Future funding approach for blood glucose meters and test strips

PHARMAC will be running a competitive process for the supply of self-monitoring blood glucose testing meters (‘meters’) and test strips during 2015. We are seeking your feedback on a proposed approach to the assessment of meters and test strips for funding.

Until any decisions are made, funding of CareSens meters will continue.

Seeking your feedback

PHARMAC welcomes feedback to our proposed approach. As well as general comments, we are seeking answers to the specific questions, to help inform our procurement process. We also welcome your views on any other related issues not covered in this consultation.

Please submit feedback by Tuesday 7 April 2015.

There are a number of ways to respond to this proposal:

1. It is our preference that people respond online.
2. However, you could also:
   1. email feedback to diabetesfeedback@pharmac.govt.nz [email not monitored]
   2. post feedback to PHARMAC – attention: Diabetes Feedback, PO Box 10254, Wellington 6143

If you have any questions please contact PHARMAC on 0800 66 00 50

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.

Background

The sole supply period for the funded CareSens meters and test strips ends on 1 July 2015. The CareSens range of meters and test strips will continue to be subject to a supply contract and funded after 1 July 2015 until further decisions are made and announced. The Accu-Chek Performa and Freestyle Optium brands of meters and test strips and Sensocard test strips remain listed, subject to Special Authority criteria.

PHARMAC is now considering the next steps it should take in relation funding of meters and test strips.

Following the change to the CareSens meters and test strips, PHARMAC commissioned an evaluation of the implementation of the change from Allen & Clarke [link no longer available]. PHARMAC has considered the recommendations of this report in deciding the next steps to take around funding of meters and test strips. We have also listened to stakeholder feedback that was received during the funding and sole-supply implementation of these products.

As a result, PHARMAC is planning to manage the future approach to determining funding of meters and test strips differently.

We will be providing a number of opportunities for stakeholder groups, individuals and suppliers to participate in the process before any funding decisions about meters and test strips are made. It may be up to 18 months before any decisions are made to ensure both clinical and consumer feedback is considered in our decision-making.

Proposed approach

PHARMAC is proposing the following three-step approach including a two-stage procurement process for meters and test strips:

i. Initial request for feedback about the proposed approach

This consultation, which will inform the steps ii and iii set out below.

ii. Request for Information (RFI)

Suppliers would be asked to provide information to PHARMAC in response to specific questions and to provide sample meters and test strips. The meters and test strip samples would be assessed and evaluated according to pre-defined criteria. Specific feedback on the proposed criteria to be used is set out below.

iii. Request for Proposals (RFP)

Similar to in 2011/12, a request for proposals will be issued seeking bids for a sole, dual, or multiple supply arrangement. All options will be considered and evaluated against criteria.  Only those suppliers who respond and submit sample meters and test strips in response to the RFI, and whose meters and test strips meet the pre-qualification criteria, would be eligible to submit a competitive proposal. 

An Evaluation Committee comprising PHARMAC staff would evaluate each proposal against criteria to select the preferred proposal(s).  PHARMAC may also seek external advice on proposals as part of the evaluation process. 

RFI evaluation criteria

PHARMAC is seeking feedback on specific questions outlined below

Functions that a meter or strips must provide/perform

As well as measuring the glucose in blood samples, meters can provide a range of other functions and features that support people to manage their diabetes. For example (but not limited to):

• memory capacity
• backlight display
• coding/non-coding of strips
• packaging
• ability to provide testing averages over 1, 7, 14, 30 and/or 90 days
• ability to delete readings, and
• ability to download readings to GP practice software and patient tracking software

No single meter is likely to have all possible functions; however, we want to know what the most important functions that a meter should have for optimal management of diabetes. 

Usability

By ‘usability’ we mean the ease with which people can learn and use a meter and test strips. PHARMAC intends to assess usability as part of the RFI.

International literature does not indicate a definitive way to assess usability; however, based on our research and initial discussions PHARMAC has identified the following three approaches:

1.  Individuals with diabetes attend a clinic/laboratory and are observed performing a few simple tasks with a meter and test strips after having the opportunity to read through the instructions/quick guide.  These tasks could include setting date/time and performing a control solution test.

2.  Individuals with diabetes are sent a meter and test strips. They are asked to use it for a 3-4 week period, then provide feedback/assessment based on a structured questionnaire.

3.  Focus groups of up to 10 people with diabetes are held with diabetes nurse specialists as ‘facilitators’. The meter and test strips are introduced to the group and they learn and assess the meter and test strips in a group situation.

We think it’s important that the individuals or members of groups include a range of people representing New Zealanders with diabetes (for the avoidance of doubt, this would include people who rely on their parents, whanau or caregivers to help them to manage their diabetes). It may be that individuals would assess many different meters, or individual meters may be assessed by different people.

Accuracy / clinical assessment

Meters and test strips would also undergo accuracy testing and clinical assessment. We expect that all meters and test strips submitted for pre-qualification during the RFI would meet the International Standards Organization (ISO) standard (ISO 15197:2013) and, potentially, be FDA and EU approved. 

Meters and strips may also need to be tested against other indicators including:

• venous and capillary testing of accuracy;
• temperature assessment;
• humidity assessment; and
• interferences of a physiological nature such as (but not limited to) maltose, galactose, acetaminophen (and other medications), ascorbic acid, pO2 level, uric acid and haematocrit.

Other

We also welcome your views on any other related issues:

Proposed timeframe

Our anticipated timeline for the proposed two-step procurement process is set out below. If there are delays at any stage, this would likely have flow-on effects to the subsequent stages.