes an RCT. Relevant outcomes are overall survival, disease-specific survival, change in disease status, and treatment-related morbidity. The RCT did not find a statistically significant difference between sipuleucel-t and a control in time to biochemical failure. The RCT was not designed to evaluate the impact of sipuleucel-t on mortality. The evidence is insufficient to determine the effects of the technology on health outcomes. Ongoing and Unpublished Clinical Trials Some currently unpublished trials that might influence this policy are listed in Table 1. Page 4 of 9

5 Table 1. Summary of Key Trials NCT No. Trial Name Planned Completion Enrollment Date Ongoing NCT Randomized Phase II Trial of Sipuleucel-T Immunotherapy Preceded by Sensitizing Radiation Therapy and Sipuleucel-T Alone in Patients With Castrate Resistant Metastatic Prostate Cancer 50 Jan 2019 NCT a NCT Unpublished NCT a A Randomized Phase 2 Trial of Combining Sipuleucel-T With Immediate vs. Delayed CTLA-4 Blockade for Prostate Cancer A Randomized, Double-Blind Phase II Study of Sipuleucel-T (Provenge ) Followed by Indoximod or Placebo in the Treatment of Patients With Asymptomatic or Minimally Symptomatic Metastatic Castration Resistant Prostate Cancer A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer (PROCEED) 54 Dec Nov Jan 2017 (completed) NCT: national clinical trial a Denotes industry-sponsored or cosponsored trial Practice Guidelines and Position Statements American Urological Association The American Urological Association (2018) amended their 2013 guidelines on castrationresistant prostate cancer. 14,15 Table 2 provides the guideline statements on sipuleucel-t. Table 2. Guidelines on Treatment of Castration-Resistant Prostate Cancer Guideline SOE LOE Clinicians should offer abiraterone plus prednisone, enzalutamide, docetaxel, or sipuleucel-t to patients with asymptomatic or minimally symptomatic mcrpc with good performance status and no prior Standard A (abiraterone plus prednisone and enzalutamide) docetaxel chemotherapy. B (docetaxel and sipuleucel-t) Page 5 of 9

6 Guideline SOE LOE Clinicians should not offer treatment with either estramustine or sipuleucel-t to patients with symptomatic, mcrpc with good performance status and no prior docetaxel chemotherapy. Recommendation C LOE: level of evidence; mcrpc: metastatic castration-resistant prostate cancer; SOE: strength of evidence. National Comprehensive Cancer Network (NCCN) Current National Comprehensive Cancer Network Guidelines for prostate cancer (v ) recommend sipuleucel-t as a category 1 treatment for patients with metastatic castrationrecurrent prostate cancer, symptomatic or minimally symptomatic; Eastern Cooperative Oncology Group Performance Status 0 or 1; no liver metastasis; and life expectancy greater than 6 months. 16 Sipuleucel-T also is recommended for second-line treatment of symptomatic patients with metastatic castration-recurrent prostate cancer who fail chemotherapy and otherwise meet criteria for treatment with sipuleucel-t (category 2A recommendation). American Society of Clinical Oncology and Cancer Care Ontario The American Society of Clinical Oncology (2014) issued an evidence-based clinical guideline on systemic therapy for men with metastatic castration-resistant prostate cancer. 17 The guidelines included a weak recommendation that sipuleucel-t may be offered to men who are asymptomatic or minimally symptomatic (benefit: moderate; harm: low; evidence strength: moderate). The 2017 guidelines on second-line hormonal therapy for men with chemotherapynaive, castration-resistant prostate cancer gives a provisional recommendation of sipuleucel-t as an option. 18 Medicare National Coverage The Centers for Medicare & Medicaid Services released a national coverage determination in 2011 approving sipuleucel-t for treatment of asymptomatic or minimally symptomatic castrateresistant prostate cancer. 19 Coverage for off-label indications was left to the discretion of local Medicare administrative contractors. Page 6 of 9

7 Regulatory Status In 2010, the U.S. Food and Drug Administration approved Provenge (sipuleucel-t; Dendreon Corp., now Sanpower) under a Biologics Licensing Application for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. 4 Approval was contingent on the manufacturer conducting a postmarketing study, based on a registry design, to assess the risk of cerebrovascular events in 1500 men with prostate cancer who receive sipuleucel-t. References 1. National Cancer Institute, Surveillance Epidemiology and End Results Program. Cancer Stat Fact: Prostate Cancer. n.d.; Accessed September Southwest Oncology G, Berry DL, Moinpour CM, et al. Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone. J Clin Oncol. Jun ;24(18): PMID Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. Oct ;351(15): PMID Food and Drug Administration (FDA). April 29, 2010 Approval Letter - Provenge. 2010; oducts/ucm htm. Accessed September Yi R, Chen B, Duan P, et al. Sipuleucel-T and androgen receptor-directed therapy for castration-resistant prostate cancer: a meta-analysis. J Immunol Res. Dec ;2016: PMID Dendreon Corporation. Provenge (sipuleucel-t) suspension for intravenous infusion prescribing information. n.d.; Accessed September Small EJ, Schellhammer PF, Higano CS, et al. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-t (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol. Jul ;24(19): PMID Higano CS, Schellhammer PF, Small EJ, et al. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-t in advanced prostate cancer. Cancer. Aug ;115(16): PMID Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. Jul ;363(5): PMID Food and Drug Administration (FDA). Summary Basis for Regulatory Action: Provenge (sipuleucel T). 2010; ApprovedProducts/UCM pdf. Accessed September Schellhammer PF, Chodak G, Whitmore JB, et al. Lower baseline prostate-specific antigen is associated with a greater overall survival benefit from sipuleucel-t in the Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT) trial. Urology. Jun 2013;81(6): PMID Page 7 of 9

8 12. Small EJ, Higano CS, Kantoff PW, et al. Time to disease-related pain and first opioid use in patients with metastatic castrationresistant prostate cancer treated with sipuleucel-t. Prostate Cancer Prostatic Dis. Sep 2014;17(3): PMID Beer TM, Bernstein GT, Corman JM, et al. Randomized trial of autologous cellular immunotherapy with sipuleucel-t in androgen-dependent prostate cancer. Clin Cancer Res. Jul ;17(13): PMID Cookson MS, Roth BJ, Dahm P, et al. Castration-resistant prostate cancer: AUA Guideline. J Urol. Aug 2013;190(2): PMID Cookson MS, Roth BJ, Dahm P, et al. Castration-resistant prostate cancer: AUA guideline. 2018; Available at: Accessed September National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: prostate cancer. Version Accessed September Basch E, Loblaw DA, Oliver TK, et al. Systemic therapy in men with metastatic castration-resistant prostate cancer:american Society of Clinical Oncology and Cancer Care Ontario clinical practice guideline. J Clin Oncol. Oct ;32(30): PMID Virgo KS, Basch E, Loblaw DA, et al. Second-line hormonal therapy for men with chemotherapy-naive, castration-resistant prostate cancer: American Society of Clinical Oncology Provisional Clinical Opinion. J Clin Oncol. Jun ;35(17): PMID Center for Medicare and Medicaid Services. National Coverage Determination (NCD) for Autologous Cellular Immunotherapy Treatment (110.22). 2011; Accessed September History Date Comments 11/09/10 New Policy; add to Therapy section - New policy. 05/13/11 Code Update - C9273 added to policy. 10/11/11 Replace Policy Previously unpublished preliminary trial information updated with published information. Medicare coverage decision granted 6/30/2011; section updated. Reference 8 added. No change to the policy statement. Codes updated: HCPCS code C9273 deleted and Q2043 added; ICD-9 codes updated; ICD-10 codes added. 11/17/11 Reviewed and recommended by OAP on November 17, /26/12 Replace Policy. Policy updated with literature review. Reference 10 added. No change to policy statements. 02/15/13 Update Related Policies. Add /27/13 Replace policy. Policy updated with literature review through May Reference 10 added. No change to policy statements. 09/23/14 Annual Review. Policy updated with literature review through June 20, Page 8 of 9

9 Date Comments References 6, 8, and 12 added; references 3, 7, 10, and 13 updated; others renumbered/removed. Policy statements unchanged. CPT code removed from policy; this code is not managed in relationship to this policy. 09/08/15 Annual Review. Hormone-refractory changed to the current clinically accepted term castration-resistant prostate cancer in the medically necessary policy statement and throughout the policy. Added brand name Provenge to the policy section. Policy updated with literature review through June 27, 2015; references 1, 10, and 14 added. Policy statements wording revised as noted. CPT code and HCPCS code J3590 removed; these do not relate to the policy. 12/01/16 Annual Review, approved November 8, No changes to policy statement. 09/01/17 Annual Review, approved August 22, Policy updated with literature review through June 6, 2017; references 5 and added. Policy statement unchanged. 10/01/18 Annual Review, approved September 20, Policy updated with literature review through June 2018; references 15 and 18 added; reference 1 updated. Policy statements unchanged. Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA) Premera All Rights Reserved. Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage. Page 9 of 9

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Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de LifeWise Health Plan of Washington. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted tiene derecho a recibir esta información y ayuda en su idioma sin costo alguno. Llame al Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng LifeWise Health Plan of Washington. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa ไทย (Thai): ประกาศน ม ข อม ลส าค ญ ประกาศน อาจม ข อม ลท ส าค ญเก ยวก บการการสม ครหร อขอบเขตประก น ส ขภาพของค ณผ าน LifeWise Health Plan of Washington และอาจม ก าหนดการในประกาศ น ค ณอาจจะต องด าเน นการภายในก าหนดระยะเวลาท แน นอนเพ อจะร กษาการประก นส ขภาพของค ณ หร อการช วยเหล อท ม ค าใช จ าย ค ณม ส ทธ ท จะได ร บข อม ลและความช วยเหล อน ในภาษาของค ณโดยไม ม ค าใช จ าย โทร (TTY: ) Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через LifeWise Health Plan of Washington. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. 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