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October 2014 A FirstWord Dossier Report Patient Assistance Programs: Payer and Pharma Perspectives ES | SAMPLE PAGES | SA
October 2014
A FirstWord Dossier Report
Patient Assistance Programs: Payer and Pharma Perspectives
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Patient Assistance Programs: Payer and Pharma Perspectives
Published October 2014© Copyright 2014 Doctor’s Guide Publishing Limited
All rights reserved. No part of this publication may be reproduced or used in any form or by any means graphic, electronic or mechanical, including photocopying, recording, taping or storage in information retrieval systems without the express permission of the publisher.
This report contains information from numerous sources that Doctor’s Guide Publishing Limited believes to be reliable but for which accuracy cannot be guaranteed. Doctor’s Guide Publishing Limited does not accept responsibility for any loss incurred by any person who acts or who fails to act as a result of information published in this document. Any views and opinions expressed by third parties and reproduced in this document are not necessarily the views and opinions of Doctor’s Guide Publishing Limited. Any views and opinions expressed by individuals and reproduced in this document are not necessarily the views and opinions of their employers.
Cover image: © everythingpossible - Fotolia.com
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All Contents Copyright © 2014 Doctor’s Guide Publishing Limited. All Rights Reserved
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Patient Assistance Programs: Payer and Pharma Perspectives
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ContentsExecutive summary .............................................................................................................................. 1
PAPs were originally recognised as a charitable move by industry to provide access for needy patients ................................................................................................... 1
The introduction of co-payment cards changed the way in which PAPs are perceived by payers ...............................................................................................................2
Payer engagement in the development of PAPs is limited ............................................................3
PAPs that deliver on outcomes will be favoured in the future ......................................................4
Research objectives and methodology .................................................................................6
Patient Assistance Programs overview .................................................................................8
What are patient assistance programs? ............................................................................................8
Why are patient assistance programs needed? ..........................................................................8
Different types of patient assistance programs ...............................................................................10
Non-industry patient assistance programs..................................................................................14
Eligibility and enrolment requirements .........................................................................................15
Payer opinions on Patient Assistance Programs .........................................................20
Payers recognise PAPs deliver benefits to those patients in financial need .......................... 21
The high cost of specialist products means patient assistance is often necessary ..............................................................................................................................23
Payers are concerned about patients who would “fall between the gaps” without PAPs ............................................................................................24
Payers have several concerns with patient assistance programs ............................................26
A key criticism is that PAPs are being used to avoid formulary restrictions ......................26
Sampling is also seen in a negative light ................................................................................28
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Patient Assistance Programs: Payer and Pharma Perspectives
Some payers are concerned that patients are being misled by PAPs ................................29
Some payers feel that, in the longer term, PAPs are more costly for the health system ...............................................................................30
Payers are cynical as to the genuine reasons for PAPs .............................................................. 31
PAPs are seen as a way to ensure product uptake.................................................................. 31
Several payers believe PAPs are a “backdoor” route to market access ............................32
PAPs are also viewed as a mechanism of maintaining inflated prices ...............................33
Industry opinions on Patient Assistance Programs ...................................................35
There are a number of key benefits that pharmaceutical companies gain from PAPs ........36
Ensuring widespread patient access to drugs is a fundamental reason for implementing PAPs ......................................................................................................................36
PAPs are now seen as essential in order to maintain competitiveness in increasingly crowded markets .................................................................................................... 37
The patient benefits that PAPs deliver are also a driver for industry ...................................38
Compliance is a driver for industry – but for different reasons to payers ......................39
The use of products that would otherwise be limited is seen as the payers’ key objection by industry ........................................................................................................39
Patient and competitive benefit are seen as the main reasons for pharmaceutical companies running PAPs ........................................................................................ 41
Payer-pharma engagement .........................................................................................................43
Payers have limited decision-making responsibilities for PAPs .................................................43
Pharmaceutical companies will inform payers of their planned PAPs .....................................45
Payers need a basic range of information about PAPs ................................................................ 47
Flexible and ongoing interaction would be useful for payers ......................................................48
PAPs that provide information on outcomes would be favoured ..........................................49
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Patient Assistance Programs: Payer and Pharma Perspectives
Future outlook ........................................................................................................................................53
The numbers of PAPs, and patients accessing them, is expected to continue to grow ...........................................................................................................53
Payers expect a rise in regulation around PAPs ............................................................................55
Continued distrust of PAPs will be the main challenge faced by manufacturers ..................56
Payers expect the management of PAPs to become more challenging .................................58
The provision and analysis of data and outcomes is vital for payers ..................................58
Industry also expects PAPs to change in the future ......................................................................60
Contributors .............................................................................................................................................63
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Patient Assistance Programs: Payer and Pharma Perspectives
Research objectives and methodologyThis FirstWord dossier report provides a qualitative analysis of key trends, issues and challenges in relation to Patient Assistance Programs (PAPs) and how these could evolve in the future.
The information for this report was gathered from multiple sources, including in-depth secondary research across multiple publically available sources of information and primary research that involved in-depth telephone interviews with five US payers and two pharmaceutical industry executives based in the US.
The payers were selected on the basis of their national, regional and local decision making responsibilities. The objectives of the interviews were:
nUnderstand how payers view PAPs
nUncover what the advantages and disadvantages of PAPs are
nEvaluate whether payers believe that PAPs actually cost the health system more money, or vice versa
nDetermine what factors influence payer decision making when it comes to the support of PAPs
nUncover when pharmaceutical companies should start engaging with payers in relation to PAP development and implementation
nUnderstand what, if any, data pharmaceutical companies need to present to payers in relation to PAPs
nEvaluate what the specific future challenges of PAP development and management in the US will be
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Patient Assistance Programs: Payer and Pharma Perspectives
The Industry Executives work for leading pharmaceutical companies and are based in the US with experience in patient assistance programs. The objectives of these interviews were:
nUnderstand how industry views PAPs and how this compares with payers
nDetermine the key drivers of developing and implementing PAPs
nUncover views and perceptions about PAPs, particularly in relation to market access and product use
nEvaluate future trends and how the PAP space is expected to evolve in the US
FirstWord Dossier’s research is guided by the needs of its clients. Our aim is to uncover and convey insights and new thinking on issues that are at the top of pharma agendas.
Recent projects have examined KOL relations, market access, pharma and mobile technologies, social media, MSL compliance, payers, sales force innovation, e-detailing, closed-loop marketing, marketing excellence, and others (for a full list, go to www.fwreports.com).
To ensure that future research continues to address subjects that are of most importance to our customers, we would welcome hearing your suggestions for topics that in your view demand FirstWord Dossier’s attention over the coming months.
If your idea is selected as a topic for one of our future reports, we will be pleased to provide you with a complimentary copy of the report on publication.
Please click here to send your ideas to the FirstWord Dossier Research Team. We look forward to hearing from you.
CALL FOR TOPICS
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Patient Assistance Programs: Payer and Pharma Perspectives
Different types of patient assistance programsThere are several different types of pharmaceutical industry-run programs, with the main ones being:
nFree drug – medication is shipped directly to the program participant
nCoupons - discount coupons that are redeemed directly with the pharmacy or manufacturer
nCo-pay assistance – the PAP has a direct relationship with the pharmacy and the discount that has been agreed for the specific drug is applied at the point of purchase
nRebates / reimbursement - where medication costs, or a percentage of the costs, are reimbursed after purchasing and providing receipt
nSampling – physicians provide a limited amount of free drug to the patient
With the exception of sampling, each of the PAPs generally offer the same thing – an incentive for a patient to choose a particular product as they are able to obtain it at a greatly discounted price. However, the eligibility criteria and method of accessing the PAP varies slightly. Coupons are widely available online and in the printed press and can be taken into a pharmacy and exchanged for a particular product. Drug coupons reduce out-of-pocket costs for patients in a variety of ways, such as instant savings offers, free trial offers and discounts. Some drug coupons may only be used once, while other drug coupons may be reused. Coupons tend to be used in therapy areas where there is a lot of competition, particularly if there are generic competitors, and companies frequently use them to encourage patients to try a new product when it is launched. Coupons are viewed positively as, without exception, they require a valid prescription written by a licensed physician and are dispensed by a registered pharmacist in order for the offer to be fulfilled. This protects patient safety, as the dual layer of professional scrutiny ensures that the drug product has been properly stored, is not expired, is dosed correctly in an age-appropriate fashion and that the patient's medication history has been checked to avoid drug interactions. However, coupons are not without their critics. Several unions have filed lawsuits seeking to ban coupons as they could be viewed as illegal kickbacks. However, as of June 2013, three of these lawsuits have been dismissed while a further six are pending. In addition, payers have mixed views on coupons, which is discussed in more detail in subsequent sections of this report.
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Patient Assistance Programs: Payer and Pharma Perspectives
Table 1: An overview of PAPs by the leading companies in the US7
Company Program Name Assistance offered
Pfizer Pfizer RxPathways Provides eligible patients with a range of support services, including insurance counselling, co-pay assistance and access to medicines for free or at a savings
Sanofi-Aventis Sanofi Patient Connection
Reimbursement Connection – helps patients to determine if they qualify for a prescription drug insurance benefitPatient Assistance Connection – provides free prescription drugs to patients who do not have insurance coverage and who meet program eligibility requirements
Novartis Patient Assistance (Now; Foundation Enrollment and for Medicare)
Now – helps with reimbursement or co-pay for selected Novartis drugs Foundation Enrollment – provides free access for those with no insurance coverage
GlaxoSmithKline GSKForYou GSK Access - provides certain GSK prescription medicines for free to qualified patients who are enrolled in a Medicare Part D Prescription Drug PlanBridges to Access - provides GSK non-cancer (non-oncology) medicines — at little or no cost — to qualified patientsCommitment to Access - provides GSK cancer (oncology) and specialty pharmacy products — at little or no cost — to qualified patientsCTA Reimbursement Support Program - helps patients find reimbursement for and access to GSK oncology and specialty medicinesGSK Vaccines Access Program - provides certain GSK vaccines to adult applicants who meet eligibility requirements
AstraZeneca AZ&Me Prescription Savings program – provides medication for free for people with no insurance or for Medicare Part D patients, as well as help for those who receive their medications through participating health care facilities and those who have faced a recent financial challenge
7 Company websites
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Patient Assistance Programs: Payer and Pharma Perspectives
Payer opinions on Patient Assistance ProgramsAs outlined in the previous section, there are several types of patient assistance program. The payers we interviewed for this report were most familiar with the programs that offer co-pay or financial assistance to patients to help them to afford their drugs. The views on PAPs vary considerably depending on the type of program, as highlighted by one US payer.
“There’s patient assistance programs, which are for patients who cannot meet certain economic thresholds and get drugs for free from pharma. I think those are great, they really help people out with some high costs diseases…Then there’s the other bucket which is co-pay assistance programs, which are pharma’s marketing tools to reduce the cost of their drugs where they have either poor formulary placement or are driving down what people pay for the product.” Executive Vice President, national PBM
However, some payers did refer, initially, to more clinical assistance programs, which are attempting to address issues such as compliance, as outlined by this US payer.
“I think of financial and I think of clinical. So the financial are more the co-pay or co-insurance, coupons, discounts, that are provided to members either to assist them if they don’t have the money. The second is more the clinical patient assistance programs which are disease management, care management, adherence, reminder calls, techniques for injection, if it’s an injectable. Those obviously we get much more involved in than on the financial ones.” Chief Medical Officer
Indeed, as several of the payers commented, the financial PAP’s are now being tied up with clinical PAPs in order to drive a more positive view and deliver tangible benefits to payers and patients. This is discussed in more detail later in the report.
Overwhelmingly, the payers we spoke to for this report had a generally negative view towards PAPs. This is driven by two main schools of thought – that pharmaceutical companies implement PAPs as they want to ensure their product is being selected ahead of competition, and in order to circumvent health insurers’ formulary processes and any resulting restrictions.
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Patient Assistance Programs: Payer and Pharma Perspectives
Payer-pharma engagement The payers that we spoke to for this report were all unanimous in their assertion that they have little, if any, involvement in the development and implementation of patient assistance programs.
“We really don’t get involved with them because - depending on type of coverage - now if you have a public assistance plan called the Medicaid Plan there’s no out of pocket for the member. So those programs don’t mean anything. If you have commercial insurance, the health insurance companies don’t interact with those programs because they don’t really help out what they’re trying to do.” Health plan medical director
Payers have limited decision-making responsibilities for PAPsMost of the payers commented that they have no real role when it comes to decision-making around PAPs. The reasons for this can be varied. As the Health plan medical director highlighted “we’re not involved in them because we’re not in favour of them period. I’m involved in programs to get people to take the right medicines for their disease and improve adherence without telling them that they needed Januvia as opposed to a different diabetic medication.”
If payers do play any role in PAPs, it is generally on a more practical level rather than influencing their structure or how they are used. As this Chief Medical Officer explained “generally we’re sort of passive on them. Most of them occur or are outside of our purview because they’re more direct to consumer. Sometimes they work to our advantage, but if we are involved in the patient assistance programs, it would be how would we participate in those and whether they fit our goals and product design.” Payers will evaluate the PAPs that are being offered to their members and make assessments as to how they are likely to affect the insurer and their budgets.
“We don’t have an internal coverage at all determination for patient assistance, but what we do is we monitor websites and journals to see if there are any types of PAPs out there for non-preferred agents to make sure we mitigate exposure to it.” Pharmacy director, national health plan
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Patient Assistance Programs: Payer and Pharma Perspectives
ContributorsnPharmacy director, government health plan
nPharmacy director, national health insurer
nExecutive Vice President of a national Pharmacy Benefits Manager (PBM)
nChief Medical Officer, Managed Care Organisation
nHealth plan medical director
nMedical director at global level for a major pharmaceutical company
nHealth Outcomes director at a US affiliate for a top pharmaceutical company
Send comments on this research to:
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