| Coverage Policy Manual | |
| Policy #: | 2018004 |
| Category: | Pharmacy |
| Initiated: | February 2018 |
| Last Review: | January 2025 |
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| Letermovir (e.g., Prevymis) | |
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| Description: |
Letermovir is a CMV terminase complex inhibitor (Clinical Pharmacology [Internet], 2017).
Letermovir is given intravenously or as an oral medication. This policy refers to the intravenous form, and the oral form will be processed under the pharmacy benefit.
Regulatory Status
Letermovir (e.g., Prevymis) was FDA approved in 2017 for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients (R+) of an allogeneic hematopoietic stem cell transplant (HSCT) (FDA, 2017).
On June 5, 2023, the Food and Drug Administration, approved the use of Letermovir (e.g., Prevymis) injection for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk [Donor CMV seropositive/Recipient CMV seronegative (D+/R-)].
On August 2, 2023, the Food and Drug Administration approved the extension of Letermovir (e.g., Prevymis) dosing regimen from 100 to 200 days post-transplant for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV seropositive recipients (R+) of an allogeneic hematopoietic stem cell transplant who are at risk for late CMV infection and disease.
On August 30, 2024, the Food and Drug Administration approved the expansion of letermovir (e.g., Prevymis) to include pediatric hematopoietic stem cell transplant recipients 6 months of age and older and weighing at least 6 kg and to include pediatric kidney transplant recipients 12 years of age and older and weighing at least 40 kg.
Coding
See CPT/HCPCS Code section below.
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Policy/ Coverage: |
Effective May 1, 2024, prior approval is required for Letermovir (e.g., Prevymis).
The use of letermovir oral tablets is not covered under the medical benefit. Please check the member’s pharmacy benefit for coverage.
The use of letermovir intravenous injection is covered under the medical benefit.
The Step Therapy Medication Act is applicable to fully insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.
Effective January 15, 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Letermovir (e.g., Prevymis) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the following indications (FDA Prevymis, 2017):
Dosing and Administration
Dosing per FDA Guidelines
Adult and Pediatric Individuals 12 Years of Age and Older and Weighing at least 30 kg Who Are HSCT Recipients or Adult and Pediatric Individuals 12 Years of Age and Older and Weighing at least 40 kg Who Are Kidney Transplant Recipients:
Pediatric Individuals 6 Months to Less than 12 Years of Age or 12 Years of Age and Older and Weighing Less than 30 kg Who Are HSCT Recipients:
Dosage Adjustment:
If Letermovir (e.g., Prevymis) is co-administered with cyclosporine, the dosage of Letermovir (e.g., Prevymis) should be decreased to 240 mg daily in adult and pediatric individuals 12 years of age and older. If Letermovir (e.g., Prevymis) is co-administered with cyclosporine in pediatric individuals less than 12 years of age, dose adjustment may be required.
Letermovir (e.g., Prevymis) injection is available as 240 mg/12mL (20 mg/mL) or 480 mg/24 mL (20 mg/mL) in a single dose vial.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Letermovir (e.g., Prevymis) for any indication or circumstance not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria Letermovir (e.g., Prevymis) for any indication or circumstance not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective May 1, 2024 through January 14, 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Letermovir meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the following indications (FDA Prevymis, 2017):
Dosing and Administration
Dosing per FDA Guidelines
HSCT:
The recommended dosage of letermovir is 480 mg once daily through 100 days HSCT. In individuals at risk for late CMV infection and disease, letermovir may be continued through 200 days post-HSCT.
Kidney transplant:
The recommended dosage of letermovir is 480 mg administered once daily through 200 days post-transplant.
Dosage Adjustment:
If letermovir is co-administered with cyclosporine, the dosage of letermovir should be decreased to 240 mg daily.
Letermovir injection is available as 240 mg/12mL (20 mg/mL) or 480 mg/24 mL (20 mg/mL) in a single dose vial.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of Letermovir for any indication or circumstance not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, the use of Letermovir for any indication or circumstance not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective February 2023 to April 30, 2024
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Letermovir meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the following indication (FDA Prevymis, 2017):
Dosing and Administration
Dosing per FDA Guidelines
Dosing must be within FDA guidelines of 480 mg once daily through 100 days post-transplant. This should be decreased to 240mg if co-administered with cyclosporine.
Letermovir injection is available as 240 mg/12mL (20 mg/mL) or 480 mg/24 mL (20 mg/mL) in a single dose vial.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of Letermovir for any indication or circumstance not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes including for the treatment of CMV not meeting the above criteria.
For members with contracts without primary coverage criteria, the use of Letermovir for any indication or circumstnace not described above is considered investigational including for the treatment of CMV not meeting the above criteria.
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective January 2022 to January 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Letermovir meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indication (FDA Prevymis, 2017):
Dosing and Administration
Dosing must be within FDA guidelines of 480 mg once daily through 100 days post-transplant. This should be decreased to 240mg if co-administered with cyclosporine.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of Letermovir for the treatment of CMV not meeting the above criteria or for any other indication does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for all other indications.
For members with contracts without primary coverage criteria, the use of Letermovir for the treatment of CMV not meeting the above criteria or for any other indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective February 2019 to December 31, 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Letermovir meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indication:
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Dosing and Administration
Dosing must be within FDA guidelines of 480 mg once daily through 100 days post-transplant. This should be decreased to 240mg if co-administered with cyclosporine.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Letermovir does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for all other indications.
For members with contracts without primary coverage criteria, Letermovir is considered investigational for all other indications. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective February 2018 to January 2019
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Letermovir meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indication:
Dosing must be within FDA guidelines of 480 mg once daily through 100 days post-transplant. This should be decreased to 240mg if co-administered with cyclosporine.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Letermovir does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for all other indications.
For members with contracts without primary coverage criteria, Letermovir is considered investigational for all other indications. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
The safety and efficacy of letermovir was evaluated in a multicenter, double-blind, placebo- controlled trial in which patients were randomized to either letermovir or placebo. Randomization was stratified by investigational site and risk level for CMV reactivation at the time of study entry. Letermovir patients received either 480mg once daily or 240mg once daily if administered with cyclosporine, and was initiated at any time between Day 0 and Day 28 post-transplant. Treatment continued through week 14 post-transplant. CMV DNA was monitored weekly through week 14 post-transplant, then twice-weekly though week 24. Patients who had CMV viremia prior to study drug initiation were excluded. In total, 325 patients received letermovir and 170 received placebo. The primary endpoint was the incidence of clinically significant CMV infection through week 24 post-transplant, which would indicate prophylaxis failure. Clinically significant CMV infection was defined as the occurrence of either CMV end-organ disease or initiation of anti-CMV preemptive therapy based on documented CMV viremia. Pre-emptive therapy was initiated based on a risk-stratified protocol, in which patients received preemptive therapy if they had CMV DNA above a certain threshold (>150 copies/ml for the high risk group or 300 copies/ml for the low risk group for the first 14 weeks then >300 copies/ml for either group during weeks 15-24). Overall, 38% failed prophylaxis in the letermovir group, as opposed to 61% of the placebo group (p<0.0001). The Kaplan- Meier event rate for all-cause mortality was 12% in the letermovir group as opposed to 17% in the placebo group at week 24 post-transplant, and was 24% in the letermovir group as opposed to 28% in the placebo group at week 48.
2019 Update
A literature search conducted through January 2019 did not reveal any new information that would prompt a change in the coverage statement.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Valganciclovir for 200 days is standard care for cytomegalovirus (CMV) prophylaxis in high-risk CMV-seronegative kidney transplant recipients who receive an organ from a CMV-seropositive donor, but its use is limited by myelosuppression.
The efficacy and safety of letermovir with valganciclovir for prevention of CMV disease in CMV-seronegative kidney transplant recipients who receive an organ from a CMV-seropositive donor was compared.
Randomized, double-masked, double-dummy, noninferiority, phase 3 trial in adult CMV-seronegative kidney transplant recipients who received an organ from a CMV-seropositive donor at 94 participating sites between May 2018 and April 2021 (final follow-up in April 2022).
Participants were randomized in a 1:1 ratio (stratified by receipt of lymphocyte-depleting induction immunosuppression) to receive letermovir, 480 mg, orally daily (with acyclovir) or valganciclovir, 900 mg, orally daily (adjusted for kidney function) for up to 200 days after transplant, with matching placebos.
The primary outcome was CMV disease, confirmed by an independent masked adjudication committee, through posttransplant week 52 (prespecified noninferiority margin, 10%). CMV disease through week 28 and time to onset of CMV disease through week 52 were secondary outcomes. Exploratory outcomes included quantifiable CMV DNAemia and resistance. The rate of leukopenia or neutropenia through week 28 was a prespecified safety outcome.
Among 601 participants randomized, 589 received at least 1 dose of the study drug (mean age, 49.6 years; 422 [71.6%] men). Letermovir (n = 289) was noninferior to valganciclovir (n = 297) for prevention of CMV disease through week 52 (10.4% vs 11.8% of participants with committee-confirmed CMV disease; stratum-adjusted difference -1.4% [95% CI, -6.5% to 3.8%]). No participants who received letermovir vs 5 participants (1.7%) who received valganciclovir developed CMV disease through week 28. Time to onset of CMV disease was comparable between the groups (hazard ratio, 0.90 [95% CI, 0.56-1.47]). Quantifiable CMV DNAemia was detected in 2.1% of participants in the letermovir group vs 8.8% in the valganciclovir group by week 28. Of participants evaluated for suspected CMV disease or CMV DNAemia, none (0/52) who received letermovir and 12.1% (8/66) who received valganciclovir had resistance-associated substitutions. The rate of leukopenia or neutropenia through week 28 was lower with letermovir vs valganciclovir (26% vs 64%; difference, -37.9% [95% CI, -45.1% to -30.3%]; P < .001). Fewer participants in the letermovir group than the valganciclovir group discontinued prophylaxis due to adverse events (4.1% vs 13.5%) or drug-related adverse events (2.7% vs 8.8%).
Among adult CMV-seronegative kidney transplant recipients who received an organ from a CMV-seropositive donor, letermovir was noninferior to valganciclovir for prophylaxis of CMV disease over 52 weeks, with lower rates of leukopenia or neutropenia, supporting its use for this indication (Limaye, 2023).
In a pivotal phase 3 trial of cytomegalovirus prophylaxis with letermovir for up to 100 days after allogeneic hematopoietic stem-cell transplantation (HSCT), 12% of participants developed clinically significant cytomegalovirus infection after letermovir was discontinued. The trial aimed to evaluate the efficacy and safety of extending the duration of letermovir prophylaxis for clinically significant cytomegalovirus infection from 100 days to 200 days following HSCT.
A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial was conducted at 32 sites in six countries (France, Germany, Italy, Japan, the UK, and the USA). Cytomegalovirus‑seropositive HSCT recipients (aged ≥18 years) who had received letermovir prophylaxis for up to 100 days following HSCT and who remained at high risk of late clinically significant cytomegalovirus infection (with no previous history of clinically significant cytomegalovirus infection, defined as initiation of pre-emptive therapy for documented cytomegalovirus viraemia, onset of cytomegalovirus end-organ disease, or both) were eligible. Participants were randomly assigned (2:1) to receive either an additional 100 days (i.e., a total of 200 days; letermovir group) of oral or intravenous letermovir 480 mg once daily, adjusted to 240 mg once daily for participants on cyclosporin A, or 100 days of a placebo comparator for letermovir (i.e., a total of 100 days of letermovir; placebo group), following HSCT. Randomisation was done using a central interactive response technology system, stratified by study center and haploidentical donor (yes or no). Participants, investigators, and sponsor personnel were masked to the treatment allocation. The primary efficacy endpoint was the proportion of participants from randomisation to week 28 (200 days after HSCT) with clinically significant cytomegalovirus infection, analyzed using the full analysis set population (i.e., those who received at least one dose of study intervention). Safety was analyzed in all participants as treated (i.e., those who received at least one dose according to the study intervention they were assigned to).
Between June 21, 2019, and March 16, 2022, 255 patients were screened for eligibility and 220 (86%) were randomly assigned (145 [66%] in the letermovir group and 75 [34%] in the placebo group). Between randomisation and week 28, four (3%) of 144 participants in the letermovir group and 14 (19%) of 74 in the placebo group developed clinically significant cytomegalovirus infection (treatment difference −16·1% [95% CI −25·8 to −6·5]; p=0·0005). The most common adverse events among participants in the letermovir group versus the placebo group were graft-versus-host disease (43 [30%] vs 23 [31%]), diarrhea (17 [12%] vs nine [12%]), nausea (16 [11%] vs 13 [18%]), pyrexia (13 [9%] vs nine [12%]), and decreased appetite (six [4%] vs nine [12%]). The most frequently reported serious adverse events were recurrent acute myeloid leukemia (six [4%] vs none) and pneumonia (three [2%] vs two [3%]). No deaths were considered to be drug-related by the investigator.
Interpretation
Extending the duration of letermovir prophylaxis to 200 days following HSCT is efficacious and safe in reducing the incidence of late clinically significant cytomegalovirus infection in patients at risk (Russo, 2023).
To evaluate PREVYMIS prophylaxis as a preventive strategy for CMV infection or disease in transplant recipients at high risk for CMV reactivation, the efficacy of PREVYMIS was assessed in a multicenter, double-blind, placebo-controlled Phase 3 Trial (P001, NCT02137772) in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). Subjects were randomized (2:1) to receive either PREVYMIS at a dose of 480 mg once daily adjusted to 240 mg when co-administered with cyclosporine, or placebo. Randomization was stratified by investigational site and risk level for CMV reactivation at the time of study entry. Study drug was initiated after HSCT (at any time from Day 0 to Day 28 post-HSCT) and continued through Week 14 post-HSCT. Study drug was administered either orally or intravenously; the dose of PREVYMIS was the same regardless of the route of administration. Subjects received CMV DNA monitoring weekly until post-HSCT Week 14 and then bi-weekly until post-HSCT Week 24, with initiation of standard-of-care CMV pre-emptive therapy if CMV viremia was considered clinically significant. Subjects had continued follow-up through Week 48 post-HSCT.
Among the 565 treated subjects, 70 subjects were found to have CMV viremia prior to study drug initiation and were therefore excluded from the efficacy analyses. The efficacy population consisted of 325 subjects who received PREVYMIS (including 91 subjects who received at least one IV dose) and 170 who received placebo (including 41 subjects who received at least one IV dose). The IV formulation of PREVYMIS was used at investigators’ discretion in subjects who were unable to take oral therapy (e.g., unable to tolerate oral intake). The median time to starting study drug was 8 days after transplantation. Thirty-four percent (34%) of subjects were engrafted at baseline. The median age was 55 years (range: 18 to 76 years). 57% were male; 84% were White; 9% were Asian; 2% were Black or African American; and 5% were other (American Indian or Alaska Native, multiple, and missing). 7% were Hispanic or Latino; 89% not Hispanic or Latino; and 4% other (not reported, unknown, and missing).
At baseline, 30% of all subjects had one or more of the following factors associated with increased risk for CMV reactivation (high risk stratum): Human Leukocyte Antigen (HLA)-related donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B or –DR; haploidentical donor; unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1; use of umbilical cord blood as stem cell source; use of ex vivo T-cell-depleted grafts; Grade 2 or greater GraftVersus-Host Disease (GVHD) requiring systemic corticosteroids. The remaining 70% of subjects did not meet any of these high risk stratum criteria and were therefore included in the low risk stratum. Additionally, 48% of subjects received a myeloablative regimen, 51% were receiving cyclosporine, and 43% were receiving tacrolimus. The most common primary reasons for transplant were acute myeloid leukemia (38%), myelodysplastic syndrome (16%), and lymphoma (12%).
The primary efficacy endpoint of Trial P001 was the incidence of clinically significant CMV infection through Week 24 post-HSCT (prophylaxis failure). Clinically significant CMV infection was defined as the occurrence of either CMV end-organ disease, or initiation of anti-CMV pre-emptive therapy (PET) based on documented CMV viremia (using the Roche COBAS® AmpliPrep/COBAS TaqMan® assay, LLoQ is 137 IU/mL, which is approximately 150 copies/mL) and the clinical condition of the subject. The protocolspecified guidance for CMV DNA thresholds for the initiation of PET during the treatment period was ≥ 150 copies/mL or > 300 copies/mL for subjects in the high and low risk strata, respectively. From Week 14 through Week 24, the threshold was >300 copies/mL for both high and low risk strata subjects. The Non24 Reference ID: 5216323 Completer=Failure (NC=F) approach was used, where subjects who discontinued from the trial prior to Week 24 post-HSCT or had a missing outcome at Week 24 post-HSCT were counted as failures.
Efficacy was comparable across all subgroups, including the use/nonuse of highly cytolytic, antilymphocyte immunotherapy during induction. In an exploratory analysis of the incidence of CMV disease through Week 28 post-transplant, the difference (PREVYMIS – Valganciclovir) was -1.7% with 95% CI of (-3.4, 0.1). No subjects in the PREVYMIS group experienced CMV disease through Week 28 post-transplant (end of treatment period) compared with 5 subjects in the valganciclovir group (FDA, 2023).
2025 Update
Sixty-three children 2 months to less than 18 years of age who had an allogeneic HSCT were enrolled in a multicenter, open-label, single-arm pharmacokinetic, safety and effectiveness study of PREVYMIS (P030, NCT03940586). Subjects received PREVYMIS daily either orally or intravenously for CMV prophylaxis within 28 days post-HSCT through Week 14 post-HSCT. The intravenous formulation was used for up to four weeks in subjects who were unable to take oral therapy. The daily doses of PREVYMIS were based on body weight [see Dosage and Administration (2.3, 2.5)]. Among the 63 treated subjects, 8 were 2 months to less than 2 years of age, 27 were 2 to less than 12 years of age and 28 were 12 to less than 18 years of age. The median age was 11 years; 70% were male; 70% were White; 14% were Asian; 5% were Black; and 22% were Hispanic or Latino.
The efficacy analyses population consisted of 56 subjects who received at least one dose of study drug and had no detectable CMV DNA at baseline. The proportion of subjects who failed CMV prophylaxis through Week 24 post-HSCT was 25% (14 of the 56 subjects). Six subjects had initiation of pre-emptive therapy based on CMV viremia and 8 subjects discontinued from the study before Week 24. None of the subjects had CMV end-organ disease.
PREVYMIS is indicated for pediatric recipients of an allogeneic HSCT aged 6 months and older and weighing at least 6 kg (Prevymis, 2024).
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| CPT/HCPCS: | |
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| References: |
Clinical Pharmacology [Internet].(2017) Letermovir. Elsevier. c2017- [cited 2017 December 18]. Available from: http://www.clinicalpharmacology.com Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA.(2023) Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023 Jul 3;330(1):33-42. doi: 10.1001/jama.2023.9106. PMID: 37279999; PMCID: PMC10245286. Marty FM, Ljungman P, Chemaly RF, et al.(2017) Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation. N Engl J Med. 2017. Prevymis (package insert). Rahway, NJ. Merck Sharp & Dohme LLC. 2023 Prohn M, Cho CR, Viberg A, Dykstra K, Davis C, Sabato P, Stone J, Badshah C, Murata Y, Leavitt R, Fancourt C, Macha S.(2022) Exposure-Response Analyses of Letermovir Following Oral and Intravenous Administration in Allogeneic Hematopoietic Cell Transplantation Recipients. Clin Pharmacol Ther. 2022 Feb;111(2):485-495. doi: 10.1002/cpt.2456. Epub 2021 Nov 29. PMID: 34674258. Russo D, Schmitt M, Pilorge S, Stelljes M, Kawakita T, Teal VL, Haber B, Bopp C, Dadwal SS, Badshah C.(2023) Efficacy and safety of extended duration letermovir prophylaxis in recipients of haematopoietic stem-cell transplantation at risk of cytomegalovirus infection: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2023 Dec 21:S2352-3026(23)00344-7. doi: 10.1016/S2352-3026(23)00344-7. Epub ahead of print. PMID: 38142695. U.S. Food and Drug Administration (FDA).(2017) Letermovir. Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209939orig1s000,209940orig1s000lbl.pdf. Last accessed Feb. 06, 2018. |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2025 American Medical Association. |
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