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| == Keskustelua vertailuperusteista == | | == Vertailuperusteissa käytettävät terveysvasteet == |
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| '''Kommentti K3
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| | | Väittämät = Näitä terveysvasteita tai kriteerejä pitäisi käyttää rokotteiden vertailussa: |
| | # Rokotteen hinta |
| | # Invasiivinen pneumokokkitauti (IPD) |
| | # Välikorvantulehdus |
| | # Keuhkokuume |
| | # Ylähengitystieinfektiot (muut kuin välikorvantulehdus) |
| | # Hoitokustannukset |
| | # Hemofilus influenzaen aiheuttamat infektiot |
| | # Tekniset kriteerit kuten palvelut, managerointi ja merkinnät. |
| | | Ratkaisu = Kriteerit tai vasteet, jotka tulisi ottaa vertailuperusteiksi, ovat a) hinta, b) invasiivinen pneumokokkitauti (IPD) ja c) tekniset kriteerit. Jos olisi riittävästi luotettavaa aineistoa, myös keuhkokuume ja ylähengitystievasteet pitäisi ottaa kriteereiksi. |
| | | Argumentaatio = |
| | {{defend|# |Katso yksityiskohtainen keskustelu sivulta [[:op_en:Talk:Comparison criteria#Health endpoints to consider|Talk:Comparison criteria]].|--[[Käyttäjä:Jouni|Jouni Tuomisto]] ([[Keskustelu käyttäjästä:Jouni|keskustelu]]) 8. syyskuuta 2014 kello 08.48 (UTC)}} |
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| 1. PCV tender criteria from other Nordic countries show that quality is valued and given greater weight than price also where the winning vaccine is considered the “economic most advantageous”. Quality points should be given to several dimensions, not just for number of serotypes in the vaccine; see examples: Norway (2011) Quality 50-70%, price 20-40%, service after delivery 5% “The offer that achieves the highest point score after adding up the calculated points for each of the weighted criteria for assignment will be considered as the financially most favorable offer.”
| | == Keskustelua vertailuperusteista == |
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| Criteria: Requirement: It must be possible to store the vaccine at 25°C for at least 48 hours, without altering the vaccine properties. Documentation: stability studies The expected number of preventable cases of systemic pneumococcal disease. The efficacy of the vaccine against systemic pneumococcal disease caused by the different serotypes in the vaccine will be of significance. Other relevant conditions, including clinical documentation on the efficacy against otitis caused by S.pneumoniae. The best possible safety profile in this particular population. The offered vaccine may be part of a vaccination program where both available pneumococcal vaccines can be used. The prevalence in Norway of the individual disease-developing serotypes will be considered. The efficacy and risk/benefit assessment of the vaccines will be assessed on a rough estimate based on the presented documentation. Documentation assessed by competent authorities in the EEA-union will be of particular importance. Price pr. dose size is given as one price, which is applicable independently of the delivered dose, i.e. if it is delivered as one dose pack or as 10-dose packs. Service after delivery (5%) Service availability and technical assistance will be emphasized Denmark (2014) Quality 75%, price 25% “The framework contract will be awarded on the basis of the award criterion the economic most advantageous tender .
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| Criteria: The effectiveness is assessed on the basis of the vaccine's coverage of invasive pneumococcal diseases in children < 2 years (35%) and the product's direct and indirect coverage of invasive pneumococcal diseases in the rest of the population (25%) in Denmark in 2009 based on the applicable SPC (Summary of Product Characteristics). The tenderer must complete a form concerning the indication of effectiveness of pneumococcal serotypes contained in the vaccine on the basis of the applicable SPC. Type and frequency of adverse effects (10%): assessed on the basis of the applicable SPC. As few and least invasive adverse effects as possible are desired. The active ingredients/trace elements of the products (5%): it is assessed whether the product is manufactured by or includes materials or trace elements of animal or human origin or other ingredients that may potentially pose a risk to the child/patient. The assessment is made on the basis of an applicable SPC, a completed form relating to active ingredients/trace elements enclosed with the tender documents as well as any statement as to no active ingredients and other relevant material, as described in section 10.4. As few active ingredients and trace elements that may potentially pose a risk to the child/the patients as possible are desired. The price will be assessed on the basis of the average price for the period 2014-2017. The lowest price possible is desired. Sweden , Stockholm (2015) Quality emphasized. If the tender gets 100 points for quality, the price will be multiplied by 1. If, for example, the tender gets 50 quality points, the price will be multiplied by 1,50.
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| Criteria: Clinical efficacy, safety (max 90 points): Range of serotype protection, documentation on efficacy and effectiveness, documentation on risk groups, documentation on antibody response, side effect profile, excipients and preservatives. Very good safety profile, good clinical efficacy, optimal protection in terms of serotype coverage, documentation on risk groups: 90 points: Very good safety profile, good clinical efficacy but not optimal protection in terms of serotype coverage, no documentation on risk groups: 20 points Line width, practical management, labelling (max 10 points) Size, needles, design (risk of mix up), clear labelling and presence of bar code, storage conditions, handling in general Sweden, VGR Quality 70%, price 30%
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| Criteria: Clinical efficacy (max 60 p): Number of serotypes, clinical efficacy on individual level, proven herd immunity, approved indications. Based on RCT and/or other studies, official authority statements Very Good:48-60 points Good: 34-47 points Acceptable: 20-33 points Less good: 10-19 points Poor or not gradable: 0-9 points: Clinical safety (max 60 p): Side effect profile in SmPC/WHO, RCT and/or other studies, official authority statements. Aluminum content. Very good: 48-60 points Good: 34-47 points Acceptable: 20-33 points Less good: 10-19 points Poor or not gradable: 0-9 points Product range (max 10 p) Will be evaluated if relevant, otherwise maximum points will be awarded. Package size: 0-5 points Dosing schedule: 0-5 points Practical management (max 30 p) Will be evaluated if relevant, otherwise maximum points will be awarded Storage conditions (e.g. light sensitive, storage in cold, durability):0-10 points Formulation aspects (e.g. dry matter/vial/pre-filled syringe, preparation instructions): 0-5 points Product itself (e.g. manageability at the preparation and administration, packaging design): 0-15 points Marking and labelling (max 20 p) The bidder shall submit Mock-ups on the outer packaging and images on the inner packaging to the bid, and blister on all offered products. If need of pharmaceutical samples, the company will be contacted. Barcode (outer and inner packaging): 0-10 points Labelling (outer and inner packaging, readability on the syringe label, removable label): 0-10 points
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| '''Kommentti K4
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| It is appreciable Opasnet is a source of transparency. As JCVI and ACIP do, is it planned to inform the general public by publishing regularly the evaluation and decision processes, including analysis and results, at Opasnet or somewhere else?
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| ''' Kommentti K5
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| Vaccine efficacy on non-typeable Haemophilus influenzae cannot be taken into account as comparison criterion because neither of the vaccines have prevention of NTHi in their indication. Moreover, for both vaccines the Summary of Product Characteristics (SmPC) approved by European Medicines Agency states in section 4.4., Special warnings and precautions, that the vaccines do not provide protection against other bacteria: Synflorix: There is insufficient evidence that Synflorix provides protection against pneumococcal serotypes not contained in the vaccine or against non-typeable Haemophilus influenzae. Synflorix does not provide protection against other micro-organism Prevenar 13: Prevenar13 will only protect against Streptococcus pneumonia serotypes included in the vaccine, and will not protect against other microorganism that cause invasive disease, pneumonia or otitis media. Based on the same sentences in SmPCs of the vaccines, the vaccines do not provide protection against other serotypes than those contained in the vaccines. Therefore, adjustability of the serotype composition in the economic assessment (http://en.opasnet.org/w/Economical_assessment ) is purposeless and the user defined option should be removed.
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| '''Kommentti K6 | | :''Tämän sivun kommentointikenttään jätetyt Pfizer Oy:n kommentit elokuun 27:nneltä päivältä on siirretty sivulle [[:op_en:Talk:Comparison criteria]], koska aiheen keskustelu käydään englanniksi. Alkuperäisessä muodossaan kommentit löytyvät tästä [http://en.opasnet.org/en-opwiki/index.php?title=Talk:Comparison_criteria&oldid=33554 arkistoversiosta]. |
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| According to the information on THL’s webpage, the duration of FinIP, Finnish Invasive Pneumococcal Disease Vaccine trial, is until the end of 2018. Would FinIP follow-up impact the tender? Ref. Lääkärilehti 22.8.2014, page 2017 Budjettileikkuri iskee rokotuksiin.
| | Sivulla [[op_en:Talk:Comparison_criteria]] on myös muuta vertailukriteereitä koskevaa keskustelua. |