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· Please find an article about drug named: loncastuximab tesirine-Ipyl, or Selinexor (Xpovio) or Polatuzumab vedotin-piiq (Polivy), which Selinexor (Xpovio) and Polatuzumab vedotin-piiq (Polivy) are alternatives for loncastuximab tesirine-Ipyl.
· The notes that I have highlighted in yellow are the instructions on how to find an article.
· Also below in red font you can see an example on how to do the assignment. Thank you
Sources: FDA approved label, Micromedex Redbook (AWP and WAC), CMS (NADAC and ASP), VA (FSS).
Micromedex REDBOOK
Submit the key economic studies that have been conducted, whether published or not. Studies reported in this section should be summarized in a clear, concise format; presenting the data from in a table. All of the following should be included:
These 2 examples below:
1. Budget Impact Model of Loncastuximab Tesirine-lpyl in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma
a. Perspective
i. To estimate the potential budget impact of adding loncastuximab tesirine-lpyl to a drug formulary for the treatment of adult patients with R/R DLBCL who had received ≥2 prior lines of therapy from a US commercial health plan perspective
b. Alternatives
i. selinexor, polatuzumab vedotin-piiq+bendamustine+rituximab, tafasitamab-cxix+lenalidomide
c. Costs
i. In a hypothetical plan of 1 million members, the BIM estimated each year a total of 13 adult patients with R/R DLBCL who had received ≥2 prior lines of therapy.
ii. Total annual costs of care over the course of treatment of newly approved pharmacological treatments were estimated at $63,372, $171,018, $308,534, and $107,812 for selinexor, polatuzumab vedotin- piiq+bendamustine+rituximab, tafasitamab-cxix+lenalidomide, and loncastuximab tesirine-lpyl respectively.
d. Health outcomes
i. In a plan of one million members, adding loncastuximabtesirine-lpyl to the drug formulary for the treatment of adult patients with R/R DLBCL who had received at least 2 prior lines of therapy was predicted to be cost saving in the 3 years after loncastuximab tesirine-lpyl’s entry.
e. Type of analysis
i. Budget Impact Model
f. Main Results
i. Over the 3-year time horizon, the largest cost savings were predicted in drug costs($52,354 to $110,206) followed by other costs ($7,267 to $13,818) and adverse event costs ($4,414 to $9,450).
ii. In the sensitivity analyses, the results were robust with predicted cost savings in nearly all scenarios (budget impact ranged -$0.0186 to $0.0029 PMPM) and were most sensitive to loncastuximab tesirine-lpyl treatment duration and least sensitive to loncastuximab tesirine-lpyl adverse event costs.
g. Assumptions and limitations
i. Assumptions
1. All adult patients with R/R DLBCL who had received ≥2 prior lines of therapy were eligible for loncastuximab tesirine-lpyl, and the number of eligible patients was stable over 3 years.
2. The introduction of loncastuximab tesirine-lpyl would replace market share3 of existing pharmacological treatments for R/R DLBCL, mostly the targeted therapies; no impact on the market share of CAR-T therapies was assumed.
3. Costs associated with grade 3 or 4 adverse events ≥5% in any treatment and hypogammaglobulinaemia of any grade (i.e., B-cell aplasia) were considered in the model.
4. CAR-T specific costs included those for leukapheresis, bridging chemotherapy, lymphocyte depleting chemotherapy, and administration-related healthcare resource use (intensive care unit [ICU] costs due to cytokine release syndrome [CRS], ICU costs not due to CRS, and other inpatient or outpatient costs that were not attributable to adverse events).
ii. Limitations
1. The proportions of patients with R/R DLBCL who received 2 and ≥3 lines of therapywere obtained from a physician survey in the Kantar Health report. Future studies (e.g., a population-based study) are needed to provide more robust epidemiology inputs.
2. Market share data of loncastuximab tesirine-lpyl and other treatments were based on forecasts and assumptions prior to the launch of loncastuximab tesirine-lpyl.
3. The model assumed loncastuximab tesirine-lpyl would not impact the market share of CAR-T, which remained constant across all 3 years. This assumption needs to be confirmed with actual market shares observed after the launch of loncastuximab tesirine-lpyl.
4. Median treatment durations and adverse event rates in clinical trials were used to estimate treatment costs, and these data may be different from real-world clinical practice.
5. Participants in clinical trials are likely to have received closer management and had better adherence to therapies than patients who are treated in real-world settings.
6. The administration-related healthcare resource utilization inputs for CAR-T therapy (such as the number of ICU days due to CRS, the number of ICU days not due to CRS, and the number of other inpatient days) were obtained from the clinical trials or assumptions, which may be different from real-world clinical practice. However, as loncastuximab tesirine-lpyl entry was assumed not to impact CAR-T market share, these inputs would not affect the budget impact of loncastuximab tesirine-lpyl.
7.
h. Publication citation(s)/references used
2. US Budget Impact Model for Selinexor in Relapsed or Refractory Multiple Myeloma
a. Perspective: To estimate the budgetary impact of adopting selinexor (XPOVIO; Karyopharm Therapeutics, Inc.) for the treatment of adult patients with penta-refractory multiple myeloma (MM) from the perspective of a third-party payer in the United States (US).
b. Alternatives: lenalidomide-, bortezomib-, carfilzomib-, and pomalidomide-based regimens in patients with RRMM in the third-line of therapy
c. Costs:
i. Total drug cost over the course of selinexor treatment: $44,079.30 per patient
ii. Treatment of severe TEAEs (ie, grade 3 or higher occurring in ≥5% of selinexor-treated patients) was estimated to cost $2,746.36 per patient over the course of treatment
iii. The estimated annual cost of best supportive care was $6,893 per patient
iv. Total annual cost of selinexor treatment per patient (ie, the sum of drug costs, TEAE treatment costs, along with continuous best supportive care costs) is calculated to be $53,718.73
v. The estimated PPPM cost with access to selinexor was $4,476.56
d. Health outcomes
i. Management of symptoms and improvement of quality of life
ii. 5 year survival rate
e. Type of analysis
i. Base-case analysis
ii. Scenario analysis
f. Main Results
i. In the base-case analysis, selinexor was associated with a per member per month (PMPM) cost of $0.0103 in year 3, assuming a market uptake of 64%, for a hypothetical private payer plan with one million members and four eligible patients.
ii. In a scenario analysis with 16 eligible patients with triple-class refractory MM regardless of the line of therapy, the estimated PMPM cost in year 3 was $0.0388. The model showed comparable sensitivity to treatment duration, wholesale acquisition cost for selinexor, and year 1 uptake.
iii. The base-case analysis conducted from the perspective of Medicare Part D was associated with a PMPM cost of $0.0078 in year 3 with 159 eligible patients.
g. Assumptions and limitations
i. This model examined direct costs associated with selinexor use (ie, drug price and TEAE management), as well as variations in market uptake, drug price, and treatment duration. There were no assumed cost offsets associated with selinexor treatment or a reduction in the cost of best supportive care.
ii. The model did not consider factors such as clinical response, mortality, and secondary clinical endpoints. Costs associated with an increase in patient life span were also not included.
iii. Selinexor is currently the only approved therapy for adult patients with penta-refractory MM in the US. There are no reasonable alternative treatment exists for patients with penta-refractory MM, costs of selinexor treatment could only be compared to best supportive treatment costs alone.
h. Publication citation(s)/references used
i. Bassali J, Gould IG, Kaye JA, Mladsi D, Mehta J. US Budget Impact Model for Selinexor in Relapsed or Refractory Multiple Myeloma. Clinicoecon Outcomes Res. 2020 Jun 19;12:317-325. doi: 10.2147/CEOR.S251070. PMID: 32606848; PMCID: PMC7310980.
3.
a. Perspective
b. Alternatives
c. Costs
d. Health outcomes
e. Type of analysis
f. Main Results
g. Assumptions and limitations
h. Publication citation(s)/references used
1. (link: https://academic.oup.com/ajhp/article/78/17/1541/6300043 )
3. Micromedex REDBOOK