Information on the tendering process for HPV Vaccine

Information on the tendering process for HPV Vaccine The award criteria for the evaluation of the contract to supply HPV vaccine were as follows: Criteria Quality of protection against cervical cancers caused by HPV strains 16/18 Duration of protection against cervical cancers caused by HPV strains 16/18 for more than 10 years duration Quality of protection against anogenital warts caused by HPV Strains 6/11 Duration of protection against anogenital warts caused by HPV Strains 6/11 for more than 10 years duration Quality of protection against HPV strains not included in the vaccine formulation Other evidence of additional clinical benefits Effective Price per dose excluding VAT Supply of the vaccine as single pre-filled syringe pack presentation Quality of labelling, leaflets and presentation Shelf life Flexibility in the vaccine dosage schedule Offers that reduce the risk of wastage if the vaccine is subject to temperatures above 8°C (this include the provision of temperature indicators and evidence based guidance on the stability of the vaccines at higher storage temperatures and subsequent safe administration.) Closeness of proposed delivery schedule to Authority requirements Pallet configuration including a preference for the use of Euro pallets Impact of proposed amendments to the terms and conditions Quality / Robustness of manufacturing contingency arrangements Quality / Robustness of the risk Management of storage and distribution Information provided relating to pack sizes, Cold Chain Delivery, Batch Numbering systems and production capacity Points Max of 5000 Max of 3000 Max of 1300 Max of 500 Max of 1000 Max of 500 Commercially confidential Max of 10 Max of 5 Max of 120 Max of 70 Max of 200 Max of 200 Max of 5 (-500). Offerors may lose up to 500 points Max of 10 Max of 10 Max of 5 Information on the tendering process for HPV Vaccine 1 of 5 The Specification set out in the procurement documents for the Human Papillomavirus vaccine identified the following categories of requirements: • Requirements described as “mandatory” are compulsory requirements. Offerors must confirm in their offer that they are able to fully meet all mandatory requirements in order for such offer to be a fully compliant offer. Offers which do not meet all mandatory requirements may be rejected by the Agency. • Requirements described as “non-mandatory” are desirable, but not compulsory requirements. The Offeror’s ability to meet the non-mandatory requirements will form part of the evaluation of the offer, but non-compliance with the non-mandatory requirements will not, of itself, render that offer non-compliant. • Requirements described as “information” are requests for information or documentation. The quality and/or content of such information or documentation will form part of the evaluation of the offer. The required information must be included in an offer in order for that offer to be a fully complaint offer. The detailed requirements were: 1.1.0 – Product 1.1.1 Human Papillomavirus Vaccine supplied as a suspension for injection in a pre-filled syringe. 1.1.2 The vaccine must be licensed for use in the UK to protect against HPV strains 16 and 18. 1.1.3 The vaccine must be indicated for the prevention of highgrade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to Human Papillomavirus types 16 and 18. 1.1.4 The vaccine must be licensed for administration to girls aged 12 and older via a maximum of three doses. 1.1.5 In addition to the protection against HPV strains 16 and 18 the Authority will consider other aspects of product efficacy, to include • Additional Licensed Indications • Cross protection against Human Papillomavirus Strains other than those types covered in the licensed indications from pre and post licensing clinical trials • Duration of protection for all licensed indications • Management of storage temperature excursions as supported by accelerated stability studies 1.1.6 Offerors are required to provide supporting information as part of their submission. 1.1.7 Offerors are requested to provide information in relation to variations to the dosage schedules for their vaccine. 1.2.0 – Presentation 1.2.1 The vaccine must be supplied as a pre-filled syringe with needle for administration. 1.2.2 The Authority has a preference for a single syringe pack presentation to reduce the potential for wastage during the Immunisation Programme. 1.2.3 Offerors must provide details of the pack sizes available. Information on the tendering process for HPV Vaccine Mandatory requirement Mandatory requirement Mandatory requirement Mandatory requirement Non Mandatory requirement Information requirement Information requirement Mandatory requirement Non-mandatory requirement Information requirement 2 of 5 1.3.0 – Shelf Life 1.3.1 The licensed shelf life of the vaccine shall be at least 3 years Shelf life of the product supplied should be equal to the maximum shelf life less the time used for release and shipment of the product to the Authority and shall be no less than 2 years. 1.3.3. Offerors must provide details of the anticipated shelf life of the vaccine to be supplied to the Authority. This must be supported by information on the production and final product release timelines, including the maximum time required for external quality assessment by the OMCL if the expiry date of a vaccine batch is determined before this production stage in the vaccine Marketing Authorisation. 1.4.0 – Temperature Indicators 1.4.1 The Authority has a preference for the inclusion in the vaccine packaging of a temperature indicator which would indicate if the vaccine had been exposed to a temperature above or below the storage requirements specified in the Marketing Authorisation. The purpose of this request is to reduce wastage where there has been a transient increase or reduction in temperature in storage and the supply as measured by the surrounding air temperature and the product temperature may have remained within the approved temperature range. 1.4.2 This response should include, but is not limited to, information on the availability of such temperature indicators and the feasibility of providing these with the vaccine doses supplied during the life of this Agreement. 1.5.0 – Cold Chain Delivery Requirements 1.5.1 Offerors are requested to provide details of the method of distribution and temperature control systems that will be employed, including the records that will be provided to the Authority. 1.6.0 1.6.1 Batch Numbering System Offerors are requested to provide details of the structure of their batch numbering system for the vaccine. This information is being requested to allow the Authority to incorporate an error checking system for the recording of batch numbering into the Child Health Monitoring computer systems. 1.3.2 Mandatory requirement Mandatory requirement Information requirement Non-mandatory requirement Information requirement Information requirement Information requirement Information on the tendering process for HPV Vaccine 3 of 5 2.1.0 – Delivery Schedule 2.1.1 Offerors must be able to deliver 820,000 doses during August and September 2008. The delivery profile for this requirement must comprise of no less than 50,000 doses delivered by 1 August 2008, 200,000 doses delivered by 15 August 2008, 115,000 doses delivered by 22 August, 255,000 doses delivered by the 5 September 2008 and 200,000 doses delivered by 19 September 2008. Offerors should note that no deliveries can be made before 1 July 2008. Offerors may vary the requirements laid out in 2.1.1 above, but only in so far that the Authority receives the quantities required before all of the dates stated in 2.1.1, though not prior to 1 July 2008. 2.1.2 Offerors should include a proposed delivery schedule detailing how they would deliver the consignments necessary to complete the delivery of the first 820,000 doses to the Authority’s nominated distributor. Offerors should note that no deliveries can be made before 1 July 2008. 2.1.3 Offerors must be able to deliver the total number of doses of vaccine as identified in the delivery requirements. 2.1.4 Offerors must be able to deliver the ‘in year’ totals that is 1,620,000 doses delivered in year 1 of the contract, 3,900,000 doses delivered in year 2 of the contract and 2,025,300 doses delivered in year 3 of the contract. 2.1.5 For all deliveries after the first 820,000 doses, in addition to 2.1.1, 2.1.3 and 2.1.4, offerors must ensure the programme stock levels are maintained and therefore the proposed schedule is mandatory in that the Authority must receive the quantities required before all of the dates stated. 2.1.6 Taking account of the mandatory requirements laid out in 2.1.1, 2.1.3, 2.1.4 and 2.1.5, Offerors are encouraged to deliver in accordance with the delivery profile outlined. Offerors should note that the offers will be evaluated on how well the proposed delivery schedule matches (or in the case of the first 820,000 doses, exceed) the requirements. 2.1.7 Offerors are required to provide their proposed delivery schedule. 2.2.0 – Pallets 2.2.1 The Authority would prefer the Offeror to use Europallets for the delivery to the Authority’s distribution agent and for storage within the distribution agent’s warehouse 2.2.2 Offerors are required to provide details of their pallet packing configuration. Mandatory requirement Information requirement Mandatory requirement Mandatory requirement Mandatory requirement Non-mandatory requirement Information requirement Non-mandatory requirement Information requirement Information on the tendering process for HPV Vaccine 4 of 5 2.3.0 – Manufacturing Contingency Plans 2.3.1 Offerors must be able to demonstrate to the Authority that they have an effective contingency plan for the maintenance of vaccine supply to cover manufacturing problems and staff shortages. This should include the use of alternative production facilities and safety stock provisions. 2.3.2 Offerors are requested to provide a summary of the contingency plan. The Authority will use the information provided in this summary document to evaluate the supply risks in the tender evaluation. Offerors should provide a summary document and clearly state the file name / reference. 2.4.0 – Production Capacity 2.4.1 Offerors are requested to provide the Authority with the following details which will also be used to assess the supply risks in the tender evaluation: a. The average number of doses in a production batch of vaccine. b. The current and maximum production capacity in terms of finished vaccine dose per week or month. c. The current production demand in doses per month. d. The number of batches submitted for release by the OMCL(s) and the pass rate in the last 12 months. e. The production cycle time. 2.4.2 Offerors are requested to include any additional information to be taken into consideration in relation to production capacity. Mandatory requirement Information requirement Information requirement Information requirement 2.5.0 – Risk Management of Storage and Distribution Offerors must be able to demonstrate to the Authority that they Information have an effective risk management approach to storage and requirement distribution of the vaccine. Offerors are required to provide a summary of their risk management plans to minimise loss of stock in relation to a. storage arrangements prior to delivery to the Authority and b. transportation of stock to the Authority’s nominated distributor Offerors should provide a summary document and clearly state the file name / reference summary. 2.6.0 – Variant Offers In addition to their core offer, offerors may wish to provide the Authority with a single variant offer that improves the clinical and / or cost effectiveness of the vaccination programme. Please note the Authority is not considering any options for direct delivery of the product from supplier to the Primary Care Trust or GP under this procurement exercise. Any valid variant offers received will be subject to the same evaluation criteria as the core offer. Information on the tendering process for HPV Vaccine Non-mandatory requirement 5 of 5