HTA and HIV: The Case of Dual NRTI Backbones in the Italian Setting
Abstract
:1. Introduction
2. Materials and Methods
2.1. Literature Review
2.2. Economic and Budget Impact Analysis
- Drugs’ costs (both HAART and other drugs): these were derived from the Italian ex-factory price updated to April 2018 and officially published on the NHS price list, considering the mandatory discounts required by law, and the VAT. For 3TC/ABC and TDF/FTC, the price of the generic drug published in the Italian Gazzetta Ufficiale (GU, the Ministerial Official Document, publishing all the approved drugs and related commercial prices [23]) was considered. For the economic evaluation of the complete therapeutic strategy, data derived from the Lombardy Region Clinical Pathway (CP) valid for the 2017 [24] were taken into account.
- Non-drug costs: other medical costs for HIV+ patients management, including the total amount of hematologic, cultural and laboratory tests, diagnostic procedures, outpatient and specialistic visits, medical examinations, and hospital admissions. The clinical pathway related to the abovementioned procedures administered to patients was defined according to Delphi methods [25], involving four infectious Disease Clinicians.
- Cost of side effect management: the clinical pathway on an annual basis for patients who develop specific adverse events was evaluated (in terms of laboratory tests, diagnostic tests, additional treatment and potential hospitalizations), as already described, by means of Delphi approach [25], thanks to the support of five infectious disease clinicians. After the definition of the percentage of adverse events occurring in the reference population (identified through evidence from the analysis of the available literature on the topic) and the standard clinical pathway resources absorption, the two variables were multiplied in order to define the overall economic impact of side effect management.
2.3. Qualitative Approach
3. Results
3.1. Results from Literature Review
3.2. Results from the Economic and Budget Impact Analysis
3.3. Results from the Qualitative Approach
4. Discussion and Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Baseline Scenario (no Emtricitabine/Tenofovir Alafenamide FTC/TAF) | ||||||
First year | Second year | Third year | ||||
Naïve | Experienced | Naïve | Experienced | Naïve | Experienced | |
TAF/FTC | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
TDF/FTC | 65.00% | 65.00% | 65.00% | 65.00% | 65.00% | 65.00% |
3TC/ABC | 35.00% | 35.00% | 35.00% | 35.00% | 35.00% | 35.00% |
First Innovative Scenario (with FTC/TAF) | ||||||
First year | Second year | Third year | ||||
Naïve | Experienced | Naïve | Experienced | Naïve | Experienced | |
TAF/FTC | 52.50% | 52.50% | 66.00% | 66.00% | 77.00% | 77.00% |
TDF/FTC | 12.50% | 12.50% | 9.00% | 9.00% | 8.00% | 8.00% |
3TC/ABC | 35.00% | 35.00% | 25.00% | 25.00% | 15.00% | 15.00% |
Second Innovative Scenario (Introduction of FTC/TAF and Tenofovir Disoproxil Fumarate/Emtricitabine FTC/TDF as a Generic Drug) | ||||||
First year | Second year | Third year | ||||
Naïve | Experienced | Naïve | Experienced | Naïve | Experienced | |
TAF/FTC | 44.50% | 44.50% | 57.00% | 57.00% | 67.00% | 67.00% |
TDF/FTC | 20.50% | 20.50% | 18.00% | 18.00% | 18.00% | 18.00% |
3TC/ABC | 35.00% | 35.00% | 25.00% | 25.00% | 15.00% | 15.00% |
TAF/FTC Based | TDF/FTC Based | 3TC/ABC Based | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Overall Quality | Generalizability | Completeness | Mean | Overall Quality | Generalizability | Completeness | Mean | Overall Quality | Generalizability | Completeness | Mean | |
Mills et al., 2016 | 3.6 | 3.6 | 3.4 | 3.5 | 4.0 | 3.0 | 3.4 | 3.5 | NA | NA | NA | NA |
Gallant et al., 2016 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 3.0 | 4.0 | 3.7 | NA | NA | NA | NA |
Greig et al., 2016 | 2.6 | 2.6 | 2.4 | 2.5 | 2.8 | 2.5 | 2.5 | 2.6 | NA | NA | NA | NA |
Antela et al., 2016 | 2.8 | 2.4 | 2.4 | 2.5 | 3.0 | 2.0 | 2.3 | 2.4 | NA | NA | NA | NA |
Whol et al., 2016 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 3.4 | 4.0 | 3.8 | NA | NA | NA | NA |
Sax et al., 2015 | 4.0 | 4.0 | 3.4 | 3.8 | 4.0 | 3.6 | 3.4 | 3.7 | NA | NA | NA | NA |
De Jesus et al., 2017 | 3.6 | 3.2 | 3.2 | 3.3 | 3.6 | 3.0 | 3.2 | 3.3 | NA | NA | NA | NA |
Okin et al., 2017 | 3.8 | 3.2 | 3.2 | 3.4 | 3.8 | 3.0 | 3.2 | 3.3 | NA | NA | NA | NA |
Cruciani et al., 2014 | NA | NA | NA | NA | 3.5 | 3.3 | 3.3 | 3.3 | 4.0 | 3.2 | 3.8 | 3.7 |
Mean | 3.6 | 3.4 | 3.3 | 3.4 | 3.6 | 3.0 | 3.2 | 3.3 | 4.0 | 3.2 | 3.8 | 3.7 |
Naïve Population | Reference | Experienced Population | Reference | |
---|---|---|---|---|
TAF/FTC based | 92% | Antela et al., 2016 | 97% | Mills et al., 2016 |
TDF/FTC based | 90% | Sax et al., 2015 | 93% | Gallant et al., 2016 |
3TC/ABC based | 88% | Walmsley et al., 2013 | 93% | Sax et al., 2017 |
Treatment-Naïve Population | TAF/FTC–Based | Reference | TDF/FTC Based | Reference | 3TC/ABC Based | Reference | Economic Evaluation of the 12-Month Clinical Pathway |
Upper respiratory tract infection | 3.6% | Antela et al., 2016 | 3.1% | Antela et al., 2016 | 9% | Walmsley et al., 2013 | EUR 199.88 |
Diarrhea | 3.3% | 2.5% | 17% | EUR 168.45 | |||
Headache | 2.9% | 2.1% | 13% | EUR 20.07 | |||
Nausea | 2.2% | 2% | 14% | EUR 153.54 | |||
Treatment-experienced population | TAF/FTC based | TDF/FTC based | 3TC/ABC based | Economic evaluation of the 12-month clinical pathway | |||
Upper respiratory tract infection | 9% | Gallant et al., 2016 | 11% | Mills et al., 2016 | 7.1% | Sax et al., 2017 | EUR 199.88 |
Diarrhea | 9% | 10% | Gallant et al., 2016 | 12% | EUR 168.45 | ||
Nasopharyngitis | 8% | 6% | 9.2% | Gallant et al., 2017 | EUR 7.05 | ||
Headache | 7% | Mills et al., 2016 | 8% | Mills et al., 2016 | 12.3% | Sax et al., 2017 | EUR 20.07 |
Cough | 6% | Gallant et al., 2016 | 5% | Gallant et al., 2016 | 2.5% | Gallant et al., 2017 | EUR 10.05 |
Syphilis | 5% | Mills et al., 2016 | 5% | Mills et al., 2016 | 7.9% | EUR 117.75 | |
Insomnia | 5% | 6% | 4.3% | Sax et al., 2017 | EUR 277.30 | ||
Arthralgia | 6% | Gallant et al., 2016 | 3% | Gallant et al., 2016 | 2.8% | EUR 148,71 | |
Bronchitis | 6% | Mills et al., 2016 | 5% | Mills et al., 2016 | 5.1% | Gallant et al., 2017 | EUR 447.97 |
Depression | 4% | 5% | Not applicable | EUR 1002.10 | |||
Osteopenia | 6% | 6% | Not applicable | EUR 666.26 | |||
Backache | 6% | Gallant et al., 2016 | 5% | Gallant et al., 2016 | 6.2% | Sax et al., 2017 | EUR 527.90 |
Nausea | 5% | Mills et al., 2016 | 3% | Mills et al., 2016 | 22.9% | Gallant et al., 2017 | EUR 153.54 |
Sinusitis | 4% | Gallant et al., 2016 | 5% | Not applicable | EUR 16.50 | ||
Fatigue | 5% | 4% | Gallant et al., 2016 | 8.6% | Gallant et al., 2017 | EUR 22.50 | |
Vomit | 7% | Sax et al., 2015 | 6% | Sax et al., 2015 | 5.4% | EUR 52.74 | |
Rash | 6% | 5% | Not applicable | EUR 320.65 | |||
Pyrexia | 5% | 5% | 6.5% | Sax et al., 2017 | EUR 232.97 | ||
Dizziness | 5% | 4% | Not applicable | EUR 113.31 |
Regimen | Virologic Control | Clinical History | Highly Active Antiretroviral Therapies HAART | Clinical Pathway | Adverse Events | Total |
---|---|---|---|---|---|---|
TAF-/FTC-based regimen | Patient with VL ≤50 copies/mL | Treatment naïve | EUR 8320.37 | EUR 591.05 | EUR 16.71 | EUR 8928.13 |
Treatment experienced | EUR 8320.37 | EUR 1994.19 | EUR 252.72 | EUR 10,567.28 | ||
Patient with VL >50 copies/mL | Treatment naïve | EUR 8320.37 | EUR 768.18 | EUR 16.71 | EUR 9105.26 | |
Treatment experienced | EUR 8320.37 | EUR 2200.50 | EUR 252.72 | EUR 10,773.59 | ||
TDF-/FTC-based regimen | Patient with VL ≤50 copies/mL | Treatment naïve | EUR 8926.49 * | EUR 1623.43 | EUR 13.90 | EUR 10,563.82 |
Treatment experienced | EUR 8926.49 * | EUR 2025.16 | EUR 248.93 | EUR 11,200.58 | ||
Patient with VL ≤50 copies/mL | Treatment naïve | EUR 8926.49 * | EUR 1800.56 | EUR 13.90 | EUR 10,740.95 | |
Treatment experienced | EUR 8926.49 * | EUR 2231.47 | EUR 248.93 | EUR 11,406.89 | ||
3TC-/ABC-based regimen | Patient with VL ≤50 copies/mL | Treatment naïve | EUR 5887.65 | EUR 2017.71 | EUR 70.73 | EUR 7976.09 |
Treatment experienced | EUR 5887.65 | EUR 2121.30 | EUR 173.83 | EUR 8182.78 | ||
Patient with VL >50 copies/mL | Treatment naïve | EUR 5887.65 | EUR 2207.93 | EUR 70.73 | EUR 8166.31 | |
Treatment experienced | EUR 5887.65 | EUR 2117.64 | EUR 173.83 | EUR 8179.12 |
Baseline Scenario (no FTC/TAF) | TAF/FTC | TDF/FTC | 3TC/ABC | TOT | |
First year | - | 56,195 | 30,259 | 86,454 | |
Second year | - | 56,515 | 30,431 | 86,946 | |
Third year | - | 56,837 | 30,604 | 87,441 | |
Total | 169,547 | 91,294 | 260,841 | ||
First Innovative Scenario (with FTC/TAF) | TAF/FTC | TDF/FTC | 3TC/ABC | TOT | |
First year | 45,388 | 10,807 | 30,259 | 86,454 | |
Second year | 57,384 | 7825 | 21,737 | 86,946 | |
Third year | 67,330 | 6995 | 13,116 | 87,441 | |
Total | 170,102 | 25,627 | 65,112 | 260,841 | |
Second Innovative Scenario (Introduction OF FTC/TAF and FTC/TDF Generic Drug) | TAF/FTC | TDF/FTC | 3TC/ABC | TOT | |
First year | 38,472 | 17,723 | 30,259 | 86,454 | |
Second year | 49,559 | 15,650 | 21,737 | 86,946 | |
Third year | 58,585 | 15,739 | 13,116 | 87,441 | |
Total | 146,616 | 49,112 | 65,112 | 260,841 |
Baseline Scenario (no FTC/TAF) | TAF/FTC | TDF/FTC | 3TC/ABC | TOT | |
First year | Not applicable | EUR 615,584,762 | EUR 245,310,865 | EUR 860,895,626 | |
Second year | Not applicable | EUR 619,087,985 | EUR 246,706,901 | EUR 865,794,887 | |
Third year | Not applicable | EUR 622,612,570 | EUR 248,111,450 | EUR 870,724,020 | |
Total | Not applicable | EUR 1,857,285,317 | EUR 740,129,216 | EUR 2,597,414,533 | |
First Innovative Scenario (with FTC/TAF) | TAF/FTC | TDF/FTC | 3TC/ABC | TOT | |
First year | EUR 449,455,540 | EUR 118,381,685 | EUR 245,310,865 | EUR 813,148,090 | |
Second year | EUR 568,245,343 | EUR 85,719,875 | EUR 176,219,215 | EUR 830,184,433 | |
Third year | EUR 666,727,217 | EUR 76,629,239 | EUR 106,333,479 | EUR 849,689,935 | |
Total | EUR 1,684,428,100 | EUR 280,730,799 | EUR 527,863,559 | EUR 2,493,022,458 | |
Second Innovative Scenario (Introduction OF FTC/TAF and FTC/TDF Generic Drug) | TAF/FTC | TDF/FTC | 3TC/ABC | TOT | |
First year | EUR 380,967,077 | EUR 141,929,368 | EUR 245,310,865 | EUR 768,207,310 | |
Second year | EUR 490,757,342 | EUR 125,330,112 | EUR 176,219,215 | EUR 792,306,669 | |
Third year | EUR 580,139,266 | EUR 126,043,640 | EUR 106,333,479 | EUR 812,516,385 | |
Total | EUR 1,451,863,685 | EUR 393,303,121 | EUR 527,863,559 | EUR 2,373,030,365 | |
Baseline Scenario vs. First Innovative Scenario | Not applicable | EUR −1,576,554,518 (−84.88%) * | EUR −212,265,658 (−28.68%) * | EUR −104,392,076 (−4.02%) * | |
Baseline Scenario vs. Second Innovative Scenario | Not applicable | EUR −1,463,982,196 (−78.82%) * | EUR −212,265,658 (−28.68%) | EUR −224,384,169 (−8.64%) | |
First Innovative Scenario vs. Second Innovative Scenario | EUR −232,564,415 (−13.81%) * | EUR 112,572,322 (+40.10%) * | EUR 0 (0.00%) * | EUR −119,992,093 (−4.81%) * |
Equity Aspects | TAF/FTC | TDF/FTC | 3TC/ABC | p-Value |
Access to care on local level | 1.96 | 1.52 | 1.85 | 0.443 |
Access to care for an individual with a legally protected status | 1.6 | 1.45 | 1.6 | 0.923 |
Impact of HAART on the hospital waiting list | 0.62 | 0.42 | 0.58 | 0.851 |
Impact of HAART on the access to care related to the management of mild and moderate adverse events (nausea, dizziness, headache or diarrhea) | 0.81 | 0.38 | 0.23 | 0.148 |
Impact of HAART on the access to care related to the management of kidney problems | 1.46 | −1.15 | 0.69 | 0.000 |
Impact of HAART on the access to care related to the management of bone problems | 1.37 | −1.37 | 0.56 | 0.000 |
Impact of HAART on the access to care related to the management of cardiac problems | 0.48 | 0.81 | −0.48 | 0.001 |
Impact of HAART on the access to care related to the management of liver problems | 0.7 | 0.04 | −0.19 | 0.005 |
Impact of HAART on the access to care related to the management of long-term acute myocardial infarction development | 1 | 0.81 | −1.3 | 0.000 |
Impact of HAART on the access to care related to the management of long-term bone disease development | 1.19 | −1.19 | 0.41 | 0.000 |
Generation of health migration phenomena | 0.77 | −0.15 | 0.12 | 0.207 |
Existence of limiting factors in the use of HAART | 0.22 | −0.22 | −0.33 | 0.196 |
HAART inequity | 0.19 | −0.04 | −0.04 | 0.296 |
Average Value | 0.95 | 0.10 | 0.28 | 0.016 |
Social and ethical aspects | TAF/FTC | TDF/FTC | 3TC/ABC | p-value |
Ability of HAART to protect the patient’s autonomy | 1.6 | 0.48 | 0.68 | 0.008 |
Ability of HAART to protect human rights | 0.85 | 0.69 | 0.69 | 0.882 |
Ability of HAART to protect human integrity | 0.96 | 0.62 | 0.62 | 0.506 |
Ability of HAART to protect the patient’s dignity | 0.92 | 0.73 | 0.73 | 0.807 |
Ability of HAART to protect the patient’s religion | 0.23 | 0.23 | 0.23 | 1.000 |
The use of HAART guarantees the willingness to pay of the patients | 0.35 | 0.04 | 0.04 | 0.499 |
Impact of HAART on social costs | 1.04 | −0.23 | 0.23 | 0.000 |
Patients and citizens can have a good level of understanding of HAART | 0.65 | 0.54 | 0.42 | 0.701 |
Impact of HAART on the easiness to be prescribed | 1.15 | 0.38 | 0.38 | 0.035 |
Impact of HAART on the safety and the tolerability profile | 1.69 | −0.5 | −0.04 | 0.000 |
Impact of HAART on the patient’s perceived quality of life | 1.85 | 0.31 | 0.38 | 0.000 |
Impact of HAART on the caregiver’s life and perception. | 1.15 | 0.5 | 0.62 | 0.062 |
Impact of HAART on the trusting relationship with the clinician | 1.5 | 0.62 | 0.77 | 0.023 |
Impact of HAART on the patient’s satisfaction | 1.68 | 0.48 | 0.68 | 0.000 |
Impact of HAART on the development of long-term adverse events and toxicity | 1.58 | −1.12 | −0.62 | 0.000 |
Ethical impact of HAART insertion in the drug handbook | 0.85 | −0.05 | 0.5 | 0.029 |
Average Value | 1.13 | 0.23 | 0.4 | 0.000 |
Legal aspects | TAF/FTC | TDF/FTC | 3TC/ABC | p-value |
Need for HAART inclusion in the national or European registry | 1.05 | 0.45 | 0.5 | 0.352 |
Need for HAART inclusion in national guidelines | 1.7 | 1.2 | 1.3 | 0.408 |
Need for HAART inclusion in national clinical pathway | 1 | 0.75 | 0.75 | 0.823 |
Legal problems related to the administration of HAART with a low safety and tolerability profile | 1.05 | −0.05 | 0.2 | 0.026 |
Need to regulate the acquisition of HAART | 0.85 | 0.6 | 0.65 | 0.770 |
The legislation covers the regulation of HAART for all categories of patients | 1.1 | 0.95 | 1 | 0.926 |
Average Value | 1.13 | 0.65 | 0.73 | 0.096 |
Organizational aspects | TAF/FTC | TDF/FTC | 3TC/ABC | p-value |
Additional staff | 0.44 | −0.11 | 0.17 | 0.257 |
Training course for the clinicians | 0.5 | 0.39 | 0.33 | 0.931 |
Training course for healthcare professionals involved in the HAART distribution (nurses) | 0.00 | 0.06 | 0.06 | 0.958 |
Training course for healthcare professionals involved in the HAART distribution (pharmacists) | 0.39 | 0.22 | 0.22 | 0.846 |
Training course for other healthcare professionals involved in HAART administration | 0.28 | 0.06 | 0.06 | 0.602 |
Patient and caregiver training | 0.44 | −0.06 | −0.11 | 0.041 |
Hospital meetings required | 0.5 | 0.17 | 0.22 | 0.653 |
Additional room space | −0.06 | −0.06 | −0.06 | 1.000 |
Additional furniture | 0.06 | 0.00 | 0.00 | 0.375 |
Additional equipment | 0.22 | −0.11 | −0.11 | 0.078 |
Impact of HAART on the internal processes | 0.67 | 0.06 | 0.22 | 0.159 |
Impact of HAART on the purchasing processes | 0.39 | 0.22 | 0.22 | 0.851 |
Impact of HAART on the hospital processes | 0.17 | −0.11 | 0.00 | 0.293 |
Impact of HAART on the access for monitoring visits and blood exams | 1.61 | −0.67 | −0.11 | 0.000 |
Impact of HAART on the access for adverse events | 1.11 | −0.56 | −0.06 | 0.000 |
Impact of HAART on the organizational management of adverse events | 1 | −0.56 | −0.17 | 0.000 |
Impact of HAART on the organizational management of toxicity | 0.83 | −0.11 | −0.17 | 0.007 |
Impact of HAART on the patient’s clinical pathway, in terms of management of kidney problems | 1.28 | −0.94 | 0.11 | 0.000 |
Impact of HAART on the patient’s clinical pathway, in terms of management of bone problems | 1.39 | −1.11 | 0.22 | 0.000 |
Impact of HAART on the patient’s clinical pathway, in terms of management of cardiac problems | 0.83 | 0.56 | −0.94 | 0.000 |
Average Value | 0.634 | −0.140 | 0.006 | 0.000 |
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Garagiola, E.; Foglia, E.; Ferrario, L.; Cenderello, G.; Di Biagio, A.; Menzaghi, B.; Rizzardini, G.; Croce, D. HTA and HIV: The Case of Dual NRTI Backbones in the Italian Setting. Int. J. Environ. Res. Public Health 2020, 17, 9010. https://doi.org/10.3390/ijerph17239010
Garagiola E, Foglia E, Ferrario L, Cenderello G, Di Biagio A, Menzaghi B, Rizzardini G, Croce D. HTA and HIV: The Case of Dual NRTI Backbones in the Italian Setting. International Journal of Environmental Research and Public Health. 2020; 17(23):9010. https://doi.org/10.3390/ijerph17239010
Chicago/Turabian StyleGaragiola, Elisabetta, Emanuela Foglia, Lucrezia Ferrario, Giovanni Cenderello, Antonio Di Biagio, Barbara Menzaghi, Giuliano Rizzardini, and Davide Croce. 2020. "HTA and HIV: The Case of Dual NRTI Backbones in the Italian Setting" International Journal of Environmental Research and Public Health 17, no. 23: 9010. https://doi.org/10.3390/ijerph17239010