Creating better global market access strategies solving value, access and outcomes challenges

>220product launches in 20 countriessupported since 2009

Global market access

Bringing the strategy to lifeThe cost of drug development is rising and healthcare budgets are constrained. By focusing on the value that the therapeutics provide, especially by improving outcomes for patients and strengthening relationships with physicians and payers, companies can optimize their route to market access with benefits for all stakeholders.

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PATIENTS

VALUEPRESCRIBERS

• Patient support programs

• Patient access schemes

• Health system navigators

• Direct-to-patient disease registries

• Clinical nurse educators

ACCESSOUTCOMES

• Burden of illness evaluations

• Buying process

• Health system navigators

• Medical science liaison engagement

• Managed entry planning

• Managed entry implementation

• Landscape assessments

• Treatment pathways

• Negotiation support tools

• Disease registries

• EHR & data analytics

• Epidemiology services

• Interventional studies

• Local pathway modeling & simulation

• Local registries

• Observational studies

• Systematic literature reviews and meta analyses

• Enriched studies for real-world research

• Comparative effectiveness research

• Portfolio assessment

• Stakeholder segmentation

• Target product profile assessment

• HTA and pricing & reimbursement submission

• Value and HTA dossiers

• Value dossier adaptation

• Local pricing & reimbursement

• Government/payer relations

• Initial pricing & reimbursement

• Local HEOR studies

• Treatment pathways

• Local pathway modeling & simulation

• Medical science liaison engagement

• Professional development

• Stakeholder unmet needs

• Direct-to-payer services

• E-detailing capability

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Your value challenges

• Drug development is expensive and risky

• Healthcare providers are focusing on price and value

• The healthcare and payer environment is becoming more complex

With Quintiles’ support, you can meet these challenges and successfully demonstrate value to payers and other relevant stakeholders.

ValueThe value story is a vital part of the route to successful market access, and a company needs a robust and clear set of value propositions to be able to engage with regulators, payers and health technology assessment (HTA) bodies.

Drug development is expensive and risky

Using our experience and know-how, Quintiles can assess drug

development portfolios and ensure that these meet target product

profiles and align with your business strategy. Working together

with you, Quintiles can help to increase the probability of success

by ensuring better assessment of risks and choosing the right

strategic options. This will help to target resources to the projects

that are most likely to succeed, and best meet all stakeholders’

needs. This has potential to reduce risk and ensure a return

on investment.

Healthcare providers are focusing on price and value

Healthcare providers and other payers are focusing ever more on

price and value to keep their drug spending within budgets while

improving patient outcomes. Quintiles’ comparative effectiveness

research expertise helps to demonstrate product value using data

from randomized controlled trials and real-world sources such

as patient registries and electronic medical records. Through

local HEOR studies and value dossier creation and adaptation,

Quintiles can aid you to build the value stories behind pricing/

reimbursement and HTA submissions.

The payer environment is becoming more complex

The payer environment continues to evolve, from HTA bodies with

local schemes seeking reassurance on value, evidence and cost-

effectiveness before recommending reimbursement, to patients

becoming stakeholders through co-pay agreements. Stakeholder

segmentation, with Quintiles’ support, allows you to understand

which stakeholders in each market have the greatest influence

over adoption and implementation, so that the right message gets

to the right people.

160 patient registries and observational studies with >45,000 sites and >427,000 patients in >100 countries since 2011

Your access challenges

• The treatment landscape can be complex

• The buying and reimbursement process can vary

• Building local relationships takes time and commitment

• Getting the final price for a drug

• Patients may not be able to access drugs at affordable prices

Quintiles can support you from drug approval through to successful access.

AccessMarket access is about getting the right drug to the right patient at the right time for the right price. While this sounds straightforward, companies can face difficulties along their way.

The treatment landscape can be complex

There are a lot of different factors feeding into the treatment

landscape, including patient and physician unmet needs. Quintiles’

industry-leading tools and technology can capture and analyze

patient data, helping you to understand stakeholder needs,

particularly in new therapeutic areas.

The buying and reimbursement processcan vary

Buying and reimbursement processes are often complex and

may vary between countries and regions, and even therapeutic

areas. Using our extensive knowledge of different local markets

and healthcare systems, we can develop approaches tailored to

different markets.

Building local relationships takes time and commitment

Creating relationships with local stakeholders helps companies to

understand the local markets and the factors underlying market

access. Quintiles has expertise in local markets, supported by

Market Access Managers who are experts in the healthcare

environment, especially pricing and reimbursement regulations,

as well as by Medical Affairs Engagement Specialists and Medical

Science Liaisons who bring in-depth medical knowledge. Quintiles

understands the importance of local guidelines and regulations

covering relationships with stakeholders and remains fully-

compliant at all times.

Getting the final price for a drug

Negotiating pricing and reimbursement is a critical step in the route

to market access. Combining understanding of the country specific

pricing process and relevant local assessment schemes with tools

such as local budget impact models and real-world data analyses,

Quintiles can act as a partner through this process.

Patients may not be able to access drugs at affordable prices

Quintiles can work with companies to create patient access

programs, from price discounts and rebates to risk-sharing

‘pay for performance’ deals that allow patients to get the access

to treatments.

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~35,000employees operating in >100 countries

Clinical trial data doesn’t always represent

the real world

Patients in clinical trials are carefully selected and monitored;

however, in the real world, patient outcomes may not entirely

reflect those in clinical trials. Because Quintiles can help to design

pre- and post-approval observational studies that more closely

reflect real world use, you can build real world datasets that more

accurately reflect patient outcomes.

Patient populations and prescribing patterns differ

Quintiles can create local registries, based on electronic health

records and insurer databases. These provide information on

patient and disease demographics, prescribing patterns and quality

of care, resource usage and patient outcomes, allowing companies

to create population- and patient-centric access programs.

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Your outcomes challenges

• Clinical trial data doesn’t always represent the real world

• Patient populations, prescribing patterns and regulations differ across the world

Quintiles’ specialization, experience and expertise can support you to get the data you need to derive the best possible outcomes for patients.

OutcomesImproving outcomes for patients is the ultimate goal for companies developing new therapeutics. However, this requires the right data and knowledge of the market and the drug.

Observational studies and quality improvement programs across

>74,000 sites since 2004

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Your prescriber challenges

• Physicians and other healthcare professionals need to maintain their skills

• Interactions with HCPs are harder to get than ever before

• Supporting stakeholders is increasingly important

Quintiles can help biopharma to get the most out of relationships with physicians and healthcare professionals through relationship building, whilst supporting prescribers with education and professional development.

Quintiles has worked on more than 39 Medical Science Liaison (MSL) projects and 13 vacancy management projects since 2006

PrescribersAppropriate prescribing means that patients can get the right drugs at the right time, helping improve patient outcomes and potentially reducing costs and workloads for prescribers.

Physicians and other healthcare professionals need to maintain their skills

Medicine is a fast-moving area, and physicians and other

healthcare professionals need to keep up to date with scientific

breakthroughs, updated guidelines and new treatments.

Quintiles can develop continuing professional development

(CPD) programs, including eLearning platforms, seminars,

presentations, online modules, workshops, study days, podcasts,

and classroom-based study. These can be tailored to meet

stakeholders’ unmet needs in specific markets.

Interactions with HCPs are harder to get than ever before

The combination of restricted sales and marketing budgets and

the increasing workload of physicians is making it harder to set

up face-to-face meetings. Quintiles can help through the creation

of customer-centric integrated multi-channel engagement (IME)

programs, making the most of different routes to prescribers.

These include digital options such as online, email and social

media campaigns, webinars, and apps, as well as traditional

routes including conferences and thought-leader engagement.

Supporting stakeholders is increasingly important

Supporting healthcare professionals is an important part of

market access, ensuring that they have the information that

they need to support their patients in the best possible way.

Quintiles can help companies to provide this support, aided by

Medical Science Liaisons and Market Access Managers. These

individuals have specific therapeutic expertise and experience

with national and subnational reimbursement regulations, and

can communicate scientific and medical information to healthcare

professionals and other stakeholders on a peer-to-peer basis.

Quintiles understands the importance of local guidelines and

regulations covering relationships with stakeholders and remains

fully-compliant at all times.

Creating better treatment pathways

Problems with treatment pathways, such as increased waiting

times, can block patients’ access to treatment, and may have an

impact on adherence. Through its pathway mapping and simulation

modeling expertise, Quintiles can improve services and reduce

barriers, making outcomes better for both staff and patients.

Understanding drug adherence

in the real world

In clinical trials, the way that patients take their drugs is closely

monitored; however, out in the real world, patients may not

take the drugs in the right doses at the right times, or may stop

treatment because of adverse effects. Quintiles can help patients

to comply with treatment regimens by putting patient support

programs in place, including health system navigators, nurses,

patient education programs, and digital patient communities.

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PatientsMaking sure that patients can get access to drugs when they need them, and can use them appropriately, is a key target for market access programs.

Your patient challenges

• Creating better treatment pathways

• Understanding drug adherence in the real world

By creating patient access and patient support programs, Quintiles can improve patients’ ability to access and use drugs, improving their health and outcomes.

>19Mpatients in observational and quality improvement programs in >100 countries since 2004

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Contact usDirect: +44 203 564 4649Website: www.quintiles.com Email: marketaccess@quintiles.com

About QuintilesQuintiles (NYSE: Q) helps biopharma and other healthcare companies improve their probability of success by connecting insights from our deep scientific, therapeutic and analytics expertise with superior delivery for better outcomes. From advisory through operations, Quintiles is the world’s largest provider of product development and integrated healthcare services, including commercial and observational solutions. Conducting operations in approximately 100 countries, Quintiles is a member of the FORTUNE 500 and has been named to FORTUNE’s list of the “World’s Most Admired Companies.” To learn more, visit www.quintiles.com.