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Author(s)

Steffen Amann, Rudolf Bernard, Georg Berndt , Meike Bindemann, Myga Brakebusch, Jörg Brüggmann, Frank Dörje, Miriam Gyalrong-Steur, Anita Kellermann, Markus Müller, Elfriede Nusser-Rothermundt, Rainer Riedel, Eva Tydecks

Why was it done?

Given rising cost-pressure and increasing numbers of supply shortages, changes between generics have become daily practice in hospital pharmacies. To ensure constant treatment quality and patient safety, the equivalence of a potential new product with the current one must be guaranteed before changing brands. So far there has been no transparent, standardised tool for the comparison of generics workable in everyday clinical practice. Developing such a tool was our project’s aim.

What was done?

We developed an Excel-based tool for the qualitative and pharmacoeconomical evaluation of generics before changing brands (aut-idem substitution) in hospitals.

How was it done?

A working-group of pharmacists from seven hospitals developed the “HERA” tool (HTA-evaluation of geneReric phArmaceuticals). Starting from a base version, 22 generic products were assessed with the tool during five evaluation rounds. Based on these results the instrument was gradually refined. Within HERA‘s Excel matrix a potentially to-be-used generic is compared with the current one. The economic evaluation is based on unit prices and prescription volumes, but also includes process costs associated with the product change. The assessment of pharmaceutical quality is based on 34 criteria from six areas (licensed uses, drug substance, dosage form and excipients, handling, safe design, packaging and storage). The objective quality evaluation is complemented by the assessment of hospital-specific features. Complex substitutions – e.g. associated with a handling change – require involvement of the medical staff using the product. The purchasing decision is taken based on the synopsis of pharmaceutical quality and economic evaluation.

What has been achieved?

The standardised evaluation of product differences before substitutions allows for the early identification of potential problems of brand changes and helps avoiding them for the benefit of patient safety. HERA also guarantees reproducibility and transparent, QM-compliant documentation of product changes. The pharmacies of our purchasing group now routinely use HERA for the assessment of generics before intended brand substitutions. Each evaluation is conducted in one pharmacy and shared with the others via data-cloud.

What next?

We have published a paper on HERA and presented it at the German Hospital Pharmacists congress in 2018. Our aim is to create a network of colleagues with shared access to all colleagues’ HERA product evaluations to reduce the workload for the individual pharmacies.

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Why was it done?

The consumption of medicine for the treatment of wAMD, DME and RVO is increasing. The medicines used are in the top five of the most expensive drugs in Denmark. With the prospect of more patients, greater costs and the introduction of new drugs in the field, there was a need to develop a national treatment guideline.

What was done?

An expert committee prepared a national treatment guideline including a clinical medicine comparison report for the treatment of wet age-related macular degeneration (wAMD), diabetic macular oedema (DME) and retinal vein occlusion (RVO). The aim was to create uniform treatment across the country and to trigger competition between medicines in the hope of achieving lower prices.

How was it done?

An expert committee consisting of physicians, clinical pharmacist, clinical pharmacologist and medicine procurement pharmacist was appointed. The committee prepared a national treatment guideline including a clinical medicine comparison report based on existing clinical evidence and Danish practice. The committee reached the conclusion that the anti-vascular endothelial growth factor (VEGF) drugs ranibizumab and aflibercept are ranked equally in terms of effect and side effects. The choice of anti-VEGF should be determined solely by price and dosage. A tender was prepared in alignment with the guidelines. This result led to the development of a medicine recommendation, which was passed onto hospital pharmacies, clinical pharmacists and physicians to ensure implementation in the clinic. Feedback from the clinics concerning estimated consumption was forwarded to the drug suppliers and was continuously monitored by the procurement pharmacist to ensure compliance at the clinics.

What has been achieved?

The clinicians switched patients to the new first-line choice. The market share of first-line treatment was 89% compared to 25% before the guideline. Two tenders were published based on the guideline. The first resulted in a price reduction of 28%, the second a reduction of 54%. Total actual savings in the first tender (based on a 31-month contract period) was €38m. In the second tender (based on the first 12 months of the contract period) was €35m.

What next?

New medicines are expected to be approved in the near future. We will continue to use and develop national treatment guidelines in combination with tender procedures and proper implementation of guidelines to obtain better and cheaper treatment options for patients.

Author(s)

Alison Anastasi, Karl Farrugia

Why was it done?

This was done as a tender was being issued also for medicines that still had a patency and had no competition and the prices quoted for were higher than other international external reference prices. Thereby a new pricing reimbursement system was undertaken and items procured were studied intensively before choosing the right procurement model. The main point was thinking outside the box inducing interest in international companies who were willing to support and assist the innovative local systems by participating in the new systems leading to improved access and better value for money.

What was done?

In September 2016, a workshop and strategy meeting was organised at WHO Denmark to discuss global procurement strategy and share country practices. Malta was one of the facilitators and invited speakers. In the past years tendering was the main system for procurement. However, on having a thorough understanding of medicines and non-pharmaceuticals, market strategy, and patency other processes have been studied and adopted. The models involve negotiations, pay per use systems, and pay per performance models.

How was it done?

This was done by setting multidisciplinary teams within the hospitals and by having good research methodology skills. This led to smoothing the gaps between the actual horizon scanning, health technology assessments and final choice of procurement strategy. International liaison, partnership with the industry, and relevant focus groups with annual seminars made this possible as mixed experts met and gave their best shot at this new system. The fact that no one size fits all made procurement more interesting and from one cycle to the other there is a learned curve that brings successful results.

What has been achieved?

Malta achieved better competition, uninterrupted sourcing, investments and stable pricing with continuous yearly reductions. From negotiations of patented medicines Malta saved approximately 1.5-2 Million Euro per year since 2013. With respect pay per use systems such as the total knee replacements Malta gave a capped price and ended up paying half of what is used to pay and companies managed to bid for the set price. In renal dialysis the cycle involved payment per patient service thereby reducing wastage, storage, and ordering of consumables and this will render a cost saving of 5Million Euro throughout cycle. The new processes launched for multiple sclerosis will dictate that whoever reaches the cheapest price ranking will be used to start the patients clinically and the pay per cure cycle for Hepatitis C will lead to savings and complete eradication in five years time.

What next?

Malta is one of 6 small EU Member States so besides its size and geography there are other elements were it triggers the procurement department to think of innovative ways to treat our patients and as yet remaining sustainable. There are other projects in the pipeline however, Malta is sharing its good practice with the industry, with the WHO and other international fora so that certain elements are taken on board as standardised systems for equality of service and treatment in all countries.

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Author(s)

Hanne Fischer, Bente Dam, Bitten Abildtrup, Helle Pasgaard Rommelhoff, Lars Munck

Why was it done?

Challenges with drug supply is a global as well as a national problem. A decline in interest among the suppliers to submit tenders in our country, has been detected. This is more profound compared to other European countries due to a small market and a strict interpretation of EU public procurement rules.

What was done?

The aim of the study was to evaluate whether three selected contract types motivated suppliers to submit tenders, submit with a lower price and whether they affected national backorders.

How was it done?

In 2015 and 2016, the national purchasing authority for all drugs used in all the public hospitals, tested three new contract types on 18 drugs: a) Purchase obligation for the national purchasing authority b) Limit on reimbursement obligation for replacement drug and c) Two national suppliers of one drug. Contract type a and b aimed to reduce the suppliers’ economic risk and c was primarily tested to secure national drug supply.

Suppliers, who had the opportunity to submit tenders for the new contract types, were included in the study. For the 2015-tenders’ 7 of 8 semi structured interviews were carried out and for the 2016-tenders, 10 electronic questionnaires were provided (50 % respond rate). In total 2 parallel importers and 15 generic suppliers participated.

What has been achieved?

The respondents reported that contract type a motivates to submit tenders and submit with a lower price. It might reduce national backorders due to a predictable sale.

The generic respondents reported that contract type b reduces their economic risk, which motivates to submit tenders and due to that might reduce national backorders.

The respondents reported that contract type c did not have considerable effect on the national supply, since the forecast and amount of orders from both suppliers is fixed months in advance.

What next?

In order to address the challenges with drug supply, new types of contracts, which reduce the suppliers’ economic risk, will be further implemented in future national tenders.

Author(s)

Alison Anastasi, Karl Farrugia

Why was it done?

The amount of shortages was considerable leading to interruption of treatment, hoarding, wastage, hospital admissions incurring more expenses. Malta is one of the small EU Member states and its geographical position does not facilitate sourcing. Thereby on analysing the matter further, walking directly into the chaos creating order, inventing, creating, connecting and making things happen was the mainstay since then. The industry accepted the partnership invitation and sourcing increased both from the local and international scenario. Best in class operational efficiency, quality & functional excellence was achieved. According to the National Audit office in 2012, Malta had a recurring issue with shortages of medicines and now in 2016 we have had nil shortages for 30 weeks.

What was done?

1. Establishment of a dedicated team – Emergency Response Unit (ERU)
2. Enterprise Resource Planning inventory management
3. Customer demand forecast modelling
4. Partnership with the industry
5. Innovative procurement strategies e.g. negotiations, therapeutic time-based agreements, e-auctioning, framework agreements, managed entry access
6. Registration: Allowing bidders to register after they were awarded the tender; parallel importation

How was it done?

The challenges faced included influencing and providing leadership to partners in the delivery of on demand innovative solutions, strategic sourcing involving language translations, registering medicines by the department, demand supplier relationships, payment within 60 days, ageing population, procurement services revenue and profit growth. The winning strategy foundation was the interaction and integration of people (internal and external stakeholders) to business information and business intelligence.

What has been achieved?

The department has achieved good results measured by the number of shortages, better quality of life, by reduction of hospital admissions thereby reduction in costs. The average medicine shortages in 2013 was 56; in 2014 (40); in 2015 (5) and in 2016 (1) till October. The budget allocated per year has increased due to longevity however more patients are being treated and the cost savings lead to innovative technology access.

What next?

Having mitigation measures in place such as pre-planned need analysis; choosing the right process; reducing unnecessary care and focusing on sustainability is good practice. Locally this is being implemented for the procurement of non-medicines and in fact cost savings running into millions have resulted.

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Author(s)

L. Munck

Why was it done?

Globally, we are facing an increasing amount of drug shortages, even though international regulatory authorities take initiatives to improve this.

We have national order data available through one national organisation that manages all tenders and backorders for drug supplies to all hospital pharmacies.

Access to order data enabled us to start this improvement initiative in May 2014, and hence fight the backorder challenge at the national level.

What was done?

We applied LEAN and Supplier Collaboration to turn around the trend of increasing amount of drug backorders to hospital pharmacies.

Our initiative consisted of tight follow-up and continuous improvements with ‘TOP6-suppliers’, (ie, the 6 suppliers with currently the most negative impact on our national drug supply).

‘TOP6-suppliers’ are selected each week at LEAN board meetings.
Tight supplier follow-up, by e-mail, weekly:
We informed the ‘TOP6-suppliers’ that they currently are among the suppliers with the most backorders, and asked them to:

• Confirm/update delivery dates for all open backorders
• Inform us of the underlying reason for each backorder

The suppliers continue to receive weekly emails, as long as they are selected as ‘TOP6-supplier’.

Continuous improvement meetings, face-to-face, quarterly:
We had meetings with the 3 suppliers with the highest level of backorders/poorest level of improvements.

Meeting agenda: Reasons behind current backorder situation and actions to improve.

How was it done?

Obstacles—>Our solutions:
Too busy managing actual backorders and no time to drive improvements—>Added one dedicated resource to drive this initiative.

How to manage our effort—>Develop leading key performance indicators (KPIs) that ensure focus on influence and improvements.

We were not always confident that our effort would provide the expected results—>Continue to focus on the agreed approach and KPIs, even if it takes approximately 12 months before we achieve improvements.

What has been achieved?

• Backorder amount decreased by 25%.
• 3rd quarter2014: On average, 99 item-numbers in backorder (range 87-117).
• 3rd quarter 2015: On average, 74 item-numbers in backorder (range 67-99).
• Closer dialogue and improved cooperation with our suppliers with most/critical backorders.

What next?

1. Share achievements.
2. Start an international network to share best practices.
3. Together achieve further improvements in drug supply.

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