THE VICIOUS CIRCLE OF PHARMACEUTICAL TENDERING

» RAF DE WILDE «SENIOR EXECUTIVE ADVISOR

WHITE PAPER

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omEXECUTIVE SUMMARY

INTRODUCTION

HOW IMPORTANT IS TENDERING FOR THE PHARMACEUTICAL BUSINESS?

The tendering process, where suppliers bid amongst themselves to win contracts, is becoming increasingly important in pharmaceutical procurement. It’s estimated to make up around 25% of total global pharmaceutical turnover, and is market and product dependent. The biggest impact of tendering is price erosion.

While tendering is an efficient tool for cost reduction, it can lead to supply issues and shortages, as well as price increases where competitors are driven out of the market. Payers splitting contracts can reduce the risk of shortages, and companies can use product differentiation to maintain their position in the market. However, aggressive bidding still continues and remains a risk to the industry.

According to the Harvard Business Journal:

“Tendering is an auction process in which customers issue tenders for contracts and suppliers bid against each other to win that contract. Prices in such markets, which are commonly referred to as bidding markets, are typically individually determined for each contract, and the buyer (i.e. the tendering authority) can compare offers and negotiate with the different competing bidders.”1

The characteristics of tendering differ tremendously between geographies. Tendering processes can be strict, with no contact allowed between customers and suppliers from the tender publication to the final award, or flexible, with negotiation opportunities at multiple timepoints.2 The key difference between tendering and contracting is the first step of tendering: the publication of the tender. No publication of a tender means contracting.

A short internal survey within Johnson & Johnson (J&J), 20 years ago, found that while tendering was very common in the medical devices and diagnostics business of the corporation, pharmaceutical tendering was rare. Back then it was chiefly restricted to one product, erythropoietin (epoetin), and only created problems in markets such as Bulgaria, Denmark, France, Hungary, Italy, Poland, Portugal, Romania, and the United Kingdom. Note that epoetin was at that time the most important product on the hospital budget, with stiff competition between Roche (epoetin beta, NeoRecormon®) and J&J (epoetin alfa, Eprex®, Erypo®).

Another project involved interviews with twenty ‘tender champions’ within J&J. This formed a solid basis for understanding the issues that are related to tendering. Workshops with tendering and pricing specialists, active participation in development of tender strategies for strategic customers, and base research into price competition offered further insights. All these elements were combined in a ‘tendering and contracting’ excellence programme that was rolled out within J&J in the first years of this millennium. When I became a consultant in late 2010, I continued working on tendering and contracting strategies, but this time for other corporations. My ever-evolving tendering and contracting excellence programme has now reached 15 middle- to large-sized pharmaceutical companies, and well over 700 professionals involved in tendering from Asia, Europe, Middle-East, and Latin-America. Working with different companies in multiple geographies lead to in depth insights in pharmaceutical tendering. This white paper describes some of the learnings from these observations.

Tendering in health care has been recommended as a procurement process for support services such as cleaning and catering in several markets since the early 1980s.3 However, the Gulf Cooperation Council (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates) was already using tendering

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omfor joint bulk purchasing of essential drugs since 1978.4 The Jamaica Commodity Trading Company covered most of the pharmaceutical needs for the public health sector through an international tendering system, with 665 awards given in the 18 months following January 1988.5 At the end of the previous millennium, tendering was endorsed as the preferred procurement process for pharmaceutical products by international institutions such as the World Health Organisation6 and the World Bank7.

The importance of tendering and contracting for the pharmaceutical business is estimated to equate to 25% of total global pharmaceutical turnover.8 This number is difficult to check as it depends on what exactly is seen as tendering and contracting, e.g. are the deals made between pharmaceutical companies and strategic customers in the US included? And what about contracts made between health authorities and companies for conditional reimbursement? Are we looking at what sales of the pharma industry has been switched into tendering? The importance of tendering is market and product dependent: some authorities have made tendering mandatory for all hospital products as soon as sales are over a certain minimum level per year; others list which products should be tendered for; several authorities count economic pressure on the hospital budgets will push towards efficient procurement;9 tendering for products used in retail is less common and mainly restricted to generics.10

The impact of tendering on pharmaceutical business is mainly through price erosion. Open tendering, which means all suppliers are invited to bid, results in the lowest prices, especially when many suppliers are interested in the contract.11 A study of tendering in Cyprus found a strong positive correlation between price erosion and availability of generic alternatives. Other drivers of price erosion were tendering by ‘winner takes all’ where there were alternatives available; high prices and high volumes.12 A study of regional tendering for biosimilars in Italy found a strong correlation between number of competitors and price erosion, with a 40-60% reduction of awarded prices in just two years of tendering for epoetin alfa and filgrastim, respectively.13 The introduction of tendering for generics in the Netherlands caused a price drop of 80-90%.14 Obviously, the risk for price erosion increases with greater purchasing power e.g. through centralised tendering.15

In conclusion, tendering may have a devastating impact on price, especially when the clients are using ‘winner takes all’ tenders, and competitive products that are not very differentiated from each other i.e. alternatives are available.

EPOETIN TENDERING

The first recombinant human erythropoietin (epoetin alfa) was developed by Amgen and launched in Europe by J&J affiliates under the brand names Eprex® and Erypo® in 1989. This was followed shortly after with the launch of epoetin beta (Genetics Institute, Boehringer Mannheim) under the brand name Recormon®. Epoetin-beta was reformulated and re-launched as Neorecormon® by Roche in 1997.16 Epoetin alfa was the first biologic with large budget impact, global sales in 2000 were already over $3.5 billion.17 While there were differences between the brands (e.g. packaging18 and pain on injection19), there were no reports on differences in clinical efficacy.20 In most countries, epoetin is available as a hospital product and hence the situation was ideal for purchasers to introduce tendering as procurement method for the product. Where possible, the subject for the tender was described as epoetin/erythropoietin/ATC code B03XA01, creating a direct competitive tendering situation between the J&J and Roche brands. In other markets such as Italy, tendering was performed per brand and the outcome was used to guide therapeutic choice. In the late 1990s, the epoetin procurement system of choice was tendering in almost all European countries (excluding Austria, Germany, Greece, the Netherlands, Switzerland). Before the dawn of the biosimilars it was not uncommon for a hospital in Europe to switch patients from epoetin alfa to beta or vice-versa, dependent on the outcome of the epoetin tender. Tendering for epoetin could reduce net prices strongly, with discounts up to over 60% to list price mentioned in the public domain.21

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THE ‘WINNER TAKES ALL’ PRICING GAMES

From the epoetin market situation came the idea to develop a pricing game. An early version was developed and used within J&J. In 2011 a new version of the game was developed that allowed adaptation of the variables of the game so that it could be used for many more situations. This version has been played over 50 times by key account managers, tender experts and market access professionals from 11 different corporations.

The participants are split into competitive teams that are bidding for the business of six hospitals. The market changed overnight into a mandatory ‘winner takes all’ market, where each hospital is tendering for full volume. The hospitals differ in volume needs, incumbent player(s) at the start of the game and price sensitivity. Participants know or can estimate these characteristics from the short descriptions of the hospitals. The game is pre-programmed on award conditions, threshold to switch (if any), and growth rates by customer. Each product has a set attractiveness to the customers, an element which cannot be influenced in the game. As the game continues, teams split into new teams, e.g. to role play a new entry of a branded or generic competitor, and more and more competitors are offering for the same set of customers. There are three to six rounds of bidding, and after each round the teams immediately receive the results of their bids to prepare for the next round. Awarding is pre-programmed, hence not dependent of the way the participants behave in the game.

The pricing game is most telling when it is played several times under the same conditions, by different players. Figure 1 shows the real results of two typical outcomes of the game: in the red game we see significant slower price erosion than in the blue game. However, simulated market conditions were similar and purchasing decision making was pre-programmed to be identical.

This illustrates a key point of price competition: while the authorities or individual customers set the conditions to allow price competition, it is the competitive behaviour of the teams that will define the intensity of price erosion. Participants regularly comment after the game that the simulation is very illustrative for the real environment. So, we may conclude that for a market with low differentiation between the products and for ‘winner takes all’ conditions, competitive behaviour is a key driving factor for price erosion.

The game has been played by participants from Asia, Middle East, Western Europe and Eastern Europe, including Russia. Although there was adequate participation from each geography, we could not observe differences in pricing behaviour. We could however recognise the impact of corporate culture, with clear barriers to strong and fast discounting in some companies and a drive to market share in others. However, in all games the end net prices after six rounds of tendering in a market with low differentiation, two incumbents, one new entry, and one biosimilar were 75-88% lower than the starting prices, just above the cost of goods of the cheapest producer (set at 10% of starting price).

Figure 1: Typical results from the pricing game

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Tendering round (0 is the starting point)

Price erosion over six rounds of tendering

Blue Game Red Game

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omAlthough the results of the pricing game look dramatic, they are very close to what is happening in the real world. Indeed, hospital tendering was named as the main cause to reduce epoetin and filgrastim prices with reductions of up to 89% in Norway for both filgrastim and epoetin alfa, whereas discounts for use outside the hospitals were 50% for filgrastim and only 25% for epoetin alfa.22 Filgrastim reached more than 90% discounts in some French hospital tenders, whereas retail prices were only 10-15% below list price.23

So, in this simulated tendering ‘winner takes all’ environment, we found substantial price erosion, leading to very low net prices after just few rounds of tendering. The speed of price erosion is function of the number of competitors, aggressivity of the players, and the lowest cost of goods in the game.

THE VICIOUS CIRCLE OF TENDERING

For the customer, tendering can be an efficient tool for lowering prices. However, there are also drawbacks to tendering; one survey of EU purchasers24 yielded the following problems:

• Some diff iculties in estimating the necessary quantity of the products needed.• Tendering procedures demand a lot of expertise and resources.• For ambulatory care, legal complaints may significantly complicate the set-up of tendering.• Dedicated tendering teams might be needed.

More recently, purchasers are starting to recognise the risks for supply problems when ‘winner takes all’ is used by larger customers, e.g. through centralised purchasing.25,26

From the company side, tendering may offer a chance to break through the monopoly of an incumbent competitor. The increased transparency and lower risks for fraud that accompany strict legally based tendering processes should also be welcomed. However, the loss of net profit by efficient tendering can be tremendous and make further commercialization unattractive. As a result, this can reduce the number of suppliers which may lead to price increases as well as higher risks for shortages.27

The effect of sharp drops in number of generic suppliers on net prices has been well established in US market: a retrospective cohort study of generic drug prices found a strong correlation between the market competition intensity and price changes, going from −31.7% over 5.5 years in highly competitive segments to +47.4% in case of generic monopoly.28 Elsevier recently surveyed stakeholders, including health plans, PBMs, retail pharmacies, drug wholesalers, manufacturers, and healthcare providers and found over 75% of survey respondents believe that the consolidation of drug manufacturers is the first or second most likely cause for the generic price increases.29 This explains why in January of 2018, a group of 450 US hospitals announced their plans to form a not-for-profit generic drug producing company.30

Several stakeholders recognise the issues and try to make the situation more sustainable. Administrative burden is reduced by using pre-qualifications and electronic bidding systems (e.g. South African NDH).31

Large European purchasers sometimes split contracts between two or more suppliers, if the bids are close to each other, to minimise the risk of shortages and to maintain long-term competition.32

On the industry side, focus is mainly on communicating the risks of tendering: quality risks when lowest price is the dominant criterion, medical risks when substituting one product for another, shortages when ‘winner takes all’ tenders are used, and lack of optimization of medical therapy by treating all patients alike and cutting back on the freedom of choice of the treating physician.33 In the market, companies will try to get out of the ‘winners take all’ and ‘lowest price’ paradigms by using differentiating elements such as advanced administration devices with added clinical benefit.34

What seems to be missing on the industry side is the understanding that price erosion in tendering markets is strongly influenced by industry, so their own behaviour. A good Italian friend, active in tendering for many years, told me once that he would rather win a tender with 1% than with 20% price difference.

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omBut in practice, in the real tendering environment, aggressive out of scale price cutting seems to be rather the rule than an exception. One of the core reasons is that almost all pharmaceutical companies use market share and sales as the most important key performance indicators of commercial and management functions.35 The mindset of commercial and management people in pharmaceutical companies is therefore focused on keeping/obtaining market share and driving sales. Generic companies seem to enjoy playing the game of the customer by deep discounts “because that is expected, and the products are burning a hole in my warehouse”.36 A simple game in an experimental environment demonstrates this behaviour all too well.

CONCLUSIONS

Pharmaceutical tendering will stay as key procurement approach for pharmaceutical products, especially for hospital products but also in outpatient settings for generics/biosimilars or other segments of products with low differentiation. All stakeholders are recognizing the opportunities (i.e. substantially lower prices) and risks (shortages, quality, choice of therapy, etc.) of efficient tendering. We should expect a reduction of the ‘winner takes all’, ‘lowest price’ tenders, however customers will keep searching for the best balance between low price and sustainable high-quality supply. The pharmaceutical industry is communicating the risks of tendering and tries to differentiate their offers so that their products remain competitive even after loss of patent protection. What the industry fails to recognise is that the most formidable factor in tendering (aggressive bidding) is under their control. We found the enemy – it is us.

Valid Insight are one of the few consultancy firms that are highly expert in helping companies develop pragmatic and effective tender excellence strategies that lead to protection of market share and revenue; to learn more about how we can help you approach tendering and contracting, call us on +44(0) 203-750-9833 or email us at discover@validinsight.com.

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ABOUT VALID INSIGHT

ABOUT THE AUTHOR

Raf De Wilde, PhDValid Insight, Senior Executive Advisor

Raf De Wilde is a Senior Executive Advisor at Valid Insight. He is a global expert in life science market access, with over 39 years’ experience in the pharmaceutical industry and over 29 years in global market access.

Raf became the Gead of International Marketing Services within Janssen Pharmaceutica (a Johnson & Johnson [ J&J] company) in 1991, introducing Health Economics at J&J that year. Raf was Chairman of EPhMRA Primary Research and Methods Committee (1993–1995). He became VP of EPhMRA in 1994 and 1997, and President in 1995 and 1998.

In 1997, he joined Peter Lauper’s team that pioneered the ‘biosimilars’ concept and the first patient access schemes. Raf led a specialist oncology, real-world evidence and virology group between 2002 and 2004, where he created a centre of excellence for oncology pricing and specialised in biologics while leading the HEOR function at CENTOCOR. Raf was VP of Market Access at J&J leading teams working on oncology, cardiovascular and biotech products from 2004 to 2010.

Raf joined United Biosource Corporation (UBC) as Associate VP in early 2011 and stayed with Evidera until 2015, prior to joining Valid Insight in 2016. In his consulting career he has led nearly 200 global market access projects, including value strategies, price finding research, patient access schemes, negotiation tactics, tendering and contracting, WHO classification and naming strategies. He has moderated over 150 training workshops in Asia, Asia-Pacific, Europe, North America and Middle-East, and led the life sciences pricing training of the European Pricing Platform from 2011 to 2014.

Raf continues to teach the sessions on PROs and evidence-based medicine at the Master of Science in Pharmaceutical Medicine course of the University of Duisburg-Essen in Germany.

Valid Insight is an award-winning pharmaceutical global market access consultancy.

With a team that includes some of the world’s leading market access and pricing experts, clients across the globe turn to us for innovative pricing, market access and value communication strategies through the full product development cycle.

Proud winners of the Queen’s Award for Enterprise: International Trade, we aim to offer world-class solutions that continue to drive growth for our global clients.

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omREFERENCES

1. Wirth D, To Bid or Not to Bid, That is the Question: The Assessment of Bidding Markets in Merger Control, https://corpgov.law.harvard.edu/2016/12/12/to-bid-or-not-to-bid-that-is-the-question-the-assessment-of-bidding-markets-in-merger-control/

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11. Management Sciences for Health. Managing the tender process. In: Embrey M, Ryan M, editors. MDS-3: Managing Access to Medicines and Health Technologies. Arlington (VA): MSH; 2012:401–428

12. Petrou, P and Talias MA, Price Determinants of the Tendering Process for Pharmaceuticals in the Cyprus Market, Value In Health Regional Issues 7c 2015: 67-73

13. Curto S et al. Regional tenders on biosimilars in Italy: An empirical analysis of awarded prices. Health Policy 116; 2014: 182-187

14. Kanavos P, Seeley L, Vandoros S. Tender Systems for Outpatient Pharmaceuticals in the European Union: Evidence from the Netherlands, Germany and Belgium. Brussels, Belgium: European Commission; 2009. Ref. Ares (2014) 3853545

15. Seidman G, Atun R. Do changes to supply chains and procurement processes yield cost savings and improve availability of pharmaceuticals, vaccines or health products? A systematic review of evidence from low-income and middle-income countries. BMJ GlobalHealth 2017;2:e000243. doi:10.1136/bmjgh-2016-000243

16. Kalantar-Zadeh K History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology A m J Nephrol 2017;45:235–247

17. InfoService BiotechnologieNovember 22, 2012, Sales of recombinant drugs http://www.i-s-b.org/sales-of-recombinant-drugs/ accessed 22/8/2019

18. See respective summaries of product characteristics

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20. Storring PL et al. Epoetin alfa and beta differ in their erythropoietin isoform compositions and biological properties. Br J Haematol. 1998 Jan;100(1):79-89

21. Yilmaz G et al. Tracking the Aftermath of a Corporate Scandal from a Network Perspective: The Case of Roche in Turkey, in Amjad Hadjikhani, Ulf Elg, Pervez Ghauri (ed.) Business, Society and Politics (International Business and Management, Volume 28) Emerald Group Publishing Limited, 2012, pp.303 - 325

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22. Mack A. Norway, biosimilars in different funding system. What works? Generics and Bio-similars Initiative Journal (GaBI Journal). 2015;4(2):90-2. Accessed 29/07/2019

23. Levêque D. [Biosimilar drugs in oncology]. [Article in French]. Bull Cancer. 2016 Mar;103(3):294-8

24. Leopold C, Habl C, Vogler S. Tendering of Pharmaceuticals in EU Member States and EEA countries Results from the country survey Final version June 2008. ÖBIG Forschungs- und Planungsgesellschaft mbH available online at https://ppri.goeg.at/Downloads/Publications/Final_Report_Tendering_June_08.pdf accessed 15/7/2019

25. Dranitsaris G et al. Drug tendering: drug supply and shortage implications for the uptake of biosimilars. ClinicoEconomics and Outcomes Research 2017:9 573–584

26. MacKay P, Is PHARMAC’s sole supply tendering policy harming the health of New Zealanders? J N Z Med Assoc (2005) 118;1214 Available at: http://journal.nzma.org.nz/journal/118-1214/1433/; and the Pharmaceutical Management Agency Annual Report for the year ended 30 June 2010. Available at: http://www.pharmac.govt.nz/AnnualReport

27. Department of Health & Social Care Investigation into NHS spending on generic medicines in primary care June 4, 2018 available at https://www.nao.org.uk/wp-content/uploads/2018/06/Investigation-into-NHS-spending-on-generic-medicines-in-primary-care.pdf

28. Dave CV et al. High Generic Drug Prices and Market Competition: A Retrospective Cohort Study. Ann Intern Med. 2017 Aug 1;167(3):145-151

29. Elsevier clinical solutions white paper: The Impact of Rising Generic Drug Prices on the U.S. Drug Supply Chain, downloaded from http://www.ncpa.co/pdf/elsevier_wp_genericdrug.pdf on 27/8/2019

30. Southey F. Shortages and soaring generic prices prompt US hospitals to form not-for-profit drug business 25-Jan-2018 HTTPS://WWW.IN-PHARMATECHNOLOGIST.COM/ARTICLE/2018/01/25/SHORTAGES-AND-SOARING-GENERIC-PRICES-PROMPT-US-HOSPITALS-TO-FORM-NOT-FOR-PROFIT-DRUG-BUSINESS

31. Pharmaceutical tenders by South African National Department of Health, see http://www.health.gov.za/tender/index1.php accessed 27/8/2019

32. Dylst P, Vulto A, Simoens S. Tendering for outpatient prescription pharmaceuticals: what can be learned from current practices in Europe? Health Policy. 2011;101:146–152.

33. EuropaBio White Paper on Public Procurement of Biological Medicines, June 2015, downloaded from

34. For example: Neulasta® Onpro®, an administration device that injects pegfilgrastim 24 hours after installation

35. In the European Pricing Platform congress in Lausanne, May 2014, participants were asked if net profit was a Key Performance Indicator for tendering people. Only one out of 40 attending companies had set its internal incentives on profit.

36. Personal communication from the CEO of an Irish generic producer